San Diego Life Sciences Roundup: Amylin Buyout, PDUFA, & More
Amylin’s acquisition topped the news out of San Diego’s life sciences sector in the week before the July 4 holiday. But there were plenty of other developments as well. Here’s my rundown:
—What a long, strange trip it’s been. San Diego’s Amylin (NASDAQ: AMLN) spent 18 years developing exenatide (Byetta), an injection that helps diabetics using insulin gain better control of their blood sugar. When the FDA approved the drug in 2005, then-CEO Ginger Graham celebrated by wearing a Snow White costume to the office and jumping into the reflecting pool outside Amylin headquarters with other senior executives. Last week, Amylin agreed to a $7.1 billion buyout offer from Bristol-Myers Squibb, which includes paying a $1.7 billion debt.
—In a bit of noteworthy timing, the FDA made public a memo that criticizes Amylin shortly before the Bristol-Myers Squibb deal was announced. The memo helps explain why it took so long for Amylin to win approval for its long-lasting version of exenatide, called Bydureon. The Street.com’s Adam Feuerstein broke the story about the memo authored by Mary Parks, the FDA division director responsible for diabetes drugs, who said Amylin withheld a study from U.S. regulators that raised heart safety concerns about exenatide. The Parks memo alleges that Amylin also hindered agency access to the data. An Amylin spokeswoman told TheStreet the company is committed to being transparent with regulators and others. Still, it’s apparent that regulators didn’t see it that way.
—The bill reauthorizing the Prescription Drug User Fee Act (PDUFA) is now awaiting President Obama’s signature. In passing the measure, Congress left plenty of time for the FDA to implement new programs before the existing prescription drug act’s authorization expires on September 30. One key provision of the legislation is entitled “Generating Antibiotic Incentives Now,” also known as the GAIN Act. It provides incentives for the life sciences industry to develop a new generation of antibiotics for treating life-threatening infections caused by drug-resistant pathogens.
—San Diego-based Trovagene (NASDAQ: TROV) said it has agreed to work with scientists at The University of Texas MD Anderson Cancer Center to develop a urine test for detecting KRAS mutations in the genomes of pancreatic cancer patients. Trovagene, which develops trans-renal molecular diagnostics, said a non-invasive urine test would greatly simplify patient monitoring.
—San Diego’s BioSurplus, which provides online listings of used laboratory equipment and provides equipment management services, has expanded its equity round from the $1.5 million disclosed in May to $2.4 million, according to VentureWire. BioSurplus said in May that KI Investment Holdings provided most of the round.
—San Diego-based MediciNova (NASDAQ: MNOV) said it has scheduled an end-of-Phase 2 meeting with the FDA on Oct. 22 to discuss the company’s plans for a late-stage trial of its experimental compound for urgent care treatment of acute asthma. In May, MediciNova reported some mixed results of its mid-stage clinical trials of the drug, which has been designated MN-221. MediciNoval laid out its plans for me earlier this year.
—Qualcomm awarded a total of $30,000 in prize money to Rich Stoner, a research engineer at UC San Diego, for demonstrating an app that could be used to detect signs of autism in 12-month-old infants during a one-day “hackathon and codefest” the company sponsored. The all-day mobile app development competition offered a total of $50,000 in cash prizes to developers in five categories. Stoner got the prize for “best prototype app using facial processing” as well as the $25,000 grand prize for best overall app.