BRIDGEWATER, NJ--(Marketwired - April 11, 2013) - Aptalis Pharma, US Inc. announced that its French sister company, Aptalis Pharma SAS, has launched PYLERA® to healthcare professionals in France. PYLERA, in combination with omeprazole, is indicated for the eradication of Helicobacter pylori (H. pylori), and prevention of relapse of peptic ulcers in patients with an active, or a prior history of, H. pylori associated ulcers.
Treatment for H. pylori infection involves a complex regimen of multiple medications. PYLERA is available in an innovative formulation that simplifies therapy by combining three of the four active ingredients in a 3-in-1 capsule.
Superior Efficacy Compared to "Gold Standard" Therapy
In a multicenter European study(1), the new O-BMT therapy with PYLERA® plus omeprazole (20 mg) showed significantly higher eradication rates when compared with the standard seven-day triple therapy consisting of omeprazole, amoxicillin and clarithromycin (OAC) (ITT population3: 80% vs. 55% [p < 0.0001]). Prior to treatment, culture and sensitivity testing for metronidazole and clarithromycin resistance was performed. With PYLERA, eradication rates of over 90 percent were demonstrated even when there was resistance to clarithromycin or metronidazole or both. For those treated only with OAC, on the other hand, resistance to clarithromycin or metronidazole or both, had considerable impact on efficacy. The eradication rates of OAC therapy in those who were not resistant to clarithromycin at baseline were 85% vs. only 8% for those who were resistant to clarithromycin at baseline. Simultaneous resistance to metronidazole and clarithromycin at baseline reduced efficacy in only the OAC treatment group (no eradication in 8/10 [80%] of patients with resistant bacteria). Compliance and safety profiles for the two therapies were similar(2); gastrointestinal symptoms like diarrhea and dyspepsia as well as black stool (reversible after cessation of therapy) were the most common side effects with PYLERA.
"We are extremely proud to have reached this milestone for patients and healthcare providers in France," remarked Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma. "A new H. pylori treatment option with demonstrated superiority over the gold standard is now available to combat this disease. Along with our January launch of PYLERA in Germany, and the FDA approval of PYLERA 10 Day Therapy PAK in the U.S., we continue to advance this franchise, as well as our global reach and core mission: To improve health and quality of care by providing specialty therapies for patients around the world."
About Helicobacter pylori (H. pylori)
Helicobacter pylori (H. pylori) is a spiral-shaped bacillus that settles in the human gastric mucosa and can produce symptoms like heartburn, abdominal pressure and diarrhea in affected individuals, and is known to be the main cause of peptic ulcers. However, H. pylori does not always actually cause symptoms.(3) The prevalence varies with, among other factors, geographical distribution: In industrialized countries the infection rate is 20-50%; in developing countries, it is especially widespread, with a prevalence of about 80 percent.(4)
Aptalis Pharma 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®, CARAFATE®, PYLERA®, RECTIV®, VIOKACE™, ULTRESA® 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.
This release contains forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding the expectations for the commercialization and marketing of PYLERA®. 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 the results, consequences, effects or timing of any inquiry or investigation by any regulatory authority or any legal or administrative proceedings, and the successful preparation and implementation of an effective marketing plan. 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.
(1) Randomized, open-label, actively controlled study in parallel groups: PYLERA® (216 patients) vs. OAC (222 patients). Patient numbers calculated for pre-planned statistical analysis of non-inferiority with the test preparations in the per-protocol population and subsequent superiority in the intention-to-treat population.
(2) Patients with treatment-related side events: Quadruple therapy 47% (N = 216), standard triple therapy 51% (N = 222)
(3) Hoffmann F, Tiller FW. Praktische Infektiologie: Erreger - Diagnose - Therapie - Prävention. [Practical Infectious Disease Medicine: Pathogens - Diagnosis - Therapy - Prevention] With current vaccine recommendations. 3rd ed. Heidelberg. Ecomed Medizin. 2011: p. 99.
(4) Suerbaum S, Michetti p. Helicobacter pylori infection. N Engl J Med. 2002; 347: 1175-86.