FDA Approves Colcrys(TM) (colchicine, USP) for Prevention of Gout Flares

New Colchicine Formulation Significantly Reduces Side Effects, Maintains Full
Efficacy; Now Indicated for Both Prophylaxis and Treatment of Gout Flares

PHILADELPHIA, Oct. 19 /PRNewswire/ -- URL Pharma, Inc., today announced that
the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM)
(colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was
first approved by the FDA on July 30, 2009 for the treatment of acute gout
flares when taken at the first sign of a flare.

Colcrys is an oral, branded form of colchicine that has been formulated for
optimal efficacy and tolerability. It is the only single-ingredient colchicine
to be approved by the FDA for the prophylaxis and treatment of gout flares.
Colcrys provides a formulation with the efficacy of colchicine while avoiding
most of the toxicity of the unapproved products historically on the market.
Colcrys is also indicated for the treatment of Familial Mediterranean Fever
(FMF) in adults and children 4 years of age or older. Colcrys is available via
prescription at pharmacies nationwide.

"With the FDA's approval of Colcrys for the prevention of gout flares,
patients and physicians will now be able to realize the full therapeutic
potential of Colcrys as a cornerstone therapy in the management of gout," said
Richard Roberts, M.D., Ph.D., President, CEO and Chairman, URL Pharma. "Our
clinical research on colchicine - the first of its kind ever conducted -- has
brought colchicine manufacturing, dosing, safety and efficacy information into
compliance with current FDA standards."

Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg
twice a day for the prophylaxis of gout flares in patients initiating
treatment with uric-acid lowering therapy. In both trials, treatment with
colchicine decreased the frequency of gout flares. Colchicine has been shown
to be well-tolerated when paired with uric acid-lowering agents such as
allopurinol. The dosing of Colcrys for gout flare prophylaxis is one tablet
(0.6 mg) once or twice a day. The maximum daily dose for prophylaxis is two
tablets (1.2 mg).

"Uric acid-lowering agents are highly effective and well-established in
chronic gout management, but the initiation of this therapy may sometimes
trigger a gout flare," said Matthew R. Davis, M.D., R.Ph., Vice President,
Branded Products and Medical Affairs, URL Pharma. "Colchicine has been proven
to be effective in preventing flares when given in conjunction with uric
acid-lowering therapy, and with Colcrys, doctors can now prescribe colchicine
with greater confidence."

The most commonly reported adverse reaction in clinical trials of colchicine
for the prophylaxis of gout was diarrhea. In the presence of mild-to-moderate
renal or hepatic impairment, adjustment of dosing is not required for use in
gout flare prophylaxis, but patients should be monitored closely for adverse
effects of colchicine. In patients with severe renal impairment, the starting
dose for prophylaxis of gout flares should be 0.3 mg per day and any increase
in dose should be done with close monitoring. For patients undergoing
dialysis, the total recommended dose for prophylaxis of gout flares should be
0.3 mg given twice a week with close monitoring. In patients with severe
hepatic impairment, a dose reduction may be needed in prophylaxis of gout
flares. Full prescribing information can be found at www.colcrys.com.

URL Pharma is establishing a Patient Assistance Program (PAP) for patients
with limited means who may require assistance in obtaining Colcrys. The
program is expected to launch in the fourth quarter of 2009. Once the program
has been established, patients may visit www.colcrys.com or www.urlpharma.com
for more information.

Colchicine in Gout Treatment
Colchicine has been utilized as a treatment for gout for centuries. However,
unapproved colchicine has not been reviewed by the FDA for safety and
efficacy. As a result, critical information about unapproved colchicine
products -- including safety and efficacy, potential adverse events, drug
interactions and manufacturing practices -- cannot be determined. The FDA has
undertaken an initiative to bring unapproved, marketed products like
colchicine under its regulatory framework. This initiative promotes the goal
of assuring that all marketed drugs meet modern standards for safety,
effectiveness, quality and labeling. The FDA has the authority to remove
unapproved colchicine from the market. More information is available at
www.fda.gov/Drugs/DrugSafety.

About Goutand Painful Gout Flares
Gout is a painful form of arthritis that affects an estimated 3 to 5 million
Americans, most commonly adult men. It occurs when excess uric acid in the
body is deposited as needle-like crystals, or tophi, in the joints or soft
tissues, which cause inflammatory arthritis and can lead to gout flares
typically lasting three to 10 days.

Gout flares are characterized by intermittent swelling, redness, heat, joint
stiffness and pain, which are often excruciating and can be debilitating
enough to significantly interfere with work, social activities and daily
living. For many people, gout initially affects the joint of the big toe,
though it can also affect other joint areas such as the ankles, heels, knees,
wrists, fingers and elbows.

About URL Pharma
URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty
pharmaceutical company with fully integrated technology development, product
development, manufacturing, and commercialization capabilities. After a long
history of generic pharmaceutical research, development, and manufacturing,
the Company has successfully transitioned to a profitable, technology-driven,
specialty pharmaceutical business. The Company seeks to develop and
commercialize scientifically and medically innovative products that address
unmet medical needs for improvements in safety and efficacy. The Company's
profits are derived predominantly from its exclusive products and
technologies. For additional information about the company, please visit
www.urlpharma.com. For further information, please contact us at 215-697-1900
or media@urlpharma.com.

SOURCE URL Pharma, Inc.

Matthew Scampoli, +1-646-284-7324