Watson Announces Agreement to Acquire U.S. Rights to Columbia Laboratories' Crinone Progesterone Gel Product Line
- Established, patient-preferred infertility treatment - - Expands Watson's Women's Health brand product portfolio - - Preterm birth clinical trials currently underway - - Company acquires 11.2 million shares of Columbia common stock -
MORRISTOWN, N.J., March 4 /PRNewswire-FirstCall/ -- Watson
Pharmaceuticals, Inc. (NYSE:WPI)
today announced an agreement to expand their Women's Health brand
product portfolio with the acquisition of the exclusive U.S. rights
to Columbia Laboratories, Inc.'s bioadhesive progesterone gel
products currently marketed under the trade names CRINONE® and
PROCHIEVE® for the indications of infertility and secondary
amenorrhea. The two companies will collaborate in the ongoing Phase
3 development program toward a new indication for these products
for the prevention of preterm birth in women with a short cervix,
as well as a global development program for second-generation
products for this indication and infertility. Watson will also
acquire 11.2 million shares of Columbia common stock.
The acquisition is subject to customary closing conditions,
including the approval of Columbia's stockholders. The closing of
the acquisition is expected to occur in the second quarter of 2010.
After the close of the acquisition, Watson intends to immediately
begin marketing CRINONE® and PROCHIEVE® in the U.S. to
reproductive endocrinologists and Ob/Gyns through the existing
Brand Sales Forces.
Under the terms of the agreement, Watson will provide Columbia
with an initial $47 million payment and will receive exclusive
progesterone gel product rights in the U.S. and 11.2 million newly
issued shares of Columbia common stock. Watson will also have the
right to designate a member of Columbia's board of directors.
Additional contingent payments related to the successful completion
of clinical development milestones, receipt of regulatory approvals
and product launches could total approximately up to $45.5 million.
Watson will also pay Columbia a royalty on Watson's sales of the
progesterone gel product and any next generation products. Columbia
will be responsible for the anticipated clinical and regulatory
costs related to obtaining approval for the progesterone gel
product for prevention of preterm birth in women with a short
cervix. Excess development costs over a defined cap, if any, as
well as costs related to the development of the second generation
product will be the responsibility of Watson. Pursuant to a supply
agreement, Columbia will be responsible for manufacturing the
progesterone gel products.
"The addition of CRINONE® and PROCHIEVE® demonstrates
our commitment to expand our emerging position in distinctive
women's healthcare products. It builds on a portfolio of products
used by the Ob/Gyn that currently includes our GELNIQUE®
(oxybutynin chloride) gel treatment for overactive bladder (OAB)
and FEMRING® (estradiol acetate) vaginal ring hormone
replacement therapy. It also provides a stronger market foundation
for the portfolio of women's health products in development,
including URACYST®, under development for cystitis, a new
emergency contraceptive, a novel oral contraceptive and two
additional unique contraceptives currently in Phase 3," said Paul
Bisaro, Watson's President and Chief Executive Officer.
"CRINONE® has a proven record in infertility, and we are
confident in our ability to expand its acceptance using our
specialty Ob/Gyn sales team. In addition, if we are successful in
receiving FDA approval for a new preterm birth indication, we will
have the opportunity to create a new market and address a
significant and unmet medical need."
CRINONE® is currently used for progesterone supplementation
or replacement as part of an Assisted Reproductive Technology (ART)
treatment for infertile women with a progesterone deficiency.
Patient preference for CRINONE® has been demonstrated in five
clinical trials. The product is also available under the trade name
A Phase 3 clinical program is currently underway in
collaboration with the National Institutes of Health (NIH) to
evaluate the safety and efficacy of PROCHIEVE® for the
prevention of preterm birth in women with a short cervix. Preterm
birth occurs in one of every eight live born infants, and short
cervix is the single most important predictor of preterm birth.
There are currently no products approved for the prevention of
Important Safety Information
The most common side effects of CRINONE® include breast
enlargement, constipation, somnolence, nausea, headache, and
perineal pain. CRINONE® is contraindicated in patients with an
active thrombophlebitis or thromboembolic disorders, missed
abortion, undiagnosed vaginal bleeding, liver dysfunction or
disease, and known or suspected malignancy of the breast or genital
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty
pharmaceutical company. The Company is engaged in the development
and distribution of generic pharmaceuticals and specialized branded
pharmaceutical products focused on Urology and Women's Health.
Watson has operations in many of the world's established and
growing international markets.
In the U.S., the Watson Brand portfolio includes RAPAFLO®,
GELNIQUE®, Oxytrol®, TRELSTAR® LA and TRELSTAR®
Depot and INFeD®. In addition, Watson markets the following
brands under co-promotion agreements: AndroGel®, with Solvay
Pharmaceuticals, Inc., and Femring®, with Warner Chilcott
Limited. The Watson Brand pipeline portfolio includes a number of
products, including a six-month formulation of TRELSTAR®, for
the treatment of advanced prostate cancer which is currently under
review by the FDA; URACYST®, under development for cystitis;
and three novel new contraceptives. All other trademarks are
property of their respective owners.
For press release and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com/.
About Columbia Laboratories, Inc.
Columbia Laboratories, Inc. is a specialty pharmaceutical
company focused on developing and commercializing products for the
women's healthcare and endocrinology markets that use its novel
bioadhesive drug delivery technology. Columbia's United States
sales organization markets CRINONE® (progesterone gel) in the
United States for progesterone supplementation as part of an
Assisted Reproductive Technology treatment for infertile women with
progesterone deficiency and STRIANT® (testosterone buccal
system) for the treatment of hypogonadism in men. Columbia's
partners market CRINONE® and STRIANT® to U.S. and foreign
Columbia is conducting, in collaboration with the NIH, the
PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study
of PROCHIEVE® 8% (progesterone gel) to reduce the risk of
preterm birth in women with a cervical length between 1.0 and 2.0
centimeters as measured by transvaginal ultrasound at
mid-pregnancy. The primary endpoint of the study is a reduction in
the incidence of preterm birth at less than or equal to 32 weeks
gestation vs. placebo.
Columbia's press releases and other company information are
available at Columbia's Web site at www.columbialabs.com and its
investor relations Web site at www.cbrxir.com.
Statements contained in this press release that refer to
non-historical facts are forward-looking statements that reflect
Watson's current perspective of existing information as of the date
of this release. For example, any statements in this press release
concerning the anticipated closing of the acquisition, the
anticipated benefits of the acquisition, future approvals or other
events related to products or future products and Watson's
strategic initiatives and business plans are forward-looking
statements. It is important to note that Watson's goals and
expectations are not predictions of actual performance. Actual
results may differ materially from Watson's current expectations
depending upon a number of factors affecting Watson's business.
These factors include, among others, the risk of not completing the
acquisition; successful integration of the Columbia products and
product rights; the impact of competitive products and pricing;
timely and successful consummation and implementation of strategic
initiatives; the timing and success of product launches; the
difficulty of predicting the timing or outcome of product
development efforts and FDA or other regulatory agency approvals or
actions; costs and efforts to defend or enforce intellectual
property and contractual rights; difficulties or delays in
manufacturing; the availability and pricing of third party sourced
products and materials; successful compliance with FDA and other
governmental regulations applicable to Watson, their third party
manufacturers' facilities, products and/or businesses; changes in
the laws and regulations, including Medicare and Medicaid,
affecting among other things, pricing and reimbursement of
pharmaceutical products; and such other risks and uncertainties
detailed in Watson's periodic public filings with the Securities
and Exchange Commission, including but not limited to Watson's
annual report for the year ended December 31, 2009. Except as
expressly required by law, Watson disclaims any intent or
obligation to update these forward-looking statements.
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Source: Watson Pharmaceuticals, Inc.
CONTACT: investors, Patty Eisenhaur, +1-973-355-8141, or media,
Mayr, +1-973-355-8483, both of Watson Pharmaceuticals, Inc.
Posted: March 2010