The need for big pharma pipeline expansion is a driving force for therapeutic vaccines, triggering mergers and partnership agreements, Chidambaram said. “The European and global vaccines markets are ripe for consolidation, owing to high costs and entry barriers for small participants and technology providers, which propel them to partner.”
For example, in December, Vivalis and Intercell announced plans to merge and form Valneva. “Completion is expected in May,” according to Reinhard Kandera, Intercell CFO. The resulting company’s combined strengths in vaccines and antibodies are expected to make it a solid contender in the therapeutic vaccines market.
The pediatric version of Intercell’s Japanese encephalitis vaccine received European approval this February. An adult version of this cell culture-derived product is already marketed to travelers. “We see 1 to 1.5 percent market penetration, and are aiming for 2.5 percent by mid-2015,” Kandera explained.
A vaccine for Pseudomonas aeruginosa is in Phase III trials and another, for Clostridium difficile, is in Phase I. The company also has three clinical trials for tuberculosis underway with partners.
Bavarian Nordic has eight vaccines in development targeting cancer and infectious disease, according to Anders Hedegaard, president and CEO. “The lead, Prostvac®, targets advanced prostate cancer and is in Phase III trials,” he said. This vaccine is administered after hormone therapy but before chemotherapy. With 550 patients treated to date, Prostvac appears to extend average survival to about 25 months, up from 16.6 months. The Prostvac platform also is being assessed for breast, lung, and ovarian cancers.
“We also have a smallpox vaccine in development for the U.S. government,” Hedegaard added. “Approval is pending in Canada and the EU.”
Dendreon focuses on activated cellular immunology, having developed Provenge as a treatment for metastatic castrate resistant disease. “In patients with prostate specific antigen scores of less than 22.1, we saw overall survival rates 13 months longer than those for patients treated with other therapies,” explained John Johnson, chairman and CEO. Direct-to-consumer advertising is scheduled to begin this quarter.
Emergent BioSolutions focuses on anthrax and tuberculosis vaccines. A Phase II trial began in January for NuThrax™, an anthrax vaccine adsorbed with CPG 7909 adjuvant. According to Daniel Abdun-Nabi, CEO, he expects his firm will release data from a different, Phase Ib, tuberculosis trial this spring. “In 2016, the company plans to transfer its operations to a new manufacturing facility featuring single-use bioreactors,” Nabi added.
“Our anthrax vaccine generates approximately $220 to $230 million in revenue. Total 2012 revenue projections range between $280 and $284 million,” he continued. “We have a contract with the U.S. government to supply nearly 45 million doses through 2016.”
Dynavax Technologies is focusing on Heplisav™, an adult hepatitis B vaccine. “European regulatory review is on track,” noted Dino Dina, M.D., CEO. Approval is considered likely, he said, with a potential PDUFA filing expected soon.
Dr. Dina reported that Heplisav has demonstrated immunogenicity with fewer injections and over a shorter period. He estimated the market for adult hepatitis B vaccines to be around $270 million now, and could be $360 million once Heplisavis is approved. “When diabetics are included, the potential market represents approximately $750 million annually,” he said.