Attached files
file | filename |
---|---|
8-K - FORM 8-K - Actavis, Inc. | a55398e8vk.htm |
EX-2.1 - EX-2.1 - Actavis, Inc. | a55398exv2w1.htm |
Exhibit 99.1
Watson Announces Agreement to Acquire U.S. Rights to Columbia Laboratories CRINONE(R) Progesterone Gel
Product Line
Established, patient-preferred infertility treatment Expands Watsons Womens 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, 2010 /PRNewswire via COMTEX/ Watson Pharmaceuticals, Inc. (NYSE: WPI) today
announced an agreement to expand their Womens 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(R) and PROCHIEVE(R) 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 Columbias 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(R) and PROCHIEVE(R) 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 Columbias 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 Watsons 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(R) and PROCHIEVE(R) demonstrates our commitment to expand our emerging position in
distinctive womens healthcare products. It builds on a portfolio of products used by the Ob/Gyn that currently
includes our GELNIQUE(R) (oxybutynin chloride) gel treatment for overactive bladder (OAB) and FEMRING(R)
(estradiol acetate) vaginal ring hormone replacement therapy. It also provides a stronger market foundation for
the portfolio of womens health products in development, including URACYST(R), under development for cystitis, a
new emergency contraceptive, a novel oral contraceptive and two additional unique contraceptives currently in
Phase 3, said Paul Bisaro, Watsons President and Chief Executive Officer. CRINONE(R) 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(R) 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(R)
has been demonstrated in five clinical trials. The product is also available under the trade name PROCHIEVE(R).
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(R) 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 preterm
birth.
Important Safety Information
The most common side effects of CRINONE(R) include breast enlargement, constipation, somnolence, nausea,
headache, and perineal pain. CRINONE(R) 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 organs.
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 Womens Health. Watson has operations in many of the worlds established and growing international
markets.
In the U.S., the Watson Brand portfolio includes RAPAFLO(R), GELNIQUE(R), Oxytrol(R), TRELSTAR(R) LA and
TRELSTAR(R) Depot and INFeD(R). In addition, Watson markets the following brands under co-promotion agreements:
AndroGel(R), with Solvay Pharmaceuticals, Inc., and Femring(R), with Warner Chilcott Limited. The Watson Brand
pipeline portfolio includes a number of products, including a six-month formulation of TRELSTAR(R), for the
treatment of advanced prostate cancer which is currently under review by the FDA; URACYST(R), 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 womens healthcare and endocrinology markets that use its novel bioadhesive drug delivery
technology. Columbias United States sales organization markets CRINONE(R) (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(R) (testosterone buccal system) for the treatment of hypogonadism
in men. Columbias partners market CRINONE(R) and STRIANT(R) to U.S. and foreign markets.
Columbia is conducting, in collaboration with the NIH, the PREGNANT (PROCHIEVE(R) Extending GestatioN A New
Therapy) Study of PROCHIEVE(R) 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.
Columbias press releases and other company information are available at Columbias Web site at
http://www.columbialabs.com/ and its investor relations Web site at http://www.cbrxir.com/.
Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that
reflect Watsons 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 Watsons
strategic initiatives and business plans are forward-looking statements. It is important to note that Watsons
goals and expectations are not predictions of actual performance. Actual results may differ materially from
Watsons current expectations depending upon a number of factors affecting Watsons 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 Watsons periodic public filings with the Securities and Exchange Commission, including
but not limited to Watsons 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.