Human Genome Sciences submitted application for new drug Zalbin
Human Genome Sciences Inc. announced today it’s submitted its second application so far this year to federal regulators to sell a drug on the market, this most recent being for its hepatitis C treatment called Zalbin.
With these applications, including a third that the Rockville biotech plans to submit in the first half of next year for a lupus treatment, Human Genome Sciences hopes to sell its first drugs on the commercial market by the end of next year — a major milestone for the 17-year-old company.
In May, Human Genome Sciences applied to the Food and Drug Administration for approval to sell its anthrax treatment, though that submission hit a stumbling block earlier this month when regulators said they still needed further information before they could sign off on it. The company has already sold several lots of that drug to the federal government for its national stockpile.
For Zalbin, Human Genome Sciences (NASDAQ:HGSI) is relying on results from two late-stage human clinical studies that enrolled a total 2,255 patients. The data showed that Zalbin performed comparably to its competitor, F. Hoffmann-La Roche Ltd.’s Pegasys, with half the number of injections — every two weeks instead of every week.
But those results, while meeting federally set endpoints, failed to excite Wall Street, which drove down the company’s stock price by 55 percent in one day to new lows below $1. Analysts said at the time that the study data didn’t differentiate Zalbin enough from the pharmacy’s current offerings and expressed skepticism that the fewer dosages alone could attract enough physicians and patients to result in healthy market share fast cash advance loan.
Instead, investors are more anxiously awaiting Human Genome Sciences’ third offering to the commercial market: what could be the first federally approved lupus treatment in decades. The local company’s drug, called Benlysta, exceeded expectations in two late-stage studies announced in July and November, sending the company’s market cap and stock soaring to new 52-week highs.
Under a partnership agreement signed in 2006 with Novartis AG for Zalbin, Human Genome Sciences will sell the drug jointly and share equally in costs and profits for U.S. sales if it gets approved. Novartis will apply by year’s end for approval to sell the drug in other countries, starting with Europe, under the brand name Joulferon.
The partnership will yield Human Genome Sciences royalties, and as much as $300 million more in payments from Novartis for meeting certain regulatory and commercial milestones.
The Centers for Disease Control and Prevention estimate that about 3.2 million Americans have chronic hepatitis C, a viral infection that kills 8,000 to 10,000 people each year.