Lupin Signs Promotional Agreement with Exeltis on SOLOSEC® (secnidazole) expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

BALTIMORE, Jan. 27, 2022 /PRNewswire/ -- Lupin Pharmaceuticals Inc., (Lupin), and Exeltis USA Inc. announced a promotional agreement for Exeltis to promote SOLOSEC® along with Exeltis' existing line of Women's Health products, further enhancing value to OBGYNs and their patients. SOLOSEC® is indicated for the treatment of Bacterial Vaginosis in adult women (a common vaginal infection) and Trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the U.S.).^1-4

"This partnership will expand the reach of SOLOSEC®, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC®, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis," said Vinita Gupta, Chief Executive Officer of Lupin. "We are extremely excited to partner with Exeltis." Salustiano Perez, Chief Executive Officer of Exeltis added, "Our team is thrilled to embark on this partnership. The addition of Solosec fits precisely within our current portfolio of products, enhancing our commercial strategy, and offering numerous solutions to our customers and their patients."

About Exeltis

Exeltis is a fast-growing division of the integrated health sciences group Insud Pharma. It boasts a leadership position in the Women's Health segment, and is constantly innovating and seeking new treatments and devices to improve women's health and wellbeing around the world. With a global footprint spanning over 40 countries, Exeltis has a team of more than 4,000 professionals supported by a global manufacturing network. Exeltis' overarching goal is to support and care for women throughout every stage of life. It offers an extensive portfolio of products to respond to women's needs in the areas of fertility, reproductive health, contraception, pregnancy, childbirth and menopause. In recent years, Exeltis has also diversified into Central Nervous System (CNS), Ophthalmology and Endocrinology.

For more information, please visit: https://exeltisusa.com/

About SOLOSEC®

SOLOSEC® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.^1-4 SOLOSEC® is designed to be easy to take and one oral dose contains a complete course of treatment.^[1]

Additional information about SOLOSEC® can be found at www.SOLOSEC.com.

INDICATION

SOLOSEC® (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women and trichomoniasis in adults. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.

DOSAGE AND ADMINISTRATION

SOLOSEC® is a single-dose therapy for oral use. The entire contents of SOLOSEC® packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC® is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC® and for at least 2 days after completing therapy.

IMPORTANT SAFETY INFORMATION

• SOLOSEC® is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives.
• Vulvovaginal candidiasis may develop with SOLOSEC® and require treatment with an antifungal agent.
• Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
• Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC®.
• Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
  

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Important Safety Information.
Or
Please click here for full Prescribing Information.

Manufactured for and Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ 07932

About Lupin Pharmaceuticals, Inc.

Lupin Pharmaceuticals, Inc. is the U.S. based wholly owned subsidiary of Lupin Limited, and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals, Inc.'s branded pharmaceuticals division provides products designed to help prevent and manage women's health conditions.

Please visit www.lupin.com/US for more information.

© 2022 Lupin Inc. All Rights Reserved. SOLOSEC® is a registered trademark of Lupin Inc. and LUPIN® is a registered trademark of Lupin Pharmaceuticals, Inc.

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

PP-SOL-XXXX, January 2022

References:

<sub>[1] Solosec Package Insert Package Insert

[2] Workowski KA, Bolan GA; CDC. Sexually Transmitted DiseasesTreatment Guidelines, 2015 [published correction appears in MMWR Recomm Rep. 2015;64(33):924]. MMWR Recomm Rep 2015;64(RR-03):1-137

[3] Onderdonk AB, Delaney ML, Fichorova RN. The Human Microbiome During Bacterial Vaginosis. Clin Microbiol Rev. 2016;29(2):223-238.

[4] Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864-869.</sub>

For further information or queries please contact –

Shweta Munjal 
Vice President & Global Head – Corporate Communications
Email: [email protected]

SOURCE Lupin Pharmaceuticals, Inc.