Inasmuch as Downey was speaking at an event designed to promote the Teva-Barr merger to the investment community, would you honestly have expected him to question the impregnability of Teva’s Copaxone franchise?
Bruce Downey, the former chairman and CEO of Barr Pharmaceuticals, has formally accepted an appointment to the board of directors of one of Teva Pharmaceutical Industries' competitors, Momenta Pharmaceuticals.
When Teva acquired Barr back in July 2008, Downey, unlike senior executives at other companies bought out by Teva, announced that he had no intention of staying on at the merged company in any capacity.[Hence, Downey’s jocular remark in #msg-30794311.]
Momenta specializes in unlocking the structures of complex sugars and in characterizing and reverse-engineering complex drugs in order to develop generic versions of those drugs. Last July, Momenta and Sandoz - which is the second-largest generic drug manufacturer in the world, after Teva - applied for approval of a generic form of Teva's flagship multiple sclerosis drug, Copaxone. Teva sued both companies a month later, on the grounds that their version of the drug violates patents that protect Copaxone until 2014.
Momenta and Sandoz cannot begin marketing their generic version of Copaxone until February 2011[when the 30-month stay under Hatch-Waxman expires], or until they win the patent suit, whichever comes first. But Teva also doubts Momenta's ability to prove that its generic version is biologically equivalent to Copaxone, due to Copaxone's unique structure.
“I believe Momenta offers the potential to build a leading position in the development and commercialization of complex mixture and follow-on biologic drugs, as well as [to] further leverage its scientific platform and capabilities to discover and develop novel drugs,” Downey said following his appointment, in a statement hinting at his confidence that Momenta can meet the technological challenge of developing a generic version of Copaxone. “I'm excited to be part of the next wave of drug development as a member of Momenta's board.”
Worldwide sales of Copaxone in the first quarter of 2009 totaled $621 million, up 15% over the parallel quarter in 2008[$430M of this, or about 70%, was in the US, and hence the Copaxone ANDA from NVS/MNTA is targeting a $1.7B annualized market] and accounted for an estimated 20% of Teva's net profits.‹
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