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.