Recently, Human Genome Sciences Inc. (HGSI) announced that its hepatitis C candidate Zalbin is unlikely to get a favorable verdict from the US Food and Drug Administration (FDA) at its current dosage.
Zalbin (albinterferon alfa- 2b) has been co-developed with Novartis (NVS). Human Genome and Novartis have selected Zalbin as the brand name for albinterferon alfa-2b in the United States, while Joulferon is the brand name for the rest of the world.
The U.S. regulatory agency has concerns regarding the safety of 900-microgram Zalbin, dosed twice monthly. The feedback was provided by the regulatory authorities via a “discipline review” letter. The agency communicates a preliminary analysis on possible shortcomings of an application via such a letter.
In November 2009, Human Genome submitted a Biologics License Application (BLA) to the FDA for Zalbin. The application was based on the results of two pivotal late-stage studies which showed that 900-mcg the candidate dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys of Roche) dosed once a week.
We note that the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Zalbin was withdrawn by Novartis a couple of months ago. The withdrawal of the MAA that was filed in Dec. 2009 was based on indications that the European regulatory authorities would ask for additional data, which the companies would not be able to furnish in the time frame permissible under the European Centralized Procedure.
The feedback from the European regulatory authorities expressed concerns whether the therapeutic benefit offered by Joulferon, dosed once every other week, outweighed the risks associated with the candidate. The candidate is also being evaluated in a monthly dose.
Joulferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.
Even though the FDA’s letter is a setback for Human Genome, we believe investor focus is more on the company’s lupus candidate Benlysta, co-developed with GlaxoSmithKline plc (GSK), which has blockbuster potential. The company filed for European as well as FDA approval earlier in the month.
Currently, we are Neutral on Human Genome Sciences.
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