Phase III Clinical Trials Set to Begin in the U.S. in the Second Half of 2003
TORONTO- April 9, 2003-- Biovail Corporation (NYSE:BVF)(TSX:BVF) and Flamel Technologies S.A. (Nasdaq:FLML) announced today that they have entered into an agreement whereby Flamel has licensed to Biovail the exclusive North American rights to Flamel's oral solid controlled release formulation of acyclovir for the treatment of episodic and recurrent genital herpes infections. Biovail intends to manufacture this novel form of the well-known and highly prescribed herpes treatment utilizing Flamel's proprietary controlled release "Micropump Technology."
Through this multi-million dollar agreement, Biovail acquires the exclusive North American rights to develop, register, promote, market and manufacture the oral solid controlled release form of acyclovir. The agreement includes an upfront payment as well as documented milestone payments and a royalty on sales of the product when commercialized. Under the agreement, Biovail is responsible for all development, clinical and regulatory costs associated with the filing and approval of the product in the U.S. and Canada. Biovail is also responsible for all expenses associated with the marketing, sales, advertising and promotion of the product in the North American market.
Biovail anticipates the start of Phase III clinical trials in the second half of 2003. Plans include two Phase III trials in two separate genital herpes indications. The first pivotal trial will focus on the use of this controlled release version of acyclovir in the treatment of recurrent episodes of genital herpes infections while the second study will focus on the suppression of genital herpes infections.
"The market for genital herpes
medication in North America is large and growing," commented Eugene Melnyk,
Chairman and Chief Executive Officer of Biovail Corporation. "Oral acyclovir has
been a trusted, safe and effective therapy for the treatment of herpes
infections since its introduction as Zovirax in 1985. Currently marketed
acyclovir products have arduous daily multi-dosing requirements for the
treatment of recurrent episodes of genital herpes. Flamel's oral controlled
release formulation presents an opportunity to offer a more convenient twice
daily (BID) dosing for acute therapy, as well as offering the first acyclovir
once daily dosing for suppressive therapy. The acquisition of this product
allows us to expand our anti-viral franchise by offering this novel formulation
of acyclovir to complement the topical Zovirax herpes treatments we already have
on the market."
Gerard Soula, president and
chief executive officer of Flamel said: "We are very excited to extend
development of Genvir, our controlled release formulation of acyclovir using our
Micropump technology, to North America. We believe Biovail is an excellent
partner for this product, in light of their existing presence in the market for
herpes products and their substantial sales force. This agreement is another
example of the progress we are achieving in bringing our Micropump technology to
market." Market size The North American market for
oral antiviral herpes treatment achieved sales of $723 million in 2002,
representing an annual growth rate of 14.6% over the previous year. Over the
same period, 11 million prescriptions were written for this class of products,
with oral acyclovir accounting for 4.4 million or 40% of the total
prescriptions. About Genital Herpes
Genital herpes is a sexually transmitted disease (STD) caused
by the herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2). HSV type 2 is
the more common cause of genital herpes and it can produce sores or lesions in
and around the genital area and on the buttocks and thighs. HSV remains dormant
in the dorsal root ganglion nerve tissue, making genital herpes a recurrent,
life-long chronic viral infection. Episodes of genital herpes lesions can recur
a number of times per year in a patient, as the virus becomes reactivated under
certain conditions. It is estimated that approximately 50 million Americans, or
20% of the total adolescent and adult population, is infected with the HSV-2
virus. In the United States, an estimated 1 million new cases of genital herpes
occur each year. Biovail Corporation is an
international full-service pharmaceutical company, engaged in the formulation,
clinical testing, registration, manufacture, sale and promotion of
pharmaceutical products utilizing advanced drug delivery technologies. Flamel Technologies, S.A. is a
biopharmaceutical company principally engaged in the development of two unique
polymer-based delivery technologies for medical applications. Flamel's
Micropump® technology is a controlled release and taste-masking
technology for the oral administration of small molecule drugs. Flamel's
Medusa® nano-particulate technology is designed to deliver
therapeutic proteins. Flamel's expertise in polymer science has also been
instrumental in the development of a photochromic eyeglass lens product now
marketed by Corning Inc. For further information at
Biovail, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com . For further information at
Flamel, please contact Steve Willard at 202-862-3993 or send inquiries to Willard@flamel.com. "Safe Harbor" statement under
the Private Securities Litigation Reform Act of 1995. To the extent any
statements made in this release contain information that is not historical,
these statements are essentially forward looking and are subject to risks and
uncertainties, including the difficulty of predicting FDA approvals, acceptance
and demand for new pharmaceutical products, the impact of competitive products
and pricing, new product development and launch, reliance on key strategic
alliances, availability of raw materials, the regulatory environment,
fluctuations in operating results and other risks detailed from time to time in
the company's filings with the Securities and Exchange Commission. This document contains a number of matters,
particularly as related to the status of various research projects and
technology platforms, that constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. The
presentation reflects the current view of management with respect to future
events and is subject to risks and uncertainties that could cause actual results
to differ materially from those contemplated in such forward-looking statements.
These risks include risks that products in the development stage may not achieve
scientific objectives or milestones or meet stringent regulatory requirements,
uncertainties regarding market acceptance of products in development, the impact
of competitive products and pricing, and the risks associated with Flamel’s
reliance on outside parties and key strategic alliances. These and other risks
are described more fully in Flamel’s Annual Report on the Securities and
Exchange Commission Form 20-F for the year ended December 31, 2001.