TEDMED Walking, FDA Clears Pacira Drug, Zogenix Close to NDA, & More San Diego Life Sciences News
Drug approvals and advances in new cancer therapies were the prevailing themes in San Diego’s life sciences news over the past week. Our briefing begins now.
—TEDMED, the exclusive medical and healthcare symposium that died in 2004 and was resurrected in 2009, is now the walking TEDMED. The entertaining show with a mix of big ideas, celebrity presentations, humor, and music that played at the Hotel del Coronado for the past three years said it is moving to Washington DC. Playing at the John F. Kennedy Center for the Performing Arts in the nation’s capital will give the $4,000-a-person symposium a bigger stage and a more influential audience, according to Priceline.com founder Jay Walker, who led an investor group that acquired the show in April. About 850 attended last week’s four-day symposium in the San Diego area.
—Federal regulators approved a new pain-killing drug intended to put off the post-surgical need for opioids that was developed by Pacira Pharmaceuticals (NASDAQ: PCRX), the Parsippany, NJ-based drug developer with operations in San Diego. The FDA’s approval marked the end to a protracted drug-development saga for the long-acting form of a pain drug called bupivacaine. Pacira plans to begin marketing the drug, branded as Exparel, in January.
—The FDA approved a new diagnostic test that was developed by San Diego-based Gen-Probe (NASDAQ: GPRO) to detect strains of the human papillomavirus (HPV) that pose a higher risk for cervical cancer and precancerous legions. Gen-Probe said regulators approved its Aptima HPV test to run on TIGRIS, a fully automated, high-throughput molecular diagnostic system. Using a Pap smear sample, the company says its test detects 14 high-risk types of HPV, giving patients and doctors information earlier and more accurately.
—Luke’s BioBeat column focused on several cancer drugs the FDA approved in August, which he suggested could be a turning point in the decades-long battle against cancer. Instead of broad-based anti-cancer drugs, Luke says regulatory approval of vemurafenib (Zelboraf), brentuximab vedotin (Adcetris), and crizotinib (Xalkori) signals the coming era of translational medicine, in which drugs home in on biologically distinct malignancies.
—Zogenix CEO Roger Hawley told me the San Diego company plans to submit a new drug application (NDA) in early 2012 for its extended-release formulation of the painkilling drug hydrocodone bitartrate (Zohydro). Zogenix estimates that more than 128 million prescriptions are written in the U.S. each year for hydrocodone drugs, a potential $7.5 billion market opportunity. The company said attaining just 1 percent of that market would generate an estimated $248 million a year.
—San Diego’s Intellikine said it earned $4 million in milestone payments from Cambridge, MA-based Infinity Pharmaceuticals (NASDAQ: INFI). Intellikine has been developing small-molecule drugs that target a key cellular signaling pathway controlled by a group of kinase enzymes known as PI3K. Intellikine licensed rights for IPI-145, a compound that blocks two of the four known variations of PI3K, to Infinity in mid-2010. As part of the deal, Infinity agreed to pay $4 million with the initiation of two early stage trials of IPI-145.
—San Diego-based Illumina (NASDAQ: ILMN) and Siemens Healthcare Diagnostics (NYSE: SI) of Tarrytown, NY, have formed a partnership to set new standards for next-generation genome sequencing of infectious microbes in patients. By making Siemens molecular HIV tests compatible with Illumina’s next generation MiSeq DNA sequencing system, the companies said they plan to offer a variety of new diagnostic assays for infectious diseases.
—Driven by sales of its new FDA-approved drug for treating hepatitis C, Cambridge, MA-based Vertex (NASDAQ: VRTX) posted its first quarterly profit based on its own product sales. Vertex said sales of telaprevir helped the company generate $659 million in total revenues, and turn a profit of $221 million ($1.02 a share) in the third quarter that ended Sept. 30. The company maintains some operations in San Diego.