Dec 6, 2018   SOURCE: PR NewsWire

ZAXINE® (rifaximin) - Now Indicated in Canada for Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D)1,2


     
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MONTREAL, Dec. 6, 2018 /PRNewswire/ - 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.

ABOUT ZAXINE® (RIFAXIMIN)

ZAXINE® (rifaximin)'s primary mode of action reduces the bacterial load and bacterial products that can negatively affect the patient, alleviating the most common symptoms of IBS-D including bloating, abdominal pain and diarrhea.(1)

As an antibacterial agent that acts locally on the microflora of the gut thereby altering the gut microbiota, ZAXINE® represents an important new therapeutic option in the treatment of IBS-D.

About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the 13(th) largest generics pharmaceutical company in terms of market capitalization (30(th) September 2018, Bloomberg) and the 8(th) largest generics pharmaceutical company in terms of revenues (30(th) June 2018, Bloomberg LTM) globally. The Company is the 3(rd) largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT September 2018); 3(rd) largest Indian pharmaceutical company by global revenues (30(th) June 2018, Bloomberg LTM); 6(th) largest generic pharmaceutical player in Japan (IQVIA MAT September 2018) and 5(th) largest company in the Indian Pharmaceutical Market (IQVIA MAT September 2018).

For the financial year ended 31(st) March 2018, Lupin's Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter - www.twitter.com/lupinglobal.

CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.


      ZAXINE(R) (rifaximin) is                   In Canada, ZAXINE(R) (rifaximin)
       manufactured by:                           is distributed exclusively by:

                   Salix Pharmaceuticals, Inc.                Lupin Pharma Canada Ltd

      400 Somerset Corporate
       Boulevard                                 1001 Bd. De Maisonneuve East

      Bridgewater, NJ 08807                      Suite 304, Montréal, Québec H2L
                                                  4P9


     USA                                      
     Canada

References:

    1. ZAXINE® Product Monograph. Salix Pharmaceuticals, Inc., November 30,
       2018.
    2. http://cdhf.ca/en/disorders/irritable-bowel-syndrome-ibs/section/resource
       s
    3. https://www.badgut.org/information-centre/a-z-digestive-topics/ibs/
    4. Pimentel M, Lembo A, Chey WD et al. Rifaximin Therapy for Patients with
       Irritable Bowel Syndrome without Constipation. N Engl J Med 2011;
       364:22-32.

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SOURCE Lupin Pharma Canada