anthrax vaccine

Emergent BioSolutions buys flu vaccine maker

Tue, 27 May 2008 06:59:56 -0400

Emergent BioSolutions has inked a deal to acquire the Protein Sciences Corporation assets for up to $75 million. The move is part of Emergent's strategy to expand its product portfolio with a drug candidate focused on infectious disease. Currently, most of Emergent's business comes from government contracts for biodefense. Emergent will acquire PSC's ongoing operations, including FluBlok, a Phase III recombinant influenza vaccine candidate, and certain other assets. "The acquisition of FluBlok is consistent with Emergent's strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease," said Fuad El-Hibri, Emergent's CEO. The company recently bought rival VaxGen's anthrax vaccine business.

- check out Emergent's release
- read the Washington Post article

Struggling VaxGen sells anthrax vaccine to rival

Mon, 05 May 2008 06:59:57 -0400

After spending $175 million in an unsuccessful effort to push a new anthrax vaccine into the clinic, VaxGen has sold the program to Emergent BioSolutions for $2 million. VaxGen also stands to earn $8 million in milestones and an unspecified portion of any sales. Emergent, once VaxGen's bitter rival, believes the problems with the vaccine candidate have been sorted out and is a prime contender for a new government contract. VaxGen's vaccine program is also further advanced than any of the experimental vaccine programs Emergent is advancing.

The Washington Post points out that Emergent's competitive position shifted significantly after PharmAthene bought the rights to a next-gen anthrax vaccine developed by Avecia, making it a contender for a government contract to supply 25 million doses.

The deal for just pennies on its research dollar marks another bitter turn for VaxGen, which is now being operated by a skeleton crew in the wake of a failed merger. Last month VaxGen axed 75 percent of its remaining 22 workers.

- here's VaxGen's release on the deal
- read the article in the Washington Post

Shareholders stymie VaxGen, Raven merger

Fri, 28 Mar 2008 07:59:57 -0400

VaxGen and Raven Biotechnologies are backing out of their proposed merger after "stronger than anticipated opposition" from shareholders. The companies say that while they initially thought shareholders would go for the deal, it became apparent that they'd reject the plan. VaxGen develops drugs for the treatment and prevention of infectious disease, and Raven develops monoclonal antibody (MAb) therapeutics for cancer. Company officials hoped that the merger would put them at the forefront of the market for MAb cancer treatments.

"We are obviously very disappointed that the proposed merger with Raven was not approved by our stockholders," said James P. Panek, VaxGen President and CEO. "...[I]t has become quite clear that there is sufficient opposition, such that this merger will not be approved." The merger rejection is more bad news for VaxGen, which has been through three rounds of layoffs since the federal government canceled its $877 million anthrax vaccine contract.

- check out this release

Related Articles:
Momentum builds for VaxGen, Raven merger. Report
VaxGen slashes staff--again. Report

PharmAthene snares two vaccines in buyout

Tue, 25 Mar 2008 07:59:57 -0400

Annapolis, MD-based PharmAthene has agreed to fork over up to $40 million to acquire the vaccines unit of the UK's Avecia Biologics. The acquisition--which is being paid for with a mix of cash and milestone paydays--gives PharmAthene two mid-stage vaccines: an anthrax vaccine that has been tested in two Phase II trials and a plague vaccine that is scheduled to enter Phase II. Avecia gets $10 million up front, $10 million more in a year and $20 million in contract milestones.

''There is a tremendous unmet need for a second-generation anthrax vaccine,'' said PharmAthene CEO David Wright. We believe that Avecia's vaccine is uniquely position to meet the current government requirements."

- here's the release
- read the report from the Gazette

Related Articles:
PharmAthene to go public through merger. Report
Siga Technologies, PharmAthene to merge. Report
EMEA panel recommends goat-milk therapy. Report
PharmAthene finds backers for research pact. Report

PharmAthene finds backers for research pact

Mon, 14 Jan 2008 06:59:56 -0500

PharmAthene has gained some powerful support in Washington for its plans to expand a herd of genetically modified goats used in drug research by housing the animals at a USDA facility in Maryland. One of the state's senators, Benjamin Cardin, has introduced a measure in the farm bill that would permit just that in a public-private partnership. PharmAthene has been developing Protexia--a therapy produced in goats' milk and used to protect people from nerve agents--under Project BioShield. PharmAthene is also in a race to produce a new anthrax vaccine, a field where Human Genome Sciences is widely considered the leader.

- read the report from The Washington Post

Related Articles:
PharmAthene to go public through merger. Report
Siga Technologies, PharmAthene to merge. Report
EMEA panel recommends goat-milk therapy. Report

ALSO NOTED: GSK losing its grip on HIV market; Ranexa gets angina review; Start-up CRO takes flight;and much more...

Tue, 20 Nov 2007 06:59:50 -0500

> Watch out, GlaxoSmithKline. The market for HIV drugs may be expanding, but it's shifting like the San Andreas Fault at the same time, and more than a handful of companies are poised to challenge GSK for dominance. Report

> CV Therapeutics says that federal regulators will review Ranexa as an initial therapy for angina. Release

> A fledgling CRO, Veracity BioTechnology, has flown the incubator to begin research life on its own. President Victor Buckwold, Veracity's sole full-timer at this point, is specializing in testing hepatitis C therapies. Report

> Emergent BioSolutions says that HHS will continue to buy its anthrax vaccine under a fixed $400 million contract. Release

> Schering-Plough has completed the acquisition of Organon. Report

> SGX Pharmaceuticals will get $25 million through a private placement. Release

> Despite a black box warning, atypical antipsychotics do big business in nursing homes. Report

> VaxInnate is in a tight race to develop the first "universal" flu vaccine that would be able to tackle a variety of influenzas and do away with the annual winter jab. Report

> A new compound has proved effective in animal studies in restoring electrical activity in the muscles of muscular dystrophy patients. Report

> A small gene therapy study involving a handful of Parkinson's patients has produced impressive data indicating that they may be on to a potential breakthrough. Report

And Finally... PS3 gamers and a team of internationally renowned scientists have joined forces on global molecular project. Report

ALSO NOTED: MiddleBrook lines up $10M in financing; Cypress releases positive fibromyalgia data;and much more...

Thu, 08 Nov 2007 06:59:50 -0500

> MiddleBrook Pharmaceuticals has raised up to $10 million in a new pact with Deerfield Management. Release

> Cypress Bioscience released positive Phase III data for its experimental therapy for fibromyalgia. Release

> Neurochem is shifting focus. The company announced plans to move lead candidate NRM-8499 into preclinical development for the treatment of Alzheimer's disease and commercialize tramiprosate as early as 2008. Release

> Metabolon has inked a contract with the US Army Medical Research Institute of Infectious Diseases to use Metabolon's proprietary metabolomics platform to study the biochemical profiles of humans given the AVA anthrax vaccine. Release

> If simvastatin (Zocor) can cause insomnia and nightmares as a new study shows, then why doesn't pravastatin (Pravachol)? It seems that Zocor and its rivals Lipitor, Mevacor, and Vytorin are fat soluble, and so they cross into the brain easily. Pravachol, Crestor, and Lescol which are water-soluble, don't. Report

> Look for Boston Scientific workers at the nearest job fair. The device maker's previously announced job cuts--some 2,300, according to company forecasts--have begun. Report

> Expect lots of smiles and hand-shaking next month, when China and the U.S. are expected to sign a new drug safety pact. Report

And Finally… People who are overweight, but not obese, suffer from lower rates of a variety of ailments, including Alzheimer's, Parkinson's and lung disease, according to a new study on weight and health. That data has persuaded some experts to call for standards outlining healthy weight levels to be revised--upwards. Article

ALSO NOTED: Genzyme has made best offer for Bioenvision; Pfizer wants investigators to pursue ex-employee; GSK licenses IP; and

Thu, 27 Sep 2007 06:59:50 -0400

> Genzyme says its current bid for all the shares of Bioenvision it doesn't already own is its best and final offer. Release

> Pfizer wants the feds to throw the book at a former employee who copied personal data on some 34,000 workers and took it off site. Report

> GlaxoSmithKline has licensed reverse genetics IP for influenza vaccine strains from MedImmune. Release

> Medarex and PharmAthene have received a $14 million contract from the U.S. government to continue funding an anthrax vaccine. Release

> San Diego-based Asphelia Pharmaceuticals has named Francois-Xavier Frapaise, M.D.,as president and CEO. Release

> The FDA issued a warning yesterday on Fentora, the Cephalon painkiller recently linked to three deaths. Report

> As Novartis CEO Daniel Vasella predicted last week, the FDA has rejected the company's Cox-2 painkiller Prexige. Report

And Finally... Researchers at MIT have developed a computer model which they say can rev up the effectiveness of an antibody-based therapy. Report

VaxGen slashes staff--again

Fri, 14 Sep 2007 06:59:58 -0400

Troubled VaxGen is at it again: the company said it will reduce its workforce from 61 to 27 employees in order to lower its monthly cash expenditures used in operating activities to $1.4 million. The layoff includes executive officer Lance Ignon, Vice President of Corporate Affairs. This is the company's third round of layoffs: shortly after VaxGen failed to meet a federal deadline to restart human trials of an anthrax vaccine, the government canceled its $877 million contract.

"Throughout this year we have retained only those resources that management felt could build value for our shareholders, either because they enhanced our ability to complete a strategic transaction or they were required to meet essential business objectives," said James P. Panek, VaxGen's President and CEO. "Based on our understanding of the nature and structure of such potential transactions, we are now able to take this further restructuring action. We remain optimistic about completing a strategic transaction and are in various stages of discussions with a variety of companies."

- check out the release from VaxGen

Related Articles:
VaxGen shutters program, axes staff in second retrenchment. Report
VaxGen misses federal deadline on anthrax vaccine. Report
US cancels VaxGen's $877M vaccine contract. Report

ALSO NOTED: Semaphore closes $9.5M round; VaxGen looks to refocus; BioCryst wins $102M contract; and much more...

Thu, 04 Jan 2007 19:01:30 -0500

> Indianapolis-based Semafore Pharmaceuticals has completed a $9.5 million second round of venture financing. Much of the money will be used to advance Semafore's clinical program for SF1126, its lead PI3 Kinase inhibitor for the treatment of cancer. "This is an exciting time for Semafore, as we prepare to initiate Phase l clinical trials of our lead PI3 Kinase inhibitor SF1126 and transition into a clinical stage company," said John Sima, interim CEO and COO of Semafore. Release

> Fresh from losing a big contract for an anthrax vaccine, speculation is heating up about how VaxGen will restructure. The company got a $51 million boost from the sale of its Celltrion stock. Report

> BioCryst has won a $102 million contract from the U.S. government to develop peramivir as a therapy against seasonal and avian flu. Report

> A new study has provided data that shows that Herceptin combined with chemotherapy after surgery for breast cancer improves the chance of surviving three years after treatment. Report

> Enzon Pharmaceuticals has submitted an INDA to the FDA for its HIF-1alpha (hypoxia-inducible factor 1alpha) antagonist. Release

> Software-maker Accelrys is closing its R&D center in Bangalore, India and laying off 60 workers. Report

> MediciNova has established a subsidiary in Japan. Release

> Chutes & Ladders: Xytis Pharmaceuticals has named Vincent F. Simmon, Ph.D., president and CEO. Release

> Scientists at Taiwan University have developed a five-gene test that can help illuminate which lung cancer patients are likely to benefit from chemotherapy. Report

And Finally... Government plans to prevent the creation for animal-human embryos has attracted criticism from the country's scientific community. Article

Press Release: HHS Cancels VaxGen's Anthrax Vaccine Contract

Maureen Martino — Wed, 20 Dec 2006 12:52:40 -0500

HHS Cancels VaxGen's Anthrax Vaccine Contract

BRISBANE, Calif., Dec. 19 -- VaxGen, Inc. announced today that the Department of Health and Human Services (HHS) has terminated for default the company's contract to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. HHS based the decision on its determination that VaxGen "failed to successfully cure the condition endangering performance and failed to" meet a milestone imposed by HHS that required VaxGen to initiate a clinical trial of the vaccine candidate by December 18, 2006.

U.S. cancels VaxGen's $877M vaccine contract

Tue, 19 Dec 2006 19:01:37 -0500

The other shoe has dropped on VaxGen's troubled effort to develop a new anthrax vaccine for the U.S. government. Shortly after the company failed to meet a federal deadline to restart human trials, which had been stopped by the FDA, the government canceled its $877 million contract. The soured deal has become emblematic of everything that was wrong with the government's $5.6 billion Project BioShield, which had hoped that the prospect of major contracts would drive the development of innovative new therapies to counter a bioterror attack. Instead of gaining the involvement of big pharma, little companies like VaxGen jumped in.

The government recently shifted its strategy, providing new funds to back research rather than expecting companies to develop therapies on their own in the hope of signing contracts. But analysts say that the future of VaxGen--which has never produced an approved therapy and had already experienced a major setback in an earlier attempt to deliver a new AIDS vaccine--has become uncertain. VaxGen officials say they're still confident in their vaccine approach, which they spent $175 million developing. VaxGen has a smallpox vaccine in development and enough funds to make it through 2007.

- see VaxGen's release on the terminated contract
- read the article on VaxGen's contract woes from The Washington Post

Related Article:
VaxGen to miss deadline for anthrax vaccine. Report
VaxGen's vaccine program in doubt. Report
FDA puts hold on Phase II anthrax vaccine trial. Report

Press Release: FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial

Maureen Martino — Tue, 19 Dec 2006 11:21:28 -0500

FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial

BRISBANE, California – December 18, 2006 – VaxGen, Inc. announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.

At a recent meeting with CBER, which was also attended by OPHEP representatives, VaxGen presented its expanded number of methods for measuring the vaccine's potency and stability, and its progress toward further enhancing the stability of the vaccine's formulation. Based on that exchange, VaxGen believes that CBER wishes to engage the company in additional, more detailed technical discussions about the analytical methods and formulation development. However, the clinical hold will remain in place until sufficient vaccine stability has been demonstrated to resume clinical testing.

About VaxGen
VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax and smallpox. VaxGen has been awarded an $877.5 million contract by HHS to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. Based in Brisbane, Calif., VaxGen operates a wholly owned manufacturing facility in California and owns a minority interest in Celltrion, Inc., a company in the Republic of Korea established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company's web site at www.vaxgen.com.

Note: This press release contains "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding VaxGen's ability to address FDA/CBER's concerns over vaccine stability, to resolve the clinical hold imposed by FDA/CBER and to perform under its contract with HHS. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 8.01 of the company's Current Report on Form 8-K filed by VaxGen on February 16, 2006 under the heading "Risk Factors" for a more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Contacts:
Lance Ignon
Vice President, Corporate Affairs
(650) 624-1016

Kesinee Angkustsiri Yip
Associate Director, Corporate Affairs
(650) 624-1041

More R&D funds allocated for Project BioShield

Mon, 11 Dec 2006 19:01:35 -0500

Congress has substantially revised the troubled Project BioShield, agreeing to funnel a billion dollars into the research arena as it finds new ways to fund biotech companies during the developmental phase. The action, which was passed by the House late last week and by the Senate four days earlier, is intended to rectify a problem in the program. When Congress passed the bill two years ago, it intended to pay for new therapies to counter a bioterror attack on delivery. But as big biopharmas took a pass (unimpressed by the potential profits to be had), a number of smaller biotechs were left struggling to push programs through to development. VaxGen has been handling the largest project to date, but it's billion-dollar effort to find a vaccine for anthrax was recently stalled when the FDA prevented human testing last month due to concerns about drug reliability. The government has extended its deadline to get human trials underway again to December 18.

- read the Washington Post article on the new funds

Related Article:
BioShield revamp adds $1B in research funds. Report
New bioterror bill could provide fresh funds. Report
Report: Project BioShield fails to deliver. Report
VaxGen to miss deadline for anthrax vaccine. Report

ALSO NOTED: VaxGen gains extension; Merck wins latest Vioxx suit;and much more...

Wed, 15 Nov 2006 19:01:30 -0500

> Officials at HHS have granted VaxGen a one-month extension of its deadline to resolve a clinical hold on its troubled development program for an anthrax vaccine. The agency has threatened to cancel its contract with VaxGen unless it resolves the hold. Report

> Biotech drugs take longer and cost more than the traditional medicines fielded by the FDA, according to a new survey from Tufts University's Center for the Study of Drug Development. On average, a complex biologic costs $1.2 billion to approval over a period of 97.7 months. Report

> A federal jury has cleared Merck of any wrongdoing in the latest federal trial over Vioxx. Report

> Daryl Faulkner has been named president and CEO of Digene. Faulkner recently retired from Invitrogen. Report

> CollaGenex has sold $45.5 million in stock. Report

> Migenix has raised $10 million through a bought-deal financing package. Release

> AtheroGenics CEO Russell Medford says the company is on track to deliver late-stage data on the heart drug AGI-1067 in March of next year. Report

> Scientists at the University of Zurich have used stem cells obtained from fetal fluid to grow new heart valves for repairing damaged hearts. Report

> A host of experimental stem cell therapies are poised to make the switch from animal studies to clinical development. But as human studies begin, experts have been quick to warn against giving into the hype that life-saving treatments are just around the corner. Report

And Finally... Researchers have found two genetic mutations in H5N1 necessary to trigger a human pandemic. Their work may help signal a coming outbreak. Article

BioShield revamp adds $1B in research funds

Tue, 14 Nov 2006 19:01:37 -0500

In an effort to salvage the deeply troubled $5.6 billion Project BioShield program, Congress is scrambling to pass new legislation that would inject a fresh $1 billion into the project while establishing a central authority inside HHS to oversee the development of new vaccines. BioShield's single largest venture is its billion-dollar effort to develop a new anthrax vaccine at VaxGen. That project has been repeatedly held up and is now stymied by the FDA's refusal to allow human trials to get underway. HHS has also threatened to terminate the contract. Other projects, meanwhile, have been held up as developers struggle to push through programs the government can't pay for until they near approval. The government had thought its commitment to stockpile vaccines against a bioterror attack would gain the interest of large companies with deep enough pockets to fund research. But that formula has been a bust, as the big developers steered away from what looked like long odds on gaining short profits. The new money lawmakers are considering for Project BioShield would fund research, essentially acting as a billion-dollar venture capital outfit.

- check out the article on BioShield from The Washington Post

Related Articles:
Project BioShield fails to deliver. Report
New bioterror bill could provide fresh funds. Report
VaxGen's vaccine program in doubt. Report

FDA puts hold on Phase II anthrax vaccine trial

Thu, 02 Nov 2006 19:01:35 -0500

The FDA has put a clinical hold on VaxGen's next Phase II trial for its troubled anthrax vaccine, "because data submitted to date by the company are insufficient to determine that the product is stable enough to resume clinical testing." In the notification, VaxGen added, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome.

VaxGen has run into repeated trouble with the FDA over its anthrax vaccine. The agency has accused VaxGen of making exaggerated claims about the vaccine and threatened court action this year in an effort to make the company shape up. And the Washington Post reported last spring that trouble in developing the vaccine was delaying delivery past an agreed November deadline.

- here's the release on VaxGen

Related Article:
VaxGen's vaccine program in doubt. Report

Avecia anthrax vaccine shows promise

Wed, 27 Sep 2006 20:01:35 -0400

A Phase I trial of Avecia's anthrax vaccine produced data that demonstrates its safety and delivers early signs of efficacy. The U.S. government sees Avecia's development program as a key back-up to the $877 million contract that was signed with VaxGen. VaxGen's program, though, has been afflicted by a series of setbacks that has become the chief example of problems with the country's biodefense program. The UK-based Avecia is working with a $71 million contract. Their new data suggests that the vaccine is generating an immune response but the response is not as strong as the one delivered by the current vaccine.

- here's the AP report on the vaccine data

Emergent BioSolutions files $86M IPO

Mon, 14 Aug 2006 20:01:36 -0400

Gaithersburg, MD-based Emergent BioSolutions has filed an $86 million IPO with the SEC. Emergent didn't say how shares would be offered or the price range of the shares. The company ,which manufactures immunobiotics, operates both a biodefense and commercial business and its lead product candidate is BioThrax, an anthrax vaccine.

- here's the AP report on the offering

ALSO: Lexington, MA-based ActivBiotics plans to pursue an IPO worth up to $46 million. The company's lead drug Rifalazil is in Phase III testing for the symptoms of peripheral arterial disease. It's also in Phase II trials for arterosclerosis. Report

WP: VaxGen's vaccine program in doubt

Tue, 09 May 2006 20:01:38 -0400

The Washington Post has a follow-up to the ongoing travails of VaxGen's anthrax program. The report cites sources who say that the relationship between government officials and the company has becomes so contentious that the program's future is in doubt. Under its original contract, VaxGen was to start delivering anthrax vaccine by the end of this year. New revisions has pushed that back to 2008. The Bush Administration gave VaxGen the billion-dollar program to protect 25 million people from a potential bioterror attack.

- here's The Washington Post report for more