Mark Iii Industries

Teva MS drug stumbles in key study

Awkwardly for Teva, while its new drug failed to show an improvement over placebo in either relapse rates or disability progression, the study did show a benefit for Biogen Idec's rival beta-interferon injection Avonex.

Patients on Avonex had a lower annualised relapse rate (ARR) than those on placebo, although, like laqinimod, it did not improve disability progression as measured by the expanded disability status scale (EDSS).

Teva officials told analysts on a conference call it remained committed to laquinimod and stressed that not only will it have no trouble getting regulatory approval, the drug is safe and should find a market among those with MS.

"It's a bit of disappointment for investors. It's not something the market expected from Teva," said Sabina Podval, an analyst at Leader Capital Markets. "The drug launch and approval process now looks more complicated."

Laquinimod is jockeying for position in the emerging area of oral treatments for multiple sclerosis (MS), where Novartis' recently approved Gilenya has a leading position.

Given the tough competition, the results from the second of two pivotal Phase III clinical trials will undermine faith in Teva's medicine, on which it is relying to make up for lost sales of its older MS treatment Copaxone.

Although the trial was not powered to compare laquinimod and Avonex directly, analysts said the picture emerging of greater benefit from the older Biogen product was not encouraging for Teva and Active Biotech.

Nonetheless, Teva said it still believed that clinical trial results to date showed the drug had a clear ability to reduce disability and brain tissue loss.

It plans to push ahead with submitting applications to regulatory authorities in the United Stated and the European Union. In a conference call, Teva said it aimed to submit the product for regulatory approval with the U.S. Food and Drug Administration by early 2012.

Harel Finance analyst Steven Tepper said that while laquinimod was not yet dead, the drug faces an uphill battle with the FDA, which may require more analysis or another experiment to verify efficacy.

James E. Boening: 06/99-05/00 Mark III Industries

Recruited by Tony Wilson to lead management team in restructure of the world’s largest stage two automotive facility.  Hired as National Sales Director and promoted to V.P. of Sales and Marketing.  Restructured the sales and marketing group to pursue the commercial transport market and reduce emphasis on traditional market.  I established a product line to address the mobility and security transport market while reducing existing models by 30%.  Reduced operating cost by 35% through facility consolidation and supplier management consolidated work force and implemented cross-functioned training for assembly efficiencies.  Reduced floor plan and negotiated financing packaging with Ford, GM and Chrysler.  Created Tiger teams to develop and implement best practices with OEM’s to reduce plan with Hertz for full size vans.  I directed an after lease resale program.  Directed the implementation of cooperative marketing programs to gain market share and brand awareness with minimal expenditure.

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