Essentialis Announces the Grant of Its First Japanese Patent Which Provides Extensive Protection to DCCR in the Treatment of Prader-Willi Syndrome

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June 17, 2014

Essentialis announced the grant of its first patent in Japan(Patent number 5543110).  The patent provides extensive protection to Essentialis’ lead product, Diazoxide Choline Controlled-Release Tablet (DCCR).  The claim scope covers the active in DCCR and a broad family of related actives, polymorphs of the active, methods of manufacture, all pharmaceutical formulations of the actives and methods of use of these pharmaceutical formulations in the treatment of a range of diseases.  In particular, the use of DCCR in the treatment of Prader-Willi syndrome is encompassed by the granted claims.

“The grant of this patent complements the protection we already enjoy in the US, Europe, Australia and elsewhere.  We are particularly pleased that the granted claims cover the use of DCCR in Prader-Willi syndrome, our lead indication.  This grant, together with a recent grant of similar claims in Australia gives us confidence that we establish this same protection in all major pharmaceutical markets,” said Dr. Neil Cowen, President and Chief Scientific Officer of Essentialis.  “The granted claims also provide protection to the earlier stage orphan products in our pipeline.”

About DCCR
DCCR is a proprietary crystalline salt of diazoxide in a controlled-release, once-a-day tablet formulation. It is in development for the treatment of Prader-Willi syndrome and hypothalamic obesity.  DCCR is covered by multiple issued US and granted EU patents, which provide composition of matter protection until 2028.  Essentialis is globally prosecuting claims to the use of pharmaceutical formulations of KATP channel activators including diazoxide and DCCR in the treatment of Prader-Willi syndrome.  Essentialis has evaluated DCCR in more than 200 subjects in multiple double-blind, placebo-controlled studies.

About Prader-Willi syndrome
Prader–Willi syndrome afflicts about 1 in 15,000 to 1 in 25,000 individuals, with the US Prader-Willi syndrome population estimated between 12,500 and 21,000.  There may be as many as 350,000 Prader–Willi syndrome patients globally.  Prader–Willi syndrome is equally frequent in males and females.  Clinical features of Prader–Willi syndrome include hypotonia and poor feeding in infancy.  Low muscle mass and low resting energy expenditure is present throughout life.  Obesity typically begins around age 2 years if the diet is not restricted. Ultimately, the central neurological defect associated with the condition causes Prader–Willi syndrome patients to sense that they are starving and signals them to further conserve energy and to significantly increase their caloric intake.  This results in even lower resting energy expenditure, hyperphagia, morbid obesity, and a progression to diabetes. Mental retardation, growth hormone deficiency, behavioral problems and neuroendocrine abnormalities are also characteristic of Prader–Willi syndrome.  The death rate among Prader–Willi syndrome patients is about twice that of the general population at all ages.

About Essentialis, Inc.
Essentialis is a Carlsbad-based pharmaceutical company focused on the development of breakthrough medicines targeted to the ATP-sensitive potassium channel, a metabolically regulated membrane protein whose modulation has potential to treat and prevent a wide range of metabolic, CNS and cardiovascular diseases.

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