Wayne, PA - May 17, 2007 - Nearly three out of four ulcerative colitis (UC) sufferers (73 percent) responding to a new nationwide survey say not feeling well has become a normal part of life. Furthermore, they describe UC as disruptive when it comes to their relationship with a spouse (64 percent), their sexual relations (75 percent) and their emotional state (82 percent).
UC patients "normalize" aspects of their experience to the point that they resign themselves to these burdens. The majority say that there is not much they can do beyond what they are already doing to feel better (70 percent) and they have learned to live with the disruptions that UC causes (83 percent).
"The findings sound an alarm because a diagnosis of UC shouldn't mean patients are settling for the level of burden reported in this survey for the next 50 or 60 years. UC is a manageable disease with the appropriate therapy," says David Rubin, M.D., a gastroenterologist and assistant professor of medicine at the University of Chicago Medical Center who helped design the surveys.
UC is a chronic autoimmune disease that causes inflammation in the intestine and can lead to symptoms such as severe abdominal pain and cramping, uncontrollable bloody diarrhea several times a day, fatigue and weight loss. It is typically first diagnosed in people between the ages of 15 to 30 and is estimated to affect nearly 700,000 Americans.
The objective of the surveys was to understand how UC affects patients' lives, including definitions of what's normal, the threshold for letting the disease disrupt life, and how patients manage their condition. The surveys, titled "UC: NORMAL (New Observations on Remission Management and Lifestyle)" were sponsored by Shire Pharmaceuticals, a specialty biopharmaceutical company which markets UC medications LIALDA™ and PENTASA® (mesalamines). Please see Important Safety Information included below.
UC patients generally report more stress/depression compared to other diseases
The findings illustrate that UC takes a heavy psychological toll, which is further brought to light when comparing UC patient responses to the survey responses of people with three other chronic health conditions - migraines, rheumatoid arthritis (RA) and asthma, who were also surveyed as part of UC: NORMAL. Eighty-two percent of UC patients said their condition made life more stressful versus 75 percent of migraine patients, 69 percent of RA patients and 46 percent of asthma patients. Furthermore, 62 percent of UC patients reported feeling sometimes or always depressed about having their condition, versus 49 percent of migraine patients, 52 percent of RA patients and 25 percent of asthma patients.
More than four out of five people (84 percent) with UC say they worry about the long-term health effects of having UC, compared to 45 percent of migraine patients, 72 percent of RA patients and 58 percent of asthma patients. Specific worries most commonly mentioned by UC patients were developing colon cancer, having their colon removed, requiring surgery and public fecal incontinence.
Compliance is a challenge
The survey found that 32 percent of UC patients are not currently taking medication to treat their UC. For patients who are taking medications, compliance is an issue. Of those UC patients taking aminosalicylates (5-ASAs), the first-line therapy and most commonly prescribed class of medication for UC, only about half (54 percent) reported that they have taken all of their 5-ASA medications in the past seven days.
Past studies confirm compliance challenges and report that patients who are noncompliant with their prescribed UC medications have a five-fold greater risk of flare-ups than compliant patients. Traditionally, 5-ASA therapies required two to four times daily dosing and up to 6 to 16 pills a day.
"It's troubling that almost one-third of UC patients are not taking medication because the standard of care is that all patients with a diagnosis of UC should be on medication to maintain control of the condition and reduce the likelihood of relapse," says Dr. Rubin. "The other challenge we need to address is compliance. More convenient dosing regimens such as once-daily dosage formulations may be part of the solution."
Bridging the physician/patient gap
Patients are also normalizing their experiences with flare-ups, a serious worsening of UC symptoms. UC patients reported an average of eight flare-ups per year. Four out of five (81 percent) of those surveyed say they consider the number of flare-ups they experience to be "normal" for their condition. On the other hand, in a survey of gastroenterologists also done as part of UC: NORMAL, physicians reported that a "typical" number of flare-ups per year on average is three among all patients (2 flare-ups if condition is mild; 4 if condition is moderate; 5 if condition is severe).
UC patients admit that they do not report all of their flare-ups to their physicians, making it difficult for physicians to understand the impact of UC on their patients' lives. One-third (34 percent) said they are sometimes reluctant to tell their doctor about flare-ups.
"If patients are experiencing multiple flare-ups a year, they should feel empowered to talk to their physicians openly about their disease and ask if their current therapy is appropriate for them," says Dr. Rubin. "As physicians, we need to ask questions to encourage patients to be forthcoming and open with us about the challenges they face and the concerns they have."
As a company committed to educating patients and working with physicians, Shire is developing a program that will launch this fall and is designed to help foster increased discussion between physicians and patients about UC and its management.
Low public awareness
Further confounding the challenges for UC patients, their disease is relatively unknown among the general public. According to UC: NORMAL's survey of a cross section of the general public, 74 percent of Americans have either never heard of UC or have heard of it but know little about it, even though UC's prevalence approaches the numbers for HIV/AIDS and Parkinson's in the United States.
More than two-thirds of UC patients report that having UC is embarrassing to them (70 percent) and that they are reluctant to tell people about their condition (66 percent). With low public awareness and this hesitation to talk openly about their UC, feeling isolated is a risk for UC patients.
"This survey highlights the need to raise awareness and engage the public in a discussion about UC," says Richard Geswell, president, Crohn's and Colitis Foundation of America (CCFA). "There's a scarcity of data relating to patient experience and opinions of UC and its treatment, so I hope these findings will help bring this disease to the forefront and assist the ulcerative colitis community in identifying areas to focus our efforts."
"Like many other chronic diseases, there's no medical cure for ulcerative colitis, but with better management of quality of life issues, improved patient communication and by getting patients on effective therapies, we can help patients live more normal, fulfilling and productive lives," concludes Dr. Rubin. "I hope the survey will spark a national dialogue about UC. I know I'll use it as a conversation starter in my practice."
The surveys were conducted by Richard Day Research and included a total of 1,975 people: 451 UC patients, 300 gastroenterologists, 309 RA patients, 305 asthma patients, 305 migraine patients and 305 adults from the general U.S. population who may have chronic health conditions. All patient surveys and the general public survey were fielded through an online panel that closely reflects the U.S. adult population overall. Physicians were recruited from a list of all board certified gastroenterologists in the U.S. Assuming no sample bias, the margin of error for the sample of 451 UC patients is ± 5 percent; assuming no sample bias, the margin of error for a sample of 300 (the other surveys) is ± 6 percent.
UC is a type of inflammatory bowel disease that produces chronic inflammation and sores or ulcers along the inside of the large intestine. Symptoms may include severe abdominal pain and cramping, frequent and sometimes uncontrollable bloody diarrhea, fatigue and weight loss. This chronic autoimmune disease is typically first diagnosed in people between the ages of 15 to 30 and is estimated to affect nearly 700,000 Americans. According to the National Institutes of Health, about 5 percent of people with UC will develop colon cancer.
LIALDA is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for UC. LIALDA is indicated for the induction of remission in patients with active, mild to moderate UC. The safety and efficacy of LIALDA have been established for up to eight weeks. LIALDA is the first new formulation in this class to be approved since 2000. LIALDA is the only ulcerative colitis treatment that utilizes MMX™ Technology. LIALDA with MMX Technology combines a pH dependent gastro-resistant coating, which delays the release of the medication to the colon (the site of the inflammation in ulcerative colitis), with a tablet core containing mesalamine with hydrophilic and lipophilic excipients.
LIALDA has only been studied in UC, not in areas outside of UC such as depression or stress. Patients should discuss these conditions with their health care providers.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize LIALDA in the U.S., Canada, Europe - known as MEZAVANT™ - (excluding Italy) and the Pacific Rim. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.
Important Safety Information for LIALDA
Lialda is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and efficacy of Lialda beyond 8 weeks have not been established.
You should not take Lialda if you are allergic to mesalamine or other salicylates (such as aspirin), or to any of the other ingredients in Lialda. Tell your doctor if you have a stomach blockage or are allergic to sulfasalazine. Mesalamines have been associated with an acute intolerance syndrome, a condition that may be difficult to distinguish from a flare of UC. Tell your doctor if you experience symptoms such as abdominal pain, cramping, bloody diarrhea, headache, and rash. Some patients taking mesalamines 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.
Lialda is generally well tolerated. In worldwide clinical trials, the most common adverse events were headache and flatulence. As with other medications, some serious side effects may occur. While taking Lialda, visit your doctor periodically. If you have any questions about Lialda, please talk to your doctor.
Important Safety Information for PENTASA
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--diarrhea, headache, nausea, abdominal pain, upset stomach, vomiting, and rash--occurred less often with PENTASA than with a sugar pill. 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.
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 and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: www.shire.com.
For further information please contact:
Media Amanda Widtfeldt (GolinHarris) +1 312 729 4264
Matthew Cabrey (Shire) +1 484 595 8248
Giuliani SpA, founded in 1889, is a privately owned specialty pharmaceutical company strategically focused in gastroenterology and dermatology. It is currently marketing proprietary products for the treatment and management of ulcerative colitis, Crohn's disease, food intolerances and dermatological disorders. Giuliani's R&D pipeline includes new chemical entities and biotechnological products targeted to treat inflammatory and autoimmune diseases.
COSMO Pharmaceuticals SpA
Cosmo is a speciality pharma company that aims to become a global leader in optimized therapies for certain gastrointestinal diseases. The company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections. Cosmo's most advanced development product is LIALDA™/ MEZAVANT™ a treatment for ulcerative colitis that is licensed globally to Giuliani and Shire Pharmaceuticals. Cosmo's proprietary MMX technology is at the core of the company's product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. For further information on Cosmo, please visit the Company's website: www.cosmopharmaceuticals.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
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, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD) and SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire's ability to secure new products for commercialization and/or development; Shire's ability to benefit from its acquisition of New River Pharmaceuticals Inc.; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.
LIALDA™ is a trademark of Shire LLC.
PENTASA® is a registered trademark of Ferring A/S.
MMX™ is a trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.