Healthcare Industry News: sanofi-aventis
News Release - April 6, 2010
Cempra Announces Expansion of Clinical Management Team to Advance Leading Antibacterial Clinical Programs TAKSTA(TM) and CEM-101Oral CEM-101 in preparation for Phase 2a CABP Studies, Intravenous CEM-101 expected to enter Phase 1 in mid-year and TAKSTA in preparation for Phase 3 trials
Four appointments, including Susan R. Moriarty, M.D. and Jennifer Schranz, M.D., are highly experienced in anti-infective clinical development
CHAPEL HILL, N.C., April 6 -- (Healthcare Sales & Marketing Network) -- Cempra Pharmaceuticals today announced the expansion of its clinical development team to manage the company's leading clinical programs, CEM-101 and TAKSTA (formerly CEM-102) through advanced clinical development. The four appointments, including Susan R. Moriarty, M.D. and Jennifer Schranz, M.D., have significant antibiotic clinical development experience.
CEM-101 is Cempra's innovative oral and intravenous next-generation macrolide exhibiting high potency against respiratory pathogens, including drug-resistant strains, and broad spectrum activity against other serious pathogens. The oral form is about to enter a global Phase 2 clinical trial in patients with community-acquired bacterial pneumonia. Intravenous CEM-101 is expected to enter Phase 1 clinical development by mid-year.
TAKSTA is an innovative oral dosing regimen of sodium fusidate, employing a PK-PD-based proprietary dosing regimen, under development for gram-positive infections including drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). TAKSTA has completed enrollment in a Phase 2 trial and is preparing for Phase 3 studies in the U.S. for acute bacterial skin structure infections.
"Cempra has steadily advanced its two lead programs into mid and late-stage clinical development," said Prabhavathi Fernandes, chief executive officer of Cempra. "We have allocated resources to build a very experienced clinical management team to continue the progress of these two differentiated antibiotic candidates. The appointments reflect the need for us to broaden and deepen our clinical development staff to manage these programs and maximize their success."
Jennifer Schranz, M.D., vice president, clinical affairs, will help lead the clinical development of both CEM-101 and TAKSTA. Dr. Schranz's career spans 15 years in clinical research and medical affairs in the pharmaceutical industry. She has held leadership positions of increasing responsibility in clinical research and/or global medical affairs at Merck & Company, GlaxoSmithKline, Vicuron and Wyeth/Pfizer Pharmaceuticals. Dr. Schranz has worked on many anti-infective clinical and commercial development programs including CRIXIVAN, PRIMAXIN, CEFOXITIN, INVANZ, AUGMENTIN XR, ERAXIS, CANCIDAS, PREVENAR and PREVENAR 13.
Susan R. Moriarty, M.D., joins Cempra as vice president, clinical research and she will be responsible for oversight in the design and execution of clinical trials for CEM-101 and TAKSTA. She trained in infectious diseases. Dr. Moriarty spent 13 years in infectious disease private practice and was the director of clinical preventive services at the Marion County (Indianapolis) Public Health Department. For the past four years, Dr. Moriarty has worked on the clinical development and medical affairs programs for the antibiotic candidate oritavancin at Targanta Therapeutics and The Medicines Company.
Dr. Schranz and Dr. Moriarty will be working with Carl Craft, M.D., a founding member of Cempra's Scientific Advisory Board who has assumed the role of consulting head of medical affairs at Cempra.
Elisa Gonzalez, M.S., and Joe Milata, B.S.N., C.C.R.P., join Cempra as clinical study managers. Elisa most recently was a clinical scientist at Wyeth/Pfizer leading the post-marketing studies for PREVENAR 13. Before that, she worked with the Central Nervous System Group as a clinical research associate with sanofi-aventis. Joe has over eight years of clinical development experience in the pharmaceutical industry with Eli Lilly and Company, Targanta Therapeutics and The Medicines Company. For the past four years, he managed the anti-infective clinical trials and the global clinical development of several indications for a new antibiotic drug candidate.
Kay Clark, senior study manager for Cempra, added, "The expansion of the Clinical Study Manager Group will allow Cempra to manage every aspect of the studies closely."
Thorsten Degengardt, Ph.D. and Cempra's vice president of drug development, will also play an increasing role in managing the clinical operations.
Cempra is also announcing that J. Gordon Still, M.D., Ph.D., has resigned as chief medical officer and will serve as a consultant to the company.
About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially and medically differentiated and novel products that reduce development risk and provide a high financial return. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.
Source: Cempra Pharmaceuticals
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