SAINT-LAURENT, QC, Jan. 29 /CNW/ - Shire plc (LSE: SHP, NASDAQ: SHPGY,
TSX: SHQ), the global specialty biopharmaceutical company, today announced the
availability in Canada of MEZAVANT(R)(*) (mesalamine delayed and extended
release tablets) with Multi Matrix System (MMX(TM)(xx)) Technology, indicated
for the induction of clinical and endoscopic remission in patients with
active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel
disease. MEZAVANT is the first and only Health Canada approved once-daily oral
formulation of mesalamine, and the first mesalamine to be approved by Health
Canada for the induction of clinical and endoscopic remission.
MEZAVANT is the only ulcerative colitis treatment that utilizes MMX
Technology, which combines a pH dependent gastro-resistant coating, thus
delaying and extending the delivery of effective concentrations of mesalamine
to the site of inflammation in the colon over an extended period of time (from
six hours after dosing to beyond 24 hours post-dose). It is available by
prescription for oral administration in dosages of 2.4g/day to 4.8g/day,
allowing patients to take as few as two tablets, once-daily. Other currently
available mesalamines require two to four times daily dosing and up to eight
pills a day.
In a chronic, life-long disease such as ulcerative colitis, complex
therapy regimens make it difficult for a patient to strictly adhere to
therapy, often leading to non-compliance. Two North American Internet
surveys(1) conducted with ulcerative colitis patients (n equals 451) and
gastroenterologists (n equals 300) reflected this difficulty of adherence with
current 5-ASA therapy. Both patients and gastroenterologists reported that
managing UC medication is a struggle for patients (49 per cent and 41 per cent
respectively) and that it is difficult for patients to take medication as
prescribed every day (42 per cent and 90 per cent respectively). This
difficulty is further exemplified by the fact that 46 per cent of patients
reported not taking all of their medication in the past week.
"The more complicated and varied a dosing regimen is for a patient, the
less likely they are to strictly adhere to it, leading to reduced efficacy and
ultimately sub-par disease control and low quality of life," states Dr. A.
Hillary Steinhart, Head, Combined Division of Gastroenterology, Mt. Sinai
Hospital and the University Health Network, Toronto, Ontario. "The
availability of Mezavant, with its convenient once-daily dosing, will go a
long way in helping address the compliance issues facing Canadian ulcerative
colitis patients, allowing them to overcome the disruptions to their life that
can be caused by their disease."
"Although not everyone's experience is the same, my complicated pill
schedule seems to consume my life - my next dosage is constantly on my mind,
and I still occasionally forget a dose" says James Mireau, an ulcerative
colitis patient from Edmonton, Alberta. "I have enough to concern myself with
due to my disease; taking my pills once-a-day will certainly make my life
easier by allowing me the freedom to focus on the more important things, like
The approval of MEZAVANT was based on the results of two, three-armed,
Phase III clinical studies comparing the efficacy of MEZAVANT 2.4g/day,
4.8g/day and placebo after eight weeks of treatment. The primary efficacy
endpoint in both trials was based on a composite endpoint indicative of
clinical remission and mucosal healing, the first time a mesalamine trial has
included both. Remission was defined as a modified Ulcerative Colitis Disease
Activity Index (UC-DAI) score of less than 1.
The first study(2) assessed the efficacy and safety of MEZAVANT at
2.4g/day given in divided doses twice-daily and at 4.8g/day given once-daily
against placebo (n equals 262). At eight weeks, both doses demonstrated
statistically significant superiority over placebo in the induction of
The second study(3) assessed the efficacy and safety of MEZAVANT 2.4g/day
and 4.8g/day, both given once-daily versus placebo (n equals 255). At eight
weeks, both once-daily doses demonstrated statistically significant
superiority over placebo in the induction of remission.
"Effective, safe and convenient therapy options are imperative for
gastroenterologists treating ulcerative colitis. Based on the results from its
clinical trials, Mezavant will be a welcome addition to our armamentarium to
help induce remission in ulcerative colitis patients," adds Dr. Steinhart.
Important Safety Information
MEZAVANT is generally well tolerated. The majority of adverse events in
the double-blind, placebo-controlled trials were mild or moderate. In clinical
trials (n equals 535), the most common treatment-related adverse events with
MEZAVANT were headache and flatulence.
About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease that produces
inflammation and sores or ulcers along the inside of the large intestine, also
called the bowel or colon. The sores may disrupt the normal digestive process,
often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and
frequent bowel movements. This serious, chronic immune disease affects
approximately 65,000 Canadians, with approximately 4,000 new cases reported
annually. For more information on ulcerative colitis, visit www.ccfc.ca
About Shire plc & Shire Canada Inc.
Shire plc'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'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. Shire believes that a carefully selected portfolio
of products with strategically aligned and relatively small-scale sales forces
will deliver strong results.
Shire Canada Inc. is a subsidiary of Shire plc. Shire Canada Inc.'s
operations are headquartered in Montréal, Québec.
For further information on Shire, please visit the Company's website:
"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 including, but not limited to, the successful development of
JUVISTA(R) (Human TGF(beta)3) and GA-GCB (velaglucerase alfa); manufacturing
and commercialization including, but not limited to, the launch and
establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate)
(Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of
competitive products including, but not limited to, the impact of those on
Shire's 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 date in
the United States of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's
ability to secure new products for commercialization and/or development; 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.
(*) MEZAVANT(R) is a registered trade-mark used under licence from
Shire LLC. By licence of Giuliani S.p.A., Milan, Italy.
(xx) MMX(TM) is a trade-mark owned by Cosmo Technologies, Ltd.,
Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.
(1) Rubin, David T. et al. Patient and physician perceptions on living
with ulcerative colitis: results from two internet surveys. Abstract
presented at the American College of Gastroenterology, Philadelphia,
PA, Oct, 2007.
(2) Kamm MA, et al. Once-daily high-concentration MMX mesalamine in
active ulcerative colitis. Gastroenterology, 2007 Jan; 132(1): 66-75:
quiz 432-3, Epub 2006 Oct 12.
(3) Lichtenstein, GR, et al. Effect of once- or twice-daily MMX
mesalamine (SPD476) for the induction of remission of mild to
moderate active ulcerative colitis. Clin. Gastroenterology &
Hepatology. 2007 Jan; 5(1): 95-102.
For further information:
For further information: about this press release, or to arrange an
interview with a gastroenterologist/patient, please contact: Chrome
Communications, (905) 567-1406: Alon Barmapov, ext. 223, (647) 405-1352,
email@example.com; or Tiana DiMichele, ext. 225, (416) 666-5331,