Replies to post #80419 on Biotech Values

[gym gravity]

NOVAVAX Virus-Like Particle Vaccine Protects Against 2009 Pandemic H1N1 Influenza Virus
First report of a vaccine protecting ferrets against the 2009 pandemic H1N1 virus
Press Release
Source: Novavax, Inc.
On Tuesday August 18, 2009, 8:00 am EDT

ROCKVILLE, Md., Aug. 18 /PRNewswire-FirstCall/ -- Novavax, Inc. announced positive preclinical results with Novavax's 2009 novel H1N1 influenza virus-like particle (VLP) vaccine. The study, conducted by scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets. The ferret model is widely accepted to be the most appropriate animal model for evaluating influenza disease and vaccines. Novavax scientists designed the vaccine using recombinant virus like particles (VLP) technology against an H1N1 virus strain (A/California/04/2009) isolated in the beginning of the 2009 H1N1 outbreak.

Novavax produced the candidate vaccine and delivered it to the CDC in less than four (4) weeks from the day the genetic sequences of the virus strain became available. The speed at which this was accomplished is a testament to the fast response afforded by Novavax's proprietary, recombinant cell-based VLP technology which is not dependent on growing influenza virus in eggs and the development of virus seed stocks.

The Novavax VLP vaccine candidate protected ferrets against the 2009 novel H1N1 virus. The ferrets received a 3.75, 7.5, or 15.0 mcg dose of the 2009 H1N1 VLP vaccine or a placebo and were boosted with a second dose after three (3) weeks. All of the H1N1 VLP vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, considered a protective level of immunity, against the H1N1 virus. Remarkably, even after receiving a single dose of 7.5 or 15 mcg 2009 H1N1 VLPs, the animals developed an HI titer of 1:40 or higher against the H1N1 virus.

Vaccinated animals were challenged with nasal exposure of live H1N1 A/Mexico/4482/2009 (MX/4482) influenza virus strain that was distinct from the H1N1 A/California/04/2009 strain against which the vaccine was derived. The MX/4482 challenge strain was isolated in Mexico from a female patient with severe respiratory disease and was described in a study published on July 24, 2009 in the journal Science by the CDC and Harvard-MIT Division of Health Science and Technology. In that study, this virus strain was demonstrated to replicate efficiently in the respiratory tract and cause significant disease in ferrets. After three (3) days post challenge, animals immunized with the 15 mcg dose of the H1N1 VLP vaccine had no detectable virus recovered in nasal washes and showed no signs of disease. By day five (5) after challenge, immunized ferrets at all vaccine dose levels had cleared the H1N1 virus and showed no sign of disease. In contrast, control animals that received no vaccine displayed lethargy, elevated body temperatures and shed infectious virus for up to six (6) days post infection.

"Demonstrating that our influenza VLP vaccine candidate protects against the pandemic H1N1 virus in an animal model is another important milestone for us to have met," said Dr. Gale Smith, Vice President of Vaccine Development. "An even broader significance of this study is that these data, for the first time, indicate that a vaccine against H1N1 A/California/04/2009 influenza strain has the potential to protect against the 2009 pandemic H1N1 virus."

About Novavax

Novavax is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches.

http://finance.yahoo.com/news/NOVAVAX-VirusLike-Particle-prnews-3270228500.html/print?x=0

[DewDiligence]

FDA Panel Endorses Prevnar-13 by 10-1 Vote

[Prevnar is one of the gems PFE picked up in the WYE acquisition (#msg-39901146), and this vaccine franchise has plenty of room for growth from an eventual approval for adults. Based on today’s closing price, PFE shareholders have enjoyed a 60% return from the Mar 2009 low including reinvested dividends.]

http://www.reuters.com/article/marketsNews/idCNN1812693020091118

›Wed Nov 18, 2009 5:53pm EST
By Lisa Richwine

BETHESDA, Md., Nov 18 (Reuters) - Pfizer Inc (PFE) won a key endorsement on Wednesday for a new version of a blockbuster vaccine that fights pneumonia, meningitis and other diseases caused by pneumococcus bacteria.

A Food and Drug Administration advisory committee voted 10-1 the Prevnar 13 vaccine was safe and effective for infants and toddlers. The vaccine is the most important experimental product the company acquired in its recent purchase of Wyeth.

The FDA usually approves products that win support from advisory panels. A decision on Prevnar 13 is due by Dec. 30.

The vaccine is designed to fight 13 forms of a bacterium called streptococcus pneumoniae, or pneumococcus.

The original Prevnar, which targets seven strains, was introduced in 2000 and has annual sales around $3 billion.

Company officials who argued in favor of Prevnar 13 to the FDA panel said the incidence of pneumococcal disease in children under five had dropped sharply after the introduction of the original vaccine.

They estimated the added protection from Prevnar 13 could reduce deaths from pneumococcus by an extra 9,800 over 10 years. The new vaccine targets a strain called 19A that has emerged as the most common cause of pneumococcal infection in the United States.

"We're very gratified to have achieved a positive recommendation," Dr. Emilio Emini, Pfizer's chief scientific officer for vaccine research, said after the panel ruling.

FDA reviewers said some measurements used in a Pfizer study failed to show the vaccine was equivalent to the original Prevnar for three of the strains. Panel members said they felt confident Prevnar 13 would be effective based on levels of infection-fighting antibodies that were seen.

Pamela McInnes, a researcher at the National Institutes of Health, said there were "quite compelling data in terms of functional antibodies. I'm very persuaded by that."

Potential side effects were similar with Prevnar 13 and the original shot and included tenderness at the injection site and irritability. Both vaccines require a total of four injections given at two, four, six and 12 to 15 months.

Vicky Debold, the panel's consumer representative and sole vote against Prevnar 13, questioned if the risks were fully understood as potential side effects were compared with the original Prevnar.

"I'm having a really hard time understanding how we can understand safety comparing Prevnar 13 to Prevnar," said Debold, director of patient safety at the National Vaccine Information Center.

Prevnar 13 also is being studied for potential use in adults, a new use that could accelerate already booming sales of the franchise.

Pneumonia caused by the pneumococcal organism is one of the biggest causes of death in older people and its incidence begins to increase after age 50.

GlaxoSmithKline Plc (GSK) has a rival vaccine, called Synflorix, that is active against 10 strains. Synflorix is approved in Europe and some other markets, but not the United States.

Merck (MRK) also sells the Pneumovax 23 vaccine, which fights 23 types of pneumococcus and is the only vaccine of its type that is FDA-approved for adults.‹

[DewDiligence]

Researchers Zero In on Holy Grail of Flu Vaccines

http://www.reuters.com/article/idCNN1520935720100715

›Thu Jul 15, 2010 7:19pm EDT
By Maggie Fox

WASHINGTON, July 15 (Reuters) - A two-step flu vaccine using DNA to "prime" the immune system and then a traditional seasonal influenza vaccine may be able to protect against all strains of the virus -- providing a long-sought "universal" flu vaccine, U.S. researchers said on Thursday.

The team at the National Institute of Allergy and Infectious Diseases is already testing the new vaccine in people and says the results of tests in mice, ferrets and monkeys suggest the industry may finally be able to dump the cumbersome process of making fresh flu vaccines every year.

"This is the first step, conceptually, towards a good shot at a universal vaccine," NIAID Director Dr. Anthony Fauci said in a telephone interview.

Every year, the influenza strains that are circulating mutate a little bit and at any given time several very different strains are infecting people. In some years a new mutant pops up -- such as the new H1N1 swine flu strain that appeared in March 2009 to spark a pandemic.

Vaccine makers have to change their formulations every year to match the current strains. To make matters worse, virtually all flu vaccines are made using decades-old technology based on chicken eggs that is both slow and prone to contamination.

So the goal is to come up with a universal influenza vaccine that could protect people from all flu strains for decades or even for life.

NIAID's Dr. Gary Nabel said his lab has taken a big step toward this goal. Their method, described in the journal Science, starts with a piece of DNA based on the hemagglutinin protein -- a mushroom-shaped structure on the outside of the virus that gives flu strains the "H" in their names.

The DNA directs the body to make antibodies against a part of the flu virus that is normally hidden -- on the "stem" of the hemagglutinin protein. This part is conserved, meaning it does not change from flu strain to flu strain.

OLD AND NEW STRAINS

Vaccinated mice and ferrets produced antibodies that protected them against flu strains from 1934 through 2007.

"We are excited by these results," Nabel said. "The prime-boost approach opens a new door to vaccinations for influenza that would be similar to vaccination against such diseases as hepatitis, where we vaccinate early in life and then boost immunity through occasional, additional inoculations in adulthood."

The vaccine, which uses DNA from Netherlands-based Crucell NV (CRXL), "looks pretty safe," Fauci said. "They are already well into, at least a full year into, a Phase 1 trial."

Such trials are meant to see if a new drug or vaccine is safe in people. A larger, Phase 2 trial could start next year, Fauci said.

Seasonal influenza kills 250,000 to 500,000 people a year globally, including 36,000 in the United States. Pandemics often kill more and while H1N1 has not been especially deadly, it has killed far more children, young adults and pregnant women than seasonal flu usually does.

The experimental vaccine protected animals against H5N1 bird flu, as well. While avian influenza only rarely infects people, it has killed 296 of the 500 sickened by it since 2003.

Flu experts fear H5N1 could mutate and cause a pandemic far worse than swine flu and, using current vaccine technology, it will take months to formulate a good vaccine against it. Swine flu made its spread global within six weeks.‹

[DewDiligence]

The Latest Chinese Export: Vaccines

http://finance.yahoo.com/news/China-prepares-big-entry-apf-1455321717.html?x=0

›By Gillian Wong
29-Nov-2011 5:10am ET

BEIJING (AP) -- The world should get ready for a new Made in China product — vaccines.

China's vaccine makers are gearing up over the next few years to push exports in a move that should lower costs of lifesaving immunizations for the world's poor and provide major new competition for the big Western pharmaceutical companies.

However, it may take some time before some parts of the world are ready to embrace Chinese products when safety is as sensitive an issue as it is with vaccines — especially given the food, drug and other scandals the country has seen.

Still, China's entry into this market will be a "game changer," said Nina Schwalbe, head of policy at the GAVI Alliance, which buys vaccines for 50 million children a year worldwide.

"We are really enthusiastic about the potential entry of Chinese vaccine manufacturers," she said.

China's vaccine-making prowess captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu — in just 87 days — as the new virus swept the globe. In the past, new vaccine developments had usually been won by the U.S. and Europe.

Then, this past March the World Health Organization announced that China's drug safety authority meets international standards for vaccine regulation. It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.

"China is a vaccine-producing power" with more than 30 companies that have an annual production capacity of nearly 1 billion doses — the largest in the world, the country's State Food and Drug Administration told The Associated Press.

But more needs to be done to build confidence in Chinese vaccines overseas, said Helen Yang of Sinovac, the NASDAQ-listed Chinese biotech firm that rapidly developed the H1N1 swine flu vaccine. "We think the main obstacle is that we have the name of 'made in China' still. That is an issue."

China's food and drug safety record in recent years hardly inspires confidence: in 2007, Chinese cough syrup killed 93 people in Central America; one year later, contaminated blood thinner led to dozens of deaths in the United States while tainted milk powder poisoned hundreds of thousands of Chinese babies and killed six.

The government has since imposed more regulations, stricter inspections and heavier punishments for violators. Perhaps because of that, regulators routinely crack down on counterfeit and substandard drugmaking.

While welcoming WHO's approval of China's drug safety authority, one expert said it takes more than a regulatory agency to keep drugmakers from cutting corners or producing fakes.

"In the U.S., we have supporting institutions such as the market economy, democracy, media monitoring, civil society, as well as a well-developed business ethics code, but these are all still pretty much absent in China," said Yanzhong Huang, a China health expert at the Council on Foreign Relations. "For China, the challenge is much greater in building a strong, robust regulative capacity."

Last year, a Chinese newspaper report linked improperly stored vaccines to four children's deaths in northern Shanxi province, raising nationwide concern. The Health Ministry said the vaccines did not cause the deaths, but some remained skeptical.

Meanwhile, Chinese researchers reported in the New England Journal of Medicine earlier this year that a pandemic flu vaccine given to 90 million people in 2009 was safe.

WHO's medical officer for immunization, Dr. Yvan Hutin, said WHO's approval of the Chinese drug regulatory agency is not "a blank check." Each vaccine will be evaluated rigorously, with WHO and Chinese inspectors given access to vaccine plants on top of other safety checks, he said.

Vaccines have historically been a touchy subject in the Western world, rife with safety concerns and conspiracy theories. Worries about vaccine safety resurfaced in the late 1990s triggered by debate over a claimed association between the vaccine for measles, mumps and rubella and autism. The claim was later discredited.

For China, the next few years will be crucial, as biotech companies upgrade their facilities and improve procedures to meet the safety and quality standards — a process that is expected to be costly and challenging. Then they will submit vaccines to the U.N. health agency for approval, which could take a couple of years.

First up is likely to be a homegrown vaccine for Japanese encephalitis, a mosquito-borne disease that can cause seizures, paralysis and death. The vaccine has been used for two decades in China with fewer side effects than other versions. Its manufacturer expects WHO approval for it in about a year. Also in the works are vaccines for polio and diseases that are the top two killers of children — pneumonia and rotavirus, which causes diarrhea.

Vaccines also are a significant part of a $300 million partnership with the Bill & Melinda Gates Foundation for the development of new health and farming products for poor countries.

China's entry into this field is important because one child dies every 20 seconds from vaccine-preventable diseases each year. UNICEF, the children's agency and the world's biggest buyer of vaccines, has been in talks with Chinese companies, said its supply director Shanelle Hall. The fund provides vaccines to nearly 60 percent of the world's children, and last year spent about $757 million.

Worldwide, vaccine sales last year grew 14 percent to $25.3 billion, according to healthcare market research firm Kalorama Information, as drugmakers which face intensifying competition from generic drugs now see vaccines as key areas of growth, particularly in Latin America, China and India.

China's vaccine makers, some of whom already export in small amounts, are confident they will soon become big players in the field.

"I personally predict that in the next five to 10 years, China will become a very important vaccine manufacture base in the world," said Wu Yonglin, vice president of the state-owned China National Biotec Group, the country's largest biological products maker that has been producing China's encephalitis vaccine since 1989.

CNBG will invest more than 10 billion yuan ($1.5 billion) between now and 2015 to improve its facilities and systems to meet WHO requirements, Wu said. The company also intends to submit vaccines to fight rotavirus, which kills half a million kids annually, and polio for WHO approval.

Smaller, private companies are also positioning themselves for the global market.

Sinovac is now testing a new vaccine for enterovirus 71, which causes severe hand, foot and mouth disease among children in China and other Asian countries. It is also preparing for clinical trials on a pneumococcal vaccine Yang says could rival Pfizer's Prevnar, which was the top-selling vaccine worldwide last year with sales of about $3.7 billion.

Pneumococcal disease causes meningitis, pneumonia and ear infection.

"In the short term, everyone sees the exporting opportunities, because outside of China the entire vaccine market still seems to be monopolized by a few Big Pharma (companies)," Yang said.

The entry of Chinese companies is expected to further pressure Western pharmaceutical companies to lower prices. Earlier this year, UNICEF's move to publicize what drugmakers charge it for vaccines showed that Western drugmakers often charged the agency double what companies in India and Indonesia do.

The aid group Doctors Without Borders criticized the vaccine body GAVI for spending hundreds of millions of dollars on anti-pneumonia vaccines from Western companies, saying it could put its buying power to even better use by fostering competition from emerging manufacturers like those in China.

GAVI's Schwalbe said the vaccine body has to buy what is available and negotiates hard for steep discounts. "We need to buy vaccines now to save children's lives now. We can't wait."‹

[DewDiligence]

Matt Herper on politicization of the vaccine business (from both the left and the right):

http://www.forbes.com/sites/matthewherper/2012/04/04/americas-gardasil-problem-how-politics-poisons-public-health