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Alcon to Purchase Ophthalmic Pharmaceutical Assets from Sirion

Key Takeaway: to Purchase Ophthalmic Pharmaceutical Assets from Sirion HUENENBERG, Switzerland - January 18, 2010 - Alcon (NYSE: ACL), the world's leader in eye care, announced today that it will purchase the rights in the United States for two FDA-approved topical eye care products from Si

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to Purchase Ophthalmic Pharmaceutical Assets from Sirion
HUENENBERG, Switzerland - January 18, 2010 - Alcon (NYSE: ACL), the world's
leader in eye care, announced today that it will purchase the rights in the
United States for two FDA-approved topical eye care products from Sirion
Therapeutics, Inc. The two products purchased are Durezol , a
marketed ophthalmic corticosteroid approved for the treatment of inflammation
and pain associated with eye surgery, and Zirgan , a recently approved antiviral
for the treatment of acute herpetic keratitis (corneal ulcers). In
addition to these marketed products, Alcon also acquired the global rights,
excluding Latin America, for Zyclorin . This product is currently in
clinical development to treat dry eye and other ocular surface
"The acquisition of these products from
Sirion is part of our business development strategy to gain access to late-stage
or approved products that will incrementally add to sales in the near-term,
while also building our long-term pipeline," said Kevin Buehler, Alcon's
president and chief executive officer. "Upon closing, this deal will
allow Alcon to capitalize on the U.S. registration approval for Durezol and
Zirgan with the existing commercial capability in the United States to maximize
the brand development and revenue opportunities."
provides physicians with a steroid to treat both inflammation and pain following
a wide range of ophthalmic surgeries," said Robert H. Osher, MD, professor of
ophthalmology at the University of Cincinnati College of Medicine and medical
director emeritus of the Cincinnati Eye Institute. "Physicians will
also appreciate the comfort and relief our patients receive for herpetic corneal
ulcers with Zirgan , due to its low toxicity, potency and targeted antiviral
closing of this agreement is expected to occur by the end of the first quarter
of 2010 and is contingent upon customary closing conditions and required
regulatory approvals.
and glaucoma affect more than 24 million people age 40 and older in the United
States. Many of these people seek surgical treatment for these and
other eye conditions. Corticosteroids and non-steroidal
anti-inflammatory drugs are commonly used after eye surgery to manage
postoperative pain and inflammation. Complications can occur if
inflammation is left untreated and can interfere with a patient's visual
Durezol (difluprednate ophthalmic
emulsion) 0.05% is a topical ophthalmic corticosteroid for the treatment of
postoperative inflammation and pain associated with ocular
surgery. Durezol received approval from the U.S. Food and Drug
Administration (FDA) in 2008 and was the first ophthalmic steroid to be approved
for both postoperative inflammation and pain. Clinical trials
demonstrated that Durezol
ocular pain and inflammation rapidly and effectively for patients following
Durezol is a difluorinated
derivative of prednisolone and has anti-inflammatory activity. The
recommended dosing regimen for Durezol is one drop four times daily beginning
24 hours after surgery and continuing throughout the first two weeks of the
postoperative period, followed by two times daily for a week and then tapering
off thereafter based on the response.
The most common ocular adverse
reactions occurring in 5-15% of subjects in clinical studies with Durezol included corneal
edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior
capsule opacification, anterior chamber cells, anterior chamber flare,
conjunctival edema and blepharitis.
Zirgan (ganciclovir ophthalmic gel)
0.15% is indicated for topical ophthalmic use as a treatment for acute herpetic
keratitis (dendritic corneal ulcers). Zirgan is an innovative
topical antiviral therapy designed to specifically target viral-infected cells
and has a low corneal toxicity profile, providing patients comfort and
relief. Zirgan has been a leading treatment for corneal ulcers,
under the brand name Virgan , in
Europe for more than 10 years. The FDA also has designated Zirgan as
an orphan drug, which is a special status for rare diseases or conditions that
affect fewer than 200,000 patients in the U.S.
recommended dosing for Zirgan is one drop five times per day until the ulcer
heals, and then one drop three times per day for seven days. The most
common adverse reactions reported in patients were blurred vision (60%), eye
irritation (20%), punctate keratitis (5%), and conjunctival hyperemia
(5%). Alcon anticipates Zirgan to become available in the U.S. by
prescription in 2010.
(cyclosporine) is a topical ophthalmic immunomodulator and immunosuppressive
agent. Zyclorin is an investigational drug and is not approved by
the U.S. Food and Drug Administration. It is being studied for the
treatment of ocular surface diseases, including dry eye, which affects millions
Inc. is the world's leading eye care company, with sales of approximately $6.3
billion in 2008. Alcon, which has been dedicated to the ophthalmic
industry for 65 years, researches, develops, manufactures and markets
pharmaceuticals, surgical equipment and devices, contacts lens solutions and
other vision care products that treat diseases, disorders and other conditions
of the eye. Alcon operates in 75 countries and sells products in 180
markets. For more information on Alcon, Inc., visit the Company's web
site at www.alcon.com.
Morgan Securities, Inc. is acting as financial advisor and Proskauer Rose LLP is
acting as legal advisor to Sirion Therapeutics, Inc. with regards to the
Caution Concerning Forward-Looking
Statements. This press release may contain forward-looking statements
within the meaning of the United States Private Securities Litigation Reform Act
of 1995. Any forward- looking statements reflect the views of our
management as of the date of this press release with respect to future events
and are based on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking
statements. Except to the extent required under the federal securities laws and
the rules and regulations promulgated by the Securities and Exchange Commission,
we undertake no obligation to publicly update or revise any of these
forward-looking statements, whether to reflect new information or future events
or circumstances or otherwise.
and Media Inquiries:
Doug MacHatton Melissa Mota
817-551-8974 817-551-4007
doug.machatton@alconlabs.com melissa.mota@alconlabs.com
Last updated: Jan 18, 2010