BOSTON, Nov. 4, 2014 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today announced the addition of three new, experienced individuals to its management team. They bring significant expertise in pharmaceutical drug development and commercialization directly relevant to antibiotics. The newly expanded team will focus primarily on the development and commercialization of Paratek's broad-spectrum IV and oral once daily antibiotic candidate, omadacycline, intended for serious community-acquired bacterial infections where resistance is of concern to prescribing physicians.
"Our recently expanded management team brings a wealth of relevant experience to Paratek's leadership as we advance omadacycline into phase 3 development for serious community acquired infections and prepare for commercialization," said Michael F. Bigham, Chairman and Chief Executive Officer of Paratek.
Adam Woodrow joins Paratek as Chief Commercial Officer. Mr. Woodrow has over 20 years of experience in leading the commercialization of brands across small molecules and proteins from pre-clinical to commercial launch. Prior to joining Paratek, he led commercial development in Pfizer's Specialty Care Business Unit, launching products for rheumatoid arthritis and rare disease. In addition, he led global strategic marketing for a range of products from rare disease to acute hospital based infections, including Enbrel®, Zyvox®, ReFacto® and Benefix®. Mr. Woodrow joined Pfizer from Wyeth Pharmaceuticals, where he was Vice President and Global Business Manager for Enbrel and inflammation. In his 10 years at Wyeth Pharmaceuticals, he held senior marketing and sales positions in the United States and in Europe. He was responsible for the successful launches of medicines in the fields of anti-infectives (Tygacil®) and hemophilia (ReFacto®).
"I am extremely pleased to be leading Paratek's commercial organization and in particular preparing for the launch and commercialization of omadacycline as it commences phase 3 clinical trials next year," said Mr. Woodrow. "Omadacycline has shown great promise in the clinical studies completed to date and has a profile that Paratek management believes could enable it to become a treatment of choice for physicians when treating serious community acquired bacterial infections where resistance is of concern."
Evan Tzanis joined Paratek in September 2014 as Vice President of Clinical Development. He will oversee the clinical development program for omadacycline, including the design and operational oversight of clinical trials, biometrics and regulatory affairs. Mr. Tzanis brings over 20 years of global drug development experience in all aspects of clinical strategy, clinical operations and regulatory processes. Prior to joining Paratek, Mr. Tzanis served as Head of Clinical Operations and Biometrics at Endo Pharmaceuticals where he also had leadership responsibility in clinical and project management. During his tenure with Endo Pharmaceuticals, Mr. Tzanis was responsible for several late stage development programs, including BEMA® Buprenorphine, which successfully completed Phase 3 clinical development. Prior to joining Endo Pharmaceuticals, Mr. Tzanis was the Global Clinical Program Leader at Wyeth Pharmaceuticals and Pfizer for a number of successfully approved new products that remain on the global market today to treat a range of central nervous system disorders including panic disorder, major depressive disorder, sleep and other medical conditions, including, opioid induced constipation and rheumatoid arthritis.
In addition to Adam Woodrow and Evan Tzanis, Paratek is pleased to announce that Sue M. Perkins is also joining Paratek as Vice President, Intellectual Property. Ms. Perkins is an attorney who brings substantial experience in the protection and enhancement of pharmaceutical-related intellectual property assets to Paratek. She has worked in a law firm preparing and prosecuting both domestic and foreign patent applications. Ms. Perkins has also been in-house counsel for five different pharmaceutical companies, including Aileron Therapeutics, Avila Therapeutics and Syntonics Pharmaceuticals. Her experience spans both small molecule and bio-therapeutics and she is a former patent examiner at the US Patent and Trademark office.
Omadacycline is a new once daily intravenous and oral tetracycline-derived, broad-spectrum antibiotic being developed for use as a first-line monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections (ABSSSI), community acquired bacterial pneumonia (CABP) and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Omadacycline was designed to provide broad-spectrum activity, and possibly shorter hospital stays, by allowing for the completion of therapy at home with an oral formulation, thereby potentially positioning omadacycline to become the primary antibiotic choice of physicians for the treatment of serious community-acquired bacterial infections.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is a new tetracycline-derived, broad-spectrum antibiotic being developed in both oral tablet and intravenous formulations for use as a first-line monotherapy antibiotic for ABSSSI, CABP, urinary tract infections (UTI) and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Paratek has Special Protocol Assessment agreements with the FDA for the phase 3 trials planned in ABSSSI and CABP.
Paratek's second product candidate, WC 3035 (sarecycline), is a new tetracycline-derived compound, with dual narrow-spectrum antibacterial and potent anti-inflammatory activity, for the treatment of acne and rosacea in the community setting. Paratek has licensed rights to WC 3035 for the treatment of acne and rosacea in the United States to a subsidiary of Actavis (formerly Warner Chilcott), while retaining rights in the rest of the world. Actavis is responsible for the clinical development of WC 3035 for the treatment of acne in the United States. A phase 3 program in moderate-severe acne is expected to be initiated in 2014 for WC 3035.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Paratek's ability to develop its drug candidates for potential commercialization, the timing of the commencement of omadacycline phase 3 trials for ABSSSI and CABP, the potential for omadacycline to be successfully developed for use as a first-line empiric monotherapy for patients suffering from serious community-acquired bacterial infections, the potential of omadacycline to become the primary antibiotic choice of physicians for the treatment of serious community-acquired bacterial infections, including ABSSSI, CABP and UTI, the potential use and effectiveness of WC 3035 (sarecycline) for the treatment of acne and rosacea in the community setting, the timing of the commencement of a phase 3 program in moderate-severe acne for WC 3035, and the value that the new members of management are expected to bring to Paratek. Paratek may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Paratek makes, including the risks that Paratek's planned clinical trials may be prolonged or delayed requiring Paratek to incur additional costs; that Paratek's planned clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities; that Paratek's product candidates may have undesirable side effects which may delay or prevent marketing approval; that, even if approved by the FDA or non-U.S. regulatory authorities, Paratek's product candidates may not achieve broad market acceptance; and the risks described in the "Risk Factors" sections of the Registration Statement on Form S-4 (file no. 333-298464) and of Paratek's periodic reports filed with the SEC. Paratek does not assume any obligation to update any forward-looking statements, except as required by law.
CONTACT: Paratek Pharmaceuticals, Inc. Evan Loh President and Chief Medical Officer (617) 275-0040 x223 eloh@Paratekpharm.com Investor Relations Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568 email@example.comSource:Paratek Pharmaceuticals