Essentialis Inc., a San Diego-based pharmaceutical company focused on the development of breakthrough medicines targeted to the ATP-sensitive potassium channel, has filed two new patent applications expanding the patent portfolio claiming its investigational triglyceride-lowering compound DCCR and new methods of using the drug.
The first is a continuation-in-part of a current application that includes data from the recently completed clinical trial, CT013; the second is a patent filing covering certain aspects of the use of DCCR in the treatment of very high triglycerides (VHTG). The filing is the fourth patent application filed by Essentialis covering DCCR, and has the potential to extend patent protection on the product to 2033. Essentialis already holds composition of matter protection for DCCR through 2028.
“With our portfolio of issued and pending patents, we already have very solid protection and these new applications will make our protection even stronger,” said Aaron D Berg, president and CEO, Essentialis, Inc. “We are targeting 2015 market availability for DCCR, and it is our hope to receive patent protection through 2033.”
Essentialis already has two issued US patents (7,572,789 and 7,799,777) providing composition of matter protection to DCCR to 2028 and two granted European patents ( EP1781265 and EP1968601) providing similar protection. With the recent filings, Essentialis is prosecuting eight US patent applications. The company is prosecuting these filings in all major pharmaceutical markets. The current protection on the product includes claims to the active ingredient, pharmaceutical formulations, methods of manufacture, and a wide range of methods to treat multiple diseases. In particular, the claims cover methods to treat dyslipidemia including co-formulation and co-administration with a range of drugs currently used in the treatment of patients with lipid disorders.
DCCR is a proprietary crystalline salt of diazoxide in a controlled-release, once-a-day tablet formulation. It is in development for patients with very high triglyceride (TG) levels. Essentialis has completed an Endof-phase II meeting with the FDA and has obtained an SPA covering a pivotal study. Essentialis expects to initiate phase III clinical trials in 2012. DCCR is covered by multiple issued US and granted EU patents, which provide composition of matter protection until 2028. Essentialis has evaluated DCCR in several double-blind, placebo-controlled studies which demonstrated that the drug was well tolerated and that statistical significance for various endpoints was achieved in patients with elevated triglycerides. More than 100,000 patient-years of treatment with diazoxide help support the acceptable safety of DCCR.