FDA Approves Plexxikon Drug
October 18, 2011
Zelboraf, the most-recent Pappas Ventures-backed product to be approved by the FDA, has attracted worldwide media interest. Click here to see the ABC News report on how the melanoma drug, pioneered by Plexxikon, is providing new hope for patients who have this deadly disease.
October 7, 2011
They came from all parts of North Carolina’s Research Triangle, and several of them from far beyond, to hear the story of how a small biotechnology company developed a breakthrough cancer treatment, blazed a path for future development of personalized medicine treatments and was purchased in a deal valued at $935 million — the biggest venture-backed acquisition this year.
The company is California biotech Plexxikon. And one of its investors was Durham, North Carolina-based Pappas Ventures, which saw a return greater than 10 times its original investment. Plexxikon President Kathy Glaub was the guest speaker at a packed house for Pappas Ventures’ annual life sciences symposium. Pappas was one of Plexxikon’s early investors, pumping money into the company shortly after its 2001 launch. Art Pappas, founder and managing partner of the firm, said the investment was as much in founder and CEO Peter Hirth as it was in the science. Pappas said he thought Hirth could do with Plexxikon what he had done with previous company Sugen, whose cancer drug Sutent is now a blockbuster drug for Pfizer (NYSE:PFE).
The IPO market might be looking a little frosty, but the M&A market so far this year has been positive enough to warm VCs’ hearts.
The median selling price through September was nearly $71 million – four times the median amount invested prior to liquidity, according to Dow Jones VentureSource. That kind of multiple hasn’t been seen since 2000.
Because M&A is affected by the stock market, the pace is likely to fall in the fourth quarter, but the total raised is sure to exceed last year. VentureSource pegs the amount raised in the first nine months at $37.3 billion, only slightly behind the $39.42 billion for all of 2010, which was the best year since 2007. (VentureSource is owned by Dow Jones & Co., the publisher of this blog.)
So far this year, six acquisitions of U.S.-based venture-backed companies have closed at $700 million or more. The biggest was Plexxikon, which Daiichi Sankyo bought for $805 million. The company, which is developing a treatment for melanoma, raised $67 million from investors including Advanced Technology Ventures, Alta Partners, Astellas Venture Capital, Pappas Ventures and Walden International. The deal includes an additional $130 million in potential milestone payments
Second place goes to another health-care company, medical device maker Ardian, which sold to Medtronic for $800 million after raising more than $66 million. Advanced Technology Ventures was an investor in that company, too, along with Emergent Medical Partners, Morgenthaler Ventures and Split Rock Partners. Medtronic also was a backer.
Those deals closed in the first half of the year. The action lately has been more on the tech side. The third-largest deal of the year – and largest of the third quarter – was the $750 million sale of PopCap Games to Electronic Arts. The price could climb by another $550 million if certain performance goals are met. PopCap raised a single round of $22.5 million led by Meritech Capital Partners.
Paul Madera, a Meritech managing director said that during the last two years, the late-stage venture investor has seen its best run of liquidity since its start in 1999. But with stock market volatility crimping IPOs, he expects corporate acquirers to become more cautious. “There isn’t as much urgency to get things done,” Madera said.
Still, large tech companies are sitting on piles of cash and competition is fierce. The most active acquirer through September was Google, which bought nine companies, three of them in the third quarter. Dell and Zynga each have made four acquisitions, tied for second on the list.
DURHAM, N.C., Sept. 16, 2011 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that investigators will present preliminary data for CMX001 in a late-breaker presentation at the 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Chicago – September 17-20).
WALTHAM, Mass., Sept. 6, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announced today that ENCORE 301, a randomized, placebo-controlled phase 2 study of exemestane with and without entinostat hit its primary endpoint of an improvement in progression-free survival (PFS). The study showed that patients who received entinostat, a novel, oral small molecule inhibitor of class I histone deacetylases, with the hormone therapy exemestane, lived longer without their disease getting worse than people who received exemestane alone. Safety and efficacy results from the trial will be presented in a poster and an oral presentation at the American Society of Clinical Oncology (ASCO) Breast Cancer Symposium 2011 in San Francisco, CA this week.
DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan. Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.
August 20, 2011
CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).
Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called "ditans", and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.
August 17, 2011
Genentech, the South San Francisco-based unit of Roche, and its Berkeley, CA-based Plexxikon, a unit of Daiichi Sankyo, said today that the FDA has approved their new drug for certain patients with melanoma that has spread through the body. The FDA said the companies can now start selling vemurafenib (Zelboraf) for patients who have mutations of a protein called BRAF that is implicated in their melanoma. The drug, which showed startlingly positive results in clinical trials, was approved ahead of the FDA’s legal deadline of Oct. 28, an action the agency rarely takes.
WALTHAM, Mass., Aug. 17, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, today announced allowance by the European Patent Office for the patent application titled "N-(2-AMINOPHENYL)-4[N-(PYRIDINE-3-YL) - METHOXYCARBONYL - AMINOMETHYL]-BENZAMINE (MS-275) POLYMORPH B." This allowance follows the recent US issuance which was granted in June adding to the extensive patent estate for the Company's lead product, entinostat.
The patent covers the novel polymorph form B of the oral histone deacetylase inhibitor, entinostat, which is the specific polymorph being developed by Syndax for combination therapy with aromatase inhibitors for metastatic breast cancer and epidermal growth factor receptor tyrosine kinase inhibitors for advanced non-small cell lung cancer.
NEW YORK, August 10, 2011 – The genotyping era of melanoma management is poised to launch.
The era will start with genetic assessment of every patient with advanced-stage melanoma becoming the standard of care, as soon as the Food and Drug Administration approves marketing of vemurafenib, the small-molecule inhibitor of a mutated form of the BRAF gene. Reuters reports that approval is imminent, based on strikingly good results from a phase III study presented in June at the annual meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine (2011;364:2507-16).
"If and when [vemurafenib] is approved by the FDA, we will need some sort of commercially available test to assess patients [with unresectable stage IIIC or stage IV melanoma] for BRAF [mutations]," Dr. Richard D. Carvajal said in an interview after speaking at the American Academy of Dermatology’s Summer Academy meeting. "In a large, phase III trial, vemurafenib impacted survival in patients with tumors with a BRAF mutation. You’ll need to know the BRAF status to use [vemurafenib]."
