flu vaccines

Protein Sciences takes on Big Pharma in vaccines race

Thu, 23 Aug 2007 06:59:57 -0400

Big Pharma has a big stake in creating new flu vaccines, but tiny Protein Sciences in Connecticut believes it can get a new vaccine approved in '08. The big trend in vaccines today is to move away from egg-based production and into cell-based production, and Protein Sciences' approach is to inject flu genes into caterpillar cells. The protein that is expressed is used in the vaccine. The company may be small, but it has some big names at the top. CEO Daniel Adams is a co-founder of Biogen and David Fedson comes from Sanofi-Aventis.

- read the report from the Wall Street Journal (sub. req.)

Related Article:
Vaccine "renaissance" attracts huge new venture investments. Report

Press Release: GSK Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Maureen Martino — Wed, 17 Jan 2007 12:38:17 -0500

GlaxoSmithKline Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Company Begins Government and Retail Shipments of its Antiviral Relenza(R)
PHILADELPHIA, Jan. 17 -- GlaxoSmithKline, one of the world's largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK's ongoing pandemic vaccine research in using the company's innovative adjuvant technology in combination with antigens to induce a strong immune response.
Under the terms of the contract, GSK will engage in research and development leading towards licensure of antigen-sparing pre-pandemic and pandemic vaccines with adjuvant that will help the U.S. Government extend the limited North American supply of pandemic flu vaccines to protect larger populations in the event of a flu pandemic. The 5-year contract also gives the U.S. Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines.
"A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines," said David Stout, President of Pharmaceuticals at GlaxoSmithKline. "GSK's research in adjuvant technology over the past two decades uniquely positions our company to develop adjuvants designed to boost immune response and give broader protection while using smaller amounts of antigen. This award leverages our adjuvant expertise, and supports GSK's short and long-term vision of helping governments around the world in their pandemic preparedness efforts."
In a separate action related to pandemic preparedness GSK also announced that the company has begun shipping up to 15.5 million treatment courses of its antiviral Relenza® (zanamivir for inhalation). The Relenza shipments are part of GSK's agreement with the Federal Government announced last year to provide the U.S. Government and the states with Relenza for building their flu pandemic stockpiles. GSK also has started to ship Relenza to retail pharmacies to fulfill patient prescriptions for seasonal flu treatment and prevention.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
About GSK Biologicals
GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world's leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.
GSK's 2005-2007 Milestones in Pandemic Preparedness
January 2007: GSK begins supplying its antiviral Relenza® zanamivir for inhalation), to the U.S. Government and begins working with private-sector businesses and other organizations to provide Relenza as part of their business continuity planning.

December 2006: GSK received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use CHMP) for its candidate alum-adjuvanted pandemic vaccine. GSK plans to submit a file to the European regulatory authorities in the coming weeks for the licensing of both a pandemic and a pre-pandemic vaccine with our proprietary adjuvant system technology.

November 2006: GSK received a $40 million initial order for bulk H5N1 antigen from HHS.

2006: GSK signs contracts with several countries for pre-pandemic vaccines.

September 2006: GSK reached an agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting the right to manufacture and sell the antiviral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.

July 2006: Clinical studies announced by GSK showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

May 2006: GSK received an award of $274 million to develop cell-culture technology to speed the development of new cell-culture-based seasonal and pandemic influenza vaccines scale-up cell-culture manufacturing capability at GSK's Marietta, PA site.

2005: GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

VC: NovImmune garners $46M in second round

Wed, 01 Nov 2006 19:01:32 -0500

NovImmune garners $46M in second round

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
NovImmune Switzerland	$46M Second	BZ Bank and Private Equity Investors	NovImmune will use the funds to advance further products from its pipeline of fully human antibodies into clinical development.
VaxInnate Cranbury, NJ	$40M Third	Leaf Venture Partners and Canaan Partners	VaxInnate is developing new flu vaccines.
Esperance Pharmaceuticals Baton Rouge, LA	$9M First	Themelios Ventures Partners and Research Corporation Technologies	Esperance is developing a targeted anticancer fusion protein that is selectively toxic to cancer cells.

VaxInnate gains $40M in third round

Tue, 24 Oct 2006 20:01:36 -0400

VaxInnate, which is developing new flu vaccines, has raised $40 million in its third round of venture capital. The company is relying on its Toll-like receptor technology to develop a new generation of vaccines that are far more effective and less expensive to produce than today's vaccines. New Leaf Venture Partners led the round, joined by Canaan Partners. Existing investors HealthCare Ventures, Oxford Bioscience Partners, MedImmune Ventures, and CHL Medical Partners also participated in this round.

- see the release on the round

ALSO: Cytheris, a French biotech, has raised $30.7 million in its second round. The new round enables Cytheris to complete Phase II trials of its IL-7 program for HIV. The funds are also earmarked for the preclinical development of its new drug candidate selected from a NKT/Dendritic cell activators platform. Release

Plentiful supply of flu vaccine predicted

Thu, 05 Oct 2006 20:01:34 -0400

Health officials say that seasonal flu vaccines are arriving early and in plentiful supply this fall. And they hope that a record 115 million doses in the U.S. will avoid the shortfalls that have bedeviled the country for years.

- here's the article on flu vaccines from The New York Times

ALSO: One reason for the optimism was yesterday's announcement that the FDA has approved GlaxoSmithKline's FluLaval. Report

Researchers tout early results for bird flu vaccine

Mon, 28 Aug 2006 20:01:38 -0400

Chinese health officials are touting preclinical data for a new bird flu vaccine. A 10 microgram dose of the vaccine, which includes four antigens, created a 78.3 percent response in antibodies needed to protect people from bird flu. Beijing Sinovac Biotech Co says it is readying a second round of tests, well on the way to completing the three rounds health officials rely on for drug approvals in China. About a dozen companies are working on flu vaccines.

- read the report on the vaccine from the People's Daily

PLUS: Federal officials at the CDC have unveiled a new avian flu test that cuts the time it takes to analyze bird flu cases from a week to less than a day. Called FluChip, it incorporates genetic material on a microchip. The new test allows for mass testing and much quicker response times in dealing with flu outbreaks among people and animals. Report

FDA OK's flu vaccines, projects 100M doses

Wed, 02 Aug 2006 20:01:36 -0400

The FDA has signed off on the flu vaccines to be made for the upcoming season by GlaxoSmithKline, Chiron, MedImmune and Sanofi-Pasteur. Those four manufacturers are intended to supply 100 million doses of vaccine to the U.S. market, which is expected to be enough to satisfy demand. Federal officials have been working hard to try to even out the kinks in the supply of flu vaccines to the country, working to prevent the kind of supply snafus that have snarled treatment programs over recent years. But in a country of 300 million people, experts also note that they never see enough vaccine to satisfy the country's full needs. Given the limited shelf life of vaccines, though, manufacturers are reluctant to manufacture more than they can sell, leading to the balancing act that is undertaken each year.

- check out the report on flu vaccines from The New York Times

Novartis to build $600M flu plant in N.C.

Tue, 18 Jul 2006 20:01:39 -0400

With the help of a $220 million federal government grant, Novartis announced it will build a $600 million flu-vaccine manufacturing facility in North Carolina. Construction will begin in 2007 and the plant will be ready for vaccine production for the 2012 flu season. Novartis's decision to construct a new plant is an effort to update older manufacturing facilities that have had production problems in recent years. Rather than making the vaccine from chicken eggs, production at the new facility will obtain the vaccines using cell-culture technologies. It's a method that is quicker and more reliable to the traditional approach, though the FDA has yet to approved the method for flu vaccines. Novartis will pump out an estimated 50 million doses of the vaccine from the new plant.

The North Carolina facility will also be equipped to produce up to 150 million avian flu vaccines in the event of a pandemic. In early May, five pharmaceutical companies--MedImmune, DynPort Vaccine, GlaxoSmithKline, Novartis and Solvay Pharmaceuticals--won a combined $1 billion dollars worth of government contracts in the race to develop new technology to make flu vaccines needed to combat a human pandemic. Interestingly, the project's $600 million price tag is $200 million more than CEO Daniel Vasella had projected May.

- read this San Francisco Chronicle article
- check out this The Washington Post report for background on the government contract

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

SPOTLIGHT: BioSante reports adjuvant success

Sun, 23 Apr 2006 20:01:33 -0400

Shares of BioSante Pharmaceuticals were buoyed by the news that its vaccine adjuvant produced more bird flu antibodies in an animal study. BioVant is being developed with the company's calcium phosphate nanotechnology, which uses microscopic materials to deliver therapies. BioVant demonstrated steadily rising antibody levels over the 10 weeks of the study. Adjuvants are considered a vital ingredient in making bird flu vaccines effective for large numbers of people. Report

GSK upbeat on bird flu vaccine trials

Thu, 30 Mar 2006 19:01:37 -0500

The race for a new vaccine to fight a human outbreak of H5N1 has heated up as GlaxoSmithKline says it has begun human trials of two experimental bird flu vaccines. Researchers have made this new vaccine with an that boosts the vaccine's effectiveness. It is also boosting the hopes of GSK researchers, who believe that the new vaccines may be much more effective at combating bird flu than a competing vaccine that is being advanced by Sanofi-Aventis. Sanofi researchers said earlier this week that their vaccine has proven effective in only its highest dose for half of the patients taking it. GSK believes the adjuvant may also play a major role in making the vaccine effective for slightly evolved viruses.

- here's the Boston Globe article for more

ALSO NOTED: Chutes & Ladders: NitroMed CEO, CFO quit; Novavax selling $38M in stock; and much more...

Mon, 20 Mar 2006 19:00:50 -0500

> Chutes & Ladders: NitroMed CEO Michael Loberg and CFO Lawrence Block resigned today. No reason for their sudden departure was given. The company's stock has slid 44 percent this year. Report

> Novavax, which is developing avian and seasonal flu vaccines, is selling $38 million in stock. Report

> Anaclim, an Indianapolis-based clinical trial firm launched by two Lilly veterans, intends to do a better job recruiting minorities for drug studies. Article

> Codexis has signed a research collaboration pact with Schering-Plough. Release

And Finally… A debate has developed over the aggressive use of drugs to deal early on with schizophrenia. Article

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

Avian flu sparks shakeup in the vaccine world

Thu, 22 Dec 2005 19:01:39 -0500

Avian flu has been spreading slowly for more than two years now, but this year marked its elevation to above-the-fold headline treatment after President Bush started talking about using troops to enforce any possible quarantines that might be needed to contain a human outbreak of the disease. Since then, practically every new day has brought a fresh raft of news on the subject, and much of it shows the drug development world at its best. Only days ago, Sanofi-Pasteur disclosed that it believed it had developed an important new procedure for enhancing the effectiveness of flu vaccines.

The global spread of avian flu has helped drive big changes in the long-moribund world of vaccines. New manufacturing methods aimed at speeding production are being introduced at a time the industry is undergoing a new round of consolidation. Low margins had made vaccines a bad bet for the shareholder-value proposition that underlies our system of business. Now billions of dollars in new government contracts and a sense of urgency to combat nightmare diseases have helped electrify the field. This year marks a watershed in the vaccine business that will long be remembered.

Novartis considers opening vaccine plant in US

Wed, 02 Nov 2005 19:01:36 -0500

The CEO of Novartis said that the company would consider building a vaccine production plant in the US. Chiron is the only major US producer of flu vaccines, and Novartis' plan to buyout Chiron could leave the US heavily reliant on foreign companies to provide flu vaccines. Novartis won approval this week to buy the 58 percent of Chiron that it does not already own. If plans are made to open a new factory, Novartis will be looking for incentives from the government such as tax breaks. Given the increased concern of a flu pandemic, Novartis is likely to face pressure from the federal government to move quickly.

- read this article from The New York Times for more information

ALSO: Novartis has received FDA approval for Exjade, its once-daily oral treatment for chronic iron overload due to blood transfusions for adults and children age two and older. It is a novel, new drug that dissolves in water or juice and can be administered to children as young as two. Article

Flu vaccines losing ability to ward off disease

Wed, 21 Sep 2005 20:01:39 -0400

In a new study published in the Lancet, flu vaccines appear to be significantly less effective among the elderly than had been believed. One reason for the diminished effect in preventing hospitalizations, researchers concluded, is that seniors' immune systems have been seriously eroded. In another study just out, a class of vaccines called adamantanes has registered a sudden jump in germ resistance.

- read this story from the Washington Post for more

GSK grabs ID Biomedical for $1.4B

Tue, 06 Sep 2005 20:01:38 -0400

GlaxoSmithKline has struck a deal to buy ID Biomedical in an all-stock deal valued at $1.4 billion. The acquisition gives GSK operations in Canada and the US gearing up to produce 75 million doses per year of fluviral vaccine. GSK officials said the acquisition will help the company prepare for a global flu pandemic. This deal also marks another big step in the shakeout of the world's vaccine makers, with Novartis in hot pursuit of a Chiron acquisition.

"GSK has moved quickly over the past few months to meet the growing demand for flu vaccines worldwide and to transform GSK into one of the leading global influenza vaccine manufacturers," said Jean-Pierre Garnier, CEO of GSK. "The proposed acquisition of ID Biomedical is a unique strategic opportunity to increase current capacity of classic flu vaccines, to provide us with increased capacity for next generation flu vaccines under development and to help GSK prepare for the threat of a flu pandemic."

- read this press release for more