Denver, CO and St. Louis, MO, February 14, 2019 -– Leiters® and Mobius Therapeutics™ announced today that they have entered into a national sales and marketing agreement for Mitosol®, the only FDA approved formulation of mitomycin-c bearing an ophthalmic indication.
Leiters®, a trusted FDA-registered 503B outsourcing provider of high-quality ophthalmology and hospital-based services has a long-standing history of compounding mitomycin for its customers.
However, consistent with its commitment to meet or exceed all FDA regulations, Leiters® is unable to compound an essential copy of an approved product. Therefore, to minimize supply disruption and continue providing outstanding service to its customers, Leiters® has entered into a collaboration with Mobius Therapeutics™ to supply Mitosol®.
Mitosol® (mitomycin for solution) 0.2mg/vial is provided as part of a Kit for Ophthalmic Use. The kit contains a 0.2 mg vial of mitomycin-c along with accessories allowing for safe, convenient and compliant acquisition, storage and handling of mitomycin-c.
We are excited to partner with Mobius Therapeutics™ to ensure our ophthalmic customers have access to the high-quality medicines they need for their patients– Robin Smith Hoke, Chief Executive Officer of Leiters®
For some time, we have believed that specialty manufacturers like Mobius™ and outsourcing facilities such as Leiters® hold more in common than in contest. Leiters’® decision creates two clear winners: patients and providers. We applaud their action and hope that such collaboration will become the norm, rather than the exception– Ed Timm, CEO of Mobius Therapeutics™
Leiters®, a trusted FDA-registered 503B outsourcing provider of high-quality ophthalmology and hospital-based services, is committed to providing healthcare professionals and their patients with high quality medications. Leiters® employs a team of sterile pharmaceutical manufacturing, repackaging, and pharmacy experts that bring a sophisticated understanding of what it takes to elevate quality and consistency of supply in outsourcing. By combining a quality team, robust processes and state-of-the art outsourcing facilities, Leiters® ensures delivery of the highest quality products and services. Please visit leiters.com to learn more about how Leiters® is elevating the standards in pharmaceutical outsourcing.
Kari Cashmore, Leiters®
About Mobius Therapeutics™, LLC
Mobius Therapeutics™ is a commercial stage venture focused upon perioperative sterile injectables used in ophthalmic surgery. Its first product, Mitosol®, is the only FDA approved formulation of mitomycin-c bearing an ophthalmic indication. Mobius™ maintains an active sterile injectable product pipeline in varying stages of development. Please see full prescribing information at Mitosol.com and EyeAmphadase.com.
Ed Timm, Mobius Therapeutics™, LLC
WMT-035 Rev 02/2019