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March 14,  2003

FDA Warns Public About Misrepresentations in Marketing Claims About Drug to Treat Cancer

(SafetyAlerts) - The Food and Drug Administration (FDA) is warning consumers and health care practitioners about misrepresentations in a SuperGen, Inc. press release dated November 15, 2002, in connection with a recently approved cancer drug, Mitozytrex (mitomycin for injection).

The press release, entitled FDA approves SuperGen's New Drug Application to Market Mitozytrex (MitoExtra) and disseminated by SuperGen, Inc., exaggerates the efficacy of Mitozytrex and fails to include the significant risks associated with the use of the drug. Indeed, the press release does not even mention acute adverse reactions that can result from administration of Mitozytrex, which include fever, anorexia, nausea, and vomiting. The press release also fails to disclose that Mitozytrex is associated with more serious adverse events, such as myelosuppression and hemolytic uremic syndrome.

A boxed warning included in the Mitozytrex package insert reads:

"Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin."

"Hemolytic Uremic Syndrome (HUS), a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at cumulative doses greater than or equal to 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome."

The press release issued by SuperGen also makes unsupported claims that Mitozytrex is a "supergeneric" from the company's Extra technology platform and that the Extra technology is "designed to enhance generic drugs," that is, create "improved generics, or supergenerics."

Mitozytrex is bioequivalent to the innovator mitomycin. It differs from the innovator formulation only in that Mitozytrex contains the excipient hydroxypropyl-beta-cyclodextrin (HPCD). No data submitted by the company provided evidence that Mitozytrex is superior to existing marketed formulations of mitomycin, and there is no evidence that the addition of HPCD yields any clinical advantage over existing formulations of mitomycin.

Despite the absence of any evidence of such a benefit, SuperGen's release states that "SuperGen's Extra technology is designed to 'shield' the drug from the injection site, thus providing the patient protection from tissue ulceration." This statement is unsupported. The adverse events associated with Mitozytrex in the bioequivalence study conducted before approval were consistent with those mentioned in the product labeling for the innovator mitomycin. In addition, the repeat dose study provided no evidence that the safety profile of Mitozytrex is different from the innovator mitomycin. In fact, one patient in this study did experience tissue necrosis at the injection site.

SuperGen, Inc., claims in its press release that the company's Extra technology could offer other important
advantages over existing generics, such as "increased solubility, stability and shelf life." The instructions for
reconstitution of Mitozytrex and the innovator mitomycin, however, are identical in terms of steps required and time necessary for dissolution. The only difference is that Mitozytrex calls for a slightly smaller amount of sterile water - an inconsequential difference. With regard to stability and shelf life, storage conditions for unreconstituted Mitozytrex and the innovator mitomycin are identical.

Finally, even though FDA rejected the name, "MitoExtra," as the proprietary name for SuperGen's brand of mitomycin for injection, the company presents the name "MitoExtra" as the drug's trade name in the press release. FDA rejected this name because it suggests clinical benefits that have not been substantiated by data. Notwithstanding this rejection, the name "MitoExtra" is used "to market Mitozytrex (MitoExtra)." SuperGen also uses the name "MitoExtra" interchangeably with "Mitozytrex" as the proprietary name. The FDA-approved name for the drug, as it appears in the approved product labeling, is "Mitozytrex (mitomycin for injection)."

FDA believes the characterizations of Mitozytrex (mitomycin for injection) warrant clarification of the
record. The company's press release concerned an oncology drug, and FDA has a practice of focusing enforcement resources on misleading information about products intended for life-threatening conditions. Moreover, the company's press release is particularly egregious in that it includes not only misleading statements about the benefits of the company's drug compared to other similar versions, but also statements that are demonstrably false. Under the circumstances, FDA determined it was imperative to correct the record, and to do so in a manner that would reached as many of the same recipients of the original false and misleading messages.

The Federal Food, Drug and Cosmetic Act, gives FDA authority to disseminate information to the public regarding drugs and other products within FDA's jurisdiction to address imminent health dangers or gross deception. To protect the public health, FDA is notifying the public that a particular product has not been found by the agency to have benefits that its manufacturer claims.

SuperGen is based in Dublin, Calif.


Source: FDA

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.