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Strength of Aptalis Pharmaceutical Technologies Patents Confirmed by AMRIX® Verdict


4/24/2012 12:25:33 PM

Bridgewater, New Jersey, April 24, 2012 – Aptalis Pharmatech, Inc. (previously known as Eurand, Inc.) and Cephalon, Inc. a wholly-owned subsidiary of Teva Pharmaceuticals Industries Ltd, and Anesta AG prevailed in their appeal to the U.S. Court of Appeals for the Federal Circuit which 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 United States.

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 our formulation technologies. Aptalis’ owned and in-licensed patent portfolio consists of over 900 granted patents and pending applications.

About Aptalis Pharmaceutical Technologies

Aptalis Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODT’s (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

About Aptalis

Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, RECTIV™, CARAFATE®, PYLERA®, LACTEOL®, DELURSAN®, PANZYTRAT® and SALOFALK®. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com.


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