Shares of Exelixis, Inc. (NASDAQ:EXEL) ended Friday session in green amid volatile trading. The shares closed up +0.15 points or 1.02% at $14.89 with 5.49 million shares getting traded. Post opening the session at $14.74, the shares hit an intraday low of $14.71 and an intraday high of $14.97 and the price vacillated in this range throughout the day. The company has a market cap of $3.43 billion and the numbers of outstanding shares have been calculated to be 230.33 million shares.
Exelixis, Inc. (EXEL) on September 21, 2016 provided an update on the timing of a key data presentation for cabozantinib at the European Society for Medical Oncology (ESMO) 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark. Detailed results from CABOSUN, the randomized phase 2 clinical trial of cabozantinib compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC), has been selected for the Presidential Symposium 3 session on Monday, October 10, 2016, starting at 16:30 CEST (local Copenhagen time) / 10:30 a.m. EDT / 7:30 a.m. PDT.
The full logistical details for the CABOSUN data presentation are as follows:
Oral Presentation[LBA30_PR] “CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 Trial.”
Dr. Toni Choueiri, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session: Presidential Symposium 3, Monday, October 10, 2016 – 16:30-18:10 CEST, Copenhagen room
Note: This is a National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) study.
The late-breaking CABOSUN abstract was initially slated for an oral presentation at a Proffered Paper session on Saturday, October 8, 2016. Exelixis previously announced that data from the Exelixis-discovered compounds cabozantinib and cobimetinib would be the subject of fifteen presentations at the ESMO 2016 Congress. For full details on Exelixis’ presence at the conference, please see the company’s press release issued on August 31, 2016.
Shares of Mylan NV (NASDAQ:MYL) ended Friday session in red amid volatile trading. The shares closed down -0.53 points or -1.24% at $42.06 with 5.36 million shares getting traded. Post opening the session at $42.69, the shares hit an intraday low of $41.95 and an intraday high of $42.69 and the price vacillated in this range throughout the day. The company has a market cap of $22.50 billion and the numbers of outstanding shares have been calculated to be 534.91 million shares.
Mylan NV (MYL) on Sept. 1, 2016 announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of Mylan in its inter partes review (IPR) proceeding and found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd., unpatentable. This is the third patent related to Copaxone® 40 mg/mL to be found unpatentable in the last week.
On Aug. 24, the PTO’s Patent Trial and Appeal Board (PTAB) found Teva’s first two patents, U.S. Patent Nos. are 8,232,250 and 8,399,413, unpatentable in Mylan’s IPR challenge of these patents.
Mylan CEO Heather Bresch commented, “Through significant investment in research and development and by challenging these invalid patents, we are working to bring a more affordable generic alternative of Copaxone® to market. Challenging patents is just one of the ways that Mylan helps to ensure patient access to medicines. In the last few years alone, Mylan’s patent challenges have allowed earlier access to generic competition for brand products equating to nearly $20 billion in annual brand sales product and reducing more than 60 years of patent life that otherwise could have blocked generics from entering the market.”
On Aug. 15, the PTAB found Mylan’s petition against a fourth Copaxone 40 mg/mL patent, U.S. Patent No. 9,155,776, ineligible for post-grant review for procedural reasons. However, Mylan believes that favorable ruling in the IPR against the ‘302 patent and the earlier favorable rulings in Mylan’s IPRs against the ‘250 and ‘413 patents strongly undermines the ‘776 patent as well. As such, Mylan will proceed with pursuing all avenues to challenge the ‘776 patent.
Mylan believes it is one of the first companies to have filed a substantially complete abbreviated new drug application containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.
Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.