DENVER, Colo. and ST. LOUIS, Feb. 14, 2019 /PRNewswire/ -- 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," said 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," said Ed Timm, CEO of Mobius Therapeutics™. "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."
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 www.Mitosol.com and www.EyeAmphadase.com.
Ed Timm, Mobius Therapeutics, LLC