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BOSTON, June 3, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today announced the addition of two experienced pharmaceutical executives to the company's senior leadership team to meet the company's growing needs as it advances the development program for its lead investigational antibiotic, omadacycline, and as it expands the company's pre-commercialization capabilities. Yulii Bogatyrenko joins Paratek as Senior Vice President, Business Development, and Randall Brenner joins as Senior Vice President of Regulatory Affairs and Quality.
Mr. Brenner will be responsible for leading Paratek's Regulatory and Quality activities with all products in the development pipeline with a specific focus on advancing the Phase 3 program and the global regulatory registration process for omadacycline.
"Yulii's appointment brings a seasoned business leader and experienced business development executive to Paratek to establish and implement our corporate development strategies for omadacycline and sarecycline to support our growth," said Michael Bigham, Chief Executive Officer, Paratek. "Randy's leadership and extensive scientific and regulatory background, specifically including antibiotics, will be essential as we enter into our Phase 3 program and develop our life cycle management plan for our lead compound, omadacycline."
Mr. Bogatyrenko is a proven pharmaceutical executive having served in multiple management and consultant roles in the life sciences industry. Most recently, he was managing partner at Atem Capital in New York, where he developed commercial strategies for clients across a variety of therapeutic areas. Prior to Atem, he held the position of Vice President and General Manager at Teva Specialty Pharmaceuticals. In this role, he directed biopharma and over-the-counter (OTC) women's health business across emerging markets, and was responsible for business development of Teva's women's health portfolio, including biologics, small molecules, and OTC products.
"The need for new antibiotics to address the problem of bacterial resistance is real and growing. With omadacycline, Paratek has the potential to introduce an important new treatment option for patients and physicians," said Mr. Bogatyrenko. "I am excited to be joining this seasoned management team and look forward to managing the overall corporate development strategies for the Company."
Mr. Brenner has more than 20 years' experience leading the development and registration of products across many different regions and therapeutic areas, including anti-infectives. He was most recently Global Head of Regulatory Affairs at Shire Pharmaceuticals where he was responsible for all aspects of regulatory affairs for a broad range of programs across multiple therapy areas. In his previous roles at Wyeth Mr. Brenner served as global regulatory lead for Tygacil, a tetracycline-based antibiotic, with responsibility for leading all the regulatory aspects of the global development program, registrations and eventual approvals.
"I am pleased to be joining Paratek at this exciting and important time for the company, in particular to prepare for the near-term implementation of the Phase 3 program for omadacycline with the goal of timely submission, and prospective approval and launch of the product." said Mr. Brenner. "I look forward to adding my skills to this experienced and capable management team to help bring omadacycline to patients as quickly as possible."
In addition, on May 29, 2015 the Board of Directors granted a stock option under Paratek's 2015 Inducement Plan (the "Plan") to Mr. Bogatyrenko. The stock option was granted as an inducement material to Mr. Bogatyrenko's employment with Paratek pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The Plan was not approved by stockholders. Mr. Bogatyrenko 's option provides him the right to purchase an aggregate of 100,000 shares of Paratek common stock and will vest over four years, with 25% vesting on May 29, 2016 with the balance vesting ratably each month thereafter over the remaining three years, subject to acceleration or forfeiture upon the occurrence of certain events. The stock option is subject to the terms and conditions of the Plan and has an exercise price of $29.80 per share, which was the closing price of Paratek's common stock on the date of grant as reported on the NASDAQ Global Market.
Omadacycline is a new once-daily oral and intravenous, broad-spectrum antibiotic being developed for use as empiric 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), urinary tract infections (UTI), 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.
Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) 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 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 an aminomethylcycline, derived from tetracyclines.
Paratek's second product candidate, sarecycline, also known as WC 3035, is a new once-daily oral tetracycline-derived compound, designed to provide both a narrow-spectrum of antibiotic activity and favorable tolerability profile, for the treatment of acne and rosacea in the community setting. Paratek has licensed rights to sarecycline for the treatment of acne 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 sarecycline for the treatment of acne in the United States. A Phase 3 program was initiated by Actavis in December 2014 for sarecycline for the treatment of moderate to severe inflammatory acne.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical trials, cash resources, prospects and expected results, including statements about identifying strategies to support Paratek's business growth, bringing omadacycline to patients as quickly as possible, the contribution of Mr. Bogatyrenko to grow Paratek, advancing our lead antibiotic candidate into clinical trials, otherwise preparing for clinical trials and the timing for completion of clinical trials for omadacycline. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We 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. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to (i) our need for substantial additional funding to complete the development and commercialization of our product candidates, (ii) our ability to raise the capital to do so, (iii) our ability to develop our drug candidates for potential commercialization, (iv) the advancement of omadacycline Phase 3 trials for ASSBI, (v) the timing of the commencement of omadacycline Phase 3 trials (vi) 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, (vii) the potential of omadacycline to become the primary antibiotic choice of physicians for the treatment of serious community-acquired bacterial infections, (viii) the potential use and effectiveness of sarecycline for the treatment of acne and rosacea in the community setting, and (ix) the timing of the commencement of a Phase 3 program in moderate-severe acne for sarecycline, risks that data to date and trends may not be predictive of future results, risks related to the conduct of our clinical trials, and risks that our clinical trials and product candidates do not receive regulatory approval. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
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