Allergan plc, of Dublin, said it submitted a prior approval supplement for Restasis (cyclosporine ophthalmic emulsion 0.05 percent) seeking approval of a multidose, preservative-free formulation. Restasis is approved for chronic dry eye.

Astellas Pharma Inc. is selling its global dermatology business to Ballerup, Denmark-based Leo Pharma A/S for €675 million (US$724.9 million). Under terms of the agreement, the assets and associated responsibilities relating to Astellas’ global portfolio of dermatology products, which include Protopic (tacrolimus), a treatment for eczema, and other products for the treatment of acne and skin infection will be transferred to Leo Pharma (except for Protopic in Japan, where distribution rights are assigned to Maruho Co. Ltd.).

Atyr Pharma Inc., of San Diego, said it selected an investigational new drug candidate based on an immuno-modulatory and fibro-modulating Physiocrine domain fused to an Fc region of a human antibody, iMod.Fc. The selected iMod.Fc molecule is intended to address patients with severe pulmonary diseases with an immune and fibrotic component. In preclinical studies, it showed promising results in a well-established rodent model of lung inflammation and pulmonary fibrosis, induced by a chemotherapeutic agent known as bleomycin, and, when given in two therapeutic doses, it was comparable to, or outperformed, approved drugs in reducing lung inflammation and fibrosis in the bleomycin model, Atyr said. The firm is initiating GMP process development with a third-party manufacturer.

Biode Ventures Ltd., of Vancouver, British Columbia, received a $500,000 clinical development milestone payment from Wayne, Pa.-based Cutanea Life Sciences Inc. pursuant to the terms of an existing license agreement between the companies that allows Cutanea to use and improve technologies relating to the diagnosis and treatment of including acne, psoriasis, rosacea and atopic dermatitis. Biode said it may also be entitled to additional payments, up to a maximum of $7 million over “a number of years,” in addition to potential commercial milestones and royalties.

Celator Pharmaceuticals Inc., of Ewing, N.J., said it was approved to sell $1.8 million of its net operating losses and unused R&D credits under the New Jersey Technology Business Tax Certificate Transfer Program for the year 2015, for which it expects to receive about $1.7 million in nondilutive financing. The company said that will further extend its cash runway into the second half of 2016 as it advances lead candidate Vyxeos, in phase III testing in acute myeloid leukemia, and its technology platform work with molecularly targeted agents.

Destiny Pharma Ltd., of Brighton, UK, said the FDA granted qualified infectious disease product (QIDP) designation to the firm’s lead candidate, XF-73 (exeporfinium chloride), a synthetic drug with antibacterial activity against a broad range of bacteria, including the multi-antibiotic-resistant strain, methicillin-Resistant Staphylococcus aureus. The QIDP designation is for the prevention of post-surgical Staphylococcal infections. XF-73 has been tested in four phase I/IIa studies in Europe and is being tested in a clinical trial in the U.S., sponsored and funded by the National Institute of Allergy and Infectious Diseases.

Eiger Biopharmaceuticals Inc., of Palo Alto, Calif., said it acquired an exclusive license to technology for targeting effects of leukotriene B4, or LTB4, to reverse structural tissue changes and improve lymphatic function, providing a potential therapeutic approach for treating lymphedema. The technology was invented by Stanley Rockson, professor of cardiovascular medicine at Stanford University and director of the Stanford Center for Lymphatic and Venous Disorders. Terms were not disclosed.

Epistem Holdings Plc, of Manchester, UK, has received funding from the U.S. Department of Defense to evaluate the effects of pegylated hematopoietic growth factors on the mitigation of the hematopoietic and gastrointestinal acute and delayed radiation syndromes. The pegylated growth factors will be provided by Bolder Biotechnology Inc. of Boulder, Colo. The project will last from 2015 to 2018 and will run from Indiana University’s facilities in Indianapolis and Epistem’s facilities in Manchester.

Five Prime Therapeutics Inc., of South San Francisco, said the FTC granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Acts of 1976 in connection with the exclusive worldwide license and collaboration agreement with New York-based Bristol-Myers Squibb Co. for the development and commercialization of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008. (See BioWorld Today, Oct. 16, 2015.)

Flex Pharma Inc., of Boston, has selected FLX-787 as its clinical candidate for studies outside the U.S. FLX-787 is a purified, GMP-synthesized single agent consisting of one highly selective and specific transient receptor potential ion channel agonist.

Galectin Therapeutics Inc., of Norcross, Ga., reported preclinical research at the Society for Immunotherapy of Cancer’s meeting in National Harbor, Md., showing that galectin-3 inhibitor GR-MD-02 boosted the frequency and persistence of antigen-specific T cells in nontumor-bearing mice. Additionally, GR-MD-02 in combination with anti-OX40, a monoclonal antibody in clinical development that activates the immune system, improved survival in mammary carcinoma models, and in a prostate cancer model. The combination also reduced lung metastases in the mammary carcinoma model.

Genkyotex SA, of Geneva, said GKT137831, its lead NOX1 and 4 inhibitor, was granted orphan drug designation by the FDA and EMA, based on preclinical data obtained in multiple models of fibrotic disorders, including scleroderma. Regulators concluded that GKT137831 may be of significant benefit for patients with systemic sclerosis as studies in experimental models showed the compound may reduce the abnormal growth of connective tissue and improve survival. GKT137831 recently completed a phase II trial, in which treatment produced a statistically significant reduction in both liver enzymes and inflammatory markers.

Horizon Pharma plc shares fell 17.6 percent to close at $18.50 on Wednesday as the company got caught up in the “captive pharmacy” debate, triggered by Express Scripts Holding Co.’s decision to remove from its network a pharmacy that primarily dispensed Horizon drugs. Horizon said that the Woodbury, N.Y.-based pharmacy, Linden Care, had been improperly characterized and called Express Scripts “reckless in its allegations.” In separate news, Dublin-based Horizon said it would collaborate with the Alliance for Lupus Research to study Rayos (prednisone) delayed-release tablets in systemic lupus erythematosus. The first study planned as part of the collaboration, called “Rayos Inhibits Fatigue in Lupus Erythematosus” (RIFLE), will investigate the effect of the drug on the fatigue commonly experienced by lupus patients. It will be an investigator-initiated, randomized, double-blind, active comparator, cross-over trial, with patients randomized to receive either prednisone for three months or Rayos at 10 p.m. for three months, and then switched to the alternative medication for an additional three months. The primary endpoint will assess fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue.

Morphotek Inc., of Exton, Pa., a subsidiary of Eisai Inc., said it entered a license agreement with Blaze Bioscience Inc. of Seattle, under which Morphotek will provide an exclusive, worldwide, royalty-bearing license to develop, license and commercialize a potential tumor-targeting chlorotoxin derivative linked to a near-infrared diagnostic agent, which may help visualize cancer cells during surgery. Blaze will use the licensed technology in its pipeline of Tumor Paint technology products. Under the terms, Morphotek received an undisclosed up-front payment from Blaze and is eligible to receive scheduled development and sales milestone payments, as well as royalties on future net sales of licensed products. Morphotek retains all rights to develop chlorotoxin derivative products not covered by the terms of the license agreement.

Novogen Ltd., of Sydney, said preclinical studies confirm the efficacy of the lead anti-tropomyosin compound, Anisina, when delivered using a clinically relevant formulation, mode of administration and dosing regimen. Data presented at the American Association for Cancer Research Advances in Pediatric Cancer Research meeting in Fort Lauderdale, Fla., demonstrated that in a preclinical animal model of neuroblastoma, intraperitoneally delivered Anisina, when used in combination with vincristine, resulted in a significant regression of tumor growth in about 60 percent of animals treated. That translated to a significant improvement in median survival, with one animal from that treatment group having no measurable tumor 100 days post treatment. Novogen is set to start clinical testing in 2016.

Opexa Therapeutics Inc., of The Woodlands, Texas, reported preclinical results showing that T-cell immunotherapy with attenuated antigen-specific T cells suppressed the T-cell response to Aquaporin-4 (AQP4) in a dose-dependent manner, compared to vehicle control, as measured by reduction in both Aquaporin-4 reactive T-cell (ARTC) proliferation and associated cytokine activity. The results were statistically significant. In neuromyelitis optimica (NMO), ARTCs mount an attack against Aquaporin-4, the autoantigen in NMO, leading to secondary demyelination of nerve fibers within the optic nerves and the spinal cord, resulting in the clinical symptoms of the disease. Opexa’s therapeutic approach is to suppress or reduce the number of these activated ARTC in patients with NMO.

Prometic Life Sciences Inc., of Laval, Quebec, said it entered a strategic agreement with Omnio AB, of Umea, Sweden, under which Prometic secured exclusive license rights to both issued and pending patents for the use of plasminogen related to wound healing. The agreement also provides Prometic access to extensive preclinical data as well as unique proof-of-concept efficacy data in patients. Specific financial terms were not disclosed. The agreement calls for the creation of a center of excellence in Umea, Sweden, and the firms entered a long-term research collaboration, to be funded by Prometic, aimed at further understanding plasminogen’s role in multiple medical conditions such as diabetic foot ulcers.

Replicor Inc., of New York, said preclinical data published in PLOS ONE demonstrate the therapeutic effect of nucleic acid polymers (NAPs) in hepatitis B virus (HBV) infection. The study, which assessed antiviral effects of 28 days of daily treatment with the company’s first NAP candidate, REP 2055, in Pekin ducks with previously established duck HBV infection (DHBV), showed that treatment reduced serum DHBV surface antigen (DHBsAg) to near or below undetectable levels within one week of treatment in all ducks and was associated with increased titers of antibodies to DHBsAg. That clearance of DHBsAg was shown to have a critical impact on the establishment of control of infection after treatment was halted: 55 percent (6/11) of treated ducks had no measurable DHBsAg and DHBV DNA in the blood by the end of treatment and for 16 weeks after treatment was halted.

Verona Pharma plc, of Cardiff, UK, said a paper published in the American Journal of Physiology - Lung Cellular and Molecular Physiology showed that its dual PDE3/4 inhibitor, RPL554, demonstrated cystic fibrosis transmembrane conductance regulator (CFTR)-stimulatory properties and that CFTR activation by RPL554 is mediated by its inhibition of PDE4 in cells from cystic fibrosis patients with the R117H/F508del mutation. RPL554-induced CFTR activity was further increased by CFTR potentiator Kalydeco (ivacaftor, VX770, Vertex Pharmaceuticals Inc.) suggesting additional potential benefit by the drug combination. RPL554 currently is in phase II testing as a nebulized treatment for acute exacerbations of chronic obstructive pulmonary disease in the hospital setting.

Wuxi Pharmatech (Cayman) Inc., of Shanghai, and Eli Lilly and Co., of Indianapolis, said they entered a collaboration to develop, manufacture and commercialize a small molecule in China. The once-daily oral agent, discovered by Lilly, could address cardiovascular risk in patients with dyslipidemia, representing an unmet medical with an estimated 276 million patients in China affected by those conditions, including about 12 million patients requiring drug treatment. The compound aims to reduce cardiovascular events in patients with elevated LDL cholesterol and triglycerides at high risk of cardiovascular events. Under the terms, Wuxi will be responsible for regulatory, development and manufacturing activities in China, while Lilly will be responsible for commercial activities. Further financial terms of the collaboration were not disclosed, though parties will invest in its development. Wuxi will file an investigational new drug application in China.

Xbiotech Inc,. of Austin, Texas, said it identified positive donors for its first anti-Clostridium difficile (C. difficile) product candidate, only two weeks after initial screening of blood donations from healthy volunteers. The company identified donors that have antibody reactivity against its targeted moieties on the C. difficile bacteria. The next step is cloning the anti-C. difficile antibody genes and potentially advancing a lead antibody toward the clinic.

X-Rx Inc., of Wilmington, N.C., said it inked an exclusive deal with Gilead Sciences Inc., of Foster City, Calif., to develop X-Rx’s small-molecule autotaxin (ATX) inhibitors. ATX plays a key role in maintaining tissue homeostasis and is up-regulated in many diseases, including idiopathic pulmonary fibrosis. Terms call for X-Rx to receive an up-front payment and research funding to advance the lead molecule through early clinical development and to support the company in further developing its other pipeline assets. X-Rx also may receive subsequent clinical milestone payments. Further financial terms were not disclosed.

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