Sunday, June 25, 2006

Lipitor caught in a squeeze?

Health insurers are arguing that MOST patients do NOT need the 57 percent reduction in cholesterol that the 80-milligram dose of Lipitor provides. For example, at Blue Cross of Northeastern Pennsylvania, which covers about 600,000 people, 81 percent of people taking Lipitor are taking 20 milligrams or less a day. Only 4 percent are taking 80 milligrams. Patients on the lower Lipitor doses can easily be switched to (generic) Zocor, Frank Koronkiewicz of Blue Cross said.

For those patients that DO need a large increase, Lipitor is separately facing competition from two drugs that lower cholesterol even more than Lipitor. One is Vytorin, made by Merck and Schering-Plough, which combines Zocor and Zetia, another cholesterol-lowering drug that has a different mechanism of action than statins. Merck is now heavily promoting Vytorin, which had sales of $378 million in the first quarter — about double its sales for the period last year. The other Lipitor challenger is Crestor, a drug from AstraZeneca that is generally considered the most potent statin.

IPBiz had noted in October 2005: "In Europe, the transfer of patient share from branded statins to generic simvastatin is already a prominent dynamic, and we expect a similar trend in the United States," said Nikhil Mehta, analyst at Decision Resources, Inc. "Although new therapies that target low high-density lipoprotein levels will address an important unmet need and add to market value, experts in the field remain uncertain as to whether their mechanisms of action will indeed confer clinical benefit."

Merck's current efforts with Zocor parallel the efforts of other proprietary companies. From IPBiz: Novartis' French rival Sanofi-Aventis, the world's third largest seller of branded drugs has equally followed suit and established its own generics division, Winthrop Medicines. Winthrop is planning to launch at least 30 generic medicines, including copycat versions of Sanofi-Aventis brands about to lose their patents.

***On authorized generics -->

from senior journal:

Today, a number of research pharmaceutical companies, seeing the need to provide lower-cost alternatives, are beginning to partner with generic manufacturers to develop "authorized generic" versions of the drugs the research company originally discovered. It's a way to get more medicines to patients at lower prices.

Under these partnerships, a generic version of the research company's medicine is either made by the company itself or made under a license granted to its generic partner. Like other generic equivalents, this new "authorized generic" is then marketed and sold for less than the original medicine of which it is a copy.

An 'authorized generic" can come into the market very quickly to provide consumers with lower prices because the know-how of the medicine's original developers can be quickly and efficiently transferred.

It can be brought to market near the end of an original medicine's patent, which is essentially identical to the way generic drug makers have introduced their copies for years. It also can be introduced at the same time as the first generic manufacturer brings its copy to market.

Either way, the competition should be welcome because it serves the needs of consumers. The original brand-name medicine now faces two competitors -- the "authorized generic" and the copy made by the first traditional generic drug maker who enters the market. Because consumers now have more choices, all of the drug companies are forced to price their products lower to stay competitive. This can only benefit consumers.

On April 28, 2006, IPBiz discussed "authorized generics"

Apotex Corp., a Canadian generic manufacturer, had six months' exclusivity for a generic version of the anti-depressant Paxil [paroxetine] in 2003. The company expected sales of up to $575 million in the first six months. But the maker of Paxil, GlaxoSmithKline, introduced an authorized generic version and Apotex's six-month sales topped out at between $150 million and $200 million.


One sees that the expiration of a patent on ONE DRUG in a field can adversely impact the sales of ANOTHER DRUG which remains on patent. Anticipating the expiration of one patent, Express Scripts, one of the nation's largest pharmacy benefit companies, recommended in 2005 that drug plans under its management make the cholesterol-lowering statin, Zocor (patent expiry June 2006), their preferred medication instead of the top-selling Lipitor.

[IPBiz post 1700]


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