Akers Biosciences Inc., of Thorofare, N.J., said it inked distribution agreements to market its test for heparin-induced thrombocytopenia (HIT) in India, Germany, Italy and Scandinavia. The HIT test is based on Akers' PIFA technology and is available in 30 countries. Akers has developed the only U.S.- and EU-cleared rapid test to detect a potentially fatal allergy to heparin, a widely used blood thinner.
Cardiome Pharma Corp., of Vancouver, British Columbia, inked an agreement with Mitsubishi Tanabe Pharma Europe Ltd., a subsidiary of Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, to co-promote Cardiome's Aggrastat (tirofiban HCL) and Mitsubishi Tanabe's Exembol (argatroban monohydrate) in the UK for an initial three-year term. Financial terms were not disclosed.
Cipher Pharmaceuticals Inc., of Mississauga, Ontario, said it has, along with its partners, Ranbaxy Pharmaceuticals Inc., part of Sun Pharmaceuticals Industries Ltd., of Mumbai, India, and Galephar Pharmaceutical Research Inc., have entered a settlement agreement with Actavis Laboratories F1 Inc., Andrx Corp., Actavis Inc. and Actavis Pharma Inc., all part of Allergan plc, of Dublin, which dismisses the patent litigation suit relating to Actavis' abbreviated new drug application (ANDA) for a generic version of Absorica (isotretinoin capsules). As part of the agreement, Cipher, Ranbaxy and Galephar have entered a non-exclusive license agreement with Actavis under which it may begin selling its generic version of Absorica in the U.S. on Dec. 27, 2020 (approximately nine months prior to the expiration of the patents in September 2021) or earlier under certain circumstances.
Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, said it met with the FDA's Division for Dermatology and Dental Products (DDDP) and representatives of the Center of Drug Evaluation and Research (CDER) to discuss the U.S. regulatory review of Scenesse (afamelanotide 16 mg) to be made available to U.S. erythropoietic protoporphyria (EPP) patients. In 2014 the product was granted marketing authorization by the European Medicines Agency as a prophylactic photoprotective drug for adult EPP patients. The DDDP stated that it was seeking a regulatory pathway to make Scenesse available in the U.S., and the regulatory avenue of accelerated approval was suggested, pending the FDA's review, analyses and further discussions on available photoprovocation and data on quality of life in EPP patients. Further discussions will be held with the DDDP following the review of photoprovocation and quality-of-life data.
Dana-Farber Cancer Institute, of Boston, petitioned a federal court to determine that one of its scientists and another researcher are co-inventors on a series of cancer immunotherapy patents previously issued to a Japanese researcher and Japanese drug company. The institute filed suit on Sept. 25 asking the U.S. District Court in Boston to correct the list of inventors on five patents issued as recently as July 2015 to Ono Pharmaceutical Co. Ltd., of Osaka, and Tasuku Honjo, of Kyoto University. The Japanese parties licensed their rights in the patents exclusively to Bristol Myers Squibb Co., of New York, which markets Opdivo (nivolumab), which is approved in the U.S. to treat melanoma and lung cancer.
Hedgepath Pharmaceuticals Inc., of Tampa, Fla., announced that it has entered into a sublicense with its commercial partner and licensor Mayne Pharma Ltd., of Melbourne, Australia, for exclusive rights in the U.S. to two additional patents regarding the use of itraconazole for treatment of cancer, namely U.S. patent No 8,980,930, titled "Angiogenesis Inhibitors," issued on March 17, and U.S. patent No 8,653,083, titled "Hedgehog pathway antagonists to treat disease," issued on Feb. 18, 2014.
Invion Ltd., of Brisbane, Australia, said it will pursue further development of its respiratory drug INV102 (nadolol) following the successful conclusion of a phase II trial in patients trying to quit smoking. Summary data from the randomized, double-blind, placebo-controlled study shows smokers administered INV102 were more likely to stop smoking completely, or dramatically reduce the number of cigarettes smoked. INV102 also reduced key biomarkers MUC5AC and ERK1 in collected sputum samples, supporting Invion's hypothesis that INV102 has a novel mechanism of action directly targeting epithelial cells lining the airway, the firm said.
Novogen Ltd., of Sydney, said it will apply to list long-term options, offered in conjunction with its previous rights entitlement, on the Australian Stock Exchange, allowing options holders to trade the securities on the ASX.
Researchers from the Japanese Osaka University have reported that the immune suppressants cyclosporine A and FK506 reversibly blocked fertility in male mice, suggesting that they might form the basis for male contraceptives. Both drugs work by inhibiting calcineurin, a phosphatase that is important in mediating the consequences of calcium signaling. Calcineurin that is expressed in the testes contains both a regulatory and a catalytic subunit specific to testicular calcineurin, and the authors demonstrated that knockout mice lacking either subunit were infertile. Such mice still produced sperm, but the sperm were not transported into the vas deferens, leading to infertility. Infertility began a few days after treatment, and ended a few days after treatment was discontinued. The authors concluded that "specific inhibition of sperm calcineurin or its interaction with substrates may lead to the development of reversible and rapidly acting male contraceptives that target spermatozoa in the epididymis but leave testicular function intact." Their work appeared in the Oct. 1, 2015, advance online issue of Science.
Paranta Biosciences Ltd., of Melbourne, Australia, has successfully closed an A$7 million (US$4.9 million) financing round that will be used to progress the company's two major commercial opportunities, which seek to harness the therapeutic properties of follistatin, a naturally occurring glycoprotein, which is a critical regulator of multiple cellular, inflammatory and fibrotic pathways within the body. PB01, a form of recombinant human follistatin, will be developed for treating inflammatory and fibrotic lung diseases with the company targeting cystic fibrosis as its lead indication. Enrollment of healthy male volunteers has begun in the first phase I clinical study of inhaled PB01. Paranta's second program is focused on the development of intravenously administered PB01 as a chemotherapy-sensitizing agent for use in the treatment of cancer.
Leukemia patients who receive an allogeneic stem cell transplant have to both fear and hope that that transplant will show some reaction against their own cells. Such an attack causes graft-vs.-host disease (GVHD) and is a leading cause of transplant failure. But it also attacks residual leukemic cells, and such a graft-vs.-leukemia reaction is an important contributor to long-term success of such transplants. So far, those two effects have proven impossible to separate. Now, researchers from the Australian QIMR Berghofer Institute for Medical Research have identified a set of killer T cells that participated in GVHD but not graft-vs.-leukemia responses. The authors showed that such cells, which were highly inflammatory but had only weak ability to kill cells, were induced by IL-6. The work opens the door to approaches to prevent such cells from developing after a bone marrow transplant, lowering the risk of GVHD without raising the risk of relapse. The work appeared in the Sept. 24, 2015, online issue of Blood.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., inked a collaboration providing Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, exclusive development and commercial rights to fasinumab (REGN475) in Japan, Korea and nine other Asian countries, excluding China, in return for up to $55 million in up front and other near-term payments. Regeneron also is entitled to receive up to $170 million in R&D reimbursement payments and development milestones. Upon commercialization, Regeneron will supply the product at a range of purchase prices, depending on net sales, as a mechanism to share in potential profits. Regeneron also is eligible for one-time purchase price adjustment payments totaling up to $100 million upon achieving undisclosed sales targets. Fasinumab is in development to treat musculoskeletal pain.
Sarepta Therapeutics Inc., of Cambridge, Mass., established a four-year collaborative research agreement to create the Sarepta Translational Laboratory with Murdoch University, of Perth, Australia. The lab, led by Murdoch University professors Steve Wilton and Sue Fletcher, will explore the applicability of the company's phosphorodiamidate morpholino oligomer technology for disease targets beyond Duchenne muscular dystrophy, such as cystic fibrosis and spinal muscular atrophy. The agreement provides the university researchers with access to Sarepta's PMO platform technology, as well as additional funding for researchers and materials. The initial project for the collaboration is anticipated to target multiple sclerosis. As part of the agreement, Sarepta will have exclusive rights to license technology and/or products resulting from the research projects.