Deals & Data
Amylin Pharmaceuticals CEO Daniel M. Bradbury said that he thought the company would answer the remaining questions that the Food and Drug Administration has the company’s once-weekly diabetes drug. The FDA announced on March 15 that it had a few more questions it needed answered before it could give a final decision on whether Exenatide LAR could be approved for market. The FDA did not ask for more expensive clinical studies. The stock market responded favorably to Amylin’s news, with shares up more than $2.
AnaptysBio, a privately-held therapeutic antibody platform and product company, announced a strategic collaboration with an undisclosed leading global pharmaceutical company to generate novel antibody therapeutics to a specified disease target. This is the third collaboration with a leading pharmaceutical company announced by AnaptysBio during 2010.
Trius Therapeutics said it is temporarily delaying its IPO until it modifies the protocol for a planned Phase 3 trial of torezolid to treat Gram-positive bacterial infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Trius said it will modify the trial to conform to draft guidance on non-inferiority (NI) trials published by FDA.
Shares of Adventrx Pharmaceuticals fell after the FDA refused to file an NDA for ANX-530 to treat non-small cell lung cancer (NSCLC). According to the company, the FDA said the CMC data from the intended commercial manufacturing site was "insufficient to support a commercially-viable expiration dating period." Adventrx expects the agency to require additional site-specific stability data. The company said stability studies are ongoing.
La Jolla Pharmaceutical said that it didn’t come close to getting enough shareholder votes to go through with a planned merger with another small company. The company said previously that its likely alternative is to close, with shareholders getting just a few pennies per share. But despite repeated encouragement from the company to submit proxy statements with their votes, only 13 percent of the shareholders did.
Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals announced that they have entered into an exclusive license and distribution agreement in which Sanofi-Aventis Deutschland will have the right to commercialize and market Novalar's OraVerse in Germany with options to extend the license to additional European countries. OraVerse is the first and only local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. OraVerse is approved for use in the U.S. by the FDA and sold by Novalar direct to dentists.
The Salk Institute for Biological Studies today announced the appointment of Professor Tony Hunter, Ph.D., as the inaugural holder of the Frederick W. and Joanna J. Mitchell Chair, created in memory of their daughter Marian Mitchell through a $2 million gift by the estate of Frederick W. Mitchell.
Shares of Sequenom rose 62 percent during the month of February, boosted by the launch of a couple of molecular diagnostic tests that will be offered through its CLIA lab, the Sequenom Center for Molecular Medicine. Those tests are its SensiGene Fetal RHD Genotyping test and its SensiGene Fetal (XY) test.
Avrio Biopharmaceuticals, a premier contract development and manufacturing organization, announced the addition of Yvonne Verburgt as Vice President of Business Development and Marketing. Verburgt brings over 28 years of pharmaceutical industry experience to the company and to the clients it serves. Her most recent venture as the head of Business Development at Pharmatek Laboratories involved successfully leading the sales team to help expand business of pharmaceutical chemistry development services.
ActivX Biosciences, a San Diego-based company that was a highflier during the genomics bubble of 2000 with their hot technology for analyzing proteins from The Scripps Research Institute, has definitely taken a different path than most start up companies. ActivX ran out of cash in 2004, by which time its VCs had lost interest in early-stage technology platforms. ActivX was then sold to Kyorin for $21 million in December 2004. This is where ActivX takes the road less traveled. ActivX president, John Kozarich, wanted the company to retain its name and identity, not just become Kyorin U.S. If ActivX could continue to sell its technology to enhance drug discovery for other companies—Pfizer being one—then the revenue could help enhance the technology, and therefore, help strengthen Kyorin’s drug discovery engine. A decade after ActivX was founded, Kozarich is still there, leading a team of 50 people. The company still provides its technology to customers like Pfizer, and it still has contacts with a stellar scientific advisory board at Scripps. Last month, ActivX demonstrated how it still has some autonomy, when it announced it had licensed technology for identifying the activity of proteins to Thermo Fisher Scientific, the Waltham, MA-based giant in the world of lab supplies.
Stemgent, a provider of biological materials for life sciences research with offices in Cambridge, MA, and San Diego, will invest $4.5 million over the next three years in the Dundee, Scotland-based biotech firm Ubiquigent. Ubiquigent is producing biological products developed by the Scottish Institute for Cell Signaling at the University of Dundee. Stemgent is handling initial marketing of the fledgling Scottish biotech’s products in the U.S. market.
San Diego-based Optimer Pharmaceuticals, the developer of an antibiotic for a dangerous hospital infection, has raised $51.5 million through a secondary stock offering after deducting expenses. The company sold about 4.9 million shares of common stock at $11 a share. Jefferies & Co. was the sole book-running manager in the offering. Last month, Optimer said its fidaxomicin drug candidate passed its second pivotal test against C.difficile bacterial infections, and that it plans to apply for FDA approval of the drug in the second half of 2010.
Isis Pharmaceuticals has earned a $6 million payment from Bristol-Myers Squibb for getting clearance from regulators to begin clinical trials of a new cholesterol-lowering drug. Isis and Bristol are collaborating on BMS-PCSK9Rx, as a targeted antisense therapy which seeks to lower cholesterol by hitting the target PCSK9.
The FDA has a deadline of March 12 to say whether it has approved a new drug from Amylin, Alkermes, and marketing partner, Eli Lilly, which seeks to transform diabetes treatment with the first once-weekly injectable drug to control blood sugar. This product has billion-dollar potential and will likely be the biggest sales driver for Amylin for years to come.
San Diego’s West Wireless Health Institute today named Donald Casey as its first chief executive officer. Casey, a former worldwide chairman of Johnson & Johnson’s Comprehensive Care group, also will serve on the institute’s board of directors, according to a statement issued today.
San Diego’s Tocagen, a biotech developing gene therapy treatments for terminal cancers, says it has raised nearly $7.8 million from 75 investors in a Series D round, according to a recent regulatory filing. Tocagen, which also raised about $3 million last month by selling preferred shares, says in the filing that it intends to raise a total of $8 million.