• Bavarian Nordic A/S, of Kvistgaard, Denmark, said the Biomedical Advanced Research and Development Authority awarded the firm a contract valued at up to $228 million for the continued supply of Imvamune smallpox vaccine. The first $110 million of the new order is secured, and the remaining portion will be secured based on availability of funds in 2014. Under the terms, payments of an additional $37 million will be received, associated with the delivery of the original 20 million dose order. Bavarian Nordic has been delivering Imvamune to the Strategic National Stockpile since 2010.

• BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., completed a Type C meeting with the FDA for intravenous peramivir. The meeting minutes were consistent with the FDA's comment letter and also confirmed that the company's proposed new drug application supports a reviewable new drug application (NDA) submission for acute uncomplicated influenza. The company is requesting a pre-NDA meeting to seek to address issues identified in the minutes and seek agreement on a complete NDA submission.

• BioInvent International AB, of Lund, Sweden, said the April 15, 2013, online issue of Cancer Cell features data demonstrating potent anticancer activity of BI-505 in multiple preclinical myeloma tumor models. BI-505 is in Phase I testing and is farthest ahead among several antibody candidates that have emerged from the company's "function-first" platform, which enables combined target and antibody drug discovery.

• Charleston Laboratories Inc., of Charleston, S.C., said the FDA granted its request for a pre-investigational new drug application meeting to discuss CL-H1T as a treatment for patients who suffer from migraine pain and migraine-induced nausea or vomiting. After the meeting, the company said, it will look for partnership opportunities for the drug, a fixed-dose formulation of a triptan combined with an anti-emetic using the firm's release technology.

• Durect Corp., of Cupertino, Calif., submitted a new drug application (NDA) to the FDA for Posidur (bupivacaine). Posidur is a postoperative pain relief depot that uses Durect's Saber technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. Durect submitted the NDA as a 505(b)(2) application.

• Genmab A/S, of Copenhagen, Denmark, said the Court of Appeals for the Federal Circuit upheld the District Court's judgment in favor of partner GlaxoSmithKline plc, of London, in a patent infringement case involving Arzerra (ofatumumab) brought against GSK by South San Francisco-based Genentech Inc. (now part of Roche AG) and Weston, Mass.-based Biogen Idec Inc. The two companies appealed the order on the patent claim construction, which led to the judgment in favor of GSK in December 2011. The lawsuit, which claimed that Arzerra infringed a patent covering methods of treating chronic lymphocytic leukemia with CD20 antibodies, is now over unless Genentech and Biogen are granted further review by the Federal Circuit or the Supreme Court.

• Gentium SpA, of Villa Guardia, Italy, said it requested a re-examination of the negative opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP) March 22, regarding the marketing authorization application (MAA) submitted for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. By European regulations, the company has 60 days to submit grounds for appeal, and the CHMP has a further 60 days to consider a revision of the initial opinion. The appeal involves a re-examination of the original MAA and must be based on the data already submitted.

• Immunovaccine Inc., of Halifax, Nova Scotia, received $407,700 from the National Research Council of Canada Industrial Research Assistance Program to develop a vaccine for respiratory syncytial virus. The funding will be used to formulate antigens using Immunovaccine's DepoVax adjuvant technology. In preclinical studies, DepoVax generated rapid and robust immune responses. The funding also will help the company prepare for its first human trial of the DepoVax platform in infectious disease.

• KemPharm Inc., of North Liberty, Iowa, completed tablet manufacturing of KP201 for clinical and commercial development. KP201 is a fixed-dose combination of KemPharm's ligand attached to hydrocodone and acetaminophen. It is in development for moderate to moderately severe pain.

• Pfenex Inc., of San Diego, and Agila Biotech Private Ltd., of Bangalore, India, a subsidiary of Strides Arcolab Ltd., entered a joint venture to develop, manufacture and commercialize an initial pipeline of six biosimilar products for the global market. Both parties will equally share in decision-making regarding product development and commercialization. Agila Biotech will be a 51 percent equity stakeholder.

• SEEK, of London, a privately owned drug discovery group, said preclinical data on its HIV immunotherapy have been published in Virology Journal. The therapy directs the immune system toward short, highly conserved regions of proteins produced by most circulating HIV strains. The triggered immune responses are highly effective both independently and in combination, SEEK said.

• Vivus Inc., of Mountain View, Calif., said the FDA approved its amendment and modification to the risk evaluation and mitigation strategy (REMS) for obesity drug Qsymia (phentermine/topiramate extended-release capsules). The REMS amendment, submitted in October, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies. Vivus President Peter Tam said the change represents a "key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice." The company is expected to roll out the drug to pharmacies within 90 days. (See BioWorld Today, Oct. 23, 2012, and March 27, 2013.)

• Xencor Inc., of Monrovia, Calif., and CSL Ltd., of Parkville, Australia, signed a license agreement for Xencor to provide CSL with access to its Xtend technology for optimizing monoclonal antibodies. CSL will receive an exclusive license to the technology for use with an undisclosed target in exchange for an up-front payment, milestone payments and royalties on product sales.

• Zymeworks Inc., of Vancouver, British Columbia, said it reached a second research milestone in its collaboration with Merck & Co. Inc., of Whitehouse Station, N.J., related to Zymeworks' Azymetric platform for the development of bispecific antibody therapeutic candidates. In conjunction with the terms of the collaboration agreement, Zymeworks is to receive an undisclosed payment from Merck. (See BioWorld Today, Sept. 7, 2012.)