Shares of Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) ended Thursday session in red amid volatile trading. The shares closed down -0.34 points or -0.67% at $50.36 with 3.44 million shares getting traded. Post opening the session at $50.86, the shares hit an intraday low of $50.36 and an intraday high of $50.89 and the price vacillated in this range throughout the day. The company has a market cap of $50.92 billion and the numbers of outstanding shares have been calculated to be 1.01 billion shares.
On Sept. 20, 2016 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced a global1 agreement to develop and commercialize fasinumab, Regeneron’s investigational NGF antibody in Phase 3 clinical development for osteoarthritis pain and in Phase 2 development for chronic low back pain. Under the terms of the agreement, Teva will pay Regeneron $250 million upfront and share equally in the global commercial value, as well as ongoing research and development costs of approximately $1 billion.
“This is a significant transaction for Teva, and we look forward to our collaboration with Regeneron, a leader in the research and development of innovative biologics, which aligns with our overall corporate strategy. With our commercial footprint, we will be able to widely educate healthcare providers about this new treatment option when it becomes available,” said Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines for Teva.
“The development of novel pain medicines, such as fasinumab, can be one important step in combating the growing opioid epidemic,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. “Fasinumab represents the culmination of more than 25 years of Regeneron scientific work in neurotrophic factors. We look forward to working with Teva, a leading global pharmaceutical company with an expertise in pain therapeutics, to advance this program for patients in need.”
Under the terms of the agreement, Regeneron is eligible to receive development and regulatory milestone payments and additional payments based on net sales. Regeneron will lead global development and U.S. commercialization. The companies will share U.S. commercialization efforts by utilizing sales teams and marketing expertise from both companies, and split profit equally. In countries outside the U.S., with the exception of those covered by a previously announced collaboration agreement between Regeneron and Mitsubishi, Teva will be responsible for development and commercialization and pay Regeneron a purchase price, which allows both companies to retain approximately equal shares of fasinumab’s global commercial value over time.
“Fasinumab has shown proof of concept in early clinical trials, and represents an exciting, novel target for pain relief. Adding the promise of fasinumab to our developing pipeline of pain products also provides a strong, strategic cornerstone to our pain franchise at Teva. It has the potential to provide a treatment option without the concerns of abuse, addiction and misuse of opioids. In the United States alone, it is estimated that 30 million people suffer pain from osteoarthritis and the same number with chronic low back pain,” said Michael Hayden, President of Teva Global R&D and Chief Scientific Officer.
Shares of Celgene Corporation (NASDAQ:CELG) ended Thursday session in green amid volatile trading. The shares closed up +0.69 points or 0.64% at $108.42 with 2.62 million shares getting traded. Post opening the session at $108.42, the shares hit an intraday low of $108.10 and an intraday high of $109.20 and the price vacillated in this range throughout the day. The company has a market cap of $83.41 billion and the numbers of outstanding shares have been calculated to be 775.11 million shares.
On September 12, 2016 Celgene Corporation (CELG) announced interim topline data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease.
The trial, CD-001, is an ongoing study evaluating three different treatment regimens of GED-0301 in a 12-week treatment phase, followed by an observation phase up to 52 weeks (off treatment). The primary objective of the study is to explore the effect of GED-0301 on endoscopic outcomes. The trial enrolled a total of 63 patients across multiple countries.
The study was designed to further enhance the understanding of GED-0301 activity in a difficult-to-treat, moderate-to-severe patient population. This population was more diverse than prior GED-0301 studies and included patients with endoscopically confirmed mucosal damage at entry and those who had previous surgeries. The study also included both biologic exposed and biologic naïve patients as well as patients with a diagnosis of Ileitis, Ileocolitis or colitis.
Topline data from CD-001 show that in a proportion of patients treated with oral GED-0301 there was endoscopic improvement (defined as a 25 percent improvement from baseline) and clinical response and remission across all treatment groups at week 12. Findings to date reveal no new safety signals and tolerability is consistent with earlier studies.
“Given the high unmet need in Crohn’s disease, we are pleased that oral GED-0301 showed both endoscopic improvements and clinically meaningful responses and remission at an early timepoint in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “These data are particularly encouraging for several reasons, including the difficult-to-treat patient population evaluated in the trial.”