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Shire Expands Gastrointestinal Patient Assistance Program for Uninsured or Unemployed Americans

Free Medication Provided by Shire to Patients Taking Lialda(R) (mesalamine) or Pentasa(R) (mesalamine) for the Treatment of Ulcerative Colitis Who Have Lost Their Jobs in 2009

PHILADELPHIA, May 18 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, is responding to the needs of patients who are diagnosed with ulcerative colitis (UC) and prescribed gastrointestinal (GI) medications from Shire by expanding its Patient Assistant Program (PAP). Thanks to the recently enhanced Shire CARES PAP, UC patients who are newly prescribed or are already taking Lialda or Pentasa and who become unemployed in 2009 can receive their medication at no cost throughout the rest of the calendar year. In addition, more UC patients can benefit from Lialda and Pentasa because Shire has raised the household income levels necessary to qualify for no cost and shared cost assistance. This expands the existing Shire PAP to help even more uninsured patients and their families save on the medicines they need to stay healthy and to manage chronic conditions like UC.

"We are committed to helping UC patients better manage their condition," said Roger Adsett, senior vice president of the GI business unit at Shire. "Offering greater financial support to those who may be struggling due to the current economic climate through our expanded Shire CARES PAP is a natural extension of the Shire mission."

More than 100,000 people with UC have been treated with Lialda, and many have benefited from the Shire PAP. The new Shire CARES PAP includes job loss prescription coverage for 2009, and financial assistance at no cost and shared cost levels. Additionally, the Shire CARES PAP offers a discounted copay pharmacy card program (not valid in Mass.) and a 30-day free trial of Lialda when patients join the Lialda UC Support Program. The Lialda UC Support program offers patients the added benefit of hearing from professionals for medical insight and advice through an unbranded patient education Web site.

"We are thrilled to launch this new, more robust program," said Mike Cola, president of the Specialty Pharmaceuticals business at Shire. "The program is designed to help patients with ulcerative colitis who are taking Lialda or Pentasa and are experiencing a financial hardship gain access to these treatments. This enhanced PAP is the first of many steps Shire is taking to reinforce our commitment to the patient community, and we are pleased that Lialda and Pentasa are leading the way."

The Shire CARES PAP has a simple enrollment process and offers free delivery of medicines for enrolled patients to their home or doctor's office for up to one year. Patients may be re-enrolled if they continue to need assistance and qualify for the Shire CARES PAP.

To learn more about the Shire CARES PAP for Lialda and Pentasa medications, please call 1-888-CARES-55 to speak with a live representative, or visit

 For Further information please contact: Media Sarah McGee (GolinHarris) +1 312 729 4125 Matthew Cabrey (Shire) +1 484 595 8248 About Lialda Important Safety Information 

Lialda is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of Lialda beyond 8 weeks have not been established. You should not take Lialda if you are allergic to salicylates (including mesalamine or aspirin) or to any of the ingredients of Lialda. Tell your doctor if you have a stomach blockage or are allergic to sulfasalazine. Mesalamine has been associated with a syndrome that may be difficult to distinguish from an ulcerative colitis flare-up. If you experience cramping, diarrhea, fever, headache or rash, talk to your doctor immediately. Some patients taking mesalamine have reported heart-related hypersensitivity reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have problems with your liver or kidneys.

In worldwide clinical trials, Lialda was generally well tolerated. The most common adverse events were headache and flatulence. As with other medications, some serious side effects may occur. Less than 1% of patients experienced inflammation of the pancreas, which led to discontinuation of therapy with Lialda.

Lialda(R) is a registered trademark of Shire LLC.

MMX(R) is a registered trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.

 About PENTASA Important Safety Information 

PENTASA is approved for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis.

PENTASA is generally well tolerated and most side effects are mild. In worldwide clinical studies, the most common side effects were diarrhea, headache, nausea, abdominal pain, upset stomach, vomiting, and rash. As with other medications, some serious side effects may occur. You should not take PENTASA if you are allergic to salicylates, such as aspirin. Tell your doctor if you have problems with your liver or kidneys. While taking PENTASA, visit your doctor periodically. If you have any questions about PENTASA, please talk to your doctor.

 Pentasa(R) is a registered trademark of Ferring A/S Corp. About SHIRE PLC 

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's Web site:


Statements included herein that are not historical facts are forward-looking statements. Such forward looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

Source: Shire plc

CONTACT: Sarah McGee of GolinHarris, +1-312-729-4125, for Shire plc; or
Matthew Cabrey of Shire, +1-484-595-8248

Web Site:

Posted: May 2009