Catalent and Aegerion Partner on Launch of Newly FDA Approved JUXTAPID™
After a close 7-year partnership on clinical development, Catalent and Aegerion will partner for international supply for newly FDA approved JUXTAPID™ (lomitapide) capsules as an adjunct to a low-fat diet and other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia (HoFH).
The productive partnership, which included close cooperation on analytical development, clinical trial supply and manufacturing, will now be expanded with Catalent as the exclusive supplier of JUXTAPID in 5 mg, 10 mg and 20 mg strengths for both US and European markets from Catalent's Kansas City, MO facility. Catalent will also support JUXTAPID packaging and Qualified Person (QP) release from Catalent facilities in Bolton and Swindon, UK for the European market.
"We are very happy that we partnered with Catalent for the JUXTAPID product development," said Craig Fraser, President for U.S. and International at Aegerion. “Their extensive oral solid clinical development expertise, integrated offerings combined with the global reach provided us a solid path to commercialization of this new, important therapy.”
“The development of Aegerion's JUXTAPID leveraged the wide array of clinical development and supply expertise at Catalent,” commented Scott Houlton, President of Development and Clinical Services at Catalent. “We are delighted that Aegerion entrusted the development and reliable global supply of this important orphan drug product to Catalent. We look forward to a continued successful relationship with Aegerion, and to helping to bring more products and better treatments to patients.”
Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. Catalent employs approximately 9,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.6 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.
More products. Better treatments. Reliably supplied.™
Catalent Pharma Solutions
Chris Halling, +44 (0) 7580-41073