• AdventRx Pharmaceuticals Inc., of San Diego, signed a contract manufacturing agreement with Pierre Fabre Medicament, of Castres, France, to produce the active ingredient in ANX-188 (purified poloxamer 188) for clinical trials, particularly a Phase III trial scheduled to begin this year. The term of the agreement, according to the companies, is multiple years.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said new findings in preclinical anemia models demonstrated the ability of an RNAi therapeutic targeting the EglN pathway to reactivate a natural developmental pathway of hepatic erythropoietin production. The increase in erythropoietin was detectable out to two weeks after administration of a single dose. It also was associated with a sustained increase in red blood cell parameters, including reticulocyte count, hemoglobin and hematocrit. The results were published in Blood.

• BioInvent International AB, of Lund, Sweden, will collaborate with Cancer Research Technology Ltd. (CRT), of London, to search for new therapeutic antibodies for oncology using BioInvent's F.I.R.S.T. Technology. CRT will provide biological pathways to target. BioInvent will have an option to license resulting candidates in exchange for milestone and royalty payments to CRT.

• Cardium Therapeutics Inc., of San Diego, entered an agreement with Advanced Biosciences Research, an affiliate of Aventura, Fla.-based bioRASI, to commercialize Excellagen, a high-molecular weight fibrillar bovine Type I topical gel used for topical wound care, in Russia and the rest of the Commonwealth of Independent States (CIS). Under the agreement, bioRASI will be responsible for the registration and approval for the marketing and sales of Excellagen in the Russian Federation, and it will help Cardium develop a plan for its marketing, sales and distribution in Russia and the CIS following final market approval. Financial terms were not disclosed.

• Edimer Pharmaceuticals Inc., of Cambridge, Mass., received fast-track designation from the FDA for EDI200, a recombinant protein being developed for X-linked hypohidrotic ectodermal dysplasia (XLHED). The disease is caused by mutations in the ectodysplasin gene, and EDI200 is an ectodysplasin-A (EDA-A1) replacement protein. It has been shown to bind the EDA-A1 receptor and activate signaling pathways to promote normal development.

• Genzyme, of Cambridge, Mass., a unit of Sanofi SA, said it submitted a supplemental biologics license application to the FDA and a marketing authorization application to the European Medicine's Agency seeking approval of Lemtrada (alemtuzumab) for treatment of relapsing multiple sclerosis. The applications are based on data from two Phase III studies showing that CD52-targeting monoclonal antibody was superior to Rebif (high-dose subcutaneous interferon beta-1a, Merck Serono) on clinical and imaging endpoints, including a reduction in relapse rate. Lemtrada is being developed in collaboration with Bayer HealthCare, part of Leverkusen, Germany-based Bayer AG. (See BioWorld Today, July 12, 2011, and Oct. 24, 2011.)

• Jazz Pharmaceuticals plc, of Dublin, Ireland, reported the closing of its acquisition of EUSA Pharma, a privately held, UK-based specialty oncology company. Jazz paid $680 million in cash, plus a potential $50 million milestone payable upon leukemia drug Erwinaze (asparaginase Erwinia chrysanthemi) achieving a specified U.S. net sales target in 2013. The transaction was financed with cash on hand and proceeds from a six-year $475 million term loan. Jazz also arranged a five-year, $100 million revolving credit facility. Post-closing, Jazz had more than $100 million in cash on hand. The acquisition is expected to be accretive to 2012 earnings, adding expected incremental revenue of $90 million to $100 million and an estimated additional 25 cents to 30 cents in adjusted earnings per share. EUSA Pharma will retain its name outside the U.S. and will be led by Bryan Morton, its founder and former CEO and president. (See BioWorld Today, April 30, 2012.)

• Pharming Group NV, of Leiden, the Netherlands, said it engaged Roth Capital Partners and Nomura Code to help it explore strategic alternatives such as a merger, equity investment or a sale. In addition, the company is taking cost-containment measures and is continuing discussions on platform technology collaborations. Meanwhile, Pharming expects enrollment to be completed within the next few weeks for a pivotal trial for U.S. approval of Ruconest to treat acute attacks of hereditary angioedema. However, an internal oversight could potentially delay the unblinding of the top-line data by up to three months, Pharming said. Results had been expected in the third quarter. Completion of the trial and read-out of the top-line results will, if positive, trigger a $10 million milestone payment from Pharming's U.S. partner, Santarus Inc., of San Diego. Already approved in Europe and several other markets, Ruconest would be the first recombinant C1 inhibitor on the U.S. market. (See BioWorld Today, March 1, 2011, and Aug. 5, 2011.)

• Regenicin Inc., of Little Falls, N.J., said the FDA granted orphan status to PermaDerm, a tissue-engineered skin prepared from autologous skin cells consisting of both epidermal and dermal layers and indicated for catastrophic burn patients. The FDA previously designated PermaDerm skin replacement technology as a biologic/drug.

• SIGA Technologies Inc., of New York, said it filed a notice of appeal seeking to overturn the Delaware Chancery Court's May 31 final order and judgment in the litigation that PharmAthene Inc., of Annapolis, Md., commenced in December 2006. The court issued a final order last month, upholding its September 2011 ruling that granted PharmAthene a 50 percent share, over 10 years, of SIGA's net profits from its smallpox drug, ST-246, which is being developed under a government contract that could be worth up to $2.8 billion. (See BioWorld Today, Sept. 23, 2011, and June 4, 2012.)

• Tokai Pharmaceuticals Inc., of Cambridge, Mass., said the FDA granted fast-track designation for its lead candidate, galeterone (TOK-001), for metastatic castration-resistant prostate cancer (CRPC). A Phase I proof-of-concept study in patients with CRPC has been completed with positive results, and the company plans to begin a Phase II trial in the second half of 2012.