• Abbott Laboratories, of Abbott Park, Ill., disclosed new results of two analyses from a Phase III study of Humira (adalimumab) in ankylosing spondylitis (AS). The first analysis showed the U.S.-approved arthritis drug maintained the reduction of signs and symptoms in patients at 12 weeks through 52 weeks of treatment. A second analysis showed the drug rapidly and significantly reduced pain and fatigue as early as two weeks compared with placebo, and that the improvement was maintained for at least 24 weeks. Data were presented at the annual congress of the European League Against Rheumatism in Amsterdam, the Netherlands, and they follow the recent approval by the European Commission of Humira as a treatment for severe, active AS.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., reported results from a Phase II study of ALTU-238 in growth hormone deficient adults showing that once-per-week dosing appeared to result in a consistent, linear dose response of human growth hormone and IGF-1 levels in the blood. Altus anticipates the results to support dose selection for upcoming Phase III trials in adult and pediatric patients set for later this year. ALTU-238 is a subcutaneously administered, long-acting crystalline formation of recombinant human growth hormone.

• Array BioPharma Inc., of Boulder, Colo., completed a series of agreements with its existing landlords for its Boulder and Longmont, Colo., facilities and with BioMed Realty Trust Inc., of San Diego, under which Array will assign options to BioMed to purchase its facilities. BioMed will buy the facilities and then lease them back to Array through 2016. Array expects to close the transactions during the third quarter. They will add about $32 million in net additional cash to Array.

• Galapagos NV, of Mechelen, Belgium, announced that its service division, BioFocus DPI, signed collaborative agreements with Indus Biosciences, a subsidiary of CiVentiChem LLC, of Hyderabad, India, and ProCitius, a division of Sanmar Specialty Chemicals Ltd., in Chennai, India, for integrated chemistry services for BioFocus' discovery products division, with the option to provide support for its medicinal chemistry division.

• Gen-Probe Inc., of San Diego, agreed with Bayer HealthCare LLC, a unit of the Bayer Group, of Leverkusen, Germany, to end a series of disputes involving multiple patent litigations and contract arbitrations. Gen-Probe will withdraw its patent litigation and will grant Bayer immunity from suit regarding its current and future nucleic acid diagnostic products, while Bayer will grant Gen-Probe immunity from suits regarding its TIGRIS instrument and future instruments. In addition, Bayer will pay Gen-Probe certain lump sum royalties over the next 18 months. The companies also agreed to a final decision in the separate arbitration related to their collaboration for viral products. It incorporates the interim awards decided by the arbitrator, but Bayer will not be required to reimburse Gen-Probe $2 million for legal expenses, as originally ordered by the arbitrator.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., started its Phase II proof-of-concept trial with pagoclone in premature ejaculation. The trial is designed to evaluate the efficacy of various doses of pagoclone vs. placebo in delaying the ejaculatory response in patients with primary premature ejaculation. The trial is expected to enroll about 100 patients at multiple sites in the U.S., with patients evaluated for a total of nine weeks, including a four-week screening phase and a five-week treatment phase. The firm expects data early next year.

• Merck KGaA, of Darmstadt, Germany, discontinued development of Sarizotan after the drug missed its primary endpoint in two Phase III studies in Parkinson's disease patients with dyskinesia. The trials were designed to test Sarizotan against placebo in more than 1,000 patients during a six-month treatment period, with the primary target defined as a 25 percent or greater improvement based on the Unified Parkinson's Disease Rating Scale. Sarizotan is a full agonist at serotonin receptors.

• MorphoSys AG, of Martinsried, Germany, expanded its therapeutic antibody collaboration with Basel, Switzerland-based Novartis AG through May 2011. The original three-year deal was signed in 2004 to jointly develop antibody-based therapeutics against a range of illnesses, involved Novartis taking a €9 million (US$11.2 million) equity stake in MorphoSys and milestone payments. The extended agreement increases the number of antibody and grants Novartis the option to access MorphoSys' HuCAL GOLD library and HuCAL affinity optimization technology. In exchange, Novartis will pay increased annual license fees, research and development milestones and royalties. Specific financial terms were not disclosed.

• Penwest Pharmaceuticals Co., of Danbury, Conn., announced that Endo Pharmaceuticals, of Chadds Ford, Pa., its partner in developing and commercializing oxymorphone extended-release tablets, reported that the FDA has granted final approval of Endo's NDA for an extended-release formulation of oxymorphone hydrochloride (Opana ER). Opana ER, intended for around-the-clock treatment of moderate to severe pain, uses Penwest's proprietary time-release technology, TimeRx.

• Vanda Pharmaceuticals Inc., of Rockville, Md., reported results from a Phase II study of VEC-162 in a model of transient insomnia showing a statistically significant shift in circadian rhythm at 50 mg and 100 mg of up to five hours in the first night, and a statistically significant dose response curve. The study involved 37 healthy subjects, and also showed that all dose groups of VEC-162 experienced a reduction in time to achieve persistent sleep over placebo. VEC-162 is a melatonin agonist in Phase III studies for insomnia.

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