Healthcare Industry News: TYGACIL
News Release - May 22, 2012
Paratek Announces Appointments of Dennis Molnar as Chief Executive Officer and Director and of Dr. Evan Loh as Chief Medical Officer and Chairman of the Board of DirectorsBOSTON, May 22, 2012 -- (Healthcare Sales & Marketing Network) -- Paratek Pharmaceuticals, Inc. today announced that Dennis Molnar, formerly Paratek's Vice President, Corporate Development, has been appointed President, Chief Executive Officer and Director, succeeding former CEO Thomas J. Bigger, following his resignation earlier this year. In addition, Evan Loh, MD, former senior R&D executive at Pfizer and Wyeth and who led regulatory approval for the antibiotic TYGACIL®, has joined the Company as Chief Medical Officer and as Chairman of the Board of Directors. Former Chairman, Dr. Walter Gilbert, will continue to serve on the Board as Vice Chairman.
"It has been a privilege to work with Tom Bigger and the rest of the team over the last eleven years as we have built and advanced a diversified pipeline," said Mr. Molnar. "We are excited about the addition of Dr. Loh as Chairman and Chief Medical Officer, and we look forward to the next chapter of the Company's development with his involvement."
Dr. Loh stated, "The need for new treatments for antibiotic resistance has never been greater, and many in the clinical community see an unfolding crisis that will require continued commitments to innovation, drug development expertise and close partnerships with regulatory agencies around the globe. I am excited to join the Paratek team and meet this challenge head on."
Paratek recently announced agreement with the U.S. Food and Drug Administration (FDA) on its second Special Protocol Assessment (SPA) related to the design of the Phase 3 program for the Company's lead antibiotic candidate, omadacycline (formerly PTK 0796). Omadacycline is a first-in-class aminomethylcycline antibiotic with oral and IV formulations with a broad spectrum of activity designed for community-acquired bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP) and urinary tract infections (UTIs), including serious infections that are increasingly leading to hospitalization and where resistant bacteria are a growing clinical concern. Omadacycline is being developed for first line use as empiric monotherapy in serious community-acquired infections where the Company believes its spectrum, dosing regimen and safety profile to be advantageous, without the serious safety complications, such as sudden cardiovascular death, bone marrow suppression and kidney toxicity, that accompany some other therapies.
Additional programs at Paratek include a narrow spectrum tetracycline-derived small molecule optimized for acne and rosacea with a Phase 2 trial planned to begin later this year and preclinical programs for non-infective applications of the Company's proprietary tetracycline technology platform in spinal muscular atrophy (SMA), multiple sclerosis (MS) and rheumatoid arthritis (RA).
Mr. Molnar has 19 years of experience in the pharmaceutical and biotechnology industries, working in a variety of capacities, including business development, management, finance, and consulting. He joined Paratek in 2001, attaining the position of Vice President, Corporate Development. During his tenure at the Company, Paratek signed collaboration and licensing agreements with a broad range of organizations to advance Paratek's product portfolio. Prior to joining Paratek, Mr. Molnar was President of JBI Associates, LLC, a software and consulting firm providing services to hospital pharmacies. From 1998 to 2000, Mr. Molnar served as Director of Finance and Business Development at Magainin Pharmaceuticals. Prior to receiving his MBA in Healthcare Management from the Wharton School of Management in 1998, Mr. Molnar held a series of positions at Bogart Delafield Ferrier, Inc., a strategic management consulting firm, providing services to the pharmaceutical and biotechnology industries. Mr. Molnar earned a B.A. in Biology and Economics from Brown University.
Dr. Loh is former Senior Vice President, Development and Strategic Operations, Worldwide Research and Development, Pfizer. Prior to joining Pfizer in 2009, Dr. Loh was Vice President, Clinical Research & Development at Wyeth, where he had global responsibility for scientific, strategic and operational leadership of clinical development efforts across multiple therapeutic areas. He is the 2006 recipient of the Heroes of Chemistry Award from the American Chemical Society for his leadership role at Wyeth in the clinical development of TYGACIL®, a novel glycylcycline broad-spectrum antibiotic. Dr. Loh received his A.B. from Harvard College and his M.D. from Harvard Medical School. He completed his Internal Medicine and Cardiovascular fellowship training at Brigham and Women's Hospital in Boston, MA. Dr. Loh served as a faculty member at both Harvard Medical School and the University of Pennsylvania School of Medicine.
About Paratek Pharmaceuticals
Paratek Pharmaceuticals, Inc. is engaged in the discovery and commercialization of new therapeutics that treat serious and life-threatening diseases, with a particular focus on the growing worldwide problem of antibiotic resistance. Paratek has designed and is developing novel compounds that can circumvent or block bacterial resistance. Paratek's lead compound, omadacycline (formerly PTK 0796), is a first-in-class aminomethylcycline antibiotic with oral and IV formulations. Paratek has reached SPA agreements with the FDA for development of omadacycline in both ABSSSI and CABP. Omadacycline is active against the key organisms found in important community-acquired infections such as ABSSSI, CABP and UTI, including resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus), MDR-SP (multi-drug resistant Streptococcus pneumoniae), and extended spectrum beta-lactamase (ESBL) producing Enterobacteriaceae. As these infections have become increasingly prevalent, omadacycline is being developed by Paratek as a first-line monotherapy that may be reliably used for serious and resistant infections where hospitalization is a consideration. Omadacycline has been tested in more than 500 healthy subjects, and oral and IV formulations of omadacycline have been compared to Zyvox ® in Phase 2 and Phase 3 clinical studies in more than 350 patients with complicated skin and skin structure infections (cSSSI). The Company believes that omadacycline has the potential to become an alternative for first-line empiric monotherapy in serious community-acquired infections such as CABP and ABSSSI that would potentially avoid the risk of sudden cardiovascular death, bone marrow suppression and kidney toxicity that accompany some other therapies.
Paratek has an active chemical synthesis effort to produce novel and diverse small molecule tetracycline derivatives that has yielded non-antibacterial compounds with improved activity in serious inflammatory and autoimmune diseases including multiple sclerosis (MS) and rheumatoid arthritis (RA). In addition, Paratek is developing distinct tetracycline derivatives that specifically modify mRNA splicing, with therapeutic potential in spinal muscular atrophy (SMA).
Paratek has active collaborations with Warner Chilcott and NIH to develop tetracycline-derived small molecule drugs for acne and rosacea and SMA, respectively. Paratek is privately held and headquartered in Boston, Massachusetts, USA. For more information, visit Paratek's website at http://www.paratekpharm.com.
Source: Paratek Pharmaceuticals
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