Shares of AbbVie Inc (NYSE:ABBV) ended Friday session in red amid volatile trading. The shares closed down XXX points or -0.08% at $-0.13 with 11,165,269 million shares getting traded. Post opening the session at $63.53, the shares hit an intraday low of $63.17 and an intraday high of $63.79 and the price vacillated in this range throughout the day. The company has a market cap of $102.91 billion and the numbers of outstanding shares have been calculated to be 1.63 billion shares.
On September 15, 2016 A new post-hoc analysis from the pivotal DECIDE study shows that a significantly greater number of people treated with ZINBRYTATM (daclizumab) achieved no evidence of disease activity (NEDA) compared to those taking AVONEX® (interferon beta-1a) intramuscular injection. The findings continue to support the positive impact of ZINBRYTA on NEDA status. Additional new interim data from the long-term extension study, EXTEND, further affirm ZINBRYTA’s efficacy on clinically meaningful measures of multiple sclerosis (MS) disease activity and provide additional information supporting ZINBRYTA’s safety profile. These results were presented by Biogen (BIIB) and AbbVie (ABBV) at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London.
“ZINBRYTA is a new, once-monthly, self-administered, subcutaneous treatment option for people living with relapsing forms of MS, including those whose disease activity has been insufficiently controlled by their prior therapy,” said Ralph Kern, M.D., senior vice president, Worldwide Medical, Biogen. “These data continue to reinforce ZINBRYTA’s robust efficacy in reducing MS relapse rates, disability progression and brain lesion development, and help further define its long-term safety profile. ZINBRYTA is now available in the United States and Germany, and will soon be introduced in additional European countries.”
New NEDA Analysis Shows Significantly Greater Efficacy Versus Interferon Beta-1a
Previously reported findings from a post-hoc analysis of the Phase 3 DECIDE study demonstrated that a significantly greater percentage of patients taking ZINBRYTA achieved NEDA status at 96 weeks compared to those taking an active comparator, AVONEX.1 A new post-hoc analysis presented at ECTRIMS examined the percentage of patients achieving NEDA status by time interval (including 24–96 weeks) to further evaluate the impact of ZINBRYTA on this measure. NEDA was defined as the composite of no clinical relapses, no 12-week confirmed disability progression, no new/newly enlarging T2 hyperintense lesions and no gadolinium-enhancing (Gd+) lesions.
Results of this new analysis show that significantly more ZINBRYTA-treated patients achieved overall NEDA status compared to AVONEX-treated patients during the first six months of treatment, and that the difference between the treatments was more evident in the 24–96 week time period:
- Baseline to week 24: 41.5 percent of ZINBRYTA patients achieved NEDA status compared to 32.6 percent of AVONEX patients (p<0.0001).
- Weeks 24–96: 44.7 percent of ZINBRYTA patients achieved NEDA status compared to 22.4 percent of AVONEX patients (p<0.0001).
“ZINBRYTA had previously demonstrated significant efficacy in helping patients achieve NEDA status compared to AVONEX at week 96. This new analysis looked at ZINBRYTA’s effectiveness on NEDA both during the first six months and the following 18 months of treatment to take into account the potential impact of pre-existing disease activity, and found the efficacy of ZINBRYTA on NEDA to be more evident at the end of the evaluation period,” said Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry.
Shares of Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) ended Friday session in green amid volatile trading. The shares closed up +0.42 points or 3.59% at $12.12 with 10.64 million shares getting traded. Post opening the session at $11.61, the shares hit an intraday low of $11.55 and an intraday high of $12.13 and the price vacillated in this range throughout the day. The company has a market cap of $2.42 billion and the numbers of outstanding shares have been calculated to be 192.71 million shares.
Ariad Pharmaceuticals, Inc. (ARIA) on August 30, 2016 announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. The Company is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which, if granted, would allow for approval of brigatinib eight months after the NDA submission, as opposed to 12 months for a standard review.
“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Corey Langer, M.D., director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania and a professor of Hematology-Oncology in Penn’s Perelman School of Medicine. “We are excited that the brigatinib NDA submission is now complete and are hopeful that brigatinib’s data, including the observation of complete responses and activity in the central nervous system, will provide patients and their oncologists with a new treatment option.”