In addition to the five approvals expected by 2008, eight approvals could come by 2012, said the report from Kalorama Information.

However, the vaccines face the challenge of gaining reimbursement approval and overcoming the disappointments of previous vaccines that have not panned out.

"Despite the enormous relief potential for mankind, vaccine manufacturers will have to demonstrate that the new vaccines are superior to currently established treatment protocols in order for insurers to accept them for reimbursement, thus making them accessible to the masses," said Melissa Elder, author of the report.

"Each vaccine will have to prove itself as being highly efficacious, reasonably cost-effective, and able to achieve widespread physician approval," added Elder.

Elder did not respond to United Press International's request for comment.

Promising vaccines, according to the report, include Intracel's OncoVAX for colon cancer and Genitope's MyVax for lymphoma.

Several companies have vaccines in development for lung cancer, including Biomire/Merck's Stimuvax, Biovest's BiovaxID and Favrille's FavId.

Melanoma is also a hot area for vaccine development. Potential products in this area include Antigenics' Oncophage, Medarex's MDX-010 in combination with MDX-1379 and Avax's M-Vax.

Prostate cancer is another area several companies are focused on. Dendreon is developing Provenge, Northest Biotherapeutics is working on DCVax, and Cell Genesys has Gvax in the pipeline.

Other vaccines that are likely to get approval during the report's timeframe include Antigenics' Oncophage for kidney cancer and Aphton's Insegia for pancreatic cancer.

Clair Gricks, an analyst with Decision Resources, told UPI the melanoma vaccine market does not look promising in the near-term.

"There's not an awful lot out there that looks exciting," Gricks said, noting that physicians' enthusiasm towards vaccines for this particular cancer have waned due to recent failures, such as Cancervax/Serono's Canvaxin.

However, a lot of physicians are really excited about the prospect of combining the melanoma vaccines with monoclonal antibodies, she said, but so far, there isn't enough data on that regimen to draw any firm conclusions.

"The prostate cancer market is a bit more rosy," Gricks added.

Dendreon's Provenge could launch next year and is anticipated to generate sales of less than $120 million each year, she said.

Another promising player is Cell Genesys's Gvax. That vaccine could launch in 2009 and is projected to take in sales of less than $340 million annually, Gricks said.

The overall vaccine market holds great potential, according to Navdeep S. Jaikaria, an analyst with Rodman and Renshaw.

"Vaccines market is going to be quite promising in near future," Jaikaria stated in a research report issued Thursday summarizing a panel discussion his firm recently hosted about trends and opportunities in the vaccine market.

He noted the panelists think concerns about bioterrorism and potential epidemics of infectious diseases, such as influenza, are shifting the way governments and big pharmaceutical/biotech companies approach vaccines.

The panelists, whom Jaikaria did not identify, think there are a couple of reasons that could drive a renewed interest in vaccines.

Profit margins are expected to increase due to changes in reimbursement policies and expanded expenditures on bio-defense. In addition, the FDA approval process of vaccines is expected to become smoother and quicker.

Small biotech companies may find it easier to compete with larger companies in the vaccine field because smaller trials will be allowed for pandemic flu vaccines.

"Recent M&A activity, i.e. Pfizer's acquisition of Powdermed, highlight the attractiveness of players in the vaccine space," Jaikaria stated.

Big pharma is also taking more of an interest in vaccines.

"Big pharmaceutical companies like Merck are interested in various vaccine developments and one of the changes in strategy has been to get to clinics quickly," Jaikaria stated. "Merck is also focusing in partnerships to co-develop these vaccines," he added.

In addition to flu and bioterror threats, such as anthrax, the potential disease targets for vaccines include hepatitis b and c, malaria and tuberculosis.

Cancer is also an area of interest. Merck's cervical cancer vaccine Gardasil was recently approved by the FDA, and GlaxoSmithKline is expected to file for approval of its cervical cancer inoculation Cervarix next year.

Companies are also developing new methods of vaccine production. MedImmune announced Thursday that it filed an investigational new drug application with the FDA for its cell culture-based flu vaccine, which would reduce production time and expand manufacturing capacity over the current method of using chicken eggs.

But Rodman and Renshaw's panelists expressed concern about cell culture-based methods. "Egg-based approach may be cumbersome, but very safe," Jaikaria said in summarizing the panelists' views. "Cell culture-based approach needs to resolve safety issues."

Jaikaria did not respond to UPI's request for comment.

Related Links
Kalorama Information
Decision Resources
Advanced Medical Science For Earth and Beyond

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