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BioCentury Extra
As published Tuesday, May 05, 2015 6:16 PM PST

  • MorphoSys reports 1Q15 earnings

    MorphoSys AG (Xetra:MOR; Pink:MPSYF) reported 1Q15 revenues of EUR 70.4 million ($78.5 million), up from 1Q14 revenues of EUR 15.9 million ($17.7 million). The gains were largely due to the receipt of deferred revenues and a one-time payment from Celgene Corp. (NASDAQ:CELG) to cover 2015 development costs for MOR202. In March, the partners terminated a 2013 deal to co-develop the compound worldwide and co-commercialize it in Europe.

    MorphoSys' shares fell sharply that month after it regained rights to the human mAb against CD38, even though the company also increased its full-year revenue guidance to EUR 101-EUR 106 million ($109-$114.4 million), up from a prior estimate of EUR 58-EUR 63 million ($62.6-$68 million) (see BioCentury Extra, March 26).

    Morphosys said it will continue development of MOR202, which is in Phase I/II testing to treat multiple myeloma (MM). On today's earnings call, CFO Jens Holstein said MorphoSys will need to see more data on MOR202 before deciding whether to seek a partner for the compound or discontinue the program. Data from the MM trial will be presented at the American Society of Clinical Oncology meeting in late May and early June.

    MorphoSys also said it terminated a Phase II trial of MOR208 to treat B cell acute lymphoblastic leukemia (ALL) after seeing an overall response rate (ORR) insufficient to justify continuation. The company and St. Jude Children's Research Hospital still plan to begin a study this year of the Fc-optimized human mAb against CD19 in combination with immune cell transplantation to treat pediatric ALL patients. MOR208 is also in development to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL); the company plans to begin two Phase II trials this year of MOR208 plus lenalidomide and bendamustine to treat diffuse large B cell lymphoma (DLBCL).

    The stock shed EUR 4.06 to EUR 63.42 on Tuesday.

  • GSK submits MAA for ADA-SCID gene therapy

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) submitted an MAA to EMA for autologous gene therapy GSK2696273 to treat severe combined immunodeficiency (SCID) due to adenosine deaminase deficiency (ADA-SCID).

    The ultra-rare disease is caused by inheritance of two mutant copies of the gene encoding ADA and results in an inability to make lymphocytes. GSK2696273 uses a retroviral vector to deliver a functional ADA gene into a patient's own hematopoietic stem cells. The cells are harvested from bone marrow, transfected ex vivo and injected back into the patient.

    GSK obtained exclusive rights to GSK2696273 in 2010 from Fondazione Telethon and Fondazione San Raffaele (see BioCentury, Nov. 1, 2010).

    The partners said the MAA is based on data from 18 patients, including 12 who participated in a pivotal Phase I/II trial. All 12 in that study were alive after an average follow-up period of seven years; the earliest treated patient was alive after 11.5 years. The rate of intervention-free survival was 92%, defined as survival without the need for long-term use of enzyme replacement therapy (>3 months) or bone marrow transplant.

    The partners said the therapy is meant for use in patients for whom a matched bone marrow donor is not available. The therapy could avoid complications of bone marrow transplant including graft-versus-host disease (GvHD).

    Under the 2010 deal, GSK has exclusive options to develop six additional ex vivo stem cell gene therapies using technology developed at the San Raffaele Telethon Institute for Gene Therapy (TIGET), a joint venture formed by Fondazione Telethon and Fondazione San Raffaele. GSK has exercised two of the options and is conducting clinical trials of gene therapies to treat metachromatic leukodystrophy (MLD) and Wiskott-Aldrich syndrome (WAS).

  • Industry partners launch Biosimilars Forum

    A coalition of 11 companies launched the Biosimilars Forum, a not-for-profit group dedicated to increasing patient access to biosimilars in the U.S.

    Founding members include Actavis plc (NYSE:ACT), Amgen Inc. (NASDAQ:AMGN), Boehringer Ingelheim GmbH (Ingelheim, Germany), Coherus BioSciences Inc. (NASDAQ:CHRS), the EMD Serono subsidiary of Merck KGaA (Xetra:MRK), Hospira Inc. (NYSE:HSP), Merck & Co. Inc. (NYSE:MRK), Pfizer Inc. (NYSE:PFE), the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN), Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Samsung Bioepis Co. Ltd., a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung Group (Seoul, South Korea).

    Sandoz and Amgen have been on opposing sides of biosimilar policy issues including non-proprietary naming, with Sandoz in favor of sharing non-proprietary names with reference biologics (see BioCentury, July 28, 2014).

    Last week, FDA issued three final guidances on biosimilars but did not address requirements for demonstrating interchangeability of biosimilars with reference products or terms establishing the exclusivity period for pioneer biologics. The agency said it would address these issues in a separate draft guidance but did not provide a timeline. FDA's Center for Drug Evaluation and Research (CDER) also announced last week its intention to publish guidance this year on non-proprietary naming for biosimilars (see BioCentury Extra, April 29).

  • Management tracks

    Oncology company Cleveland BioLabs Inc. (NASDAQ:CBLI) named Langdon Miller president and CMO. Miller was VP of clinical research in oncology at Gilead Sciences Inc. (NASDAQ:GILD) after it acquired Calistoga Pharmaceuticals Inc., where he had been EVP of R&D.

    Cardiovascular play Omeicos Therapeutics GmbH (Berlin, Germany) named Ulrich Dauer CEO. Dauer was chief strategy officer for Activaero GmbH, which was acquired by Vectura Group plc (LSE:VEC).

    Biomanufacturing play Groupe Novasep S.A.S. (Pompey, France) named Pierre-Louis Mikus chief legal officer. Mikus was in the life sciences practice at HBC Avocats.

  • PTC falls on SMA trial suspension

    PTC Therapeutics Inc. (NASDAQ:PTCT) lost $7.71 (13%) to $53.13 on Tuesday after it said partner Roche (SIX:ROG; OTCQX:RHHBY) had suspended the Phase II MOONFISH trial of RG7800 to treat spinal muscular atrophy (SMA). In its 1Q15 earnings statement released Monday, PTC said a separate study showed an "eye finding" in monkeys receiving RG7800. PTC did not disclose the nature of the finding, but said the complication occurred at higher doses than those used in human studies.

    The partners agreed to suspend dosing in MOONFISH while they evaluate the finding and explore next steps. PTC CEO Stuart Peltz said on a conference call that PTC has not yet adjusted its expected timeline for the trial.

    PTC said RG7800 was well-tolerated in an initial cohort of patients in MOONFISH.

    Roche licensed the small molecule survival of motor neuron 2 centromeric (SMN2) splicing modifier from PTC in 2011.

  • Symbiomix caps series A, reports vaginosis data

    Symbiomix Therapeutics LLC raised $13 million in the third and final close of its series A round from OrbiMed, Fidelity BioSciences and HBM Partners. The company, which raised a total of $32.5 million in the round, also said a single oral dose of its SYM-1219 met undisclosed primary and secondary endpoints in a 215-patient pivotal Phase II trial to treat bacterial vaginosis.

    The granule formulation of secnidazole has Qualifying Infectious Disease Product (QIDP) designation from FDA for the indication. Symbiomix plans to start a Phase III trial this quarter, and to submit an NDA to FDA in mid-2016.

    President and CFO Robert Jacks told BioCentury the Phase III trial "will be very similar" to the Phase II study. "The primary endpoint will be the same and the size will be similar."

    In addition to equity funding, Symbiomix has raised $8.5 million in venture debt from Square 1 Bank.

  • Flagship partners with AstraZeneca, Nestle, Bayer

    Flagship Ventures announced partnerships with AstraZeneca plc (LSE:AZN; NYSE:AZN), the Nestle Health Science subsidiary of Nestle SA (SIX:NESN) and the Bayer CropScience subsidiary of Bayer AG (Xetra:BAYN) to develop innovations that lead to newcos. The newcos will be part of Flagship's VentureLabs unit (see BioCentury, Aug. 18, 2014).

    The three strategic investors will collaborate with resulting newcos, and may invest in, partner with or acquire them.

    Flagship also disclosed that AZ, Nestle and Bayer invested in the firm's $537 million Fund V, which closed in March (see BioCentury, April 6).

  • Financial tracks

    Alternative asset management firm The Carlyle Group (NASDAQ:CG) named Jose Almeida an operating executive in its global heathcare group. Almeida was chairman, president and CEO of Covidien.

    Jason Kantor resigned as a managing director and senior analyst at Credit Suisse Group. He will be taking a buyside position at a long-only global fund.

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