Human Genome's partner pulls EU hep C drug application

Human Genome's partner pulls EU hep C drug application
Mon Apr 19, 2010 11:51am EDT

"Recall in Phase III trials Joulferon demonstrated non-inferior efficacy, but higher rates of discontinuations and unique side effects,"

* Chronic hep C treatment being developed with Novartis

- Application withdrawn due to EU regulatory feedback
* Focus on lupus drug Benlysta -- analysts
* Shares down more than 1 pct (Adds analyst comment, details, updates share movement)

April 19 (Reuters) - Human Genome Sciences Inc said its partner Novartis AG withdrew the European marketing application for its chronic hepatitis C drug, after the European regulator indicated that it may seek additional new data.

The feedback from the European Medicines Agency included whether the therapeutic benefit offered by the drug, Joulferon, dosed once every two weeks was sufficient relative to risk, the company said in a statement.

"With today's news...we think it's reasonable to wonder if Food and Drug Administration delays might follow," Christopher Raymond, an analyst at Robert W. Baird, said in a research note.

Human Genome is awaiting a U.S. FDA approval decision later this year for the same treatment, known in the United States as Zalbin, that would compete with Roche Holding AG's big-selling Pegasys and Merck & Co's Inc Pegintron.

Joulferon would be the brand name outside the United States.

However, analysts said Monday's news was not a surprise and the focus remained on Human Genome's eagerly anticipated experimental drug Benlysta, which could become the first new lupus drug approved in half a century.

"Recall in Phase III trials Joulferon demonstrated non-inferior efficacy, but higher rates of discontinuations and unique side effects," said Piper Jaffray analyst Ian Somaiya.

RBC Capital Markets analyst Michael Yee said nobody really expects FDA approval for Zalbin, and if the drug was not approved, Human Genome would not have to invest cash and resources in the product.
Piper Jaffray's Somaiya said he believed a once monthly dosing of Joulferon would provide a more compelling benefit risk profile.

Shares of Human Genome were down 1 percent in late morning trade on Nasdaq. They earlier touched a low of $31.95. (Reporting by Shailesh Kuber in Bangalore; Editing by Aradhana Aravindan)

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Human Genome Sciences Announces Withdrawal of European Marketing Authorization Application For JOULFERON(R) (ZALBIN(TM)) For the Treatment of Chronic Hepatitis C

ROCKVILLE, Md., Apr 19, 2010 (BUSINESS WIRE) -- Human Genome Sciences, Inc. today announced that Novartis has withdrawn a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market JOULFERON(R) (albinterferon alfa-2b, known in the United States as ZALBIN(TM)) for the treatment of chronic hepatitis C.

The decision to withdraw the application was based on feedback from European regulatory authorities in preliminary response to the EMA application, indicating that additional new data would be requested which could not reasonably be generated within the timeframe allowed in the European Centralized Procedure. Feedback included whether the therapeutic benefit offered by JOULFERON dosed once every two weeks is sufficient relative to risk.

ZALBIN (JOULFERON) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. In November 2009, HGS submitted a Biologics License Application (BLA) to the FDA in the United States for ZALBIN dosed every two weeks, which continues under review. HGS and Novartis are also developing ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.

About ZALBIN (albinterferon alfa-2b)
ZALBIN (also known as JOULFERON) is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 19 days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins.