The award recognizes outstanding industry leaders and companies with a significant footprint in New Jersey, including those that have earned noteworthy achievements or have received FDA drug approval.
Recognition of Approval of Novel Women’s Health Product: Solosec
East Brunswick, NJ (February 2, 2018) – Symbiomix, a Lupin Company, received an “Innovator Award” from BioNJ, New Jersey’s trade association for the biotechnology community. Leadership from the company was on hand to accept the award at BioNJ’s 25th Annual Gateway Gala and Innovation Celebration dinner at the Hilton East Brunswick on February 1. The award recognizes outstanding industry leaders and companies with a significant footprint in New Jersey, including those that have earned noteworthy achievements or have received FDA drug approval. In 2017, Symbiomix received FDA approval for Solosec™(secnidazole) oral granules, for the treatment of bacterial vaginosis (BV) in adult women. Lupin acquired Symbiomix in Oct 2017. Lupin expects Solosec™ to be commercially available by mid-2018. Lupin has a substantial presence in NJ, with an R & D and manufacturing center in Somerset, NJ.
BioNJ’s signature event of the year, the Annual Dinner, brought together New Jersey’s biotechnology community to celebrate the many achievements of the industry in 2017, and to discuss the challenges and opportunities ahead in 2018. Good Morning America anchor Robin Roberts presented a Key Note address.
“We are honored to be recognized among our peers for our efforts to bring innovation and value to the U.S. market,” said Vinita Gupta, Chief Executive Officer of Lupin Limited. “The ‘Innovator Award’ is especially exciting as the Solosec™ brand immediately expands Lupin’s US women’s health specialty business into the highly-complementary gynecological infection sector. This novel product is an important milestone in the evolution of our Specialty business and gives Lupin a new therapeutic to bring to obstetricians and gynecologists to treat a serious health condition they see frequently in their practices.”
“BioNJ’s 25th Annual Dinner Meeting and Innovation Celebration is about honoring the important innovation coming from New Jersey. We are thrilled to recognize Lupin Pharmaceuticals with a BioNJ 2017 Innovator Award for its approval of Solosec™,” stated Debbie Hart, President and CEO, BioNJ. “2017 was a record-breaking year with nearly 50% of approvals coming from companies with a footprint in New Jersey. We thank Lupin for its continued innovation on behalf of Patients.”
Lupin is quickly growing as a leader in the U.S. branded pharmaceutical sector, focusing much of its efforts on the women’s healthcare space. Solosec™ will be the second women’s health brand Lupin launches in the US. Our first women’s health brand, Methergine™, was launched in 2016. In addition, Lupin’s generic arm has already launched more than 25 oral contraceptive products.
“We have set ambitious targets for ourselves in the U.S. market,” said Kurt Nielsen, Lupin President, who is based in Somerset. “We are grateful to BioNJ for acknowledgement of Lupin’s efforts to enhance the pharmaceutical space, especially in women’s healthcare. The recent approval for Solosec™, which was a deciding factor for our recognition, highlights our continued commitment to grow our women’s healthcare portfolio. The demand for quality products for women is high, and so we will continue to focus our efforts on this space, providing new and cutting-edge approaches to improve a woman’s quality of life over her lifetime.”
Since 2016, Lupin has invested more than $1 billion in R&D and manufacturing in the United States. With commercial headquarters in Baltimore, Maryland, and R&D centers in Somerset, New Jersey and Coral Springs, Florida, Lupin employs 635 highly skilled and specialized employees in the US. More than 50 jobs are expected to be added over the next 18 months. With the acquisition of the Somerset facility in March 2016, more than 80 jobs were created, bringing the total number of employees in Somerset to 380. In addition, Lupin has invested over $20 million annually in R&D and infrastructure in New Jersey.
About Solosec™
Indication: SOLOSEC™ (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.
Important Safety Information
- SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.
- Vulvo-vaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
- Potential risk of carcinogenicity in patients taking single-dose of SOLOSEC to treat bacterial vaginosis is unclear. Chronic use should be avoided.
- SOLOSEC may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
- 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.
- In clinical studies, the most common adverse events occurring in (?2%) of patients receiving SOLOSEC 2g oral granules were vulvovaginal candidiasis (9.6%), headache (3.6%), nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), and vulvovaginal pruritus (2.0%).
About Methergine™
For More Information about Methergine™ visit: www.Methergine.com
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 8th and 6th largest generics pharmaceutical company by market capitalization (September 30th, 2017, Bloomberg) and revenues (March 31st, 2017, Bloomberg) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2nd largest Indian pharmaceutical company by global revenues (March 31st, 2017, Bloomberg); 6th largest generic pharmaceutical player in Japan and 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 2017).
For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively.
Please visit http://www.lupin.com for more information.
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For further information or queries please contact –
Pooja Thakran
VP – Corporate Communications
Email: poojathakran@lupin.com
Ph: +91-22-66402531 / 8291013225
or
Arvind Bothra
Head – Investor Relations and M&A
Email: arvindbothra@lupin.com
Ph: +91-22-66402137
Christy Fox, Director
Moore Communications Group
p: 850.224.0174 c: 646.246.3743
