Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the European Commission granted orphan drug designation to Soliris (eculizumab), a terminal complement inhibitor, for the prevention of delayed graft function (DGF) after solid organ transplantation. The company plans to start a single multinational DGF registration study in kidney transplants this year. Soliris previously gained approval in paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Amarin Corp. plc, of Dublin, said the FDA awarded three years of marketing exclusivity to Vascepa (icosapent ethyl) capsules in connection with the July 26, 2012, approval of the drug, allowing exclusivity to extend through July 25, 2015, with expectations that it will be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following valid notice of the FDA’s acceptance of an application to market a generic version of Vascepa. The company said it is reviewing the FDA’s reasoning for granting Vascepa a three-year, rather than a five-year period of exclusivity and is evaluating whether to challenge that decision. Vascepa is an ultra-pure omega-3 fatty acid product approved for severe hypertriglyceridemia.

Andromeda Biotech Ltd., of Yavne, Israel, said it entered an agreement with Teva Pharmaceutical Industries Ltd., of Jerusalem, for the acquisition of Teva’s rights to Andromeda’s Diapep227 for the treatment of type I diabetes. According to the agreement, Teva will transfer the rights for total consideration of about $72 million, payable in installments through future payments based on Andromeda’s revenues or on proceeds payable to its shareholders. Andromeda said it will ensure that the development program for Diapep227, currently in a confirmatory phase III trial, will continue as planned. Diapep227 is a peptide of 24 amino acids derived from the sequence of human heat-shock protein 60.

Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., said the FDA accepted its submission of a supplemental biologics license application requesting approval of Xiaflex (collagenase clostridium histolyticum for the treatment of two Dupuytren’s contracture cords concurrently. The PDUFA date is Oct. 20, 2014. Xiaflex currently is approved for use in adult Dupuytren’s patients with a palpable cord and for the treatment of adult men with Peyronie’s disease.

Intelgenx Corp., of Saint Laurent, Quebec, completed a pilot biostudy with its Versafilm tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug tadalafil product (Cialis, Pfizer Inc.). The randomized, two-period, two-way crossover study was conducted in healthy male subjects. The study results demonstrated that Versafilm was within an acceptable range of bioequivalency on measures of peak plasma concentration and area under the curve.

Pharming Group NV, of Leiden, the Netherlands, and Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA extended the PDUFA date to July 16 for the biologics license application for Ruconest (recombinant human C1 esterase inhibitor) 50 IU/kg to treat acute angioedema attacks in patients with hereditary angioedema.

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA accepted for standard review the company’s supplemental biologics license application for Eylea (aflibercept) for the treatment of macular edema following branch retinal vein occlusion. The target action date is Oct. 23.

Sirenas Marine Discovery, of San Diego, was awarded a phase I Small Business Innovation Research grant totaling $291,941 by the National Institute of Allergy and Infectious Disease (NIAID), to further develop a breakthrough HIV small-molecule therapeutic.

Synta Pharmaceuticals Corp., of Lexington, Mass., reported on progress with lead compounds from its Hsp90-inhibitor drug conjugate platform at the IASLC 14th Annual Targeted Therapies of the Treatment of Lung Cancer Meeting in Santa Monica, Calif. The new compounds, consisting of an Hsp90-inhibitor conjugated with SN-38 (HDC SN-38) and an Hsp90-inhibitor conjugated with docetaxel, demonstrated proof of principle in multiple preclinical cancer models. Complete or near complete regressions of tumors were observed in models of non-small-cell lung cancer, small-cell lung cancer, breast cancer, pancreatic cancer, colon cancer and skin cancer, in models that are generally resistant or show limited response to treatment with the unconjugated chemotherapies.

Vertex Pharmaceuticals Inc., of Cambridge, Mass, said the FDA approved a supplemental new drug application for Kalydeco (ivacaftor) for people 6 and older with cystic fibrosis (CF) who have one of eight additional mutations in the CF transmembrane conductance regulator gene. The drug was approved in January 2012 for people with CF 6 and older who have at least one copy of the G551D mutation. In the U.S., the additional G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D mutations affect approximately 150 people, according to Vertex. Data from the two-part, randomized, double-blind, placebo-controlled, crossover phase III study of Kalydeco with the additional mutations also were used to support regulatory filings in Europe, Canada and Australia for expanded approval, where the drug potentially could be used to treat approximately 250 additional people. In conjunction with disclosure of the sNDA approval, Vertex reaffirmed its 2014 revenue guidance for Kalydeco. (See BioWorld Today, Feb. 1, 2012, and Oct. 30, 2013.)