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Protein Sciences Corporation News

Web Site: http://www.proteinsciences.com
- Sanofi Pasteur Inc. 1000 Research Pkwy., Meriden, CT 06450 - 7159
Tel: (203) 686-0800 Fax: (203) 686-0268

Protein Sciences Corporation, founded in 1983, is a privately held vaccine company with headquarters in Meriden, Connecticut. PSC's mission is to save lives and improve health.

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As president and chief executive officer of Protei ...

May 16, 2004

"We've just got to be better," Adams said. "We applied for the grant, we had to be very good, we had to make a lot of sense."

Protein Sciences has high hopes of cashing in on the $1.5 billion worldwide influenza vaccine business. Its latest endeavor, FluBLOK has successfully completed double-blind phase II trials that showed it more effective than the leading vaccine and can be used at higher doses with fewer side effects, the company reported.

The trial was sponsored by the National Institute of Allergy and Infectious Diseases, which is part of the National Institute of Health. Protein Sciences was only one of three vaccine makers, and the smallest, to receive a grant to begin the studies. A field test of the vaccine is set for the fall, providing Adams can raise about $15 million to conduct it.

"There is competition but this is promising. It has tremendous potential," Manny Ratafia, president of Technology Management Group said. The New Haven firm studies the pharmaceuticals market.

Influenza is the most common cause of acute respiratory illness in the United States often involving fever, chills, muscle weakness, cough, sore throat, nasal congestion, headache and general malaise. Field studies indicate the infection rate ranges from a low of 10 percent in persons over age 65 to a high of 36 percent in children aged one to 18. According to the Centers for Disease Control and Prevention and the American Lung Association, 20 to 50 million people are affected annually in the U.S. influenza-related deaths can result from pneumonia as well as from intensified cardiopulmonary complications. And when new strains emerge, the consequences can be particularly devastating.

For that reason, Protein Sciences has gained a reputation for working closely with the CDC to respond rapidly to international needs. One reason is that their protein-based immunizations don't require the same incubation and fertilization time as egg-based technology.

"They have a different technology which may give them an advantage," Ratafia said. "These promising trials should make the prospect of meeting venture funding they're looking for, much brighter."

What sets Protein Sciences apart from companies such as Aventis Pasteur, and Evans, both based outside the United States, is that it avoids developing its vaccines in eggs, which is now the industry standard.

FluMist sales by MedImmune/Wyeth introduced in 2003, which is also egg-based, were negligible. This method infects chicken eggs with a live virus, allows it to incubate, uses chemicals to deactivate the virus, then screens out the chicken "gunk," as Adams put it. The end result is effective, but is still dirty, leads to side effects and doesn't always work in the elderly whose immune systems are diminishing or in children, who have developing immune systems.

Protein Sciences uses insect cells, RNA and a match of the strain from the Center for Disease Control to create a protein that matches the virus. That means a lower risk of infection for the vaccine user.

Founded in 1983, Protein Sciences formerly MicroGeneSys, originally had developed commercial protein-based human and veterinary vaccines and therapeutics in insect cells. After a turbulent battle over government trials of its HIV vaccine, its founder and Chief Executive Officer Franklin Volvovitz was ousted and Adams was brought in to revamp the company's image. All original MicroGeneSys employees have since left the company.

Adams, whose background is in chemistry and law, found his niche in biotech and turning around troubled companies. He changed the name and Protein Sciences now has more than 400 shareholders.

In May 1997, Protein Sciences won U.S. patents covering both humans and animals for its influenza vaccines. In December of the same year, the NIH awarded Protein Sciences the vaccine contract designed to protect humans from the Hong Kong H5NI influenza. The company, which employs 36 people, produced 1,700 vaccines in fewer than eight weeks. "We were the only people in the world to do it," Adams said. "We're about two years ahead of the others."

Two years ago, the NIHD gave Protein Sciences a $2 million grant to help develop a SARS vaccine that recently finished animal trials. The organization expects human testing by the end of this year.

Adams is passionate when he talks about how 20,000 to 50,000 people die annually from the H3 strain flu, with 90 percent being elderly. While the licensed vaccine does an adequate job protecting many people, the side effects prevent higher doses that could save more elderly patients and prevent egg-allergy patients from receiving the vaccine. Side effects to egg-based vaccines also prevent many adults between the ages of 18-49 from getting the vaccine.

Although this population might feel their immune systems are strong enough to battle the strains, they should be immunized to protect any elderly or children they come in contact with, Adams said. The absence of side effects in the new shot should help draw them in, Adams said.

Securing a license for their flu immunization would be a major coup for the small company, Ratafia said. Analysts estimate that the potential market for a modern human influenza vaccine exceeds $4 billion annually for the right product, and potentially twice that under certain conditions.

In the most recent trial, 399 elderly subjects at three NIAID clinics were inoculated with FluBLOK which proved to be safe even at doses that contain up to nine times more active ingredients than the licensed egg-grown vaccines. A second goal showed that at least 20 percent more elderly subjects receiving high doses of FluBLOK achieved higher antibody levels against an H3 influenza virus than subjects receiving the licensed vaccine. All groups vaccinated with FluBLOK achieved a higher antibody level than the group that received the licensed vaccine. "That was a wonderful result," Adams said. "We can make a serious cut in those deaths."

The study was conducted by Dr. John Treanor, Dr. Robert Couch and Dr. Gilbert Schiff at the Vaccine Treatment and Evaluation Units of the University of Rochester, Baylor College of Medicine and the Cincinnati Children's Hospital Medical Center respectively and was 100 percent monitored, said Manon Cox, chief operating officer for Protein Sciences.

"We have recognized that there is a critical need to develop alternatives to egg-grown influenza vaccines for many years. The technology used for this vaccine is a promising step in this direction, and the finding of potentially enhanced immune responses in the elderly is an exciting additional bonus," Treanor said.

After the field trials are complete, Protein Sciences hopes to have the flu shot licensed by 2006, Adams said. "This is what we've been working on for years."

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