Tuesday, December 18, 2018
Tilray signs global collaboration agreement with Sandoz
Tilray Canada, a subsidiary of Tilray (TLRY), announced that it entered into a global framework agreement to collaborate with Sandoz, a part of Novartis (NVS) group, to increase availability of high quality medical cannabis products across the world. An evolution of an existing alliance between Tilray and Sandoz Canada, the Framework Agreement represents the intentions of the two companies to jointly operate in jurisdictions where cannabis is or will be approved for medical purposes. Tilray has products available in twelve countries and operations in Australia & New Zealand, Canada, Germany, Latin America, and Portugal. This agreement builds on Tilray’s pioneering track-record as a company committed to making pharmaceutical-grade medical cannabis products available to patients in-need. Tilray was the first licensed medical cannabis producer in North America to obtain current Good Manufacturing Practice certification in accordance with the European Medicines Agency’s standards. The Framework Agreement outlines the opportunity for the companies to agree to collaborate in different forms: Sandoz AG may support the global commercialization of Tilray’s non-smokable/non-combustible medical cannabis products; Tilray and Sandoz AG may co-brand certain non-smokable/non-combustible products; Tilray may supply non-smokable/ non-combustible medical cannabis products and license rights to and from Sandoz AG in relation to such products; Both companies may also partner to leverage best-in-class knowledge to educate pharmacists and physicians about medical cannabis products; Tilray and Sandoz AG may collaborate to develop new innovative medical cannabis products.
https://thefly.com/landingPageNews.php?id=2838585
Vertex receives Breakthrough Therapy designation from FDA for VX-150
Vertex announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to VX-150 for the treatment of moderate-to-severe acute pain. Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint or endpoints. Vertex recently initiated a Phase 2b dose-ranging study evaluating VX-150 in patients with acute pain following bunionectomy surgery. The study is designed to evaluate multiple oral doses of VX-150 to potentially support pivotal development. Vertex now has positive Phase 2 data for VX-150 in multiple pain conditions, including chronic pain caused by osteoarthritis and small fiber neuropathy, as well as acute pain following bunionectomy surgery. The company continues to invest in the discovery and development of other potential pain molecules that target NaV1.8 and other new pain mechanisms and anticipates initiating clinical development with the first of these molecules in 2019.
https://thefly.com/landingPageNews.php?id=2838595
Medigus in advanced talks to license MUSE technology
Medigus announced that it is in advanced negotiations to grant a license or licenses to its MUSE technology Globally and/or in greater China. For this purpose, Medigus commenced advanced talks with relevant multi-national medical device companies and is expected to receive upfront payments that may add up to millions of U.S. dollars should such transactions close.
https://thefly.com/landingPageNews.php?id=2838609
Evofem top-line data ‘reveals convincing efficacy,’ says Cantor Fitzgerald
Cantor Fitzgerald analyst Matthew Lillis reiterates an Overweight rating on Evofem with a $9 price target saying yesterday’s top-line data release “reveals convincing efficacy.” The analyst continues to believe that Amphora, if successfully approved, could become an important new contraceptive modality. The results of the AMP002 pivotal trial support that Amphora is safe and effective, Lillis tells investors in a research note. He believes that as a non-hormonal contraceptive, Amphora should appeal to women who want to avoid use of hormone-based products out of concern for safety and side effects.
https://thefly.com/landingPageNews.php?id=2838615
Aclaris data positive despite patient withdrawals, says Cantor Fitzgerald
Aclaris Therapeutics’ data for ATI-502 were positive, despite patient withdrawals by participants that were typically lost to follow-up or who withdrew due to lack of effect, Cantor Fitzgerald analyst Louise Chen tells investors in a research note titled “Don’t Need a Gingerbread Man to Make Your Life Sweet; Catch ACRS’s Stock Instead.” She believes the positive updates underscore that Aclaris’ drugs “can treat tough patient populations and provide a positive read-through to additional readouts coming in 2019.” The data also demonstrate that a topical JAK can work, contends the analyst. Chen keeps an Overweight rating on Aclaris Therapeutics with a $50 price target.
https://thefly.com/landingPageNews.php?id=2838623
Monday, December 17, 2018
Concert Initiates Phase 1 for the Treatment of Schizophrenia
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has initiated its Phase 1 clinical program for CTP-692, which is being developed as a novel adjunctive treatment for schizophrenia, a devastating, chronic illness with significant unmet need. CTP-692 is a deuterated form of D-serine, an endogenous co-agonist of the N-methyl-D-aspartate (NMDA) receptor, which has been demonstrated to be important to mood, memory, and cognition. Concerts Phase 1 program will include a crossover pharmacokinetic comparison of CTP-692 to D-serine and single- and multiple-ascending dose studies to assess the safety, tolerability and pharmacokinetic profile of CTP-692 in healthy volunteers. Initial Phase 1 data are expected in the first quarter of 2019.
Significant unmet need still exists to improve upon the existing standard-of-care in schizophrenia and we believe CTP-692 has the potential to act on a key mechanism not addressed today with currently available agents. By enhancing NMDA receptor activity, CTP-692 offers the promise of improved clinical outcomes for patients with schizophrenia, said James Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. We plan to advance CTP-692 through Phase 1 and then into a single Phase 2 efficacy trial in patients with inadequately controlled symptoms of schizophrenia in 2019.
The Phase 1 program is expected to enroll approximately 80 healthy volunteers. Dosing has been initiated to assess the safety, tolerability, and pharmacokinetics of a single oral dose pharmacokinetic comparison of CTP-692 versus D-serine. Following successful completion of the crossover trial, Concert will assess the safety, tolerability, and pharmacokinetics of single-ascending oral doses of CTP-692 in a double-blind, placebo-controlled trial. The Phase 1 program will also assess multiple doses of CTP-692 dosed orally over several days in a double-blind, placebo-controlled, multiple-ascending dose trial.
The CTP-692 clinical program is supported by Concerts preclinical studies which have shown the potential for CTP-692 to improve upon the safety profile of D-serine. D-serine has been shown to cause nephrotoxicity in published preclinical studies. Concerts preclinical studies have demonstrated that selective deuterium modification resulted in increased exposure of CTP-692 relative to a similar dose of D-serine, and administration of CTP-692 resulted in no changes in serum creatinine and blood urea nitrogen at doses where D-serine caused substantial nephrotoxicity assessed by these kidney markers. These preclinical results were presented by Concert at the American College of Toxicology 2018 Annual Meeting in November 2018.
NuVasive initiated at Credit Suisse
NuVasive initiated with an Outperform at Credit Suisse. Credit Suisse initiated NuVasive with an Outperform rating and $66 price target.
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