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 June, 2004
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: FDA Approval
For immediate release
23 June 2004
CELLTECH GROUP PLC
CELLTECH ANNOUNCES U.S. FDA APPROVAL FOR 12-HOUR CODEPREXTM
- First codeine cough suppressant to be dosed every 12 hours -
Celltech Group plc (LSE: CCH; NYSE: CLL) announces that the U.S. Food and Drug
Administration ("FDA") has approved CodeprexTM (codeine polistirex/
chlorpheniramine polistirex) Extended-Release Suspension CIII for cough relief.
CodeprexTM uses Celltech's proprietary Pennkinetic® extended-release drug
delivery technology to provide 12-hour dosing. CodeprexTM is the first
codeine-based cough suppressant to provide 12-hour dosing and offers patients
the convenience of less frequent dosing compared to other codeine cough
suppressants, in particular by avoiding the need for middle of the night dosing.
CodeprexTM is indicated for the temporary relief of cough - as may occur with
the common cold or inhaled irritants - and for the temporary relief of: runny
nose, sneezing, itching of the nose or throat; and itchy watery eyes due to hay
fever, other upper respiratory allergies, or allergic rhinitis. CodeprexTM is
expected to be available in retail pharmacies by the fourth quarter.
"Celltech is introducing CodeprexTM in order to offer a 12-hour dosing option
for patients requiring a prescription codeine cough suppressant, " said Dan
Greenleaf, president, US operations, Celltech Pharmaceuticals. "The approval of
CodeprexTM extends our leadership in the cough/cold market, which can be in part
attributed to Celltech's proprietary Pennkinetic® technology. It is the
foundation for a full range of antitussives developed by Celltech to meet
individual patient needs."
Celltech also manufactures Tussionex® (hydrocodone polistirex/chlorpheniramine
polistirex) Extended-Release Suspension CIII, the number one prescribed
hydrocodone antitussive, and Delsym® Extended-Release Suspension, an
over-the-counter (OTC) dextromethorphan antitussive that provides 12-hour cough
relief. Delsym®'s efficacy has helped position it as the number two brand in
the cough suppressant category, and the number one brand in pediatric dollar
sales.
CodeprexTM is contraindicated in persons with sensitivity to codeine or
chlorpheniramine. CodeprexTM should be used with caution in patients with
persistent or chronic cough, as occurs with smoking, asthma or emphysema, or
with cough accompanied by excessive phlegm. Caution is also advised when
prescribing to patients with narrow-angle glaucoma or prostatic hypertrophy.
The possibility of tolerance and/or dependence, particularly in patients with a
history of drug abuse, should be considered. Common side effects may include
drowsiness, confusion, dizziness, nausea, constipation, dry mouth, headache, and
allergic reactions.
Tussionex® is contraindicated in the presence of known allergy to hydrocodone
or chlorpheniramine. The most common adverse reactions associated with Tussionex
® are sedation, drowsiness, and mental clouding, which may impair the mental
and/or physical abilities required for potentially hazardous tasks. The
possibility of tolerance and/or dependence, particularly in patients with a
history of drug dependence, should be considered.
CodeprexTM and Tussionex® are not recommended for use in children under six
years of age.
Please see enclosed full-prescribing information for CodeprexTM and Tussionex
®.
Codeprex: http://www.celltechgroup.com/Products/PI/LR428_COL.pdf
Tussionex: http://www.celltechgroup.com/Products/PI/Tussionex_LR242A.pdf
Contacts:
Investors / Financial Media
Peter Allen Deputy CEO and CFO
(44) (0) 1753 534655
Richard Bungay Director of Corporate Communications
Jon Coles
Brunswick
(44) (0) 207 404 5959
Wendel Carson Brunswick
Trade Media
Julie Napieralski Martino Flynn
(1) 585-421-0100
jnapieralski@martinoflynn.com
Celltech Group plc (LSE: CCH; NYSE: CLL) is one of Europe's largest
biotechnology companies, with an innovative development pipeline funded by its
profitable, cash-generative pharmaceutical business. Celltech also possesses
drug discovery capabilities of exceptional strength, including a leading
position in antibody engineering. More details can be found at
www.celltechgroup.com
Codeprex, Tussionex, Delsym and Pennkinetic are trademarks of Celltech.
Celltech desires to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995, with respect to forward-looking statements contained within this document. In particular certain statements with regard to the timing of launch of CodeprexTM are forward-looking in nature. By their nature forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. In addition to factors set forth elsewhere in this document, the following factors, although not exhaustive, could cause actual results to differ materially from those the Company expects: pricing and product initiatives of the Company's competitors, including the introduction of branded competition or generic substitution for the Company's products, failure to maintain required approvals for products from governmental authorities, unavailability of raw materials or other interruptions in production or product distribution both internal and external, unexpected difficulties in the scale-up of production to viable commercial levels, unexpected fluctuations in production yields, fluctuations in currency exchange rates, inability of the Company to market new products effectively, and the risk of substantial product liability claims. Other factors that could affect these forward-looking statements are described in the Company's reports filed with the US Securities and Exchange Commission. The forward-looking statements included in this document represent the Company's best judgement as of the date hereof based in part on preliminary information and certain assumptions which management believes to be reasonable. The Company disclaims any obligation to update these forward-looking statements.
ENDSIGNATURES
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 June, 2004