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Dynavax's Date With FDA Panel


There are just four days left for Dynavax Technologies Corp. (DVAX) to face the penultimate regulatory hurdle in its quest of bringing the lead vaccine candidate Heplisav to market.

Heplisav is a hepatitis B prophylactic (preventive) vaccine designed to provide rapid and superior protection with fewer doses than the current commercial vaccines used to prevent hepatitis B infection like Engerix-B, produced by GlaxoSmithKline plc (GSK), and Recombivax-HB, produced by Merck $ Co. Inc. (MRK).

In one of the phase III trials, which compared a two-dose regimen of Heplisav with a three-dose regimen of GlaxoSmithKline's Engerix-B in adults 40 years and older, Heplisav demonstrated non-inferiority, superiority and safety.

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.

Dynavax submitted a Biologics License Application to the FDA for Heplisav, seeking approval for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, in April of this year. The FDA decision date on the Heplisav BLA is set for February 24, 2013.

Before the regulatory agency announces its decision, the Heplisav BLA is to be reviewed by the FDA's panel of outside medical experts on November 15.

The Heplisav BLA is also under review by the European Medicines Agency.

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 leading 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 hepatitis B while the number of chronic infections totals 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 key players. (*Twinrix is a combination vaccine for hepatitis A and B available for adults).

A quick look at Dynavax's balance sheet...

With no drugs yet in the market, the company's revenue comes from collaboration agreements, services and license fees. Significant losses have been incurred each year since inception in August 1996.

In third quarter ended September 30, 2012, the company's net loss was $17.79 million or $0.10 per share compared to $15.23 million or $0.12 per share in the year-ago quarter. Revenue for Q3, 2012, rose to $2.9 million from last year's quarterly revenue of $1.2 million, helped by higher collaboration and grant revenue from Dynavax's partnerships with AstraZeneca and the National Institute of Allergy and Infectious Diseases.

The company ended Q3, 2012, with $148.3 million in cash, cash equivalents and marketable securities.

Shares of Dynavax have thus far hit a 52-week low of $2.67 and a 52-week high of $5.34. The stock closed Friday's trading at $4.17, up 3.99% on a volume of 3.87 million shares, nearly 2 times the average volume over the last three months.

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by RTTNews Staff Writer

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