Shares of Perrigo Company plc Ordinary Shares (NYSE:PRGO) ended Friday session in red amid volatile trading. The shares closed down -0.65 points or -0.69% at $93.30 with 4,258,590 shares getting traded. Post opening the session at $93.70, the shares hit an intraday low of $92.53 and an intraday high of $94.71 and the price vacillated in this range throughout the day. The company has a market cap of $13.37 billion and the numbers of outstanding shares have been calculated to be 143.28 million shares.
Perrigo Company plc Ordinary Shares (PRGO) on Sept. 1, 2016 announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%).
Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%) is indicated for the treatment of acne vulgaris in patients 12 years of age and older. Annual sales for the 12 months ending July 2016 were $379 million.
Perrigo’s CEO John T. Hendrickson stated, “This tentative approval is another example of Perrigo’s ongoing commitment to developing high quality value alternatives in important treatment categories. The Rx team continues to leverage Perrigo’s development capabilities in order to deliver Quality Affordable Healthcare Products® to our customers and consumers around the world.”
Shares of Eli Lilly and Co (NYSE:LLY) ended Friday session in red amid volatile trading. The shares closed down -0.02 points or -0.03% at $78.80 with 4,255,102 shares getting traded. Post opening the session at $78.70, the shares hit an intraday low of $78.17 and an intraday high of $78.91 and the price vacillated in this range throughout the day. The company has a market cap of $86.96 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.”