URL Pharma Expands Colcrys(R) Patient Assistance Program

PHILADELPHIA, March 15 /PRNewswire/ -- URL Pharma, Inc. today announced the launch of an expanded Colcrys® (colchicine, USP) Patient Assistance Program (PAP) that significantly increases the number of patients eligible for low-cost Colcrys therapy. Uninsured and Medicare Part D patients with household incomes of up to 6 times the federal poverty level are eligible for the new Colcrys PAP. This expanded program is available to patients immediately.

Colcrys is indicated for the prevention and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF).

The expanded Colcrys PAP covers eligible patients as follows:

• Uninsured or Medicare Part D patients with household incomes up to 4 times the federal poverty level (up to $88,000 per year for a family of four) may obtain Colcrys for $5 per month

• Uninsured or Medicare Part D patients with household incomes between 4-6 times the poverty level (up to $132,000 per year for a family of four) may obtain Colcrys for $25 per month

"URL Pharma is committed to making Colcrys therapy available to all who need it. We have worked closely with physicians and patients to ensure this program meets the needs of those with gout and FMF, and we are proud that our program is among the most generous patient assistance programs ever offered by any pharmaceutical company," said Richard H. Roberts, M.D., Ph.D., President, CEO and Chairman, URL Pharma. "Patients can now be assured of receiving an FDA-approved colchicine that meets all modern standards of safety, efficacy, purity and consistency, with no financial barriers to access."

Patients can learn more and sign up for the expanded Colcrys PAP by visiting www.needymeds.org or www.colcrys.com, or by calling 1-888-811-8423 from 8:00 am to 6:00 pm Eastern Time, Monday through Friday. Patients not eligible for the expanded PAP but who still need help in paying for Colcrys are also encouraged to call the toll-free number to determine if additional assistance may be available for them.

The program is open to all U.S. residents with a valid Colcrys prescription who meet the income eligibility requirements and who are uninsured or covered only by Medicare Part D.  Verification of household income will be required as part of the application process. Patients will be asked to attest that they will not claim co-payments on any Medicare plan.  Patients are eligible to receive Colcrys through the program for a period of one year from the date of initial enrollment, and will need to reapply to the program annually.

Important Safety Information

Colcrys® (colchicine, USP) tablets are indicated for the prophylaxis and treatment of acute gout flares and Familial Mediterranean Fever (FMF).

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. In a controlled clinical trial, the most common adverse events reported 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 under these conditions.

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 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. For more information, visit www.urlpharma.com.

For further information, please call 215-697-1900 or e-mail us at [email protected].

SOURCE URL Pharma, Inc.