Ardelyx Inc., of Fremont, Calif., and Tokyo-based Kyowa Kirin Co. Ltd. said they expanded their partnership by adding two new agreements. The first covers a two-year research collaboration, with Ardelyx executing a research plan, in which Kyowa Kirin will also join, to advance two of its ongoing programs focused on the identification and design of compounds to two undisclosed targets. In return, Kyowa Kirin will pay $10 million ($5 million a year for two years) to support the ongoing research. At the end of the research period, Kyowa Kirin will have the option to license any candidates nominated by the companies for further development and commercialization in certain specified territories, with additional commitments payable to Ardelyx of up to $10.5 million in up-front fees and up to $500 million in development and sales milestones. In the second agreement, Kyowa Kirin has made a $20 million equity investment in Ardelyx for 2.87 million shares at $6.96 each. Ardelyx's cardiorenal pipeline includes tenapanor in phase III development for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis, and RDX-013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease.
Berkeley Lights Inc., of Emeryville, Calif., said Incheon, South Korea-based Samsung Biologics Co. Ltd. has become the first Korean company to use its optofluidic platform for cell line development. It will allow the company to reduce the timeline for cell line development and bolster its capabilities as an end-to-end solution provider for drug development and manufacturing. The Beacon platform is designed to rapidly screen thousands of clones simultaneously while measuring valuable parameters, such as growth rate or IgG production, Berkeley Lights said. The characteristic profiles that result for each clone help to quickly inform selection of stable and high-producing cell lines.
Biosyent Pharma Inc., a subsidiary of Mississauga, Ontario’s Biosyent Inc., signed an exclusive license and supplement agreement with New Zealand’s AFT Pharmaceuticals Ltd. for a portfolio of pain management products in Canada, including Combogesic (also known as Maxigesic). Health Canada recently approved the first form of Combogesic, and Biosyent plans to launch the product next year in Canada.
Data from Lund, Sweden-based Camarus AB’s DEBUT study of weekly and monthly Buvidal (prolonged-release buprenorphine) vs. standard of care with daily sublingual buprenorphine in 120 randomized outpatients at six clinical sites in Australia met its primary endpoint, demonstrating superiority for the Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction score (p=0.0143), as well as significantly higher TSQM effectiveness and convenience domain scores (p<0.0001). Patients treated with Buvidal reported statistically significant improvements in quality of life, reduced burden of treatment and other secondary outcomes vs. daily standard of care.
CNS Pharmaceuticals Inc., of Houston, granted Poland’s WPD Pharmaceuticals Sp. z o.o. the rights to research, develop and manufacture or sell Berubicin in an area composed mainly of Eastern Europe and Central Asia. CNS receives a 1% royalty on all commercial sales in the territory. WPD has a $2 million minimum expenditure on the development, testing, regulatory approval and commercialization of Berubicin during the agreement’s three-year term. WPD plans a multicenter pediatric phase I trial to determine the maximum tolerated dose and to determine the efficacy of Berubicin in phase Ib and II trials in adults. WPD also plans preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as cancer drugs.
The Institute for Clinical and Economic Review (ICER) evidence report on the comparative clinical effectiveness and economic value of JAK inhibitors for treating rheumatoid arthritis found, in a head-to-head trial comparing upadacitinib (Rinvoq) to adalimumab (Humira), both sold by North Chicago-based Abbvie Inc., that upadacitinib is associated with statistically significant but modestly higher rates of disease remission and improvement in other important outcomes. Providing moderate certainty, ICER noted, that upadacitinib offers a small to substantial net health benefit over adalimumab. Separate evidence provides high certainty that tofacitinib, sold as Xeljanz by New York-based Pfizer Inc., offers a comparable net health benefit to adalimumab, ICER continued, adding that there is no evidence to compare baricitinib (Olumiant, Eli Lilly and Co.) to adalimumab. When comparing JAK inhibitors to conventional disease-modifying antirheumatic drugs (cDMARDs), ICER said the evidence provides high certainty that both upadacitinib and tofacitinib offer a substantial net health benefit. The evidence is insufficient to compare baricitinib to the cDMARDs, ICER concluded.
Findings from Staines-Upon-Thames, U.K.-based Mallinckrodt plc showed using Acthar Gel was associated with improved overall health status in 95% of patients as reported by physicians' assessments, with more than half of patients (54%) seeing improvements in two or more symptoms. An association also was observed between use of Acthar Gel therapy and reduced overall use of other medications. Injectable Acthar Gel is FDA-approved to treat 19 indications, including symptomatic sarcoidosis.
Maxivax SA, of Geneva, received a €2.78 million ($3.1 million) European Commission grant and closed a series B2 round of $5 million from new and existing investors to support clinical development programs that include an ongoing multicentric efficacy phase II trial for advanced, refractory head and neck cancers. Maxivax plans an international phase II study in a yet to be disclosed rare cancer indication. The funds will also be used to scale up production of the company’s lead compound, MVX-ONCO-1.
Motif Bio plc, of New York, said it is delisting the company’s American depository shares and listed warrants from Nasdaq following a review of "the administrative burden and costs and benefits of being a Nasdaq-listed, reporting company, as well as the uncertainties of the company being able to regain and maintain compliance with the Nasdaq requirements for continued listing."
Q Biomed Inc., of New York, said its technology research partner, Mannin Research Inc. presented new data showing that the Ang-Tie2 signaling pathway is a promising therapeutic target to prevent acute kidney injury after ischemia caused by ischemia-reperfusion injury to the kidney at the American Society for Nephrology meeting in Washington. The companies have been partners since 2015 and Q Biomed has an exclusive option on all Mannin portfolio assets.
Soricimed Biopharma Inc., of Toronto, highlighted a review of recent work on the cancer target TRPV6, which its lead candidate SOR-C13 inhibits, in a recent edition of the Journal of Cancer. SOR-C13, the first TRPV6 inhibitor to enter trials, according to the company, is being tested at MD Anderson Cancer Center as a potential treatment for late-stage pancreatic cancer patients in an investigator-initiated phase Ib trial.
Taurx Therapeutics Ltd., of Aberdeen, Scotland, said a new analysis of completed phase III trials of the tau aggregation inhibitor hydromethylthionine, previously referred to as LMTM, found that even with an 8-mg/day dose, the majority of patients had high enough blood levels of the drug to produce meaningful reductions in cognitive decline and brain atrophy.
Woolsey Pharmaceuticals Inc., of New York, completed a license agreement with Tokyo-based Asahi Kasei Pharma Corp. for rights to develop, manufacture and commercialize its drug, fasudil, a Rho-kinase inhibitor, in the U.S., Europe, and all other territories outside of Japan, China, South Korea and Taiwan. An injectable formulation of fasudil hydrochloride has been launched in Japan and China for the improvement of cerebral vasospasm and associated cerebral ischemic symptoms following surgery for subarachnoid hemorrhage. Woolsey intends to reformulate the drug into an oral medication and repurpose it for new indications, initially focusing on the treatment of rare, neurodegenerative diseases. The agreement included an undisclosed up-front payment and development milestones as well as royalties and sales milestones.