• Amarin Corp. plc, of London, said it has obtained the exclusive development and commercialization rights to a broad intellectual property portfolio in the field of lipid science from UK-based Scarista Ltd. Under the deal, Amarin will pay Scarista an up-front fee of $500,000 and royalties upon commercialization. Amarin had obtained the rights to the lipid science portfolio covering applications in diseases of the central nervous system for North America, the EU and Japan in 2004. The new license provides Amarin with rights to all remaining therapeutic areas and all territories worldwide.
• Arpida Ltd., of Reinach, Switzerland, reported that the rolling new drug application submission for intravenous iclaprim in complicated skin and skin structure infections will be completed within the next few weeks. The company said there were a few delays due to data being delivered later than expected, as well as additional processing steps required for electronic filing format.
• Arriva Pharmaceuticals, of Amsterdam, the Netherlands, completed a financing of $6 million led by new Investor Nordic Biotech II K/S and with participation by MPM BioVentures. The funds will be used to continue development of recombinant alpha-one antitrypsin for hereditary emphysema, which is now in a Phase IIb trial.
• BioAlliance Pharma SA, of Paris, reported a 38.6 percent increase in its net loss to €18.2 million in 2007 from €13.2 million in 2006, despite a 667 percent jump in revenues to €3.5 million from just €460,000 before. The company nevertheless had cash and cash equivalents of €56.3 million as of Dec. 31, up from €17.6 million a year earlier, thanks to a €40 million funding round completed last August. The higher loss mainly reflected a 69.2 percent hike in research and development outlays due to the company's continued clinical development program for Loramyc, acyclovir Lauriad and doxorubicin Transdrug in the U.S., as well as the costs of launching Loramyc in France.
• Crucell NV, of Leiden, the Netherlands, has entered into an exclusive vaccine development agreement with Wyeth Pharmaceuticals, of Madison, N.J. Under the terms of the agreement, Crucell will be responsible for the development and manufacture of certain components of a vaccine for use by Wyeth in clinical studies. The development activities will take place in Crucell's dedicated vaccine manufacturing facilities in Bern, Switzerland. Wyeth will be responsible for the clinical development of the vaccine. Financial details were not disclosed.
• Galapagos NV, of Mechelen, Belgium, said in a pipeline update that it selected preclinical candidates in its rheumatoid arthritis and bone metastasis programs and plans to submit investigational new drug applications later this year. Galapagos also said it will select a preclinical candidate in its osteoarthritis program this year, and it is seeking a partner for its early stage Alzheimer's disease program. Additionally, Galapagos is discontinuing its early-stage selective androgen receptor modulator program and its Estrogen Glucoside (E2G) program.
• Genmab A/S, of Copenhagen, Denmark, received antitrust clearance under the Hart-Scott-Rodino Act for its agreement to purchase Fremont, Calif.-based PDL BioPharma Inc.'s antibody manufacturing facility in Brooklyn, Minn., for $240 million. That transaction, reported earlier this month, is expected to close at the end of this quarter. In other news, Genmab A/S entered a research collaboration with Pepscan Systems BV, of Lelystad, the Netherlands, focused on identifying fully human monoclonal antibodies against intractable disease targets. Pepscan will identify functional mimics of certain difficult targets, while Genmab will use the mimics to create antibodies. Terms were not disclosed.
• ImmuPharma plc, of London, said the first patients were dosed in its Phase IIb trial of IPP-201101 for the treatment of systemic lupus erythematosus, with headline efficacy data expected in the summer of 2008. The primary objective of the study is to assess the effect of subcutaneous IPP-201101 on the signs and symptoms of disease activity over a 12-week treatment period, compared to placebo.
• Karo Bio, of Stockholm, Sweden, reacquired the rights to its selective androgen receptor modulator program from Radius Health Inc., of Cambridge, Mass. Radius had licensed the preclinical compounds in a $17 million deal, and no reason was given for the termination of the agreement.
• Kyowa Hakko Kogyo Co. Ltd., of Tokyo, said its wholly owned subsidiary Kyowa Pharmaceutical Inc. received a not approvable letter from the FDA for the adenosine A2A antagonist istradefylline (KW-6002) in Parkinson's disease. The agency expressed concerns about the drug's efficacy and requested additional nonclinical mineralization data and clinical pharmacology data. Kyowa said it will work with the agency to determine a path forward.
• Living Cell Technologies Ltd., of Melbourne, Australia, signed a term sheet with the Barbara David Center for Childhood Diabetes to establish a diabetes clinical trial program in Denver. Under the agreement, LCT and BDC collaboratively pursue regulatory approval and then conduct a U.S. trial in Type I diabetes patients with DiabeCell, LCT's encapsulated porcine insulin-producing cells. The study is planned to start in 2009.
• MorphoSys AG, of Munich, Germany, and Sigma-Aldrich Corp., of St. Louis, entered into a collaboration to design, produce and distribute recombinant research antibodies using MorphoSys's proprietary HuCAL Gold technology. MorphoSys unit AbD Serotec will develop and qualify unique antibodies from MorphoSys's HuCAL Gold library against a committed number of targets identified by Sigma-Aldrich. Sigma-Aldrich will offer the HuCAL-based recombinant research antibodies for use in research applications through its Internet sales platforms. Financial terms were not disclosed.
• Phoqus Pharmaceuticals plc, of West Malling, UK, announced positive results from a Phase II study of its delayed, sustained release hydrocortisone therapy Chronocort, in patients with congenital adrenal hyperplasia, a genetic disorder characterized by deficiency of the hormone cortisol and excess production of androgens. In healthy males, cortisol is produced in a distinct circadian rhythm that builds up over night, peaks early in the morning and declines throughout the day to its lowest point around midnight. In the Phase II trial, which was conducted at the National Institutes of Health in Bethesda, Md., Chronocort generated an overnight cortisol profile much closer to the normal physiological profile than conventional immediate-release hydrocortisone. Phoqus now will progress the product to Phase III.
• Photocure ASA, of Oslo, Norway, said that as part of its previously announced plan to de-merge its cancer-focused drug delivery subsidiary, PCI Biotech AS, it will transfer its interest in PCI to a holding company known as PCI Biotech Holding ASA. The holding company will issue up to NOK30 million (US$5.7 million) worth of shares prior to seeking a listing on the Oslo Stock Exchange.
• Sucampo Pharma Europe Ltd., of Oxford, UK, said it filed a marketing authorization application for lubiprostone in the UK for chronic idiopathic constipation in adults. That product previously gained approval in the U.S. by parent firm Sucampo Pharmaceuticals Inc. and is sold under the brand Amitiza. Lubiprostone is designed to work by selectively activating Type-2 chloride channels in the intestinal lumen, which facilitates intestinal fluid secretion and enhances intestinal motility.
• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said its new drug application for Type II diabetes drug alogliptin was accepted for review by the FDA. The acceptance triggers a $15 million milestone payment to contract research group PPD Inc., of Wilmington, N.C., from which Takeda licensed the drug in 2005. Alogliptin is oral, once-daily selective dipeptidyl peptidase-4 (DPP-4) inhibitor.