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Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%

NEW YORK, May 20 /PRNewswire/ -- Spear Pharmaceuticals, Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, a generic equivalent to Valeant's Efudex(R) Cream. On April 11, 2008, the FDA approved the ANDA (Abbreviated New Drug Application) based on Spear's 318 patient study proving bioequivalence to Efudex(R) for the precancerous Actinic Keratoses (AK) skin condition, the indication for which the product is overwhelmingly prescribed (approximately 98% of patients). The product is also useful in the treatment of superficial basal cell carcinoma (sBCC).

Since December 2004, Valeant Pharmaceuticals has taken action to make it far more difficult for any generic Efudex(R) product to gain FDA approval (Efudex(R) was first approved in 1970 and has been off patent for 20 years.) Specifically, Valeant filed in December, 2004 a Citizen Petition that delayed the approval of the Spear generic product from the industry average of 16.6 months to 39 months.

Following this 39-month review, on April 11, 2008 (the same day the Spear ANDA was approved) Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, notified Valeant in a detailed 11-page document that FDA had carefully considered its arguments, and decided to approve the Spear product, confirming that the Spear product is bioequivalent to Efudex(R) Cream. In explaining FDA's decision to approve, Dr. Woodcock writes " ... even when clinical trials are needed, it has not been the Agency's policy to require that bioequivalence be shown in every indication if drug release from the dosage form and appearance at the site or sites of activity has been demonstrated ... Therefore, if a study demonstrated efficacy for a topical 5-FU formulation to treat AK, this would provide assurance that the formulation would penetrate the skin sufficiently to treat sBCC." Dr. Woodcock further points out "The courts have expressly upheld FDA's regulatory implementation of the Act's bioequivalence requirements." Like thousands of generic drugs that have been approved over the years, the FDA approved the Spear product based on precedent and pursuant to its well established scientific, medical, and statistical review procedures for determining bioequivalence.

Despite this very clear position of the FDA, and the fact that the Courts do not overrule the FDA on matters of science, Valeant, in a further effort to block generic competition, sued the FDA asking the court to substitute its scientific judgment for that of the FDA.

Because of certain administrative issues regarding the FDA's record, Spear has voluntarily agreed not to ship additional product until the end of May, at which time we fully expect that the FDA will resolve its administrative issues and Spear shipments of Fluorouracil Cream will resume.

Stephen Basile

Senior Vice President, Sales and Marketing

Spear Pharmaceuticals, Inc.

973-895-6447 phone

SOURCE Spear Pharmaceuticals, Inc.
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