• Atlab Pharma SAS, of Nantes, France, and BZL Biologics LLC, of New York, entered a sublicense agreement to develop (177)Lu-J591 as a prostate cancer treatment. The agreement includes exclusive rights to manufacture, develop and commercialize the radiopharmaceutical worldwide, as well as a joint Phase IIb/III program. Atlab will fund certain product development and clinical trials, but no financial terms were disclosed. (177)Lu-J591 has shown an attractive efficacy and tolerability profile in Phase I and II trials involving 108 patients with metastatic castrate-resistant prostate cancer (CRPC). A large randomized, multicenter Phase IIb study is ongoing in CRPC patients with rising PSA but no detectable metastasis. The drug combines the humanized J591 monoclonal antibody targeting prostate-specific membrane antigen plus the (177)Lu radioisotope, creating a tumor-specific delivery system that targets radiation to radio-sensitive prostate cancer cells.

• Bavarian Nordic A/S, of Kvistgard, Denmark, announced that it has received a milestone payment of $25 million to deliver 20 million doses of its unlicensed smallpox vaccine, Imvamune, to the U.S. Strategic National Stockpile.

• Dynavax Technologies Corp., of Berkeley, Calif., reported that the FDA had concurred with the company's plan to submit a biologics license application (BLA) for Heplisav for people older than 40, followed by a supplemental BLA for licensure of a specific regimen for vaccinating chronic kidney disease patients against hepatitis B infection at the time the initial application is approved. Dynavax also said it had updated its timeline for the first BLA submission and now expects to submit in the first quarter of 2012.

• Hybrigenics SA, of Paris, reported that recent research showed that HBX 19,818, a specific Ubiquitin-Specific Protease 7 (USP7) inhibitor discovered by the company, exerted cytotoxic effects in vitro on chronic lymphocytic leukemia (CLL) cells. The company presented results at the 14th International Workshop on CLL in Houston.

• The Medicines Co. GmbH, of Parsippany, N.J., and Tokyo-based Daiichi Sankyo Deutschland GmbH will co-promote Angiox (bivalirudin) in Germany, beginning Nov. 1. The Medicines Co.'s Angiox, an injectable direct thrombin inhibitor, is indicated in Europe as an anticoagulant for adult patients undergoing percutaneous coronary intervention, including patients with STEMI undergoing primary PCI. Financial terms were not disclosed.

• MediGene AG, of Martinsried, Germany, announced that the UK's Medicines and Healthcare Products Regulatory Agency granted the authorization of the planned clinical formulation study of RhuDex, an oral therapy being developed for the treatment of rheumatoid arthritis.

• Pearl Therapeutics Inc., of Redwood City, Calif., presented preclinical data demonstrating the strong aerosol performance of its cosuspension drug delivery technology, even when two or three drugs are combined. The data were presented at the American Association of Pharmaceutical Scientists annual meeting.

• Pfizer Inc., of New York completed its acquisition of Icagen Inc., of Durham, N.C. The transaction, first announced in July, had an aggregate value, including the value of approximately 11 percent of Icagen's stock already owned by Pfizer, of about $56 million. Pfizer acquired the remaining 8.3 million shares at $6 per share. (See BioWorld Today, July 21, 2011.)

• Poniard Pharmaceuticals Inc., of San Francisco, said Egan-Jones Proxy Services, an independent proxy advisory firm, has recommended that Poniard shareholders vote for proposals related to the issuance of stock in connection with the company's proposed merger with Allozyne Inc., of Seattle, and a 1-for-40 reverse stock split. The measures will be voted on at a special shareholder meeting Nov. 21. (See BioWorld Today, June 24, 2011.)

• Repligen Corp., of Waltham, Mass., acquired Novozymes Biopharma Sweden AB, a subsidiary of Bagsvaerd, Denmark-based Novozymes AS, for $22.7 million in cash and 5.6 million in potential milestone payments. In addition to advancing a pipeline, Repligen runs a bioprocessing business through which it supplies technologies and ingredients used to manufacture biologics. The Novozymes acquisition will supplement that business by expanding its product offerings and doubling manufacturing capacity, allowing Repligen to reach profitability by fiscal year 2013, the company said.

• Shire plc, of Basingstoke, UK, filed for FDA approval of Replagal (agalsidase alfa), an enzyme replacement therapy for Fabry disease that is already approved in 46 countries. Replagal was granted fast-track designation by the FDA, so it is eligible for accelerated approval. Shire expects to complete the rolling submission in November. Fabrazyme (agalsidase beta, Genzyme), the only FDA-approved Fabry treatment, is in the third year of a severe global shortage that has led to rationing for patients worldwide. Because of the shortage, the FDA permitted Shire to provide Replagal to U.S. patients under an early access program. (See BioWorld Today, Aug. 4, 2010, and May 6, 2011.)

• Topotarget A/S, of Copenhagen, Denmark, said it has licensed exclusive rights to further development of the company's multimeric TNF superfamily ligands (TNFSF) for all therapeutic uses to Multimeric Biotherapeutics Inc., of La Jolla, Calif. Multimeric will license the rights to all multimeric fusion proteins containing TNFSFs covered by Topotarget's issued and pending patents in Europe, U.S., Canada, Japan, Australia and South Korea. The agreement also grants Multimeric the rights to sublicense. Other terms were not disclosed.

• Valeant Pharmaceuticals International Inc., of Mississauga, Ontario, now holds 81.6 percent of the outstanding common shares of Afexa Life Sciences Inc., enabling it to approve its acquisition of the Edmonton, Alberta-based company. Afexa will hold a special shareholders meeting in December to vote on the acquisition. Once Valeant purchases the remaining shares at C85 cents (US82 cents), Afexa shares will be delisted from the Toronto Stock Exchange.

• Ziopharm Oncology Inc., of New York, presented preclinical data showing that palifosfamide (Zymafos or ZIO-201) inhibits tumor growth in models of pediatric sarcoma. Palifosfamide, a bi-functional DNA-alkylator, did not exhibit aldehyde dehydrogenase resistance. The data were presented at the 2011 meeting of the combined Connective Tissue Oncology Society Musculoskeletal Tumor Society.