Avian flu pandemic

BioCryst trial scuttled by short needles, fat arms

Tue, 13 Nov 2007 06:59:58 -0500

Clinical trial designers might want to pay extra attention to the travails at BioCryst. A mid-stage study of its lead therapy, the experimental flu med Peramivir, delivered disappointing data after researchers decided to switch their 1.5-inch needles with one-inch needles. The staff wanted to reduce the discomfort of injecting patients, but wound up failing to get the dose through the fat and into the muscles of many of their overweight trial subjects. As a result, the trial came up short of its primary endpoint. The drug is a potential therapy that can be deployed against a bird flu pandemic, which has earned BioCryst $103 million in U.S. research support.

BioCryst is pushing ahead, though. The FDA hasn't told the developer to repeat the Phase II trial and its researchers are rolling ahead into Phase III. Evidently no one has been fired, either, but you can bet the full dose hits home in Phase III.

- read the article from the Financial Times
- see BioCryst's original release on the trial failure

Related Articles:
BioCryst's peramivir flunks trial. Report
BioCryst begins mid-stage peramivir study. Report
Stonehouse tapped to run BioCryst. Report
BioCryst seeks approval for flu trial, signs deal with Roche. Report

ALSO NOTED: Pharmaxis touts late-stage study; ALS gains orphan drug status; H5N1 passed human-to-human; and much more...

Wed, 29 Aug 2007 06:59:50 -0400

> Pharmaxis says that a late-stage study of its experimental drug for a chronic lung condition demonstrated its effectiveness. Release

> Advanced Life Sciences says the FDA has granted orphan drug status to its cancer drug, ALS-357. Report

> Simmering fears of a bird flu pandemic have been heating up in the wake of a new study that confirms human-to-human spread of the deadly disease. Experts at Fred Hutchinson Cancer Research Center confirm that the avian influenza A (H5N1) virus in 2006 spread between a small number of people within a family in Indonesia. A number of biotech companies have joined the race to develop a vaccine against bird flu. Report

> Families of Spinal Muscular Atrophy and Tikvah Therapeutics announced a collaboration to accelerate the clinical development of TIK-201 for the treatment of spinal muscular atrophy. Release

> Tercica says it expects the FDA to make a decision on Somatuline Autogel later in the week. Report

> The FDA has accepted Merck's NDA for Cordaptive. Report

> Roche has lost turf to Amgen in their patent battle over Mircera, an anti-anemia drug now under FDA review. FiercePharma

> In another step under the patent shelter for AstraZeneca's Seroquel, the company won approval from Dutch regulators for an extended release form of the drug. FiercePharma

And Finally…The battle of the bulge is not going well for the forces of slim. A new study shows that obesity grew worse in 31 states last year, with no state posting an advance. Report

ALSO NOTED: Aegera raises $21 million; M&A activity soars; and much more...

Sun, 19 Nov 2006 19:01:30 -0500

> Canada's Aegera Therapeutics has raised $21 million in the first close of its third round of financing. The round includes $14 million in venture equity and $7 million in venture debt. Report

> Metrics: There have been $16.6 billion worth of mergers and acquisitions in biotech since July, compared to $2.6 billion in the first half of the year. Report

> The UK's Acambis might be one of the next takeover targets, analysts say, after the biotech company missed out on a big U.S. vaccine contract. Report

> UN Secretary General Kofi Annan is raising new warnings about the spread of biological weapons. Report

> Mountain View, CA-based VIVUS is raising $33.6 million through the sale of common stock. Release

> Dyadic has raised $12.3 million through a private placement. Report

> Chutes & Ladders: Lawrence C. Fritz has been named president and CEO of Anadys Pharmaceuticals. Fritz had been CEO of Conforma Therapeutics. Report

And Finally... Australia's chief medical officer says containment efforts may have successfully averted the threat of a bird flu pandemic. Article

WHO calls for $10B in bird flu vaccine research

Mon, 23 Oct 2006 20:01:35 -0400

The World Health Organization is warning governments around the globe that they need to invest another $10 billion if they expect to be able to stockpile enough vaccines to ward off a global bird flu pandemic. The WHO's global plan also calls for a big increase in seasonal flu vaccine production in order to expand vaccine production capacity and long-term R&D efforts to build better pandemic vaccines.

WHO would like to see annual production of seasonal vaccines boosted from 350 million to 560 million doses. And several billion dollars in new investments in R&D would offer the world a reasonable chance of gaining new vaccine protection from bird flu in three to five years.

- here's the report from the Financial Times for more information

Related Articles:
Indonesia agrees to release bird flu data. Report
WHO study points to threats of avian flu. Report
The challenges of infectious disease. Report

ALSO NOTED: Pharmacopeia gains funds in research deal; Serono sees better response for Rebiff formulation; and much more...

Wed, 27 Sep 2006 20:01:30 -0400

> Pharmacopeia Drug Discovery is gaining new research funds from an extension of its development pact with Schering-Plough. Schering-Plough is funding 10 full-time researchers along with milestones for new drug candidates. The collaboration is being extended to April 2007. Report

> Serono announced that new data shows that a new formulation of its bestselling Rebiff for MS shows that it has improved tolerability and antibody formation. Report

> Nitec Pharma announced positive results in a Phase III clinical trial with Lodotra, a modified-release tablet that has been developed to optimize the efficacy of orally administered low-dose prednisone in rheumatoid arthritis. Release

> Inyx Pharma has inked a deal to buy Pharmapac UK, a contract pharmaceutical production and packaging provider, for $17 million. Release

> Shares of Germany's MediGene were buoyed by the news that it had received a patent on its cancer drug candidate EndoTag-1. Report

> Discovery Laboratories says it has addressed the FDA's concerns on Surfaxin and is seeking a meeting with regulators to push for approval of the lung therapy. Report

> EpiCept's stock jumped after its collaborator Myriad Genetics reported positive Phase I data for a new brain cancer therapy, Azixa. Report

> Threshold Pharmaceuticals has won orphan drug status for its pancreatic cancer therapy glufosfamide. Report

> Researchers have concluded that the active ingredient in Accutane appears to cause depression-related symptoms in mice. Report

> GlaxoSmithKline has licensed a Chinese company to manufacture Relenza for stockpiles against a potential bird flu pandemic. Report

> XOMA announced it will manufacture and supply AV-299, AVEO's anti-HGF antibody, in support of early clinical trials. Release

And Finally…In an editorial, The New York Times supports the IOM's position urging additional funding for the FDA. Editorial

ALSO NOTED: Serono inks pact with Syntonix; Sanofi mentioned as possible BMS suitor; and much more...

Sun, 17 Sep 2006 20:01:30 -0400

> Serono has signed a development and commercialization pact with Syntonix Pharmaceuticals for its FSH:Fc candidates to treat infertility. Syntonix gains a collaboration fee and will stand to earn up to $54 million in milestones if Serono exercises its option in the deal. Report

> You can add the name of Sanofi-Aventis to the growing list of potential suitors for Bristol-Myers Squibb. Article

> GlaxoSmithKline has filed for U.S. approval of Tykerb in combination with Xeloda for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in women who have received prior therapy. Release

> Tenby Pharma, a shell company, has acquired Sirion Therapeutics and arranged $25 million in financing. Report

> Opexa Therapeutics is reporting positive data for its Phase I/II trial of the MS drug Tovaxin. The drug developer has also announced the launching of its 150-patient Phase IIb Tovaxin trial. Release

> The European Commission has granted orphan medicinal status to Nektar Therapeutics' Amphotericin B Inhalation Powder. Release

> Schering has granted an exclusive worldwide license to Bausch & Lomb to develop and market a selective glucocorticoid receptor agonist for the non-systemic treatment of eye disorders. Release

> The World Bank estimates that a bird flu pandemic could cost between $1 trillion and $2 trillion, or about three percent of global GNP. Report

> Chutes & Ladders: Targanta Therapeutics has named Mark Leuchtenberger as the company's new president and CEO. Release

And Finally… New research indicates that 40 percent of the people who get botoxed become addicted to the cosmetic procedure that paralyzes facial muscles. Report

Sinovac to mass produce bird flu vaccine

Wed, 30 Aug 2006 20:01:38 -0400

China's Sinovac Biotech says it plans to ramp up mass production of a new bird flu vaccine after its first clinical trial found no adverse reactions among the 120 participants in the study. Sinovac says it expects to produce 20 million doses of the vaccine annually within a few years. "These results indicate that we should expand our production capabilities to prepare for mass production of the vaccine against a possible bird flu pandemic," a company spokesperson was quoted as saying by Xinhua on Wednesday. The vaccine faces two more rounds of testing before it can be approved for marketing under existing Chinese regulations. A number of vaccine makers, though, have noted that the usual rules for producing a vaccine are likely to be discarded in the event a human pandemic breaks out.

- read a report on Sinovac's plans from The Independent

WHO study points to threats of avian flu

Sun, 02 Jul 2006 20:01:38 -0400

A new study by the World Health Organization concludes that the number of avian flu cases is likely to spike again this winter as the average age of the victims who die of the virus slowly drops. Overall, bird flu killed 56 percent of the people who caught it, with most falling in the age range of 10 to 19. The virus is difficult to catch, the report adds, but notes that with the H5N1 virus widely spread in poultry, the chances of it mutating into a form that can trigger a human pandemic remains high. These trends reflect the development of the 1918 Spanish flu pandemic, which killed 2 percent of all the people who caught it and 5.7 percent of young people.

- read the article on avian flu from The New York Times

PLUS: A group of health experts meeting in Paris say that it could take 10 years to develop a vaccine that would protect the world's population from a bird flu pandemic. Report

Feds allow emergency testing without permission

Thu, 08 Jun 2006 20:01:35 -0400

A new federal rule allows health officials to use experimental tests to determine why patients are ill during a public health emergency without the patient's permission. The rule allows labs to run blood and other tests in the event of a bioterror attack, bird flu pandemic or dirty bomb attack. But patient advocates maintain that labs are left to decide for themselves what constitutes a public health emergency, raising the prospect that conflicts of interest may play a role in their decisions.

- here's this Wall Street Journal report (sub. req.)

U.S. hands out $1B in vaccine contracts

Thu, 04 May 2006 20:01:39 -0400

Five pharmaceutical companies won a billion dollars worth of government contracts in the race to develop new technology to make flu vaccines needed to combat a human pandemic. U.S.-based MedImmune and DynPort Vaccine along with Europe's GlaxoSmithKline, Novartis and Solvay Pharmaceuticals will divvy up the money. Novartis plans to do its vaccine work at the newly acquired Chiron facilities in California.

For MedImmune, it's a welcome bit of good news for its beleaguered FluMist program that relies on a weakened live virus to protect people from flu. MedImmune is converting a Maryland plant to produce cell-based vaccine, which is a much more efficient process than the traditional manufacturing method that relies on eggs. If all works according to plan, the five companies will be able to produce 300 million doses of vaccine in six months. The downside is that the work will take five years, and no one is sure when or if the deadly H5N1 virus that is circulating around the globe will mutate into a virus that is readily transmitted among people.

- read the report from the Washington Post

ALSO: A serious bird flu pandemic would not only sicken a third of the population, it would seriously destabilize the U.S. economy. The government's plan estimates that a pandemic could cost the country $600 billion in lost income. Article

Novartis wins $220M flu vaccine contract

Wed, 03 May 2006 20:01:37 -0400

Novartis has won a $220 million contract to supply cell culture-derived flu vaccine to the Department of Health and Human Services. The deal will help support seasonal flu programs as well as preparation efforts for a possible bird flu pandemic and the biopharma giant announced plans to create a new manufacturing site in the country using a biotech process to make vaccines. "We will be investing additional resources in highly skilled researchers to set up one of the first flu cell culture manufacturing sites in the US. This plant will contribute to America's vaccine infrastructure for seasonal flu and support the US government's ability to respond quickly to a potential pandemic, with access to new technologies to ensure sufficient capacity," said Novartis CEO Dr. Daniel Vasella.

- read the release on the contract

PLUS: A new study indicates the ideal dosage of Tamiflu for fighting bird flu. Article

ALSO: Noted virologist Robert Webster says that cultural prohibitions on autopsies in Asian countries are hampering scientific efforts to understand bird flu. Report

U.S. to buy 95 million flu drug doses

Tue, 02 May 2006 20:01:38 -0400

The federal government plans to stockpile 75 million doses of antiviral drugs and 20 million doses of an experimental vaccine to help combat a potential bird flu pandemic. The plan is expected to be released later today, but The New York Times was briefed on the essential outlines of the government's response. In addition, the government has outlined plans to have police and the National Guard maintain public order, with help from the military as needed. And businesses are being encouraged to develop plans that would factor a 40 percent absenteeism rate during successive waves of bird flu outbreaks.

- here's the New York Times report on the plan

ALSO: Shares of Vical, meanwhile, soared 31 percent after the drug developer announced promising results from an animal study of its experimental bird flu vaccine. The vaccine completely protected mice and ferrets exposed to the virus. Investors were particularly enthused by signs that the vaccine could work against multiple strains of the virus. Any human pandemic requires a viral mutation that can significantly alter the way it works, and change its response to more narrowly targeted therapeutics. Report

ALSO NOTED: PerkinElmer buys Spectral Genomics; Europe OKs early use of Herceptin; and much more...

Mon, 01 May 2006 20:00:50 -0400

> PerkinElmer has acquired the screening and diagnostics company Spectral Genomics for an undisclosed amount. Report

> European regulators have backed a request to make Herceptin available for early-stage use against breast cancer, a move that is likely to significantly increase sales while adding new cost pressures to government health agencies. In the U.S., the FDA is giving the application for early use a priority review. Herceptin is sold by Genentech and Roche. Article (WSJ sub. req.)

> Efforts to provide $150 million in state support for the biosciences are running into resistance in Arizona's legislature. Report

> Chemokine has begun a Phase Ib/II trial of its cancer therapy CTCE-9908. Report

> Novocell has hired Alan Lewis as president and CEO. Report

> The FDA will accept Critical Therapeutics' NDA for a time-controlled release version of zileutin. Report

> Tanox has released 48-week results for its HIV drug TNX-355. Report

> Telik has begun a Phase III trial of a combination of Telcyta and Doxil for ovarian cancer. Release

And Finally… A federal plan to deal with a bird flu pandemic is scheduled for release tomorrow, with recommendations for quarantining patients, keeping workers three feet apart and providing surgical masks to sick airline passengers. Article

Vaccine industry regains its luster for investors

Sun, 16 Apr 2006 20:01:38 -0400

With Novartis poised to win control of Chiron on Wednesday, the Wall Street Journal takes a look at the sudden popularity of the vaccine business. Long considered a marginal endeavor, new fears of a possible pandemic have boosted government spending and helped make vaccine makers look more attractive than ever. Also driving this trend are new technologies that promise to make manufacturing vaccines much less complex. New investments should help avert any repeats of Chiron's debacle two years ago when UK regulators forced the company to temporarily shut its UK facility.

- here's the Wall Street Journal report on vaccines (sub. req.)

ALSO: The government's nearly completed bird flu pandemic plan is calculating that up to 90 million Americans could be infected and two million could die from a potential outbreak. Article

ALSO NOTED: OrthoLogic CEO resigns; Tapestry Pharmaceuticals raises $25.5M; and much more...

Wed, 05 Apr 2006 20:00:50 -0400

> Chutes & Ladders: OrthoLogic announced that president and CEO James M. Pusey, MD, has resigned to pursue other opportunities. Release

> Tapestry Pharmaceuticals of Boulder, CO has raised $25.5 million through a private placement. Release

> In a new report, the Center for Public Integrity says that drug makers spent $52 million in 2003 and 2004 lobbying state governments and supporting local candidates for office. The surge in state lobbying efforts was directly tied to the growing debate over how states handle drug prices and mandates. Article

> GSK has licensed Kissei's experimental diabetes drug, which is still in the preclinical stage. Report

> Congressman is calling for an investigation into VaxGen's $877 million contract for an anthrax vaccine, citing concerns over reports that VaxGen's program is off schedule and the company has made false claims about its effectiveness. Report

> Researchers say they have discovered new factors that could contribute to better pain drugs. Report

> Barr Pharmaceuticals has pulled its application for low-dose Seasonale after determining the FDA would need new clinical trial data to support it. Report

> The UK's IOMAI has announced positive results for its Phase 1/2 clinical trial of its dry vaccine patch for travelers' diarrhea. Release

> Roche says that Xeloda was as effective as standard therapy for treating stomach cancer. Report

> Valera Pharmaceuticals has completed the clinical portion of its Phase III study of Supprelin LA, for treating for treating the early onset of puberty and plans to file an NDA in the second quarter. Release

> FIBREX Medical says it has successfully completed a first dose in man study with its lead product, the anti-inflammatory peptide FX06 for preventing reperfusion injury. Release

And Finally…The prospects of a bird flu pandemic has analysts speculating on which life insurers face the biggest risks. Article (WSJ sub. req.)

FDA to speed vaccine development

Thu, 02 Mar 2006 19:01:39 -0500

The FDA has drafted new guidelines aimed at cutting the development process for new flu vaccines by one to two years. These guidelines outline the data that developers will need to provide to gain the agency's approval. The FDA has been pushing a variety of new measures aimed at speeding the development process. The change includes a fresh look at live virus treatments delivered through a nasal spray. The agency is particularly interested in fostering new technology for the speedier introduction of vaccines that can fight both traditional flu as well as a possible bird flu pandemic.

- read this AP report for more information

PLUS: Australia's Biota says it is well positioned to earn royalties from the huge demand that has developed for the anti-influenza drug Relenza. Report

ALSO: With countries around the globe shunning French poultry in the wake of a bird flu outbreak, the country's poultry industry is losing $48 million a month. Report

ALSO NOTED: Tequin study highlights blood glucose concerns; HHS orders more antiviral drugs; and much more...

Wed, 01 Mar 2006 19:00:50 -0500

> A new study of the popular antibiotic Tequin shows it is linked to threatening changes in the level of blood glucose. Report

> The Department of Health and Human Services has ordered more than 14 million doses of antiviral drugs from Roche and GlaxoSmithKline in preparation for a potential bird flu pandemic. The Bush administration plans to treat about 25 percent of the population in the event of a pandemic, but there are no assurances that the drugs will work against a mutation in the virus that triggers human-to-human transmission. Report

> HHS Secretary Michael Leavitt says that bird flu may soon appear in domesticated and wild bird flocks in the U.S. Article

> The U.K.'s Alizyme has reported positive results from a Phase IIa trial of ATL-104 for mucositis. Release

> Rebel investors at SkyePharma renewed calls to install Bob Thian as the new chairman at the March 9 Extraordinary General Meeting. Report

> King Pharmaceuticals has acquired the exclusive rights to market and sell EpiPen in Canada from Allerex Laboratory. Release

> Novelos Therapeutics announced a $12.9 million private placement. Release

> BioScrip has acquired Intravenous Therapy Services for $13 million plus earn-out payments. Release

> And Finally… The New York Times examines the sudden popularity of Byetta, a new diabetes drug that has helped diabetics shed pounds and regain their health. Article

EU approves Tamiflu for children

Mon, 30 Jan 2006 19:01:38 -0500

The European Union has approved the use of Tamiflu to prevent flu in children. The antiviral drug was cleared by the FDA for children in December. The twin approvals are aimed at giving doctors another weapon to stop the spread of influenza. Children are much more likely than seniors to contract and die from the flu. Governments around the world have also been stockpiling Tamiflu in the hope that it would help protect people in the event of a worldwide bird flu pandemic.

- read this report from the Financial Times

ALSO: A 15-year-old Iraqi girl has died of avian flu, marking the spread of the virus to another country. Report

Sanofi-Pasteur touts new method for upping vaccine potency

Wed, 14 Dec 2005 19:01:37 -0500

Researchers for Sanofi-Pasteur say they have developed a new prototype of a flu vaccine that could be effective in preventing a potential bird flu pandemic. The company says that by adding a new ingredient called alum to the vaccine they're able to make supplies more potent, allowing health officials to use stockpiles for a larger group of people. Adding potency to vaccines has been a key strategy in the frenzied push to equip the world with larger, more effective vaccine stockpiles.

- see this AP report for more information

Gilead shares surge after $62M Tamiflu settlement

Tue, 15 Nov 2005 19:01:38 -0500

Shares of Gilead Science surged to a 52-week high in early trading this morning after it announced that Roche would pay $62.5 million in adjusted royalties for Tamiflu, the antiviral drug governments around the globe are clamoring for to help protect people from a possible bird flu pandemic. Gilead licensed the drug to Roche in 1996. Last June, Gilead triggered the dispute when it claimed that Roche has neglected to market the drug properly. A joint committee will now oversee production of Tamiflu.

- read this AP report for more