Lupin Pharma Canada Announces Partnership with Endoceutics for the Commercialization of INTRAROSA®

Brings to the Canadian market the first prescription drug for the local treatment of postmenopausal vulvovaginal atrophy that does not carry any serious warnings and precautions, a long-awaited innovation in women’s health.

Quebec, Canada, March 08, 2021: Lupin Pharma, a subsidiary of global pharma major Lupin Ltd, today announced a partnership with Endoceutics, a women’s health focused innovative Canadian biotech company, to commercialize INTRAROSA® in Canada. INTRAROSA® is Endoceutics’ flagship product indicated for the treatment of postmenopausal vulvovaginal atrophy offered as a vaginal ovule containing 6.5 mg of Prasterone.

Commenting on the partnership, Dr. Sofia Mumtaz, President, Lupin Pharma Canada said, “We are very pleased to partner with Endoceutics to bring this long-awaited innovative product to the Canadian market. Intrarosa will not only expand and strengthen our product portfolio into Women’s Health in Canada but will cater to satisfy the unmet medical needs.”

“We are very excited to be working closely with Lupin Pharma. We believe it is the partner of choice to make INTRAROSA® available to Canadian women in need of innovative treatment,” commented Dennis Turpin, President and Chief Executive Officer, Endoceutics.

It is estimated that over 50% of postmenopausal women suffer from the symptoms of vulvovaginal atrophy and that less than 10% of these women are treated with prescription medicines.

About INTRAROSA®

About INTRAROSA®

INTRAROSA® was developed in Quebec City, Canada by Endoceutics. INTRAROSA® will be manufactured by Endoceutics in Mont-Saint-Hilaire, Canada.

INTRAROSA® is indicated for postmenopausal vulvovaginal atrophy, it is a vaginal ovule containing 6.5 mg of Prasterone. It comes in blister packs of 28 ovules, with 6 reusable applicators. The recommended dose is one vaginal ovule inserted once a day at bedtime, using the provided applicator or fingers.¹

Prasterone is a natural steroid compound, inactive by itself, with no estrogenic, androgenic, or other hormonal activity. Following intravaginal administration, it is transformed inside the vaginal cells into estrogens and androgens, and the sex steroids made intracellularly are also inactivated locally inside the same cells, thus avoiding exposure to other tissues. This mechanism is comparable to the physiological functioning observed in normal postmenopausal women, where the peripheral tissues make and inactivate their own intracellular sex steroids exclusively from circulating endogenous Prasterone, explaining why serum estrogens and androgens remain at low concentrations following menopause and during intravaginal administration of INTRAROSA®.¹ The effectiveness of INTRAROSA® on moderate to severe dyspareunia and vaginal dryness, two symptoms of vulvovaginal atrophy due to menopause, was confirmed in two pivotal 12-week placebo-controlled efficacy trials.¹

Statistically significant beneficial effects (p=0.017 to < 0.0001) were observed at 2 weeks on pH as well as on parabasal and superficial cells, with 52% to 81% of the 12-week effects observed by 2 weeks. For the effect on pain with sexual activity and vaginal dryness, the severity score decreased by 40% and 65% at 2 weeks compared to 12 weeks, an effect which became statistically significant at 8 weeks (p=0.004 and 0.004, respectively).¹

INTRAROSA® is approved for commercialisation in the US, Europe, UK, Canada, Hong-Kong, Israel, United Arab Emirates, Switzerland, Lebanon, and Macau.

Contraindications¹

• INTRAROSA® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.

• INTRAROSA® is contraindicated in women with undiagnosed abnormal genital bleeding.

About Lupin Limited

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. For the nine months ended December 31, 2020, the Company invested 9.8% of its revenues on research and development.

 Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupinpharma.ca for more information on lupin in Canada or www.lupin.com.

Follow us on Twitter: https://twitter.com/LupinGlobal LinkedIn: https://www.linkedin.com/company/lupin

Facebook: http://www.facebook.com/LupinWorld/

About Endoceutics

Endoceutics, Inc. is focused on women’s health. Endoceutics also manufactures its innovative INTRAROSA as well as other drugs on behalf of its partners and customers. Endoceutics has the expertise for clinical development, registration and commercialization of its products and it has a portfolio of drugs at various stages of development. Endoceutics’ mission is to provide women the quality of life they deserve.

For more information, please visit www.endoceutics.com

For further information or queries please contact –

LUPIN

Shweta Munjal
Head – Corporate Communications
Email: shwetamunjal@lupin.com

 Arvind Bothra
Head – Investor Relations/Corporate M&A
Email: arvindbothra@lupin.com

Manjira Sharma
General Manager – Corporate Communications
Email: manjirasharma@lupin.com

ENDOCEUTICS

info@endoceutics.com
(418) 653-0033

References

1. INTRAROSA® Product Monograph. Endoceutics, Inc. October 2019

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.

For more information, click here.

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.

For more information, click here.

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.

For more information, click here

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.

For more information, click here