We saw a flurry of updates from San Diego’s biotech and medical device companies over the past week, running the gamut from the formation of a new startup to funding deals and fresh regulatory concerns. Here’s my wrap-up:
—Shares of San Diego’s Optimer Pharmaceuticals (NASDAQ: OPTR) gained more than 13 percent Wednesday, rising by over $1.40 to close at $12.13 a share in trading that was more than six times Optimer’s recent average volume. Wall Street rushed to buy after Optimer said it is exploring a possible sale of the company. Investors seemed unconcerned that Optimer also said it had replaced its CEO and general counsel and hired a new independent auditor—after ousting its previous chairman and purging several other executives last April. Few people seemed focused on a sentence in Optimer’s disclosure that I found riveting: “The previously disclosed investigations of these issues by the relevant U.S. authorities are ongoing and the Company continues to cooperate with those authorities.”
—San Diego-based MediciNova (NASDAQ: MNOV) said the FDA granted “fast track” status to ibudilast, the company’s proposed treatment for methamphatamine dependence. MediciNova said fast track status can shorten the time that federal regulators typically need to decide whether a proposed drug should be approved.
—San Diego’s Zogenix (NASDAQ: ZGNX) said the FDA had notified the company that its ruling on the company’s application to market extended-release hydrocodone bitartrate would be delayed by at least several weeks past March 1, the agency’s original target date for taking action. In its statement, Zogenix said the FDA did not say why its ruling would be delayed.
—An Xconomy-led discussion billed as San Diego Biotech Leaders of Tomorrow identified genomics, genetic diagnostics, industrial biotechnology, biologics R&D, stem cell therapies, and health IT technologies as emerging clusters of expertise in San Diego. I recapped the conversation—which came pretty close to serving as a summary of the life sciences industry here.
—Three of San Diego’s most-prominent cancer-research leaders deplored across-the-board federal budget cuts set to take effect today. If no action is taken, they say San Diego will lose more than $54 million in so-called sequestration of National Institutes of Health (NIH) funding. Kristiina Vuori of the Sanford-Burnham Medical Research Institute, Scott Lippman of the UC San Diego Moores Cancer Center, and Tony Hunter of the Salk Institute issued the call yesterday. With more than $850 million in NIH grants awarded here each year, they say the mandated 6.4 percent cut is equivalent to the annual salaries of 1,465 graduate students and postdocs.
—San Diego-based Synthetic Genomics says SGI-DNA, a subsidiary created with Integrated DNA Technologies (IDT) of Coralville, IA, has moved to focus its operations exclusively on commercializing a wide range of synthetic DNA products and technologies. Synthetic Genomics and IDT began co-manufacturing synthetic gene products a year ago in small batches—as many as 5 kilobases (5,000 base pairs of DNA or RNA). The partners said they now are expanding to produce co-branded, cloned synthetic DNA constructs up to 2 Mbp, a product offering that was not previously available.
—San Diego’s Ligand Pharmaceuticals (NASDAQ: LGND) said it received a $1.4 million milestone payment from Retrophin under a 2012 licensing agreement for the development of Retrophin’s lead drug candidate. The drug is under development for the treatment of focal segmental glomerulosclerosis (FSGS), a rare disease that attacks the kidney’s filtering system.
—San Diego’s Tandem Diabetes Care said the FDA has cleared “t:connect,” its Web-based data management application for use in the United States. The app, which is both iOS and PC-compatible, is intended to serve as the data management companion to Tandem’s t:slim insulin pump. The company says pump users will be able to download the app from Tandem’s website by the end of March.
—San Diego-based Ignyta said Silicon Valley Bank has added $1 million in venture debt to a $500,000 financing deal signed last summer. Ignyta CEO Jonathan Lim told me a few months ago that the startup plans to begin clinical studies this year to validate its new type of molecular diagnostic for rheumatoid arthritis (RA), the chronic and systemic inflammatory disorder that afflicts more than 1.5 million Americans.