Issue: November/December 2016, Posted Date: 1/9/2017
Catalent to Develop Softgel Capsules for JOT's Leading Orphan Disease Candidates
Catalent Pharma Solutions, the leading global provider
of advanced delivery technologies and development solutions for drugs,
biologics and consumer health products, recently 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.
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. More products. Better treatments. Reliably supplied.™
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/.
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