Anthera Pharmaceuticals Inc., of Hayward, Calif. has purchased Sollpura, an experimental pancreatic enzyme replacement therapy, from Indianapolis-based Eli Lilly and Co. The drug will be sublicensed to Anthera subsidiary Alkira Therapeutics Inc., which plans to develop it to treat patients with low digestive enzyme levels, or exocrine pancreatic insufficiency due to cystic fibrosis. The drug will be tested in a phase III pivotal trial in the U.S. and Europe in 2015. It is intended that Alkira will make all future contingent milestone payments under the license agreement upon product approval and on certain annual sales achievements and will make royalty payments on any product sales after achieving certain sales thresholds of cumulative net sales of Sollpura.
Antiop Inc., of Lexington, Ky., said its intranasal naloxone spray, designed to treat opioid overdoses, received fast track designation from the FDA. The company recently received continuing support from the NIH and its National Institute on Drug Abuse, which approved grant funding of $1 million annually for three years to advance development of the naloxone spray. In addition, the Kentucky Economic Development Cabinet provided Antiop with development funding.
Atheronova Inc., of Irvine, Calif., said it filed pre-investigational new drug documents with the FDA for using a patented bile acid in combination with a statin for the treatment of patients who fail to reach their LDL cholesterol targets with statin treatments alone. The company is seeking to develop the treatment using the 505(b)(2) pathway.
Atyr Pharma Inc., of San Diego, said a splice variant of a tRNA synthetase in association with a rare muscle disease has been published in the Journal of Biological Chemistry. The article demonstrated findings relative to physiocrine proteins, which include extracellular functions derived from the tRNA synthetase gene family. Those data further highlight the potential role of physiocrine splice variants in muscle physiology. The data are consistent with the discovered splice variant being a target of auto-antibodies in a rare muscle disease. Among their various homeostatic functions, some physiocrines act as extracellular signaling molecules to orchestrate immuno-homeostasis in response to stress and other physiological changes. Physiocrines comprise naturally occurring proteins derived from tRNA synthetases that play fundamental roles in the function of human physiology and restoring pathophysiological states to a healthier state. The company reported that it is currently focused on physiocrines that act as endogenous modulators of immune and regenerative systems.
Bial SA, of Porto, Portugal, and Moksha8, of Sao Paolo, Brazil, announced an exclusive license for the commercialization of eslicarbazepine acetate (Zebinix/ Exalief) in Brazil and Mexico for the treatment of epilepsy. The product, developed by Bial, is an adjunctive therapy for adults with partial-onset seizures, with or without secondary generalization (where the seizure spreads to both sides of the brain). It was approved by the European Commission in 2009 based on data showing that the drug reduces seizure frequency and improves health-related quality of life. Eslicarbazepine acetate received FDA approval in November 2013 and is sold in the U.S. under the trade name Aptiom.
Cel-Sci Corp., of Vienna, Va. has been awarded a $225,000 phase I Small Business Innovation Research grant by the National Institute of Arthritis Muscoskeletal and Skin Diseases. The grant will fund the further development of Cel-Sci's LEAPS technology as a potential treatment for rheumatoid arthritis.
Cellact Pharma GmbH, of Dortmund, Germany, said the EMA's Committee for Orphan Medicinal Products granted orphan drug designation to the company's CAP7.1, an adapted version of cancer agent etoposide, for the treatment of biliary tract cancers.
Cloud Pharmaceuticals Inc., of Research Triangle Park, N.C., said it was granted supercomputing time at Argonne National Laboratory to design inhibitors of multiple parasitic targets. Through a discretionary allocation of 1 million core-hours at the Argonne Leadership Computing Facility, Cloud researchers will use Mira, a 10-petaflops IBM Blue Gene/Q supercomputer, to investigate inhibitors of the dihydrofolate reductase enzyme, or DHFR, from multiple sources. The purpose is to identify leading drug candidates for broad-impact, antiparasitic therapeutics targeting several orphan diseases, including malaria.
Epirus Biopharmaceuticals Inc., of Boston, said it completed its merger with Zalicus Inc., of Cambridge, Mass. The combined company, renamed Epirus Biopharmaceuticals, will focus on the business of Epirus, which develops and commercializes biosimilar monoclonal antibodies, and will operate under Epirus' management team, with Amit Munshi serving as president and CEO. Beginning Wednesday, the company's shares will trade on Nasdaq under the symbol EPRS. The company also disclosed a reverse stock split, in which, following the merger, every 10 shares of stock will be combined and reclassified into one share. (See BioWorld Today, April 17, 2014.)
Genentech Inc., of South San Francisco, a member of the Roche Group, said the FDA has accepted its supplemental biologics license application (sBLA) and granted priority review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
Iroko Pharmaceuticals LLC, of Philadelphia, said its affiliate, Iroko Pharmaceuticals Inc., has signed a licensing agreement with EMS SA, of Sao Paolo, Brazil, one of Brazil's biggest domestic pharma companies, for exclusive rights to market and sell pain reliever Zorvolex (diclofenac) capsules in Brazil. EMS will be responsible for obtaining regulatory and pricing approval, as well as the marketing and supply of the medication, in that territory. Financial terms were not disclosed.
La Jolla Pharmaceutical Co., of San Diego, saw its shares (NASDAQ:LJPC) rise 11.4 percent Tuesday to close at $12.09, as the company announced positive preclinical data for LJPC-1010 in non-alcoholic steatohepatitis (NASH). In a study of liver fibrosis in a model of NASH, LJPC-1010 showed a significant reduction (p < 0.001) vs. the control vehicle in nonalcoholic fatty liver disease (NAFLD) activity score. The drug also had a significant impact on all three measures used to derive the NAFLD score: steatosis, lobular inflammation and hepatocyte ballooning.
Merrion Pharmaceuticals plc, of Dublin, and the Lisbon, Spain-based contract manufacturer Hovione agreed to allow Hovione clients to use Merrion's patented GIPET absorption enhancing technology for converting injection-only medicines into tablets or capsules. The companies said they already have established a cooperative relationship on technical issues relating to technology and that the agreement provides for a framework for collaboration on the feasibility assessment of GIPET with development compounds introduced by third parties.
Regenerx Biopharmaceuticals Inc., of Rockville, Md., said a paper published in Heart Circulation Physiology showed that thymosin beta 4 (TB4) is able to reduce the incidence of cardiac rupture post myocardial infarction (MI) and markedly improved cardiac function at five weeks after MI. Data also demonstrated that cardiac protective effects of TB4 after MI were associated with a significant reduction of excessive inflammatory response and cardiomyocyte apoptosis as well as with an enhancement of angiogenesis. The study treated animals with TB4 daily at a relatively low dose for seven days using a minipump implant.
Sernova Corp., of London, Ontario, said it agreed on key terms with the University Health Network of Toronto to gain access to worldwide, exclusive rights to certain patent-pending technologies for the advancement of insulin-producing stem cells for the treatment of patients with insulin-dependent diabetes. A product development program is also being designed to advance the technologies from preclinical proof-of-concept studies through to human testing on an expedited basis. The company said it believes the proprietary product – insulin producing stem cells, protected locally from immune system attack and placed within its prevascularized Cell Pouch – has the potential to provide a significant breakthrough in the quality of treatment of insulin-dependent diabetes, following successful preclinical and clinical testing.