Acucela Inc., of Seattle, a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co. Ltd., of Tokyo, inked an R&D agreement with an exclusive option to acquire global rights to biomimetic technology and an initial candidate molecule for ophthalmic use from privately held Eyemedics LLC. The technology, licensed by Eyemedics from the University of Southern California, modulates endogenous factors released during the inflammatory process at the early pathogenic stages of age related macular degeneration, proliferative diabetic retinopathy, diabetic macular edema and other retinal neovascular conditions. In an in vivo preclinical study, the lead candidate suggested the ability to inhibit vascular endothelial growth factor (VEGF)-induced vascular leakage comparable to anti-VEGF therapy, without loss of native microvasculature. Financial terms were not disclosed.

The Australian government's $500 million Biomedical Translation Fund (BTF) announced that three venture capital fund managers – Brandon Capital Partners, Oneventures Management and Bioscience Managers – will help to move the ideas of Australian start-ups from the lab into new medicines, medical devices and therapies. The managers will screen investment proposals to the BTF and develop a broad portfolio of investment in Australian science and research. The BTF, and support for the commercialization of innovative ideas, is a key element of the National Innovation and Science Agenda. The government will provide $250 million to the fund, to be at least matched by the fund managers, who will then direct the funding to high-potential innovations.

Celsion Corp., of Lawrenceville, N.J., said it met with CFDA officials to discuss the ongoing phase III OPTIMA program and regulatory pathway for Thermodox, its heat-activated liposomal encapsulation of doxorubicin to treat primary liver cancer, and presented final overall survival data from the Chinese patient cohort of its HEAT study, which showed a survival benefit in patients treated with Thermodox plus optimized radiofrequency ablation (RFA) compared with optimized RFA alone. Celsion said the CFDA agreed that OPTIMA, if successful, could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or EU. OPTIMA is expected to enroll up to 550 patients at up to 75 clinical sites in the U.S., Europe, China and Asia Pacific. The company said all Chinese sites will be active by early 2017, with enrollment on pace to have the trial fully enrolled by the first quarter of 2018. Celsion also advanced its manufacturing in China with Zhejiang Hisun Pharmaceutical Co. Ltd., of Taizhou City, China, and reported that recent bioequivalence studies of Thermodox produced in China by Hisun were equivalent to batches produced at its U.S. manufacturing site. In addition, Celsion said its team met with the Ministry of Health in Vietnam and plans to launch additional OPTIMA trial sites in the country.

CSPC Pharmaceutical Group Ltd., of Hong Kong, said that its subsidiary CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. entered into an agreement with Teva Pharmaceuticals USA Inc., of Woodcliff Lake, N.J., for the product licensing and commercialization of an undisclosed injectable antibiotic generic drug in the U.S. and countries in the EU. CSPC Zhongqi is responsible for preclinical development, manufacturing authority and regulatory drug applications. CSPC Zhongqi granted exclusive rights to Teva to perform the necessary non-clinical and clinical studies and apply for the relevant approvals required for the distribution and sale. Teva will make milestone payments to CSPC Zhongqi of up to $100 million. CSPC Zhongqi will also be entitled to receive an undisclosed percentage of the net profits.

Daiichi Sankyo Co. Ltd., of Tokyo, and Darwinhealth, of New York, announced a strategic partnership to use quantitative systems biology-based algorithms and validated approaches focused on tumor checkpoints to help prioritize investigational compounds in the Daiichi Sankyo Cancer Enterprise pipeline for clinical development. The vast majority of investigational compounds in the Daiichi Sankyo Cancer Enterprise portfolio will be evaluated against patient-derived tumor samples using Darwinhealth's oncotecture-based technology. Those studies will provide information including their mechanism of action, biomarkers and their ability to synergize with other drugs.

Eisai Co. Ltd., of Tokyo, said the European Commission granted an extension to the marketing authorization for Zebinix (eslicarbazepine acetate) to be used as a daily adjunctive drug to treat children 6 and older who have partial-onset (focal) seizures with or without secondary generalization. The treatment was already approved in the EU for those 18 and older.

Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, and I-MAB, of Shanghai, China, said they inked a licensing agreement, giving I-MAB exclusive rights to olamkicept (pINN), a recombinant protein inhibitor of the interleukin-6 pathway, in Asia. Under the terms, I-MAB is responsible for funding further product development in autoimmune disease and will receive an exclusive license in Asia with the option for worldwide use. Financial terms were not disclosed.

Gilead Sciences Inc., of Foster City, Calif., said its once-daily drug to suppress viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function, Vemlidy (tenofovir alafenamide) 25 mg, was approved by the Japanese Ministry of Health, Labour and Welfare. That approval was supported by data from two phase III trials, Study 108 and Study 110, which enrolled 27 patients at 11 sites and 46 patients at 16 sites, respectively, in Japan.

Harbour Biomed, of Shanghai, China, said it acquired Harbour Antibodies BV for cash and equity interest in Harbour Biomed. The new oncology-focused biotech said it aims to generate next-generation therapeutic antibodies for cancer using the just-acquired patented transgenic mouse platforms. Support came from Harbour Biomed investors, Advantech Capital and Legend Capital.

Iq Group Global, of Sydney, opened its Iq Series 8 Life Science Fund (Global), which was approved as an Early Stage Venture Capital Limited Liability Partnership, registered with Innovation Australia. The $100 million fund will focus on early stage life science companies involved in late discovery to preclinical development of medicines and medical technologies. In particular, the group will focus on genomic and molecular medicines, diagnostics and medical devices where it can seek to bridge the gap between research and commercialization. Applications for funding are expected to close before June 30, 2017. The fund is expected to help address a dearth of venture investment for early stage biopharma efforts in Australia. (See BioWorld Today, Oct. 25, 2016, and Dec. 12, 2016.)

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., snagged a $15 million milestone payment from its partner Astellas Pharma Inc., of Tokyo, on the occasion of marketing approval from the Japanese Ministry of Health, Labor and Welfare for Linzess (linaclotide) as the first prescription treatment for adults with irritable bowel syndrome with constipation in Japan. Ironwood anticipates that Astellas will launch the drug in Japan in the first half of 2017. Ironwood and Astellas entered into a licensing agreement in 2009. In addition to the milestone paid in conjunction with the approval, Ironwood stands to receive royalties on sales of Linzess, which escalate based on sales volume. The drug is approved for the treatment of adults with IBS-C or chronic idiopathic constipation in the U.S. and more than 30 other countries.

Merck & Co. Inc., of Kenilworth, N.J., said that Keytruda (pembrolizumab), the company's anti-PD-1 therapy, has been approved in Japan for the treatment of certain patients with PD-L1-positive unresectable advanced/recurrent non-small-cell lung cancer in the first- and second-line treatment settings at a fixed dose of 200 mg every three weeks. Merck subsidiary Merck Sharp & Dohme Corp. will manufacture and market Keytruda in Japan and will promote it with Taiho Pharmaceutical Co. Ltd. The PD-L1 IHC 22C3 Pharmdx kit made by Dako North America Inc., an Agilent Technologies company, was approved in Japan on Nov. 25 for use in detecting PD-L1, an immune-related biomarker expressed on some tumor cells. It will be used to aid in identifying appropriate patients for treatment with Keytruda.

Pfizer Inc., of New York, and Astellas Pharma Inc., of Tokyo, reported that the phase IV PLATO study testing Xtandi (enzalutamide) plus Zytiga (abiraterone acetate, Johnson & Johnson) and prednisone vs. Zytiga and prednisone alone did not meet its primary endpoint of improvement in progression-free survival in patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen has previously progressed on Xtandi. Detailed data were not disclosed. Xtandi is FDA-approved to treat metastatic CRPC.

Phylogica Ltd., of Perth, Australia, said Genentech, a member of the Roche Group, of Basel, Switzerland, has extended its exclusivity period for the research collaboration and license agreement to discover antibiotics using Phylogica's Phylomer drug discovery platform, including its proprietary cell penetrating peptide discovery technology. Phylogica will receive a milestone payment of $2 million and is eligible to receive research, development, and commercialization milestone payments totaling up to $142 million.

Pulmagen Therapeutics Ltd., of Slough, U.K., reported observing a statistically significant difference between two doses of PTR-36, its investigational eosinophilic asthma candidate, and placebo during an exploratory phase II study. The double-blind, randomized study was run by Teijin Pharma Ltd., of Tokyo, Pulmagen's licensee for the program in Japan. The trial includes 158 patients with mild to moderate asthma who had their long-acting beta-agonists discontinued and were standardized on a medium dose of inhaled corticosteroid (ICS) for 28 days prior to randomization. At the start of the 16-week treatment period the dose of ICS was reduced to a low dose and patients were randomized (1:1:1) to two doses of PTR-36 (5 mg or 20 mg once daily) or to placebo for an initial 28 days after which the ICS was fully discontinued. Patients then remained on PTR- 36 or placebo for a further 12 weeks. Pulmagen said that, for the primary endpoint of change in morning peak expiratory flow (mPEF) from randomization to the last visit, there was a statistically significant difference between PTR-36 and placebo at both doses (p = 0.015, 5 mg; 0.027, 20 mg).

Redhill Biopharma Ltd., of Tel Aviv, Israel, and Intelgenx Corp., of Saint Laurent, Quebec, said they signed an exclusive license agreement with Pharmatronic Co. Ltd., of Seoul, Korea, for the commercialization of Rizaport, an oral thin film formulation of rizatriptan to treat acute migraine, in the Republic of Korea. Specific terms were not disclosed, but Redhill and Intelgenx are entitled to an up-front payment and will be eligible to receive additional milestone payments and tiered royalties. The initial terms of the agreement is for 10 years from the date of first commercial sale and will automatically renew for an additional two-year term. Commercial launch in South Korea is estimated to be in the first quarter of 2019.

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said that it received approval from the CFDA to run phase II/III trials of its oral hypoglycemic agent, imigliptin dihydrochloride. The candidate, a DPP-4 inhibitor, is a potential treatment for type II diabetes.

Shionogi & Co. Ltd., of Osaka, Japan, and its wholly owned U.S. subsidiary, Shionogi Inc., formed an alliance with Purdue Pharma LP, of Stamford, Conn., for the joint U.S. launch and commercialization of Symproic (naldemedine). Financial terms were not disclosed. The peripherally acting mu opioid receptor antagonist, designed to treat opioid-induced constipation in adults with chronic non-cancer pain, is under review by the FDA with a PDUFA date of March 23, 2017. (See BioWorld Today, Feb. 22, 2016.)

Takara Bio USA Holdings Inc., of Mountain View, Calif., a wholly owned subsidiary of Japan's Takara Bio Inc., and Rubicon Genomics Inc., of Ann Arbor, Mich., said they signed a merger agreement, under which Takara will acquire Rubicon and its pre-analytical library preparation kits, acquiring all the outstanding capital stock for a purchase price of about $75 million.

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