• Acucela Inc., of Bothell, Wash., reported that a scientific paper co-authored by its chairman, CEO and president, published in Experimental Eye Research, demonstrated for the first time the impact of treatment with a visual cycle modulator (VCM) on retinopathy in an immature eye. VCMs, like Acucela's own ACU-4429, are designed to prevent or inhibit the generation of toxic byproducts of the eye's visual cycle that can lead to degenerative eye conditions. The paper demonstrated a possible reduction of oxygen demand in the retina by modulating the visual cycle to treat neurovascular retinopathy, like retinopathy of prematurity or an even more common condition like diabetic retinopathy. In March, ACU-4429 was granted fast-track designation.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass. and collaborators from the Massachusetts Institute of Technology, the University of British Columbia (UBC), AlCana Technologies Inc., of Vancouver, British Columbia, and Tekmira Pharmaceuticals Corp., of Burnaby, British Columbia, presented results from multiple ongoing research efforts on the discovery of technologies for the systemic delivery of RNAi therapeutics at the International Liposome Research Days and Lipids, Liposomes & Membrane Biophysics meeting held at UBC in Vancouver last week. Among many reports, Alnylam scientists described the discovery of a new lipid called MC3 that has been formulated with siRNAs into lipid nanoparticles that achieve effective in vivo gene silencing activity at single-digit microgram per kilogram dose levels.

• Cynapsus Therapeutics Inc., of Toronto, entered into a license option agreement with Adagio Pharmaceuticals Ltd., of Hamilton, Ontario, granting Cynapsus the option to execute a proposed exclusive, worldwide agreement to license all intellectual property relating to APL-130277, a reformulation of an approved Parkinson's drug. The firms also finalized an exclusive worldwide license where Cynapsus will assume product development and commercialization rights to APL-130277 from Adagio in return for development milestones and royalties to Adagio. Under the deal, Adagio is entitled to be issued 750,000 common shares in the capital of Cynapsus based on a price of 10 cents per share. The license agreement includes an exclusive option period for the first 12 months, which allows Cannasat to conduct further due diligence and proof-of-concept studies for APL-130277 prior to executing the full license. Cynapsus also completed an additional financing of secured debentures in the aggregate amount of $180,000.

• Epitherix LLC, of San Diego, identified multiple chemical scaffolds related to the Wnt pathway that are potent and selective against colorectal carcinoma.

• Lentigen Corp., of Gaithersburg, Md., received a small business innovation research Phase II grant in an undisclosed amount from the National Institutes of Health to develop an experimental immunotherapy for melanoma, discovered by Michael Nishimura, a surgery professor at the Medical University of South Carolina.

• Osteotech Inc., of Eatontown, N.J., incurred costs and expenses of $391,000 and $539,000, respectively, from its ongoing evaluation by its financial adviser, Deutsche Bank Securities Inc., for strategic alternatives focused on enhancing shareholder value. While the firm said those out-of-pocket costs were significant, it said the evaluation process was a needed investment to make a well-informed decision about its future. The company said its board's decision to pursue other alternatives to unlock shareholder value was based on the belief that the company's stock price did not reflect the fundamental value of its business.

• Pfizer Inc., of New York, was granted FDA approval of the use of a prefilled dual-chamber syringe for administration of Xyntha (antihemophilic factor, recombinant plasma/albumin-free) for patients with hemophilia A. Xyntha, which was initially approved in February 2008, is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A, congenital factor VIII deficiency or classic hemophilia, and for surgical prophylaxis in patients with hemophilia A.

• Pluristem Therapeutics Inc., of Haifa, Israel, reported data from two preclinical studies in animal models which demonstrated that its PLacental eXpanded (PLX) cell therapy may be an effective treatment for both neuropathic and inflammatory nerve pain.

• Repros Therapeutics Inc., of The Woodlands, Texas, said it received positive feedback from the FDA regarding its planned Phase III program for Androxal in the treatment of secondary hypogonadism in men who want to preserve fertility. The program will include two placebo and active-controlled trials focused on normalization of serum testosterone levels while preserving fertility, defined by World Health Organization fertility standards. Repros said it will submit final protocols to the FDA soon. Androxal stimulates the pituitary gland to increase testosterone secretion. Shares (NASDAQ:RPRX) gained 3 cents, or 7.7 percent, to close at 39 cents on Monday.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA has accepted for priority review the efficacy supplement to the firm's new drug application for Xifaxan (rifaximin) 550 mg as a treatment for nonconstipation irritable bowel syndrome (IBS), including patients with diarrhea-predominant symptoms and those who experience intermittent periods of diarrhea and constipation, known as mixed IBS, and IBS-related bloating. The agency assigned Dec. 7 as the Prescription Drug User Fee Act action date.

• Talecris Biotherapeutics Holdings Corp., of Research Triangle, N.C., and Barcelona, Spain-based Grifols S.A., have each received a request for additional information and documentary material from the Federal Trade Commission (FTC) in connection with a proposed merger. The $3.4 billion deal, first reported in June, came just one year after the FTC prevented Talecris from merging with another plasma protein provider, CSL Ltd., of Victoria, Australia. And the Talecris-Grifols deal came less than a year after Talecris' $950 million initial public offering. Talecris said it is preparing a response. In June, Grifols CEO Victor Grifols said he does not expect the deal to fall foul of the FTC since his company is much smaller than CSL. (See BioWorld Today, June 9, 2009, Oct. 2, 2009, and June 8, 2010.)