Anavex Life Sciences Corp (AVXL)

[georgejjl]

LATE BREAKING NEWS

Thursday, December 8

6:15 -7:15 PM EXPEDITION3: A Phase 3 Trial of Solanezumab in Mild Dementia due to Alzheimer's Disease Presentation and Panel Discussion

http://www.ctad-alzheimer.com/ctad-abstracts

On the very first day of the conference, Thursday Dec. 8, 2016, CTAD will start with news regarding Eli Lilly's high profile monoclonal anti-body Solanezumab. So CTAD will start the conference with news that appears to be not so good. Anavex will make an oral presentation on the very last day of the CTAD conference, Saturday Dec. 10, 2016. Do you think that CTAD would want to end on a high note or a low note?

This is just an observation and a thought. It might be just a coincidence and the order of presntation could be random chance. Or not. Just food for thought.

Saturday, December 10
8.45 a.m OC60 - 9-Months and 12-Months Safety and Exploratory Efficacy Data of ANAVEX 2-73 in a Phase 2a Study
in Mild-to-Moderate Alzheimer’s Disease Patients
Stephen Macfarlane, MD1
, Marco Cecchi, PhD2
, Paul Maruff, PhD3
, Kristina M Kapiak4
, Christopher U Missling, PhD4
(1) Caulfield Hospital, Melbourne, Australia, (2) Neuronetrix, Louisville, KY, USA, (3) Cogstate Ltd., Melbourne, Australia, (4) Anavex Life Sciences Corp., New York, NY,
USA

Lilly Announces Top-Line Results of Solanezumab Phase 3 Clinical Trial

INDIANAPOLIS, Nov. 23, 2016 /CNW/ -- Eli Lilly and Company (NYSE: LLY) today announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a phase 3 study of solanezumab in people with mild dementia due to Alzheimer's disease (AD).


Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=.095), as measured by the ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive subscale).

While the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small. There were no new safety signals identified in the study. Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease.

"The results of the solanezumab EXPEDITION3 trial were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer's disease," said John C. Lechleiter, Ph.D., chairman, president and chief executive officer, Lilly. "We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets."

Lilly will work with investigators to appropriately conclude the open-label extensions for EXPEDITION, EXPEDITION2 and EXPEDITION3. The next steps for the remaining elements of the solanezumab development program have not yet been determined.

"Lilly is grateful for the dedication of the patients, their families, and the clinical investigators who participated in this study," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "Lilly remains committed to Alzheimer's research as we have been for nearly 30 years, and our portfolio includes many other promising approaches."

Lilly will present further findings from the study at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on Thursday, December 8th at 9:15 p.m. ET. The presentation will be shared live via webcast from the meeting. To access the webcast, please visit http://www.ctad-alzheimer.com.

"Lilly has strong growth prospects without solanezumab," said David A. Ricks, Lilly's incoming chief executive officer and president of Lilly Bio-Medicines. "Driven by new product launches, we continue to expect to grow average annual revenue by at least 5 percent between 2015 and 2020. Over that time frame, we also expect to increase our margins and provide annual dividend increases to our shareholders."

The EXPEDITION3 study outcome is expected to result in a fourth-quarter charge of approximately $150 million (pre-tax), or approximately $0.09 per share (after-tax). The company will provide updated 2016 financial guidance and announce its 2017 financial guidance on December 15, 2016 and will also conduct a conference call with the investment community and media at 9:00 a.m. ET on that date, instead of on the originally-scheduled date of January 4, 2017.

Good luck and GOD bless,

George