New Data Presented at ACR Meeting Demonstrates Colcrys(TM) (Colchicine, USP) Significantly Reduces Pain of Acute Gout Flare Within 24 Hours With Side Effects Comparable to Placebo

New Data Presented at ACR Meeting Demonstrates Colcrys(TM) (Colchicine, USP)
Significantly Reduces Pain of Acute Gout Flare Within 24 Hours With Side
Effects Comparable to Placebo
Studies Confirm Clinical Benefit, Reveal New Information on Safety and
Pharmacokinetics of Colcrys

PHILADELPHIA, Oct. 19 /PRNewswire/ -- URL Pharma, Inc., today announced data
from a pivotal Phase III study demonstrating that Colcrys(TM) (colchicine,
USP), a low-dose colchicine, reduced the pain of gout flares within a 24-hour
period as effectively as high-dose colchicine with a side effect profile
statistically indistinguishable from placebo. These data and two other Colcrys
studies were presented this week at the 2009 American College of Rheumatology
(ACR) Annual Scientific Meeting in Philadelphia.

"These studies confirm that Colcrys offers patients effective relief of gout
flares with significantly reduced side effects and a greater margin of
safety," said Robert A. Terkeltaub, M.D., Section Chief, Rheumatology-Allergy,
VA Medical Center San Diego, and Professor of Medicine and Rheumatology
Training Program Director, University of California San Diego. "The data
provide critical guidance for physicians on the optimal use of colchicine, and
signal a positive change in how we manage acute gout flares." Dr. Terkeltaub
was the primary investigator for the AGREE (Acute Gout Flare Receiving
Colchicine Evaluation) study presented at the 2008 ACR Annual Meeting.

Colcrys(TM) is approved for the prophylaxis and treatment of gout flares. It
is the first and only single-agent colchicine treatment to receive FDA
approval. Colcrys provides a formulation with the same efficacy of high dose
colchicine while avoiding most of the toxicity of the unapproved products
currently on the market.

"These clinical studies with colchicine - the first of their kind ever
conducted - have resulted in significant benefit and value to patients living
with gout," said Richard H. Roberts, M.D., Ph.D., President, Chief Executive
Officer and Chairman of URL Pharma. "The data presented today reaffirm the
role of colchicine as a cornerstone therapy in the treatment of gout, provide
valuable information on how to dose colchicine while reducing side effects,
and highlight potential and previously unknown drug-drug interactions, giving
physicians the information they need to prescribe colchicine with greater
confidence."

Study Design
This Phase III, randomized, double-blind, placebo-controlled, parallel group
study represents a secondary analysis of the previously presented AGREE trial
data. A total of 184 patients having a clinical diagnosis of gout according to
ACR guidelines received either study drug or placebo. Fifty-two patients
received high-dose colchicine (1.2 mg, then 0.6 mg hourly x 6 hours = 4.8 mg
total); 74 received Colcrys (1.2 mg, then 0.6 mg in 1 hour = 1.8 mg total,
followed by 5 placebo doses hourly); and 58 were assigned to placebo (2
capsules, then 1 capsule hourly x 6 hours).

The study's primary endpoint was a 50 percent reduction in joint pain at 24
hours post first dose. Researchers also compared pain improvement scores at 24
and 32 hours after the first dose. Patients recorded pain intensity (as
measured by a 0-10 point Likert pain scale) and adverse events over 72 hours.

Study Results
In this analysis, 43.2 percent of patients experienced a 2 point or greater
reduction in pain on the Likert scale 24 hours after taking Colcrys compared
with 17.2 percent in the placebo group (p = 0.0015). The therapeutic effect
was sustained at 32 hours post-Colcrys dosing, with 45.9 percent of Colcrys
patients experiencing a 2 point or greater reduction in pain versus 17.2
percent in the placebo group (p = 0.0005). While the Colcrys and high-dose
colchicine groups experienced similar pain relief at 24 and 32 hours, the
safety profile of Colcrys was significantly improved over high-dose
colchicine. The rate of adverse events seen in the Colcrys-treated patients
was comparable to placebo.

Additional Colcrys Studies
Two additional studies provide new data on the concomitant dosing of
colchicine with the calcium channel blocker verapamil and additional evidence
of the safety of Colcrys(TM) dosing in the treatment of gout flares.

Verapamil Drug Interaction Study
Researchers presented a Phase I study assessing the effect of verapamil on the
pharmacokinetics of single-dose colchicine, the first time this
commonly-prescribed hypertension medication has been evaluated for
interactions with colchicine. Hypertension is one of many co-morbid conditions
often experienced by gout patients, so an understanding of interactions with
drugs often used in conjunction with colchicine is of critical importance to
physicians.

This open-label, 2-period, drug-drug interaction (DDI) study examined 24
fasting subjects, who received a single 0.6-mg oral dose of colchicine on Day
1. Blood samples were drawn at various times for pharmacokinetic (PK) analysis
on Days 2-5. After a 10-day washout period, subjects received 240 mg verapamil
once daily for five days. On day 19, a second colchicine dose (0.6 mg) was
given. Blood samples were drawn for PK analysis on Days 20-23.

The study demonstrated that verapamil increases colchicine concentrations in
the blood by 30 percent. The researchers concluded that, for the treatment of
acute gout flare, the standard dose of colchicine should be reduced from 3 to
2 tablets for patients on verapamil or diltiazem. Colchicine dosing should be
reduced by 50 percent when administered chronically and concomitantly with
verapamil or diltiazem (another calcium channel blocker previously studied by
URL Pharma for drug-drug interactions).

Pharmacokinetic dosing of colchicine
Investigators presented a Phase I study of 75 healthy volunteers evaluating
the pharmacokinetics of Colcrys as single dose, low-dose and high-dose
regimens. Plasma samples were collected following single-dose (0.6mg, both
after food and while fasting), low dose (1.2 mg + 0.6 mg after 1 hour) and
high-dose (1.2 mg + 0.6 mg x6) Colcrys regimens. Adverse events were assessed
and cardiac safety was measured by ECG.

Results showed that high-dose and low-dose regimens of Colcrys had similar
steady-state plasma concentrations and blood levels. However, the high-dose
regimen showed a two-fold greater total exposure when compared with the
low-dose regimen. The analysis suggested that peak colchicine blood levels of
about 6 ng/mL are adequate for pain reduction in the first 24 hours after a
gout flare.

The investigators concluded that additional exposure from high-dose colchicine
may only increase unwanted side effects, and recommended low-dose Colcrys (1.2
mg + 0.6 mg after 1 hr) for early acute gout flare treatment. The most common
adverse events in this study were headache, diarrhea, dizziness, nausea,
stomach pain, and vomiting. All were mild-to-moderate and did not result in
discontinuation.

About Gout and 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.

Important Safety Information
COLCRYS (colchicine, USP) tablets are indicated for the prophylaxis and
treatment of acute gout flares in adults.

COLCRYS is contraindicated in patients with renal or hepatic impairment who
are concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as
life-threatening or fatal toxicity has been reported. The most common adverse
events in clinical trials for the prophylaxis and treatment of gout were
diarrhea and pharyngolaryngeal pain. Rarely, myelosuppression,
thrombocytopenia, and leukopenia have been reported in patients taking
colchicine. Rhabdomyolysis has been occasionally observed, especially when
colchicine is prescribed in combination with other drugs known to cause this
effect. Monitoring is recommended for patients with a history of blood
dyscrasias or rhabdomyolysis.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

You may also report negative side effects to the manufacturer of COLCRYS by
calling 1.888.351.3786. Please see www.colcrys.com for full Prescribing
Information.

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 call 215-697-1900 or
media@urlpharma.com.

SOURCE URL Pharma, Inc.

Matthew J. Scampoli, +1-646-284-7324, matthews@bmccommunications.com