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BioCentury Extra
As published Friday, December 02, 2016 5:13 PM PST


  • Celgene acquiring Acetylon after spinout of newco

    Acetylon Pharmaceuticals Inc. (Boston, Mass.) said Celgene Corp. (NASDAQ:CELG) will acquire it for undisclosed terms. Prior to the deal's completion, Acetylon will spin out some histone deacetylase (HDAC) assets into newco Regenacy Pharmaceuticals LLC (Boston, Mass.).

    Celgene will gain rights to Acetylon's lead candidates, oral HDAC6 inhibitors ricolinostat (ACY-1215) and citarinostat (ACY-241), in oncology, neurodegeneration and autoimmune indications. Both are in development for multiple myeloma (MM). In June, Acetylon said ricolinostat in combination with Celgene's Pomalyst pomalidomide and dexamethasone produced an overall response rate of 46% in a Phase II study to treat relapsed or refractory MM.

    Acetylon said Regenacy will have exclusive, worldwide rights to ricolinostat in "certain" non-cancer indications, and plans to develop its HDAC6 program in diabetic and peripheral neuropathies. It will also have rights to preclinical HDAC1 and HDAC2 inhibitors in all indications, and intends to evaluate them to treat sickle cell disease, beta-thalassemia, psychiatric disorders and acute myelogenous leukemia (AML).

    Acetylon said "key members" of Acetylon's executive team will manage the newco, which will be based in Acetylon's former headquarters.

    Celgene held an option to acquire Acetylon under a 2013 deal, but allowed the option to expire in May. Acetylon would have received at least $500 million and been eligible for another $1.1 billion in milestones if Celgene had exercised the option. Celgene retained an equity stake in Acetylon after the option expired (see BioCentury Extra, Aug. 8).

    Acetylon announced the deal during market hours. Celgene lost $1.24 to $117.63 on Friday.

  • Jardiance label adds CV risk indication

    FDA approved Jardiance empagliflozin from Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (NYSE:LLY) to reduce the risk of cardiovascular death in adults with Type II diabetes and cardiovascular disease. The drug had been approved since 2014 to improve glycemic control in Type II diabetes patients.

    The approval was based on the EMPA-REG OUTCOME cardiovascular outcomes trial (CVOT), in which Jardiance in combination with standard of care (SOC) met its primary endpoint of time to first CV event and showed superiority vs. placebo plus SOC in CV risk reduction (see BioCentury Extra, Aug. 20, 2015).

    In June, FDA's Endocrinology and Metabolic Drug Advisory Committee voted 12-11 that EMPA-REG OUTCOME data showed that Jardiance had "substantial efficacy" in reducing CV mortality. Jardiance is a sodium-glucose cotransporter 2 (SGLT2) inhibitor (see BioCentury Extra, June 28).

    Lilly is banking on a handful of recently launched drugs, including Jardiance, to make up for loss of patent protection for other drugs and to drive future growth. Sales of Jardiance and combinations including the drug were $125.8 million in the first nine months of 2016 (see BioCentury, Oct. 24).

  • Management tracks

    Prescription and OTC pharma Taro Pharmaceutical Industries Ltd. (NYSE:TARO) said Uday Baldota will replace Kal Sundaram as its CEO, effective April 2017. Baldota is EVP and CFO at Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA). Abhay Gandhi, who is CEO of Sun's North America operations, will be Taro's interim CEO from Jan. 1 until Baldota's arrival.

    Cell therapy company bluebird bio Inc. (NASDAQ:BLUE) named Susanna High COO and Andrew Obenshain SVP and head of Europe. High was SVP of strategy and business integration at Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY). Obenshain was general manager of France and Benelux at Shire plc (LSE:SHP; NASDAQ:SHPG).

    Scholar Rock LLC (Cambridge, Mass.), which develops biologics that target dysregulated growth factors, named Alan Buckler CSO. He was VP of cell and protein sciences at Biogen Inc. (NASDAQ:BIIB).

    Cell therapy company Kite Pharma Inc. (NASDAQ:KITE) named Jian Irish SVP of supply chain. She was VP of biologics strategic supply, sourcing and partnerships at Sanofi (Euronext:SAN; NYSE:SNY).

    Gilead Sciences Inc. (NASDAQ:GILD) promoted James Meyers to EVP of worldwide commercial operations. He was SVP of North American commercial operations.

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) named Herve Gisserot head of pharmaceuticals for the Asia Pacific region, effective Jan. 1. He was SVP and general manager for GSK's China/Hong Kong pharmaceuticals and vaccines.

    Cancer immunotherapy company Medigene AG (Xetra:MDG1) named Thomas Taapken CFO, effective Jan. 1. He was CEO and CFO at Epigenomics AG (Xetra:ECX; OTCQX:EPGNY).

    Neurology company AC Immune S.A. (NASDAQ:ACIU) said Joerg Hornstein will succeed George Pavey as CFO, effective 1Q17. Hornstein was SVP of group controlling at Theo Mueller Group S.e.C.S. (Luxembourg).

    Hepatic company Albireo Pharma Inc. (NASDAQ:ALBO) named Martha Carter chief regulatory officer. She was SVP and chief regulatory officer at Aegerion Pharmaceuticals Inc., which merged with QLT Inc. to form Novelion Therapeutics Inc. (NASDAQ:NVLN; TSX:NVLN).

    Cell therapy company Nohla Therapeutics Inc. (Seattle, Wash.) named Shelly Heimfeld EVP of research and manufacturing. He was a scientific director at the Fred Hutchinson Cancer Research Center (Seattle, Wash.) and Seattle Cancer Care Alliance (Seattle, Wash.).

    Cardiovascular company MyoKardia Inc. (NASDAQ:MYOK) named Marc Semigran CMO. He was section head and medical director of the heart failure and cardiac transplant program at Massachusetts General Hospital (Boston, Mass.).

  • Takeda, Lightstone back CNS newco Cerevance

    Neurology newco Cerevance LLC (Cambridge, Mass.) launched with $36 million, including a $21.5 million series A from co-leaders Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Lightstone Ventures. Cerevance declined to name the source of the balance, but said a portion of the money raised was non-dilutive.

    Cerevance will license target identification technology developed in Nathaniel Heintz's lab at The Rockefeller University (New York, N.Y.) for use in its efforts to discover and develop therapies for neurological and psychiatric disorders.

    Takeda will grant Cerevance a license to preclinical and clinical programs and provide the company lab space and personnel from its former operations in Cambridge, U.K. In a restructuring announced in July, Takeda said it would likely spin out some programs into a start-up after it closed the Cambridge facility (see BioCentury Extra, July 29).

    Cerevance's CEO will be Brad Margus, who was CEO of CNS company Envoy Therapeutics Inc. prior to its acquisition by Takeda in 2012. Heintz was a co-founder of Envoy, which had been a longtime partner of the pharma (see BioCentury, Dec. 3, 2012).

    Takeda and Lightstone will each have representatives on Cerevance's board.


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