Yardley, PA – August 1, 2011 – OptiNose Inc. today announced the additions of Peter Fernandes as Vice President of Regulatory Affairs and Quality US, and Michele Janis as Vice President of Finance. Both appointments are effective immediately.
In his new role, Mr. Fernandes will be responsible for the Company’s US regulatory strategy development, FDA negotiations and regulatory filing around OptiNose’s unique range of bi-directional nasal drug-delivery products. In addition, he will support the establishment and monitoring of the quality systems and pharmacovigilance functions within the US organization.
Mr. Fernandes joined OptiNose in 2011, and has over 22 years of US and global pharmaceutical development experience. He has also served in several senior leadership positions, including Head of the US Development Site at pharmaceutical company Nycomed, Vice President of Regulatory Affairs and Quality Assurance at Altana Pharma and Vice President of Regulatory Affairs at Novartis. He has also gained extensive regulatory and project leadership experience through roles at Boehringer Ingelheim, Scios-Nova and Wyeth-Ayerst.
“Peter has a demonstrated record of successfully navigating the US and global approval processes for a diverse spectrum of products, including both drug and drug-device combinations,” said Peter Miller, CEO of OptiNose Inc. “He has built a strong working relationship with the FDA and other regulatory bodies, and I am confident that his experience will be extremely valuable as we seek to bring our innovative products to market.”
In joining OptiNose, Ms. Janis will be responsible for managing all accounting and finance activities within the Company. She brings over 15 years of accounting and financial management expertise from a variety of roles in both development-stage companies and global publically traded organizations. Ms. Janis previously served as the Director of Business Analysis and Planning at Take Care Health Systems, a Walgreens Company, where she was responsible for leading financial and business analytics for strategic initiatives, including the budgeting and forecasting process for over 350 retail health clinics located within select Walgreens stores. Before her tenure at Take Care Health, she served as CFO/Controller to several pharmaceutical and technology-based early stage companies.
“Michele’s performance at Take Care and her prior experience service as a CFO in a range of organizations has provided her an excellent financial management background which she will bring to OptiNose,” continued Miller. “She will continue to help us drive our business and achieve both our short-term and long-term strategic objectives, and we are thrilled to have her on the team.”
The Company also announced the departure of Henrik Bruun Andersen, who had served as OptiNose’s Finance Director.
About OptiNose Inc.
OptiNose is a drug delivery company with breakthrough bi-directional nasal technology set to transform the static nasal drug delivery market. Founded in 2000, OptiNose’s devices are designed to deliver intranasal drugs to target regions of the nasal cavity, including the sinuses and the olfactory region while preventing lung deposition. The company offers both single and multi-use intranasal delivery devices for liquid and powder formulations. The technology has been successfully tested in a number of clinical trials demonstrating both clinical efficacy and safety. Investors in OptiNose include Avista Capital Partners in New York, WFD Ventures LLC located in New York and Entrepreneurs Fund LP based in Jersey, Channel Islands. For more information please visit www.OptiNose.com.
About Bi-directional Nasal Delivery Technology
OptiNose’s bidirectional nasal delivery technology significantly improves delivery to the targeted sites deep into the nose. While exhaling into the device, the soft palate automatically closes off the nasal cavity completely. The breath enters one nostril through a sealing nozzle and triggers the release of drug particles into the airflow. This action causes the narrow nasal passages to expand and carry these particles beyond the nasal valve to targeted sites. After delivering drug particles to the targeted sites, the air flow then exits the nasal cavity through the other nasal passage in the opposite direction.