Abbvie Inc., of North Chicago, gained approval in Australia for Venclexta (venetoclax) to treat advanced forms of chronic lymphocytic leukemia. CLL is the most common type of leukemia in Australia, with 1,300 people diagnosed each year. Venclexta was approved for CLL patients with 17p deletion, a mutation that makes the disease resistant to standard treatment options, as well as for patients with relapsed or refractory CLL for whom on other options are available. The drug, a BCL-2 inhibitor, was discovered and developed at Abbvie and Genentech Inc., of South San Francisco, as part of a collaboration with the Walter and Eliza Hall Institute.
Biocon Ltd., of Bangalore, India, said the FDA accepted the biologics license application (BLA) for Mylan NV's MYL-1401O for filing through the 351(k) pathway. The Hertfordshire, U.K.-based company's product is a biosimilar to trastuzumab, which is a treatment for certain HER2-positive breast cancers. The FDA set a goal date of Sept. 3. Mylan and Biocon's proposed biosimilar is currently under review by the EMA. (See BioWorld Today, Nov. 21, 2016.)
Hutchison China Meditech Ltd., of Hong Kong, started a phase I trial of its spleen tyrosine kinase inhibitor, HMPL-523, in patients with hematological malignancies in China. The first patient was dosed on Dec. 27, 2016. This study complements the ongoing phase I trial in patients in Australia with hematological malignancies, which is expected to complete dose-escalation in the first half of 2017.
Intas Pharmaceuticals Ltd., of Ahmedabad, India, through its wholly owned subsidiary Accord Healthcare Ltd., completed the deal to acquire Actavis UK Ltd. and Actavis Ireland Ltd. from Jerusalem-based Teva Pharmaceutical Industries Ltd., for £603 million (US$733.3 million) payable in cash. The transaction is part of the European Commission's anti-trust divestiture requirements arising from Teva's acquisition of Allergan's generics business.
Legochem Bioscience Inc., of Daejeon, South Korea, said it inked a research licensing agreement with Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan, involving next-generation antibody drug conjugate (ADC) candidates. The agreement calls for Takeda to use Legochem's next-generation ADC technology platform: specifically, Conjuall, a site-specific bio-conjugation method and a stable beta-glucuronide linker. Both companies will evaluate ADC candidates, and Takeda will retain the option to license global rights to viable candidates. Financial terms were not disclosed.
Merck KGaA, of Darmstadt, Germany, is expanding its end-to-end biodevelopment centers to meet increasing customer demand for its portfolio of bioprocessing products, manufacturing capabilities and technological expertise. The expansion includes the opening of two new process development centers in the U.S. and China, close to Boston and Shanghai customers. They will provide cell line development services, upstream and downstream process development, as well as non-GMP clinical production.
Microbix Biosystems Inc., of Toronto, signed a distribution agreement with Meridian Life Science Inc. ("Meridian") a wholly owned company of Meridian Bioscience Inc., of Cincinnati, which will receive exclusive distribution rights to Microbix's branded antigen products for China, Hong Kong, Taiwan and Macau. Microbix will also provide bulk-finished product to Meridian to be sold under Meridian-label to customers in the Asia Pacific region (China, Macau, Hong Kong and Taiwan, India, Singapore, Malaysia, Australia, New Zealand, Thailand, Vietnam, the Philippines and Pakistan). Both companies will explore additional collaboration opportunities in the future. Further terms were not disclosed.
Newron Pharmaceuticals S.p.A., of Milan, Italy, said its partner, Zambon S.p.A., part of the Zambon Group, of Vicenza, Italy, has entered into a long-term partnership with Seqirus, a CSL Ltd. subsidiary, covering Zambon's Parkinson's disease product, Xadago (safinamide) in Australia and New Zealand. Zambon will be responsible for product supply and Seqirus will undertake registration and commercialization. The orally available monoamine oxidase-B inhibitor blocks one of the key enzymes involved in the breakdown of dopamine and has been shown to have an effect on symptoms both in combination with dopamine agonists in the early stages of the disease, and when taken with levodopa at the more advanced stages. In 2014, Xadago became the first new chemical entity in 10 years to get a positive opinion from the EMA in Parkinson's disease. (See BioWorld Today, Dec. 30, 2014.)
Orthocell Ltd., of Perth, Australia, disclosed a research collaboration agreement with Depuy Synthes Products Inc., part of New Brunswick, N.J.-based Johnson & Johnson, for its Ortho-ATI stem cell approach for the regeneration of degenerate tendons and ligaments. Ortho-ATI is described as a non-surgical approach to treat chronic treatment resistant tendon injuries that have a significant negative effect on patients' activities of daily living. Terms were not disclosed.
Prima Biomed Ltd., of Sydney, said the first patient was dosed for the second cohort of the phase I TACTI-mel study testing IMP321 in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in Australia. The second cohort will recruit up to six patients with unresectable or metastatic melanoma who have had a suboptimal response to Keytruda. Interim data from the first patient cohort, reported last month, indicated IMP321, an antigen-presenting cell activator based on immune checkpoint LAG-3, is safe and well-tolerated.
Regeneus Ltd., of Sydney, formed a strategic collaboration and licensing agreement with Tokyo-based AGC Asahi Glass Co. for the manufacture, clinical development and commercialization of Progenza, a patented, off-the-shelf stem cell technology platform, for the Japanese market. Under the terms of the agreement, Regeneus granted AGC exclusive rights to manufacture Progenza in Japan and a 50 percent interest in Regeneus Japan, which has the exclusive rights for the clinical development and commercialization of Progenza in Japan for osteoarthritis and all therapeutic applications. Regeneus will receive up to $16.5 million from AGC, with $5.5 million as an up-front payment and the remaining $11 million to be paid through development and approval milestone payments. Regeneus will also be entitled, through its 50 percent interest in the joint venture, to a share of up-front license fees, milestone payments and royalties from sublicensing the development and commercialization of Progenza for osteoarthritis and all other clinical indications in Japan. AGC will be responsible for funding the manufacture of Progenza for the proposed phase II trial for osteoarthritis in Japan under certain conditions, the companies said.
Transplanting retinal tissue made from induced pluripotent stem cells (iPSCs) into mice lacking the outermost layer of the retina improved the animals' vision, as judged by behavioral experiments. Retinal degeneration is an inherited condition that leads to blindness as an individual's photoreceptors die. Previous experiments had shown that transplanted photoreceptors could integrate into pre-existing retinas, but whether they could transmit visual signals that would improve the ability to see in a meaningful way had not been shown. Researchers from the Japanese Riken Institute transplanted retinal sheets derived from iPSCs into mice with end-stage retinal degeneration, and showed that post-transplant, the sheets connected to the existing visual signaling pathways, and that they could condition mice using light as a stimulus. The team, which is currently testing the ability of a human iPSC-derived retina to restore vision, wrote that "our data provides a proof of concept for transplanting ESC/iPSC retinas to restore vision in end-stage retinal degeneration." They published their results in the Jan. 10, 2017, issue of Stem Cell Reports.
Shionogi & Co. Ltd., of Osaka, Japan, said cefiderocol (S-649266), a siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for noninferiority vs. imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with gram-negative bacteria. Cefiderocol was superior to IPM/CS at test of cure (TOC). The study, APEKs-cUTI, enrolled 452 patients with cUTI. The median duration of treatment was nine days for both cefiderocol and IPM/CS for all populations. Cefiderocol met the primary efficacy endpoint of composite of clinical cure and microbiologic eradication at test of cure (TOC) in 72.6 percent of patients (n=252) which was superior to IPM/CS at 54.6 percent (n=119), a weighted difference of 18.58 percent (95 percent CI: 8.23, 28.92).
Starpharma Holdings Ltd., of Melbourne, Australia, said its Vivagel BV candidate was granted qualified infectious disease product and fast track designation by the FDA to treat and prevent indications for bacterial vaginosis.
Tesorx Pharma LLC, of San Francisco and Aska Pharmaceutical Co. Ltd., of Tokyo, said they have entered a partnership to develop and commercialize Tesorx's oral testosterone product, THG-1001, in Japan. The product candidate is currently in preclinical development for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. Aska has made an upfront payment for an exclusive option to license the product for Japan in a deal containing a license fee, milestones and royalty payments on sales in the territory.