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BioCentury Extra
As published Friday, September 04, 2015 4:10 PM PST


  • Cancer Drugs Fund de-lists additional therapies

    NHS England dropped or restricted coverage of 17 additional drugs covering 25 indications from its list of therapies covered by the Cancer Drugs Fund (CDF). Eight drugs were cut altogether, while nine had the number of reimbursed indications reduced.

    Among the drugs completely removed from the list were Kadcyla trastuzumab emtansine from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat second-line metastatic breast cancer and Imbruvica ibrutinib from AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ) to treat chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Imbruvica had been added in December to the list of covered drugs.

    Other notable cuts included Celgene Corp.'s (NASDAQ:CELG) Revlimid lenalidomide as a second-line treatment for multiple myeloma (MM) and Imnovid pomalidomide as a third-line MM treatment. The fund will continue to reimburse Revlimid for myelodysplastic syndromes (MDS).

    The CDF also de-listed Avastin bevacizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat cervical cancer, breast cancer and advanced colorectal cancer. The humanized mAb against VEGF is still covered for two other indications.

    NHS England said that despite previous cuts to CDF coverage, the fund was projected to run over its 2015-16 budget of L340 million ($524.1 million) by L70 million ($107.9 million) "in the absence of further prioritisation."

    The CDF was launched in 2011 to cover cancer drugs not recommended by NICE. NHS began de-listing drugs in January due to budget concerns (see BioCentury Extra, Jan. 13).

    The coverage changes will take effect Nov. 4.

  • Breakthrough designation for Roche, Chugai's ACE910

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQXL:RHHBY) and Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said FDA granted breakthrough therapy designation to ACE910 to prevent bleeding episodes in hemophilia A patients aged 12 and older who have Factor VIII inhibitors.

    The companies said they plan to start three Phase III trials of ACE910 by YE16, including studies in patients with and without Factor VIII inhibitors and a pediatric trial.

    The bispecific mAb that binds Factor IXa and Factor X has Orphan Drug designation in the EU.

    In 2014, Roche opted in to co-develop ACE910 with Chugai. Roche is Chugai's majority owner.

  • PDUFA date delayed for Alexion's Kanuma

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said FDA postponed the PDUFA date for a BLA for Kanuma sebelipase alfa to treat lysosomal acid lipase deficiency (LAL-D). The new PDUFA date is Dec. 7. Kanuma is under Priority Review and has breakthrough therapy designation to treat infants with LAL-D.

    Alexion said it recently responded to an FDA request for additional chemistry, manufacturing and controls information, and noted that FDA did not ask for additional clinical data.

    The European Commission approved an MAA for the recombinant human LAL enzyme replacement therapy on Tuesday (see BioCentury Extra, Sept. 1).

    Alexion obtained Kanuma via its acquisition of Synageva BioPharma Corp. in June.

    Alexion lost $3.30 to $171.98 on Friday.

  • Management tracks

    Musculoskeletal company Summit Therapeutics plc (LSE:SUMM; NASDAQ:SMMT) hired Ralf Rosskamp as CMO. Rosskamp was VP of global clinical development at NPS Pharmaceuticals Inc., which Shire plc (LSE:SHP; NASDAQ;SHPG) acquired.

    The Crescendo Biosciences unit of Myriad Genetics Inc. (NASDAQ:MYGN) named Elana Hitraya CMO effective Oct. 1. Hitraya was group medical director of rheumatology and immunology at the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).

    Hearing disorders play Autifony Therapeutics Ltd. (London, U.K.) named John Hutchison CMO. Hutchinson was CMO and VP of clinical research at the Neusentis unit of Pfizer Inc. (NYSE:PFE).

    Generics company TWi Pharmaceuticals Holding Inc. (TPEx:4180) said President and CEO Tina Guilder will resign. Chairman and founder Chih-Ming Chen will serve as interim president and CEO.

    Cancer play FLX Bio Inc. (South San Francisco, Calif.) named Brian Wong CEO and William Ho CMO. Wong was SVP of research and head of immuno-oncology at Five Prime Therapeutics Inc. (NASDAQ:FPRX). Ho was VP of clinical development at Igenica Inc. (Burlingame, Calif.).

    Diagnostics company Cynvenio Biosystems Inc. (Westlake Village, Calif.) named Paul Song CMO. Song is CMO at ATGen Co. Ltd. (Seongnam, South Korea) and a faculty member at Cedars Sinai Medical Center. He will continue in both roles.

  • IMI launches ADAPT SMART

    The Innovative Medicines Initiative launched a new project Friday titled "Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes" (ADAPT SMART).

    The aim of the public-private partnership is to develop Medicines Adaptive Pathways to Patients (MAPPs) that would allow researchers, regulators and reimbursement authorities to gather, evaluate and act upon new evidence for therapies that are approved with limited safety and efficacy data via mechanisms like EMA's Adaptive Licensing pathway.

    ADAPT SMART said it wants to develop a model "that aligns the needs of all stakeholders, including patients, member state payers, regulators, medical practitioners and industry," and noted that the "continuous evaluation of a therapy supports needed early access for patients, and provides an evolving understanding of benefits and risks that is better aligned with the realities of today's emerging sciences in personalised medicine."

    The group will focus on three areas: evidence generation throughout the lifecycle of a product, pathway design and implementation of adaptive decision making. The partnership includes 32 participants from industry, patient advocacy and regulatory and reimbursement authorities.

    The project is led by EMA and coordinated by the not-for-profit TI Pharma (Leiden, The Netherlands).

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