Thursday, January 10, 2013

Copaxone Generics - With Synthon conducting global clinical trials to prove bioequivalence of its generic Glatiramer Acetate to Teva's Copaxone, will others (Natco/Mylan or Sandoz/Momenta) follow suit?

Synthon has developed a generic version of Copaxone (Glatiramer Acetate) which is supposed to have a similar quantitative and qualitative composition as Copaxone, with regard to active substance and excipients and is presented in the same dosage form (pre-filled syringe containing a solution for injection).  While Synthon has already submitted an ANDA application to the USFDA for approval (in December 2011), it is also conducting a worldwide clinical trial comparing its generic copy (Glatiramer Acetate) with the branded version - Teva's Copaxone.

The 9 Month Equivalence trial would enroll 750 patients to compare the efficacy and safety and tolerability of Synthon's Glatiramer Acetate (GTR) to Teva's Copaxone®  in Subjects With Relapsing Remitting Multiple Sclerosis.
This trial consists of two parts:
Part 1 is a multi-country, multi-centre, randomized, double-blind, active and placebo-controlled, equivalence trial comparing the efficacy and safety and tolerability of GTR versus Copaxone® in subjects with RRMS. Eligible subjects will be randomly assigned to receive daily 20 mg GTR (Synthon BV), 20 mg Copaxone® (TEVA) or placebo for a period of 9 months.
In Part 2, the trial continues as an open-label uncontrolled trial to evaluate efficacy and safety of long-term treatment with GTR. Subjects completing the 9-month double-blind period will be treated with open-label 20 mg daily GTR for another 15 months.

Other Generic Players which are also looking to roll-out  generic versions of Copaxone

Natco / Mylan and Sandoz / Momenta are also in the fray to develop a generic version of Teva's Copaxone. Sandoz / Momenta is believed to have the first to file status. 
So far the USFDA has not mandated requirement of clinical trials for generics to demonstrate BA/BE to the branded version Copaxone.

Copaxone - Immensely Valuable for Teva 

Copaxone is immensely valuable for Teva as it generates about 20 percent of its annual sales and should be about 40% of EBITDA. Over the last 3 years Teva has hiked Copaxone prices by almost 100 percent and currently sells for whooping annual cost of ~ $45K. Hence assuming 60 percent net profit margins from this product would be a safe assumption. Knocking off one off opportunities (Para-IV FTF) and Copaxone entirely from its P&L could even push this giant into losses. 
Teva is all after blocking generics from reaching the market and has filed several citizen petitions to the USFDA to not approve a  generic copy without a clinical trial. Besides threat from generics, Teva also faces threat from new NCE entrants in the markets. BG-12 which is an oral treatment option unlike Copaxone (injectable) is expected to be launched soon. BG-12 is the most immediate and potent threat to Copaxone sales going forward. Currently Copaxone is positioned as a first line therapy in MS with about 40 percent share. It is expected BG-12 would take share from Copaxone as in head to head trials comparing BG-12 to Copaxone, BG-12 demonstrated better efficacy. In an attempt to block the approval of BG-12, Teva has recently filed a citizen petition asking the USFDA to thoroughly evaluate the risk and benefits of BG-12 by appointing an advisory committe. This is the fifth citizen petition that Teva has filed to the USFDA, the previous four being against generics.

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