BRIDGEWATER, NJ--(Marketwire - January 09, 2012) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, today announced that it has signed an exclusive license agreement with ProStrakan Group plc to market RECTIV™ (nitroglycerin) Ointment 0.4% in the U.S. for the treatment of moderate to severe pain associated with chronic anal fissure. ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, received Food and Drug Administration (FDA) approval for RECTIV on June 21, 2011.
Financial terms of Aptalis's transaction with ProStrakan include an upfront license fee, a commercialization payment, and payment upon the achievement of certain sales milestones and royalties on sales of RECTIV.
RECTIV is the first and only medication approved by the U.S. FDA for the treatment of moderate to severe pain associated with chronic anal fissure. The product is already marketed by ProStrakan under the name RECTOGESIC® in 20 countries worldwide, including all major European markets.
Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma, stated, "RECTIV provides physicians with an FDA-approved treatment option for moderate to severe pain associated with chronic anal fissure. We expect that this agreement will add strength and breadth to Aptalis' portfolio of products. With Aptalis' commercial expertise and infrastructure in the U.S., and our deep knowledge of and experience in the GI space, we believe that we are positioned to make a positive impact in the lives of patients diagnosed and treated for this condition."
Tom Stratford, Chief Executive of ProStrakan, said, "We are delighted to be partnering with such a highly regarded gastrointestinal specialty pharma company as Aptalis for this important launch. Chronic anal fissure can cause significant pain for patients, and Aptalis' team will work to inform physicians across the U.S. of the availability of the only FDA approved prescription product for patients with this condition."
Aptalis and ProStrakan expect the deal to close by the end of January.
Important Safety Information
RECTIV is contraindicated in patients taking phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, vardenafil, and tadalafil), which can potentiate the hypotensive effect of nitrate, and in patients with severe anemia, increased intracranial pressure, or known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment. The most common adverse reactions are headache and dizziness. For full U.S. prescribing information please see www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf (i)
About Anal Fissures
An anal fissure is a small tear in the skin that lines the anus, which typically causes severe pain and bleeding with bowel movements. When anal fissures do not heal with interventions such as diet and lifestyle changes, fissures may become chronic. The pain associated with chronic anal fissure has been shown to have a significant impact on patients' quality of life. (ii - xi)
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, formed from the recent combination of Axcan Pharma and Eurand, has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, 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.
(i) RECTIV prescribing information at FDA.gov: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf
(ii) Gearhart SL. Diverticular disease and common anorectal disorders. In: Fauci AS, et al. Harrison's Principles of Internal Medicine. 17th ed. New York, N.Y.: McGraw-Hill; 2008.
(iii) Lacy BE, et al. Common anorectal disorders: Diagnosis and treatment. Current Gastroenterology Reports. 2009;11:413.
(iv) Herzig D. Anal fissure. Surgical Clinics of North America. 2010;90:33.
(v) Greenwald DA. Common disorders of the anus and rectum: Hemorrhoids and fissures. American College of Gastroenterology. http://www.acg.gi.org/patients/gihealth/hemorrhoids.asp. Accessed July 28, 2010.
(vi) Yamada T, et al. Anorectal diseases. In: Yamada T, et al. Textbook of Gastroenterology. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2003.
(vii) Breen E, et al. Anal fissures. http://www.uptodate.com/home/index.html. Accessed July 28, 2010.
(viii) Anal fissure. American Society of Colon & Rectal Surgeons. http://www.fascrs.org/patients/conditions/anal_fissure. Accessed July 28, 2010.
(ix) Anal fissure. The Merck Manuals: The Merck Manual for Healthcare Professionals.
(x) Gil J, et al. Screening for the effectiveness of conservative treatment in chronic anal fissure patients using anorectalmanometry. International Journal of Colorectal Disease. 2010;25:649.
(xi) Klein MD, et al. Surgical conditions of the anus, rectum, and colon. In: Kliegman RM, et al. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, Pa: Saunders Elsevier; 2007.
This release contains forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding the transaction, its timing and terms and statements regarding the expectations for the commercialization and marketing of Rectiv. Forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. The words "expects," "potentially," "anticipates," "could," "calls for" and similar expressions also identify forward-looking statements. These statements are based upon Aptalis' current expectations and are subject to risks and uncertainties which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results and developments include successful consummation of the transaction on a timely basis, the impact of regulatory reviews, the satisfaction of customary conditions, the ability of Aptalis to achieve the anticipated benefits of commercializing and marketing Rectiv in the territory, the results, consequences, effects or timing of any inquiry or investigation by any regulatory authority or any legal or administrative proceedings, the successful preparation and implementation of an effective marketing plan, and any other risks set forth in Aptalis' filings with the SEC, including Aptalis Pharma Inc.'s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, in each case together with all amendments thereto. Investors should evaluate any statement in light of these important factors. Forward-looking statements contained in this press release are made as of this date, and, other than as required by applicable law, Aptalis undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward-looking statements.