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Lupin Announces Acquisition of Worldwide Rights for its first NDA – AllerNaze™

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Pharmaceutical Major, Lupin Ltd. announced recently the acquisition of worldwide rights for the intra-nasal steroid (INS) product, AllerNaze™ (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™, 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™ (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™ 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™ 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™ 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™ 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™ 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.

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Written by sreelakshmi

2 July, 2009 at 9:29 pm

Lupin Announces Litigation Settlement with Wyeth for Venlafaxine Extended Release Capsules

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 Pharma Major, Lupin Ltd. announced on 11th May, 2009 that it has settled all ongoing Hatch-Waxman litigation relating to Venlafaxine extended release capsules, Lupin’s generic version of Wyeth’s antidepressant “Effexor XR®” capsules.

 
 

As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product on or after 1st of June, 2011, or earlier in certain limited circumstances, but in no event earlier than January 1, 2011.

 
 

Lupin had earlier filed a Paragraph IV certification to U.S. Patent Nos. 6,274,171, 6,403,120 and 6,419,958, contesting that these patents were either invalid or had not been infringed.- resulting in the subsequent litigation by Wyeth.

 
 

Wyeth’s “Effexor XR®” capsules had U.S. sales of $3.01 billion for the year 2008 (IMS) and accounted for 17 percent of the company’s net revenue last year.

 
 

Commenting on the settlement, Dr. Kamal Sharma, Managing Director, Lupin said – “The settlement with Wyeth is in line with our growth strategies and would help us further strengthen our product pipeline and build strong market positions in the U.S. It is a testament to our prowess in Research & Development and our Intellectual Property management competencies – not to mention our strong focus to deliver high value, high quality products.”

 

Written by sreelakshmi

22 May, 2009 at 12:33 am

Lupin acquires majority stake in Multicare Pharmaceuticals Philippines, Inc

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Strengthens its position in the ASEAN market

Lupin Limited recently announced the acquisition of a 51 percent stake in Multicare Pharmaceuticals Philippines, Inc (MC) of Philippines. MC is a premium branded generics company with a strong position in the women’s health and child care segment. The company reported revenues of Php 272 Mill (approx. USD 6mn) for the year ending December 2008. The acquisition has been made with internal cash accruals by Lupin.

This acquisition, which is Lupin’s sixth since 2008, marks the company’s entry into the USD 2.5 bn pharmaceuticals market in Philippines, currently dominated by multinational companies. Under the agreement, Mr. Romeo Sy, founder, MC will continue to lead the company as President.

Commenting on the development, Dr. Kamal Sharma, Managing Director, Lupin Limited
said, “This is a very positive step ahead for Lupin to establish its stronghold as a top league generics company in the promising market of Philippines in the ASEAN Region. We have seen immense success with our previous acquisitions, all of which have been profitable. Taking this philosophy forward, we believe that MC is a strategic fit in Lupin’s business model. We will continue to focus and leverage on operational efficiencies and capitalize on synergies between the two companies to drive revenues at robust growth rates from the region in the near term.”

Multicare President, Romeo Sy said that the partnership will be of considerable benefit to MC’s position in the generics industry locally. “The equity acquisition by Lupin gives us increased access to international research and development, world-class manufacturing capabilities which will further strengthen our local position”, he said.

MC, with field strength of about 140 people enjoys a commendable franchise with the medical fraternity and harbors strong distribution alliances. The dedicated Global Business Development department of Lupin will ensure continual exposure to international companies and product opportunities. Lupin is amongst the fastest growing pharmaceutical company in India with dedicated R&D facilities and is vertically integrated with presence in many global markets. This strategic partnership will provide significant benefits for both parties. MC will gain access to Lupin’s existing product pipeline and manufacturing expertise, while Lupin will gain access to the established brands and supply chains in Philippines.