SOMERSET, N.J. – January 9, 2017 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it is to evaluate Jupiter Orphan Therapeutics, Inc.’s (JOT) novel formulation of resveratrol, JOTROL, for delivery using Catalent’s R.P. Scherer softgel technology. Under the agreement, Catalent will assess different softgel delivery technologies for JOTROL to determine the optimum oral dosage form, before going on to manufacture doses for human PK studies and Phase II clinical studies.
JOTROL, which is being developed to remedy resveratrol’s poor bioavailability and dose limiting gastrointestinal side effects, is being studied in multiple pre-clinical and clinical trial programs in progress for the treatment of rare diseases linked to single gene deficiencies. These include Friedreich’s Ataxia and Mucopolysaccharide (MPS) diseases, as well as partner programs for treatments in pancreatic cancer, Machado-Joseph and Alzheimer’s disease.
Under the arrangement, Catalent will assess both conventional softgel and Catalent’s proprietary OptiShell® gelatin-free technology, which allows for higher fill temperatures and pH, and therefore can accommodate semi-solid and highly viscous formulations, and a wider range of excipients designed to improve bioavailability and stability.
“Developing better treatments that improve patient experience and lead to better real world outcomes is vital for drug innovators’ success,” commented Dr. Aris Gennadios, Catalent’s President of Softgel Technologies. “Catalent is dedicated to using our breadth of formulation technology expertise and experience across thousands of innovative molecules to improve patient acceptance and adherence.”
Christer Rosén, Chairman, CEO and Founder of JOT added, “We selected Catalent as our development partner for our JOTROL therapies because of their breadth of experience in formulation and softgel technology, coupled with their wide range of complementary capabilities.”
Catalent will conduct its work on JOTROL from its primary, 453,000 square feet, North American softgel development and manufacturing center-of-excellence in St. Petersburg, Florida, where the company offers formulation development and manufacturing of prescription and over-the-counter softgels, and has an annual capacity of more than 18 billion capsules a year.
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Christer “Chris” Rosén
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Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,500 people, including over 1,400 scientists, more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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About Jupiter Orphan Therapeutics
Jupiter Orphan Therapeutics, Inc. (JOT) is a clinical stage specialty pharmaceutical company developing therapies for rare diseases linked to single gene deficiencies. JOT, a Delaware Corporation with its principal office located in Jupiter, FL, USA, was founded in the summer of 2015. In its short period of operations, JOT has assembled a very strong management and scientific team as well as defined five pipeline products which of one is already in Phase II.
JOT is developing treatments for various different orphan diseases such as Friedreich's Ataxia and MPS1. Orphan diseases are defined in Law as a disease that affects less than 200,000 people in the USA. Other areas in the world have similar laws. Although the incidence of orphan diseases may be small, the effects on the afflicted and society are profound.
JOT has developed a unique formula, JOTROL, for the well-known natural product resveratrol that has many observed pharmacologic effects. Resveratrol is a dietary polyphenol found in grapes, red wine, berries and nuts. It has several postulated effects such as anti-cancer, anti-diabetic, cardioprotective, antioxidant, neuroprotective as well as clinically showing a prolonged lifespan in mice. It has, however, poor bio-availability in humans and at high doses causes GI side effects.
For more information visit, http://www.jupiterorphan.com/