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We are a specialty pharmaceutical company focused on the development and commercialization of products for patients treated by ear, nose and throat (ENT) and allergy specialists. Our first commercial product, XHANCE® (fluticasone propionate) nasal spray, 93 microgram (mcg), is a therapeutic utilizing our proprietary Exhalation Delivery System (EDS) that delivers a topically-acting corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps and, if approved, chronic rhinosinusitis without nasal polyps (also known as chronic sinusitis). In September 2017, the U.S. Food and Drug Administration (FDA) approved XHANCE for the treatment of nasal polyps in patients 18 years of age or older. XHANCE was made widely available through commercial channels in April 2018. We have initiated two Phase 3b clinical trials of XHANCE for a follow-on indication for the treatment of chronic sinusitis and expect top-line results by the end of 2021 from one trial and in the first half of 2022 from the second trial. If successful, we believe XHANCE would be the first drug therapy product approved by the FDA for the treatment of chronic sinusitis. As of February 28, 2021, we had a total of 204 full-time employees and three part-time employees. A majority of our employees are field-based, in customer-facing roles. Culture is a critical element in the management of our organization. Our talented employees, known as colleagues, are focused on driving our business with the Optinose values as the foundation for all our efforts. Our goal is that each colleague feels a deep connection to what they do, loves coming to work and is aligned to our One Mission – to improve lives. Our values of Authenticity, Fearless Conversations, Friendship, Openness, Perseverance and Possibility Thinking guide our actions and decisions.
A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry
RESTAT is a West Bend, WI-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D. Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.
We are a specialty pharmaceutical company developing transformative therapies to advance the treatment of gastrointestinal (GI) disorders. We focus on developing treatments for GI disorders for which meaningful therapeutic innovation is required to satisfy unmet patient need and disease burden. Our management team and board of directors are comprised of professionals with extensive backgrounds in drug research and development, commercialization, finance and business development for leading global pharmaceutical companies and growth-stage biopharmaceutical companies. Our scientific advisory board consists of well-known gastroenterologists and clinical thought leaders. Today, our pipeline consists of two unique clinical stage therapies with the potential to bring benefit to millions of patients with chronic and debilitating GI disorders that are not adequately controlled.