Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety
LONDON – Shares in Erytech Pharma SA began trading in Paris last week following an initial public offering (IPO) that exceeded the €15 million (US$19.5 million) target, raising €16.7 million. The Lyon, France-based company added a further €11 million, mostly through the conversion of bonds, providing sufficient funding to take the lead program Graspa through to approval in Europe and to start a U.S. Phase Ib trial of the product in the treatment of acute lymphoblastic leukemia (ALL). "I'm very
By Nuala Moran | BioWorld International | Wednesday, May 15, 2013
LONDON – Creabilis SA reported positive Phase IIb results for its topical TrkA kinase inhibitor CT327 in the relief of chronic pruritus (itch) caused by psoriasis, paving the way for a Phase III study designed to gain approval for treating itch in any dermatological disease. "We are delighted by the outcome," said Eliot Forster, CEO. "In addition to some benefits in terms of the underlying disease, CT327 showed a highly significant impact on itch, which in psoriasis and other dermatological
By Nuala Moran | BioWorld International | Wednesday, May 15, 2013
LONDON – There may be a completely new way to block the estrogen receptor on breast cancer cells, which normally thrive on estrogen. Researchers working in the Netherlands have shown that blocking the receptor at that point reduces the growth rate of breast tumor cells. What is more, they have already found a small molecule that blocks the receptor, and they have crystallized the binding pocket, which should make it possible to design or find other small molecules that can be used as drugs to
By Sharon Kingman | BioWorld International | Wednesday, May 15, 2013
Cardio3 BioSciences (C3BS) closed a €19 million (US$25 million) investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure, C-Cure. Just €7 million of the total represents new money, however. The remainder comprises an equity conversion of existing loans. The new cash comes from the company's existing investors. C3BS, of Mont-Saint-Guibert, Belgium, is developing a therapy that originated at the Mayo Clinic in Rochester, Minn. C-Cure
By Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013
Cosmo Pharmaceuticals SpA landed a hefty chunk of upside, that all-too-elusive commodity, by grossing $89.2 million from a sale of Santarus Inc. stock. The transaction will enable the already-profitable company to begin paying dividends to its shareholders. The Lainate, Italy-based drug delivery specialist disposed of 4.25 million shares, priced at $18.25 per share, Friday. On Monday, Jefferies LLC, which underwrote the offering, exercised its option to purchase an additional 637,500 Santarus
By Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013
DUBLIN, Ireland – Elan Corp. plc is putting down a $1 billion bet that the respiratory franchise shared by Theravance Inc. and GlaxoSmithKline plc will pay generous dividends over the next decade. Elan is acquiring a 21 percent stake in Theravance's future royalty streams from four drugs that are partnered with London-based GSK. One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily
By Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013
Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo. Takeda will pay $35 million up front and up to $215 million contingent on various clinical and commercial milestones. The transaction will be conducted through Takeda's wholly owned subsidiary Takeda America
By Peter Winter | BioWorld International | Wednesday, May 15, 2013
Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution. The drug has orphan status for use in improving neurological outcome in adults with subarachnoid hemorrhage. Prior to the approval of Nymalize, nimodipine was available only in gel capsule form. Arbor said it will launch the drug in the next few months. Cempra Inc., of Chapel Hill, N.C., signed an exclusive license and development agreement for oral solithromycin
Pearl Therapeutics Inc. launched its much-anticipated Phase III (PINNACLE) trial of PT003, a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered by pressurized hydrofluoroalkane, in chronic obstructive pulmonary disease (COPD). The Redwood City, Calif.-based company raised $65 million in a Series D financing in November to support the trial. (See BioWorld Today, Nov. 14, 2012.) The product is a combination of a long-acting muscarinic antagonist (LAMA), glycopyrrolate
By Catherine Shaffer | BioWorld Today | Wednesday, May 15, 2013
AbbVie Inc.'s $70 million up front buys an option to acquire Alvine Pharmaceuticals Inc.'s drug candidate for celiac disease or the company itself, after Phase IIb trials are finished with ALV003, a two-enzyme combo that degrades gluten. The 500-patient Phase IIb study with ALV003, which is composed of a cysteine protease and a prolyl endopeptidase, should be finished late next year or early in 2015, said James Watson, chief business officer of San Carlos, Calif.-based Alvine. "It's starting
By Randy Osborne | BioWorld Today | Wednesday, May 15, 2013
PharmaMar SA, of Madrid, Spain, a subsidiary of Zeltia, said it completed a Phase Ib trial testing PM01183 in combination with doxorubicin, with the combination displaying antitumor activity in all types of cancer included in the study. Complete and partial radiological remissions were observed in patients with small-cell lung, bladder, breast, endometrial and ovarian cancers, neuroendocrine tumors and synovial sarcoma. The company is planning a potential pivotal trial in small-cell lung cancer
Cosmo Pharmaceuticals SpA landed a hefty chunk of upside, that all-too-elusive commodity, by grossing $89.2 million from a sale of Santarus Inc. stock. The transaction will enable the already-profitable company to begin paying dividends to its shareholders. The Lainate, Italy-based drug delivery specialist disposed of 4.25 million shares, priced at $18.25 per share, Friday. On Monday, Jefferies LLC, which underwrote the offering, exercised its option to purchase an additional 637,500 Santarus
By Cormac Sheridan | BioWorld Today | Wednesday, May 15, 2013
Astellas Pharma Inc. jumped on the bandwagon of big pharma restructurings, disclosing plans to close U.S. units OSI Pharmaceuticals LLC and Perseid Therapeutics LLC this year and to downsize Astellas Research Institute of America LLC to focus on central nervous system therapies. The company also plans to terminate its in-house fermentation research and, by fiscal 2015, to fold the operations of its Kashima facility in Osaka into other sites, including its Tsukuba (Japan) Research Center. Last
By Marie Powers | BioWorld Today | Wednesday, May 15, 2013
The ErbB family of receptor tyrosine kinases is well known to drug developers, though often under one of its aliases. ErbB1, better known as epidermal growth factor receptor, or EGFR, is the target of drugs such as Tarceva (erlotinib, Roche AG and Astellas Pharma Inc.), Iressa (gefitinib, AstraZeneca plc.), Vectibix (panitumumab, Amgen Inc.) and Erbitux (cetuximab, Eli Lilly and Co.) Roche drugs Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine) target ErbB2
By Anette Breindl | BioWorld Today | Wednesday, May 15, 2013
A lack of standards from the Office of the U.S. Global Aids Coordinator (OGAC) is hampering the assessment of the President's Emergency Plan for AIDS Relief (PEPFAR) as partner-countries assume more responsibility for AIDS treatment programs within their borders, according to a report from the Government Accountability Office (GAO). Fully functioning monitoring and evaluation (M&E) systems are critical for tracking results and ensuring the effectiveness of the treatment programs, the GAO said
Omeros Corp., of Seattle, said it closed the registered direct offering of 3.9 million shares of common stock priced at $4.14 per share, raising net proceeds of about $16.1 million. Funds will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as funding planned clinical trials for its OMS103HP, PDE10, MASP-2 and PDE7 programs. Proceeds also may be used to fund
By Peter Winter BioWorld Insight Editor By any measurement the U.S. biotechnology industry is the envy of the world. Perspectives on the reasons for the nation's dominance in this sector are provided by the latest Scientific American Worldview Scorecard, which for the past five years has been ranking countries on their global competitiveness in biotechnology. The 2013 edition reflects increased global competition and a growing list of countries being added to the rankings. The first Scorecard
By Mari Serebrov Washington Editor A U.S. appellate court blocked Genentech Inc.'s end run around foreign arbitration that could give Sanofi SA a share of the royalties on blockbuster biologic Rituxan. In a precedent-setting decision Friday, the U.S. Court of Appeals for the Federal Circuit upheld a district court's decision to deny Genentech's request for an injunction on foreign arbitration over its terminated licensing contract for DNA enhancers allegedly used in the making of the biologic
Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety