Agenix Ltd., of Melbourne, Australia, said it reached a binding agreement to sell its AGX-1009 China project to Cinkate Pharmaceutical Intermediates Co. Ltd., of Shanghai, for $2 million. Cinkate will assume development of AGX-1009, a tenofovir prodrug for hepatitis B virus that is patented in China. With the sale, Agenix said it was exiting operations in China. The transaction is expected to close in the second half of 2014.

Anavex Life Sciences Corp., of New York, cheered new data published in The Journal of Neuroscience that implied favorable implications for Anavex Plus (Anavex 2-73 and donepezil), the company's Alzheimer's disease drug candidate combination. The findings indicate that too much calcium signaling in neurons may be involved in causing Alzheimer's. Since calcium levels can be modulated directly through the inositol triphosphate (IP3) receptor, Avanex said the findings indirectly confirm the therapeutic opportunity for Avanex Plus, an agonist of the sigma-1 receptor (S1R), since S1R acts as a calcium signaling modulator via IP3.

Biorestorative Therapies Inc., of Jupiter, Fl., entered a two-year collaborative research agreement with New York-based Pfizer Inc. to study human brown adipose tissue and cell lines to determine if its cell lines have utility in the treatment of obesity. Biorestorative has accumulated a large collection of human brown adipose tissue samples, preadipocyte cell lines and immortalized cell lines for use in potentially developing a cell therapy product, it said. Terms of the deal were not disclosed.

Gilead Sciences Inc., of Foster City, Calif., continues to inspire controversy with the high price of Sovaldi (sofosbuvir), its pricey hepatitis C medication. The AIDS Healthcare Foundation Wednesday joined the insurance trade group American Health Insurance Plans in decrying the drug's high price, calling it "the primary example of pharmaceutical companies gouging drug prices to unsustainable levels." Gilead has responded by promoting access programs to lower out-of-pocket costs for patients.

H3 Biomedicine Inc., of Cambridge, Mass., and Selvita SA, of Krakow, Poland, said they achieved the first research milestone in their strategic collaboration to develop precision medicines for cancer by validating the importance and druggability of a kinase target in a specific genetic context and generating multiple chemical series against the target. The companies expect the first candidate molecule originating from the collaboration to move to investigational new drug-enabling studies next year. H3 said it will provide an undisclosed milestone payment to Selvita.

Mucosis B.V., of Groningen, the Netherlands, said it has received a credit line of up to €5 million (US$6.8 million) from the Netherlands Enterprise Agency, an agency of the Dutch Ministry of Economic Affairs. The company will use the credit to further advance development of Syngem perfusion F respiratory syncytial virus vaccine candidate through human proof-of-concept studies. The company raised an additional €5 million in an April financing. (See BioWorld Today, April 16, 2014.)

Opko Health Inc., of Miami, completed the acquisition of the Israel-based device firm Inspiro Medical Ltd.

Protalix Biotherapeutics Inc., of Carmiel, Israel, said the Australian Therapeutic Goods Administration has granted regulatory approval to Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy for both adult and pediatric patients with a confirmed diagnosis of type 1 Gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anemia, thrombocytopenia. Elelyso will be marketed in Australia by Pfizer Inc., of New York, Protalix's commercialization partner. Taliglucerase alfa was approved by the FDA in May 2012 for adults with type 1 Gaucher disease.

Protea Biosciences Group Inc., of Morgantown, W.V., said the Depository Trust Corp. has approved its common stock for DWAC/FAST transfer through Island Stock Transfer, the company's transfer agent. With DWAC/FAST transfer capabilities, Protea's shareholders can now electronically transfer their shares of common stock purchased or sold in the open market, eliminating the need to transfer physical certificates.

Regenerx Biopharmaceuticals Inc., of Rockville, Md., disclosed in a letter to shareholders that, based on receiving orphan drug designation from the FDA for RGN-259, its Thymosin beta 4 candidate to treat neurotrophic keratopathy (NK), the company is considering moving directly into a phase III trial to seek FDA approval. Regenerx said a phase III in NK could be completed in approximately six months, suggesting the study could be completed by mid-2015 if initiated by year-end. The company plans to meet with the FDA to discuss the phase III trial design.

Santhera Pharmaceuticals Ltd., of Liestal, Switzerland, reported that the results of secondary respiratory function endpoints from the ongoing analysis of the DELOS trial in Duchenne muscular dystrophy (DMD) corroborate the positive outcome for the primary endpoint. These data provide further supportive evidence of a treatment benefit for idebenone Catena/Raxone in DMD.

Sarepta Therapeutics Inc., of Cambridge, Mass., disclosed an agreement to acquire a multifunctional manufacturing facility in Massachusetts. Sarepta intends to manufacture investigational exon skipping therapies for Duchenne muscular dystrophy. The transaction comprises about $25 million in acquisition costs and planned enhancements, and is expected to close in July subject to conditions and extensions in the agreement.

Servier SA, of Paris, inked a global collaboration agreement with Novartis AG, of Basel, Switzerland, to develop and commercialize a series of drug candidates emerging from Servier's oncology research programs, partnered with Vernalis plc, of London, that target the apoptosis regulation pathways. The collaboration covers global co-development of BCL-2 selective inhibitor candidates now entering clinical development. Servier will oversee research activities and share responsibilities with Novartis on a development program aimed at identifying a lead indication. Commercialization rights to products arising from the collaboration will be allocated between the parties on a geographic basis. Other terms were not disclosed.

Topotarget A/S, of Copenhagen, and Paris-based Bioalliance Pharma SA confirmed the terms of their April merger agreement, announcing that the combined orphan oncology company will operate under the name Onxeo. Judith Greciet, CEO of Bioalliance will lead the combined company, while Topotarget's Patrick Langlois will serve as chairman. The announcement did not discuss the role Topotarget CEO Anders Vadsholt will play in the new venture. (See BioWorld Today, April 17, 2014.)

Txcell SA, of Valbonne, France, said that Col-Treg, its second therapeutic candidate, for the treatment of autoimmune uveitis, from its ASTrIA platform, has been granted advanced therapy medicinal product classification by the Committee for Advanced Therapies of the European Medicines Agency. Col-Treg is a personalized cell-based immunotherapy product, based on the properties of autologous collagen II-specific regulatory T lymphocytes. The product has already shown efficacy and safety in several different autoimmune disease models. The company, a spin-off of Inserm (France's National Institute for Health and Medical Research), recently raised €16.2 million (US$22.4 million) in an initial public offering on the Euronext exchange in Paris. (See BioWorld Today, April 16, 2014.)

Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, said that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the granting of a marketing authorization for Envarsus for the prevention of organ rejection in adult transplant patients in the European Union. The positive opinion is for both kidney and liver transplant recipients and includes both the de novo transplant and "switch" settings, as well as for treatment of rejection episodes resistant to treatment with other immunosuppressive products in adult patients.

Viking Therapeutics Inc. obtained an exclusive worldwide license to five therapeutic programs from Ligand Pharmaceuticals Inc. The license includes programs targeting type 2 diabetes (phase IIb) and cancer cachexia (phase II) that Viking is currently preparing to advance into mid-to-late stage clinical trials. Viking is solely responsible for all development activities under the license. Ligand also agreed to invest $2.5 million in Viking to fund operating expenses. The San Diego-based companies said the drug candidates and programs covered by the license agreement include: VK0612, a selective inhibitor of fructose-1,6-bisphosphatase for type 2 diabetes; VK5211, an orally available, non-steroidal SARM in development for the treatment of cancer cachexia; VK0214, an orally available, liver-selective TRβ agonist for lipid disorders such as dyslipidemia and NASH; a portfolio of orally available small-molecule EPOR agonists for the potential treatment of anemia; and a portfolio of orally available small-molecule inhibitors of the enzyme DGAT-1 for the potential treatment of lipid disorders such as obesity and dyslipidemia.