New patent for the use of estrogens in the treatment of DED to be issued in the US
The US Patent and Trademark Office has issued a notice of allowance indicating that a new patent will be granted to Redwood Pharma regarding the use of estrogens in the treatment of dry eye disease. When officially received, this patent will serve as another critical cornerstone in Redwood Pharma’s patent portfolio.
This new patent will complement existing patent protection of RP101 including the use of IntelliGel in the US. As such, Redwood Pharma’s estrogen therapies will have thorough protection through both the exclusive use of active substance and drug delivery system.
“In March of 2018, Redwood Pharma acquired a patent portfolio including applications in the US and EU for the use of estrogen and estrogen analogs in the treatment of Dry Eye Disease from UK-based CapaVision Ltd. Redwood Pharma has been actively prosecuting these patent applications to strengthen the protection of RP101 and other therapies based on estrogen. When issued, the patent will further strengthen Redwood Pharma’s exclusive use of therapeutic estrogens in the treatment of dry eye disease in the US. Consequently, this is very good news for Redwood Pharma and its shareholders,” states CEO Martin Vidaeus.
RP101 is a novel, topical treatment for post-menopausal women suffering from chronic, moderate-to-severe dry eye disease (DED). This Phase II product candidate consists of a low-dose estrogen analog formulated in IntelliGel, a proprietary controlled-release drug delivery platform, and will be the first hormonal therapy for DED targeted to specific underlying biological mechanisms in critical tissues in and around the eye. Redwood Pharma recently completed and published results of a randomized, placebo-controlled multicenter Phase II trial in March of 2020. Highlights include:
- Phase II RP101 data confirm results from the 2 prior Phase II trials in the US. Improvement was demonstrated in both objective and subjective endpoints. 104 patients were included in the Phase II trial.
- Serious unmet medical need (US$5.4bn global DED market) and well-defined addressable market – 7% of all post-menopausal women suffer from moderate-to-severe DED, 10m in the US & Europe alone.
- Estrogen – a safe and effective API found in 500+ products sold globally. RP101 will deliver a topical, low dose to the eye.
- Novel IntelliGel drug delivery platform well-suited for ophthalmic use – increases bioavailability, reduces number of doses.
- Strong IP and market exclusivity.
IntelliGel is Redwood Pharma’s exclusive technology for delivering drug to the front of the eye with a new hydrogel based on poloxamers and water. IntelliGel is applied as eye drop and gels on contact with the eye. This transparent, lubricating, reversible thermogel can increase the bioavailability of the active substance, as the gel holds the drug in the eye for longer. This, in turn, allows for a reduction of the amount of active substance administered, a reduction in the number of doses and possible side effects related to the active substance. IntelliGel is currently used in dermatological products sold commercially in the US and China. IntelliGel can be used for prescription products as well as for OTC products.
For more information:
Martin Vidaeus, CEO Redwood Pharma AB (publ.)
Tel: +46 (0) 70 232 29 29
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, July 23, 2020.
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 the Spotlight Stock Market (Ticker: REDW.ST, ISIN: SE008294789).