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Aptalis Pharma™ Launches PYLERA® 10 Day Therapy PAK in the United States


9/3/2013 11:04:22 AM

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BRIDGEWATER, NJ--(Marketwired - September 03, 2013) - Aptalis Pharma, US Inc. announces the launch of PYLERA® 10 Day Therapy PAK in the U.S. PYLERA® capsules (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride), in combination with omeprazole, is indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. PYLERA is the only branded treatment option available that does not contain clarithromycin, a macrolide antibiotic. Utilization of macrolide antibiotics are believed to contribute to the growing rate of clarithromycin-resistant H. pylori. With the 10 Day Therapy PAK, physicians now have a PYLERA option that leverages innovative 3-in-1 capsule technology in blister packaging for convenient administration.

"Almost 20 years after the establishment of clarithromycin-based triple therapy for the eradication of Helicobacter pylori, eradication rates are declining with this therapy due to increasing rates of clarithromycin-resistant H. pylori," said Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma. "Given this, it is important for physicians and patients to have a convenient non-macrolide treatment option like PYLERA for H. pylori in the 10 Day Therapy PAK."

Guidelines from the American College of Gastroenterology recommend asking patients if they have previously used a macrolide for any reason, such as for the treatment of upper respiratory infection, before treating H. pylori. The likelihood of clarithromycin-resistant H. pylori infection increases with multiple macrolide antibiotic courses prescribed before diagnosis of H. pylori. In one study, 92% of patients who had a clarithromycin-resistant H. pylori strain had been treated with a macrolide antibiotic in the past 10 years.

About Pylera:

INDICATION

  • PYLERA® Capsules (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride), in combination with omeprazole, are indicated for the treatment of patients with Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
  • The eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA® and other antibacterial drugs, PYLERA® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
  • When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy

IMPORTANT SAFETY INFORMATION:
CONTRAINDICATIONS
PYLERA® is contraindicated in:

  • Patients with renal impairment
  • Patients with known hypersensitivity to product components

ADVERSE REACTIONS
The most frequently reported adverse reactions (≥5%) during clinical trials were:

  • Abnormal feces -- Diarrhea -- Nausea -- Headache

WARNINGS AND PRECAUTIONS

  • Fetal Toxicity: Advise pregnant women of the risk for permanent discoloration of teeth with tetracycline if used during the second or third trimester
  • Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high doses of intravenous tetracycline also resulting in stillborn or premature birth
  • Central and Peripheral Nervous System Effects: Encephalopathy and peripheral neuropathy with metronidazole, pseudotumor cerebri with tetracycline and neurotoxicity with bismuth-containing products; monitor patients with CNS conditions closely and discontinue promptly if abnormal neurologic signs develop
  • Use in Patients with Blood Dyscrasia: Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of, or history of, blood dyscrasia. A mild leukopenia has been observed; however, no persistent hematologic abnormalities attributable to metronidazole have been observed
  • Development of Superinfection: If superinfection occurs, discontinue PYLERA® and institute appropriate therapy

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 cause symptoms. The prevalence varies with, among other factors, geographical distribution: in industrialized countries the infection rate is 20-50 percent; in developing countries, it is especially widespread, with a prevalence of about 80 percent.

About Aptalis
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.

Forward-Looking Statements
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.




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