On August 30, 2012 Teva reported that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years (Press release Teva, AUG 30, 2012, View Source [SID:1234500814]). Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections.

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Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar to Neupogen. Tbo-filgrastim was filed in the U.S. as a Biologics License Application (BLA) since a biosimilar approval pathway had not been established at the time of submission. Teva will market tbo-filgrastim as early as November 2013, in accordance with the settlement reached with Amgen.

"As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. "The approval of tbo-filgrastim demonstrates Teva’s strong commitment to providing patients with new treatment options. It expands upon Teva’s existing Oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients."

In studies of tbo-filgrastim, the drug was shown to have statistically significant reductions in the duration of severe neutropenia compared to placebo. During the first 21-day chemotherapy cycle, patients treated with tbo-filgrastim had severe neutropenia for an average of 1.1 days, compared with 3.8 days for those receiving placebo.

(Press release, TNI BioTech, AUG 28, 2012, View Source [SID:1234507310])

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(Press release, TNI BioTech, AUG 28, 2012, View Source [SID:1234502811])

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On August 11, 2012 Immune Pharmaceuticals Ltd. ("Immune"), a privately held Israeli company, and EpiCept Corporation ("EpiCept") (NASDAQ OMX Stockholm Exchange and OTCQX: EPCT) reported that they have entered into a definitive merger agreement (Press release, Immune Pharmaceuticals, AUG 11, 2012, http://www.immunepharma.com/immune-pharmaceuticals-and-epicept-corporation-agree-to-merge/ [SID:1234508652]). The transaction is anticipated to close during the first quarter of 2013 and is subject to satisfaction of certain customary closing conditions, including the approval of a majority of EpiCept shareholders.

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The combined company, to be named Immune Pharmaceuticals, Inc. ("Immune Pharmaceuticals"), will be primarily focused on developing antibody therapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer. Immune’s lead product candidate, bertilimumab, is a full human monoclonal antibody that targets eotaxin-1, a chemokine involved in eosinophilic inflammation, angiogenesis and neurogenesis. Immune is currently initiating a placebo-controlled, double-blind Phase II clinical trial with bertilimumab for the treatment of ulcerative colitis.

The companies’ collective oncology portfolios comprise: Immune’s NanomAbs, a new generation of antibody drug conjugates, and EpiCept’s vascular disruptive agents. Immune Pharmaceuticals will continue efforts to secure a partner for EpiCept’s Phase III clinical development candidate AmiKet, for which efficacy has been demonstrated for the treatment of chemotherapy-induced neuropathic pain and post-herpetic neuralgia. Daniel Teper, PharmD, CEO of Immune and Robert Cook, Interim President and CEO of EpiCept, jointly commented: "This transaction will create a publicly traded specialty biopharmaceutical company with a portfolio of four clinical-stage drug candidates for the treatment of inflammatory diseases and cancer. Immune’s bertilimumab, a first in class monoclonal antibody, is being evaluated clinically to address unmet medical needs in multiple severe disease indications. EpiCept’s Amiket has clinical data in over 1600 patients in various neuropathies, Fast Track designation and Phase III Special Protocol Assistance from the U.S. Food and Drug Administration as well as a defined clinical path through the European Medicines Agency for the treatment of chemotherapy induced neuropathic pain."

Merger Details

The terms of the merger agreement provide for EpiCept to issue shares of its common stock to Immune shareholders in exchange for all of the outstanding shares of Immune, with EpiCept shareholders retaining approximately 22.5 percent ownership of the combined company and Immune shareholders receiving approximately 77.5 percent, calculated on an adjusted fully diluted basis. Dr. Daniel Teper will become the Chairman and Chief Executive Officer of Immune Pharmaceuticals, which will have dual headquarters in Herzliya-Pituach, Israel and in the New York City area, with research laboratories in Rehovot, Israel. Dr. David Sidransky, Director of Head and Neck Research Division, Professor of Oncology at the Johns Hopkins School of Medicine, and a former Vice Chairman of the Board of Directors of ImClone Systems, will be the Vice Chairman of the Board of Immune Pharmaceuticals. The combined company’s board of directors will consist of not more than six current Immune directors and at least one current EpiCept director. The Immune Pharmaceuticals management team will include Robert Cook, EpiCept’s Interim Chief Executive Officer, who will become the combined company’s Chief Financial Officer, and Stephane Allard, M.D., EpiCept’s Chief Medical Officer, who will become Immune Pharmaceutical’s Chief Medical Officer. Serge Goldner, Chief Financial Officer of Immune will take the new role of Executive Vice President and Chief Operating Officer. Suzy Jones, a former Genentech executive, and Myrtle Potter & Company will continue to advise Immune Pharmaceuticals on business development and the combined company’s Scientific Board will be jointly led by Professor Marc Rothenberg (Cincinnati Children’s Hospital) and Professor Shimon Benita (Hebrew University).

(Filing, 10-Q, Cleveland BioLabs, AUG 9, 2012, View Source [SID:1234502767])

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