Dynavax Technologies Corp announced that the U.S. Food and Drug Administration decided to postpone the approval of their hepatitis B vaccine and requested for more safety data.
The hepatitis B vaccine, which will carry the product name Heplisav, have passed the Phase 3 trials conducted by the Biologics License Application (BLA) proving that it is more effective than existing products in the market. The vaccine was administered into 4,800 individuals in 2011 giving two doses within a month. It was proven effective as well even for males, obese, and smokers.
Dynavax projected revenue of around $700 million per year once the FDA approves its release in the market and planned to compete with existing pharmaceutical companies GlaxoSmithKline and Merck. The company had been waiting since 2011 and when they hoped that they will be able to launch it this quarter, FDA told them during the meeting that they need an additional trial for Heplisav due to a conflict on their data collection.
Dynavax will schedule another meeting with the FDA to discussed about the guidelines of data collection before they start another trial.
"We believe the FDA reasonably understands that a safety study designed to include say 30,000 patients is not economically feasible for a small company like Dynavax," CEO Eddie Gray said on a conference call on Monday with Reuters.
The FDA requires at least 10,000 participants for a result to produce highly accurate and safe report. This is what Dynavax missed because they closed at 5,845 patients only.
Meanwhile, this disappointing news seemed to have affected the performance of Dynavax Technologies Corp (DVAX.PH) in the stock market as it dropped by $1.10 or 44.48 percent of its value. The value as of 3:59pm EDT is $1.39. Yesterday it closed at $2.49.
The company hopes to recover as they are testing new products for autoimmune disorders and inflammatory diseases.
