FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a - 16 or 15d - 16 of
the Securities Exchange Act of 1934
For the month of April, 2003
Commission File Number: 1-10817
CELLTECH GROUP PLC
(Translation of registrant's name into English)
208 Bath Road, Slough, Berkshire SL1 3WE ENGLAND
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
(If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-________).
Enclosure: Study Shows Metadate(R) CD is a Preferred Treatment for ADHD
Metadate(R) CD Preferred
By Majority of Study Patients Previously
Treated with Concerta(R) or Immediate-Release
Methylphenidate
ROCHESTER, N.Y., Jan. 29 /PRNewswire-FirstCall/ — A Phase IV open-label clinical experience study of previously treated and untreated ADHD patients published in the December 2002 issue of “Current Medical Research and Opinion,” showed that 71 percent of all previously treated ADHD patients rated their treatment with Metadate(R) CD (methylphenidate HCl, USP) Extended- Release Capsules (CII) 20 mg as better or much better than their previous ADHD treatment. Among patients who were previously treated with Concerta(R) or immediate-release methylphenidate, 86 percent and 92 percent, respectively, were very satisfied or moderately satisfied with Metadate(R) CD. In addition, a majority of patients indicated that they would continue to use Metadate(R) CD.
(Photo: http://www.newscom.com/cgi-bin/prnh/20030129/NYW010 )The study also provided additional
evidence that Metadate(R) CD is a safe and effective medication for the treatment of ADHD.
“We are pleased with the outcomes of this Phase IV open-label clinical experience
trial with Metadate(R) CD,” said Simon Hatch, M.D., Director, Clinical Development,
Celltech. “This study provides physicians with clinical data on Metadate(R) CD as it
relates to patient response and satisfaction when switching currently treated ADHD
patients to Metadate(R) CD. Although this was an open-label study, we believe these data
may help physicians determine which is the most appropriate once-daily methylphenidate
treatment for patients that require optimal control of ADHD symptoms during the morning
and afternoon hours.” Study Methodology
Three hundred and eight patients, ages six to
17, with a confirmed primary diagnosis of ADHD receiving either no treatment or
maintenance treatment with another FDA-approved methylphenidate agent, were treated in a
multi-center, open-label, post-marketing study. Study participants were treated with
Metadate(R) CD Capsules, 20 to 60 mg, once daily throughout the three-week study period.
Patients’ treatments were titrated against both reported and observed symptoms.
Efficacy was assessed on the Clinical Global Impression (CGI) scale. Safety and
tolerability were assessed by laboratory testing, vital signs and adverse events reported
by the patient and or parent. Patient and parent treatment satisfaction and treatment
preference were assessed by a questionnaire administered at the final evaluation visit.
Study Results
At the final evaluation visit, 65 percent of patients were classified as
responders to Metadate(R) CD (defined as much improved or very much improved
Of the previously treated patient population, nearly three-quarters of the patients (71%) rated their treatment with Metadate(R) CD as better or much better than their previous treatment protocol: 59 percent rated it better or much better than Concerta(R) and 85 percent rated it better or much better than immediate-release methylphenidate agent. Of all study participants, 75 percent stated that they would absolutely or probably continue treatment with Metadate(R) CD.
Treatment related adverse events occurred in 27 percent of patients, with most commonly reported adverse events being: headache (6%), stomachache (5%), and decreased or loss of appetite (3%). The adverse event profile was consistent with product labeling. Metadate(R) CD: An optimal once-daily formulation Metadate(R) CD is a once-daily biphasic formulation of methylphenidate for the treatment of ADHD in patients six years of age and older. Metadate(R) CD offers fast and lasting control of ADHD symptoms with a single dose, controlling symptoms without impacting appetite or sleep in the majority of patients. Metadate(R) CD can be sprinkled (onto 1 tablespoon of applesauce) for patients who may have difficulty swallowing a capsule.
Metadate(R)
CD Capsules are contraindicated in patients with marked anxiety, tension, and/or
agitation; in patients with glaucoma, tics or Tourette’s Syndrome; with or
within 14 days of using MAO inhibitors. Metadate(R) CD should not be used in
children under six years of age.
Use caution in patients with a history of
psychosis; drug or alcohol dependence; seizures; hypertension or cardiovascular
disease. As with all methylphenidate products, abuse may lead to dependence. The
most common adverse reactions are headache, abdominal pain, decreased appetite
and insomnia. Facts About ADHD
Celltech Pharmaceuticals, Inc. is the US sales, marketing and manufacturing pharmaceutical marketing arm of Celltech Group plc (NYSE: CLL; LSE: CCH). Celltech is one of Europe’s largest biotechnology companies, with an extensive late stage development pipeline and drug discovery capabilities of exceptional strength, including a leading position in antibody engineering. Celltech’s U.S. operations are headquartered in Rochester, NY. In addition to being an emerging leader in gastroenterology, its areas of therapeutic focus include ADHD; liquid extended release cough and cold products; and a variety of niche products.
More details about the Celltech Group
can be found at http://www.celltechgroup.com.
Please see accompanying full prescribing
information.
Metadate(R) CD is a registered trademark of Celltech Pharma Ltd.
Concerta(R)
is a registered trademark of Alza Corporation.
1.
Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder. NIH Consens
Statement 1998 Nov. 16-18; 16(2) p 3, 4, 8: In press.
2. Dulcan, M. Practice
parameters for the assessment and treatment of
children,
adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child
Adolesc Psychiatry 1997; 36;10: 101S.
3.
Diagnostic and Statistical Manual of Mental Disorders, 4th ed. DSM- IV(R).
Washington, D.C.: American Psychiatric Association, 1994, p 82.
SOURCE Celltech
Group plc -0- 01/29/2003 /
CONTACT: Kelly Laban of Kovak-Likly Communications,
+1-203-762-8833, Klaban@KLCpr.com/
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CELLTECH
GROUP PLC
(Registrant)
By: /s/
PETER ALLEN
Peter
Allen
Chief
Financial Officer
Dated: 23 April, 2003