BUSINESS WIRE
HUENENBERG, Switzerland, Jan 18, 2010 (BUSINESS WIRE) -- 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(TM), a marketed ophthalmic corticosteroid approved for the
treatment of inflammation and pain associated with eye surgery, and
Zirgan(TM), 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(TM). This product is currently in clinical
development to treat dry eye and other ocular surface diseases.
"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(TM) and Zirgan(TM)
with the existing commercial capability in the United States to maximize
the brand development and revenue opportunities."
"Durezol(TM) 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(TM), due to its
low toxicity, potency and targeted antiviral effect."
The 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.
About Ocular Inflammation
Cataracts 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
rehabilitation.
About Durezol(TM)
Durezol(TM)(difluprednate ophthalmic emulsion) 0.05% is a topical
ophthalmic corticosteroid for the treatment of postoperative
inflammation and pain associated with ocular surgery. Durezol(TM) 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(TM)
reduced ocular pain and inflammation rapidly and effectively for
patients following ocular surgery.
Durezol(TM)is a difluorinated derivative of prednisolone and has
anti-inflammatory activity. The recommended dosing regimen for Durezol(TM)
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(TM) included corneal edema, ciliary and
conjunctival hyperemia, eye pain, photophobia, posterior capsule
opacification, anterior chamber cells, anterior chamber flare,
conjunctival edema and blepharitis.
About Zirgan(TM)
Zirgan(TM)(ganciclovir ophthalmic gel) 0.15% is indicated for
topical ophthalmic use as a treatment for acute herpetic keratitis
(dendritic corneal ulcers). Zirgan(TM) 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(TM) has been a leading treatment for corneal ulcers, under the brand
name Virgan(R), in Europe for more than 10 years. The FDA also
has designated Zirgan(TM) 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.
The recommended dosing for Zirgan(TM) 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(TM) to become
available in the U.S. by prescription in 2010.
About Zyclorin(TM)
Zyclorin(TM) (cyclosporine) is a topical ophthalmic immunomodulator and
immunosuppressive agent. Zyclorin(TM) 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 of Americans.
About Alcon
Alcon, 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.
J.P. 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 transaction.
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.
