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BioCentury Extra
As published Wednesday, August 27, 2014 5:58 PM PST


  • Arch closes $410 million fund

    Arch Venture Partners raised $410 million for its eighth fund, well above the firm's $250 million target for Arch Venture Fund VIII LP. The firm said it will invest the fund in early stage technologies in the healthcare, energy and material sectors. Arch closed its seventh fund with $400 million in 2007. Including the eighth fund, the firm has about $1.9 billion in committed capital. Portfolio companies include RNAi company Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), gene therapy play bluebird bio Inc. (NASDAQ:BLUE) and cancer immunotherapy company Juno Therapeutics Inc. (Seattle, Wash.).

  • EC approves BMS's daclatasvir for HCV

    The European Commission approved Daklinza daclatasvir (BMS-790052) from Bristol-Myers Squibb Co. (NYSE:BMY) in combination with other therapies to treat HCV genotypes 1, 2, 3 and 4.

    BMS said the selective HCV NS5A protein inhibitor's label recommends multiple regimens, including treatment of genotypes 1 and 4 with or without compensated cirrhosis in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD); HCV genotype 3 with compensated cirrhosis or previous HCV treatment in combination with Sovaldi and ribavirin; and HCV genotype 4 in combination with ribavirin and peginterferon alfa.

    FDA is reviewing an NDA for daclatasvir in combination with BMS's asunaprevir (BMS-650032) and other agents to treat HCV genotype 1b infection, with a Nov. 30 PDUFA date. Last month Japanese regulators approved daclatasvir to treat chronic HCV genotype 1 infection with and without compensated cirrhosis. BMS plans to market the drug in Japan beginning next week, and in the EU as soon as possible.

  • European approval for Velphoro

    The European Commission approved Velphoro sucroferric oxyhydroxide from Vifor-Fresenius Medical Care Renal Pharma Ltd. to control serum phosphorus levels in adults with chronic kidney disease (CKD) on hemodialysis or peritoneal dialysis. The oral iron-based phosphate binder is marketed for the indication in the U.S.

    Velphoro was developed by the Vifor Pharma Ltd. specialty pharma business of Galenica Ltd. (SIX:GALN), which transferred rights to the product to Vifor-Fresenius, a JV formed by Galenica and the Fresenius Medical Care unit of Fresenius SE & Co. KGaA (Xetra:FRE; OTCQX:FSNUY). Fresenius Medical Care was down EUR 0.19 to EUR 37.44 on Wednesday.

  • Amgen gets Priority Review for ivabradine

    FDA accepted and granted Priority Review to an NDA from Amgen Inc. (NASDAQ:AMGN) for ivabradine to treat chronic heart failure (CHF). The selective If channel inhibitor is already marketed as Procoralan in about 100 countries, excluding the U.S. Amgen -- which has exclusive U.S. commercialization rights to ivabradine from Servier (Neuilly-sur-Seine, France) -- was up $0.56 to $137.83 on Wednesday.

  • Allergan sets special meeting date

    Allergan Inc. (NYSE:AGN) set a Dec. 18 date for a special shareholder meeting at which Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX) and hedge fund Pershing Square Capital hope to install board members who would approve Valeant's hostile takeover bid. Valeant and Pershing Square are suing Allergan and seeking a November date.

    In its own lawsuit, Allergan alleges that Valeant, Pershing Square and its manager violated insider trading laws. Allergan said Wednesday that it is seeking a federal court order to strip those parties of voting rights it alleges they acquired illegally.

    Valeant and Pershing Square began their takeover attempt in April. Allergan has rejected multiple bids, including a $52.5 billion cash and stock offer. Allergan was down $1.21 to $162.76 on Wednesday, with a market cap of $48.4 billion.

  • Sanofi's Moulding to become North America president

    Sanofi (Euronext:SAN; NYSE:SNY) said Jez Moulding will transition to president of North America pharmaceuticals, effective Oct. 1. He will replace Anne Whitaker, who is joining Synta Pharmaceuticals Corp. (NASDAQ:SNTA) as president, CEO and a director. Moulding is currently SVP of Japan and Pacific and general manager of Japan global operations at Sanofi. Fabrice Baschiera, who is general manager of commercial operations for greater China at the pharma, will succeed Moulding.

  • Bellicum secures $55 million in series C

    Bellicum Pharmaceuticals Inc. (Houston, Texas) secured $55 million in a series C round from 11 new investors, including RA Capital; Perceptive Advisors; Jennison Associates; Sabby Capital; Ridgeback Capital Management; venBio Select; Redmile Group; and AJU IB Investment. All of the companies' existing investors also participated, including AVG Ventures and Remeditex Ventures.

    Bellicum's BPX-501 is in Phase I/II testing to treat graft-versus-host disease (GvHD) in hematopoietic stem cell transplant (HSCT) patients. The therapy comprises T cells containing Bellicum's CaspaCIDe gene, which allows elimination of cell treatments if they become toxic. The company's BPX-201 -- which comprises genetically modified, autologous dendritic cells containing Bellicum's DeCIDe on-switch gene -- is in a Phase I trial to treat metastatic castration-resistant prostate cancer (CRPC).

    Both products use AP1903, which activates genetically engineered receptors of cell therapies to activate the caspase pathway and trigger apoptosis. Bellicum has non-exclusive rights to AP1903 for use in cancer vaccines from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA).

  • Rhythm files for IPO

    Rhythm Pharmaceuticals Inc. (Boston, Mass.) filed to raise up to $86.3 million in an IPO on NASDAQ underwritten by Citigroup; Cowen; Canaccord Genuity; Oppenheimer; and Cantor Fitzgerald. Rhythm expects to begin a Phase IIb trial of ghrelin agonist relamorelin (RM-131) to treat diabetic gastroparesis in 4Q14. Earlier this year, relamorelin met the primary endpoint of reducing gastric half-emptying time from baseline to week four vs. placebo in a Phase II trial.

    Rhythm has exclusive, worldwide rights to relamorelin from Ipsen Group (Euronext:IPN; Pink:IPSEY) (see BioCentury Extra, May 6).

  • Dermatology play Dermira files for IPO

    Dermira Inc. (Redwood City, Calif.) filed to raise up to $75 million in an IPO on NASDAQ underwritten by Citigroup; Leerink; Guggenheim Securities; and Needham. Dermira said partner UCB Group (Euronext:UCB) may purchase about $7.5 million of stock in the offering.

    Dermira's topical small molecule anticholinergic DRM04 is in Phase IIb testing to treat hyperhidrosis (excessive sweating), with data expected next half. Also next half, the company plans to start a Phase IIb study of topical small molecule sebum inhibitor DRM01 to treat acne.

    In July, Dermira gained exclusive rights to develop UCB's autoimmune drug Cimzia certolizumab pegol for psoriasis in the U.S., Canada and the EU. Next half, the company plans to start a Phase III program for the pegylated humanized antibody fragment against TNF alpha to treat moderate to severe plaque psoriasis.

    Dermira raised $51 million in a series C round earlier this month (see BioCentury Extra, Aug. 19).

  • Capnia amends IPO

    Capnia Inc. (Redwood City, Calif.) amended its IPO on NASDAQ and now plans to raise $11.1 million through the sale of 1.7 million units at $6.50. Each unit comprises a share and a five-year warrant to purchase a share at $5. Last month, the company said it planned to sell 2.7 million units at $6.50-$8.50. Capnia filed to raise up to $23 million in the offering in June. Maxim; National Securities; and Dawson James Securities are underwriters.

    Capnia's CoSense, which aids in the diagnosis of hemolysis, has 510(k) clearance in the U.S. and CE Mark approval in the EU but is not yet commercially available. Capnia said it plans to launch the product -- which combines a portable detection device with a single-use disposable nasal cannula to measure carbon monoxide -- this half.

  • Napo's Jaguar Animal Health files for IPO

    The Jaguar Animal Health Inc. subsidiary of Napo Pharmaceuticals Inc. (San Francisco, Calif.) filed to raise up to $70 million in an IPO on NASDAQ underwritten by BMO Capital Markets; Guggenheim Securities; and Roth Capital Partners. Napo formed Jaguar last year to develop and commercialize animal health products. Jaguar has exclusive, worldwide rights to Napo's IP and technology for all veterinary applications.

    By year end, Jaguar expects to begin submission of a rolling new animal drug application for Canalevia to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia is a canine-specific formulation of crofelemer. A human-specific formulation of crofelemer -- a purified proanthocyanidin oligomer extracted from the bark latex of the Amazonian tree Croton lechleri -- is approved in the U.S. as Fulyzaq to treat non-infectious diarrhea in HIV/AIDS patients on antiretroviral therapy.

  • NIH issues final policy on genomic data sharing

    NIH released a final policy with guidelines for sharing large-scale genomic data from NIH-funded research, making only minor changes and clarifications to draft guidance published in 2013. The new policy applies to submissions with a receipt date on or after January 25, 2015 (see BioCentury Extra, Sep. 23, 2013).

    The Genomic Data Sharing (GDS) policy applies to genomic data generated by array-based and high throughput genomic technologies. It extends and replaces NIH's prior policy on the subject, which had been in effect since 2007.

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