As the world’s largest maker of generic drugs, Teva Pharmaceutical Industries has been critical of brand-name manufacturers that try to block generic versions of their high-priced medicines.
But Teva is now emulating its rivals, mounting an aggressive effort to stave off generic versions ofCopaxone, its big-selling brand-name drug for multiple sclerosis, which is set to lose patent protection late in May.
On Monday, Teva got help from the United States Supreme Court, which agreed to hear its appeal of a lower-court ruling that invalidated a patent that would have protected Copaxone until September 2015.
Teva, based in Israel, is desperate to stave off generic competition to Copaxone, which had global sales last year of $4.3 billion; $3.2 billion of that figure came from the United States. The drug, which has been on the market for 17 years and is the best-selling treatment for M.S., accounts for about 20 percent of Teva’s revenue and about half its profit.
But a generic version of Copaxone could provide needed cost relief to the health care system. The list prices of Copaxone and other older M.S. drugs have roughly quadrupled over the last decade, to about $60,000 a year.
“The prices would go up 10, 20, 30 percent at a time for no apparent reason,” said Dr. John R. Corboy, co-director of the Rocky Mountain Multiple Sclerosis Center at the University of Colorado. “We spend a quarter, some days half our time talking to patients about insurance and figuring out how we are going to get them medications.”
At the same time, Teva has been frantically trying to convert patients to a new, more concentrated form of Copaxone that requires patients to inject themselves only three times a week instead of every day. That new form would not be subject to generic competition. Once patients convert, it would be harder for insurers to force them to use a generic that would require them to go back to daily injections.
Teva has also submitted one petition after another to the Food and Drug Administration claiming, in essence, that Copaxone has such a complex makeup that it is virtually impossible to demonstrate that a copy is the same as the original. Subtle differences could make a generic less effective or even dangerous.
Ten years ago, Aventis, now part of Sanofi, made the same complexity argument about its blood thinner Lovenox.
In that case, Teva was on the other side, trying to introduce a generic. It accused Aventis of “blatant and unjustified efforts” to deny consumers “the cost savings associated with robust and fair generic competition.” The F.D.A. approved Teva’s generic.
Teva says Copaxone, which is known generically as glatiramer acetate, is more complex than Lovenox. It rejected suggestions it was being hypocritical in trying to block generic versions of Copaxone.
“I think it would be hypocritical if there would not be quality and efficacy and safety issues for patients here,” Dr. Robert Koremans, president of Teva’s specialty medicines division, said in an interview.
Copaxone is made up of four amino acids linked in chains of various sizes and sequences. It is not clear how the drug works, but it does reduce the frequency of M.S. relapses. The disease results from attacks on the protective covering of nerves by the body’s own immune system, causing symptoms like blurred vision and difficulty walking.
The F.D.A. has not yet approved a generic version of Copaxone, perhaps because of its complexity. But two teams have said they are confident the agency will approve their drugs as early as May. One team consists of Momenta Pharmaceuticals and Sandoz, the generic arm of Novartis. The other is Mylan and Natco Pharma.
The companies declined to comment Monday on whether they would still start selling their drugs given the Supreme Court’s decision to hear Teva’s appeal. But Craig A. Wheeler, the chief executive of Momenta, said last week that it “shouldn’t change things in my view.”
Sailesh K. Patel, an intellectual property lawyer in Chicago who is not involved in this case, said the generic companies could face damages if they market their products now and Teva ultimately prevails.
Even if the generics get to market by late May, Teva hopes by then to have converted 30,000 of the roughly 85,000 American Copaxone users to the new version of Copaxone, which was approved by the F.D.A. in late January.
To do that, Teva has expanded the staff of its patient support operation, Shared Solutions. The organization has made “thousands of phone calls” to patients and doctors, Dr. Michael Hayden, Teva’s chief scientific officer, said at an investor conference in late February.
Shared Solutions has also been holding complimentary dinners for patients. Two patients who attended a buffet dinner at a Mexican restaurant in Downey, Calif., on Thursday said they would switch to the new Copaxone, enticed by having only three injections a week.
“I just signed my paper right now,” said one of them, who gave her name only as Linda A.
Teva has set the price of the new Copaxone at $4,641 a month, lower than the older, daily version, which costs $5,060 monthly.
The conversion is “nicely ahead of plan,” Dr. Koremans said.
But there is some resistance. Excellus BlueCross BlueShield in upstate New York is requiring that a switch to the new Copaxone be medically necessary, not just for convenience. It hopes to keep patients on the daily version so their prescriptions would be automatically switched to a generic, saving employers money.
In six petitions to the F.D.A. since 2008 Teva has said, among other things, that generics should not be approved without clinical trials, something not usually required.
Synthon, a Dutch company that is developing a generic, just completed such a trial showing its drug was as good as Copaxone in reducing brain lesions. Synthon says European regulators want such trials. But the F.D.A. has not required them.
Source: The New York Times © 2014 The New York Times Company (01/04/14)