NEWARK, N.J., Feb. 22, 2017 /PRNewswire/ -- Symbiomix today announced it has hired David L. Stern, MBA, a seasoned biopharmaceutical executive with over 20 years of experience leading the commercialization of treatments in women's health and fertility, as Chief Executive Officer of the company.
Mr. Stern joins Symbiomix on the heels of the company's recent submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its drug candidate Solosec™, an innovative antibiotic designed to treat BV. The company hired Taunia Markvicka, PharmD, MBA, as Chief Commercial Officer in 2016 and has been rapidly preparing for the commercialization of Solosec™.
"Symbiomix is delighted to have a leader of David Stern's caliber take on the position of Chief Executive Officer," said Klaus Veitinger, MD, PhD, Chairman of the Board of Directors at Symbiomix and an Orbimed venture partner. "We are entering a very important period as we await feedback from the FDA on our NDA and prepare for the launch of Solosec™. David's experience in women's health will be a valuable asset to the company."
Mr. Stern brings to Symbiomix more than 20 years of leadership in strategic planning, business development, reimbursement strategy, and marketing and sales. He is an independent board member of California Cryobank, the leading provider of reproductive and stem cell services in the US. Previously, he was Chief Commercial Officer of Celmatix, a personalized medicine company focused on fertility and women's health. Before joining Celmatix, Mr. Stern was Executive Vice President of Global Commercial Operations for OvaScience, where he was responsible for the global launch of the company's first new fertility treatment, Augment®. He also served as Senior Vice President and Head of Global Business as well as other leadership positions for fertility at Merck Serono, and was director of reproductive marketing at Organon USA, responsible for the company's contraceptive and fertility portfolio. Mr. Stern has an MBA from the F.W. Olin School of Business at Babson College, and a Bachelor's degree in biology from Brandeis University. He is a member of the European Society for Human Reproduction and Embryology and the American Society for Reproductive Medicine.
"I am excited to be a part of the strong, accomplished management team at Symbiomix," commented Mr. Stern. "Solosec™ has had a rapid and successful clinical development program, and I believe it will be well received by physicians and patients when it is approved. I'm honored to be part of the preparations for commercialization, and look forward to guiding Symbiomix as we consider the development of other innovative drugs."
Solosec™ is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. In clinical trials Solosec™ demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, with excellent safety, tolerability and adherence.
About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44 [1,2]. Today more than four million women are treated in the US for BV annually . More than 50 percent of women treated for BV have a recurrence within 12 months . The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including:
- Increasing the risk of HIV transmission;
- Increasing the risk of contracting other sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility; and
- In pregnant women, increasing the risk of delivering a baby too early .
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women's health outcomes [5,6].
BV has a significant impact on the work productivity and quality-of-life of affected women, with 60% of recurrent sufferers reporting a negative impact on work attendance, job performance and productivity, and 95% reporting a severe restriction in intimate partner relations [7,8].
The current recommended regimen of a first-generation nitroimidazole requires twice-a-day dosing for seven days for a total administration of seven grams of drug. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent . Poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms . These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity .
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections that can have serious health consequences. The Company's lead investigational drug Solosec™ (secnidazole oral granules), a potent, next-generation 5-nitroimidazole antibiotic, is anticipated to be the first and only single-dose oral treatment approved for bacterial vaginosis (BV). Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world's leading healthcare venture capital firms: OrbiMed, F-Prime Capital Partners, and HBM Partners. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.
- Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstetrics and gynecology 2007;109:114-20.
- IMS Health, 2014
- Bradshaw CS, et al. (2006). "High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence" J Infect Dis. 2006 Jun 1;193(11):1478-86.
- Fiscella, K. (1996). "Racial disparities in preterm births. The role of urogenital infections." Public Health Rep 111(2): 104-113.
- Payne et al. (2010). "Evidence of African-American women's frustrations with chronic, recurrent bacterial vaginosis." Jn AANP 22(2010) 101-108.
- Bilardi et al. (2013). "The Burden of Bacterial Vaginosis: Women's Experience of the Physical, Emotional, Sexual and Social Impact of Living with Recurrent Bacterial Vaginosis." PlusOne Sept 2013, vol 8, issue 9.
- Bartley, J.B., et al. (2004). "Personal digital assistants used to document compliance of bacterial vaginosis treatment." Sex Transm Dis 31(8): 488-491.
- Kardas, P. (2002). "Once-Daily Dosage Secures Better Compliance With Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily Dosage." WONCA Europe 2002 Conference, London.
- Kardas, P., Bishai, W., (2006). "Compliance in anti-infective medicine." Adv Stud Med 2006; 6(7C):S652:S658.
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SOURCE Symbiomix Therapeutics, LLC