Strength of Aptalis Pharmaceutical Technologies Patents Confirmed by AMRIX Verdict

Aptalis Pharmatech, Inc. (previously known as Eurand, Inc.); Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceuticals Industries Ltd; and Anesta AG prevailed in their appeal to the US Court of Appeals for the Federal Circuit that reversed a lower court’s determination and held that two patents covering the AMRIX muscle relaxant (Cyclobenzaprine Hydrochloride Extended-Release Capsules) are valid. The full text of the Court’s decision can be found at: http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1399-1409.pdf

The two patents, owned by Aptalis Pharmatech, Inc. and licensed to Cephalon, expire in 2023 and 2025. The patents, along with other additional patents that protect AMRIX, are all listed on the FDA’s Orange Book and will be enforced to the fullest extent possible.

AMRIX is a convenient extended-release (once-daily administration) dosage form of cyclobenzaprine that is indicated for short-term relief of muscle spasm as an adjunct to rest and physical therapy. Prior to the approval of AMRIX in 2007, only immediate-release formulations of cyclobenzaprine were available, such formulations often requiring administration two to three times daily. According to recent IMS data, Cyclobenzaprine is the most frequently prescribed drug for muscle relaxation in the US.

The use of Aptalis Pharmaceutical Technologies DIFFUCAPS Technology in AMRIX satisfies an unmet medical need by providing a modified-release formulation, once-daily dosing of cyclobenzaprine, thereby allowing for increased patient compliance.

“Aptalis Pharmaceutical Technologies endeavors to offer to our partners the most effective patent protection possible of our broad and diversified portfolio, and this court decision confirms the strength of these formulation patents,” said John Fraher, President of Aptalis Pharma.

The Aptalis portfolio is composed of numerous patents with broad claims directed to its formulation technologies and related materials, processes, equipment, and methods of manufacture. Aptalis also has many product-related patents, which contain more specific claims directed to particular drugs or classes of drugs in combination with its formulation technologies. Aptalis’ owned and in-licensed patent portfolio consists of over 900 granted patents and pending applications.

Aptalis Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODTs (orally disintegrating tablets) and other dosage forms. Together, these technology platforms combined with licensing, manufacturing, and R&D capabilities enable Aptalis Pharmaceutical Technologies to produce customized drug formulation solutions for partners across a range of dosage forms and therapies. Aptalis Pharmaceutical Technologies develops and manufactures products for its partners and supports the drug development process for the Aptalis Pharma pipeline and portfolio of products. For more information about Aptalis Pharmaceutical Technologies, visit www.AptalisPharmaTech.com.