Announces Acquisition of Worldwide Rights for its first NDA - AllerNaze(TM)
BSE: 500257 NSE: Lupin REUTERS: LUPN.BO BLOOMBERG: LPC IN
MUMBAI, India, June 30 /PRNewswire/ -- Pharmaceutical Major, Lupin Ltd. announced today the acquisition of worldwide rights for the intra-nasal steroid (INS) product, AllerNaze(TM) (triamcinolone acetonide, USP) Nasal Spray, 50mcg from Collegium Pharmaceutical, Inc.
The United States will be the first market in which Lupin will launch the product. Lupin expects to expand its US sales force as it launches AllerNaze(TM), building on its presence in pediatrics and expanding into other key specialties such as allergy/immunology and otolaryngology.
The U.S. Food and Drug Administration (FDA) has already approved AllerNaze(TM) (triamcinolone acetonide, USP) Nasal Spray, 50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children twelve (12) years of age and older. The safety and efficacy of AllerNaze(TM) in both SAR and PAR have been well established in 14 controlled clinical trials involving almost 1,200 subjects. The studies assessed the safety and effectiveness of AllerNaze(TM) in treating the symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with allergic rhinitis.
The United States alone reports up to 40 million cases every year that severely affect quality of life of such patients. The INS market generated $ 2.5 Billion in annual sales in United States alone (IMS data).
Commenting on the development, Dr. Kamal Sharma, Managing Director, said: "Our investment in AllerNaze(TM) reflects our commitment to expand our brand business in the US and also in some select markets. Having built a significant base in the US by leveraging our internal research & development initiatives we remain focused on growing our brand presence with strategic investments in exclusive brand products which we will nurture and grow. With this we reaffirm our commitment to bringing new and effective therapies to patients around the world in areas where we feel there still remains a significant unmet medical need."
"We are excited about Lupin's first NDA acquisition and this opportunity to expand our US brand business into another specialist segment. The AllerNaze(TM) acquisition demonstrates Lupin's commitment to its brand franchise in US. It will allow Lupin to draw on its existing strengths within Pediatrics and grow into other specialties to carve a share out of the multi-billion dollar allergic rhinitis market. AllerNaze(TM) offers a quality intra-nasal steroid option to physicians as they deal with adherence and compliance issues when treating allergic rhinitis," said Vinita Gupta, President and CEO, Lupin Pharmaceuticals, Inc.
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company today has significant presence in Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs not to mention global leadership positions in the Anti-TB and Cephalosporins. The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
Today, Lupin is not only the fastest growing Generic business in the US market but is also ranked 9th in terms of prescriptions base for the market (IMS Health). The company is also the 5th largest pharmaceutical player in India (ORG IMS - March 2009) and one of the fastest growing, top 10 Generic players in Japan and South Africa. (IMS)
For the financial year ended March 2009, Lupin's Consolidated Revenues and Profit after Tax were Rs. 39,145 million and Rs. 5015 million respectively.
For further information contact: Shamsher Gorawara Head - Corporate Communications Lupin Limited firstname.lastname@example.org Mobile: +91 9820338555 OR Sonia Mansata Text 100 email@example.com Mobile: +91 9820112481
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.
|SOURCE Lupin Ltd.|
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