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BioCentury Extra
As published Tuesday, December 01, 2015 5:46 PM PST

  • Sinopharm affiliate licenses Oramed's insulin capsule

    Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) granted an affiliate of China National Pharmaceutical Group Corp. (Sinopharm) exclusive rights in Greater China to ORMD-0801, its oral capsule formulation of insulin to treat Type II diabetes. Hefei Tianhui Incubator Technologies Co. Ltd., which is part-owned by Sinopharm, will receive the license covering China, Macau and Hong Kong.

    Sinopharm will make a $12 million equity investment in Oramed, which will also receive $3 million up front and $8 million in near-term payments. Oramed is eligible for an additional $26.5 million in milestones, plus 10% royalties.

    ORMD-0801 is in a Phase IIb study to treat Type II diabetes. Oramed did not respond to inquiries.

    In July, the partners signed a non-binding letter of intent to enter the deal (see BioCentury Extra, July 7).

    Oramed gained $0.31 to $9.41 on Tuesday.

  • Adaptimmune licenses Universal's gene editing tech

    Universal Cells Inc. (Seattle, Wash.) granted Adaptimmune Therapeutics plc (NASDAQ:ADAP) an exclusive, worldwide license to use Universal Cells' gene editing technology to develop and manufacture allogeneic T cell immunotherapies.

    Universal Cells will receive $5.5 million up front and is eligible for $41 million in milestones, plus a profit-share payment for the first product that emerges from the collaboration and royalties on sales of additional products.

    Other companies developing off-the-shelf approaches include Cellectis S.A.(Euronext:ALCLS; NASDAQ:CLLS). Last month, Servier (Neuilly-sur-Seine, France) and Pfizer Inc. (NYSE:PFE) gained shared rights to Cellectis' UCART19, which consists of chimeric antigen receptor (CAR)-modified CD19-targeted allogeneic T cells (see BioCentury Extra, Nov. 19).

    Adaptimmune gained $0.35 to $9.39 on Tuesday. It added EUR 1.40 to EUR 31.65 on Euronext. The news was announced aftermarket hours in Paris.

  • UnitedHealth's Oxford unit favors Praluent

    The Oxford Health Plans unit of UnitedHealth Group Inc. (NYSE:UNH) issued a policy update favoring Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) over competing PCSK9 inhibitor Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN). Oxford covers beneficiaries in New York, New Jersey and Connecticut.

    Starting Jan. 1, Oxford will require primary hyperlipidemia patients to demonstrate a history of failure after 12 consecutive weeks of treatment with Praluent, or a history of intolerance to Praluent, before it will cover Repatha. Oxford will also reimburse Repatha for patients who are already receiving treatment with the drug as of Jan. 1.

    Last month, PBM CVS Health Corp. (NYSE:CVS) and regional insurance company Harvard Pilgrim granted Repatha exclusive preferred status in exchange for undisclosed discounts (see BioCentury Extra, Nov. 23).

    In October, Express Scripts Holding Co. (NASDAQ:ESRX) said it would provide both Repatha and Praluent on its National Preferred Formulary (see BioCentury Extra, Oct. 6).

    Optum Rx, UnitedHealth's PBM, has not yet issued a formulary decision for the PCSK9 inhibitors.

  • Express Scripts adds Imprimis' Daraprim alternative

    Express Scripts Holding Co. (NASDAQ:ESRX) added Imprimis Pharmaceuticals Inc. (NASDAQ:IMMY) to its pharmacy network and said it will offer Imprimis' compounded formulation of pyrimethamine and leucovorin to patients in the network. Imprimis said in October it had launched the formulation as a low-cost alternative to toxoplasmosis drug Daraprim pyrimethamine from Turing Pharmaceuticals AG (Zug, Switzerland) (see BioCentury Extra, Oct. 22).

    Express Scripts will make the formulation available to patients in its network for $1 per pill as early as this week.

    Turing came under fire in September after it raised the price of Daraprim fiftyfold to $750 per pill (see BioCentury, Sept. 28).

    Last week, Turing said it will provide discounts of up to 50% to hospitals for Daraprim, but will not cut the drug's list price (see BioCentury Extra, Nov. 24).

    Compounded drugs are not approved by FDA, and they can only be used when prescribed by a physician for a specific patient.

    Imprimis gained $0.71 (11%) to $7.44 on Tuesday.

  • Management tracks

    Opthalmology company Avalanche Biotechnologies Inc. (NASDAQ:AAVL) hired Paul Cleveland as CEO, effective Dec. 9. Cleveland was CEO at Celladon Corp. (NASDAQ:CLDN).

    Oncology and inflammation play Zai Laboratory Ltd. (Shanghai, China) named Qi Liu CMO. Liu was executive medical director for oncology at AstraZeneca plc (LSE:AZN; NYSE:AZN).

    Pulmonary company Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) hired Michael Parini as EVP and chief legal officer, effective Jan. 4. He was SVP and associate general counsel at Pfizer Inc. (NYSE:PFE).

    C4X Discovery Ltd. (LSE:C4XD) said CEO Piers Morgan has resigned to pursue other opportunities. Executive Chairman Clive Dix will assume day-to-day operational responsibilities at the molecular imaging company.

    Pain company Purdue Pharma L.P. (Stamford, Conn.) named Alan Dunton SVP of R&D. Dunton was founder and principal of consulting business Danerius LLC (Sarasota, Florida).

    Neurology company Afferent Pharmaceuticals Inc. (San Mateo, Calif). named Prabha Ibrahim CTO. She was SVP of chemistry and non-clinical development at the Plexxikon Inc. unit of Daiichi Sankyo Co. Ltd. (Tokyo:4568).

    Cancer play Idera Pharmaceuticals Inc. (NASDAQ:IDRA) named Joanna Horobin SVP and CMO. Horobin was CMO at Verastem Inc. (NASDAQ:VSTM).

  • Symic raises $25M in series A-2 round

    Symic Biomedical Inc. (San Francisco, Calif.) raised $25 million in a series A-2 round led by existing investor Lilly Ventures. New investors Alexandria Real Estate and Purdue Research Foundation also participated, as did existing investors Den Danske Forskningsfond, Mitsui Global Investment, Ally Bridge Group, InCube Ventures, Purdue Foundry Investment Fund, Mission Bay Capital and QB3 Partners.

    Symic develops therapeutics that mimic proteoglycans to treat inflammatory conditions. The company has two clinical candidates. In early 2016 it expects data from the Phase I/II SHIELD study of SB-030 to reduce neointimal hyperplasia following percutaneous transluminal angioplasty (PTA), and it expects to start a Phase I/II trial of SB-061 to treat osteoarthritis in 2Q16.

    SB-061 is a mimic of the proteoglycan aggrecan. SB-030 is a mimic of decorin, which binds to collagen that is exposed when the vascular endothelium is denuded.

    In January, Symic raised $15 million in a separate series A round.

  • Velicept raises first tranche of $21M series B

    Velicept Therapeutics Inc. (Malvern, Pa.) raised an undisclosed first tranche of a planned $21 million series B round of funding led by CAM Capital and Longitude Capital. Velicept intends to begin a Phase II study of adrenergic receptor beta 3 (ADRB3) agonist solabegron (GW427353) to treat overactive bladder. Valicept did not respond to inquiries.

    Biopharma management company NeXeption formed Velicept in June. The newco subsequently merged with AltheRx Pharmaceuticals Inc., which acquired solabegron from GlaxoSmithKline plc (LSE:GSK, NYSE:GSK) in 2011.

    NeXeption's Steve Tullman is Velicept's chairman. The board also includes Velicept President and CEO James Walker, Becker Ventures' Jim Bennethum, Longitude's David Hirsch and CAM Capital's Scott Morenstein.

  • uniQure rebounds after pipeline update

    uniQure N.V. (NASDAQ:QURE) regained $1.02 to $19.80 on Tuesday after dipping 17% Monday on news announced along with 3Q15 earnings.

    uniQure said it would not pursue FDA approval of Glybera alipogene tiparvovec. The gene therapy consisting of an adeno-associated virus (AAV) vector carrying lipoprotein lipase (LPL) gene is approved in the EU to treat LPL deficiency. uniQure CEO Jorn Aldag told BioCentury in August that the company had "moved on from Glybera" (see BioCentury Extra, Aug. 27).

    The company also said it hopes to announce top-line data by the second week of January 2016 from the first two patients in a Phase I/II study of AMT-060 to treat hemophilia B. The company had hoped to report preliminary safety and efficacy data by YE15 from the study's first patients.

  • Financial tracks

    MS Ventures hired Bram Vanparys as investment director. Vanparys was senior investment manager in life sciences at Belgian investment company PMV.

  • Reserve your place for dinner and discuss FDA Waivers for TQT studies

    Learn how Early Precision QTâ" for cardiac safety testing can elevate drug development and lower study costs by supporting an FDA waiver for TQT studies. Hear from Dr. Borje Darpo, CSO, iCardiac and Dr. Emanuel DeNoia, Medical Director at ICON, a preferred provider of Early Precision QT.

    Reserve a spot to these exclusive dinners.

    Thursday, November 5 - Boston

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