Drug advances boost Human Genome Sciences

Company wins patent, proceeds with lupus treatment

This month, the biotech repurchased from GlaxoSmithKline the full rights to its promising TRAIL receptor antibodies to treat cancer. The acronym stands for TNF-related apoptosis-inducing ligand.

HGS had previously sold the rights to Glaxo in exchange for Glaxo eventually giving HGS smaller royalties on a diabetes drug candidate.

Analysts had mixed reviews of the repurchase deal and HGS stock dipped about 6.5 percent. The deal, however, seemed ‘‘pretty fair” to Joseph P. Schwartz, a biotech analyst with Leerink Swann.

The stock rebounded when the company received patent approval later that week for its TRAIL receptor antibodies from the U.S. Patent and Trade Office; HGS now holds nearly 600 patents.

HGS is developing the antibodies to treat a broad range of cancers. It announced Wednesday in a conference call that it plans to initiate its phase 2 chemotherapy combination trial of one of the treatments by midyear in patients with hepatocellular cancer.

‘‘As our Phase 3 products near commercialization, we are investing strategically to bring our next products forward,” H. Thomas Watkins, president and CEO, said in a statement. ‘‘We are building our oncology portfolio around our leading expertise in the apoptosis pathway.” Apoptosis is a naturally programmed process of cell death in higher animals.

The company has ‘‘pioneered” in developing highly targeted antibody therapies for cancer based on the TRAIL receptor apoptotic pathway, according to its Web site.

Lupus treatmentshows promise

HGS could also end up dominating induction and maintenance in several autoimmune diseases with its antibody LymphoStat-B, or belimumab, following the recent failure of a competitor, Genentech’s Rituxan, in treating multiple sclerosis, Schwartz said.

Rituxan is used to treat non-Hodgkin’s lymphoma. Genentech’s results on treating lupus with Rituxan are expected in two weeks. Even if they are better than the multiple sclerosis results, they may not be enough to persuade the Food and Drug Administration to approve it soon for lupus because of an FDA advisory in place.

‘‘Many have assumed that Rituxan would be used as induction therapy in lupus, followed by belimumab as maintenance therapy,” Schwartz said. ‘‘The door may now be left open for belimumab.”

The Centers for Disease Control and Prevention considers lupus a prototype autoimmune disease with a wide array of symptoms, including rash, photosensitivity, oral ulcers, arthritis, kidney problems, seizures and psychosis.

The growing concern, says the Lupus Foundation of America, is that there have been no new treatments since the 1950s. No current drug targets the disease itself, and physicians have been able to treat only complications.

In recent years, the federal government has begun spending more on lupus research and drug companies have begun paying more attention to the disease.

Other lupus treatments are being developed by Bristol-Myers, Genentech, Biogen and Aspreva Pharmaceuticals.

Despite continued losses at HGS — the company reported a net loss of $262.4 million last year, compared with a net loss of $251.2 million for 2006 — Schwartz said earlier this year that its ‘‘core programs in [hepatitis C] and lupus are also advancing to the goal line, and each has the potential to be a blockbuster in its own right if ongoing phase 3 studies are successful in 2009.”

Through all the recent developments, biotech analysts Hari Sambasivam of Merrill Lynch and Annabel Samimy of UBS Investment Research have maintained an ‘‘out perform” rating of HGS shares.

HGS spokesman Jerry Parrott said this week that progress on LymphoStat-B is ahead of schedule and the company may be ready to apply for federal approval by the end of next year. He said the drug may hold indications to treat other autoimmune diseases but first ‘‘we are focused on lupus because you have an unmet medical need there.”

This report originally appeared in The business Gazette.