TEL AVIV, July 14 (Reuters) - There will not be any generic version of Teva Pharmaceutical Industries' (TEVA) multiple sclerosis drug Copaxone before 2014, the company's president and chief executive said in an interview published on Monday.
Momenta Pharmaceuticals (MNTA) on Friday said U.S. regulators had accepted for review its generic version of Copaxone, one of Teva's (TEVA.TA: Quote, Profile, Research, Stock Buzz) two branded drugs, sending Teva's Nasdaq-listed shares down 7.2 percent to $41.78.
Israel-based Teva is the world's biggest maker of generic drugs, but Copaxone, which had global sales of $1.7 billion in 2007, is an important product for the company. Teva says it has patent protection on Copaxone in the United States until May 2014 and in much of Europe until 2015.
"Things must be put into proportion," Teva Chief Executive Shlomo Yanai said in an interview published in the Maariv daily. "Despite Copaxone, Teva's main business is generics, from where we get our income. This is a growing business and there are exceptional opportunities."
Yanai said he saw no reason to be concerned by Momenta's announcement as he believes the company [MNTA] will be required to conduct extensive clinical trials, which could take five years.
"Copaxone does not resemble what everyone is familiar with in the generic world," he said. "It is a product that must be injected daily and affects the body's nervous system.
"The obstacles Momenta will have to overcome will not end until 2014," he added.
He said Teva was conducting trials on other products for multiple sclerosis and the company would have results for these trials well before anyone gains approval for a generic version of Copaxone.
"Even if I am wrong in my estimate about the entry of a generic version to the market, Teva has a clear answer on the commercial side for this day. We are 'mister generic' and we will know how to do this," he said.
It is not a foregone conclusion that someone will come up with a generic version of Copaxone and take away market share, certainly not immediately, Yanai said.
Maariv also said Yanai will not change Teva's strategic plan that calls for doubling its sales within five years to $20 billion.
"We are even more confident in them (the plans) than when we announced them a year ago, for many reasons that I cannot detail now," Yanai said. (Reporting by Tova Cohen; Editing by David Holmes) <<
[Updated likely timing of Lovenox launch based on comments from today’s NVS CC.]
3Q08: Resubmit Lovenox ANDA with immunogenicity info requested by FDA.
2H08: Present M118 phase-2a data in stable angina at a medical conference (probably ASH in Dec 2008).
2H08: Start M118 phase-2b trial in PCI.
Late 2008/early 2009: Partnership deal for M118.
2008-2009: Announcements re follow-on biologics program.
Early 2009: Probable FDA action on Lovenox ANDA (assuming resubmission of ANDA in 3Q08).
2009-2010: Possible FDA action on Copaxone ANDA. There is no formal review schedule and the first action taken by the FDA could be a request for more information (as was the case with the Lovenox ANDA). Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires, the FDA is allowed to take other actions during this period including tentative approval, rejection, or a request for more information. (The 30-month stay could be overridden if MNTA/Sandoz prevailed against Teva in a patent trial.)
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