Human Genome Sciences (HGSI) has laid claim to a rich prize for its success getting albinterferon alfa-2b ready for regulatory review as a new hepatitis C therapy. The Rockville, MD-based biotech says that it has completed presubmission meetings with the FDA as well as European regulators, clearing its way to filing for marketing approval in the fourth quarter and qualifying HGS for a milestone payment of $75 million from its development partner Novartis.
HGS has so far received $132.5 million of the $507.5 million deal. And now that the hepatitis C therapy is ready to be filed for approvals, the developer is ready for its next big serving of cash. The drug will be sold as Zalbin in the U.S. and Joulferon in the rest of the world, provided regulators approve it.
"Submission of global marketing authorization applications for Zalbin and Joulferon is planned for later this quarter," said Tom Watkins, the CEO of Human Genome Sciences. "Assuming licensure by the FDA and other regulatory agencies, HGS believes Zalbin could become a market-leading treatment for chronic hepatitis C." If it does, HGS stands to benefit directly. The developer has held on to co-promotion rights in the U.S. market with a deal to split profits.
HGS faces an even bigger milestone as new late-stage data is readied for Benlysta, its lupus therapy. HGS stunned the market earlier this year with the news that the drug had proven effective in a late-stage trial. Now analysts are waiting to see if the second Phase III study will either support the company's quest or derail it.
- here's the HGS release