Drug's Release is Imminent on Showtime
Dynavax Technologies (NAS: DVAX) has taken a significant step towards potentially entering the lucrative hepatitis B vaccine market, as the company submitted a Biologics License Application (BLA) for its adult hepatitis B vaccine, Heplisav, to the Food and Drug Administration (FDA) earlier this year.
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will evaluate Heplisav in mid-November, with a meeting scheduled to discuss the vaccine's potential approval for adult Hepatitis B vaccination. This evaluation comes after the FDA cleared the way in September 2009 for resumption of clinical trials for Heplisav.
The hepatitis B vaccine market is currently dominated by GlaxoSmithKline and Merck, with GlaxoSmithKline's Engerix-B vaccine, Pediarix, and Twinrix vaccines, and Merck's Comvax and Recombivax HB vaccines being the market leaders. However, the global market for hepatitis B vaccines is estimated to reach around $1.4 billion within the next six years, presenting an opportunity for new entrants like Dynavax.
Heplisav showed promise for protecting patients with chronic kidney disease at Week 24, according to results announced by Dynavax in 2009. Furthermore, further testing confirmed that Heplisav performed as well as or better than the competing Engerix-B vaccine developed by GlaxoSmithKline.
Dynavax isn't just seeking to be a "B player" in the hepatitis B vaccine market. The company also has development underway for an asthma product in partnership with AstraZeneca. All funding for the AZD1419 asthma drug through phase 2a will be provided by AstraZeneca.
In 2008, the FDA placed a clinical hold on Heplisav due to a patient in a study contracting Wegener's granulomatosis. However, the company has since moved past this setback and is now eagerly awaiting the VRBPAC's decision.
FDA approval for Heplisav could position Dynavax for success in the hepatitis B market, as the company tries to carve out a niche for itself amidst the competition. Sanofi's Hexaxim pediatric vaccine, which protects infants against multiple diseases including hepatitis B, received a positive opinion from the European Medicines Agency in June, further highlighting the market's potential.
Investors need to be fully informed at all stages to stay on top of these developments. While Dynavax isn't just seeking to be a "B player," a good performance in the upcoming Heplisav showtime could mean ultimately hitting the big time for the company.
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