Shares of Eli Lilly and Co (NYSE:LLY) ended Monday session in red amid volatile trading. The shares closed down -1.65 points or 2.03% at $79.52 with 4.33 million shares getting traded. Post opening the session at $81.00, the shares hit an intraday low of $79.50 and an intraday high of $81.15 and the price vacillated in this range throughout the day. The company has a market cap of $87.64 billion and the numbers of outstanding shares have been calculated to be 1.10 billion shares.
Eli Lilly and Co (LLY) on Sept. 16, 2016 announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the granting of a conditional marketing authorization for olaratumab, in combination with doxorubicin, for the treatment of adults in the European Union (EU) with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin. The CHMP reviewed olaratumab under EMA’s accelerated assessment program. If approved, olaratumab will be marketed under the trade name LARTRUVO™.
This is the first regulatory step in the world towards approval for olaratumab. The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing authorization in the EU. The Commission usually makes a decision on marketing authorization within two to three months of the CHMP issuing its recommendation.
“Patients with advanced soft tissue sarcoma have been seeking new treatment options that can potentially extend lives, so they can have more time with their families and loved ones,” said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. “Advanced soft tissue sarcoma is a rare disease that is difficult to treat, and this milestone brings us one step closer to providing physicians in Europe with a new option that they can offer to their patients.”
Shares of Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) ended Monday session in red amid volatile trading. The shares closed down -1.20 points or 2.33% at $50.27 with 4.24 million shares getting traded. Post opening the session at $51.11, the shares hit an intraday low of $50.12 and an intraday high of $51.15 and the price vacillated in this range throughout the day. The company has a market cap of $50.67 billion and the numbers of outstanding shares have been calculated to be 1.01 billion shares.
On Sept. 20, 2016 Regeneron Pharmaceuticals, Inc. (REGN) and Teva Pharmaceutical Industries Ltd. (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 global1 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.”