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.
www.spearpharma.com

Stephen Basile
Senior Vice President, Sales and Marketing
Spear Pharmaceuticals, Inc.
973-895-6447 phone
basile@spearpharma.com

SOURCE Spear Pharmaceuticals, Inc.

Stephen Basile, Senior Vice President, Sales and Marketing of Spear
Pharmaceuticals, Inc., +1-973-895-6447, basile@spearpharma.com