Anika Therapeutics Inc., of Bedford, Mass., said regulatory authorities in India granted approval to Monovisc, its single injection viscosupplement for the treatment of pain associated with osteoarthritis of all human synovial joints. The treatment already is commercially available in the U.S., Canada and Europe, and Anika plans to expand into India, Australia, New Zealand and additional international markets over the next six to nine months. Anika has a multiyear, exclusive distribution agreement with Modi-Mundipharma Pvt. Ltd., of New Delhi, to market the product in India. Monovisc is composed of highly purified, partially cross-linked sodium hyaluronate in a phosphate buffered saline solution.
Aslan Pharmaceuticals Pte. Ltd., of Singapore, is partnering with Taiwan's Hope Foundation for Cancer Care to develop a new digital application to assist cancer patients in managing their care. Funded by a grant from Aslan, the new mobile application will help patients track their medical appointments, follow-up treatments and medications via their phones. The app will be made available for free to all cancer patients in Taiwan, Aslan said.
Astellas Pharma Inc., of Tokyo, said it is winding down its Agensys research operations in Santa Monica, Calif., to further refine its oncology strategy by expanding its investment in the research of new technologies and modalities and reducing its focus on antibody-drug conjugate research. Operations in Agensys are expected to complete the wind-down process in the first quarter of 2018, and Astellas said it is still reviewing the impact of that development on financial forecasts for the fiscal year ending March 31, 2018. Astellas paid $387 million up front, with $150 million in potential milestones, to buy out Agensys in 2007. (See BioWorld Today, Nov. 28, 2007.)
Celltrion Inc., of Incheon, South Korea, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA accepted for review the BLA for CT-P6, a proposed monoclonal antibody biosimilar to Herceptin (trastuzumab, Roche Holding AG). A recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody, Herceptin is approved for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer in the U.S. The BLA for CT-P6 includes data for CT-P6 and trastuzumab in terms of efficacy, safety, immunogenicity, pharmacodynamics and pharmacokinetics. Results were taken from trials conducted in more than 500 patients in 22 countries. CT-P6 has been approved by the Korean Ministry of Food and Drug Safety. Celltrion also filed marketing authorization applications for CT-P6 to the EMA in October 2016.
Cytokinetics Inc., of South San Francisco, said it opened enrollment in the phase II Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints in Amyotrophic Lateral Sclerosis (FORTITUDE-ALS) trial. The study will measure the change from baseline in the percent predicted slow vital capacity and other measures of skeletal muscle function in 450 ALS patients after 12 weeks of treatment with CK-2127107, a fast skeletal muscle troponin activator being developed in collaboration with Tokyo-based Astellas Pharma Inc.
Dr. Reddy's Laboratories Ltd., of Hyderabad, India, and CHD Bioscience Inc., of Fort Collins, Colo., said they inked a global licensing deal for the clinical development and commercialization of Dr. Reddy's phase III candidate, DFA-02 (gentamicin and vancomycin sterile gel), intended to be used for the prevention of surgical site infections following non-emergency, elective colorectal surgery. Phase II studies for DFA-02 have been completed, and the product will move into pivotal registration studies. Under the terms, Dr. Reddy's would receive equity in CHD valued at $30 million upon an IPO of CHD or a minimum of $30 million in cash within 18 months of execution of the agreement. Dr. Reddy's will also receive additional milestone payments of $40 million upon FDA approval and will be entitled to double-digit royalties on sales and commercial milestones.
Flex Pharma Inc., of Boston, gained FDA fast track status for FLX-787, the company's co-activator of TRPA1 and TRPV1, to treat severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS). The company expects to start phase II trials in both ALS and Charcot-Marie-Tooth (CMT) this quarter in the U.S. As the phase II ALS trial, called Commend, gets underway in the U.S., the company said it would end a small exploratory Australian ALS study early. Flex Pharma shares (NASDAQ:FLKS) rose 11 percent on Tuesday to close at $4.33.
Frontier Biotechnologies Inc., of Nanjing, China, signed an agreement with Rockefeller University, of New York, for a worldwide license for combining 3BNC-117, an experimental broad-spectrum HIV neutralizing antibody discovered in the lab at the university, with its lead candidate, albuvirtide, for the treatment and prophylaxis of HIV infection and AIDS. Frontier plans to start testing the combination in clinical trials in 2018. Financial terms of the deal were not disclosed.
Glenmark Pharmaceuticals Ltd., of Mumbai, reported data from a phase IIa study of GBR-830, an anti-OX40 monoclonal antibody, in patients with moderate to severe atopic dermatitis with a history of inadequate response to topical therapies. A total of 31 patients were evaluated following the last study visit and assessed on multiple endpoints after receiving two doses with two viable biopsies. In the GBR-830 cohort, 17 out of 23 patients experienced at least a 50 percent reduction in their Eczema Area and Severity Index scores at day 57 compared to baseline, a key secondary endpoint of the study. Although not powered for statistical differences between GBR-830 vs. placebo, data from that analysis suggest clinically meaningful improvement of symptoms that is continuous and sustained, with consistency observed between biological and clinical response. Based on the data, Glenmark expects to start a phase IIb trial in the first half of 2018.
Haemalogix Pty. Ltd., of Eveleigh, Australia, inked an agreement with Westmead Institute for Medical Research, Western Sydney Local Health District, Children's Medical Research Institute and the University of Sydney for commercialization rights to an immuno-oncology agent designed to target malignant cancer cells present in the bone marrow of individuals with multiple myeloma. Researchers at Haemalogix and Westmead expect to test the CAR T-cell therapy in myeloma patients beginning next year. Financial terms were not disclosed.
Jaguar Animal Health Inc. and Napo Pharmaceuticals Inc., both of San Francisco, said stockholders of the respective companies approved proposals to merge the companies in separate stockholder meetings. The merger is on track to close on July 31, at which point Jaguar will change its name to Jaguar Health Inc. and Napo will operate as a wholly owned subsidiary of Jaguar that will focus on human health and the commercialization of Mytesi, which is approved for the treatment of diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.
Lanstead Capital LP said it invested A$10 million (US$8 million) in Melbourne, Australia-based Neuren Pharmaceuticals Ltd. ahead of an upcoming phase III trial of trofinetide in Rett syndrome. Neuren received A$1.5 million from Lanstead in July. The remaining A$8.5 million will be invested in a sharing agreement, which will enable Neuren to receive the proceeds on a pro-rata monthly basis over 18 months.
Oncolys Biopharma Inc., of Tokyo, enrolled the first patient in the phase II trial with Telomelysin (OBP-301) for the treatment of melanoma in the U.S. The drug will be administered locally on unresectable or metastatic melanoma patients in clinical centers, and the trial will enroll up to 50 patients in five sites across the country. After obtaining the results of the trial, Oncolys will also consider an additional clinical trial of Telomelysin in combination with immune checkpoint inhibitors. Telomelysin is an oncolytic adenovirus in which gene is modified to be able to selectively replicate in cancer cells by introducing human telomerase reverse transcriptase promoter.
Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Valby, Denmark, said Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the FDA for the maintenance monotherapy treatment of bipolar I disorder in adults. The drug, which won its first approval in 2013 for schizophrenia, is a once-monthly injectable formulation for intramuscular use created by Otsuka and has been co-developed and co-commercialized with Lundbeck. Based on phase III study data, it delayed the time to recurrence of any mood episode in adult patients experiencing a manic episode at screening compared to placebo.
Recce Ltd., of Sydney, said it remains on track to submit an IND to the FDA for lead synthetic antibiotic compound Recce-327 following additional positive preclinical study data on mode of administration, drug clearance, dosing and efficacy.
Santen Pharmaceutical Co. Ltd., of Osaka, Japan, and Tracon Pharmaceuticals Inc., of San Diego, said Santen initiated a phase IIa study of DE-122 in patients with wet age-related macular degeneration (AMD). The randomized, controlled trial will assess efficacy and safety of intravitreal injections of DE-122 in combination with Lucentis (ranibizumab, Roche Holding AG) compared to Lucentis monotherapy in patients with wet AMD. DE-122 is the ophthalmic formulation of Tracon's anti-endoglin antibody, TRC-105. The initiation of the study triggers a $7 million milestone payment from Santen to Tracon.
Tabuk Pharmaceuticals Manufacturing Co., of Amman, Jordan, licensed Zydena (udenafil) in the Kingdom of Saudi Arabia and the Gulf area from Dong-A Pharmaceutical Co., of Seoul, South Korea. Tabuk gains rights to manufacture, commercialize and distribute Zydena in the area. Financial terms of the deal weren't disclosed.
Taiwan Liposome Co. Ltd., of Taipei, Taiwan, said it is due to receive a government subsidy of NT$30.9 million (US$1 million) from Taiwan's Ministry of Economic Affairs toward its fast track designation plan for ophthalmology product candidate TLC-399, a liposomal encapsulated dexamethasone using TLC's Bioseizer technology. The grant will be allocated in installments over the 36 months of planned development and used for the TLC-399 phase II trial currently enrolling patients at multiple sites in the U.S.
Telix Pharmaceuticals Ltd., of Melbourne, Australia, said it completed a master services agreement with Cyclotek (Aust) Pty Ltd., of Victoria, Australia, under which Cyclotek will provide radiopharmaceutical manufacturing and distribution services for Telix's pipeline of oncology products, for both clinical trial purposes and, where appropriate, prescriber exemption use. Terms were not disclosed.
As part of its efforts to encourage the use of biosimilars, Australia's Therapeutic Goods Administration (TGA) wants public input on the naming of biologics, both novel and biosimilars. Currently, the TGA uses the Australian-approved biological name, which is typically the international nonproprietary name (INN), with no requirement for a specific identifier suffix like the one used in the U.S. or packaging bar code, as required in the EU. Given the various international standards and with the Australian government preparing to pursue approaches to e-prescribing software that support default prescribing by the INN, the TGA is questioning whether more information is needed for pharmacovigilance. In a consultation released Friday, the TGA outlines several biologic naming options and asks stakeholders to identify the option they support and provide their reasoning. The comment deadline is Sept. 8.
Vilacto Bio Inc., of Copenhagen, said it plans to expand its exposure in Asia, meeting with partners, distributors and investors. The company also expects to start fundraising efforts in the fourth quarter of this year, targeting $5 million. Vilacto has developed the fully patented Lactoactive, which consists of highly refined colostrum and has demonstrated above-average effect treating conditions such as inflammatory diseases, diabetes, psoriasis, skin aging, and skin issues, the company said.