Prescription Medication Completes Mutual Recognition Process
Wins UK Marketing Authorization
PEAPACK, N.J., April 23 /PRNewswire-FirstCall/ -- Pharmacia Corporation
(NYSE: PHA) announced today that the company has successfully completed the
Mutual Recognition Process in Europe for the use of XALATAN(R) (latanoprost
ophthalmic solution) as a first line treatment for lowering elevated
intraocular pressure (IOP) in patients with open-angle glaucoma and ocular
hypertension. The new indication means the prescription eye drop XALATAN can
be used in Europe as initial treatment in place of older prescription eye
drops, such as beta-blockers. XALATAN is the only prostaglandin glaucoma
medication with first line status in Europe. Regulatory authorities in Sweden
recently approved XALATAN for first line use under a separate application.
Xalatan is also approved as first line glaucoma therapy in Japan.
The UK Medicines Control Agency is acting as the Reference Member State
for XALATAN, where the product was first licensed six years ago for patients
with elevated IOP not adequately controlled with other medicines. National
approvals for use of XALATAN as first line treatment are expected in all EU
member states.
"Gaining mutual recognition for XALATAN first line in Europe is further
evidence that XALATAN is emerging as a new standard in glaucoma therapy," said
Paul Chaney, Vice President, Global Ophthalmology Business, Pharmacia. "Now
doctors in Europe will have the option of prescribing once-daily XALATAN
instead of a beta blocker as initial monotherapy treatment. This is good news
for the estimated four to five million glaucoma patients in Europe, because
once-daily XALATAN has unsurpassed efficacy and can be prescribed for patients
with cardiovascular or cardiopulmonary conditions, unlike some older glaucoma
medicines."
When introduced in Europe in 1996 as a second-line therapy, XALATAN was
the first prostaglandin-based medicine to treat elevated IOP in patients with
open-angle glaucoma and ocular hypertension. Over time, XALATAN increasingly
became an important therapeutic alternative to older medications, particularly
for patients with asthma or heart conditions in whom beta-blocker eye drops
are contraindicated and those with an IOP not adequately controlled by other
medications.
Pharmacia Corporation manufactures XALATAN(R) (latanoprost ophthalmic
solution), the world's number one brand of glaucoma medication (based on
market share). XALATAN is available in more than 50 countries, with more than
300 peer-reviewed published papers and 74 million prescriptions written
worldwide. In the United States, XALATAN is indicated for the reduction of
elevated IOP in patients with open-angle glaucoma and ocular hypertension who
are intolerant of other IOP-lowering medications or insufficiently responsive
(failed to achieve target IOP determined after multiple measurements over
time) to another IOP-lowering medication. The most commonly reported side
effects in eyes of patients treated with XALATAN for six months in clinical
studies include blurred vision, burning and stinging, eyelid redness, the
feeling that something is in the eye, eye itching, darkening of eye color and
irritation of the clear front part surface of the eye. XALATAN can slowly
darken eye color in the treated eye by increasing the amount of brown color
and can darken eyelids and increase the growth of eyelashes; these changes can
be permanent.
Physicians or pharmacists who have clinical questions about XALATAN, and
consumers who would like additional information on XALATAN, can call Pharmacia
Corporation at 1-800-323-4204.
Pharmacia (NYSE: PHA) is a top-tier global pharmaceutical company with a
leading agricultural subsidiary. Pharmacia's innovative medicines and other
products save lives and enhance health and wellness. Pharmacia's 59,000
people work together with many diverse stakeholders to bring these benefits to
people around the world, and to create new health solutions for the future.
XALATAN(R) is a registered trademark of Pharmacia Corporation.
Pharmacia Corporation Website: http://www.pharmacia.com
XALATAN Website: http://www.xalatan.com
SOURCE Pharmacia Corporation
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Related links:
http://www.pharmacia.com
http://www.xalatan.com
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CONTACT:
Media, Rosemarie Yancosek, +1-908-901-8517,
or cell, +1-908-313-4896, or Investors, Linda C. Heller,
+1-908-901-8853, both of Pharmacia Corporation
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