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BioCentury Extra
As published Wednesday, September 02, 2015 5:42 PM PST

  • CAFC ruling clears path for Zarxio launch

    The U.S. Court of Appeals for the Federal Circuit denied an attempt by Amgen Inc. (NASDAQ:AMGN) to further delay the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN). The denial could allow Sandoz to launch the biosimilar as early as Thursday. Novartis spokesperson Eric Althoff declined to comment on the company's launch timeline.

    The court denied an emergency motion filed by Amgen last week seeking an injunction to delay Zarxio's launch pending a potential en banc review of the case. The court did not provide a reason for its decision (see BioCentury Extra, Aug. 27).

    FDA approved Zarxio, a biosimilar of Amgen's Neupogen filgrastim G-CSF, on March 6. In July, a CAFC ruling barred Sandoz from launching Zarxio until after Sept. 2 (see BioCentury Extra, July 21).

    Amgen and Sandoz filed separate petitions last month for a rehearing en banc. Each party's response to the petitions is due Sept. 8.

  • Sangamo regains hemophilia gene therapies from Shire

    Sangamo BioSciences Inc. (NASDAQ:SGMO) fell $0.50 to $7.15 after regaining exclusive, worldwide rights from Shire plc (LSE:SHP; NASDAQ:SHPG) to preclinical zinc finger DNA-binding protein (ZFP) programs for hemophilia A and B. Sangamo plans to file INDs for its hemophilia B program by YE15 and its hemophilia A program in 2016. Shire holds a right of first negotiation to re-license both programs.

    Under the revised partnership, Shire will retain rights to develop ZFP therapeutics for Huntington's disease and against one undisclosed target. Rights to the remaining targets under the original collaboration will revert to Sangamo.

    Each company will fund its own development programs and will be eligible for single-digit royalties from the other party up to an undisclosed cap.

    Sangamo President and CEO Edward Lanphier said on a conference call Wednesday that the deal amendment was a strategic decision for both companies, noting that Sangamo is "deeply committed to the in vivo protein replacement strategy" while the Huntington's program is in line with Shire's focus.

    Shire spokesperson Elizabeth Kalina said the revised deal "aligned with the best interests and strengths of our two companies" and added that it does not "preclude an interest by Shire in hemophilia."

    On a conference call last month regarding Shire's bid for Baxalta Inc. (NYSE:BXLT), CEO Flemming Ornskov indicated Shire's interest in opportunities in the hemophilia market.

    There are at least four gene therapy programs in the clinic for hemophilia B, including Baxalta's BAX 335, an adeno-associated virus vector-based gene therapy that provides a mechanism for the patient's own liver to begin producing Factor IX. That compound is in Phase I/II testing. Baxalta also has BAX 888, a preclinical hemophilia A gene therapy targeting Factor VIII (see BioCentury, Aug. 10).

    Also on Wednesday, Sangamo lowered its 2015 revenue guidance to $35-$40 million from $60-$70 million and reduced its expected 2015 operating expenses to $90-$100 million from $100-$110 million. Lanphier said the company expects to end the year with at least $180 million in cash, in line with earlier estimates.

  • Incyte licenses Hengrui's anti-PD-1 mAb

    Incyte Corp. (NASDAQ:INCY) acquired exclusive, worldwide rights outside of Greater China to SHR-1210, a mAb against PD-1 from Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:3600276).

    Hengrui will receive $25 million up front and is eligible for $90 million in regulatory milestones, $530 million in commercial milestones, and $150 million "based on clinical superiority" of the compound, as well as double-digit royalties. Incyte will be responsible for all development and commercialization costs outside China, Hong Kong, Macau and Taiwan.

    Incyte spokesperson Catalina Loveman told BioCentury Incyte expects to file an IND with FDA in the coming months for a Phase I study in the U.S. Hengrui SVP and President of Global R&D told BioCentury a Phase I study has begun in Australia.

    Incyte gained $8.16 to $123.28 on Wednesday.

  • Another IPR denial for Bass

    The U.S. Patent and Trademark Office denied an inter partes review (IPR) petition from Kyle Bass' Coalition for Affordable Drugs challenging a patent for Tecfidera dimethyl fumerate from Biogen Inc. (NASDAQ:BIIB) to treat multiple sclerosis (MS).

    The USPTO's Patent Trials and Appeals Board (PTAB) disagreed that the prior art supplied by the coalition established that claims in U.S. Patent No. 8,399,514 were obvious.

    PTAB is still reviewing Bass' petition against U.S. Patent No. 8,759,393, which also covers Tecfidera and expires in 2019. The coalition filed the '393 petition in April (see BioCentury Extra, April 22).

    Bass has filed a string of IPRs this year challenging drug patents. Last week, PTAB denied two IPR petitions from Bass challenging patents from Acorda Therapeutics Inc. (NASDAQ:ACOR) covering Ampyra dalfampridine (see BioCentury Extra, Aug. 27).

    Biogen gained $11.71 to $302.21 on Wednesday.

  • FDA approves Tesaro's Varubi for CINV

    Tesaro Inc. (NASDAQ:TSRO) said FDA approved an NDA for Varubi rolapitant (SCH 619734) in combination with other antiemetic agents to prevent chemotherapy-induced nausea and vomiting (CINV) in adults. The company plans to launch Varubi in 4Q15. Spokesperson Jennifer Davis declined to disclose the drug's price.

    Tesaro has exclusive, worldwide rights to the oral neurokinin 1 (NK1) substance P receptor (TACR1) antagonist from Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK).

    Tesaro was up $1.71 to $53.40 on Wednesday. Opko gained $0.49 to $11.30 in New York and NIS117 to NIS4,309 in Tel Aviv.

  • Opdivo gets Priority Review for non-squamous NSCLC

    Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted for filing and granted Priority Review to an sBLA for Opdivo nivolumab to treat non-squamous non-small cell lung cancer (NSCLC) in previously treated patients. The PDUFA date is Jan. 2.

    BMS also said FDA granted breakthrough therapy designation to the human IgG4 mAb against PD-1 for the indication. The sBLA submission is based on data from the Phase III CheckMate -057 trial (see BioCentury Extra, May 29).

    Opdivo is approved in the U.S. to treat advanced melanoma in patients previously treated with BMS's Yervoy ipilimumab and to treat metastatic squamous NSCLC in patients who have progressed on or after platinum-based chemotherapy.

    The PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) is under FDA review to treat advanced squamous and non-squamous NSCLC. The PDUFA date is Oct. 2.

  • Ariad gives back gains from rumored Baxalta bid

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) shed $1.55 (17%) to $7.55 after media reports said Baxalta Inc. (NYSE:BXLT) had abandoned a rumored bid to acquire the biotech. Ariad shares gained $2.91 (42%) to $9.89 when the rumors surfaced on Friday, Aug. 28. The stock closed Wednesday at $0.57 above its Aug. 27 price of $6.98.

  • Management tracks

    Anemia and asthma play Pieris Pharmaceuticals Inc. (NASDAQ:PIRS) named Darlene Deptula-Hicks as CFO and SVP. Deptula-Hicks had been acting CFO via a consulting agreement. Pieris also said it is moving its corporate headquarters to Boston, Mass., from Freising, Germany.

    Neurology company NeuroVive Pharmaceutical AB (SSE:NVP; Pink:NEVPF) said CEO Mikael Bronnegard has left the company. COO Jan Nilsson will serve as interim CEO until the company recruits a successor.

  • Ascletis closes $35M financing

    Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) raised $35 million in a venture round led by C-Bridge Capital at a pre-money valuation of $300 million. Tasly Pharmaceutical Co. Ltd. (Shanghai:600535) and Pavilion Capital also participated.

    This month, Ascletis plans to begin the Phase II EVEREST trial in Taiwan of danoprevir (ASC08) plus ASC16 (PPI-668) to treat HCV. A clinical trial application (CTA) for the regimen is under China FDA review (see BioCentury Extra, Aug. 31).

    The company is attempting to beat Gilead Sciences Inc. (NASDASQ:GILD) to the China market with an HCV treatment (see BioCentury, April 13).

    C-Bridge's Wei Fu will join Ascletis' board in connection with the financing. Ascletis did not respond to inquiries.

    Tasly Group, the majority shareholder in Tasly Pharmaceutical, is an investor in C-Bridge.

  • ADC raises $80M in private placement

    ADC Therapeutics S.a.r.l. (Lausanne, Switzerland) raised $80 million in a private placement. Undisclosed new investors in the U.S. and Europe joined existing investors Auven Therapeutics Management LLLP (St. Thomas, Virgin Islands) and AstraZeneca plc (LSE:AZN; NYSE:AZN).

    ADC develops antibody-drug conjugates that combine monoclonal antibodies specific to tumor antigens with a cytotoxic pyrrolobenzodiazepine (PBD). ADC's lead candidate is ADCT-301, an antibody-drug conjugate targeting CD25, a cell-surface antigen. It is in a Phase I trial to treat lymphoma and leukemia.

    The company said it expects to have seven candidates in clinical trials by 2017.

    ADC was launched in 2012 by private equity firm Auven. AstraZeneca's MedImmune LLC unit partnered with ADC in 2013 to co-develop two of ADC's cancer programs (see BioCentury Extra, Oct. 15, 2013).

    The company has access to ADC linker technology from Spirogen Ltd., also founded by Auven. AstraZeneca acquired Spirogen in 2013.

  • U.K. organizations weigh in on genome editing

    Five U.K. organizations including the Medical Research Council and the Wellcome Trust released a joint position statement on Wednesday supporting the use of genome editing technologies for preclinical research applications in both somatic and germline human cells. The statement also called for increased discussion around clinical applications of the technologies for somatic and germline modifications. The statement was also signed by the Academy of Medical Sciences, Association of Medical Research Charities and the Biotechnology and Biological Sciences Research Council (BBSRC).

    The statement was released in advance of a series of meetings on the ethics of human germline modification. This month, the Hinxton Group, Medical Research Council and Wellcome Trust will host a meeting about the convergence of genome editing, stem cell research and human germline modification in the U.K. In December, the U.S. National Academy of Sciences and National and National Academy of Medicine will hold an international summit to discuss the scientific, ethical and policy issues associated with human genome editing research.

    Earlier this year, NIH Director Francis Collins released a statement against the use of genome editing in the human germline, saying that the NIH will not fund any research involving the use of genome editing technologies to modify human embryos.

    In the U.K., preclinical research using genome editing is permitted in somatic and germline cells including human embryos up to 14 days old. Germline modification using genome editing tools is not permitted, but the U.K. was the first country to legalize mitochondrial replacement therapy, which involves replacing the mitochondrial DNA from one egg or embryo with that from another during in vitro fertilization to prevent transmission of inherited mitochondrial diseases.

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