Admedus Ltd., of Brisbane, Australia, reported long-term data from its phase II extension study on the repair of congenital heart defects in pediatric patients using its Cardiocel candidate. The company said the 14 patients in the study continued to progress for up to eight years following implantation, with no sign of calcification or need for repeat procedures, which ranged from ventricular septal defects to complex reconstructions. Admedus said the findings represented the longest follow-up data from a study in congenital defect pediatric patients.
Biolinerx Ltd., of Modi’in, Israel, said it entered a joint venture (JV) with I-Bridge Capital, a Chinese venture capital fund. The JV, Ipharma, aims to develop clinical and preclinical therapeutics, which will originate primarily in Israel and serve Chinese and global markets. Under the terms, Biolinerx and I-Bridge will fund the venture with $1 million each. Biolinerx will focus on screening and identifying drug candidates with particular therapeutic interest in China, and I-Bridge will license those which show promise.
CSL Ltd., of Melbourne, Australia, said its Seqirus unit, which oversees the influenza vaccine business acquired from Novartis AG, of Basel, Switzerland, disclosed results from three analyses of a total of 42 clinical trials that evaluated the safety and immunogenicity of its MF59-adjuvanted seasonal trivalent influenza vaccine in adults 65 years and older. The analyses, which add to the body of evidence of benefit in using adjuvanted influenza vaccines among elderly patient populations, were presented at the Options IX for the Control of Influenza conference (Options IX) in Chicago. The first integrated analysis of safety data from 36 clinical trials assessed the risk of less common but serious adverse events with MF59-adjuvanted seasonal trivalent influenza vaccine in adults 65 years and older compared to non-adjuvanted trivalent influenza vaccines. Results showed vaccination with the product resulted in an increase in mild to moderate solicited adverse events (AEs) as compared to non-adjuvanted trivalent vaccines, but no increased risk of unsolicited AEs, including serious AE or deaths. Results also suggested that revaccination with MF59-adjuvanted seasonal trivalent influenza vaccine in subsequent influenza seasons was well tolerated in older adults 65 and older, the company said.
Daiichi Sankyo Europe GmbH, part of Daiichi Sankyo Co. Ltd., of Tokyo, reported that new subanalyses of a company-sponsored registry of atrial fibrillation (AF) patients, called PREFER, revealed that AF patients with diabetes, on insulin treatment are at a significantly increased risk of stroke/systemic embolism at one year follow-up compared to AF patients without diabetes (5.2 percent vs. 1.9 percent respectively; hazard ratio 2.89, 95 percent confidence interval 1.67-5.02; P=0.0002) and compared to those with diabetes not on insulin treatment (5.2 percent vs. 1.8 percent respectively; HR 2.96, 1.49-5.87; P=0.0019). The registry has revealed that women experience a greater burden of symptoms compared to men and that treatment with oral anticoagulation is similar in both genders.
Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, said it has been granted the exclusive worldwide rights (excluding Japan) to SI-6603 (condoliase), a chemonucleolytic product in phase III development for the treatment of radicular leg pain (e.g., sciatica) due to lumbar disc herniation under an agreement with Seikagaku Corp., of Tokyo. The Japanese company has been developing condoliase for the U.S. and Japan and has two on-going phase III trials (a pivotal double-blind study and an open-label safety study). It will be responsible for completing development and obtaining FDA regulatory approval after which Ferring will commercialize the product in the U.S and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan. Ferring will pay Seikagaku an up-front licensing fee, development and regulatory milestones and royalties.
Gordagen Pharmaceuticals Inc., of Melbourne, Australia, said it received a research and development tax incentive refund of A$1.3 million (US$989,988) for 2015/16 financial year. The company incurred A$2.8 million in eligible R&D expenses in various programs including developing new formulations for the company’s Melt3 delivery platform. Gordagen plans to use part of the refund to settle a loan facility with Metamor Capital Partners, and the rest toward launch preparations for its nutraceutical products in the U.S.
Nichi-Iko Pharmaceutical Co. Ltd., of Tokyo, said, as a result of its tender offer to purchase all of the outstanding shares of common stock of Sagent Pharmaceuticals Inc., of Schaumburg, Ill., at $21.75 per share, a total of 28.22 million shares of Sagent common stock had been validly tendered and not withdrawn, representing approximately 85.6 percent of the outstanding shares. Nichi-Iko intends to complete its acquisition of Sagent as soon as practicable through a merger and once completed the shares of Sagent common stock will be delisted and cease to trade on Nasdaq.
Paxvax Corp., of Redwood City, Calif., said it inked a marketing agreement with Seqirus, of Maidenhead, U.K., part of CSL Ltd., of Melbourne, Australia. Under the terms, Paxvax will be responsible for marketing, selling and distribution of two influenza vaccines in Switzerland from Seqirus: Agrippal and Fluad. Agrippal is indicated for adults and children older than 6 months, and Fluad is indicated for those 65 and older. Financial details were not disclosed.
Regenerx Biopharmaceuticals Inc., of Rockville, Md., said that Regentree LLC, a joint venture it established with South Korea’s Gtreebnt Co. Ltd., received FDA permission to proceed with a second phase III trial using RGN-259 to treat patients with dry eye syndrome. Regentree has completed preparation for all aspects of the double-masked, placebo-controlled clinical study trial, which is set to include about 500-patients, and is ready to immediately start the trial, it said.
Seqirus, a Maidenhead, U.K.-based subsidiary of Australia’s CSL Ltd., announced an analysis of data from six clinical studies of its trivalent MF59-adjuvanted seasonal influenza vaccine involving more than 10,000 children. During the trial, 5,542 children were exposed to at least one dose of the vaccine for young children to evaluate immunogenicity, efficacy and safety. Results showed that immunogenicity and efficacy were greater in children who received the vaccine vs. those who received a non-adjuvanted influenza vaccine, while maintaining an acceptable safety profile (≤1 percent severe events). Another analysis of the same six randomized trials found that the safety of the trivalent MF59-adjuvanted seasonal influenza vaccine for young children was compared with non-adjuvanted influenza vaccines among 373 young children with underlying medical conditions. Of the children at risk, 179 received the trivalent MF59-adjuvanted seasonal influenza vaccine for young children and 194 received control vaccines. Children with underlying medical conditions most frequently had a medical history of underlying respiratory system illnesses (62 percent to 70 percent). The two analyses were presented at the 28th International Congress of Pediatrics in Vancouver, British Columbia, Aug. 17-22. Seqirus was formed in July 2015 after CSL Group and its affiliates acquired the influenza vaccines business of Basel, Switzerland-based Novartis AG in the U.S. In other news, Seqirus said the FDA approved Afluria Quadrivalent influenza vaccine for those 18 and older. Afluria Quadrivalent, an inactivated influenza vaccine, is indicated for active immunization against influenza caused by subtypes A and B viruses (contained in the vaccine). Afluria Quadrivalent and Afluria are available in the U.S. for the 2016-2017 influenza season. Seqirus’ other product, Flucel Vax Quadrivalent was approved in May.
Shionogi & Co. Ltd., of Osaka, Japan, said a single oral dose (10 mg, 20 mg or 40 mg) of S-033188, a cap-dependent endonuclease inhibitor targeting influenza, showed favorable safety and efficacy compared to placebo in a phase II proof-of-concept study that enrolled 400 patients in Japan, supporting its advance into a global phase III program next year. Although no statistically significant difference was found using the Cox proportional hazard model, all three doses showed significant reductions in time to alleviation of symptoms compared to placebo using the pre-specified stratified generalized Wilcoxon test. Viral load reduction from baseline was statistically significant 24 and 48 hours post dose for all active doses, compared to placebo, and S-033188 was well tolerated in all dose groups. The results were presented at Options IX for the control of influenza in Chicago. The candidate is being developed in collaboration with F. Hoffmann-La Roche Ltd., a unit of Roche AG, of Basel, Switzerland.
Taigen Biotechnology Co. Ltd., of Taipei, signed an exclusive licensing agreement with Productos Científicos S.A. de C.V. (PC), a Mexican pharmaceutical company, to develop and commercialize the antibiotic Taigexyn (nemonoxacin) in Latin America. Under the terms of the agreement, PC will be responsible for the development, registration and commercialization of Taigexyn in the territory and assume all associated costs. In exchange for the exclusive rights, Taigen will receive an undisclosed upfront payment and is eligible for additional regulatory and commercial milestones in the future. In June, Taigexyn became the first made-in-Taiwan drug marketed in mainland China. (See BioWorld Today, June 22, 2016.)
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, launched an initiative to increase access to its products in territories and therapeutic areas with the highest unmet need, including emerging health care systems in Latin America, Southeast Asia and Africa.
Valneva SE, of Lyon, France, signed an agreement with Seqirus, a Maidenhead, U.K.-based subsidiary of Australia’s CSL Ltd. and now the second largest flu company in the world, for the marketing & distribution of Seqirus’ seasonal flu vaccines Sandovac and Fluad in the Austrian market at the beginning of the 2016-2017 flu season. Valneva said that the deal supports its strategy to leverage its sales and marketing infrastructure and expand its commercial footprint worldwide.