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Monday, 11/02/2015 5:38:20 PM

Monday, November 02, 2015 5:38:20 PM

Post# of 22684
Finally some good news!

Axovant announces Nelotansarin news

Axovant Announces Expansion Of Dementia Drug Development Pipeline And Reports Financial Results For The Second Fiscal Quarter And Six Months Ended September 30, 2015

11.02.2015
- Acquired global rights to nelotanserin, a potential best-in-class 5HT2A inverse agonist- Two clinical studies with nelotanserin planned to start in early 2016 to address multiple aspects of Lewy body dementia- Expanded RVT-101 development program to include a phase 2b study for the treatment of dementia with Lewy bodies- Expansion of pipeline adds multiple key clinical catalysts- Axovant senior management team to host conference call and presentation today at 4:30 p.m. ET

HAMILTON, Bermuda, Nov. 2, 2015 /PRNewswire/ -- Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced an expansion of its dementia drug development pipeline with the acquisition of nelotanserin and the addition of three new clinical programs to address cognitive, behavioral and functional aspects of Lewy body dementia, a disease affecting approximately 1.4 million people in the U.S. The Company also provided an update on its ongoing Phase 3 development program for RVT-101 to treat Alzheimer's disease. In addition, the Company reported financial results for the second fiscal quarter and first half of 2015.
Axovant Sciences

"Consistent with our mission, we have expanded our development pipeline in a capital-efficient manner that we believe will enable Axovant to create value for patients and our shareholders," stated Vivek Ramaswamy, Chief Executive Officer of Axovant Sciences, Inc. "The acquisition of global rights to nelotanserin and the addition of a development program for RVT-101 in dementia with Lewy bodies should lead to multiple value-creating catalysts in 2016 and help establish Axovant as the global leader in the treatment of Lewy body dementia."

Dr. James Leverenz, Chair, Scientific Advisory Council of the Lewy Body Dementia Association and Director of the Cleveland Lou Ruvo Center for Brain Health at the Cleveland Clinic, stated, "Pharmaceutical companies have historically neglected Lewy body dementia despite its status as the second leading degenerative cause of dementia, next to Alzheimer's disease. The new development programs for RVT-101 and nelotanserin represent an important and promising step towards addressing this devastating disease, and I look forward to the progress of these exciting innovations in the field."

Acquisition of Global Rights to Nelotanserin
In October 2015, Axovant exercised its option to acquire global rights to nelotanserin from its parent company, Roivant Sciences Ltd. (RSL). RSL had previously acquired the global rights from Arena Pharmaceuticals, GmbH (Arena).

After exercising the option, Axovant paid RSL approximately $4.8 million, which includes reimbursements for amounts paid to date by RSL to Arena. Under the development, marketing and supply agreement to which Axovant is now a party, Arena is eligible to receive future payments from Axovant of up to an aggregate of $101.5 million based on the achievement of specified developmental, regulatory and commercial milestone events. Under the agreement, Arena will be the sole and exclusive manufacturer of nelotanserin for both clinical and commercial supply and will provide finished drug product to Axovant from Arena's qualified manufacturing facility in Switzerland for a price equal to 15 percent of Axovant's net sales of nelotanserin.

Axovant intends to initiate two Phase 2 clinical studies with nelotanserin in the first quarter of 2016. The first study will be in patients with either dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD) who suffer from visual hallucinations. The second study will be in DLB patients experiencing REM Behavior Disorder (RBD).

Axovant also intends, pending additional data available in 2016, to initiate programs for nelotanserin in Alzheimer's disease psychosis and Parkinson's disease psychosis.

Dominic Behan, Ph.D., D.Sc., Chief Scientific Officer and Co-Founder of Arena, commented, "We are excited to work with Axovant to bring this potentially best-in-class 5HT2A inverse agonist to market. We chose Axovant's team based on their clear leadership in the field of dementia. The impressive development plans that Dr. Larry Friedhoff and his team have created reaffirms our belief that working with Axovant will give nelotanserin the best opportunity to reach dementia patients."

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