Almirall SA, of Barcelona, and Bicosome Co., also of Barcelona, entered a research, collaboration and sublicense agreement for the development of multiple topical dermatological products, based on Bicosome's delivery technology platform, Bicosome Technology. Bicosome will be responsible for the research activities to deliver preclinical product prototypes using its encapsulating system, and Almirall will perform the clinical development, regulatory filings, manufacturing and commercialization activities of the developed products. Under the collaboration agreement, Bicosome granted Almirall a sublicense to develop and commercialize products in certain dermatological indications. In return, Bicosome will receive research payments of undisclosed value and is entitled to potential development milestone payments as well as tiered royalties on future net sales and sales milestones.
Alvotech Biopharmaceuticals Co., of Reykjavik, Iceland, said it is acquiring Jülich, Germany-based Baliopharm GmbH, previously a subsidiary of Baliopharm AG, to provide complementary capabilities in the area of biosimilar development. Baliopharm will be fully integrated into Alvotech, it said, and will be rebranded as Alvotech Germany in the near future. Financial terms were not disclosed.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported that its negotiations with the Economic Committee on Health Care Products in France regarding pricing and reimbursement for Iclusig (ponatinib) have now concluded. As a result, Ariad will record net product revenue related to cumulative shipments in France of about $25 million in the second quarter of 2016. Iclusig has been available to patients in France since late 2012 through a pre-licensed sales mechanism called an ATU, or temporary authorization of use.
Bind Therapeutics Inc., of Cambridge, Mass., reached an agreement with its secured lender, Hercules Technology III LP, an affiliate of Hercules Capital, for the use of cash collateral through July 8, subject to certain terms and conditions. As part of the agreement, negotiated under Bind's chapter 11 bankruptcy filing, the company agreed to pay down $4 million in principal on an existing principal loan balance of about $12.4 million. (See BioWorld Today, May 3, 2016.)
Biolight Life Sciences Ltd., of Tel Aviv, Israel, has obtained the worldwide rights (excluding Israel and Italy) for the manufacturing, distribution, marketing and sales of a new eye drop product for the treatment of dry eye syndrome and other ophthalmic indications. The product, not named in a statement about the deal, was in-licensed by Biolight from Israeli firm Fischer Pharmaceuticals Ltd. and Ramot, the technology transfer arm of Tel Aviv University. The product has CE Mark marketing approval in Europe, and Biolight is currently evaluating the clinical and regulatory efforts required to commercialize it in other territories. Terms of the deal were not disclosed.
Caldan Therapeutics Ltd., of Glasgow, U.K., said it inked an exclusive collaboration with Sygnature Discovery, of Nottingham, U.K., which will provide integrated drug discovery support to Caldan's research projects in the metabolic disease area. Caldan is aiming for first-in-class preclinical candidates to address type 2 diabetes. Terms of the deal were not disclosed.
Celator Pharmaceuticals Inc., of Ewing, N.J., gained FDA breakthrough status for Vyxeos (CPX-351). its investigational candidate in development as a treatment for AML and other blood cancers. The designation is based on the positive results from the pivotal phase III trial in older patients with previously untreated high-risk AML. The designation for the treatment of adults with therapy-related AML, or AML with myelodysplasia-related changes.
Chugai Pharmaceutical Co. Ltd., of Tokyo, and the Osaka University Immunology Frontier Research Center (IFReC) established a comprehensive collaboration for advanced research in immunology. Chugai will provide ¥1 billion (US$9.1 million) per year for a period of 10 years in return for access to information on results relating to independent basic research projects at IFReC and the right of first refusal for joint research.
Decode Genetics, of Reykjavik, Iceland, a wholly owned subsidiary of Amgen Inc., reported the discovery of a rare variation in the sequence of the human genome that confers on carriers a substantial reduction in levels of non-HDL cholesterol, the best measure of the type of cholesterol that causes the build-up of plaques in the arteries that are at the root of most heart disease. However, the company said, the most remarkable quality of that variation is that it confers greater protection against coronary heart disease than can easily be accounted for by the reduction in cholesterol alone. The variant – a 12-letter deletion in the ASGR1 gene on chromosome 17 – was discovered through the analysis of whole genome and clinical data from across the population of Iceland and was linked to a roughly 35 percent reduction in the risk of coronary artery disease and heart attack. Its effect was then replicated in data from some 300,000 people in the Netherlands, Denmark, Germany, New Zealand, the U.K. and the U.S. The finding provides robust evidence that developing drugs to inhibit the ASGR1 protein may offer a promising new means for lowering non-HDL cholesterol and preventing heart disease. The study is published in the online edition of the New England Journal of Medicine.
Delmar Pharmaceuticals Inc., of Vancouver, British Columbia, disclosed a 1-for-4 reverse stock split in preparation for its planned uplisting to a senior stock exchange. The split, expected to be effective May 20, is intended to fulfill the minimum price requirement.
Dimension Therapeutics Inc., of Cambridge, Mass., said preclinical dose-escalating data in a mouse model of hemophilia B demonstrated dose-dependent expression of factor IX (FIX) levels and stability of FIX expression after single-dose administration of DTX101 across the majority of doses during the 90-day study period. DTX101 is designed to deliver FIX gene expression in adults with moderate to severe hemophilia B. Data from a study in hemophilia A mice and cynomolgus macaques showed that factor VIII (FVIII) expression levels, achieved during the 30-week course of the study with DTX201, supported advancement investigational new drug-enabling studies for the potential treatment of hemophilia A. DTX201 is designed to deliver FVIII gene expression.
Enterome Bioscience SA, of Paris, said it opened a new office in Cambridge, Mass., to support its operations and corporate development activities in the U.S. The company is developing pharmaceuticals and diagnostics to support personalized therapies in microbiome-related diseases such as inflammatory bowel disease, cancer and metabolic diseases.
Evoke Pharma Inc., of Solana Beach, Calif., said it signed an exclusive commercial supply agreement with manufacturer Cosma SpA for the active pharmaceutical ingredient (API) in product candidate EVK-001, a nasal spray for delivery of metoclopramide for the symptomatic relief of acute and recurrent diabetic gastroparesis in women. Cosma will provide the API that will enable the production of commercial-scale quantities of EVK-001 in accordance with FDA standards for chemistry, manufacturing and controls.
Horizon Pharma plc, of Dublin, entered an agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to acquire the rights to interferon gamma-1b, which Boehringer commercializes under the trade names Imukin, Imukine, Immukin and Immukine in about 30 countries, primarily in Europe and the Middle East. Under the terms, Horizon paid Boehringer €5 million (US$5.6 million) upon signing and will pay €20 million upon closing for the rights for interferon gamma-1b in all territories outside of the U.S., Canada and Japan. The firms expect to close the transaction by year-end. Under the terms of a separate agreement with an undisclosed third party, Horizon also licensed the U.S., European and Canadian intellectual property rights for interferon gamma-1b for the treatment of Friedreich's ataxia, though it is not indicated or approved for that indication.
Neurotrope Inc., of Newark, N.J., entered a research collaboration with the International Rett Syndrome Foundation to study the potential of bryostatin, which targets protein kinase C epsilon, for the treatment of Rett syndrome. The purpose is to run a behavioral battery of tests to screen and assess the potential for bryostatin for the therapeutic treatment of Rett syndrome in a mouse model. Assessments will include body weight, grip strength, gait analysis and neurologic/behavioral parameters. All raw data, samples and specimens arising from the performance of that study will remain the property of Neurotrope. The study will be funded and managed by the Rett group.
Pain Therapeutics Inc., of Austin, Texas, said an advisory panel of the FDA will review the Remoxy (extended-release oxycodone) new drug application, tentatively scheduled for Friday, Aug. 5. It is intended to be a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. The FDA said the PDUFA date for Remoxy is unchanged.
Pelican Therapeutics Inc., of Austin, Texas, said it won a $15.2 million New Company Product Development Award from the Cancer Prevention and Research Institute of Texas to support development of agonists directed at TNFRSF25, a recently discovered T-cell co-stimulator for immuno-oncology indications. TNFRSF25 antibodies have a distinct mechanism for preferential activation of the tumor cell-killing (CD8+) arm of the immune system. The award will allow Pelican to develop its lead agonist monoclonal antibody, PTX-25, through a first-in-human trial involving about 70 patients. An investigational new drug application filing is expected in 2017.
Regen Biopharma Inc., of San Diego, said it started preclinical development aimed at creating a cord blood-based cancer immunotherapeutic product using its NR2F6 immunological checkpoint. Regen said the product in development will be a universal donor cellular immunotherapy, which can be shipped frozen to the site of use and does not involve complex cellular manipulations by the treating institution.
Regent Pacific Group Ltd., of Hong Kong, said the EMA approved its type Ib variation for a reduced dose version of PSD502, a transdermal spray containing lidocaine and prilocaine for premature ejaculation. The variation includes the addition of Pharmaserve (North West) Ltd. as an EU-located manufacturer of the reduced-dose spray, triggering a €6 million (US$6.7 million) payment from Regent's commercial partner, Recordati SpA, of Milan, Italy, and brings the total payments to €11 million.
Selecta Biosciences Inc., of Watertown, Mass., said it obtained an exclusive license to Anc80, an in silico-designed gene therapy vector, from Massachusetts Eye and Ear for use in a rare disease. Selecta also gained options for other pre-defined indications in the areas of lysosomal storage disorders, genetic muscular diseases and genetic metabolic diseases. Selecta intends to develop Anc80 in combination with its SVP-Rapamycin (SEL-110) to increase the potential applicability of gene therapies.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said Health Canada approved Entyvio (vedolizumab) to treat adults with moderate to severely active Crohn's disease. Entyvio was first approved by Health Canada last year for the treatment of ulcerative colitis. It gained FDA approval for both indications in May 2014.
Tiziana Life Sciences plc, of London, said preclinical data published in Immunotherapy highlighted attributes of the firm's candidate, foralumab, that differentiate it from the other anti-CD3 monoclonal antibodies (MAbs) evaluated in the past. In particular, it was noted that foralumab is currently the only fully human anti-CD3 MAb in development, which should potentially translate into reduced side effects and improve the overall safety profile. Tiziana plans to initially evaluate the drug in two indications: graft-vs.-host disease and ulcerative colitis.