ALK-Abellos A/S, of Copenhagen, Denmark, said its partner for Japan, Torii Pharmaceutical Co. Ltd., of Tokyo, reported positive results from its phase II/III trial of sublingual allergy immunotherapy tablet (SLIT-tablet) for Japanese cedar tree pollen allergic rhinitis (hay fever). The trial met its primary efficacy endpoint, providing statistically significant improvement in the total combined rhinitis score compared with patients who received placebo, demonstrating that the SLIT-tablet reduced symptoms of Japanese cedar pollen allergic rhinitis. The trial also showed the treatment was well tolerated and had a favorable safety profile. Torii is preparing for a new drug application to the Japanese regulatory authority.

Aveo Oncology Inc., of Cambridge, Mass., said it entered a license agreement with a subsidiary of Pharmstandard Group, the largest Russian pharmaceutical group, to develop, manufacture and commercialize Aveo's small-molecule vascular endothelial growth factor tyrosine kinase inhibitor, tivozanib, in Russia, Ukraine and the Commonwealth of Independent States for all indications excluding ocular conditions. Under the terms, Pharmstandard will pay Aveo an up-front amount of $1.5 million, and Aveo will be eligible to receive up to $7.5 million upon the first marketing authorization of tivozanib in Russia, $3 million for each additional approved indication and a high single-digit royalty on net sales in those same territories. Pharmstandard will be responsible for all activities and costs associated with the further development, regulatory filings, health services and commercialization of tivozanib in the specified territories. A percentage of all up-front, milestone and royalty payments paid to Aveo are due to Kyowa Hakko Kirin Co. Ltd., of Tokyo, as a sublicensing fee.

China Cord Blood Corp., of Hong Kong, said its board received a nonbinding acquisition proposal letter from Nanjing Xinjiekou Department Store Co. Ltd., which has offered to acquire all the company's China business, including all equity interests in its China subsidiaries. The purchase price offered is in the region of ¥6 billion (US$966 million), to be paid in cash or shares or a combination of the two.

Daiichi Sankyo Co. Ltd., of Tokyo, said the UK's National Institute for Health and Care Excellence recommended its oral, once-daily selective factor Xa inhibitor Lixiana as an option for preventing stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors. In a Final Appraisal Determination, the institute said Lixiana was "cost effective compared with warfarin and could be recommended as an alternative to warfarin for preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation who have one or more risk factors for stroke."

Dr. Reddy's Laboratories Ltd., of Hyderabad, India, said it entered a strategic collaboration with Amgen Inc., of Thousand Oaks, Calif., to market and distribute three of Amgen's medicines in India. Under the terms, Dr. Reddy's will perform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), Blincyto (blinatumomab) and Repatha (evolocumab) in India. Kyprolis was approved by the FDA last month, in combination with Revlimid (lenalidomide, Celgene Corp.) and dexamethasone, for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including Velcade (bortezomib, Takeda Oncology Co.) and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Blincyto is the first approved bispecific CD19-directed CD3 T-cell engager. It was approved by the FDA in 2014, to treat patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Last month the European Commission granted marketing authorization for Repatha, the first proprotein convertase subtilisin/kexin type 9 inhibitor to be approved for the treatment of patients with uncontrolled cholesterol despite taking maximum doses of statins or who cannot take statins, who require additional intensive low-density lipoprotein cholesterol reduction.

Heptares Therapeutics, a subsidiary of Tokyo-based Sosei Group Corp., is getting $10 million up front and potentially more than $500 million in milestones by out-licensing to London-based Astrazeneca plc its A2A adenosine receptor (A2AR) antagonist HTL-1071 for development in immuno-oncology indications. It also would receive tiered double-digit royalties on product sales.

Hetero Group, of Hyderabad, India, launched its biosimilar to rituximab (Rituxan, Biogen Inc. and Roche AG) in India. Branded Maball, the drug will be marketed and distributed by Hetero Healthcare Ltd., a unit of Hetero, for use by patients with non-Hodgkin's lymphoma and chronic lymphocytic leukemia. The company said it plans to introduce the biosimilar product into key markets outside India through partners.

Medivation Inc., of San Francisco, said U.S. net sales of prostate cancer drug Xtandi (enzalutamide), as reported by partner Astellas Pharma Inc., of Tokyo, were $298.4 million for the second quarter, up 108 percent over the same period in 2014 and 33 percent higher than first quarter 2015 sales. Medivation said it estimates that second quarter unit demand increased by a low- to midteens percentage rate, compared with unit demand in the first quarter of this year. Ex-U.S. net sales were about $188 million, a 121 percent jump over the prior year and a quarter-over-quarter increase of 42 percent. Medivation recorded collaboration revenue totaling $175.6 million for the quarter. The company reported non-GAAP net income of $48.7 million, or 58 cents per share. As of June 30, Medivation had about $497.5 million in cash, equivalents and short-term investments. Its shares (NASDAQ:MDVN) closed Friday at $102.71, up $1.27.

Pharmaxis Ltd., of Sydney, and Southampton, UK-based Synairgen plc have agreed to co-develop a selective inhibitor to the lysyl oxidase type 2 enzyme (LOXL2) to treat the fatal lung disease idiopathic pulmonary fibrosis (IPF). The LOXL2 inhibitor program comes from the same Pharmaxis chemistry platform as the semicarbazide-sensitive amine oxidase inhibitor that was acquired by Boehringer Ingelheim GmbH, of Ingelheim, Germany, in May. Under terms of the agreement, Synairgen will fund further activity of the program at Pharmaxis, use its Biobank and in vitro lung model platform, and collaborate with the IPF research team at the University of Southampton to complete preclinical and early clinical development. The program will be managed by a joint steering committee through to the end of phase I or phase IIa trials, at which time the collaboration will seek a license partner. Pharmaxis and Synairgen will split any licensing revenues from the program in accordance with the ratio of total investment by the two companies at that time, they said. (See BioWorld Today, May 20, 2015.)

Regeneus Ltd., of Sydney, said the first patient has been enrolled and treated in the STEP (Safety, Tolerability and Efficacy of Progenza) trial, the first trial of Progenza, the company's allogeneic stem cell product for the treatment of knee osteoarthritis. A review of the sentinel patient's safety data by the study safety oversight committee identified no safety concerns. Enrollment is now open to the remainder of the first cohort of 10 patients. A second and final cohort of 10 patients will receive a higher dose of cells, the company said.

Somalogic Inc., of Boulder, Colo., said Otsuka Pharmaceutical Co. Ltd., of Tokyo, extended its collaboration agreement from May 2008 to continue developing several Somamer therapeutics. No other details were disclosed regarding specific products and financial terms. Under the original terms, Somalogic was entitled to receive a royalty on any marketed products developed, and Otsuka had an option to acquire distribution rights in Asia for certain Somalogic clinical diagnostics products. Somalogic also received an equity investment from Otsuka.