Montreal, QC, CA, May 11, 2017 – Milestone Pharmaceuticals Montreal, Canada, Inc., a clinical stage cardiovascular company, today announced positive data from its Phase 2 NODE-1 trial evaluating etripamil, a novel, potent, fast-acting and short-acting calcium channel blocker in development for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT), a potentially debilitating cardiac arrhythmia. The data were presented in a late breaking oral presentation at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions in Chicago. The results from the Phase 2 NODE-1 trial show that etripamil demonstrated statistically significant efficacy compared to placebo for the acute termination of PSVT induced in an electrophysiology laboratory.
Milestone Pharmaceuticals Announces Etripamil Phase 2 Clinical Program Success for the Treatment of Paroxysmal Supraventricular Tachycardia
TESARO Announces U.S. FDA Approval of ZEJULA™ (niraparib) for Women with Recurrent Ovarian Cancer
WALTHAM, MA, March 27, 2017 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULA™ (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum based chemotherapy. ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. TESARO anticipates launching ZEJULA in the United States in late April.
Milestone Pharmaceuticals Announces Appointment of Joseph G. Oliveto as Chief Executive Officer
MONTREAL, March 7, 2017 – Milestone Pharmaceuticals USA, Inc., a clinical stage cardiovascular company, today announced the appointment of Joseph G. Oliveto as President and Chief Executive Officer, effective immediately. His appointment follows a recent, successful outcome from the company's Phase 2 study of lead candidate etripamil for the acute treatment of paroxysmal supra-ventricular tachycardia (PSVT), a potentially debilitating cardiac arrhythmia. Mr. Oliveto brings more than 25 years of pharmaceutical and biotech experience across the areas of drug development, commercialization, manufacturing and business development to Milestone. Philippe Douville, Ph.D., who founded the company and served as CEO, will now assume the newly created position of Chief Scientific Officer.
Lilly Completes Acquisition of CoLucid Pharmaceuticals
INDIANAPOLIS, IN, March 1, 2017 – Eli Lilly and Company (NYSE:LLY) today announced the successful completion of its acquisition of CoLucid Pharmaceuticals, Inc. (NASD:CLCD). The tender offer for all outstanding shares of common stock of CoLucid, at a price of $46.50 per share, expired as scheduled on Tuesday, February 28, 2017.
Envisia Therapeutics Releases Interim ENV515 (Travoprost XR) Phase 2 Data Demonstrating 11-Month Duration-of-Action After a Single Dose in Patients With Glaucoma
RESEARCH TRIANGLE PARK, N.C., Feb. 3, 2017 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of the second cohort of its ENV515 (travoprost XR) phase 2 trial in patients with glaucoma showing a clinically meaningful reduction in intraocular pressure (IOP) for the entire 11-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
Lilly and CoLucid Pharmaceuticals Announce Agreement for Lilly To Acquire CoLucid
INDIANAPOLIS, IN and CAMBRIDGE, MA, January 18, 2017 – Eli Lilly and Company (NYSE: LLY) and CoLucid Pharmaceuticals, Inc. (Nasdaq: CLCD) today announced an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million. This all-cash transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.
Envisia Therapeutics Releases ENV515 (travoprost XR) Phase 2 Data Showing Nine-Month Duration Of Action After A Single Dose In Patients With Glaucoma
RESEARCH TRIANGLE PARK, N.C., Oct. 17, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
Athersys Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Study of MultiStem® Treatment for Ischemic Stroke
CLEVELAND, Sept. 28, 2016 – Athersys, Inc. (NASDAQ:ATHX) announced today that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys' novel MultiStem® cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys' planned Phase 3 study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase 3 trial entitled, "MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2" (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.
CoLucid Pharmaceuticals Announces Achievement of Both Primary and Key Secondary Endpoints in the SAMURAI Phase 3 Pivotal Trial of Lasmiditan in Migraine
CAMBRIDGE, Mass., September 6, 2016 – Cambridge, MA, September 6, 2016 -- CoLucid Pharmaceuticals, Inc., a biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura, announced today that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
Rotation Medical Secures $12 Million in Series B Extension Financing
PLYMOUTH, MN (August 16, 2016) – Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that it completed a $12 million Series B extension financing. The existing investors – New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures – all participated in the financing, which is fundable in two tranches: $8 million initially and $4 million in 2017. The company intends to use the proceeds to continue the acceleration of U.S. commercialization activities for the Rotation Medical rotator cuff system, which is comprised of a proprietary bioinductive implant and disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.
