Aeterna Zentaris Inc., of Charleston, S.C., signed an exclusive license agreement with Rafa Laboratories Ltd., of Jerusalem, for their lead anti-cancer compound, Zoptrex (zoptarelin doxorubicin), for the initial indication of endometrial cancer, for Israel and the Palestinian Territories. Zoptrex, a synthetic peptide carrier linked to doxorubicin, is currently in a fully enrolled phase III trial in endometrial cancer, which is expected to be completed in the third quarter of 2016. Aeterna Zentaris will be entitled to receive a non-refundable upfront payment from Rafa, who has also agreed to make additional payments upon achieving certain pre-established regulatory and commercial milestones. The company will receive double-digit royalties on future net sales of Zoptrex. Rafa will be responsible for the development, registration, reimbursement and commercialization of the product in Israel and the Palestinian Territories.

Altimmune Inc., of Gaithersburg, Md., said it was awarded a contract valued at up to $120.2 million over five years from the U.S. Biomedical Advanced Research and Development Authority to fund the clinical development of Nasoshield, its anthrax vaccine candidate. The base contract of $14.3 million will fund its phase I trial. The remainder of the contract is expected to encompass a dose-selection phase Ib study; scale-up in manufacturing; non-clinical studies; phase II studies for immunogenicity, effectiveness and interactions with antibiotics; regulatory efforts; and formulation development to improve stability.

Biolinerx Ltd., of Tel Aviv, said it signed an exclusive worldwide agreement with Hadasit, the Technology Transfer Company of Hadassah Medical Organization, to in-license a drug candidate to treat liver fibrosis and, in particular, nonalcoholic steatohepatitis. Terms were not disclosed. The candidate, BL-1210, designed to control liver fibrosis by modulating the immune system, is the first project to be in-licensed under a multi-year strategic collaboration between Biolinerx and Novartis AG, of Basel, Switzerland, initiated in December 2014. Novartis is evaluating projects identified by Biolinerx for potential co-development and future licensing.

Dimerix Ltd., of Melbourne, Australia, said the FDA sent the company the minutes from the pre-investigational new drug (IND) meeting for DMX-200 as a treatment for patients with chronic kidney disease (CKD), in particular for an orphan indication of focal segmental glomerular sclerosis, or FSGS. The FDA confirmed the path to U.S. drug registration of DMX-200 for CKD with no roadblocks for filing the IND for the drug's first U.S. study, and also recommended that the drug be used as an adjunct therapy to standard treatment, instead of a combo treatment, which means a smaller, less-expensive trial. The FDA also validated the potential for approval from just one pivotal phase III trial with only one end point (improvement in proteinuria from baseline). Finally, the agency recognized the important of Dimerix's technology to identify new therapies.

Emergent Biosolutions Inc., of Gaithersburg, Md., said it completed the spin-off of Aptevo Therapeutics Inc., of Seattle. Aptevo began trading as of Monday on Nasdaq Global Select Market as APVO, and has the goal of developing oncology and hematology therapies. The company will utilize its Adaptir platform in immune-oncology programs. Under terms of the launch, Emergent stockholders as of July 22, received one share of Aptevo common stock for every two shares of Emergent. About 20 million shares of Aptevo common stock were distributed in the action.

Galapagos NV, of Mechelen, Belgium, said it was notified by Federated Equity Management Company of Pennsylvania that funds managed by Federated hold about 2.29 million shares of the 46.11 million shares of Galapagos that are currently outstanding. On July 20, a share sale caused a decrease below the 5 percent notification threshold of the company's voting rights.

Hutchison China Meditech Ltd. (Chi-Med), and Astrazeneca plc, both of London, said they amended their 2011 agreement on global licensing, co-development and commercialization for savolitinib, a selective c-Met inhibitor being studied in a number of cancers. The companies aim to accelerate the drug's development and will increase the amount Chi-Med is contributing to up to $50 million over three years for a global phase III trial in c-Met-driven papillary renal cell carcinoma (PRCC). In addition, Chi-Med's global tired royalty rate on savolitinib sales across all indications will be increased by 5 percentage points. The remaining terms of that 2011 deal will stay the same. Data from savolitinib's phase II trial in PRCC are to be presented at an upcoming scientific meeting.

Ipsen SA, of Paris, said the FDA approved Dysport (abobotulinumtoxinA) as an injection to treat pediatric lower limb spasticity in those 2 and older. The company said the drug is the only botulinum toxin approved by the FDA for the new indication. Data from the phase III pivotal trial showed that a majority of those treated achieved a response that lasted between 16 and 22 weeks or greater.

MEI Pharma Inc., of San Diego, said the FDA granted breakthrough therapy designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years of age or unfit for intensive chemotherapy. In addition, agreement has been reached with the FDA on the company's proposed phase III study design. A phase II study of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML, not candidates for induction chemotherapy, showed a median overall survival of 19.1 months and a complete response rate of 42 percent. Pracinostat is an oral inhibitor of a group of enzymes called histone deacetylases, or HDACs.

Orexigen Therapeutics Inc., of San Diego, has completed its acquisition of the U.S. rights to obesity drug Contrave (naltrexone HCl/bupropion HCl extended release) and relaunched it with the company's own sales organization. The acquisition from Takeda Pharmaceuticals USA Inc., a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, was originally announced March 2016 and completed two months ahead of schedule. Orexigen is now entitled to 100 percent of net sales and controls all U.S. commercial and development activities. Outside the U.S., Orexigen's strategy is to commercialize Contrave and Mysimba (naltrexone HCl/bupropion HCl prolonged release), as the drug is known in Europe, through partnerships. Separately, Orexigen said that wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Laboratorios Farmacéuticos Rovi S.A., of Madrid, have executed a commercialization and distributorship agreement for Mysimba in Spain. Mysimba is approved by the EMA for the management of weight in adult patients (≥18 years) with an initial body mass index of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities.

Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., reported that the EMA accepted for review the marketing authorization application for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The MAA for sarilumab is primarily based on results from seven phase II trials in the global SARIL-RA clinical development program, which include data from more than 3,300 adults with moderately to severely active RA. A biologics license application for sarilumab was accepted for review by the FDA in the first quarter of 2016.

Shire plc, of Dublin, gained FDA approval for the Baxject III reconstitution system for Adynovate [Antihemophilic Factor, (Recombinant), PEGylated]. Adynovate and the diluent will be pre-packaged in the Baxject III reconstitution system. The system reduces the number of steps in the treatment process by two, compared to the previous process with the Baxject II Hi Flow Needleless transfer device. Shire said that the new system will be available to most customers in the fourth quarter of 2016, with a 2 mL diluent for the 250, 500, and 1000 IU potencies; and a 5 mL diluent for the 2000 IU potency. Adynovate, an extended circulating half-life recombinant Factor VIII treatment, was approved by the FDA in November 2015 for use in hemophilia A patients 12 years and older for on-demand treatment and control of bleeding and for prophylaxis to reduce the frequency of bleeding episodes.

Days after calling off a pivotal phase III trial comparing its triple-acting prostate cancer drug, galeterone, to Xtandi (enzalutamide, Medivation Inc.) because it was unlikely to meet its primary endpoint, Tokai Pharmaceuticals Inc., of Boston, said that it is reducing its workforce by about 60 percent, to a total of 10 full-time equivalent employees. The reduction, expected be largely complete by the end of the third quarter of 2016, is designed to reduce operating expenses while the company conducts a comprehensive evaluation of strategic options for galeterone and its pipeline. Tokai expects the reduction in force to result in approximately $4.2 million in reduced annualized operating expenses once the plan is fully implemented. The company also expects to incur a charge in the third quarter of 2016 of approximately $1.3 million related to the reduction, including severance, benefits and related costs. (See BioWorld Today, July 27, 2016.)

Vaccinex Inc., of Rochester, NY, gained FDA fast track status for VX15 as a potential treatment for Huntington's disease. The monoclonal antibody blocks the activity of semaphorin 4D (SEMA4D), a molecule that is believed to promote chronic inflammatory responses in the brain. Vaccinex initiated a phase II multi-center, randomized, double-blind, placebo-controlled trial of the MAb in subjects with late prodromal (pre-manifest) and early manifest Huntington's disease in June 2015. The company anticipates completing an interim analysis in the third quarter of 2016 and top-line data in 2018.

Vical Inc., of San Diego, announced an agreement by its long-time partner and existing shareholder Anges MG Inc., of Tokyo, to purchase about $7.8 million of Vical's common stock in a private placement. The shares are being sold at a price of $4.24 per share, the 90-day volume weighted average price of Vical's common stock and a premium compared to the closing price on July 29. With the new investment, Anges' equity position in Vical will increase from 2.4 percent to about 18.6 percent of Vical's outstanding shares. The private placement is expected to close on or about August 2. The shares will be subject to a two-year lock up period in which they may not be sold. Anges also agreed to refrain from taking specific actions with respect to Vical's stock, including not increasing its ownership position beyond 19.9 percent.