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Watson to acquire rights to CRINONE
and PROCHIEVE and 11.2 million shares of
common stock for upfront and milestone payments of up to $92.5 million
plus royalties
Also announces contingent agreements to retire debt
Investor conference call at 8:30 AM ET today
LIVINGSTON, N.J.(BUSINESS WIRE)
Columbia Laboratories, Inc. (Nasdaq: CBRX) has entered into a definitive
agreement to sell substantially all of its progesterone related assets
and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc.
(NYSE: WPI) for a $47 million upfront payment plus royalties of 10 to 20
percent of annual net sales of certain progesterone products. Additional
payments up to $45.5 million can be earned by the successful completion
of clinical development milestones in the ongoing PREGNANT Study,
regulatory filings, receipt of regulatory approvals and product
launches. Watson will fund the development of a second-generation
vaginal progesterone product as part of a comprehensive life-cycle
management strategy. Watson will also have the right to designate a
member of Columbia's Board of Directors. The transaction was unanimously
approved by Columbia's Board of Directors. Its closing is subject to
customary conditions, including approval by Columbia's stockholders. It
is expected to close during the second quarter of 2010.
With their commitment to women's health and significant sales
resources, Watson is a great strategic fit for our progesterone
business,? said Frank C. Condella, Jr., Columbia's interim chief
executive officer. Watson has a field force of 350 representatives
calling on OB/GYNs and urologists, plus specialists to focus on
infertility clinics. Because of the structure of its sales force, Watson
has the capability to expand sales resources for CRINONE as
required, and we are confident in their ability to execute a strong
launch in the new short cervix preterm birth indication, assuming data
from the PREGNANT Study are positive and the product is approved for
this new indication by the FDA.?
The addition of CRINONE to our branded products business is
in line with our stated objective to grow our women's health franchise,?
said Paul Bisaro, president and chief executive officer of Watson. With
a strong heritage in women's health, an expanding pipeline of additional
distinctive products in this category, and a sales team committed to
serving OB/GYNs and women's health providers, Watson is uniquely
positioned to make this agreement a significant win-win for both
parties, and for patients.?
After the sale of these assets, Columbia's business will consist of
domestic and international royalties and milestone payments,
manufacturing revenues from CRINONE and PROCHIEVE,
STRIANT sales, and its bioadhesive drug delivery
technologies, which include bioadhesive vaginal gel, buccal system and
progressive hydration tablet delivery mechanisms. Also, Columbia will
retain certain assets and rights to its progesterone business, including
all rights necessary to perform its obligations under its agreement with
Merck Serono S.A.
Torreya Partners LLC acted as financial advisor to Columbia, Kaye
Scholer LLP acted as legal advisor to Columbia, and RBC Capital Markets
provided a fairness opinion to Columbia's Board of Directors in
connection with the transaction.
In a separate transaction, Columbia has entered into a contingent
agreement with PharmaBio Development, an affiliate of Quintiles
Transnational Corp., to pre-pay the approximately $16 million balance of
the minimum royalty payments on U.S. net sales of STRIANT
(testosterone buccal system) due in November 2010. Columbia has also
entered into contingent agreements to pre-pay 100% of the $40 million in
convertible notes due December 31, 2011. Note holders will receive their
proportional share of the following: $26 million in cash (plus accrued
and unpaid interest up to, but excluding, the closing date), warrants to
purchase 7.75 million shares of Columbia's common stock, and $10 million
in shares of Columbia's common stock. The strike price of the warrants
and the pricing of the common shares of $1.35 was determined by taking a
10% premium to the 10-day closing average prior to the announcement of
the transaction but no less than 100% of the last closing price prior to
the time of signing. The warrants become exercisable 180 days after the
closing and expire five years later, unless earlier exercised or
terminated. The closings of the transactions under the note pre-payment
agreements are subject to various closing conditions, including
stockholder approval and the closing of the Watson transaction. In
connection with the contingent note pre-payment agreements, the notes
were amended so that the Watson transaction would not trigger the change
of control put right in the notes. This amendment expires on August 31,
2010, if the closings do not occur on or prior to that date. The net
effect of these contingent agreements is that at the closing of the
Watson transaction, Columbia's debt will be retired.
With stockholder approval of the Watson transaction, Columbia will
emerge a focused development company, debt-free, with a clearer path to
profitability,? said Condella. Our infrastructure costs will decrease
significantly, and we will benefit from ongoing royalty and
manufacturing revenues and payments that can be earned by the successful
achievement of certain milestones as PROCHIEVE advances toward
commercialization in the preterm birth indication. As a result, Columbia
will be well positioned to leverage our drug delivery expertise to
develop new products.?
CALL ACCESS INFORMATION
Columbia's management team will hold a conference call on March 4, 2010,
to discuss the Watson agreement and other transactions covered in this
press release as follows:
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Date:
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Thursday, March 4, 2010
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Time:
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8:30 AM ET
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Dial-in numbers:
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(877) 303-9483 (U.S. & Canada) or (760) 666-3584
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Live webcast:
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www.cbrxir.com,
under "Events"
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A replay of the conference call and webcast will be available after the
conference call transcript is filed with the Securities and Exchange
Commission (the SEC?). The replay will be available by telephone
through Thursday, March 11, 2010, at (800) 642-1687 (U.S. & Canada) or
(706) 645-9291 using conference ID 60890330, and as a webcast for six
months on Columbia's investor website, www.cbrxir.com,
under "Events."
ADDITIONAL INFORMATION ABOUT THE PROPOSED TRANSACTIONS AND WHERE TO
FIND IT
This communication is not a solicitation of a proxy from any security
holder of Columbia. In connection with stockholder approval of the sale
of the assets contemplated by the Purchase and Collaboration Agreement
and certain other matters, Columbia intends to file with the SEC a
preliminary proxy statement and a definitive proxy statement and it
intends to mail to its security holders a definitive proxy statement and
other materials. THE PROXY STATEMENT WILL BE SENT TO COLUMBIA SECURITY
HOLDERS AND WILL CONTAIN IMPORTANT INFORMATION ABOUT COLUMBIA, WATSON,
THE SALE OF THE ASSETS PURSUANT TO THE PURCHASE AND COLLABORATION
AGREEMENT AND RELATED MATTERS. INVESTORS AND SECURITY HOLDERS ARE URGED
TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH
THE SEC CAREFULLY WHEN THEY ARE AVAILABLE BEFORE MAKING ANY VOTING OR
INVESTMENT DECISION WITH RESPECT TO THE PROPOSED SALE OF THE ASSETS AND
THE OTHER MATTERS DESCRIBED THEREIN. Free copies of the proxy statement
and other documents filed with the SEC by Columbia, when they become
available, can be obtained through the website maintained by the SEC at www.sec.gov.
In addition, free copies of the proxy statement will be available from
Columbia by contacting Lawrence A. Gyenes at (973) 486-8860 or lgyenes@columbialabs.com,
or on Columbia's investor relations website at www.cbrxir.com.
PARTICIPATION IN THE SOLICITATION
Columbia and its directors and executive officers and certain other
members of management may be deemed to be participants in the
solicitation of proxies from Columbia's stockholders in connection with
the proposed transactions described herein. Information regarding the
special interests of these directors, executive officers and members of
management in the proposed transactions will be included in the proxy
statement and other relevant documents filed with the SEC. Additional
information regarding Columbia's directors and executive officers is
also included in Columbia's Annual Report on Form 10-K for the fiscal
year ended December 31, 2008, which was filed with the SEC on March 16,
2009, and Columbia's proxy statement, dated April 9, 2009, which was
filed with the SEC on April 17, 2009. Columbia's Form 10-K and proxy
statement are available free of charge at the SEC's website at www.sec.gov
and from Columbia by contacting it as described above.
ABOUT CRINONE
CRINONE 8% (progesterone gel) 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 8%
has been demonstrated in five clinical trials. This product is also
available under the trade name PROCHIEVE. For more
information, please visit www.crinoneusa.com.
Columbia is conducting, in collaboration with the NIH, a Phase III
clinical program, called the PREGNANT (PROCHIEVE Extending
GestatioN A New Therapy) Study, to evaluate the safety and efficacy of
PROCHIEVE 8% 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. 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.
The most common side effects of CRINONE 8% include breast
enlargement, constipation, somnolence, nausea, headache, and perineal
pain. CRINONE 8% 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 COLUMBIA LABORATORIES
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 8% (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
8% and STRIANT to United States and foreign markets.
Columbia's press releases and other company information are available at
Columbia's website at www.columbialabs.com
and its investor relations website at www.cbrxir.com.
ABOUT WATSON PHARMACEUTICALS
Watson Pharmaceuticals, Inc. is a leading global specialty
pharmaceutical company. Watson 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.
For press release and other company information, visit Watson
Pharmaceuticals' website at www.watson.com.
Safe Harbor Statement Under the Private Securities Litigation Reform
Act of 1995: This communication contains forward-looking statements,
which statements are indicated by the words may,? will,? plans,?
believes,? expects,? anticipates,? potential,? and similar
expressions. Such forward-looking statements involve known and unknown
risks, uncertainties, and other factors that may cause actual results to
differ materially from those projected in the forward-looking
statements. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date on which
they are made. Factors that might cause future results to differ
include, but are not limited to, the following: approval of the sale of
the assets and other matters contemplated by the Purchase and
Collaboration Agreement by Columbia's stockholders; the timely and
successful completion of the ongoing Phase III PREGNANT (PROCHIEVE
Extending Gestation A New Therapy) Study of PROCHIEVE 8% to reduce the
risk of preterm birth in women with a short cervix in mid-pregnancy;
successful development of a next-generation vaginal progesterone
product; success in obtaining acceptance and approval of new products
and new indications for current products by the United States Food and
Drug Administration and international regulatory agencies; the impact of
competitive products and pricing; the strength of the United States
dollar relative to international currencies, particularly the euro;
competitive economic and regulatory factors in the pharmaceutical and
healthcare industry; general economic conditions; and other risks and
uncertainties that may be detailed, from time-to-time, in Columbia's
reports filed with the SEC. Completion of the sale of the assets under
the Purchase and Collaboration Agreement and the other transactions
described above are subject to various conditions to closing, and there
can be no assurance those conditions will be satisfied or that such sale
or other transactions will be completed on the terms described in the
Purchase Agreement or other agreements related thereto or at all. All
forward-looking statements contained herein are neither promises nor
guarantees. Columbia does not undertake any responsibility to revise or
update any forward-looking statements contained herein.
CRINONE, PROCHIEVE and STRIANT are
registered trademarks of Columbia Laboratories, Inc.
Columbia Laboratories, Inc. Lawrence A. Gyenes, 973-486-8860 Senior
Vice President, Chief Financial Officer & Treasurer or The
Trout Group LLC Seth Lewis, 617-583-1308 Vice President or Watson
Pharmaceuticals, Inc. Patty Eisenhaur, 973-355-8141 VP,
Investor Relations and Corporate Communications
Source: Columbia Laboratories, Inc.
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