Dynavax Technologies Corp. (DVAX) is up nearly 87 percent since we profiled it in depth on our website last June.
The company's lead vaccine candidate is Heplisav, a hepatitis B prophylactic vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. Having successfully completed phase III trials with Heplisav, Dynavax is all set for the next major catalyst event namely, BLA submission, and so it may be worth taking a look again.
In one of the phase III trials, which compared a two-dose regimen of Heplisav administered at 0 and 1 month with a three-dose regimen of GlaxoSmithKline's Engerix-B administered at 0, 1 and 6 months, in adults 40 years and older, Heplisav demonstrated non-inferiority, superiority and safety.
Dynavax plans to seek FDA approval for Heplisav in healthy adults 18-70 years of age by mid-May 2012, and European approval is expected to be sought shortly thereafter.
In yet another phase III trial, which evaluated Heplisav against Engerix-B in patients with end-stage renal disease (chronic kidney disease patients), Heplisav demonstrated both superiority and non-inferiority to Engerix-B. A supplemental BLA for Heplisav with an indication for patients with chronic kidney disease will be filed when the initial BLA is approved.
Hepatitis B is a chronic disease which attacks the liver that can lead to cirrhosis of the liver or liver cancer. An estimated 2 billion people worldwide have been infected with HBV. In the U.S., 12 million people have been infected with this disease while the number of chronic infections total about 1.25 million.
Some of the FDA-approved drugs to treat hepatitis B, include, Schering-Plough's Intron A, Roche's Pegasys, GlaxoSmithKline's Epivir , Gilead Sciences' Hepsera and Bristol-Myers Squibb's Baraclude, to name a few.
However, there is no cure for chronic hepatitis B as yet. Therefore, prevention through effective hepatitis B vaccines is very important. The worldwide market for adult hepatitis B vaccines is estimated to exceed $700 million annually - with GlaxoSmithKline's Engerix-B and Twinrix as well as Merck's Recombivax-HB being the primary players in the hepatitis B prophylactic vaccines market.
Also in the company's pipeline are
* DV1179, under phase I testing for autoimmune and inflammatory diseases. Dynavax has a worldwide strategic alliance with GlaxoSmithKline for the development of DV1179.
* Universal flu vaccine, which is under phase I testing, being developed in collaboration with Novartis Vaccines and Diagnostics, a division of Novartis AG (NVS)
* DV-601, hepatitis B therapeutic vaccine, under phase I testing
* AZD1419, a preclinical program partnered with AstraZeneca, for asthma.
Dynavax has no marketed products, and it recognizes revenue from collaboration agreements and government and private agency grants. In 2011, the company's net loss narrowed to $48.59 million or $0.39 per share from $57.31 million or $0.69 per share in 2010. Annual revenue in 2011 was $21.61 million compared to $23.95 million a year ago. The company ended 2011 with debt of $12.81 million and cash of $113.96 million.
This has been a great year for Dynavax stock, which has gained over 42% year-to-date. DVAX is currently up 0.65% at $4.74.
Updated
Dynavax submitted the Biologics License Application for Heplisav today (April 26), well ahead of their proposed date of submission, and has requested a priority review. The company anticipates submitting a European Marketing Authorization Application for Heplisav in the third quarter of 2012.
For comments and feedback: editorial@rttnews.com