BioLineRx Ltd., of Jerusalem, and Compugen Ltd., of Tel Aviv, Israel, are collaborating to develop mutually selected Compugen-discovered drug candidates to treat various diseases. Compugen is providing the drug candidates, which are primarily peptides, while BioLineRx will develop them through Phase II. The goal is then to license promising candidates to other pharmaceutical companies for advanced clinical development and commercialization. The collaboration started with three peptides, all of which have undergone proof-of-concept animal studies. Two are being developed, as BL-7070, to prevent and treat cardiovascular diseases by controlling inflammation and reducing hypertension. The third, BL-8010, is intended to treat diseases characterized by excessive growth of new blood vessels, such as retinopathy and cancer.
Biotie Therapies Corp., of Turku, Finland, signed a Collaborative Research and Development Agreement with the National Institute on Drug Abuse for a government-funded, randomized, double-blind, placebo-controlled trial of nepicastat (SYN117) in the treatment of cocaine dependence. Nepicastat is an oral inhibitor of dopamine ß-hydroxylase.
Cellceutix Corp., of Beverly, Mass., reported the FDA has reviewed the investigational new drug application for Kevetrin, the company's anticancer compound, and advised that the batch formulation needs to be redone since Formatech, the company that produced the filled vials, has ceased operations after filing for bankruptcy. Cellceutix has identified an alternative formulation site with production planned for January. Meanwhile, the company has initiated a study of Kevetrin's antitumor activity related to risk factor aging in collaboration with the Pioneer Valley Life Sciences Institute, a Baystate Medical Center/University of Massachusetts Amherst Research Partnership.
EnVivo Pharmaceuticals Inc., of Watertown, Mass., said the journal Neuropharmacology published data confirming the mechanism of action of its lead program EVP-6124 and demonstrating that the compound is a potent and highly selective agonist of alpha-7 neuronal nicotinic acetylcholine receptors in the brain. Treatment with EVP-6124, both alone and in combination with donepezil, restored memory loss and improved memory function in preclinical models, supporting the clinical development strategy for EVP-6124 in restoring and improving cognitive function in schizophrenia and Alzheimer's disease. The company expects to report data from a multicenter, multinational, double-blind, placebo-controlled Phase IIb study of EVP-6124 in Alzheimer's in the first half of next year.
Intarcia Therapeutics Inc., of Hayward, Calif., and Quintiles Transnational Corp., of Research Triangle Park, N.C., signed definitive agreements making Quintiles a financial and strategic partner for the global clinical development of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide). In October, the companies signed a letter of intent to collaborate on the Phase III program for ITCA 650, which could become the first once-yearly injection-free GLP-1 therapy for Type II diabetes. Patient enrollment is expected to begin in the first quarter of 2012. Quintiles will support accelerated development of ITCA 650 by providing equity, product and operational investments. Intarcia is negotiating to select a global pharmaceutical partner to contribute funding for the compound's clinical development and commercialization.
Numoda Capital Innovations, an investment arm of Philadelphia-based Numoda Corp., will become an investor in regenerative medicine specialist IntelliCell BioSciences Inc., of New York. Specific terms were not disclosed.
Liquidia Technologies Inc., of Research Triangle Park, N.C., entered an agreement with PATH, a global nonprofit organization, to conduct preclinical proof-of-concept studies on a next-generation pneumococcal vaccine. The goal is to produce a vaccine that could allow for broadened efficacy and manufacturing efficiencies and result in greater access across the world.
The Department of Health and Human Services (HHS) reported that the first U.S. facility to use a faster, more flexible technology to make influenza vaccine was dedicated Monday as part of an initiative to provide vaccine supplies sooner in an influenza pandemic. Developed through a 25-year HHS partnership with Novartis Vaccines and Diagnostics Inc., of Cambridge, Mass., the plant in Holly Springs, N.C., can create vaccine using cultured animal cells instead of the conventional process of using fertilized eggs. It has the potential to produce 25 percent of the vaccine needed in the U.S. in the event of a pandemic.
Nuron Biotech Inc., of Exton, Pa., exercised its option to license the TheraPEG conjugation technology developed by PolyTherics Ltd., of London, with the goal of developing and commercializing a long-acting human interferon beta-1b (NU400). PolyTherics will receive an undisclosed option fee from Nuron and is eligible for further milestone payments and royalties as NU400 progresses through development. Additional terms were not disclosed.
Pharmalink AB, of Stockholm, Sweden, inked an exclusive global license to the TARGIT drug delivery technology developed by Archimedes Pharma Ltd., of Reading, UK, for its lead program, Nefecon, in the treatment of the kidney disease IgA nephropathy. Pharmalink also acquired certain specialized equipment and technologies needed to manufacture TARGIT capsules for Nefecon for its ongoing clinical development program. Pharmalink made an undisclosed up-front payment for the license and other assets and will pay Archimedes a royalty on sales of Nefecon, an enteric formulation of a locally acting corticosteroid that down-regulates the inflammatory process in the kidneys by suppressing the gut immune system. Additional terms were not disclosed. Pharmalink now assumes full control and responsibility for the program's development, with Archimedes retaining rights to TARGIT outside the Nefecon areas.
Profectus BioSciences Inc., of Baltimore, a developer of vaccines against infectious diseases and cancers, received a $5.4 million grant under the Partnerships for Biodefense RFA by the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases. The funds will used to support preclinical development of m102.4, an antibody intended as a postexposure prophylactic against Nipah or Hendra virus infection.
Receptos Inc., of San Diego, is collaborating with Ono Pharmaceutical Co. Ltd., of Osaka, Japan, on the R&D of small-molecule modulators of an undisclosed G-protein coupled receptor target. Receptos will use its technology platform to produce high resolution protein crystal structures of the discovery target and drive Ono's structure-based drug design efforts. Ono will pay Receptos an up-front payment, research funding and success payments, including product development milestones. Financial details were not disclosed.
The SEC charged Stiefel Laboratories Inc., a subsidiary of GlaxoSmithKline plc (GSK), of London, and Charles Steifel, its former chairman and CEO, with defrauding employees and other shareholders by buying back their stock at severely undervalued prices. The SEC alleges that Stiefel Laboratories, prior to being bought by GSK two years ago, used low valuations for stock buybacks from November 2006 to April 2009, omitting information that would have alerted employees that their stock was actually worth as much as 300 percent more. Consequently, employee shareholders lost more than $110 million by selling their stock in the privately held Coral Gables, Fla., company based on the misleading valuations, the SEC said.
Synergy Pharmaceuticals Inc., of New York, filed a lawsuit in New York State Supreme Court against Ironwood Pharmaceuticals Inc., of Cambridge, Mass., and Mark G. Currie, its chief scientific officer and senior vice president of research and development. The suit alleges that after European patent 1,379,224 was granted to Synergy, but before it was issued, Ironwood and Currie opposed the patent before the European Patent Office and presented false, contradictory, inaccurate and misleading data and arguments both to the European Patent Office and the U.S. Patent and Trademark Office. The complaint accuses Ironwood and Currie of unfair competition, fraud and unjust enrichment and seeks $500 million in actual and punitive damages.
Tengion Inc., of East Norriton, Pa., presented data from its Neo-Urinary Conduit (NUC) and Neo-Kidney Augment (NKA) programs at the TERMIS North America Annual Conference in Houston. The presentations included cellular and molecular studies demonstrating the genetic stability of the autologous smooth muscle cells used in the NUC and experimental data showing the suitability of using adipose-derived smooth muscle cells from bladder cancer patients who had previously undergone cancer treatment. The company also presented an analysis demonstrating that NKA had broad regenerative outcomes in multiple kidney tissue compartments.
Valeant Pharmaceuticals International Inc., of Mississauga, Ontario, said the Federal Trade Commission (FTC) has approved its acquisition of Dermik, a Sanofi SA dermatology unit, and the U.S. assets of Ortho Dermatologics, a division of Janssen Pharmaceuticals Inc. Under the FTC consent order, Valeant is required to dissolve its collaboration on Refissa and a generic tretinoin emollient cream and return the assets to Spear Pharmaceuticals, Fort Myers, Fla. It also is divesting its generic versions of Benzaclin and Efudex. Valeant expected to complete its $345 million acquisition of Ortho Dermatologics shortly and will complete the $425 million Dermik deal by the end of the year.
Vanda Pharmaceuticals Inc., of Rockville, Md., signed an exclusive license agreement with Megapharm Ltd., of Raanana, Israel, for the commercialization of Fanapt (iloperidone) in Israel. The atypical antipsychotic is approved for schizophrenia in adults. (See BioWorld Today, May 8, 2009.)