27 Nov 2008

How New Biotech Breakthrouhs Make It To Market

Think of life sciences, and what comes to mind might very well be the behemoths of the industry — the Genzymes and the Bristol-Myers Squibbs of the world

But there are plenty of smaller companies too — smaller even than the startups that can be seen for their first few years at one of the three Massachusetts Biomedical Initiatives incubators in Worcester.

A great example of the very small companies that start with an idea and very little cash is Bradley L. Hodges’ Prothelia Inc., which is based in Milford. He is working to commercialize a small molecule protein that he believes will help children with muscular dystrophy.
Small Quarters, Big Dreams

He is literally a staff of one. He can’t afford space at MBI and even if he could, they require a certain amount of financial backing or a source of funding through revenues for at least the first year spent in their space. It’s been a pretty successful model, with close to 30 startups successfully leaving to become established elsewhere.

But Hodges is undeterred by his passion. “I want to create drugs for people. I have a passion about doing that and I have expertise about muscles. I want to use those things to bring a drug that will help kids with muscular dystrophy,” he said.

Hodges had a dream job working for Genzyme for seven years, but began to realize he wasn’t going to be able to help create new products. Big companies tend to buy other small companies or buy specific scientific work and have their scientists evaluate the work. Checking out other people’s discoveries instead of making his own eventually led him to lose interest in his job.

“I just started thinking: I can’t do this for another 30 years,” Hodges said.

So he left Genzyme and began looking for the right drug to bring to market. In his search he contacted a former friend and fellow student from college who only weeks before had discovered a small molecule that helps muscular dystrophy.

“The timing was incredible. I got my foot in the door very early. I learned about it before it went to patent, before research was publicly printed in a journal,” he said.

The protein is made naturally in our kidneys, and when it is purified and then injected directly into the muscles, there is a noticeable difference right away and the dose continues working for four weeks, Hodges said.

And as Craig Mello is wont to point out, the Worcester biotech community tends toward collaboration with each other and Hodges has become a beneficiary of that desire.

Kevin O’Sullivan, who heads the Worcester incubators, directed Hodges to local biotech entrepreneur Dennis Guberski, the CEO of Biomedical Research Models Inc., who gave him pointers on grant writing and agreed to house Hodges’ experiments on mice when the time comes.
Driven To Succeed

Guberski said he talks to as many as 20 entrepreneurs a year that ask for advice about how to proceed, and only a couple of those will actually make it.

“Less than five of those 20 people who say ‘I want to do this” have the drive to actually do it. And of those three or four people who try, only one or two will succeed,” Guberski said.

Hodges said he has successfully applied for a Small Business Innovation Research, or SBIR, grant for $100,000, which he will get in late winter or early spring. In the meantime, a muscular dystrophy patient advocacy group is paying his salary until the grant comes in.

The grant process is a natural vetting process that works well, Guberski said.

“It’s so difficult to get started. There are all these obstacles and it takes a strong desire to overcome them. But boy, it is fun. He (Hodges) went for a public health grant without ever having done this before and the first time out he succeeded. Our only help to him was showing him how to write a grant. We said never mind what the book tells you about applying for grants, do this. And he listened.”

Hodges agreed the process was difficult, but he sounded like he was enjoying himself so far. “It’s fun, but it’s kind of scary. I’ve learned more in the last year than I have in the previous 15 years.

He’d like some day to be a company as big as Genzyme, which began in the 1980s with one drug, Cerazyme, which has been a mainstay for them for 14 years and a $1 billion market.

“I want to be the person who says where the research will stop, who will take the data and run with it,” Hodges said.

Now if you could just bottle that drive that Guberski talks about, someone could really make a killing.


26 Nov 2008

Biotech industry expected to grow despite global meltdown

India's biotechnology industry is confident of excellent augmentation in the coming years despite global meltdown.

Experts feel that the Indian biotechnology industry, which currently holds only two percent share of the global market, has the potential to grow and emerge as global player in coming years.

Expressing confidence at the prospect of biotech industry attaining the target of five billion dollars by 2010, Kiran Majumdar Shaw, Chairman and Managing Director of Biocon Limited, said agri biotech products and services will contribute a lot towards achieving this target.

"The five billion dollar target that the Biotech industry has is definitely something that is going to be attained in that time frame of 2010. And this five billion dollar market that is forecast is going to comprise largely of pharmaceutical products like vaccines and other therapeutic products. It is going to comprise of agri biotech products, which will almost comprise a billion dollars. Then we are also going to form a billion dollar component of that particular business," said Shaw.

According to a survey by Ernst and Young, India is projected as one of the emerging leaders in biotechnology, and is ranked third in the Asia-Pacific region, based on the number of biotech companies in the country.

According to another survey conducted by Association of Biotech Led Enterprises (ABLE), Indian biotech industry has reported a growth of 20 per cent during the year 2007-08.

The industry earned revenue worth 2.56 billion dollars, as against the last fiscal, which was 2.1 billion dollars. Out of this, the research services notched up growth of 500 million dollars. 250 dollars million growth was reported by bio informatics sector.

India is emerging as an important destination for biotech development requirement of global companies. The industry is also grappling with global meltdown, where it has paved way for a lot of joint ventures and collaboration in the sector.

The collaborations are being looked upon as means to bring down the cost of developing products to make the entire process quite affordable.

The scenario looks favorable for the Indian biotech firms as industry experts say, they should focus on acquiring biotechnology units in foreign countries like the US, where global meltdown has led to fall in their valuations.


25 Nov 2008

Govt to issue tender for Kharagpur biotech park

The government is planning to issue a tender for the Kharagpur biotech park inviting expression of interest (EoI) from developers.

"We will soon issue a tender inviting bids from developers for the Kharagpur biotechnology park," West Bengal Commerce & Industry Principal Secretary Sabyasachi Sen said here today.

In September 2005, the West Bengal Industrial Development Corporation (WBIDC) and Indian Institute of Technology (IIT), Kharagpur had entered into a memorandum of association (MoU) to develop the park and attract investment in the knowledge-based sector.

The proposed park would come up on 100 acres of land, owned by WBIDC, and it was earlier decided that both WBIDC and IIT Kharagpur would jointly approach the Ministry of Defence for more land.

The cost of developing the project would be around Rs 100 crore.

Sen, however, declined to comment on the amount of investment the proposed park would attract, saying, "It is hard to say".

WBIDC is responsible for facilitating the receipt of fiscal benefits and concessions from the state and the central governments.

Apart from focusing on multiple biotechnology areas like, biometrics, healthcare devices and industrial enzymes, the park would also provide training and technical advice and constitute a technical committee to oversee research and development facilities.


Novartis targets biotech drugs as it boosts R&D

Novartis has gone out of its way to persuade analysts that it is going all out to advance new medications in its pipeline. There are 139 new projects in clinical studies, including 88 new molecular entities--a 40 percent increase over 2005. And four out of every five compounds that demonstrated clinical proof-of-concept in 2006/2007 are now either in Phase II or Phase III.

Like other Big Pharma companies, Novartis knows that a big part of its future success will depend on biologics. One in four of the company's clinical studies now are devoted to biotech drugs. And Novartis wants to bring biotech's razor sharp focus to all of its discovery work.

"We are working to transition pharmaceuticals development into highly integrated teams that consistently deliver innovative medicines to patients with biotech-like intensity, focus and flexibility," said Trevor Mundel, MD, head of Global Development Function.

"Our strategy is working to deliver more effective medicines to patients rapidly," said Mark Fishman, MD, president of the Novartis Institutes for BioMedical Research. "In a relatively short time we have dramatically increased the size and power of our pipeline and believe many of these compounds have the potential to change the practice of medicine."

- read Novartis' release

19 Nov 2008

Biotech R&D to get fillip with RS 350cr package

The department of biotechnology's latest initiative — the Biotechnology Industry Partnership Programme (BIPP) — could provide a fillip for research, more so in light of industry facing a credit squeeze following the global financial crisis.

The Rs 350-crore package will underwrite the risk of research and development of innovate molecules and processes. It will be open to all innovative biotech companies, who are looking to do research in agriculture, health, bioenergy and green manufacturing. The industry has welcomed the move, with participants at the BioInvest 2008 forum lauding it as a positive step by the government.

“The government broke the mindset of taking risks when it approved process patents. It is now up to them to try and fix the system and encourage people to take risks in research. The idea is to encourage and reward people who do innovative research,” said Shrikumar Suryanarayan, director general of the Association of Biotechnology-Led Enterprises (ABLE).

The BPII report states that 100% grant-in-aid support would be provided for phase-I, II and III clinical trials of biotechnology-based research efforts and for limited and large-scale field trials in the case of agriculture products provided there is Indian innovation involved in technology development.

The grant would not include any capital investment. Small and medium enterprises (SMEs) as defined by the Small Business Innovation Research Initiative (SBIRI) would be preferred recipients of support. “With the current liquidity crisis, the government has to step in and support research. Otherwise there will be no research and five years down the line there will be a dearth of drugs,” said an industry member said.


18 Nov 2008

Accelerator adds $5 million to fund biotech startups

Biotechnology incubator Accelerator has snagged a commitment of about $5 million from a new investor to fund additional startups.

Accelerator, a Seattle-based incubator for biotechnology companies, snagged a commitment of about $5 million from a new investor to fund additional startups.

The commitment will bring to $27 million for the Accelerator's third round of investment, dubbed Accelerator III. The investor, PPD, is a large contract clinical research and development company based in Wilmington, N.C.

Accelerator Chief Executive Carl Weissman said PPD's expertise "should make a huge impact" in its farm team of young biotechs.

Accelerator's funding will allow it to invest in three or four more startups over the next few years.

At a time when few companies are willing to part with cash, PPD's involvement underscores its long-term thinking as an investor, said David Schubert, the Accelerator's chief business officer.

"They never even blinked when the economy or the markets went into turmoil," Schubert said.

In August Accelerator netted an initial $22.5 million for the third investment round.

Other investors include Amgen Ventures, ARCH Venture Partners, OVP Venture Partners, WRF Capital and Alexandria Real Estate Equities.

The Accelerator has invested in nine early stage companies, three of which have left the incubator and collectively raised more than $114 million.


17 Nov 2008

Another goof-up in MSc biotech exam

Nagpur University, it seems, will never learn from its mistakes. Tuesday’s MSc first semester biotechnology question paper had a couple of questions from the old syllabus. Last Friday too the varsity had committed the same blunder.

Students informed ToI that the marks allotted for individual questions were not mentioned in the entire paper. It only had total marks (75) at the top of the paper which, according to the students , is again violation of rules. No authority from the university was available for comments on this second blunder within four days.

The syllabus was changed from this academic year and the students were being taught as per that. However, on Friday, the invigilators told them that the university had sent only one paper — the one that had been set as per the old syllabus. TOI reported this issue on Saturday. Subsequently, the university authorities took cognisance of the students’ complaints and rescheduled Friday’s exam to November 17. There are 11 colleges in the Nagpur University which are conducting MSc biotechnology course with over 250 students.

In Tuesday’s exam, two sub-questions in question No. 2 were again drafted from the old syllabus, which the students simply failed to answer. Moreover, how many marks were allotted to those “out of syllabus” questions were not known since no individual marks were mentioned.

Various teachers of biotechnology confirmed the students’ claims and have demanded that, since this is a university faux pas, grace marks be awarded to them to save their academic year.

A senior varsity official blamed communication gap amongst the university authorities and a lackadaisical attitude. “After Friday’s blunder the authorities set the second paper as per new syllabus. But all this has been done in haste, leading to blunders,” he said.


15 Nov 2008

Biotech options for value addition of farm produce

Vanilla from pomegranate? A reality, says Dr Christopher Augur, senior scientist with the Institute of Research and Development, University of Paul Cezanne in Marseille, France. The scientist was delivering a talk on ‘Microbes and their enzymes: transforming specific agro-industrial waste’ at the Kerala State Council for Science, Technology and Environment Hall.

It was the first of a series of lectures on biotechnology organised by the Kerala State Biotechnology Commission. ‘’We can get some very interesting compounds by the microbial degradation of agro-industrial waste. Some of the most promising ones are vanillin from pomegranate fruit peel and taxifolin from coffee waste,’’ said Dr Augur.

While agro-industrial waste like the coffee seed waste cannot be used as animal feed because of their high tannin content, they can be used to generate much useful compounds, he said. ‘’Degradation of these waste materials using fungus can generate some very interesting compounds that are important in biotechnology. Generating taxifolin this way can also be a blessing to the trees, which otherwise are damaged due to the peeling of the bark’’ he said.

In addition to being eco-friendly, these solutions can be very cheap too. In the case of vanilla derived from pomegranate peel, the cost of the end-product can be brought down significantly, he said. In a discussion thereafter, Dr ugur said that the acceptability of such microbe-derived vanillin should not be a problem as it is ‘naturally bio-transformed’ and not synthetic.

Dr Augur also went on to explain in detail the process by which coffee waste can be preserved for months even after the coffee season. This and the technology for making taxifolin, if it can be produced in a cost-effective manner, can become a boon to the coffee-farmers of the State too.


Zydus Cadila buys Dutch firm Etna Biotech

The Ahmedabad-based pharma major Zydus Cadila on Tuesday said it has acquired Etna Biotech, a subsidiary of the Dutch biopharma company, Crucell. This is the sixth foreign acquisition by Zydus in the last five years. The company has not divulged the details of the deal.

In an official statement issued by the Zydus Cadila CMD Pankaj Patel said: “This acquisition will help us to be in the forefront in the innovation for vaccine research and development. The deal marks company’s first acquisition in the research space and offers the group a highly evolved research platform for developing new vaccines and technology.”

Zydus, the Rs 2,300-crore company is striving for a strong foot-hold in the lucrative vaccines market. The global vaccine industry is expected to grow by 18% by 2010, which is roughly three times the growth of the global pharmaceutical industry. The company would look at scaling up its vaccine products, as the newly-acquired research oriented company will provide cost advantage, sources said.

Last month, the group received WHO accreditation for rabies vaccine. So far Zydus had only a few products in vaccines segment through collaborations which were more for marketing other vaccines. The only vaccine that the company owned is the rabies vaccine.

Economic Times

New York City Angles To Become A Biotech Hub

The latest effort to transform the city into a magnet for R&D and investment has its official opening today in the 90-year-old Brooklyn Army Terminal, where the International AIDS Vaccine Initiative, or IAVI, will occupy part of a cavernous warehouse built as a military supply depot during World War I.

The center is the latest effort in a long-running campaign to make New York a biotech capital and, as The New York Times notes, reduce the city’s economic dependence on Wall Street. “This is a down payment on an industry that we think is going to be a major tax generator for both the city and the state for many years,” Seth Pinsky, who heads the city’s Economic Development Corporation, tells the paper.

So far, the city has invested more than $35 million to build or renovate office and lab space for bioscience ventures, the paper writes, adding that about one-third of that is going toward the new quarters for IAVI in Brooklyn. The state has pledged an additional $48 million to convert 500,000 square feet of the Brooklyn Army Terminal into space for biotechs.

Also under development is the East River Science Park, a $700 million complex adjacent to New York University Medical Center in Manhattan, which will house more than 1 million square feet of office and lab space and is expected to be completed in 2010. “The academic medical centers that are here spin off about 20 companies per year and we’re missing out on them,” Lenzie Harcum, vp biosciences at the Economic Development Corporation, tells the paper.

The idea, of course, is to offer alternatives to budding upstarts that are persuaded to locate in places where biotech is established and operating costs are lower, such as San Diego or Cambridge, Massachusetts.

“The joke here was that venture capitalists came into New York from the West Coast with the three M’s - the money, the management and the moving van - and relocated them,” Kathryn Wylde, chief executive of the Partnership for New York City, an association of large employers that has invested in some biotech startups, tells the Times. “They either went to the West Coast, some went to New Jersey, a lot went to Massachusetts, some to New Haven.”


HIV genomic detection method being developed by Nepalese biotech company

A recently established biotechnology company based in Kathmandu, Intrepid Nepal Pvt. Ltd., has claimed that it has successfully detected proviral HIV DNA using molecular based technique utilizing Polymerase Chain Reaction (PCR) in its Thapathali based laboratories, from blood samples obtained from consenting HIV-affected individuals. This is the first time the technique of QPCR has been used to precisely detect HIV incorporated within the human genome, in Nepal, a press release by the company said.

The HIV virus becomes lethal once it becomes part of the human genome (provirus). To date, there have been no reports of HIV virus being quantified or detected as a provirus in any laboratory in the country. This company, with focus on molecular diagnostics of infectious diseases, has already carried out a number of tests including detection and quantification of Tuberculosis (TB) causing bacteria using real time Polymerase Chain Reaction (QPCR), again a first of its kind within the country.

According to a press release, the company also hopes to foster biotechnology in Nepal by providing accurate diagnostic services in areas of infectious and chronic diseases (such as HIV, HPV, Hepatitis, TB), genetic disorders, paternity determination and other tests that require genomic (DNA and RNA) detection.

nepalnews.com Nov 10 08

14 Nov 2008

Biotech expert says GM crops reduce CO2 emission

Genetically modified (GM) crops have an immense capability of protecting the environment, an agricultural economist said.

According to Graham Brookes of PG Economics (United Kingdom), the use of GM crops has reduced carbon dioxide (CO2) emissions by an estimated 14.76 billion kilos in 2006.

He added that the growing impact of GM crops from 1996 to 2006 has resulted in pesticide use reduction by a whopping 15.47 percent, covering a total of 27 pesticide active ingredients used by the European Union (EU) on arable crops in one year.

In GM insect-resistant cotton, for instance, 5.6 million kilos of insecticide were observed to be reduced, said Brookes. With the reduction on spraying, less fuel is used which resulted in the reduction of CO2 emission by 5.8 billion kilos or equivalent to 2.6 million cars off the road.

"This is equivalent to removing 6.56 million cars or 25 percent of cars registered in the United Kingdom from the road in one year," he said in a forum.

Biotechnology crops were also said to promote low or no till farming, a system which has cancelled the release of 13.5 billion kilos of CO2 into the atmosphere. If no tillage would be continued, 63.9 billion kilos of CO2 would be reduced through additional soil carbon sequestration.

In addition to this, Brookes said that the production of GM crops has benefitted farmers, generating an accumulated income of $33.8 billion. He added that such were able to effectively lower food prices, especially in developing countries.

"Additional production has allowed significantly higher volumes of commodities to be traded globally. It must have had an important positive impact on mitigating the level of price increases in world markets," he said.


Pinoy agri scientist pushes biotech seeds

A Filipino agricultural scientist is promoting the use of biotech seeds to help local farmers increase crop yields.

Dr. Calixto Protacio, a professor of agronomy at the University of the Philippines-Los Baños, said “biotech seed is a weapon that reaches the farmer and does not need to be trained on improved technology to benefit from the crops grown through genetic improvement.”

Reports said biotech is the most rapidly adopted new farming technology in history.

Protacio noted that improved technology seldom reaches the intended targets and that extension workers are not trained appropriately to impart the new knowledge.

“Biotechnology’s potential is to bring science to the countryside even without extension workers. How? Just by giving the farmer improved seed,” Protacio, a US-trained scientist, said.

“If we can incorporate into a seed all that science has to offer, then the fruits of science (actually a seed) would have reached the farmer. This scheme fits in the natural cycle of agriculture where a farmer will secure the best seed he can get,” he said.

Apart from these seeds, he said biotech product may also be a tissue-cultured plantlet.

“But even if produced by tissue culture, especially if by somatic embryogenesis, synthetic seeds can also be produced by encapsulating the somatic embryo in a suitable gel-like medium usually along with everything that the embryo will need- just like a natural seed,” he explained.

Protacio said so far the promise of biotechnology has only been realized commercially in corn.

“Bacillus thuringiensis (Bt) corn’s built-in crop protection capability has reduced the chemical-related expenses for growing the crop and the farmers seem to find it cost effective,” he said.

“The herbicide resistance also incorporated in corn is also relevant to our aging farmers as less labor is required to weed the extensive corn fields,” Protacio said.

He said that while there has been enormous success in propagating Bt corn in the country, commercial seeds developed by biotechnology still have to make their mark in the rice farms and coconut plantations.

“The reason for this is that the private industry invested heavily in corn biotechnology research unlike in the two other crops. Biotech research in rice and coconut are primarily publicly funded. However, the fact that public money is spent on this crops promises that the crop eventually developed will be more relevant to the farmers and the general population,” Protacio said.

Protacio said increasing crop yield would help the government fight hunger and poverty in the country.

The biotech expert also said that government has been working hard to develop “Golden Rice,” which have genes that carry vitamin A. Vitamin A is crucial in battling blindness.

“Nonetheless, experts are still arguing over the practical impact of Golden Rice since vitamin A levels in the variety are still and research has to be done to boost the capability of the strain to harbor a bigger amount of the nutrient,” he said.


12 Nov 2008

Biotech firms fear pricing pressure from Obama

Biotechnology industry advocates didn't wait for election day to rehearse arguments against the broad policy changes they expect the Barack Obama administration to propose.

* Pender: Obama wants to limit foreclosures - but how? 11.09.08
* Health care improvements have to wait awhile 11.09.08
* Tighter oversight of financial services needed 11.09.08
* President-elect likely to boost alternative energy 11.09.08
* Biotech firms fear pricing pressure from Obama 11.09.08
* Cybersecurity, more workers deemed crucial 11.09.08

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Obama's victory, and the Democratic party's commanding control of Congress, are expected to put tough pressure on drug prices as the new president tries to realize his campaign vision of expanded health care coverage for Americans at substantially lower cost. The new regime could also bring policy reversals at the Food and Drug Administration, an agency that became a political battleground during the Bush administration.

But James Greenwood, president of the Biotechnology Industry Organization, said Obama's management of the continuing financial crisis will be the most important influence on the fate of biotech companies coping with tight credit markets and risk-averse investors.

"We're at a very, very difficult time right now, particularly our smaller companies," Greenwood said. "The most important thing this administration has to do is get the economy rolling again."

Greenwood hopes to convince the new leadership that this is no time to cut drug prices. Such moves would further undermine incentives for investors to risk their money on the uncertain chance that new biotech treatments will deliver attractive returns, he maintains.

Fledgling biotechnology companies, often unable to finance the pricey drug development process through to FDA approval, also depend on cash-rich pharmaceutical giants to license their new products or buy the smaller firm outright.

"You can't simply go after big pharma on pricing and not expect it to have an impact on the most innovative young companies," Greenwood said.

Obama's health care plan challenges drug prices on three main fronts. It would increase the use of cheaper generic drugs, allow the importation of low-cost drugs from developed countries, and authorize Medicare to negotiate with drugmakers for lower U.S. prices. The latter policy change could save as much as $30 billion, Obama's plan estimates.

Venture capital executive James Thomas said the drug industry may gain from health care reform even if price pressure increases.

Because drug prices include very high gross margins, he said, growth is driven more by the number of units sold than by price. An expansion of health coverage will boost sales. "That's good for units, and good for us," said Thomas, a co-founder of Thomas, McNerney & Partners.

Greenwood isn't so sure. Cuts in drug prices might come quickly because they would be relatively easy to implement, he said. But any upside in increased sales might be substantially delayed during complex negotiations over health care reform, Greenwood said.

Latham & Watkins attorney John Manthei, who represents drug companies in negotiations over new federal laws, said the Democratic Congress will try to beef up an FDA it sees as underfunded and ineffective.

Congressional committees that had sharply scrutinized the FDA under the Bush administration will now turn their focus to the industry itself, he predicted. Manthei expects Congress to demand answers to questions like: "Were they forthright with their data? Are they adequately policing themselves?"

Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said the trade association will urge Obama to appoint "a strong independent FDA commissioner." The group also supports more funding for the agency.

"There's no question, the FDA is under-resourced," he said.

Names being floated for the FDA commissioner's job include Janet Woodcock, a veteran agency official who is the favored choice of drug manufacturers, Bloomberg News reports.

On the other side of the spectrum are FDA whistle-blowers and prominent drug safety advocates such as Cleveland Clinic cardiologist Steven Nissen, who has raised alarms over heart-related side effects of medicines including the diabetes drug Avandia and the painkiller Vioxx.

Greenwood said Obama's term will probably begin with some welcome initiatives, such as the expansion of health care benefits for children, which could establish common ground between the new administration and drug developers. He also expects Obama to overturn the Bush administration's ban on federal funding for embryonic stem cell research, which was a thorn in the side of the biotech industry.

Drugmakers, however, may lose ground they had gained during Bush's presidency. For example, the Bush administration has asked the Supreme Court, in a pending case called Wyeth vs. Levine, to insulate drug companies from lawsuits by injured patients.

If the high court does so, Manthei said, the Democratic majority may easily change the law because the reduced Republican contingent no longer has as much power to resist.

"The margins are such that they could do things very quickly," the industry lawyer said. "It's a different day."


Food Biotech: Asthetics or Health Benefits?

November 8, 2008

Scientists have identified a gene in cattle, the expression of which is linked to the tenderness of meat. The researchers, at the University of Guelph, Canada, used DNA collected each year from semen of bulls used for breeding, to trace factors such as the weights of fat and bone, and lean muscle, in the animals once they are processed. A test called called the Shear Force Measurement is used to determine the force required to cut through a steak. With knowledge of which genes affect lean muscle mass and resulting tenderness of meat products, breeders can use selective breeding, or possibly other methods of optimizing gene expression, to enhance desirable traits into their herds. While this is great for farmers and consumers, is the asthetic improvement of a quality like meat tenderness really good use of our government funding?

While it's still a bit of a stretch, another research project at Guelph, in which the diets of pigs are being manipulated to enhance the amount of Omega-3 fatty acids in pork products, strikes me as having a little more value to taxpayers. Omega-3 fats, found predominantly in fish and certain seeds, are widely accepted as being healthy, contributing significantly to the mental development of children...so much so that they are added to food products geared towards children, such as school lunch-size yogurt packs.

Call me idealistic, but I'd rather see funding for agricultural biotech being used towards products that are going to significantly contribute to improved health and welfare of the masses, not just the ease with which a select few that can afford prime rib can run their steak knives through their dinner.

Source : http://biotech.about.com/b/2008/11/08/food-biotech-asthetics-or-health-benefits.htm

6 Nov 2008

Are Biotech Start-Ups A Bargain? Or Toast?

In a spate of recent articles, it would seem that the world has come to an end in terms of high-tech IPOs — not to mention venture backing of early-stage start-ups. Because of the recent market turmoil, the M&A market has has come to a screeching halt and the window of opportunity for IPOs has shut completely. Even angel investors are rethinking investment moves.

According to recent articles in Wired, VCs are mostly pumping money on hand into existing portfolio companies or in large, established start-ups that have already gone through several rounds of funding. What’s more, the slow down may hit the Midwest even harder. Mirroring the regoin itself, Midwest VCs have are a lot more conservative in their investing than coastal investors.

Companies looking to secure financing are needing to look beyond venture groups to a variety of non-traditional sources such as hedge funds, retirement accounts, family trusts, deposed dictators, individual or angel investors. Even the tried and true home equity route is shut down.

Reuters reported that the biotech industry has not seen an IPO since November 2007, when Nanosphere, which develops diagnostic tests, made its $113 million debut at the bottom of its price range. Since then, it is down 68 percent. Those waiting in line are finding no exit. In the last two weeks, nearly half of the biotech companies in the IPO pipeline have dropped out. Five biotech companies remain in the pipeline, with deals totaling $330.5 million, according to Thomson Reuters data.

All this is counter-intuitive. Biotechs are companies that generally sell products — diagnostics and therapeutics — that are unaffected by market conditions. Then why the long face for biotech start-ups? The market is skittish about the length of time for return on investment and the prospect of huge returns. Only seven of the 61 biotech companies to have gone public since 2000 are currently trading above their IPO prices.

So, what is selling? Biotechs with products ready for market. The venture spigot is off for early-stage companies including most any Phase 1 or Phase 2 stage company. Right now, companies on the early side of the curve will need to look to doing more partnerships and mergers.

While all the doom-and-gloom strikes fear in many start-ups and entrepreneurs say that money just isn’t flowing, it could be that this is the perfect time to invest. Start-up equity can be found cheap in this buyer’s market. OK, admittedly you don’t get money for have an idea scratched out on a bar napkin just because it involves the internet and sock puppets, there’s still opportunities to be had.

The key to survival in this market — as it should be in all markets — is having a great management team and a low burn rate.

Source : Patent Baristas

Novel Enteric Dialysis(TM) technology

Kibow Biotech, Inc. will be introducing the concept of Enteric Dialysis(TM) at the American Society of Nephrology (ASN) Renal Week 2008, being held at PA Convention Center in Philadelphia, November 4-9.

Dr. Natarajan Ranganathan, the key founder, VP (R&D) and interim CEO stated, "We are pleased and honored to present the latest developments concerning our patented and proprietary Enteric Dialysis™ technology to the international nephrology community at Renal Week 2008. We are extremely grateful to our scientific advisory board members who have guided and encouraged our R&D work over the past 10 years, supporting us in our belief that the elegant simplicity, cost savings, convenience and effectiveness of our probiotic-based technology will have profound clinical implications for the management of CKF in both advanced and developing countries”.

Kibow Biotech Inc., with headquarters in Newtown Square, Pennsylvania, will also be exhibiting Kibow Biotics(R), the company's core product, at the ASN meeting. Presented as an enteric coated gel capsule, Kibow Biotics(R) is an orally consumable formulation, intended to help improve the quality of life for chronic kidney failure (CKF) patients by possibly delaying the progression of their condition into End-Stage Renal Disease (ESRD stage V). Having a high affinity for uremic toxins, Kibow Biotics(R) works on the principal of Enteric Dialysis(TM) to remove the accumulated uremic toxins diffusing from the blood into the bowel.

Kibow Biotech is currently conducting a pilot- scale, double-blind, randomized, cross-over human clinical trial for a period of six months at 6 study sites in the USA (2 sites), Canada, Mexico, Argentina and Nigeria (www.clinicaltrials.gov - identifier NCT00760162). Kibow Biotics(R) is scheduled to be available for marketing and sale in the USA by early 2009 upon successful completion of the on-going multisite clinical trials in the aforementioned countries. Licensed to Vétoquinol, S.A., the veterinary application of Kibow's technology and its patented probiotic product formulation (trade named AZODYL™) for cats and dogs with moderate to severe kidney failure has been successfully sold in the US and in Canada since 2006.

About Kibow Biotics(R)
Kibow Biotics(R) is an orally administered patented formulation of specially developed strains of naturally occurring bacteria or microbes which metabolize targeted uremic toxins in the gut and consume them as nutrients for their own growth. Clinical evidence shows that it may reduce bloodstream concentrations of urea, uric acid, creatinine, indoles and phenols, nitrosamines and related uremic metabolites. Kibow Biotics(R) also promote maintenance of normal healthy gut flora.

About Kibow Biotech, Inc.
Kibow Biotech, Inc. is an eleven-year-old, developing-stage biotechnology company having its R&D operations in Newtown Square, PA, USA. The company is dedicated to finding a simple, convenient and cost-effective worldwide solution for patients suffering from chronic kidney failure. The company's first generation product called Kibow Biotics(R); an orally consumable, enteric coated gel cap product formulation is composed of food grade microbes ("Probiotics") which metabolize the uremic toxins diffusing into the bowel as a consequence of increased levels of these toxins in the blood. It is targeted to help augment or maintain kidney function for Chronic Kidney Failure (CKF) patients (pre-dialysis) and has the potential to reduce the duration and/or frequency of dialysis for End Stage Renal Disease (ESRD) patients.

For additional information, contact:
Kibow Biotech, Inc.
4629 West Chester Pike
Newtown Business Center
Newtown Square, PA 19073 USA
Tel: (610) 353 5130
Fax: (610) 353 5110

Source : http://www.einnews.com/pr-news/10529-novel-enteric-dialysis-tm-technology-to-be-introduced-by-kibow-biotech-at-asn-2008

Global meltdown raises joint venture opportunities in biotech

Unlike other sectors, the global meltdown may lead to more joint ventures and acquisitions among the foreign and domestic biotech compa
nies in the current fiscal, says the industry analysts.

"We have the knowledge of joint venture and merger opportunities for some of the Indian biotech majors," Ernst & Youngs Partner, Utkarsh Palnitkar said.

He predicted that there will be a paradigm shift in the biotechnology sector in the current year.

Endorsing the views of Palnitkar, the CEO of Ocimum Biosolutions Anuradha Acharya said, Indian (biotech) companies may acquire more foreign biotech units.

The valuations of most of the foreign biotech companies have receded due to global meltdown, she added.

Jupiter Bioscience Chairman and Managing Director Venkat R Kalavakolanu said that the global meltdown will also benefit the Indian firms to attract the key talent from the foreign companies.

He also added that the Indian biotech companies should focus acquiring biotech units in US & Europe, following the fall in their valuations due to global meltdown.

Palnitkar, who was associated with the Andhra government for drafting the biotechnology policy, observed that the biotechnology industry is now moving from fee based activity to risk & reward mode.

Source: ET

EU panel OKs 2 genetically modified corn products

The European Union's food safety agency approved two genetically modified corns Friday, putting renewed pressure on EU nations to drop their objections to the use of biotech crops.

Scientists at the Parma, Italy-based European Food Safety Authority, or EFSA gave clearance to a Bt-11 corn seed made by Switzerland's Syngenta AG and the 1507 corn made by the U.S.-based Pioneer Hi-Bred and Dow Agrosciences.

Both varieties offer resistance to insects, including corn borers and certain butterflies. They were already deemed safe by the agency in 2005, but were resubmitted for testing by the EU Commission in May amid fresh claims by environmental groups that they were a threat to the environment and human health.

The EU agency also said a French ban on another GM corn product, produced by U.S. biotech giant Monsanto Co., was unjustified. The EU granted approval to sell the seeds in the bloc in 2004.

Mike Hall, spokesman for Pioneer, welcomed the panel's opinion.

"This dossier has already been unduly delayed contrary to EU legislation for nearly four years now and we urge the speedy approval of 1507 so that European farmers can benefit," Hall said.

It will now be up to the European Commission to decide whether to issue the companies licenses to sell the products in the 27-nation bloc.The issue poses a headache for the Commission, which is trying to force reluctant EU governments to drop some national GM crop bans, amid increasing global pressure from Europe's trade partners.

The panel's decisions sparked a strong reaction from environmental group Greenpeace, which called on the EU to suspend the agency's power to issue safety checks until a full review of how the EU approves GM crops is done.

Greenpeace claims more research is needed to assess the long-term impact of altered crops on the environment and human health and alleges the scientist panel ignored evidence that the two crops could have a bad effect on biodiversity and the environment.

"EFSA is becoming the laughing stock of the scientific community. Rubber stamping anything the agro-biotech industry puts forward, with the blessing of the European Commission, is destroying its credibility," said Marta Vetier of Greenpeace.

EU countries are currently debating whether to change the way the bloc decides on granting user licenses to GM crops and seeds.

Many member states, including Greece, Austria, Poland and France are hesitant to adopt new crops fearing environmental consequences. Under EU rules member states have to approve new licenses unanimously. If they can't, the EU's executive commission makes the decision on behalf of all countries.

Source : AP

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