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BioCentury Extra
As published Tuesday, August 26, 2014 5:24 PM PST

  • Zai raises over $30M in A round

    Zai Laboratory Inc. (Shanghai, China) raised more than $30 million in a series A round led by Qiming Venture Partners. Also participating were Kleiner Perkins Caufield & Byers; Sequoia Capital; TF Capital; and undisclosed investors. Zai Lab was founded by former Hutchison MediPharma CEO Samantha Du, and in-licenses compounds for both Chinese and global development.

    Earlier this month, Zai obtained from Sanofi (Euronext:SAN; NYSE:SNY) worldwide rights to two preclinical compounds to treat chronic respiratory diseases (see BioCentury Extra, Aug. 12).

  • FortuneRock raises $23.6 million

    FortuneRock Ltd. (Beijing, China) raised RMB145 million ($23.6 million) in a venture round from international investors including Jinhua Pharmaceutical Co. Ltd. FortuneRock will use RMB120 million to spin out a company housing its lead compound, a recombinant human serum albumin and G-CSF fusion protein that is in Phase II trials. FortuneRock uses its technology to extend half-lives of recombinant proteins.

  • Civitas files for IPO

    Civitas Therapeutics Inc. (Chelsea, Mass.) filed to raise up to $86.3 million in an IPO on NASDAQ underwritten by J.P. Morgan; BofA Merrill Lynch; Cowen; and Oppenheimer. Civitas plans to start Phase III testing of CVT-301 to treat motor fluctuations associated with Parkinson's disease (PD) early next year, with data expected in 2016. CVT-301 is an inhaled formulation of levodopa delivered via Civitas' Arcus inhalation technology.

    The filing comes a day after Civitas announced a $55 million series C (See BioCentury Extra, Aug. 25).

  • Cancer play Calithera files for IPO

    Calithera Biosciences Inc. (South San Francisco, Calif.) filed to raise up to $80 million in an IPO on NASDAQ underwritten by Citigroup; Leerink Partners; Wells Fargo Securities; and JMP Securities. In February, Calithera started Phase I trials of lead product CB-839, an oral selective glutaminase (GLS) inhibitor to treat acute leukemia, advanced multiple myeloma (MM), non-Hodgkin's lymphoma (NHL) and advanced solid tumors. Calithera expects final data for CB-839 monotherapy in mid-2015 and as a combination therapy in late 2015.

  • NeuroSigma files for IPO

    NeuroSigma Inc. (Los Angeles, Calif.) filed to raise up to $50 million in an IPO on NASDAQ underwritten by Jefferies; BTIG; and Craig-Hallum Capital Group. NeuroSigma markets its Monarch external trigeminal nerve stimulation (eTNS) system in the EU, Canada and Australia for drug-resistant epilepsy and in the EU and Canada for major depressive disorder (MDD). Monarch comprises external electrodes placed on the forehead and a pulse generator. NeuroSigma also is developing a second-generation system.

  • FDA approves Promacta sNDA

    FDA approved an sNDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for once-daily use of Promacta eltrombopag in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy.

    FDA granted Promacta breakthrough therapy designation for the rare disorder in which the bone marrow fails to make enough new blood cells.

    Eltrombopag is approved in the U.S., EU and elsewhere to treat thrombocytopenia in patients with chronic idiopathic thrombocytopenic purpura (ITP) and with chronic HCV infection. Outside the U.S., it is known as Revolade.

    GSK has worldwide rights to the small molecule thrombopoietin (TPO) receptor agonist from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), which was up $2 to $51.85 in after-hours trading on Tuesday.

  • Medtronic acquires Sapiens

    Medtronic Inc. (NYSE:MDT) acquired medical device company Sapiens Steering Brain Stimulation B.V. (Eindhoven, the Netherlands) for EUR 150 million ($200.8 million) in cash. Sapiens, which is developing deep brain stimulation technology to treat degenerative or functional brain disorders such as Parkinson's disease and dystonia, was in the top 10% of private European fundraisers in 2013 (see BioCentury, May 26).

    Medtronic was off $0.11 to $63.52 on Tuesday.

  • Luye gains Chinese rights to Hanmi's poziotinib

    Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) granted Luye Pharma Group Ltd. (HKSE:2186) exclusive rights to develop and commercialize poziotinib (HM781-36B) in China. The oral pan-HER inhibitor is in Phase II trials to treat HER-2 positive advanced gastric cancer and solid tumors, including HER2-positive breast cancer and EGFR-mutant non-small cell lung cancer (NSCLC). Hanmi will receive up to $20 million in an undisclosed upfront and milestones, plus royalties.

    Luye develops and commercializes small molecules, biologics and traditional Chinese medicine, primarily in China. The company raised HK$4 billion ($509.8 million) in a Hong Kong IPO last month (see BioCentury Extra, July 9).

  • Biogen Idec hires Johns as VP of new ALS unit

    Biogen Idec Inc. (NASDAQ:BIIB) hired Donald Johns as VP of the company's new innovation hub focused on amyotrophic lateral sclerosis. Johns was VP and global head of neuroscience translational medicine at Novartis Institutes for BioMedical Research (NIBR), part of Novartis AG (NYSE:NVS; SIX:NOVN).

    Last year, Biogen Idec paid Isis Pharmaceuticals Inc. (NASDAQ:ISIS) $100 million up front in an antisense discovery and development deal focused on neurological diseases, including ALS. Biogen is also investing in basic science and is working with academics to identify pathways, mechanisms and molecules involved in axonal degeneration of motor neurons in ALS patients (see SciBX: Science Business eXchange, Oct. 3, 2013).

    Early last year, Biogen discontinued development of its prior lead ALS compound, dexpramipexole, after the compound missed the primary endpoint in a Phase III trial (see BioCentury, Jan. 21, 2013).

    Biogen Idec was up $0.29 to $342.99 on Tuesday.

  • PhRMA wants payment system clarity from CMS

    The Pharmaceutical Research and Manufacturers of America asked the Centers for Medicare & Medicaid Services (CMS) to clarify reporting regulations for the online Open Payments system. The website is a payment disclosure system required by the Physician Payments Sunshine Act, part of the Affordable Care Act.

    CMS said on Aug. 15 it removed some "incorrect payment transactions" from the system during a 12-day period of downtime, when it addressed technical issues. PhRMA said it analyzed the removed data and found that its members' submissions were consistent with CMS's reporting guidelines. It asked CMS to further explain its decision to remove the data.

    CMS could not be reached for comment.

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