National Institutes of Health

Crucell wins $70M to develop new vaccines

John Carroll — Fri, 03 Oct 2008 08:54:20 -0400

Crucell has nailed a $70 million contract from the National Institutes of Allergy and Infectious Diseases to develop new vaccines to combat the Ebola and Marburg viruses. That contract will be worth $30 million initially with another $40 million in options.

"We are grateful to the NIAID/NIH for this award, which makes use of Crucell's proprietary AdVac technology," said Dr. Jaap Goudsmit, Crucell's CSO. "This award recognizes the scientific basis for using rare adenovirus serotypes to develop vaccines. The contract builds upon earlier work Crucell has performed with the Vaccine Research Center at NIH, and brings us a step closer to being able to provide effective countermeasures against a highly lethal infectious disease."

Crucell will be the primary contractor with additional services being supplied by the San Antonio-based Southwest Foundation for Biomedical Research Quintiles Guys Drug Research Unit in London.

- check out the Crucell release

SIGA gets $20M to speed smallpox antiviral work

John Carroll — Fri, 19 Sep 2008 09:51:46 -0400

SIGA Technologies is getting a $20 million shot in the arm from the National Institute of Allergy and Infectious Disease to accelerate development of the smallpox antiviral ST-246. The extra money will be used to supplement SIGA's existing $16.5 million contract, accelerating process development related to large-scale manufacturing and packaging of the drug and commercial-scale validation.

"Funding provided by this contract brings us one step closer to our goal of commercialization by allowing us to initiate commercial manufacturing of the drug in a timely manner and supporting the operating process," said CSO Dr. Dennis E. Hruby. "The support that we continue to receive from NIH for research and development of ST-246, we believe, speaks to the urgent need for a smallpox antiviral, as well as the continued success demonstrated by ST-246."

- check out the SIGA release

NIH earmarks $280M for research program

John Carroll — Tue, 02 Sep 2008 11:47:58 -0400

The NIH has earmarked $280 million over the next four years for nine institutions involved in small molecule screening programs to advance the use of chemical probes in researching new medicines. "This network marks a new era in academic and government research as NIH-funded scientists will have access to the tools for rapidly screening hundreds of thousands of small molecules against many novel biological assays at lower costs than previously possible," NIH Director Elias Zerhouni said in a statement. NIH release

Luxembourg launches new bioscience initiative

Fri, 06 Jun 2008 06:59:55 -0400

The Luxembourg government has turned to three prominent biomedical science leaders in the U.S. for an international collaboration to establish a bioscience center in the heart of the European Union.

The government announced an ambitious plan to increase the pace of innovation based on research in the areas of molecular biology, systems biology and personalized medicine. The initiative will include formation of a centralized biobank/tissue repository, two major projects to further research in the field of molecular biology, which is the cornerstone of personalized medicine, and a project to demonstrate the effectiveness of new diagnostics tests for earlier detection and treatment of lung cancer.

The U.S. organizations involved in the collaboration are: The Partnership for Personalized Medicine led by Dr. Leland H. Hartwell, director, Nobel Laureate in Physiology or Medicine in 2001 and president of the Fred Hutchinson Cancer Research Center in Seattle, Washington; The Institute for Systems Biology, also in Seattle, led by Dr. Leroy Hood, president of ISB and co-founder of U.S.-based Amgen Inc.; and Arizona's Translational Genomics Research Institute, led by Dr. Jeffrey Trent, president and scientific director of TGen and former scientific director at the National Human Genome Research Institute of the National Institutes of Health.

- check out the press release

Harvard prez says NIH funding system is broken

Thu, 24 Apr 2008 06:59:55 -0400

Harvard President Drew Faust has crunched the numbers on NIH funding of extramural research programs and concludes that the government-backed system to support biotech research efforts is broken. Out of the 47,455 grant requests made in the last fiscal year, only 10,100 were funded by NIH, says Faust. And that represented less than $4 billion of the NIH's $28 billion budget.

"The responses to rejected grants are downsized labs, lay-offs of post docs, slipping morale, and more conservative science that shies away from the big research questions," Faust told lawmakers. "Today, China, India, Singapore and others have adopted biomedical research and the building of biotechnology clusters as national goals. Suddenly, those who train in America have significant options elsewhere."

- read the report in Genetic Engineering

What's in store for stem cell treatments?

Fri, 11 Apr 2008 06:59:55 -0400

At yesterday's hearing on stem cells, the FDA set a high bar for the treatments, saying that any therapies would have to have very compelling data in order to move into human trials. The FDA's wariness is due to uncertainty about stem cells effects on the body. While the treatments show promise, researchers do not yet have all the answers regarding the long-term effects of such treatments. Tumors, in particular, are a concern. Geron, Novocell, Neuralstem and Advanced Cell Technology are nearing human trials--uncharted territory for stem cell therapies.

The FDA took a key step as it began drafting a blueprint for how the stem cell therapy trials would be conducted. "We've talked about how long we need to monitor people for, and the answer is forever," said Gordon Weir, a panelist on the advisory committee. "We're putting in these cells, and we don't know what they're going to cause in terms of trouble." Drug developers are looking to the FDA to elucidate the regulatory hurdles they'll face as stem cell therapies move through clinical trials. Without clear guidelines, drugmakers will face an unclear development process complicated by uncertainty and controversy.

- check out the CNNMoney article
- read this Wall Street Journal report for more

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Stem cell developers shift focus to FDA hearings

Thu, 10 Apr 2008 06:59:54 -0400

Everyone involved in embryonic stem cell programs will be paying close attention to hearings the FDA is holding on how they plan to regulate the field. Developers want a much clearer idea of the regulatory pathway they'll have to follow to gain approvals. And they're looking for some assurances that the agency won't adopt the political leanings of the Bush administration--a longtime opponent of ESC research--when it comes to making critical decisions. It's a tough position to be in, notes Richard Garr, CEO of Neuralstem, which is advancing adult stem cell therapies. Garr's "nightmare" scenario: Unresolved safety issues surrounding stem cells could cause the agency to apply the brakes on considering new therapies.

- read the story in The Wall Street Journal

ALSO: In new work that has both political as well as scientific implications, a team of scientists has been able to reprogram skin cells into functioning neurons and used them to eliminate symptoms of Parkinson's disease. Report

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Millennium chief scientist takes offbeat approach

Thu, 03 Apr 2008 07:59:55 -0400

The Scientist profiles Millennium Pharmaceuticals CSO Joe Bolen, whose team has been advancing a new therapy that targets molecules "upstream" from Velcade. The data will be released at the American Association of Cancer Research meeting. "We'll be the belles of the ball at AACR with this one," says Bolen, whose scientific journey started at the University of Nebraska and wound through 10 years of work at the NIH, where he won the institute's Meritorious Research for his work on protein tyrosine kinase oncogenes.

- read the profile in The Scientist

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SBA looks to boost grants to small biotechs

Mon, 31 Mar 2008 07:59:55 -0400

In a possible boon to the biotech industry, the SBA is looking to hike research grants to small U.S. businesses. And regulators are considering new rules that would allow grants to go to businesses owned by venture capital firms. Current laws require the grants to go to companies that are majority owned by American citizens or permanent alien residents. And the House appears to be ready to take a second look at new legislation that would allow the grants to go to companies so long as no single VC group owns more than 50 percent of the company. BIO has been actively pressing for the new legislation.

- read the article in the Dallas Business Journal

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Clinical trial data disappears in NIH laptop heist

Mon, 24 Mar 2008 07:59:58 -0400

After waiting for nearly a month, officials at the National Institutes of Health alerted some 2,500 people that their names, addresses and detailed personal health information gathered from heart scans in a clinical trial were purloined when an unknown person stole a government laptop with the data on it. NIH officials told the Washington Post that they had hesitated to contact the people, worried that they may be unduly alarmed by the news. But the report notes that the same kind of delay helped raise a hue and cry at the Veterans Administration after one of its laptops loaded with the personal data of U.S. servicemen was stolen. In the case of the NIH laptop, none of the data had been encrypted, as required.

"The shocking part here is we now have personally identifiable information--name and age--linked to clinical data," Leslie Harris, executive director of the Center for Democracy & Technology, told the Post. "If somebody does not want to share the fact that they're in a clinical trial or the fact they've got a heart disease, this is very, very serious. The risk of identity theft and of revealing highly personal information about your health are closely linked here."

- check out the article from the Washington Post

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ALSO NOTED: Memory refocuses on lead programs; GRL, Sirnaomics extend RNAi deal;and much more...

Wed, 12 Mar 2008 07:59:50 -0400

> Memory Pharmaceuticals is retooling its operations to focus less on drug discovery research a near-term and mid-term efforts. Report

> General Research Laboratory (GRL) and Sirnaomics are advancing their partnership initiated in July 2007 for development of two RNAi therapeutic products. Release

> Japan-based TPG Biotech and JCR Pharmaceuticals jointly announced that they have entered into an investment agreement to fund the late-stage clinical development of two drug candidates for JCR, JR-013 and Growject. Release

> Northwestern University scientist Richard Silverman's work led to the blockbuster Lyrica, which translated into more than $700 million in royalties from Pfizer. And his story--told by the Chicago Tribune--illustrates the crucial role that a technology transfer office can play in moving an experimental therapy into the hands of a biopharma company with deep pockets. Report

> The FDA is taking a look at a fresh set of standards that demand new tests to determine if diabetes drugs elevate heart risks. Report

> A group of some of the most prestigious research groups in the country says that five years of flat budgets for the National Institutes of Health is threatening to deter an entire generation of young researchers. Report

> Connecticut is joining the queue of states suing Eli Lilly over Zyprexa marketing. Report

> Scientists at the Virginia Bioinformatics Institute used a new computer modeling program supported by the NIH to simulate how a lethal pandemic flu outbreak could hit a modern American city. Report

> Since the Democrats took over Congress, drug makers have been scrambling to make nice with their former foes. Report

And Finally... According to a news CDC study, one in four teenage girls has an STD. Release

Stem cell outfits a winner in upcoming election

Wed, 27 Feb 2008 06:59:56 -0500

The nation's top biotech analysts have looked over the field of presidential candidates and announced a big winner: Stem cell companies. All of the three major presidential candidates have given their blessings to pumping up federal funding of research in the field--in a marked reversal to President Bush's steadfast stand on restricting funds related to embryonic stem cell research.

"Any candidate is going to have a better policy on stem cells than our current president," Ren Benjamin, biotech analyst for Rodman & Renshaw, tells CNNMoney. "If that's the case, then it will be good news not only for the companies working in the space, but for the space in general."

- read the CNNMoney report

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More feedback on negative data publishing

Tue, 22 Jan 2008 06:59:59 -0500

Recent exchanges over the publication of negative data continues to draw strong responses from FierceBiotech readers. Here's a sampling:

Wes McDermott, PhD, writes: "Jennie Mather's complaint that negative data is difficult to publish is well taken. Even if traditional journals can be made to accept such a paper, it would likely take more rewriting and shopping around of the manuscript than anyone would want to do. However, there is now a journal which aims to publish all scientific results on purely technical criteria. That journal is PLoS ONE. As they say:

"Too often a journal's decision to publish a paper is dominated by subjective criteria, which can be frustrating and delay the publication of your work. PLoS ONE will publish all papers that are judged to be rigorous and technically sound. Judgments about the importance of any particular paper are then made after publication."

There are already a number of clinical papers published at PLoS ONE. Given its success, I expect other online journals with similar editorial policies to be founded. I don't have any connection with PLoS ONE or PLoS (though I did do a small amount of volunteer work for PLoS a few years ago), but I do like the journals and the open access ethic.

From Lee Buckler: "Further to your ongoing discussion with Jennie Mather, there is the Journal of Negative Results in Biomedicine. I'm not sure it would work to have the FDA force publication. It might be easier to have the NIH tie it as a condition to funding, but that of course only impacts NIH-funded projects. I would think that if there are a sufficient number of respectable, peer-reviewed journals (print and/or online) accepting negative results, that we can count on researcher's motivation for publication to get this data out there. To date I think the primary issue, as Jeannie pointed out, is the lack of journals that accept these papers and perhaps some stigma associated with publishing negative data. I think there is room for one or more journals in the biopharm sector to make it a matter of policy--if not primary focus--to encourage the publication of negative results. Perhaps these exist already and simply need more profile or perhaps, as an industry, we can encourage one or two more publishers to see the opportunity here.

And finally: In general I agree with Dr. Mather's comments. However, mandating publication is fraught with problems as publishers of journals are independent agents and they ultimately need to please their readership to maintain and grow their subscription lists. It is unclear that increasing the number of negative studies will ultimately benefit them.

With respect to the FDA, its has limited resources and can't adequately monitor the increasing tasks Congress has heaped on it over the years without proportionately increasing its annual budget. We do have freedom of the press in this country and editors ultimately control what gets published and what does not. I think it can be strongly argued that such a mandate to force publication would be unconstitutional.

That's from Douglas Winship, vice president-regulatory operations, Catalyst Pharmaceutical Partners. Thanks for all your feedback. - John Carroll

ALSO NOTED: Cephalon, NitroMed make cuts jobs; IonGate gains funds; and much more...

Wed, 16 Jan 2008 06:59:50 -0500

> Cephalon is cutting jobs as it restructures, shifting manufacturing work from Minnesota to Salt Lake City and relocating some R&D work from Salt Lake City to Minnesota. Report

> NitroMed is in trouble. The company is not only shutting down its sales force and laying off 70 of the 90 people work work there, but asking the investment bank Cowen & Co. to advise it on "strategic alternatives." Report

> IonGate Biosciences has garnered €4.6 million in its third venture round. Heidelberg Innovation and KfW (Kreditanstalt für Wiederaufbau) led the round. Release

> Nycomed is looking for partners in the U.S. following the FDA's approval of Alvesco, its asthma inhaler therapy. Release

> ExonHit Therapeutics has created two commercial business units: the Molecular Diagnostics and Genomic Services Unit and the Therapeutics Unit. Release

> Germany's MorphoSys has acquired patent rights on protein inhibitors from the University of Melbourne, advancing its work on an experimental rheumatoid arthritis therapy. Release

> Teva Specialty Pharmaceuticals and UCB have signed a commercialization pact on Teva's respiratory products. Release

> MAP Pharmaceuticals and the FDA have reached a protocol agreement for a clinical study of MAP0004, a migraine therapy. Release

> Scientists in Singapore are advocating new rules that would permit researchers to splice human DNA into animals to further stem cell research. Report

> Research groups were left shaking their heads in disappointment over news that next year's budget for the National Institutes of Health--the largest single supporter of biomedical research in the U.S.--will boost spending by a meager 0.5 percent. Report

> Science has taken another big step in the direction of building new body organs from stem cells. A team of scientists have constructed a new rat heart, injecting cells from newborn rodents onto a scaffold of valves that were left intact after dead heart cells were removed. Report

> The European Commission has launched a pharma antitrust probe, looking for evidence that industrial hijinks are keeping new products off the market and delaying cheaper generics. Report

> It didn't take long for allegations of improper marketing from two Amgen sales reps to attract the attention of government watchdogs. First, the New Jersey Attorney General formed a task force to investigate pharma-doctor interaction. And now, perpetual pharma bloodhound Sen. Charles Grassley (R-IA) is sniffing around the cases. Report

And Finally... A new genetic test kit is being marketed that will give men an advance warning on going bald. Report

Ipsen, Salk Institute ink research pact

Fri, 11 Jan 2008 06:59:58 -0500

Paris-based Ipsen and the nonprofit Salk Institute have teamed up to create the Ipsen Life Sciences Program at The Salk Institute. Over the next three to five years, Ipsen will pay Salk $10 million dollars to research three disease areas: cancer biology, degenerative diseases and maladies associated with metabolic syndrome.

Declining funding from the National Institutes of Health to nonprofit research centers has made the nonprofits more likely to ink deals with paying companies. But critics say these research agreements can cause problems. They contend that companies reap the benefits of research paid for by taxpayers, and that scientist may be encouraged to pursue the most economically beneficial targets rather than discoveries with the most medical benefit for patients. In a similar recent deal, Pfizer agreed to pay the Scripps Research Institute $20 million a year for five years to help develop new therapies for diabetes, cancer, mental diseases and other conditions.

- check out this release on the deal
- see this report for more

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BayBio touts local biotech industry

Fri, 11 Jan 2008 06:59:56 -0500

BayBio, northern California's life sciences trade association, has released a study detailing the area's contributions the drug research field. Northern California currently houses one-third of the U.S. life sciences industry. The 1,377 life science companies and 90,000 employees currently market 408 drugs and technologies, and have 492 products in Phase II and Phase III clinical trials. Another fun fact? Every 10 to 14 days another new biotech springs up.

However, BayBio will still need to fight to keep its edge. "[W]e still face many hurdles, and complacency among policymakers is dangerous. In order to ensure success, we need action," notes BayBio President Matt Gardner. The trade group calls for legislatures to take several steps, including increasing the NIH and National Science Foundation budgets, investing in the FDA and patent office, and reforming patent legislation.

- see this BayBio release for more
- read this report for more

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VC model raises cash for rare disease drugs

Wed, 19 Dec 2007 06:59:56 -0500

The Wall Street Journal looks at the work of Boston-based venture capitalist Roger Kitterman, who has been able to coax investors to back badly needed therapies with none of the big upside that most would demand. He set up a shell company called Bezoloven that attracted angel backing for a grape-flavored therapy for lead poisoning, a category that developers had shunned and patient advocacy groups had ignored. By keeping trial costs down, Kitterman still projects the investors can double or triple their investments. And that same model could be used to fund other research programs into rare diseases.

- read the article from the Wall Street Journal

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Long delay seen for Merck's AIDS vaccine

Wed, 14 Nov 2007 06:59:57 -0500

The fallout over Merck's disastrous AIDS vaccine trial continues. There are new reports out that other developers have put their trials on hold while researchers and the FDA ponder the safety issues posed by Merck's program, which may have exposed trial participants to a heightened risk of contracting the virus. Merck is now going back to the trial participants to let them know about the extra danger they face.

"The recent Merck trial results were a big blow to the field," Dr. Gary Nabel, director of the National Institutes of Health's Vaccine Research Center in Bethesda, told the Baltimore Sun. Some now estimate that any new vaccine to protect people from AIDS is at least a decade away. But work in the field is continuing.

- see this report from The Baltimore Sun
- read the report on the trial participants

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NeoStem acquires Stem Cell Technologies

Wed, 14 Nov 2007 06:59:55 -0500

NeoStem has bought out Stem Cell Technologies, a subsidiary of Utek, in an all-stock transaction. Stem Cell Technologies has been focused on developing technology that allows developers to isolate rare stem cells called VSELs from bone marrow. The company says that the VSELs offer a versatile alternative to embryonic stem cells, a field that has been plagued by controversy and the Bush administration's funding restrictions.

"NeoStem is enthusiastic about this technology and its potential to help expand our proprietary position in the adult stem cell collection and storage arena as well as the burgeoning field of regenerative medicine," said Dr. Robin Smith, M.D., M.B.A., CEO of New York-based NeoStem.

- check out the release for more info
- read the report on the deal from Tech Journal South

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Merck, Dynavax ink $136M deal on hep B therapy

Thu, 01 Nov 2007 07:59:58 -0400

Merck has agreed to put up $31.5 million as a down payment for the worldwide rights to Dynavax Technologies' late-stage hepatitis B therapy. Merck will also cover the remaining development cost on the drug, pay royalties and fork out up to $105 million in milestones. On Tuesday Dynavax reported that Hepislav hit its Phase III endpoint; protecting older adults as well as healthcare workers.

Merck already markets a hep B therapy, but appeared to be attracted by an easier dosing schedule for Hepislav and its ability to work on the weakened immune systems of older people. Hepislav combines a segment of the hepatitis B virus and a DNA sequence that activates a toll-like receptor, triggering an early immune response. A spokesperson for Dynavax told The New York Times that the potential market for the drug--which could hit the market in 2010--at around $500 million. Berkeley, CA-based Dynavax also has partnerships with AstraZeneca and the NIH.

- see this release
- check out the report from Hemscott

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