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Thursday, January 07, 2010 6:38:45 PM
Teva Pharma Sees Copaxone Pressure Coming But No Generic
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Teva Pharmaceutical Industries Ltd. (TEVA) doesn't expect generic competition for its blockbuster multiple sclerosis treatment Copaxone before 2014, but the company warned that competition from oral MS drugs will likely pressure sales before that time.
The Copaxone battle is notable because it pits the world largest generics company, which has benefited from challenging the patents of other pharmaceutical companies, against generic competitors to protect the exclusivity of its own brand.
Momenta Pharmaceuticals Inc. (MNTA) and Mylan Inc. (MYL) have both filed to produce generic versions of Copaxone, a process that is likely to span years. The drug, one of the world's best selling MS treatments with 2008 sales of $2.26 billion, is a key component of Teva's business.
"We believe Copaxone remains the most significant concern for {TEVA} investors, given potential for generic competition," Goldman Sachs analyst Randall Stanicky wrote in a note to clients Thursday.
Teva has sued both Momenta and Mylan, triggering an automatic 30-month stay on Food and Drug Administration approval, as required by a generics-related law, meaning no generic version of Copaxone can enter the U.S. market until early 2011.
At the company's meeting with analysts in New York on Thursday, the Israeli generic drug maker gave financial goals until 2015. In the middle of that projection period, annual sales of Copaxone would peak at about $3 billion but fall to around $2 billion by the end of the period.
William Marth, president and chief executive of Teva North America, said its projections for Copaxone sales were conservative and that pressure in the period would come from competition, not a generic version of the drug.
Marth said it was "unlikely" that a pure generic of Copaxone would ever be approved and reiterated Teva's long-held stance that generic drug makers can't show their drug is a precise copy of Copaxone {MNTA disagrees!!} - a fact that should preclude market approval and require comprehensive clinical trials.
Furthermore, Marth downplayed how the MS market would receive a generic to a drug that has been used since its approval in 1996.
"We think the willingness to switch off of a proven therapy with proven safety and efficacy is extremely unlikely," Marth said.{We'll see
}
http://www.advfn.com/news_Teva-Pharma-Sees-Copaxone-Pressure-Coming-But-No-Generic_41017693.html
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Teva Pharmaceutical Industries Ltd. (TEVA) doesn't expect generic competition for its blockbuster multiple sclerosis treatment Copaxone before 2014, but the company warned that competition from oral MS drugs will likely pressure sales before that time.
The Copaxone battle is notable because it pits the world largest generics company, which has benefited from challenging the patents of other pharmaceutical companies, against generic competitors to protect the exclusivity of its own brand.
Momenta Pharmaceuticals Inc. (MNTA) and Mylan Inc. (MYL) have both filed to produce generic versions of Copaxone, a process that is likely to span years. The drug, one of the world's best selling MS treatments with 2008 sales of $2.26 billion, is a key component of Teva's business.
"We believe Copaxone remains the most significant concern for {TEVA} investors, given potential for generic competition," Goldman Sachs analyst Randall Stanicky wrote in a note to clients Thursday.
Teva has sued both Momenta and Mylan, triggering an automatic 30-month stay on Food and Drug Administration approval, as required by a generics-related law, meaning no generic version of Copaxone can enter the U.S. market until early 2011.
At the company's meeting with analysts in New York on Thursday, the Israeli generic drug maker gave financial goals until 2015. In the middle of that projection period, annual sales of Copaxone would peak at about $3 billion but fall to around $2 billion by the end of the period.
William Marth, president and chief executive of Teva North America, said its projections for Copaxone sales were conservative and that pressure in the period would come from competition, not a generic version of the drug.
Marth said it was "unlikely" that a pure generic of Copaxone would ever be approved and reiterated Teva's long-held stance that generic drug makers can't show their drug is a precise copy of Copaxone {MNTA disagrees!!} - a fact that should preclude market approval and require comprehensive clinical trials.
Furthermore, Marth downplayed how the MS market would receive a generic to a drug that has been used since its approval in 1996.
"We think the willingness to switch off of a proven therapy with proven safety and efficacy is extremely unlikely," Marth said.{We'll see
} http://www.advfn.com/news_Teva-Pharma-Sees-Copaxone-Pressure-Coming-But-No-Generic_41017693.html
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