• Alexza Pharmaceuticals Inc., of Mountain View, Calif., said it submitted its responses regarding the Adasuve marketing authorization application to the European Medicines Agency (EMA). In March, the company received the Committee for Medicinal Products for Human Use's Day 120 list of questions. According to the EMA timetable, Alexza expects to receive the Day 180 list of outstanding issues in late September. Adasuve (Staccato loxapine) is under review for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

• Array BioPharma Inc., of Boulder, Colo., said it achieved an $8.5 million milestone in its collaboration with Thousand Oaks, Calif.-based Amgen Inc. The two firms entered the agreement in December 2009 for worldwide development of a small-molecule glucokinase activator program, including AMG 151. The latest milestone was achieved after Amgen reached a pre-defined patient enrollment level in a Phase IIa study testing AMG 151 in combination with metformin in patients with Type II diabetes. The trial's primary endpoint is change in fasting plasma glucose levels from baseline to end of treatment. (See BioWorld Today, Dec. 16, 2009.)

• BioAlliance Pharma SA, of Paris, said it signed a binding term sheet with Vestiq Pharmaceuticals Inc., of Research Triangle Park, N.C., for commercialization rights in the U.S. to mucoadhesive product Oravig (known as Loramyc in Europe) for the treatment of oropharyngeal candidiasis in adults. Under the agreement, BioAlliance should receive up to $44 million from Vestiq, including significant unconditional payments and payments linked to sales performance. BioAlliance also will receive sales royalties.

• Ligand Pharmaceuticals Inc., of San Diego, said partner Pfizer Inc., of New York, reported that the European Medicines Agency accepted for review the marketing authorization application for bazedoxifene/conjugated estrogens (BZA/CE), under review for use in postmenopausal women with a uterus for treating estrogen deficiency symptoms and treating osteoporosis in women at risk of fracture. Pfizer expects a decision in 2013. BZA/CE was developed as part of a research collaboration between Ligand and Wyeth, which was acquired by Pfizer in 2009. Under the terms of the deal, Ligand is entitled to milestone and royalty patents.

• Pain Therapeutics Inc., of Austin, Texas, said preclinical data showed that its compound, PTI-125, can suppress the toxic effects of beta-amyloid in a mouse model and in brain tissue from deceased Alzheimer's patients. Those findings, published in the Journal of Neuroscience, suggested that the drug may improve cognition and protect against the toxic effect of beta-amyloid in neurons. PTI-125 is a small molecule designed to bind to a target critical to beta-amyloid's toxicity.

• Satori Pharmaceuticals Inc., of Cambridge, Mass., said its lead compound, a gamma-secretase modulator (GSM), is efficacious in preclinical models following single- or multiday dosing. Data showed that the GSM compounds are selective for AB42, penetrate the brain and are dose responsive at achievable exposure levels. Those and other findings were presented at the Alzheimer's Association International Conference in Vancouver, British Columbia.