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ZAXINE® (rifaximin) – Now Indicated in Canada for Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D)

Montreal, Quebec, December 6, 2018 – Lupin Pharma Canada is pleased to announce the approval from Health Canada for ZAXINE® 550 mg (rifaximin) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. ZAXINE® for IBS-D is being launched in December of 2018 under a strategic licensing agreement with Salix Pharmaceuticals, Ltd., one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. The agreement grants Lupin exclusive rights to promote, distribute and market ZAXINE® in Canada. This is in addition to ZAXINE®’s previously approved indication for the reduction in risk of overt hepatic encephalopathy (HE) in adults.1

Canada has one of the highest rates of IBS worldwide, affecting 13-20% of the population.2, 3 Of those who do suffer from IBS, about one third have IBS with diarrhea as the primary symptom. Although the exact cause of IBS-D is not known, scientists believe that the microbiota in the gastrointestinal (GI) tract plays an important role in the development of the symptoms associated with IBS-D, such as abdominal pain, bloating, and diarrhea.1

Speaking on the occasion, Dr. Sofia Mumtaz, President - Pipeline Management & Legal, Lupin said, “We are delighted to receive the approval from Health Canada for ZAXINE® (rifaximin, 550 mg tablets) for the treatment of IBS-D. With this new indication approved, the medical fraternity and patients will now have access to an effective medication against one of the most rampantly prevailing issues of IBS-D.”

“There is an unmet treatment need for those who have irritable bowel syndrome with diarrhea, so this is great news for those still grappling to manage their digestive symptoms”, said Gail Attara, Chief Executive Officer of the Gastrointestinal Society, a patient group known for its popular website, www.badgut.org.

The safety and efficacy of ZAXINE® 550 mg three times daily for 2 weeks were demonstrated in 3 Phase-III placebo-controlled trials. After treatment, significantly more ZAXINE®-treated patients experienced self-reported relief of IBS symptoms.1 In addition, a significantly greater proportion of ZAXINE®-treated patients reported relief of abdominal pain and improvement in stool consistency.1, 4

“In irritable bowel syndrome, it is not always easy to manage the symptoms effectively,” said Dr. Guy Aumais, MD, CSPQ, FRCP (C), Gastroenterologist at Maisonneuve-Rosemont and Associate Professor, University of Montreal. He further added, “ZAXINE® is a short-term, two-week therapy for IBS-D, which will act on symptoms such as diarrhea, bloating and abdominal pain, with lasting relief. With this indication, we now have an interesting new option in the management of IBS-D.”

“An alteration in host-microbiota interactions is a factor in the expression of subsets of IBS patients. ZAXINE® has been shown to improve symptoms in diarrhea predominant IBS-D and its action is likely mediated through attenuation of host microbiota interactions and subsequent symptom generation. This is an important new treatment option for IBS-D patients”, said Dr. Stephen Collins MBBS, FRCP (UK), FRCPC, Professor, Department of Medicine at McMaster University.

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ZAXINE® (rifaximine) is now covered with special authorization on all provincial formularies, the NIHB and the Yukon Drug Programs Formulary in Canada!

Lupin Pharma Canada is pleased to announce that ZAXINE® is now listed across all Canadian provinces with the recent addition of PEI coverage.

The coverage criteria for PEI (special authority criteria) as of July 23, 2018 are:

For reducing the risk of overt hepatic encephalopathy (HE) recurrence (i.e., ≥2 episodes) in patients who meet the following criteria:

  • Patients are unable to achieve adequate control of HE recurrence with maximal tolerated dose of lactulose alone.

  • Must be used in combination with maximal tolerated doses of lactulose.

  • For patients not maintained on lactulose, information is required regarding the nature of the patient’s intolerance to lactulose.

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ZAXINE® (rifaximin) now covered by British Columbia Pharmacare!

Lupin Pharma Canada is pleased to announce that ZAXINE is listed with special authority criteria as February 6, 2018.
The coverage criteria are as follows:

For reducing the risk of overt hepatic encephalopathy (HE) recurrence in patients who meet the following criteria:

  • Have been hospitalized with HE associated with cirrhosis of the liver; AND
  • Are unable to achieve adequate control, despite taking the maximum tolerated dose of lactulose; AND
  • Rifaximin must be prescribed by an internal medicine specialist or a gastroenterologist.

Rifaximin should be used in combination with a maximal tolerated dose of lactulose.

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Lupin and Salix Announce Exclusive Distribution Agreement for Canada Zaxine®, Relistor® and Other Gastroenterology Products

September 12, 2014 Lupin Limited (Lupin) and Salix Pharmaceuticals, Inc. (Salix) announced today that they have entered into a definitive distribution agreement under which Salix has granted Lupin the exclusive right to market, distribute and sell certain Salix products in Canada. This includes immediate rights to distribute Zaxine® (rifaximin) 550 mg tablets for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or
older, and Relistor® Subcutaneous Injection for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond 4 months has not been studied. Additionally, the agreement includes future dosage forms, strengths, and indications for such products. Under the agreement, Lupin also has the option to exclusively market, distribute and sell other gastroenterology products in Salix’s Canadian pipeline once approved by Health
Canada.

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