Showtime Is Drawing Near for This Drug


Is Heplisav on the way? News from biopharmaceutical company Dynavax Technologies (NAS: DVAX) indicates that it just might be.

The company announced this week that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss Heplisav at its meeting in mid-November. This marks the next step in the process to ultimately gain approval for the adult hepatitis B vaccine.

The long and winding road
It hasn't been an easy path for Dynavax to get to this point. In 2008, the FDA placed a clinical hold on Heplisav after a patient in a study contracted Wegener's granulomatosis, a rare blood-vessel disorder. The wording of the decision had some referring to it a "kiss of death" for the trial.

Dynavax plugged along, though. It tried to obtain approval from European regulators in 2009 to develop Heplisav for adults over 40 who didn't respond to other therapies. And the company kept pushing for the FDA to allow additional clinical trials for the drug.

Persistence paid off. The FDA cleared the way in September 2009 for resumption of clinical trials for Heplisav. Several months later, Dynavax announced positive results from those trials. Heplisav showed promise for protecting patients with chronic kidney disease at Week 24.

Another obstacle lay around the corner, though. Dynavax revealed in July 2011 that higher antibody responses were found at eight weeks in one of three test lots compared with the other two lots. The inconsistency raised doubts about Heplisav.

But Dynavax moved forward. Further testing confirmed that Heplisav performed as well as or better than the competing Engerix-B vaccine developed by GlaxoSmithKline (NYS: GSK) .

The FDA review process kicked into gear earlier this year, with Dynavax's submission of a Biologics License Application (BLA) for Heplisav. Dynavax also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency in July.

After this long and winding road, showtime draws near for Dynavax and Heplisav. The stakes are large, with the global hepatitis B vaccine market estimated to reach around $1.4 billion within the next six years.

GlaxoSmithKline and Merck (NYS: MRK) currently dominate the hepatitis B vaccine market. GlaxoSmithKline makes the aforementioned market-leading Engerix-B vaccine, along with the Pediarix and Twinrix vaccines. Merck develops the Comvax and Recombivax HB vaccines.

Sanofi (NYS: SNY) also appears to be gaining some traction. The company's Hexaxim pediatric vaccine, which protects infants against multiple diseases including hepatitis B, received a positive opinion from the European Medicines Agency in June.

FDA approval for Heplisav should position Dynavax for success in the hepatitis B market. Dynavax isn't just seeking to be a "B player," though. The company also has development under way for an asthma product in partnership with AstraZeneca (NYS: AZN) . All funding for the AZD1419 asthma drug through phase 2a will be provided by AstraZeneca.

A good performance in the upcoming Heplisav show time could mean ultimately hitting the big time for Dynavax -- and its investors.

Foolish bottom line
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