Axsome Therapeutics Inc., of New York, and Veeva Systems said they established a strategic partnership to augment the build of Axsome’s Digital-Centric Commercialization (DCC) platform in preparation for the potential launch of two differentiated CNS investigational medicines, AXS-05 for depression and AXS-07 for migraine, anticipated next year. The DCC platform incorporates specialized digital tools, proprietary data and analytics, integrated systems, and an intelligent operating model that Axsome said it aims to use to optimize physician and patient engagements, enhance engagement quality, and increase the effectiveness of promotional efforts as compared to traditional approaches.
Bristol Myers Squibb Co., of New York, and Brisbane, Calif.-based Myokardia Inc. said the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with BMS’ tender offer to acquire all outstanding shares of Myocardia for a purchase price of $225 per share in cash, or approximately $13.1 billion, has expired.
Equillium Inc., of La Jolla, Calif., said data will be presented virtually, at the 2020 American College of Rheumatology Virtual Convergence meeting, demonstrating that modulation of the CD6-ALCAM pathway with itolizumab, a monoclonal antibody that selectively targets the pathway, improves kidney and skin pathology in mouse models of systemic lupus erythematosus. The studies provide further insight into the role of the CD6-ALCAM pathway in lupus nephritis, specifically in the pathogenesis of glomerulonephritis and in the wider context of systemic lupus. The findings establish that CD6 and ALCAM are overexpressed on T cells and antigen-presenting cells in models of lupus during disease. Importantly, the work highlights the role that the CD6-ALCAM pathway plays in promoting disease by creating an inflammatory environment that recruits other cells such as neutrophils and inflammatory macrophages, and that this can be ameliorated by blocking CD6.
Generex Biotechnology Corp., of Miramar, Fla., said it signed an agreement with the China CDC, Beijing Guoxin Haixiang Equity Investment Partnership and Beijing Youfeng International Consulting Co. Ltd. to develop and commercialize the Ii-Key-SARS-CoV-2 coronavirus vaccine in China. Generex will receive up-front development fees and back-end licensing payments. The partners will conduct research and development while paying all commercial approval costs including lab work, manufacturing, regulatory filings and clinical development program for regulatory approval of the vaccine in China. Should the vaccine be approved in China, Generex will earn royalties on sales.
Ionis Pharmaceuticals Inc., of Carlsbad, Calif., and its subsidiary, Akcea Therapeutics Inc., said a $75 million milestone payment from Pfizer Inc., of New York, was triggered by the latter’s start of a phase IIb study testing vupanorsen (AKCEA-ANGPTL3-LRx), an antisense oligonucleotide, in patients with elevated non-high-density lipoprotein cholesterol and triglycerides.
Jubilant Radiopharma Ltd., of Yardley, Pa., and Sofie Biosciences Inc., of Dulles, Va., entered a partnership to grow production capacity, advance the pipeline, and support novel diagnostic manufacturing and distribution in the U.S. Jubilant will invest $25 million into Sofie to accelerate readiness timelines for Sofie’s manufacturing facility in Totowa, N.J,, as well as advance its protein inhibitor program.
Three people each have been awarded $250,000 grants from Myokardia Inc., of Brisbane, Calif., to research biology and the underlying mechanisms of cardiomyopathies. They are Ju Chen, of the University of California San Diego, to study the protective role of BAG3 in heart failure, Da-Zhi Wang, of Boston Children’s Hospital, to study AAV-based strategies to define the function of long noncoding RNAs in the heart and Jorge Alegre-Cebollada, of the Spanish National Center for Cardiology Research in Madrid, to study titin allelic discrimination to uncover pathophysiology mechanisms in dilated cardiomyopathy.
Novan Inc., of Morrisville, N.C., said Nasdaq approved the company’s listing transfer, which takes effect Nov. 5. Shares will trade under the symbol NOVN. Novan’s nitric oxide-based technology platform is designed to generate macromolecular new chemical entities to treat multiple indications in dermatology, men’s and women’s health, infectious diseases and gastroenterology conditions.
Novavax Inc., of Gaithersburg, Md., said it will supply 40 million doses of its COVID-19 vaccine, NVX-CoV2373, to Australia in the first half of 2021 should the vaccine be approved by the Therapeutic Goods Administration. The company has similar agreements in the U.S., the U.K. and Canada. The candidate is engineered from the genetic sequence of SARS-CoV-2.
Ocular Therapeutix Inc., of Bedford Mass., said its application to create a Category I Current Procedural Terminology (CPT) procedure code has been granted. A permanent Category I CPT procedure code will replace the currently available Category III CPT code (0356T) for administering drug-eluting intracanalicular inserts, including Dextenza (dexamethasone ophthalmic insert) 0.4 mg, effective Jan. 1, 2022. Until then, the company said, payments to physicians are expected to continue with the service reported using CPT code 0356T.
Prothena Corp. plc, of Dublin, said it will present preclinical data from two programs in its Alzheimer’s disease portfolio at the 13th Clinical Trials on Alzheimer’s Disease Conference 2020. The programs are about next generation anti-amyloid beta (Aβ) antibodies for subcutaneous administration to improve patient access, and a multi-immunogen vaccine targeting key Aβ and tau epitopes, the two main pathological proteins involved in the cause and progression of Alzheimer’s disease, for prevention and treatment of Alzheimer’s disease. The programs center on the potential of amyloid beta monoclonal antibodies to create convenient dosing and greater patient access, and the development of a dual Aβ-tau vaccine for preventing and treating Alzheimer’s disease.
Salliant Therapeutics BV, of Nijmegen, the Netherlands, said it obtained proof of concept for its lead compound, ST-02, indicated for the treatment of heart failure. The compound was tested in a well-established preclinical heart failure model in which it induced a clear reversal to normal of the functional impairments in heart failure, such as cardiac output and ejection fraction. Moreover, histological reversal demonstrated an unprecedented rejuvenation of myocardial tissue. Salliant said it expects to start clinical trials within one to two years.