Disappointing trial results of quit-smoking vaccine staggers Biotech

Earlier this Monday Rockville biotech company, Nabi Bioharmaceuticals, declared that a phase 3 clinical trial failed to meet its primary objective thus causing a major hit to the company’s “quit-smoking vaccine”.

Under a 2009 deal almost worth $500 million, Nabi has been collaborating with Britain’s pharma giant GlaxoSmithKline for NicVax. An upfront payment of $40 million to Nabi was a part of the deal.

In the phase 3 trial, it was observed that similar to subjects receiving placebo, 11 percent of those receiving NicVax quit smoking for 16 weeks.

In a short conference call with analysts on Monday morning, CEO Raafat Fahim said that company executives were “quite surprised” by the “extremely disappointing” results. He added that as indicated by study data, those receiving NicVax produced the expected level of antibodies which established that the particular vaccine lot used in the trial had no problems.

Fahim further stated that based on the results, the $20 million payment that was supposed to be triggered by two successful phase 3 trials will no longer be awarded to Nabi under the Glaxo deal.
A second phase 3 trial of NicVax conducted by Nabi is expected to announce its results either late this year or early 2012. About 1,000 subjects have been enrolled in each trial.

Fahim stated that “We are in the process of assessing the reasons for these unexpected data, as we await the results of the second phase 3 trial. Data from this second trial may provide clues that could help explain the disappointing results from the first trial. In the meantime, the board of directors is actively evaluating any and all appropriate strategic alternative actions to preserve shareholder value, while management is working to further control the operational expenses of the company.”

The news declared a 70 percent plummet in Nabi’s stock.
NicVax was the wonder vaccine that created high hopes not only for Nabi, GlaxoSmithKline, and their investors but also for the World Vaccine Congress who presented Nabi with its Best Therapeutic Vaccine award in April.
In 2009, the National Institute on Drug Abuse awarded Nabi a grant of $10 million including $7.9 million in federal stimulus money to continue the development of NicVax.

Nora Volkow, director of the drug abuse institute, stated that “We are immensely encouraged by the results of this innovative research that promises to change the way we treat nicotine addiction in this country.”

NicVax prevents addiction by stimulating the immune system to produce antibodies that bind to nicotine. The antibody-nicotine complex is then too large to cross the blood-brain barrier and cannot reach receptors in the brain.