NEW YORK, March 26, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the appointment of John A. Bardi as Senior Vice President for Market Access, Policy and Government Affairs. Mr. Bardi has over 30 years of biopharmaceutical and health system industry experience with a strong track record of innovation and building high-performing Market Access, Government Affairs, and Digital Medicine business development teams and capabilities across many disease areas. He has been an industry leading voice in the Mental Health Policy and Advocacy field through his commitment to ensuring patients who are suffering from serious mental health diseases have access to treatments and services that they require.
“Critically important to our preparation for the commercialization of lumateperone is hiring strong talent to comprise the Commercial Leadership Team. I am very pleased that, with the addition of John, we now have senior leaders in place across the commercialization functions, including the Heads of Marketing, Sales, Market Access & Government Affairs, and Strategy & Commercial Development,” said Mark Neumann, Executive Vice President and Chief Commercial Officer.
Mr. Bardi joins ITCI from Otsuka America Pharmaceuticals, Inc where he was initially recruited as Vice President, Market Access, Policy Advocacy, and Government Affairs to build and establish new functions and capabilities to support their products including Abilify®, Abilify Maintena® and Rexulti®. Most recently Mr. Bardi led the Payer & Integrated Delivery Networks Business Development efforts in support of the launch of the first FDA approved Digital Medicine Product.
Prior to Otsuka, Mr. Bardi spent 7 years at Bristol-Myers Squibb (BMS) where he served as one of the original members of the US Abilify® Marketing team leading the Payer, Pricing and Advocacy function. In his final years at BMS, Mr. Bardi was Vice President for Market Access leading the function and field based teams in support of BMS’ full portfolio of products including Neuroscience, Cardiology, and Oncology.
John received his Bachelor of Arts in Public Administration from West Chester University of Pennsylvania and his Masters in Health Services Administration from The George Washington University in Washington, DC.
“I am delighted to join the leadership team at Intra-Cellular Therapies in supporting the commercial preparedness for the potential launch of lumateperone and contributing to our mission of improving the lives of patients suffering from serious mental illness. In support of these efforts and on behalf of ITCI, I will continue to be a strong voice in advancing those policies that provide the mental health community with necessary access to the treatments and services that they need,” said Mr. Bardi.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. Lumateperone is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression. Intra-Cellular Therapies is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company's PDE1 portfolio, ITI-214, is in development for the treatment of symptoms associated with Parkinson's disease and for the treatment of heart failure.
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, potential approval by the FDA of the NDA for lumateperone for the treatment of schizophrenia; potential commercialization of lumateperone; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: whether the NDA for lumateperone for the treatment of schizophrenia will be approved by the FDA and whether the FDA will complete its review within the target timelines; the risk that the NDA will not be approved despite the FDA’s acceptance of the NDA for review or that the FDA will require additional information; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with lumateperone in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
Burns McClellan, Inc.
Patrick Ryan, Esq.
Corporate Media Relations, W2Owcg
Source: Intra-Cellular Therapies Inc.