Sebela Pharmaceuticals Announces New Division Named Sebela Women's Health

Kelly Culwell, MD, Joins as Head of Research and Development, Women's Health with a Focus on Innovative Products That Meet Women's Needs

ROSWELL, Ga., Nov. 15, 2022 /PRNewswire/ -- Sebela Pharmaceuticals^® today announced a new division of the company named Sebela Women's Health along with the appointment of Kelly Culwell, MD, as Head of Research and Development for the division. Bringing more than twenty years' experience in women's health across public, private and non-profit organizations, Dr. Culwell joins the team when the company is in the final stages of clinical development of two next-generation intrauterine devices (IUDs) for contraception.

"We are very pleased to officially announce Sebela Women's Health and consider ourselves fortunate to be able to add an expert of Dr. Culwell's caliber to our executive team," said Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals. "Sebela has made significant contributions to the gastroenterological community toward improved patient experience, and we fully intend to also contribute significant innovative solutions in the women's health space."

Prior to joining Sebela, Dr. Culwell was Senior Vice President and Chief Medical Officer at Afaxys, Inc., where she led the company's drug research and development programs. Prior to Afaxys, Kelly was Chief Medical Officer at Evofem Biosciences, where she oversaw clinical trials and regulatory approval for a recently approved women's contraceptive product.

"I am delighted to join Sebela Women's Health and I look forward to working with the team to enrich the health and well-being of women, and the lives of those who care about them," said Dr. Culwell. "In addition to my training as a women's health physician, I have had the unique opportunity to work in both global and US public health settings as well as in private industry, and I hope to bring these learnings to the development of next-generation products with innovative features that acknowledge and prioritize the needs of women today."

Dr. Culwell has held various leadership roles at WCG (formerly WomenCare Global), Planned Parenthood of the Pacific Southwest, and at the International Planned Parenthood Federation in London, UK. Dr. Culwell was also an Assistant Professor at University of California at Davis and held a position at the World Health Organization in Geneva, Switzerland as a Medical Officer/Research Assistant Professor. She earned a Bachelor's Degree in Biological Sciences from California Lutheran University, a Master of Public Health from Northwestern University, and a Doctor of Medicine from the University of California at Davis. Additionally, Dr. Culwell continues to be a licensed and practicing obstetrician/gynecologist and holds a faculty appointment at University of California, San Diego.

Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development. In addition, Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth.

Please visit sebelapharma.com for more information or call 800-874-6756.

This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Pharmaceuticals under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Sebela Pharmaceuticals does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law.

SOURCE Sebela Pharmaceuticals Inc