Medicines that are used in clinical trials are stringently regulated. Regulated production begins now of the active pharmaceutical ingredient in RP101, which will be used in the clinical Phase II trial scheduled for the coming fall. RP101 is a new medical treatment for post-menopausal women suffering from chronic dry eye disease.
Medicines used in clinical trials are stringently regulated. The manufacturing process is made up of a series of complex activities which include synthesis of the active pharmaceutical ingredient, formulation within a practical matrix, as well as controlling of their purity and stability.
The aim of developing a process for production of the active pharmaceutical ingredient is to secure a robust and safe method that is scalable for commercial volumes. The active ingredient has been demonstrated stable in initial stability tests, which will support the remaining process where the active ingredient will be combined with IntelliGel® – the drug delivery platform included in the medicine.
”It’s pleasing to have come so far in our development program. To secure our material needs for the clinical trial is a key activity. As we have already now developed a manufacturing process, which can be used for coming production of commercial volumes, it is important for future business. Development has proceeded according to plan and we confidently look forward to the continued work”, says Martin Vidaeus, CEO of Redwood Pharma.
For more information:
Martin Vidaeus, CEO Redwood Pharma AB (publ.)
Tel: +46 (0) 70 232 29 29
Hans Ageland – Chief Operation Officer (COO) Redwood Pharma AB (publ.)
Tel: 073-334 66 01
This information is information that Redwood Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at June 2, 2017.
About Redwood Pharma
Redwood Pharma develops ophthalmic products for unmet medical needs. The Company’s first project is the development of drug candidate RP101 with a known active substance against chronic dry eye in postmenopausal women who have moderate to severe symptoms. With the drug delivery platform IntelliGel® the release of active substances is controlled. Through the use of IntelliGel®, Redwood Pharma can also improve dosing of other established drugs. Redwood Pharma’s strength lies in formulation and early clinical development. Revenues will be generated through licensing agreements with pharmaceutical companies that have capabilities to manufacture and sell commercial products worldwide.
Redwood Pharma AB (publ.) is listed on AktieTorget, a Swedish Multilateral Trading Facility (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit: www.redwoodpharma.com