Teva Pharmaceutical Industries Limited, Israel, has filed a Citizen Petition with the US FDA as a part of its effort to prolong its monopoly on Copaxone® - used in the treatment of multiple sclerosis in the United States. This Citizen Petition is very similar to another petition which Teva had filed in 2008, which was rejected by US FDA earlier this year. NATCO would like to state that filing of a Citizen Petition is a common tactic employed by the branded pharma companies in the USA to delay generic competition and Teva seems to have borrowed this manoevour from the branded pharma industry. NATCO stands firmly behind the safety and integrity of its marketed Glatiramer Acetate products and NATCO intends to suitably respond to Teva's unfounded claims. Teva had alleged that there is a significant difference between NATCO's product and its Copaxone®.
NATCO & Mylan's abbrevited new drug application - ANDA for Glatiramer Acetate has been accepted for review by the US FDA in Septembe 2009 and the review is presently ongoing. This attempt of Teva is to delay the approval of the ANDA. This product is extremely important for TEVA's sales (US$ 1085 Million - 2008) and it is the largest product in their portfolio (US$ 2262 million - 2008). For NATCO, this product, on approval, represents a significant upside. NATCO is the only generic producer in world of this product, involving complex peptide chemistry.
The stock closed the day at Rs.110.15, down by Rs.3.40 or 2.99%. The stock hit an intraday high of Rs.114.80 and low of Rs.109.10.
The total traded quantity was 28327 compared to 2 week average of 83122.
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