Teva Ceases Oral Copaxone Development

The company said it is still considering development of “various non-parenteral formulations” for the MS therapy.

Teva has discontinued development of an oral form of its multiple sclerosis therapy Copaxone (glatiramer) due to disappointing results from recent clinical trials, the company said in a March 20 filing with the Securities & Exchange Commission.

The company's decision is based on the results of two pilot Phase II clinical studies initiated in 2004 by Teva and partner Lundeck that evaluted two doses of enteric coated Copaxone.

However, "based on the results, received in March 2006, Teva and Lundbeck will not continue the development of this formulation," Teva said in its annual report.

Copaxone is currently available as a subcutaneous injection.

The Phase III 1,650-patient CORAL study using 5 mg and 50 mg doses of orally administered Copaxone was completed in 2002 but failed to produce statistically significant results.

Based on an interim analysis of CORAL, the company had considered increasing the dosage to 300 mg, 500 mg or higher. A Phase I study of the 300 mg dosage of Copaxone did not produce any change in side effects, according to the company.

"Teva is considering future development of Copaxone in various non-parenteral formulations and will make its decision in the context of its entire MS portfolio," the company said.

A new addition to Teva's MS portfolio is Ivax/Serono's Phase III oral MS therapy Mylinax (cladribine), which Teva gained through its acquisition of Ivax (¹ (Also see "Copaxone Growth Helps Teva Offset Declining Generics Business" - Pink Sheet, 1 Aug, 2005.)).

Teva also has an oral MS therapy, laquinimod, in its second Phase II trial in Europe.

Sanofi-Aventis is developing an oral formulation of a teriflunomide immunomodulator while Elan is pursuing a sustained-release oral formulation of a fampridine potassium channel blocker 4-aminopryridine for MS. Both products are in Phase III.

-Kathryn Phelps