Biotech Values

[DewDiligence]

More on the NVS lawsuit against the FDA:

[For readers of this board, most of this article is probably old news.]

http://online.wsj.com/article/0,,SB112664326873039592,00.html

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Novartis Unit Sandoz Sues FDA
Over Biotech Growth Hormone

By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
September 13, 2005 4:48 p.m.

Escalating a high-stakes fight over how to produce generic copies of biotechnology drugs, a unit of Novartis AG sued the Food and Drug Administration over the agency's refusal to approve its copycat version of human growth hormone.

Sandoz, a generics maker owned by the Swiss pharmaceutical giant, filed a suit against top officials of the FDA and its parent agency, the Department of Health and Human Services, in U.S. District Court in Washington, D.C., yesterday. The suit argued that agency officials violated U.S. federal law through their "failure to perform their nondiscretionary duty to act upon the fully FDA-reviewed new drug application" for Omnitrope, and it asks the court to force FDA to make a decision about the drug.

The suit throws into court one of the most sensitive scientific and policy issues facing regulators and the drug industry: creating low-cost copies of some of the most complicated, expensive and important treatments for cancer and other diseases.

There are a number of human growth hormone products on the market, made by companies that include Genentech Inc., Eli Lilly & Co. and Pfizer Inc., which petitioned the FDA to reject Omnitrope.

The patents on the oldest biotech drugs are beginning to expire, but the U.S. Congress hasn't defined a clear legal pathway to win U.S. approval for generic versions of biotech drugs, like the one that exists for traditional chemically based medicines. That spares biotech companies the competition of knockoffs and also prevents the price breaks that such rivalries bring.

Because of a bureaucratic quirk, a handful of biotech products, including human growth hormone and insulin, wouldn't require a change in the law for copies to get through the FDA. The FDA said early last year that it planned a process to clarify the scientific issues surrounding such products -- which it calls follow-ons, not generics -- but so far, the agency has made little public progress in issuing regulatory guidelines.

The issue will only gain more attention as biotech drugs -- which include many of the most innovative treatments for life-threatening diseases -- represent a bigger portion of the world's medical bills. An FDA approval of Omnitrope, or a court ruling forcing the agency to take action, could open the door to more biotech copies, a prospect eagerly sought by companies, including Barr Pharmaceuticals Inc.

Last September, the FDA told Sandoz that it was unable to reach a final decision on Omnitrope because of uncertainty about scientific and legal issues, according to Sandoz. In its suit, the company argued that the agency "lacked any basis in fact or law upon which to deny approval" of Omnitrope. The FDA's professional staff advised the company about what studies to do, the suit says, and data prove that Omnitrope is "safe and effective for its intended use" and "indistinguishable" from Pfizer's Genotropin product.

Moreover, the suit argues that for the small group of biotech products that fit the bureaucratic quirk, the FDA's rules don't make any distinction between traditional drugs and biotech products. The company argues that the FDA has effectively approved drugs derived from biologic materials before. The suit also says that in reviewing Omnitrope, the FDA didn't have to rely on any confidential data from Pfizer's application for its human growth hormone product, Genotropin.

European regulators, which like the FDA are struggling with how to move forward with copies of biotech drugs, have also stalled Omnitrope. Sandoz is protesting that move as well.

For two decades, generic makers of traditional, chemically based drugs -- such as Eli Lilly's Prozac -- have been able to shortcut the FDA-approval process by relying on data generated by the original manufacturer. That opening was defined by a landmark 1984 law. So far, though, U.S. lawmakers have taken little action toward a similar legislative fix for generic biotech drugs.

The issue has generated a bitter political and regulatory clash. Biotech companies argue that their medicines are too complex for others to duplicate without performing the extensive tests conducted on the original products and also raise concerns about whether it is legitimate for generic competitors to rely on their research. On the other side, generic makers maintain that they can make safe, effective copies of biotech drugs -- just as they do with chemically based drugs -- without replicating all of the brand makers' work, which requires many years and millions of dollars.

Traditional drugs are easier to duplicate than biotech medicines, in part because making the active ingredients typically involves well-understood chemical processes. Biotech medicines, by contrast, are generally produced by splicing a genetic sequence that corresponds to a particular protein, such as human insulin, into living cells.

The proteins in biologic medicines are much larger and less well understood than traditional drug molecules. In addition, proteins made in different cell lines, or even in different manufacturing facilities, can behave very differently as medicines, exhibiting unexpected side effects or requiring different dosing.
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