Navigation Links
Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on Efficacy Results
Date:8/29/2012

INDIANAPOLIS, Aug. 29, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the decision to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from schizophrenia. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. The decision was not based on any safety signals.

Additionally, the recently completed Phase II study, HBCO, which investigated pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint. 

Lilly is contacting study investigators to outline specific actions related to the close-out of each ongoing study. Lilly will work with study investigators to ensure an appropriate transition of study participants to continuing clinical care outside of the trials.

"I'm disappointed in what these results mean for patients with schizophrenia who still are searching for options to treat this terrible illness," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories.  "While there are many challenges in this complex field of research, neuroscience remains a core area of focus at Lilly. Our clinical development pipeline includes nearly a dozen neuroscience molecules being studied to treat illnesses such as depression, bipolar disorder and cognitive impairment associated with schizophrenia."

The decision to stop ongoing Phase III development of pomaglumetad methionil is expected to result in a third-quarter charge to R&D expense in the range of $25 million to $30 million (pre-tax), or approximately $0.02 per share (after-tax).  The company's previously-issued financial guidance for 2012 remains unchanged.

About Lilly's Pipeline
Lilly currently has a number of unique potential medicines in its Phase III clinical development pipeline, representing a variety of therapeutic areas including diabetes (4), cancer (3), neuroscience (2) and autoimmune diseases (2).  To learn more about the molecules in Lilly's clinical development pipeline, please visit Lilly's interactive pipeline website available at Lilly.com/pipeline.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains forward-looking statements about the impact of ending studies of pomaglumetad methionil for the treatment of schizophrenia, and reflects Lilly's current beliefs. The financial information included in this release is an estimate only. For further discussion of risks and uncertainties affecting the company's business, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

P-LLY

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. U.S. Court of Appeals Upholds Validity of Lillys Alimta Compound Patent
2. Lilly Revises 2012 Reported Guidance to Reflect Income from Early Payment of Amylin Obligations
3. Lilly Announces Study Results Regarding Postmenopausal Women with Back Pain Caused by Vertebral Fractures
4. Lilly Supports Research to Determine What a Dogs Nose Knows About People with Diabetes and Severe Hypoglycemia
5. Lilly Reports Second-Quarter 2012 Results, Raises 2012 EPS Guidance
6. Lilly Confirms Date and Conference Call for Second-Quarter 2012 Financial Results Announcement
7. Lilly Announces Pomaglumetad Methionil Did Not Meet Primary Endpoint of Clinical Study
8. Lilly Diabetes Announces Once Upon A Time Contest Winner
9. Lilly Statement on Affordable Care Act Ruling by Supreme Court
10. Lilly Statement on PDUFA Vote by Senate
11. PrimeraDx Announces Commencement of Product Development Collaboration with Eli Lilly and Company
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 ... Tomorrow,s Leaders Scholarship is any indication, the future is ... online at www.diabetesscholars.org by the Diabetes Scholars ... in the way of academic and community service excellence. ... program since 2012, and continues to advocate for people ...
Breaking Medicine Technology:
(Date:6/26/2016)... Aliso Viejo, California (PRWEB) , ... June 26, 2016 , ... ... for Final Cut Pro X. , "Film editors can give their videos a whole ... artistically," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
Breaking Medicine News(10 mins):