LAVAL, Quebec and RALEIGH, N.C., Aug. 20,
2015 /PRNewswire/ -- Valeant Pharmaceuticals International,
Inc. (NYSE: VRX) (TSX: VRX) and Sprout Pharmaceuticals, Inc. today
announced that they have entered into a definitive agreement under
which a wholly-owned subsidiary of Valeant will acquire Sprout, on
a debt-free basis, for approximately $1
billion in cash, plus a share of future profits based upon
the achievement of certain milestones.
On Tuesday, August 18, 2015,
Sprout received approval from the U.S. Food and Drug Administration
(FDA) on its New Drug Application (NDA) for flibanserin, which will
be marketed as Addyi in the U.S. Addyi has demonstrated
improvements in desire for sex, reducing distress from the loss of
sexual desire and increasing the number of satisfying sexual
events. Sprout also has global rights for flibanserin.
Valeant will leverage its global scale to register flibanserin
internationally.
Sprout is passionate about women's sexual health and has focused
solely on the delivery of a treatment option for the unmet need of
premenopausal women with acquired, generalized Hypoactive Sexual
Desire Disorder (HSDD) as characterized by low sexual desire that
causes marked distress or interpersonal difficulty and is not due
to a co-existing medical or psychiatric condition, problems within
the relationship, or the effects of a medication or other drug
substance.
Addyi is not indicated for use in postmenopausal women or men or
to enhance sexual function. Addyi was approved with a Boxed
Warning. Use of Addyi with alcohol increases the risk of severe
hypotension and syncope; therefore, alcohol use is
contraindicated. Severe hypotension and syncope occurs when
Addyi is used with moderate or strong CYP3A4 inhibitors or in
patients with hepatic impairment; therefore use of Addyi in
patients with hepatic impairment is also contraindicated.
Hypotension, syncope and central nervous system (CNS)
depression can occur with Addyi alone. The most common adverse
reactions are dizziness, somnolence, nausea, fatigue, insomnia and
dry mouth.
Valeant expects Addyi to be available in the United States in the fourth quarter of
2015 through prescribers and pharmacies that have been certified
under the U.S. FDA's comprehensive Risk Evaluation and Mitigation
Strategy (REMS) program to assure safe use. Following the closing
of the transaction, Valeant, under the REMS, will offer physicians
and pharmacists the required certification programs for prescribing
and dispensing Addyi.
Following the closing of the acquisition, Sprout will remain
headquartered in Raleigh, N.C. and
become a division of Valeant. Cindy
Whitehead, Chief Executive Officer of Sprout, will join
Valeant to lead this division dedicated to the introduction and
global commercialization of Addyi, reporting to Anne Whitaker, Executive Vice President and
Company Group Chairman.
Valeant's Chairman and Chief Executive Officer, J. Michael Pearson, said, "Delivering a
first-ever treatment for a commonly reported form of female sexual
dysfunction gives us the perfect opportunity to establish a new
portfolio of important medications that uniquely impact women. We
applaud the efforts of the Sprout team to address this important
area of unmet need and look forward to working with them to bring
the benefits of Addyi to additional markets around the
world."
Sprout Chief Executive Officer, Cindy
Whitehead, said, "I am extremely proud of the commitment and
passion of our 34 employees who have been mission driven to get to
this breakthrough first for women. This partnership with
Valeant allows us the capacity to now ensure broader, more
affordable access to all the women who have been waiting for this
treatment. Beyond building this in the United States, Valeant also offers us a
global footprint that could eventually bring Addyi to women across
the globe."
"The Valeant team is excited to be a part of the launch of this
critically important treatment for women, and I am personally
delighted to welcome Cindy and her colleagues at Sprout to
Valeant," added Anne Whitaker,
Executive Vice President and Company Group Chairman. "The
Sprout team, along with the healthcare providers involved in the
Addyi pivotal clinical trials, has delivered on its promise to
provide access to a safe and effective treatment for a condition
that affects millions of women."
Under terms of the acquisition agreement, Valeant will pay
approximately $500 million, subject
to customary purchase price adjustments, upon the closing of the
transaction and an additional payment in the amount of $500 million, payable in the first quarter of
2016, plus a share of future profits based upon the achievement of
certain milestones. Valeant expects no impact to 2015
earnings, and moderate accretion to 2016 earnings.
The transaction is subject to customary closing conditions and
regulatory approval, including Hart-Scott-Rodino antitrust
clearance. The transaction is expected to close in the third
quarter of 2015.
Skadden, Arps, Slate, Meagher & Flom LLP served as Valeant's
legal counsel. Sprout was advised by Sullivan & Cromwell
LLP as its legal counsel and Perella Weinberg Partners as its
financial advisor.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, gastrointestinal disorder,
eye health, neurology and branded generics. More information about
Valeant can be found at www.valeant.com.
About Addyi
Addyi is a novel, non-hormonal oral pill taken once daily at
bedtime. Flibanserin has been studied in over 11,000 women. For
premenopausal women with HSDD, Addyi has demonstrated improvements
in desire for sex, reducing distress from the loss of sexual desire
and increasing the number of satisfying sexual events. The most
common adverse events among patients treated with Addyi were
dizziness, somnolence, nausea, fatigue, insomnia and dry mouth.
Hypotension, syncope, and central nervous system (CNS) depression
were seen with Addyi alone and more frequently when Addyi was taken
in the morning and when co-administered with alcohol or certain
other drugs. Alcohol consumption is contraindicated for women
taking Addyi. With the FDA, Sprout Pharmaceuticals developed a
comprehensive Risk Evaluation and Mitigation Strategy (REMS)
program, including prescriber and pharmacist certification, to
ensure safe use of Addyi.
About Sprout Pharmaceuticals
Sprout Pharmaceuticals, Inc. is passionate about women's sexual
health. With a breakthrough concept for women, the company
"sprouted" out of Slate Pharmaceuticals in 2011. Based in
Raleigh, N.C., the company is
focused solely on the delivery of a treatment option for women with
HSDD. For more information or the latest news about Sprout
Pharmaceuticals, visit www.sproutpharma.com or call 1-844-PINK-PILL
(1-844-746-5745).
Forward Looking Statements
This press release may contain forward-looking statements,
including, but not limited to, statements regarding the acquisition
of Sprout Pharmaceuticals, including the anticipated timing of the
closing of such acquisition, the anticipated timing of the launch
of the Addyi product and Valeant's marketing and sales plans.
Forward-looking statements may generally be identified by the use
of the words "anticipates," "expects," "intends," "plans,"
"should," "could," "would," "may," "will," "believes," "estimates,"
"potential," "target," or "continue" and variations or similar
expressions. These statements are based upon the current
expectations and beliefs of management of Valeant and are subject
to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. These risks and uncertainties include the risks and
uncertainties discussed in Valeant's most recent annual or
quarterly report and detailed from time to time in Valeant's other
filings with the Securities and Exchange Commission (the
"SEC") and the Canadian Securities Administrators, which factors
are incorporated herein by reference. Readers are cautioned not to
place undue reliance on any of these forward-looking statements.
These forward-looking statements speak only as of the date
hereof. Valeant undertakes no obligation to update any of
these forward-looking statements to reflect events or circumstances
after the date of this press release or to reflect actual outcomes,
except as required by law.
Contact
Information:
|
|
|
|
Valeant Media
Contacts:
|
Sprout
Pharmaceuticals Contacts:
|
Sard Verbinnen &
Co
|
Edelman
|
Renee Soto / Meghan
Gavigan /Jared Levy
|
Amy Rose
|
212-687-8080
|
312-297-6912
|
|
|
Valeant Investor
Contact:
|
|
Laurie W.
Little
|
|
949-461-6002
|
|
laurie.little@valeant.com
|
|
|
|
Logo -
http://photos.prnewswire.com/prnh/20101025/LA87217LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/valeant-pharmaceuticals-to-acquire-sprout-pharmaceuticals-300131224.html
SOURCE Valeant Pharmaceuticals International, Inc.