Almirall SA, of Barcelona, Spain, said it finalized its product acquisition from Dublin-based Allergan plc's medical dermatology unit in the U.S., which includes Aczone (dapsone), Tazorac (tazarotene), Azelex (azelaic acid) and Cordran tape (flurandrenolide). In addition, sarecycline, a new chemical entity under FDA review for approval in the treatment of acne is part of the transaction. Almirall paid $550 million in cash, with the agreement contemplating a possible earn-out, up to $100 million and payable in the first quarter of 2022, depending on business performance.

Altimmune Inc., of Gaithersburg, Md., said the Biomedical Advanced Research and Development Authority is adding $2.5 million to the company's existing $21.6 million base contract and extending the performance period through November 2019. The increase, for its Nasoshield program, is intended to allow vaccine characterization, including key formulation parameters and batch consistency. In addition, Altimmune will assay clinical samples from its ongoing phase I trial for a mucosal immune response and will compare different methods of intranasal administration of the vaccine in preclinical models.

Biorestorative Therapies Inc., of Melville, N.Y., said it entered a one-year material transfer agreement with the University of Pennsylvania providing access to its brown adipose tissue (brown fat) fat cells. The university's contemplated research proposes studying both primary adipose tissue and adipocyte cells differentiated in culture. It will focus on measuring specific RNAs, proteins, gene regulatory elements and metabolites of interest, and also unbiased profiling by methods including RNA-seq, ChIP-seq and ATAC-seq (to assess gene expression, transcription factor genomic occupancy and accessible chromatin, respectively).

Cellectar Biosciences Inc., of Madison, Wis., said the FDA has initiated talks concerning a possible exemption for CLR-131, a small-molecule targeted phospholipid drug conjugate (PDC) designed to deliver cytotoxic radiation directly and selectively to cancer cells, from the import alert placed on the Centre for Probe Development and Commercialization (CPDC), the sole supplier of its CLR-131 drug. Since notification of the alert, Cellectar has been actively assisting CPDC to secure its timely removal and allow CPDC to resume supply.

Cerveau Technologies Inc., of Boston, announced a research collaboration agreement with Ionis Pharmaceuticals Inc., of Carlsbad, Calif., for the use of [F-18] MK-6240, an investigational imaging agent, to be used in positron emission tomography scans for assessing the status and progression of neurofibrillary tangles (NFTs) in the brain. NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimer's disease, the company noted. The collaboration is focused on using the product as a biomarker in Ionis' neurodegenerative disease research studies.

Endo International plc, of Dublin, agreed to an additional stay of its litigation against the FDA until Dec. 31, 2018. The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by the company's subsidiaries, Par Sterile Products LLC and Endo Par Innovation Co. LLC, seeks a declaration that the FDA's "interim policy" on compounding using bulk drug substances under section 503B of the Drug Quality and Security Act of 2013 (DQSA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to law because it authorizes bulk compounding of new drugs where the applicable DQSA requirements are not satisfied and because it is fundamentally inconsistent with the plain language and structure of the FDCA statutory regime for introducing new drugs. The litigation also seeks the immediate removal of vasopressin from the FDA's category 1 nominations list to assure that outsourcing facilities do not engage in bulk compounding of vasopressin-containing drug products under section 503B. Shortly after Endo commenced the litigation, the FDA took initial steps to comply with the DQSA and Endo agreed to the FDA's prior stay requests in January 2018 and April 2018.

Enesi Pharma Ltd., of Oxford, U.K., entered a cooperative research and development agreement with the Walter Reed Army Institute of Research, a U.S. Department of Defense laboratory, regarding Shigella vaccine development. The pact is focused on the development of a robust and stable solid-dose formulation of Reed's Shigella flexneri 2a artificial Invaplex (Sfl2a InvaplexAR) vaccine for delivery via Enesi's Implavax technology. A vaccine able to protect against Shigella is a high-priority objective for the U.S. Army and is an equally high-priority for vaccine developers targeting pediatric populations in endemic areas of the world, Enesi said.

Gilead Sciences Inc., of Foster City, Calif., disclosed plans to launch authorized generic versions of Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) and Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Gilead's leading treatments for chronic hepatitis C virus (HCV), in the U.S. through a newly created subsidiary, Asegua Therapeutics LLC. The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019. Since the launch of Gilead's first HCV medication in 2013, the average price paid for each bottle of medicine in the U.S. has decreased by more than 60 percent off of the public list prices, across health insurers and government payers, the company said, but due to the complexity and structure of the health care system, discounts provided by Gilead may not always translate into lower costs for patients. Also existing contracts, together with laws associated with government pricing policies, make it challenging to quickly lower a product's list price once it is on the market, Gilead noted.

Immutep Ltd., of Sydney, signed a clinical trial collaboration and supply agreement with Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, to evaluate in a phase I trial the combination of Immutep's lead immunotherapy product candidate, eftilagimod alpha (IMP-321), with Bavencio (avelumab), a human anti-PD-L1 antibody, in patients with advanced solid malignancies. Terms were not disclosed. Avelumab received accelerated approval by the FDA for the treatment of patients with metastatic Merkel cell carcinoma and previously treated patients with locally advanced or metastatic urothelial carcinoma, and is under further clinical evaluation across a range of tumor types under a global alliance between Merck and Pfizer.

Lumos Pharma Inc., of Austin, Texas, acquired the license for LUM-201, an investigational orally administered small molecule that promotes secretion of growth hormone from the pituitary gland, from Ammonett Pharma LLC, of Midlothian, Va. Lumos plans to start a phase IIb trial in 2019 in patients with pediatric growth hormone deficiency to compare multiple doses of LUM-201 to daily injections of recombinant human growth hormone, which is the current standard of care. Terms were not disclosed.

Mebias Discovery LLC, of Philadelphia, secured grant funding from the National Institute of Drug Abuse to advance a mu-opioid receptor candidate through preclinical pharmacological and pharmaceutical profiling. Preclinical studies of the company's lead molecules have shown absence of respiratory depression, rewarding behavior, sedation and constipation associated with traditional opioids, it said. Mebias did not disclose the value of the grant.

Mediwound Ltd., of Yavne, Israel, said the Biomedical Advanced Research and Development Authority awarded the company a new contract to develop Nexobrid for the treatment of sulfur mustard injuries during mass casualty events. The contract provides about $12 million of funding to support R&D activities up to pivotal studies in animals under the FDA's Animal Rule. It also contains options for additional funding of up to $31 million for additional development activities, animal pivotal studies and biologics license application submission.

Mithra Pharmaceutical SA, of Liège, Belgium, finalized an exclusive license and supply agreement with Hyundai Pharm Co. Ltd., of South Korea, for the commercialization of its oral contraceptive, Estelle (estetrol E4 plus drospirenone), in South Korea. Under the terms of the 20-year contract, Mithra will be eligible for up-front and milestone payments, minimal annual quantities and sales-related royalties. Mithra will produce Estelle for the South Korean market at its contract manufacturing organization in Belgium.

Noxopharm Pty Ltd., of Sydney, said that, together with its majority-owned subsidiary, Nyrada Inc., it has discovered a way to inhibit IRAK4, "a protein widely regarded as the 'master switch' in the development of many forms of chronic inflammation, including autoimmune diseases." Preclinical programs now are being undertaken to identify the most appropriate therapeutic indications, with human studies likely in 2020, the company said.

Replicel Life Sciences Inc., of Vancouver, British Columbia, and Ningbo, China-based Yofoto Health Industry Co. Ltd. have received Canadian and Chinese clearances needed to close Yofoto's C$5.1 million (US$3.9 million) purchase of Replicel common shares (TSXV:RP) and warrants. Yofoto will collaborate with Replicel on the further development and commercialization of the tendon regeneration cell therapy RCT-01, the skin rejuvenation cell therapy RCS-01 and an injection technology for dermal applications, RCI-02, excluding hair-related treatments, in greater China.

Seattle Genetics Inc., of Bothell, Wash., received a $10 million milestone payment from Osaka, Japan-based Takeda Pharmaceutical Co. Ltd., triggered by Japanese Ministry of Health, Labour and Welfare approval for the use of Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine as first-line treatment for CD30-positive Hodgkin lymphoma patients.

Transgene SA, of Strasbourg, France, said it plans to enter clinical development next year with myvac, an individualized, viral vector-based immunotherapy targeting cancer. Myvac is designed to stimulate and educate the immune system of patients to recognize and destroy tumor cells.