With the news that a generic version of Copaxone was possibly on the horizon, Teva, maker of the drug filed three Citizen Petitions with the FDA to block the approval of any new drug application that may result in a generic, and cheaper, version of Copaxone.
Taken from Teva’s website:
Teva Files Citizen Petition Surrounding Purported Generic Version of Copaxone®
Jerusalem, Israel, December 12, 2010 – Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that the company has filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) for a purported generic version of COPAXONE® (glatiramer acetate injection).
Teva’s requests in this CP are based on the inability to establish acceptable “sameness” of the active ingredients in glatiramer acetate, the complexity of the mechanism of action of a glatiramoid and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence. Teva urges that any purported follow-on version of COPAXONE® undergo pre-clinical testing as well as full-scale clinical trials with measured clinical endpoints in multiple sclerosis (MS) patients to prove safety and efficacy.
Teva also requests that the FDA convene a multidisciplinary Advisory Committee to consider the approval of follow-on glatiramer acetate products in the interest of public health.
Maybe in the interest of public health but more in the interest of Teva’s stock price. And in what we think is a sneaky way to keep the price of Copaxone high and out of generic hands and a lower cost, they also requested a new drug approval for a more concentrated injection of Copaxone. The FDA did not approve this, stating new clinical trials would be necessary. Of course, Teva is using that ruling as a means to keep a generic off the market. So what happened to their stock price? It climbed on the speculation that no generic would enter the market. Taken directly from Bloomberg.com on December 26, 2010:
Teva Pharmaceutical Industries Ltd. climbed the most in more than two weeks on speculation failure by the company to win U.S. approval for a new formulation of its multiple sclerosis drug Copaxone means it will be more difficult for competitors to enter the market.
The shares of the world’s largest maker of generic drugs increased 2.9 percent, the biggest gain since Dec. 9, to 187.70 shekels at the 4:30 p.m. close in Tel Aviv. The stock has lost 12 percent this year.
The two companies involved in the generic version of Copaxone are Novartis AG (maker of the $48,000 per year Gilenya) and Momenta Pharmaceuticals Inc.
Teva has sued to block both companies from making a copy of the drug. And Momenta, they are suing Teva for patent infringements. CAMBRIDGE, MA — December 2, 2010 — Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it has sued Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents.
And you with MS? You are still stuck with an expensive drug, with a mechanism of action that is not fully understood,while those out to make money from your disease, from pharmaceutical companies to investors the world over, have zero awareness of your lives and how it has been affected by MS.
Call us cynical but when we read where Teva settled for $169 million for misrepresenting their drug prices to Medicaid programs in our country, “The first settlement against Teva Pharmaceuticals was resolved last summer with Teva paying a 169 million dollars, more than 50 million of which went to Texas,” we have to take issue with a company who hid documents showing the true costs of their drugs so that they could take taxpayer money–your money. Their intentions have absolutely nothing to do with helping you with your disease and all the PR in the world can’t change that fact. You can find the articles here and here.
It’s time for a single payer system in our country and it’s time for Uncle Sam to step up and use his buying power to tame the health care industry beast.