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ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting wit

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By Business Wirevia The Motley Fool

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ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting with FDA

Single Pivotal Phase III -020 Study and Other Supportive Data Sufficient for Future NDA Filing for the Treatment of Parkinson’s Disease Psychosis

Conference Call and Webcast to Be Held Today, April 11, 2013, at 8:00 am Eastern Time

SAN DIEGO–(BUSINESS WIRE)– ACADIA Pharmaceuticals Inc. (NAS: ACAD) , a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson’s disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month.

ACADIA is currently focused on completing the remaining elements of its pimavanserin PDP development program that are needed for submission of an NDA. These include customary supportive studies, such as drug-drug interaction studies, and CMC development, such as stability testing of registration batches. Subject to changes that could result from future interactions with the FDA or other developments, ACADIA is currently targeting an NDA submission near the end of 2014. While the FDA has agreed to accept and review an NDA for pimavanserin on the basis of ACADIA‘s positive pivotal -020 study, along with supportive efficacy and safety data from other pimavanserin studies, the NDA will be subject to a standard FDA review to determine whether the filing package is adequate to support approval of pimavanserin for PDP.

“We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program,” said Uli Hacksell, Ph.D., ACADIA‘s Chief Executive Officer. “This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson’s patients who suffer from the psychosis frequently associated with this disease.”

Conference Call and Webcast Information

From: http://www.dailyfinance.com/2013/04/11/acadia-pharmaceuticals-announces-expedited-path-to/

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ACADIA Pharmaceuticals Reports Financial Results for the Fourth Quarter and Year Ended December 31,

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ACADIA Pharmaceuticals Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2012

SAN DIEGO–(BUSINESS WIRE)– ACADIA Pharmaceuticals Inc. (NAS: ACAD) , a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced its financial results for the fourth quarter and year ended December 31, 2012.

ACADIA reported a net loss of $6.8 million, or $0.11 per common share, for the fourth quarter of 2012, compared to a net loss of $5.3 million, or $0.10 per common share, for the fourth quarter of 2011. For the year ended December 31, 2012, ACADIA reported a net loss of $20.8 million, or $0.38 per common share, compared to a net loss of $22.8 million, or $0.44 per common share, for 2011.

At December 31, 2012, ACADIA‘s cash, cash equivalents, and investment securities totaled $108.0 million compared to $31.0 million at December 31, 2011. This increase was primarily due to $98.2 million in net proceeds from sales of equity securities, including $80.5 million raised in an equity financing in December as well as earlier financings completed by ACADIA, offset in part by cash used to fund ACADIA‘s operations.

“2012 was a transformational year for ACADIA, highlighted by the impressive results from our pivotal Phase III trial with pimavanserin in Parkinson’s disease psychosis and the strengthening of our balance sheet through our successful financing,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “We are now positioned with a strong foundation to continue to advance our pimavanserin Phase III Parkinson’s disease psychosis program toward registration and to strategically broaden this program to address other neurological disorders. This includes plans to initiate our second, confirmatory pivotal Phase III Parkinson’s disease psychosis trial in the first half of this year and a Phase II trial in Alzheimer’s disease psychosis in the second half of the year. We believe that our pipeline of product candidates, spearheaded by pimavanserin, provides ACADIA with multiple attractive product and commercial opportunities and significant growth potential.”

Revenues totaled $380,000 for the fourth quarter of 2012 compared to $588,000 for the fourth quarter of 2011, and were comprised of revenues from ACADIA‘s collaborations with Allergan as well as its agreements with other parties. The decrease in revenues was primarily due to the termination of ACADIA‘s collaboration with Meiji Seika Pharma Co., Ltd. in July 2012. This agreement contributed $199,000 of revenue during the fourth quarter of 2011.

Research and development expenses increased to $4.9 million for …read more
Source: FULL ARTICLE at DailyFinance