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Lilly Stops Phase III Development of Pomaglumetad Methionil; Hospira to Acquire API Manufacturing and R&D Facilities; and More.
Eli Lilly will stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for treating schizophrenia. Lilly expects the decision to stop ongoing Phase III development of the drug will result in a third-quarter pretax charge of $25 million to $30 million. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly’s studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. The decision was not based on any safety signals. Additionally, the recently completed Phase II study, HBCO, which investigated pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint. Read More
Genmab has entered into a global license and development agreement for daratumumab (HuMax-CD38), a human CD38 monoclonal antibody with Janssen Biotech, a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson. Under the agreement, Genmab will grant Janssen an exclusive worldwide license to develop and commercialize daratumumab as well as a backup human CD38 antibody. Under the agreement, Genmab will receive an upfront license fee of $55 million and Johnson & Johnson Development Corporation will invest DKK 475 million, (approximately $80 million) to subscribe for 5.4 million new shares of Genmab at a price of DKK 88 per share (approximately $15 per share). Genmab could also be entitled to up to $1 billion in development, regulatory, and sales milestones, in addition to tiered double-digit royalties. Janssen will be fully responsible for all costs associated with developing and commercializing daratumumab going forward, including the costs of two ongoing Phase I/II studies. Read More
Hospira has agreed to acquire an API manufacturing facility and an associated R&D facility from Orchid Chemicals & Pharmaceuticals, an Indian pharmaceuticals company, for approximately $200 million. The proposed acquisition follows Hospira’s 2010 purchase of Orchid’s generic injectable business and permits Hospira to be vertically integrated into certain beta-lactam antibiotic APIs. Read More
Teva Pharmaceutical Industries has announced that FDA has granted approval for tbo-filgrastim (XM02 filgrastim), a granulocyte colony-stimulating factor (G-CSF). 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 (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar to Amgen’s Neupogen. Tbo-filgrastim was filed in the US as a biologics license application because 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 a previous settlement reached with Amgen. Read More
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More