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BioCentury Extra
As published Tuesday, November 25, 2014 5:49 PM PST


  • Cell Medica raises L50M series B

    Cell therapy developer Cell Medica Ltd. (London, U.K.) raised L50 million ($78.2 million) in a series B round led by Imperial Innovations. Invesco Perpetual and Woodford Investment Management also participated.

    Cell Medica's CMD-003 (Cytorex EBV) is in a Phase II trial to treat advanced lymphoma associated with Epstein-Barr virus. CMD-003 is comprised of EBV-specific cytotoxic T lymphocytes (CTLs).

    The company acquired exclusive, worldwide rights to CMD-003 under a 2011 deal with the Baylor College of Medicine.

    Imperial, an original seed investor in Cell Medica, provided L15 million of the newest round, and now holds a 27.9% stake in the biotech.

  • FDA extends review of Novartis' panobinostat

    FDA will extend by up to three months its review of an NDA for panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN). The agency granted Priority Review in May to the oral pan-deacetylase (DAC) inhibitor in combination with Velcade bortezomib and dexamethasone to treat multiple myeloma (MM).

    On Nov. 5, FDA's Oncologic Drugs Advisory Committee (ODAC) voted 5-2 that panobinostat's 3.9 month progression-free survival (PFS) benefit did not outweigh the safety risks of treating MM patients who have received at least one prior therapy. Patients receiving the panobinostat combination in the Phase III PANORAMA-1 trial had twice as many on-study deaths and almost 50% more non-fatal serious adverse events than those receiving Velcade and dexamethasone without panobinostat (see BioCentury, Nov. 17).

    If approved, panobinostat would be first-in-class. Novartis submitted an MAA to EMA for panobinostat to treat MM in 2Q14.

    Johnson & Johnson (NYSE:JNJ) and the Millennium Pharmaceuticals Inc. subsidiary of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) market Velcade, a proteasome inhibitor.

  • NICE recommends Selincro for alcohol dependence

    The U.K.'s NICE issued final guidance recommending the use of Selincro nalmefene from H. Lundbeck A/S (CSE:LUN) to reduce alcohol consumption by adults with alcohol dependence who have a high drinking risk level without physical withdrawal symptoms and who do not require immediate detoxification. The European Commission approved Selincro to reduce alcohol consuption in adults with alcohol dependence last year (see BioCentury Extra, Feb. 28, 2013).

    NICE recommends that Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Its recommendation is in line with draft guidance issued in July (see BioCentury Extra, July 9).

    Lundbeck has exclusive, worldwide rights to the opioid receptor antagonist from Biotie Therapies Corp. (HSE:BTH1V) under an amended 2006 deal.

    Otsuka Pharmaceutical Co. Ltd. paid Lundbeck EUR 50 million ($69.1 million) up front for Japanese rights to Selincro in a 2013 deal that also included milestones and royalties.

  • Promethera raises EUR 20.3M in series C

    Liver disease company Promethera Biosciences S.A. (Mont-Saint-Guibert, Belgium) raised EUR 20.3 million ($25.2 million) in a series C round led by existing investor Vesalius BioCapital. New investors included Germany's SMS Group and Belgium's SFPI-FPIM, while existing investors SRIW; Vives-Louvain Tech Transfer Office Fund; Boehringer Ingelheim Venture Fund; Shire plc (LSE:SHP; NASDAQ:SHPG); the Mitsui Global investment unit of Mitsui & Co. Ltd. (Tokyo:8031); Pall Corp. (NYSE:PLL); and angels also participated.

    Promethera also secured an additional EUR 5 million ($6.2 million) in government loans and subsidies from the Walloon region of Belgium.

    Last month, Promethera began a Phase IIb/III trial of lead program HepaStem to treat children with urea cycle disorder (UCD). CEO and Co-Founder Eric Halioua told BioCentury the company expects the first data from the trial in early 2017. The cell therapy comprising human adult liver-derived mesenchymal stem cells (hALDMSCs) has Orphan Drug designation in the U.S. and EU to treat UCD and Crigler-Najjar Syndrome.

    Halioua would not say whether the financing is tranched, and said a new board member will be introduced "in the coming weeks."

    In 2012, Promethera raised a EUR 17 million series B round accompanied by a EUR 6.6 million loan from the Walloon region (see BioCentury Extra, March 28, 2012).

  • Eleven raises $20M in private placement

    Eleven Biotherapeutics Inc. (NASDAQ:EBIO) raised $20 million through the sale of 1.7 million shares at $11.47 in a private placement with undisclosed investors. The company also issued three-year warrants to purchase 871,840 shares at $15. Citigroup; Cowen; and Leerink were placement agents. In February, Eleven raised $57.5 million in an IPO.

    The company expects top-line data in 2Q15 from a Phase III study of EBI-005 to treat dry eye disease. EBI-005 is an IL-1 receptor antagonist. Shares were down $0.11 to $11.36 on Tuesday.

  • Medgenics raises $21M in follow-on

    Medgenics Inc. (NYSE-M:MDGN) raised $21 million through the sale of 5.1 million shares at $4.10 in a follow-on underwritten by Piper Jaffray and JMP Securities.

    Medgenics' lead compound, TARGTEPO (MDGN-201), is in Phase I/II testing to treat anemia in end-stage renal disease (ESRD) and chronic kidney disease (CKD) patients. The product is a transdermal biopump implant device that produces erythropoietin (EPO).

  • Lawmakers propose Medicaid rebates for generic price hikes

    U.S. Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) introduced legislation in the Senate and House that would require generic drug makers to pay rebates to state Medicaid programs when they raise drug prices at a faster rate than inflation. Brand name drug manufacturers are already required to pay similar rebates.

    According to the lawmakers, the Congressional Budget Office estimated the proposed Medicaid Generic Drug Price Fairness Act (S. 2948, H.R. 5748) would save $500 million over 10 years.

    In a statement, the Generic Pharmaceutical Association (GPhA) said the bill "reflects a basic misunderstanding of the pharmaceutical marketplace" and advised Congress to encourage competition to increase access and reduce costs.

    The CEOs of Marathon Pharmaceuticals LLC (Northbrook, Ill.), Lannett Co. Inc. (NYSE:LCI) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) declined to testify at a Senate hearing last Thursday to investigate generic drug pricing.

    Sanders and Cummings launched an investigation into generic prices last month. The legislators sent letters to 14 generic drug manufacturers, including Marathon, Lannett and Teva, requesting information about rising prices for particular drugs (see BioCentury Extra, Oct. 3).

  • IQWiG raises WHO's ante on trial transparency

    Germany's Institute for Quality and Efficiency in Health Care (IQWiG) applauded the proposed clinical trial transparency policy from the World Health Organization, but said the policy "does not go far enough."

    The German organization made a public comment on WHO's Statement on Public Disclosure of Clinical Trial Results, issued last month. The proposed policy called for all human trials to be registered in a public database, with trial results published no later than 30 months after they are completed (see BioCentury Extra, Oct. 23).

    WHO's policy applies only to future clinical trials. IQWiG called for publication of data from older trials as well, which the agency said would allow it to compare new therapies with older therapies and would give patients insight into benefits and risks of established treatments.

    IQWiG also called for publication of all trial outcomes including quality-of-life assessments, not just primary and secondary endpoints. IQWiG said comparative effectiveness research "increasingly uses indirect comparisons," which require the use of detailed data to assess similarities and differences between trials.


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