O2h Wins Erbi Award - Innovation in Enabling Biotechnology

ERBI's Innovation in Enabling Bio-Technology Award 2008 was presented to Oxygen Healthcare Ltd (O2h) at the ERBI Winter Ball held at Duxford's Imperial War Museum. This award recognises the role O2h has played in developing technologies that facilitate drug discovery and development.

"To receive recognition for innovation from an organisation that hosts the largest bio cluster in Europe makes us extremely proud," said Sunil Shah, CEO and Head of Business Development who accepted this award from Lady Archer. "O2h was incorporated in 2003 and we have grown the company organically as owner-entrepreneurs from business plan," he added.

O2h, founded by brothers Prashant and Sunil Shah, is a 4+ year old, discovery services company. Its 90 employees work from a client project office in Cambridge, UK and its operations in Ahmedabad India. The current clients of O2h include several top 20 pharmaceutical and biotechnology companies in the US, Europe and Japan. The Indian operation enables O2h to provide a high level of discovery expertise while its UK office provides project management support. O2h has set a target of becoming the 'Best Performing Discovery Services Company in the World' and has therefore set for itself the highest standards of performance with a particular emphasis on rapid interactive communications and delivery speed. The services include FTE-based synthetic chemistry, Medicinal Chemistry, Computational Chemistry, Full services lab-units and ADME.

Commenting on the award, Prashant Shah, co-founder and COO of Oxygen Healthcare said: "I am delighted that O2h has won this award, it is a recognition that drug discovery has become truly global and of the hard work the team has put into ensuring fast results for our collaborations."

Contact: Ekta Ahuja, email: info@oxygenhealthcare.com, Tel: +91-2717-250262 / 63 / 64

SOURCE Oxygen Healthcare Ltd (O2h)

The Changing Face of Biotech Venture Capital

Last weekend I participated in a healthcare panel, as part of the MIT VC Conference in Cambridge. Sitting alongside me were VCs from Polaris Venture Partners, Bain Capital Ventures and Flybridge Capital Partners.

In response to a question about how metrics are changing for VCs investing in biotech, one panelist said that the combination of reimbursement challenges and capital costs are forcing VC-backed therapeutics (Tx) companies to look much farther down the road, and become more like medical device companies. For a long time, medical device company founders have made reimbursement analysis part of the work they did before even starting a company. They would frequently deliver a package to their startup VCs, including the specific CPT (reimbursement) codes. In fact, he said, sometimes the companies started from the goal, reimbursement, and worked their way backward to a product.

Tx companies, by contrast, have started with the molecule or platform and said: “Because your uncle or my dad died of cancer, it’s a good idea to fund this and there will be a big market.” That approach is no longer good enough. In fact, VC-backed companies are often asked to (or volunteer to) put together both a mock-up of their eventual product label and an analysis of what the reimbursement landscape will look like in ten to twelve years (when the product would be commercialized).

I detect a tiny little fallacy in that approach. Here’s Polaris, one of the most successful funders of early-stage startups in history, insisting on some absurd-sounding levels of analysis from their putative portfolio companies. Therefore, I predict that Polaris will not be doing too many molecule-driven startups for a while. And if others in the industry share this approach - which I am pretty sure they do - then companies with molecules more than 2-3 years away from market need not apply for venture capital. Those deals that do get done (e.g., Proteostasis, a $45M deal that closed in Boston just before the economic crisis hit) will be evolving milestone to milestone the way that biotech startups always have.

What will happen to VC-backed biotech companies that are farther away from commercial milestones? There seems to be a general refocusing of VC activity away from new deals and toward existing portfolio companies. There are already some tough discussions within VC partnerships about which companies to keep funding and which to sell or let wither. The VCs on the MIT panels all pledged to maintain a pace of something like 80% their previous pace investing in new deals.But given the politics inside VC partnerships, I cannot see the rate being anywhere near that. There will be too many turf wars that result in increased funding to existing companies and consequently far fewer new deals. But even that renewed focus on existing investments will not be enough to save more than 50-60% of existing companies, which will start to get sold at bargain prices in the next few months.

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Ocimum Biosolutions CEO Wins Astia and Biospectrum Awards

Ocimum Biosolutions, a leading integrated genomics company, today announced that Anuradha Acharya, CEO, has been awarded the Astia Life Science Innovators Award and the Biospectrum Entrepreneur of the Year award.

In its 4th year, the Astia Awards honor exceptional women innovators and recognize the investors and mentors who championed their success. Seven awards are presented each year within the three areas of innovators, investors and mentors.

The annual BioSpectrum Awards, which were started in 2003, recognize the exceptional contributions of the industry to the development of biotech sector in the country. The jury for the awards was headed by Varaprasad Reddy, Chairman, Shantha Biotech, and comprised Prof. Vijay Chandru, Chairman, Strand Life Sciences; Dr Shrikumar Suryanarayan, Director General, Association of Biotechnology-Led Enterprises (ABLE), Bangalore; Tapan Ray, Director General, Organization of Pharmaceutical Producers of India (OPPI), Mumbai; A Ramesh, General Partner, APIDC-Venture East, Hyderabad; Narayanan Suresh, Group Editor, BioSpectrum; and Abraham Mathew, Chief Editor, BioSpectrum.

Anu Acharya said: "It is an honor to receive these recognitions from Astia and Biospectrum. I would like to thank our global customers, partners, employees, investors and well wishers who made this happen. We will continue to hone our capabilities to provide integrated range of quality genomic solutions to our global clientele."

About Anuradha Acharya
Ms. Acharya is the founder & CEO of Ocimum Biosolutions, a global genomics outsourcing partner for discovery, development and diagnostics. The company was founded in the year 2000 and has completed 3 international acquisitions, Gene Logic Genomics from Maryland, USA in the year 2007, Isogen Life Sciences from The Netherlands in 2006 and the GD business of MWG Biotech of Germany in 2005. Ocimum today has 2000 customers worldwide and operates under 3 main business units of BioIT, BioMolecules and Bioresearch. Ocimum recently raised capital from Kubera Cross Border Fund (KUBC) for an equity investment of up to US$17 million (including the pro rata investment by affiliates of Kubera Partners, LLC, the Investment Manager of KUBC). Ocimum was previously financed by the International Finance Corporation (IFC), the private Equity arm of the World Bank.

Prior to founding Ocimum Biosolutions, Ms. Acharya has had rich experience in the Telecom, IT and entrepreneurship arenas. She worked for a startup in the telecommunications space called Mantiss Information and a consulting firm called SEI Information where she helped create a social networking site for entrepreneurs. Her experience is backed by education at premier institutions like the Indian Institute of Technology at Kharagpur, India (IIT) and University of Illinois where she has two Post Graduate degrees in Physics and MIS.

She is a regular in technology forums and round tables and one of the well known first generation entrepreneurs in the Indian life-sciences space. She was named by Red Herring Magazine to the list of "25 Tech Titans under 35" in 2006. Ocimum has received several awards including "Fastest Growing Life Sciences Company in India", Red Herring Asia 100, "IT Innovation Award" by NASSCOM and has been named to the Deloitte list of Fastest Growing companies in Asia, four years in a row.

About Ocimum Biosolutions
Ocimum Biosolutions is a leading integrated genomics company providing comprehensive genomic reference databases, life science lab information management solutions, GLP-compliant microarray services and essential research consumables. Over 2/3rd of the top 25 pharma companies, leading research institutes and emerging biotech companies worldwide have chosen us as their preferred outsourcing partner and utilize our expertise for understanding underlying mechanisms of diseases, discovery and prioritization of gene targets and biomarkers.
We are a preferred outsourcing partner for providing integrated biorepository and genomic services for several global pharmaceutical companies. Our global infrastructure, standardized procedures, capacity, expertise and highly skilled staff support drug development programs from pre-clinical target development and toxicogenomic assessment to clinical biomarker identification and patient stratification. In creating the world's largest commercial gene expression databases - BioExpress(R) and ToxExpress(R), we have developed expertise and capabilities that are unparalleled in the genomic services industry. Our specialty LIMS solution, Biotracker(TM) caters to the growing needs of core labs in global companies and research centers involved in Life Science Research. We provide multiple GLP-compliant platforms for gene expression and SNP genotyping data generation. We also provide full biorepository and genomic services support for the Genetic Alliance, which is an umbrella organization representing ~600 genetic advocacy groups. Besides providing the physical infrastructure for storing thousands of biological samples, we provide services to assist sample accrual, IRB approvals, CRO training, sample collection, clinical data capture and management.

For more information, please visit www.ocimumbio.com www.genelogic.com.

SOURCE: Ocimum Biosolutions

Food crunch leading more nations to relax resistance to biotech crops

Zeng Yawen’s outdoor laboratory in the terraced hills of southern China is a trove of genetic potential — rice that thrives in unusually cool temperatures, high altitudes or in dry soil; rice rich in calcium, vitamins or iron.

“See these plants? They can tolerate the cold,” Zeng says as he walks through a checkerboard of test fields sown with different rice varieties on the outskirts of Kunming, capital of southwestern China’s Yunnan province.

“We can extract the cold-tolerant gene from this plant and use it in a genetically manipulated variety to improve its cold tolerance,” Zeng says.

In a mountainous place like Yunnan, and in many other parts of the developing world, such advantages can tip the balance between hunger and a decent living. And China now is ready to tip that scale in favor of genetically modified crops.

Surging costs, population growth, drought and other setbacks linked to global climate change are pressuring world food supplies, while soaring prices on the street have triggered riots and raised the number of people going hungry to more than 923 million, according to U.N. estimates.

Growing incentive

With food demand forecast to increase by half by 2030, the incentive to use genetic engineering to boost harvests and protect precious crops from insects and other damage has never been greater.

In Europe, Africa and Asia, governments that have resisted imports of genetically modified foods and banned growing such crops are loosening those restrictions. Meanwhile, they are pushing ahead faster with their own research, despite lingering questions over the safety of such technology.

“Influential voices around the world are calling for a re-examination of the GM debate,” says C.S. Prakash, a professor of plant molecular genetics at Alabama’s Tuskegee University. Biotechnology provides such tools to help address food sustainability issues.”

Genetic manipulation to insert desirable genes or accelerate changes traditionally achieved through crossbreeding can help make crops resistant to insects and disease or enable them to tolerate herbicides. Livestock similarly can be altered by inserting a gene from one animal into the DNA of another.

Many researchers think such methods are essential for a second “green revolution,” now that the gains from the first, in the mid-20th century, are tapering off.

Bioengineered crops are widely grown in Canada, Argentina and the United States, where nearly all soybeans, most cotton and a growing proportion of corn are designed for tolerance to herbicides or resistance to insects. A virus-resistant GM variety of papaya is commercially grown in Hawaii and China.

Ag of the future

Biotechnology is bound to play an important role in the agriculture of the future, Robert Zeigler, director of the International Rice Research Institute, says.

Such crops “bring tremendous power and advantages to producers and consumers,” Zeigler says, noting the potential savings from reduced use of farm chemicals and of fuel for the tractors to spread them.

After delaying the long-

expected commercialization of GM grains for years, China’s leaders in July endorsed a 13-year, $2.9 billion program to promote use of genetically altered crops and livestock. Beijing is on the verge of releasing an insect-resistant rice variety, Zeigler says.

Chinese Premier Wen Jiabao is a champion of the new agriculture.

“I strongly advocate making great efforts to pursue transgenic engineering. The recent food shortages around the world have further strengthened that belief,” Wen recently told Science magazine.

He praises the benefits — higher farm incomes and reduced use of pesticides — from widespread use of so-called Bt cotton engineered to prevent bollworm infestations.

Global reach

The trend extends beyond China: Worldwide cultivation of bioengineered crops has expanded by more than 10 percent a year for a decade, although by 2007, it still had reached only 282 million acres, an area about the size of Cuba, in 22 countries.

Vietnam is pushing ahead with an ambitious program to develop commercial GM crops to reduce reliance on imports. In May, South Korea, which already imports GM soybeans, began importing bioengineered corn to help bridge shortfalls of conventional corn after China began limiting its exports.

Brazil’s National Biosafety Commission recently approved two new varieties of genetically modified corn seeds, after giving the green light two years ago for GM varieties of soybeans. India has followed China’s example, tripling acreage of GM cotton, the only bioengineered crop it allows.

In Africa, where governments sometimes have rejected food aid shipments containing GM grains, South African scientists have completed field tests of a potato developed to fend off tuber moths. They also recently approved trials of sorghum genetically enhanced to improve the digestibility and nutritional content of the coarse grain, which thrives in arid soils.

Tests ongoing

European countries face growing pressure, under World Trade Organization rules, to open their markets to GM products. Many among the EU’s 27 member nations remain wary and, backed by consumers opposed to what some call “Frankenfoods,” are fighting to keep genetically altered crops out of their fields and supermarkets.

“Why should we change what nature has given us, when it is everything we need?” Filippo De Angelis says. “I don’t think we can solve the problem of world hunger through genetics.”

Even in China, despite its hefty investments in the research, few are familiar with genetic modification. Some who have heard of it remain cautious.

“It’s impossible to know if it’s harmful to the body,” says Zheng Wencai, a retired architect in Kunming shopping for soybeans in a downtown market. “There is still a global debate on this. So basically, I don’t use it.”

Besides papayas, China allows farmers to grow GM varieties of green peppers and tomatoes, along with several nonfood crops. But genetically modified rice and wheat are still in field tests.

Those test facilities are kept under high security, both to prevent contamination of non-GM crops and to protect the country’s own GM technology. Beijing seems determined not to cede its potentially huge local markets to big agribusinesses like the U.S. company Monsanto and Switzerland’s Sygenta AG.

“In general, the government has a very positive view toward GM technology and its products,” says Lu Baorong, a member of the National Biosafety Committee, whose desk at Shanghai’s prestigious Fudan University was piled with GM rice seed samples to be tested on Hainan, a tropical southern island.

“Since China is a big country and we have so many people to feed, to have our own technology and guarantee food security is very important,” Lu says.

He won’t speculate on a timeline for commercial approvals of GM rice.

Ultimately, widespread cultivation of such crops will depend on work done at IRRI and by researchers like Zeng, who have spent years painstakingly searching for traits that might unlock the secrets to future abundance.

Zeng views genetic engineering as just one of many strategies, including irrigation and soil improvements and better farm management, needed to increase productivity to ensure future generations will have enough to eat.

“Without all these, it will be very hard to boost output further. There will be breakthroughs, but it will be very hard,” he says.

Editor’s Note: Associated Press writer Paul Alexander in Manila and AP researcher Ji Chen in Shanghai contributed to this report.

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BioQatar: Luring Biotech Dollars to the Desert

It is not every day that one attends a conference where the housekeeping announcements include the location of the prayer room or the moderator is a television news anchor with Al Jazeera. But it is not every day that a tiny Arab principality decides to make a concerted effort to woo foreign biotech and capital investment. Judging by the delegates and proceedings at the BioQatar 2008 symposium*, Qatar is well on its way.

Qatar is a tiny nation nestled between Kuwait to the north and the United Arab Emirates to the south. The 200,000 native Qataris are outnumbered 3:1 by foreign workers from countries such as India and the Philippines. While the newly opened Museum of Islamic Art, designed by I.M. Pei and sitting majestically on its own island in the Doha Corniche, is certain to draw throngs of visitors, the Qatar Foundation (QF) has its sights on modern science and medicine rather than antiquities. “Our goal is to become the scientific center of excellence in the Middle East, and rekindle the reputation for learning in the region from several centuries ago,” said QF president Fathy Saoud.

The country has already fostered close ties with several US universities, including Georgetown, Carnegie Mellon, and Texas A&M. Last May, the Weil Cornell Medical College in Qatar, on the sand-swept outskirts of Doha, proudly saw its first class of 15 medical students take the Hippocratic Oath before starting their residencies in the US. Cornell is the first American university to offer its MD degree overseas, with the same admission standards and curriculum as the parent institution. The Qatar school has enrolled students from more than 30 countries, and boasts enviable e-learning technologies, with lectures regularly streamed live from Ithaca to Doha. In all, Doha’s Education City boasts 70 nationalities among its faculty and students.

Saoud said a priority was to build a reputation for research excellence and culture. “Education is not enough on its own,” he said. “We must become generators of knowledge, not just consumers of it.” To that end, the Emir of Qatar has dedicated 2.8% of the nation’s GDP to research and technology. Given that Qatar is the world’s third largest producer of liquefied natural gas, Saoud was being a tad modest when he noted that was “a very credible proportion by international and regional standards.”

Three Pillars

Qatar is seeking to attract investors in fundamental and applied research, and technology development, focusing on three areas: energy, the environment and biomedical research. There was talk of advancing personalized and predictive healthcare, bringing academic health sciences closer to hospital practice and delivery at the bedside and raising the standard of healthcare throughout the country. The two major health problems facing Qatar are cancer and diabetes, with speculation that the country’s high levels of consanguinity – one in two to one in three marriages are between first cousins – might contribute to the disease prevalence.

The BioQatar symposium attracted an impressive list of speakers, including outgoing NIH director Elias Zerhouni, Nobel laureate and stem cell pioneer Sir Martin Evans, and one of the UK’s best known venture capitalists, Sir Christopher Evans (no relation). Zerhouni gave an overview of global medical and research priorities, talking about the shift from acute to chronic diseases; the impact of an ageing population on the frequency of neurodegenerative diseases; the threat of re-emerging infectious diseases; the new mechanistic understanding of disease; and the new paradigm of the 4 P’s – predictive, personalized, participatory and preemptive medicine.

Speaking in a thick Welsh accent, Christopher Evans must have ingratiated himself to his hosts by pointing out that “medical science literally started here – Islamic medical science was fantastic 1000 years ago.” The first vaccine and the first pharmacies were developed in the Middle East, he said, but “Islamic medical science got lost somewhere in the past 1000 years,” while Europe moved out of the Dark Ages.

Whether Evans’ firm Excalibur (a successor to Merlin Ventures) will charge to the rescue remains to be seen, although his post-conference private audience with Her Highness Sheikha Mozah signals genuine interest. Evans says he is excited about building one or two local biotech companies in Qatar and stimulating US and European investment. He is poised to open a major office in Doha.

His resume speaks volumes: the venture fund has built 45 medical companies, developed 200 novel medicines, and a net worth of some $7.5 billion. “Our firms have saved many lives,” he said. Evans said Qatar’s future looked fantastic, but it “must cover the whole waterfront – don’t specialize in cancer or diabetes.” He praised the facilities currently under construction, and said it was important for Qatari students to travel before returning home to establish businesses.

Qatar’s health minister, Ghalia Al Thani, discussed the country’s priorities: diabetes is rampant, the median age is 76 and improving, but a major cause of premature death is something more mundane: traffic accidents (299 in 2006) and workplace injuries. Consanguineous marriages (54%) were being addressed from social and medical aspects. Smoking (42% men) and obesity, especially in children, are also concerns.

The director of Qatar’s Science and Technology Park, Eulian Roberts, said that the country’s flagship teaching hospital, the 380-bed Sidra Medical and Research Center, will be finished by 2011. “Cooperation is essential to help Qatar become recognized as a hub for research, innovation and entrepreneurship,” he said. The Science Park is a truly 21st century conglomeration of new construction surrounding a massive convention center, seeking to lure biotech companies to join the likes of Shell and Conoco-Phillips as the first tenants. Companies such as GE Healthcare and Microsoft already have a presence in Qatar, and there is much activity in areas such as biobanking, proteomics, and digital imaging.

On the Move

One scientist-entrepreneur who is definitely moving to Qatar is John Hassard, co-founder of deltaDOT. He’s launching a subsidiary called QSP Proteomics, which will work on therapeutic/vaccine development and new technologies.

Niels Porksen talked about Lilly’s move to establish new centers outside the US, including Singapore, India, China, and possibly Qatar, where there may be greater local expertise. “We’re willing to do less in Indianapolis and more in the rest of the world….. It’s a way to get us into the future,” he said, shrugging off the recent closure of three sites in Europe. A promising model is Lilly’s Chorus program, managed by 24 staff over the past 2.5 years, has validated 18 molecules in the clinic, at a fraction of the cost of regular clinical programs.

Phillipe Froguel, a geneticist working at Imperial College, London, said that diabetes offered some of the best examples of genomic medicine success, such as the high cure rate of neonatal diabetes. Froguel is conducting a genome-wide association study in Morocco to compare the susceptibility of an African/Arabian population with the genes identified so far in Europeans.

Cornell’s Ron Crystal is an expert in gene therapy but said the very side effects experienced using adenovirus vectors could prove beneficial in vaccine development. The genetic delivery of monoclonal antibodies could provide more persistent expression and more localized concentrations for certain tumors. A good candidate is Avastin, which causes GI perforation in a minority of patients. Another interesting application would be to bind nicotine (and other drugs) to an adenovirus to develop an anti-smoking vaccine.

Despite the enormous opportunities it presents, Qatar must overcome many hurdles to realize its ambitions. Manpower is severely limited, and an entire biomedical infrastructure must be built, including regulatory policies, animal facilities, and safety standards. Conference attendees cautioned that the country’s goals may prove too far-reaching. And there was precious little sign of collaboration with other Arab nations, which could prove a fatal mistake.

But Evans sees strong parallels between Qatar today and the UK in the early 1990s, when biomedical companies began to make a splash in the markets. It was important for Qatari scientists to receive incentives to train abroad before returning home, where their research and businesses can help the clinical community. “I’m very pro Qatar,” said Evans. “Think selfishly for five years and globally thereafter.”

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Spain Invests in Quest for Big Biotech Payoff

This year’s “BioSpain08” conference in Granada exposed the Spanish biotech industry for what it is—an industry that began way behind the starting line, but is showing evidence of growing and flourishing. Genoma España (the Spanish Foundation for the Development of Genomic and Proteomic Research) estimates that Spain is the fourth largest country in the EU-15.

According to Cristina Garmendia, the minister for science and innovation, Spain is enjoying growth of over 25% a year in the biotech sector in terms of job creation, attracting investment, and increase in sales and exports.

This increase in activity is due largely to Spanish government investments via its Ministry of Education and Science and Ministry of Health and Consumers.

By increasing subsidies for R&D and scientific infrastructure by over 200% from 2000–2006 and spending more than one billion euros a year since 2006, many biotech companies have been encouraged to spin off from government institutions and large Spanish pharma companies.

To sustain this growth, the Spanish government has put in place the Ingenio 2010 Program, an initiative involving government departments, universities, and other research agencies to ensure that by 2010, Spain is spending 3% of its GDP on R&D, which will indirectly benefit its biotech industry.

The investment in infrastructure in the past decade has resulted in a number of bioparks springing up all over the country, with some of Spain’s most promising biotechs being housed at the Parc Cientific de Barcelona, Parc de Recerca Biomedica de Barcelona, or Parque Tecnologico Madrid. There are also good networking groups such as BioMadrid, (the Association of Biotechnology Companies of the region of Madrid), and Biocat (BioRegió de Catalunya) serving companies in Barcelona and the Catalonia region.
Full of Promise

Among the shining stars of Spanish biotech is Madrid-based Cellerix, a spin-off from Genetrix, a group of biotech companies that began activities in 2001 at the National Center for Biotechnology.

Cellerix is developing adult stem cells from adipose tissue to treat conditions caused mainly by autoimmune diseases. The firm has two products in clinical trials.

The lead product, Cx401 (which will be marketed in Europe as Ontaril®), consists of adult stem cells isolated from patient’s adipose tissue. It is being evaluated in Phase III trials to treat complex perianal fistulas in patients without inflammatory bowel disease and in Phase II trials for complex perianal fistulas associated with Crohn’s disease. So far results have been promising. According to Eduardo Bravo, CEO of Cellerix, Ontaril is well positioned for approval in the EU by 2011, and because it treats a highly niche indication it should achieve high-product margins.
Memory-Enhancing Drugs
The Parc de Recerca Biomedica de Barcelona, an initiative of the government of Catalonia, the city council of Barcelona, and the Pompeu Fabra University, is physically connected to the Hospital del Mar de Barcelona.


In his keynote speech at BioSpain, Steve Burrill, CEO, Burrill & Company, commented, “With an increasingly aging population it will become more important to develop memory-enhancing drugs. Spanish biotechs should begin now, and they’ll have a market for them in 2020.”

This is exactly what Madrid-based Noscira, formerly Neuropharma, is doing. The company is a spin-off from Zeltia. Its focus is on using the library of marine compounds isolated by PharmaMar to look for compounds to treat neurodegenerative diseases. Using this library, Zeltia has isolated several promising drug candidates and currently has two (NP-12 and NP-61) in clinical development to treat Alzheimer’s Disease.

“Just as PharmaMar has found the anticancer treatment, Yondelis, we’re hoping to do the same for diseases such as Alzheimer’s,” said Alfonso Hurtado de Mendoza, CFO of Noscira. “There is a great need to find drugs that are effective at halting or stopping disease progression, as many new compounds are failing in trials. Additionally, with several current drugs on the market due to lose their patents in 2009, there will be a flood of generics. We should be developing new drugs for this market.”

According to Hurtado de Mendoza, NP-12 is the only GSK-3 enzyme inhibitor in trials. It has an innovative mechanism of action which works well to slow disease progression in all four transgenic Alzheimer’s Disease animal models the company has used.

“NP-12 essentially reduces tau protein phosphorylation to prevent neurofibrillary degeneration in the brain,” Hurtado de Mendoza explained. “It has just completed Phase I trials and is now entering the recruitment stage of Phase II studies. We intend to out-license U.S. marketing rights to NP-12 but would like to retain European rights to market this compound. Our intention to outlicense has triggered significant international interest, so we are hopeful that we can move forward with this compound. Since our other compound, NP-61 works to inhibit b-amyloid peptide secretion we have a well-balanced pipeline for Alzheimer’s Disease treatments,” concluded Hurtado de Mendoza.

Another Spanish biotech working in this field is Barcelona-based Oryzon, a spin-off from the Spanish National Research Council and the University of Barcelona. The firm, originally set up in 2000 as a biomarker discovery company, supplied these services to various pharma and biotech companies and became a revenue-generating business in 2005. Oryzon is one of the largest biotech companies in Spain with more than 60 scientists.

Carlos Buesa, Ph.D., CEO, commented, “We have a strong appetite for partnerships, so we have many clients. We are also lucky enough to have access to a large collection of primary tumor and tissue samples from Spanish hospitals from which we have identified biomarkers.”

“We are developing an NCE for neurodegenerative diseases as we have a number of good biomarker targets that we believe are unique,” Dr. Buesa added. “We’re using NCEs rather than mAbs due to the difficulty of getting a mAb across the blood brain barrier, but the new targets identified in our oncology biomarker discovery program are being targeted either by NCEs or by mAbs.”

The company intends to invest s20 million in developing therapeutics and associated diagnostics for oncology and neurodegenerative diseases, which they will take to Phase I and then outlicense, according to Dr. Buesa.

Business Challenges

With less than 30 drugs in the clinical stages of development, according to ASEBIO’s (The Spanish Association of Bioenterprises) latest figures, Spain’s biopharma industry is still in its infancy. This is especially true when you compare this to the U.K., where ERBI (Eastern Region Biotechnology Association) estimates that in just the Cambridge biocluster alone, biotechs have 20 products in clinical development for cancer and related indications.

Speakers and delegates at “BioSpain” did cite a number of issues Spanish biotechs still have to deal with if the country is to increase its drug output.

Steve Burrill observed,“In Spain, they’ve filled every available parking lot with a science park, so I don’t doubt the government’s commitment to building the infrastructure, but it’s now up to Spanish commerce to make sure they are developing in the right markets.”

One difficulty Spain faces is a lack of experienced and internationally focused management teams to help commercialize the research properly.

“It is very difficult, even when you have the money to find the right people,” stated Dr. Buesa. “We have found that we have to transmit enthusiasm, show we have all the IPs covered, and stake a claim that we’re going to be leaders in this field in order to attract those commercially astute people working in large pharma who are brilliant but bored. We have to convince them that joining a Spanish biotech is not a kamikaze action.”

As many Spanish biotechs are relatively late to the party, they are finding some areas difficult to break into because of their patent position. For example, Sylentis is developing siRNA based drugs to treat glaucoma and inflammatory bowel disease.

“Since RNAi is heavily protected in cancer, we’ll leave this area to the big boys. But, as it is not sewn up so tightly in niche indications, we can still score here,” observed Eduardo Gómez-Acebo, director at Sylentis. “We have approximately 20 sequences with strong IP protection. All investors want to know about is our freedom to operate in this field before they will think about partnering with us.”
Adopt a Global Outlook

One of Spanish biotech’s biggest challenges is the ever present lack of funding.

“Noscira has invested s48 million in research on diseases of the nervous system since it was created in the year 2000, but it still needs funding,” commented Hurtado de Mendoza. “The company was renamed in September in preparation for an IPO but we are now looking for alternative international finance while we wait for market conditions to be more favorable.”

Burrill added that, “the biotech industry is bigger than Spain, but Spain has traditionally relied on internal funding via Spanish investors and IPOs. At our company, we receive between 1,000–2,000 business plans for funding every year and last year we had only one from a Spanish biotech. We’ll invest in the best technology, no matter where it comes from.”

“Spanish biotechs may not be able to access enough to fund the massive amounts they will need to push many of these compounds to market by continuing to look locally,” Burill warned. “In fact, if they continue to build their drugs in a parochial environment, they will fail. So the challenge is to raise international finance and not look to local IPOs to raise the cash.

“Disease knows no borders and even the smallest Spanish biotech has to be global in its outlook from day one or it will never thrive.”

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Lower-cost drugs predicted under Obama administration

Cheaper drugs could be on the way to U.S. consumers under the Barack Obama administration.

"We are likely to see some movements with prescription drugs and pricing," said David Dranove, professor of health industry management for Northwestern University's Kellogg School of Management.

The reason: President George W. Bush blocked, or allowed Republican leaders to stall, several bills that would have resulted in lower drug prices. In doing so, he sided with the pharmaceutical industry, which cited safety concerns about cheaper imported drugs and worried about threats to drug company research budgets if the federal government interfered with pricing.

Now, initiatives that could lead to lower prices, which Obama supported as a Democratic senator from Illinois, are expected to gain traction with him in the Oval Office, especially since he will be backed by stronger Democratic majorities in Congress. They include proposals that would allow for cheaper copies of expensive drugs derived from biotechnology, unleashing the government's Medicare program to negotiate drug prices directly with drug companies and making it legal for pharmaceuticals to be imported into the U.S.

The larger Obama push aimed at providing health benefits to more than 45 million uninsured Americans is seen as too costly, complicated and difficult to achieve in the first year of his administration, particularly given the country's financial crisis and massive deficits run up in part by wars in Iraq and Afghanistan. Congressional proposals have been emerging, but it is unclear how far they will go.

"There are many other demands on the federal purse strings, and [health-care reform] requires a lot of new bureaucracy that will be tough to accomplish," Dranove said. "But there is low-hanging fruit, and they have been hanging there [in Congress] for some time and will be easy sells and easy to get through."

Lowering drug prices could hurt profits and stocks of companies such as North Chicago-based Abbott Laboratories and Deerfield-based Takeda Pharmaceuticals North America, analysts say.

In particular, both companies could be weakened if import restrictions are lifted on some commonly used drugs that they manufacture outside the U.S. Examples include Abbott's Tricor cholesterol pills and Takeda's Prevacid for severe heartburn. Some experts believe that imported brand-name drugs could be priced more like generics, which are generally 50 percent to 80 percent cheaper.

Supporters of importation say it makes no sense for U.S. consumers to pay more for the same pills made in countries where U.S. companies have foreign-based manufacturing plants that meet Food and Drug Administration standards. The difference in pricing can reflect lower wages paid in countries such as Ireland and India.

But the drug industry's trade group, the Pharmaceutical Research and Manufacturers of America, contends that imports could undermine drugmakers' ability to fund expensive research and development.

So far, the FDA under Bush has blocked importation, and Congress has not changed the law to allow drugs to be legally moved across U.S. borders, with the effort largely bogged down in the Senate, where Democrats had held a one-vote majority.

Since the Democrats gained more congressional seats in the election, the pharmaceutical industry is preparing for battle.

"Clearly, we are getting prepared for anything and everything next year," said Ken Johnson, senior vice president of the industry trade group, which has opposed allowing Medicare to negotiate directly with drug firms.

"The government does not negotiate prices, it dictates prices, and that impairs our companies' ability to be innovative with the ability to develop life-saving medicines. In the end, the real losers are patients."

One area where Congress and the Bush administration had been making progress was legislation to allow competition from lower-price versions of biotech drugs.

Such a move would open the door to innovations for cancer and anemia and other treatments that are derived from human or animal cells and can cost tens of thousands of dollars a year. In the absence of legislation, biotech companies would enjoy longer patent protection because there is no regulatory pathway within the FDA to bring generic versions of biotech drugs, known as biogenerics or biosimilars, to market.

Biotech drugs were not part of the landmark 1984 Hatch-Waxman law that allowed for cheaper generics. That law largely covers products derived from chemicals, such as the cholesterol drugs Zocor and the popular antidepressant Zoloft. Many biotechnology drugs, first created in the 1980s when technology cleared the way for genetic engineering on DNA, are only now beginning to face patent expirations.

Take Epogen, which was launched in 1989 as one of the "first biologically derived human therapeutics," according to its maker, California-based Amgen Inc. Its U.S. patents are expected to expire within the next four years. Lake Forest-based Hospira Inc., a maker of generic injectable drugs and hospital products, has begun selling a biosimilar equivalent in Europe, where the regulatory process allows for generic versions of biotech drugs.

"We know that biogenerics will improve lives while saving the federal government and American consumers billions of dollars," said Hospira Chief Executive Christopher Begley.

Makers of brand-name biotech drugs, however, say they support the European regulations and want U.S. regulators to ensure safeguards and quality standards before biosimilar drugs are approved here.

"Substantial clinical trials need to be done that are based on science," said Audrey Phillips, executive director of biopharmaceutical public policy at New Brunswick, N.J.-based Johnson & Johnson.

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DNA profiling solves crimes: BIOTECH’S CONTRIBUTION to JUSTICE SYSTEM

DNA sequencer

Most commonly associated with renewable energy and genetically modified produce, biotechnology is also having a profound effect on society and, in particular, the justice system with the advent of DNA (deoxyribonucleic acid) profiling, which helps local forensic investigators solve criminal cases.

DNA profiling is a molecular testing method used to identify people or organisms by the particular structure of their DNA, which is determined to be unique to each person—like a fingerprint—and can be extracted from saliva, blood, hair and even finger- or toenails.

And while DNA testing for this purpose is “relatively” new in the country, according to Major Lito Cabamongan, one of the leading crime-scene specialists with the Philippine National Police (PNP), local enforcement agencies have already begun reaping the benefits.

“Almost 30 percent or more of [criminal] cases are being solved [now with the help of DNA profiling techniques],” the forensic investigator said partly in Filipino. He added that it was more difficult in previous times without DNA testing, as other forms of evidence were inconclusive.

He spoke to the BusinessMirror in last week’s DNA forensic training workshop for police officers that was part of the National Biotechnology Week activities.

But working behind the scenes is the DNA Analysis Laboratory in the Natural Sciences Research Institute at the University of the Philippines (UP).

Dr. Maria de Ungria, who heads the UP DNA Laboratory, said DNA is one of the most powerful tools available to Philippine investigators today.

“You’ll know who was and wasn’t there,” she said, referring to a crime. “It brings us closer to the truth, and serves as a crucial factor to reconstruct the sequence of events leading to the crime.”

She noted, however, that the UP DNA lab does not directly handle criminal cases, unless passed on to them by the PNP or by the courts, and instead focuses on the research aspect of forensic investigation.

“They [PNP and National Bureau of Investigation] have their own labs, but because of the scale of criminal cases that they have, they can’t do research,” said the former Philippine Science High School scholar.

She said their research activities take a “lot of time,” such as testing different types of evidence using several parameters, like variations in temperature, among others. Such research endeavors, she said, fall under their responsibility, being attached to an academic institution.

“We don’t go into crime scenes and we don’t handle the [actual] evidence, but if one of the [law enforcement] agencies feel they have not handled that type of evidence, they might call our lab for assistance,” she said.

Dr. de Ungria added that the UP DNA lab may step in during special cases, such as those requested by families seeking an independent forensic investigation.

In October 2007, the Supreme Court issued the Rule on DNA Evidence, which provided the guidelines on assessing the value of DNA evidence in court. It was also viewed as a precedent for reversing convictions through post-DNA testing.

Dr. de Ungria said activities intensified after the Supreme Court decision. She said the cases passed to the UP DNA lab have doubled, and they have even noted some acquittals after doing DNA testing.

She said that among rape cases in the past nine years, there have been five acquittals because it was discovered that the suspects did not share the DNA profile of the victims’ children born as a result of the crime. She said the suspected rapists spent an average of seven years in jail.

She noted that the lab is helping the government, as well, declogging jails and also preventing future abuses to human rights.

“The real perpetrators are still outside doing what they were doing before,” she said.



Budget constraints

Still, as a DNA analysis lab, carrying out research studies and bringing criminals to justice carries a hefty price tag. Dr. de Ungria said that in the past two years, they have received some P5 million a year, but it was not enough. She said equipment alone could cost several millions of pesos.

“We should be looking at P10 million, P20 million to P30 million a year,” she admitted, adding that the funds will be used to buy better equipment, making it a one-time arrangement.

She said the lab, for instance, would be an updated version of their DNA sequencer, which can only run one sample at a time, versus other newer machines which can do eight or even 15 samples.

She added that running a sample takes at least 30 minutes, which is why the lab is planning to purchase a DNA sequencer that costs P10 million that can handle eight samples.

A DNA sequencer automates the arduous task of DNA sequencing, a process where the order of nucleotides—the structural unit of DNA—is determined. DNA sequencing is credited with large advances in biological research and is an integral aspect of forensic investigation.

“We would like to have results as soon as possible. The longer we wait [for DNA results], the longer the time that person [if innocent] is incarcerated,” she said.

She added that the small number of staff is also another issue with them, because while they have at least 10 scientists manning the labs, only three are considered as permanent while the rest are classified as “contractual.”

“We look for budgets for scientists, which actually adds to the work that we are doing,” she said.



The DNA business

One way is to tap the private sector. The UP DNA lab, for instance, charges fees for paternity tests which, according to Dr. de Ungria, composes up to 50 percent of the lab’s activities today.

The lab charges P60,000 for a paternity test—which is used as evidence in court, such as in proving the legitimacy of an heir. If the test is for “private reasons,” where it will not be used in any legal forum, the fee is P40,000. The reason for this, she said, is that court cases require more scrutiny, hence, a more laborious task for the laboratory.

She also noted cases where “high-profile clients” or wealthy individuals ask the lab to have their DNA profiled and then stored. This is for possible use in the future, when, for instance, the subject is cremated or when facing other legal hurdles.

For this, the UP DNA lab charges P3,000 for five years of storage, after which the contract expires and the clients will be charged again.

For all the extra work, Dr. de Ungria, who finished her doctoral degree at the University of New South Wales in Australia, does no regret coming back to the Philippines—after 10 years abroad.

“Science should serve society. I needed to go back to the Philippines [because] I knew that I only had the opportunity to study because of taxpayers’ money,” she said.

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20 more biotech parks to come up in India: Sibal

Union Minister of Science and Technology Kapil Sibal on Sunday announced 20 more biotech parks will be set up throughout the country for promoting research in the field of life sciences.

"Setting up of new biotech parks is one of our initiatives for promoting quality research in biotechnology and its applied fields," he said in his address at the inaugural function of the Biotech Park here.

At present, besides Lucknow, there are only three "functional" biotech parks at Hyderabad, Pune and in Punjab.

Sibal also announced that in order to produce "high quality human resource", an agreement would be signed with the Welcome Trust of Britain.

"The Department of Biotechnology (DBT) will form a 10-year pact with the Welcome Trust for ensuring high quality human resource, which is one of the key elements for scientific leadership," he said.

The minister also said a regional UNESCO centre would come up in Faridabad in Haryana to help bring academia, industrialists and government officials on a common platform for promoting utility-based research.

Expressing concern over the shortage of the number and quality of human resource needed to take the biotechnology revolution forward, Sibal called the scientists to undertake research projects for countering diseases that are considered a "burden for the poor", food security, new varieties of crops, vaccines, and to mitigate industrial pollution.

He assured the state government that his ministry would seriously consider its proposal to set up five science parks and five agrotech parks in the state and invited the state science and technology minister Abdul Manan to New Delhi for talks.

Although set up in 2002, the Lucknow Biotech Park was officially inaugurated on Sunday. Spread over eight acres, the park is a joint venture of the central and the state governments, with assistance from the Council of Scientific and Industrial Research (CSIR) and the Indian Institute of Technology (IIT), Kanpur, and some other educational institutions and industries.

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Biotech breakthroughs Britain failed to exploit

One of the problems with using taxpayers' money to bail out the precariously placed banks this autumn is that other industries which find themselves troubled by the dire economy will also start knocking on the Treasury's door in pursuit of state aid.

The latest is the biotech sector. The life sciences industry is a graveyard of good ideas as, more often than not, those companies charged with making a commercial success of the ideas developed in university laboratories fall over long before the drugs get to market. It can happen for a variety of reasons, but in most cases it is the City deciding to stop funding after growing tired of setbacks and failed trials.

Enter the biotech entrepreneur Sir Christopher Evans, who last week, along with other leading players in the industry, wrote to the Prime Minister and Lord Mandelson, the Business Secretary, to ask for £500m of public money to go towards securing a future for the UK's beleaguered biotech sector.

"A lot of us have believed that we've been teetering on the edge of this abyss for too long and we are really looking down a deep, dark pit. What happens in 2009 should shape the industry forever," says Sir Christopher. "The Government has got to step in to counter a complete market failure. There is a complete failure now because there is no money anywhere. What's needed is cash – real, bold-action cash."

Every industry has had trouble attracting funds from risk-adverse institutional investors, but for biotech, this problem is particularly stark. Often a fledgling group will spend all its cash on trying to prove the efficacy of its treatments and when it runs out after an unexpected trial failure, it is forced to go back cap in hand to its investors for more money.

There are life science successes, with companies such as the critical care group BTG, which is profitable and is expected to enter the FTSE 250 in the next six months, now that its market capitalisation has topped £400m. Britain is, however, littered with examples of failure. As UK firms have found equity-raising almost impossible in the past six months, so several have collapsed and others have been teetering on the brink. Ardana, a firm that specialised in reproductive medicine, which listed in 2005, went into administration in June after burning its way through £43m of venture capital money. Within the last month, Phytopharm, a company that produces the appetite suppressant Hoodia, has said it is reviewing its future after a deal to supply Unilever with the Slimfast range of dietary products collapsed.

The phenomenon is not new. For the last 20 years or so university scientists have been encouraged to patent their discoveries, and some, such as Sir Greg Winter, the Cambridge University scientist who founded the gene sequencing company Cambridge Antibody Technology, which was eventually sold to AstraZeneca for £702m in 2006, became very wealthy.

But the UK even has a poor record for retaining the rights over those treatments that are found to work, despite its scientists winning 23 Nobel prizes in the last 40 years. Professor Sir David Lane of Dundee University, for example, is responsible for discovering BRCA1, the gene that leads to breast cancer. The find was patented in the UK, but it is the US life sciences company Myriad Genetics that now owns the intellectual property rights for the discovery.

There may be other UK success stories on the horizon, with positive trial data expected next year for Ark Therapeutics, a gene-based medicine group, and GW Pharmaceutical, which is famous for developing treatments from the cannabis plant. To date, however, only FTSE 250-listed Shire Pharmaceutical can claim to have emerged as a successful and independent UK biotech company.

Sir Christopher's bid for a biotech bailout also has a self-help element. He is asking for the Government's money to be matched by the market to "ensure substantial national focus during the next three to five years where the industry will encounter very serious difficulties".

The Department for Business and 10 Downing Street said yesterday that it is too early to respond to the request, but Sir Christopher reckons that intervention now would bear considerable fruit. "With £500m from government matched by another £500m from private investors here and a further billion or two from abroad you'd be looking at £3bn in cash that has somehow materialised from around the world, which would be invested in British companies. Gordon Brown would be a hero."

Troubled companies Good ideas but too little cash

*Skyepharma

The drug delivery system group Skyepharma has a product, in asthma inhaler Flutiform, which looks like a winner and has enabled the company to sign licensing deals with the likes of Japan's Kyorin Pharmaceuticals. Sadly, Skyepharma is saddled with £89m of convertible bonds, the terms of which it has been forced to renegotiate with bondholders over the last year. While call dates on the bonds have been pushed back to 2013 at the earliest, the group has not recovered from losing nearly 80 per cent of its value.

*Phytopharm

Last month Unilever abandoned plans to help Phytopharm develop the appetite suppressant Hoodia, based on the plant, right. The plan was to use Hoodia in Unilever's Slimfast range, but the two were found not to be compatible. While the company remains solvent and is embarking on testing other drugs, the loss of the deal led to group's value falling by 50 per cent.

*Ardana

The reproductive medicine group brought in the administrator in June after getting through £43m after listing in spring 2005. The company had some success with testosterone products, but burnt the cash too quickly and was left in the cold when it could not convince investors that it had a commercial future.

*Phoqus

A month after Ardana called in the administrators, so did the speciality biotech group Phoqus. It had desperately tried to find a partner for its promising lead product, Chronocort, used to treat cortisol deficiency. Sadly, it could not, and the company went to the wall.

*PPL Therapeutics

The company grabbed the headlines in 1996 when it cloned Dolly the Sheep, right. Others stepped up to the plate with horses and bulls following Dolly, but sadly for the groundbreaking company it went the same way as its famous exploit and collapsed in 2004.

*BRCA1Last month the European Patent Office upheld the US group Myriad Genetics' intellectual property rights over the breast cancer gene BRCA1. The discovery of BRCA1 was made by a team led by Professor Sir David Lane at Dundee University. The rights had been sold to strengthen the gene's prospects and is now lost to UK biotech.

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Tortilla chips going biotech as limits change on seeds

White corn, the variety that's milled into chips, taco shells and tortillas, has for years been free of genetic engineering. Millers and companies such as snack-food giant Frito-Lay bought only conventional, biotech-free varieties of the specialty corn from farmers.

But that's changing. Farmers in Iowa, Nebraska and other states started growing a small amount of genetically modified white corn this year after word came down from processors they would start accepting it.

"Our domestic millers have always been in favor of it," said Todd Gerdes, specialty grains manager for Aurora Cooperative, which buys white corn at three of its locations in Nebraska. The corn is sold to domestic mills and for export. "What they've always wanted to do is to make sure that they didn't accept (biotech versions) and drive away their customers."

"They've come to a comfort level where they can convince their customers it's OK."

That change of heart has opened a new business for Pioneer Hi-Bred, which offered three white varieties of its Herculex corn for the first time this year and plans to bring out three more in 2009. About 2 percent of Pioneer's white corn seed this year was genetically modified.

Virtually all of the corn grown in Iowa and nationwide is of yellow varieties and used for livestock feed, ethanol and for sweeteners and other food uses. Some 80 percent of the yellow corn seed planted this year was genetically engineered to make the plants toxic to insect pests or immune to a popular weed killer, or both.

Biotech varieties have been in the market for more than a decade, and there were even some versions in white corn in the 1990s. But industry officials said millers got spooked by the controversies that initially surrounded biotech crops, including the StarLink episode in 2000.

StarLink, a variety of biotech corn produced by a Pioneer rival, was found in taco shells and other food products without having been approved for food use.

Morry Bryant, Pioneer's key account manager for corn processing, said millers have changed their minds about biotech corn in part because of concerns about grain quality. Corn that has insect damage is susceptible to diseases that can make the grain toxic.

"When you have a healthier plant you typically have better grain quality," Bryant said. "They also like it because their growers like it."

Foreign corn buyers also are playing a role in the acceptance of biotech corn, Gerdes said. They already pay farmers a premium for white corn and feared that would go up unless they allowed farmers to grow genetically engineered versions, he said.

Darrel McAlexander, who farms near Sidney, Ia., and sells white corn to the Grupo Minsa mill in Red Oak, grew 50 acres of the biotech version this year. It turned in a sizable increase in yield of about 25 bushels per acre over the production he got on the other 1,400 acres of conventional white corn, he said.

"Now that Frito-Lay has approved it and some of the other food processors, I think we're going to see more" biotech white corn, said McAlexander, who is chairman of the Iowa Corn Promotion Board.

But as prices for yellow corn have risen to historically high levels during the past two years, premiums for white corn also have gone up, and are now running at about 60 to 70 cents a bushel, Gerdes said.

A spokeswoman for Frito-Lay said the company's individual business units can decide whether to buy genetically engineered ingredients. Officials with Mexico-based Minsa and Azteca Milling, a Texas-based unit of another Mexican company, GRUMA, did not respond to requests for comment on their buying decisions.

The fact that another food market has fallen to agricultural biotechnology isn't evidence that consumers are accepting genetically engineered crops, said Bill Freese of the Center for Food Safety, an advocacy group long critical of the industry.

The continued growth in sales of organic foods shows consumers don't want biotech foods, he said. Organic farming rules prohibit use of genetically engineered seeds.

Domestic use of white corn has been growing about 4 percent to 7 percent a year as the Latino population has grown, although white corn still represents a fraction of overall corn production, according to the Agricultural Marketing Resource Center at Iowa State University. About 700,000 acres were planted to white corn in 2005, up from 430,000 acres in 1990.

Texas and Nebraska are the leading producers, although white corn is also grown in southwest Iowa, Illinois, Indiana, Kentucky and Tennessee.

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Obama's Team Includes Dangerous Biotech "Yes Men"

Biotech "Yes Men" on Obama's team threaten to expand the use of dangerous genetically modified (GM) foods in our diets. Instead of giving us change and hope, they may prolong the hypnotic "group think" that has been institutionalized over three previous administrations--where critical analysis was abandoned in favor of irrational devotion to this risky new technology.

Clinton's agriculture secretary Dan Glickman saw it first hand:

"It was almost immoral to say that [biotechnology] wasn't good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . If you're against it, you're Luddites, you're stupid. That, frankly, was the side our government was on. . . . You felt like you were almost an alien, disloyal, by trying to present an open-minded view"

When Glickman dared to question the lax regulations on GM food, he said he "got slapped around a little bit by not only the industry, but also some of the people even in the administration."

By shutting open-minds and slapping dissent, deceptive myths about genetically modified organisms (GMOs) persist.

• The industry boasts that GMOs reduce herbicide use; USDA data show that the opposite is true.
• We hear that GMOs increase yield and farmer profit; but USDA and independent studies show an average reduction in yield and no improved bottom line for farmers.
• George H. W. Bush fast-tracked GMOs to increase US exports; now the government spends an additional $3-$5 billion per year to prop up prices of the GM crops no one wants.
• Advocates continue to repeat that GMOs are needed to feed the world; now the prestigious International Assessment of Agricultural Knowledge, Science and Technology for Development has joined a long list of experts who flatly reject GMOs as the answer to hunger.

Food Safety Lies

Of all the myths about GMOs, the most dangerous is that they are safe. This formed the hollow basis of the FDA's 1992 GMO policy, which stated:

"The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way."

The sentence is complete fiction. At the time it was written, there was overwhelming consensus among the FDA's own scientists that GM foods were substantially different, and could create unpredictable, unsafe, and hard-to-detect allergens, toxins, diseases, and nutritional problems. They had urged the political appointees in charge to require long-term safety studies, including human studies, to protect the public.

Their concerns stayed hidden until 1999, when 44,000 pages of internal FDA memos and reports were made public due to a lawsuit. According to public interest attorney Steven Druker, the documents showed how their warnings and "references to the unintended negative effects" of genetic engineering "were progressively deleted from drafts of the policy statement," in spite of scientists' protests.

"What has happened to the scientific elements of this document?" wrote FDA microbiologist Louis Pribyl, after reviewing the latest rewrite of the policy. "It will look like and probably be just a political document. . . . It reads very pro-industry, especially in the area of unintended effects."

Who flooded the market with dangerous GMOs

Thanks to the FDA's "promote biotech" policy, perilously few safety studies and investigations have been conducted on GMOs. Those that have, including two government studies from Austria and Italy published just last month, demonstrate that the concerns by FDA scientists should have been heeded. GMOs have been linked to toxic and allergic reactions in humans, sick, sterile, and dead livestock, and damage to virtually every organ studied in lab animals. GMOs are unsafe.

At the highest level, the responsibility for this disregard of science and consumer safety lies with the first Bush White House, which had ordered the FDA to promote the biotechnology industry and get GM foods on the market quickly. To accomplish this White House directive, the FDA created a position for Michael Taylor. As the FDA's new Deputy Commissioner of Policy, he oversaw the creation of GMO policy.

Taylor was formerly the outside attorney for the biotech giant Monsanto, and later became their vice president. He had also been the counsel for the International Food Biotechnology Council (IFBC), for whom he drafted a model of government policy designed to rush GMOs onto the market with no significant regulations. The final FDA policy that he oversaw, which did not require any safety tests or labeling, closely resembled the model he had drafted for the IFBC.

Michael Taylor is on the Obama transition team.

Genetically engineered bovine growth hormone and unhealthy milk

Taylor was also in charge when the FDA approved Monsanto's genetically engineered bovine growth hormone (rbGH or rbST). Dairy products from treated cows contain more pus, more antibiotics, more growth hormone, and more IGF-1--a powerful hormone linked to cancer and increased incidence of fraternal twins (see www.YourMilkonDrugs.com.) The growth hormone is banned in most industrialized nations, including Canada, the EU, Japan, Australia, and New Zealand. But under Michael Taylor, it was approved in the US, without labeling.

As more and more consumers here learn about the health risks of the drug, they shift their purchases to brands that voluntarily label their products as not using rbGH. Consumer rejection of rbGH hit a tipping point a couple of years ago, and since then it has been kicked out of milk from Wal-Mart, Starbucks, Kroger, Subway, and at least 40 of the top 100 dairies. In 2007, Monsanto desperately tried to reverse the trend by asking the FDA and FTC to make it illegal for dairies to label their products as free from rbGH. Both agencies flatly refused the company's request.

But Monsanto turned to an ally, Dennis Wolff, the Pennsylvania Secretary of Agriculture. Wolff used his position to single-handedly declare rbGH-free labels illegal in his state. Such a policy would make it impossible for national dairy brands to declare their products rbGH-free, since they couldn't change packaging just for Pennsylvania. Wolff's audacious move so infuriated citizens around the nation, the outpouring caused the governor to step in and stop the prohibition before it took effect.

Dennis Wolff, according to unbossed.com, is being considered for Obama's USDA Secretary.

Although Pennsylvania did not ultimately ban rbGH-free labels, they did decide to require companies who use the labels to also include a disclaimer sentence on the package, stating that the according to the FDA there is no difference between milk from cows treated with rbGH and those not treated. In reality, this sentence contradicts the FDA's own scientists. (Is this sounding all too familiar?) Even according to Monsanto's own studies, milk from treated cows has more pus, antibiotics, bovine growth hormone, and IGF-1. Blatantly ignoring the data, a top FDA bureaucrat wrote a "white paper" urging companies that labeled products as rbGH-free to also use that disclaimer on their packaging. The bureaucrat was Michael Taylor.

Betting on biotech is "Bad-idea virus"

For several years, politicians around the US were offering money and tax-breaks to bring biotech companies into their city or state. But according to Joseph Cortright, an Oregon economist who co-wrote a 2004 report on this trend, "This notion that you lure biotech to your community to save its economy is laughable. This is a bad-idea virus that has swept through governors, mayors and economic development officials." He said it "remains a money-losing, niche industry."

One politician who caught a bad case of the bad-idea virus was Tom Vilsack, Iowa's governor from 1998-2006. He was co-creator and chair of the Governors' Biotechnology Partnership in 2000 and in 2001 the Biotech Industry Organization named him BIO Governor of the Year.

Tom Vilsack was considered a front runner for Obama's USDA secretary. Perhaps the outcry prompted by Vilsack's biotech connections was the reason for his name being withdrawn.

Change, Truth, Hope

I don't know Barack Obama's position on GMOs. According to a November 23rd Des Moines Register article, "Obama, like Bush, may be Ag biotech ally", there are clues that he has not been able to see past the biotech lobbyist's full court spin.

- His top scientific advisers during the campaign included Sharon Long, a former board member of the biotech giant Monsanto Co., and Harold Varmus, a Nobel laureate who co-chaired a key study of genetically engineered crops by the National Academy of Sciences back in 2000. - [Obama] said biotech crops "have provided enormous benefits" to farmers and expressed confidence "that we can continue to modify plants safely."

On the other hand, Obama may have a sense how pathetic US GMO regulations are, since he indicated that he wants "stringent tests for environmental and health effects" and "stronger regulatory oversight guided by the best available scientific advice."

There is, however, one unambiguous and clear promise that separates Obama from his Bush and Clinton predecessors.

President Obama will require mandatory labeling of GMOs.

Favored by 9 out of 10 Americans, labeling is long overdue and is certainly cause for celebration.

(I am told that now Michael Taylor also favors both mandatory labeling and testing of GMOs. Good going Michael; but your timing is a bit off.)

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Genetically Modified Peanuts Could Save Lives

Image: Hypoallergenic peanuts (left) and wild peanuts

Genetically engineered peanuts may help fight the most common cause of fatal allergic reactions to food in the United States. While the research is unlikely to result in the creation of completely allergen-free peanuts, it could result in fewer outbreaks and even fewer deaths.

For years now, government scientists have been testing ordinary peanuts in the hope of finding one that cannot cause the deadly allergic reactions which kill more than 50 Americans every year. But nature may not be able to provide an answer.

Horticulture expert Peggy Ozias-Akins at the University of Georgia in Tifton is taking a different tack by using genetic engineering to grow hypoallergenic peanuts.

Most allergic reactions to peanuts are triggered by the same eleven molecules. In theory, peanuts without the genes responsible for those molecules would be far less likely to trigger allergic reactions.

"Some proteins cause more severe allergic reactions than others," said Ozias-Akins.

Tackling the worst offenders first, her team has made and tested peanuts that do not produce two proteins that are among the most intense allergens. The research appears in The Journal of Agricultural and Food Chemistry.

The biologists shot a customized DNA sequence into the plants with a gene gun, causing the legumes to produce hairpin-shaped RNA molecules, which halt the production of the two proteins.

Messing with the genetic code of a plant could potentially cause the seeds to develop improperly, change the taste of the crop, or render it more susceptible to fungal infections. But Ozias-Akins' team found that they grow normally and can resist a common mold without any problems.

Still, getting rid of every allergy-causing substance in peanuts would not be easy, Ozias-Akins said. "Given the number of allergenic proteins in peanuts, I doubt that developing an allergen-free peanut is realistic."

Although it may be impossible to make a perfectly safe peanut, clipping the right genes out could make food accidents far less common.

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Healthy bacteria Sale in Supermarkets

A company in Mayfield Heights is marketing a probiotic that might help the health trend already accepted in Europe and Asia catch on in America.

It's selling its healthy bacteria as a food ingredient -- one that unlike most other probiotics remains effective even when it's baked, boiled, frozen or squeezed.

The company, Ganeden Biotech, has teamed with two dozen food companies since January to incorporate its probiotic in everything from muffins to health bars to energy drinks -- even ice cream.

Main Street Gourmet in Akron recently began adding GanedenBC30 to the raisin bran muffins in its Isabella's Healthy Bakery line under the label Activate: Probiotic Enriched Muffins.

You can't buy these muffins in Ohio yet. But foods with the GanedenBC30 logo could start hitting the shelves of local grocery and drug stores by early next year.

Probiotics are live microorganisms containing bacteria or yeasts that can make people who take them healthier. Foods like yogurt naturally contain probiotics. Some believers say probiotics improve their digestion, boost their immunity and even enable them to digest dairy foods.

The number of new products containing probiotics has doubled since 2003, according to a database kept by NutraIngredients-USA.com.

The top categories for probiotics are yogurt, yogurt drinks, milk, baby food, supplement tablets and cheese, according to Nielsen LabelTrends, which keeps track of manufacturer labeling practices.

The trouble is, probiotics must be delivered to the gut alive to have a positive effect. Including probiotics in moist, refrigerated foods like yogurt is easy.

But processing the healthy bacteria for use in vitamin tablets, or baking or boiling it in food, often kills it. So do digestive acids in the stomach.

That's where Ganeden may have a leg up on many of its competitors. The company's patented strain of Bacillus Coagulans -- GanedenBC30 -- generally survives processing and digestion, and is stable in items on store shelves for up to two years.

So instead of drinking a few ounces of probiotic-rich Yakult dairy beverage every morning like Japanese people do, Americans soon may be able to get their daily dose of probiotics in breakfast cereal.

Ganeden has made dietary supplements with its probiotic -- discovered by Sean Farmer, a California microbiologist -- under the Digestive Advantage brand for nearly a decade. Farmer is Ganeden's founder and chief science officer.

These supplements come in the form of capsules aimed at helping people who have digestive ailments such as Crohn's disease or lactose intolerance, said Andrew Lefkowitz, the company's chief executive and president.

The Ganeden supplements "work wonderfully well with balancing the gut," said Dr. Terence Isakov, a family practice doctor in Lyndhurst.

Isakov, who has a financial interest in Ganeden, said probiotics have been found to help other inflammatory diseases such as arthritis.

"I think people are starting to look at probiotics in an entirely new light," Isakov said.

Ganeden, which means "Garden of Eden" in Hebrew, has spent millions of dollars testing its probiotic for safety and efficacy, said Michael Bush, who runs his company's food ingredient business as vice president of business development.

Figuring out when in the recipe to add the tasteless probiotic was the biggest challenge for Main Street Gourmet, said Harvey Nelson, co-chief executive.

It's too soon to say whether adding the Ganeden probiotic to its muffins will boost sales. However, food distributors "are calling us instead of us calling them," which is an indication of unusual demand, said Steve Marks, co-CEO.

Jack Kelly, president of PC Brands in Solana Beach, Calif., is adding Ganeden's probiotic to its Pop Culture health bars. GanedenBC30's proven survivability through the manufacturing process and stable shelf life made it an attractive addition.

"We believe in the use of probiotics in a more convenient form for most consumers," Kelly said. "Refrigerating is limiting for an energy bar."

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Support for biotech strongest in RP - survey

Philippine consumers are aware of biotechnology benefits and do not have safety concerns with GMO, a recent survey by the Asian Food Information Centre (www.afic.org) shows.

The AFIC survey covered five Asian countries, namely China, India, Japan, the Philippines and South Korea. It aimed to provide insights on how consumers in Asia perceive the use of biotechnology to produce foods and how likely it is consumers are accepting the various benefits biotechnology derived foods may bring.

The survey findings for the Philippines indicate that consumers are knowledgeable and positive about food biotechnology. Consumers largely believe that biotechnology crops have the potential to deliver high quality, nutritional foods. A large majority of Philippine consumers also indicated that they accept biotechnology as a way to increase the production of food staples and to supply sustainable food. Compared to the other countries surveyed, support for biotechnology appears stronger in the Philippines.

Dr. George Fuller, executive director of AFIC, says: “Acceptance from Philippine consumers of crop biotechnology to produce nutritionally enhanced foods is an important outcome of this research. For instance, Golden Rice (enhanced in B-carotene to prevent vitamin A deficiency) is close to commercialization in the Philippines and the AFIC research shows that consumers in the country will accept this nutritionally superior rice.”

“The survey also indicates that food security is on the consumers’ mind and consumers support biotechnology’s potential for improving agricultural productivity”, added Dr. Fuller.

Key findings from the different areas included in the survey:

Plant biotechnology and food

Awareness about plant biotechnology is high in the Philippines and positively correlates with favorability and acceptance of biotechnology to produce foods.

Almost one in three Philippine consumers report that they are very knowledgeable about biotechnology and in total two thirds say they have at least some knowledge.

The majority of consumers (59 percent) have favorable impressions of plant biotechnology while 19 percent are neutral. A large majority (73 percent) of Philippine consumers believes that they would personally benefit from food biotechnology in the next five years. Key expected benefits are improved food quality and making food more affordable.

A vast majority of the surveyed consumers would be ready to purchase foods produced through biotechnology for specific benefits. More than 90 percent of the consumers would be likely to buy cheaper rice or rice with an increased nutritional value (like a higher vitamin A content) produced through biotechnology. Consumers expressed an equally high (greater than 90 percent) likelihood of buying biotechnology-derived foods such as cooking oil with reduced levels of saturated or trans fats or fresher and better tasting tomatoes.

Plant biotechnology and sustainability

Consumers in the Philippines are also very positive towards plant biotechnology if the technology is related to sustainable food production.

Although most of the consumers are not familiar with the concept of sustainable food production, once the concept is explained, 84 percent of the respondents believed sustainable food production is important. When asked to rank seven factors related to sustainable food production, Philippine consumers picked ‘increasing the production of food staples in the world, thereby reducing world hunger’ as the most important factor, and ‘increasing the productivity in the field and thus reducing production cost, thereby reducing the cost of food’ second.

Ninety-two percent of those surveyed said they support food production using plant biotechnology if the technology delivers sustainable benefits.

Confidence in safety of food supply

The survey was conducted in July and August of 2008 and 71 percent of the respondents indicated to be neutral to confident with the food safety level in the country. When asked to rank specific food safety concerns, Philippine consumers indicated a rather high level of concern for many of the issues, with food poisoning, pesticides residue, and improper handling of food topping the list. Food biotechnology is much less of a concern compared to other food safety issues with none of the respondents citing this as a top of mind concern.

Food labeling

Almost three out of four respondents said they read food labels regularly. The kind of information that Philippine consumers normally look for on food labels include expiry date (most important information for 59 percent of the consumers), vitamin content (mentioned by 13 percent of the consumers as the most important info) and food additives (seven percent).

A majority of consumers (74 percent) state that there is no information they would like to see added to food labels. Those who are not satisfied with the current information on food labels said they would like to have additional information about the content (presence of vitamins, minerals and other basic ingredients) and expiration/production dates.

GM labeling is not a spontaneous labeling demand, none of the respondents suggested presence of GM ingredients as an additional item to be included on food labels.

Compared to the other surveyed countries, consumers in the Philippines appear to be most knowledgeable about food biotechnology and the increased awareness positively correlates with acceptance.

The survey also shows that crops produced through biotechnology do not generate a high level of concern. In addition, although most Asian consumers are not familiar with the concept of “sustainable food production,” once the concept is explained, a majority believe sustainable food production is important and accept plant biotechnology if the technology contributes to a more sustainable way of producing foods. Asian consumers are also ready to accept nutritional benefits from biotechnology-derived foods. However, specific benefits are linked to the dietary habits in each country. Consumers from the food producing countries, China, India and the Philippines, tend to be more positive about food biotechnology and the benefits it can bring compared to consumers from Korea and Japan, where local agricultural production is less important.

Methodology

AFIC commissioned The Nielsen Company Research to conduct a quantitative assessment of adult consumer attitudes toward food biotechnology from July 15 to Aug. 15, 2008. The research was conducted via an on-line survey of 1007 adults, aged 18 to 64 years, and living in five major cities in five different countries. The number of respondents for each city was: Beijing - 200; New Delhi - 204; Manila - 200; Seoul - 202 and Tokyo - 201.

Quotas were set to best reflect the demographic population in the cities.

About Asian Food Information Centre (AFIC) Singapore registered not-for-profit organization, its mission is to effectively communicate science-base information on food safety, nutrition and health information to media, regulators, food/health professionals, and consumers in the Asia region.

For more information, please contact infor@afic.org or visit the Asian Food Information Centre website www.afic.org

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A Better Way to Invest in Biotech?

With the market down so much, even losing funds look good if they haven't lost very much. The Biotech HOLDR (NYSE: BBH) fund, for instance, has managed to eke out relatively good returns, drawing investor interest. Still, this is not your typical portfolio and should be looked at very carefully before dipping your toe in.

Fund specifics
HOLDRs enable investors to purchase a slice of the market in a number of specific sectors, from broadband companies to regional banks. Structured as a trust, the Biotech HOLDR holds common stock of companies in the biotechnology industry.

Unlike some sector exchange-traded funds (ETFs) that are well-diversified with dozens of securities, Biotech HOLDR has nearly 95% of its assets in just five stocks: Genentech (NYSE: DNA), Amgen (Nasdaq: AMGN), Gilead Sciences (Nasdaq: GILD), Biogen Idec (Nasdaq: BIIB), and Genzyme (Nasdaq: GENZ). Investors also have direct ownership of the underlying stocks. That means dividends are paid directly, resulting in numerous tax reporting obligations. There are no management fees, but there are transaction costs and an annual custody fee of $0.08 per HOLDR share.

Fund facts

* Year-to-Date Return: 2.5%
* Expense Ratio: none; $0.08/share custody fee
* Assets: $1.2 billion

Fund prospects and risks
A HOLDR is a basket of stocks just like an ETF. But there the similarity ends, as each HOLDR is a static portfolio that doesn't change over time. The HOLDR is unmanaged and its component stocks do not vary. This is very different from most ETFs, which track indexes that adjust periodically due to rebalancing. If a stock is acquired, the index will often replace it, but the HOLDR will remove it and not replace it.

That means that over time, the HOLDR's portfolio can become more and more concentrated. Investors look to ETFs for their diversification benefits, yet with Biotech HOLDR, you are really not getting that benefit.

Portfolio fit?
With a new president, there's potential for changes to the American health-care system. So investors should monitor the mood in Washington and make sure their portfolios are optimally positioned for any changes.

But remember that HOLDRs may not be the best tool for biotech investors. Don't get fooled into thinking this is just another sector ETF, as its unique structure makes it more like a concentrated five-stock fund. That level of concentration brings an unusually high degree of stock-specific risk, which most investors don't want. Although the strong performance of those five biotech stocks has led to good returns for Biotech HOLDR, it requires you to put your eggs into a pretty small basket.

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Biotech blues : 1.2bn over decade to develop a medically useful molecule

It takes an average of $1.2bn over 10-12 years to develop a medically useful molecule. This huge expense of time and money means that almost all biotechnology start-ups require top-ups of funding or other outside sources of revenue in order to survive. In normal times, companies with promising technologies are able to attract the funds needed to soldier on through clinical trials while those whose products fail to clear various scientific and regulatory hurdles are left by the wayside. But now, the financial crisis has left even healthy companies wondering where the cash is going to come from next.

Traditionally, struggling businesses have sought shelter in the arms of big drug companies or stronger rivals willing to buy their intellectual property and hire their scientific talent. Others can elect to go into "hibernation" if their technologies fail to bear fruit, shutting down research while holding on to their intellectual property in the hope it may one day prove useful.

This year looks different. Venture capitalists have begun to shun high-risk bets such as biotech. Meanwhile, the public funding market has all but dried up. So far this year, there has been just one initial public offering of a biotechnology company - for a minuscule $5.8m - compared with more than two dozen last year. At least five biotechnology companies have gone bankrupt in recent weeks for lack of funds, according to Bloomberg. Others have begun to shutter research projects in an effort to preserve cash.

Like many problems sparked by the financial crisis, this, too, will pass. Several big drug companies are set to lose patent protection on lucrative medicines over the next few years. Demand for medically promising molecules will eventually pick up as pharmaceuticals companies search for the next big thing. Unfortunately, these long-term dynamics are likely to come as cold comfort to medical patients who might have benefited from research projects now set for the chopping block.

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