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, 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: Celltech Submits Xyrem
| Embargoed for release at 07:00 | 1 April 2004 | ||
CELLTECH GROUP PLC
CELLTECH SUBMITS XYREM FOR APPROVAL IN EUROPE
Celltech Group plc (LSE: CCH; NYSE: CLL) today announces that the European
Medicines Evaluation Agency (EMEA) has accepted for review its marketing
authorisation application for Xyrem (sodium oxybate) oral solution, a treatment
for symptoms of narcolepsy. Xyrem has been filed through the EU centralised
procedure, and has been granted Orphan Drug designation status in Europe, which
provides a 10-year period of marketing exclusivity upon approval. Celltech will
use its specialist sales forces to market the product to neurologists and sleep
specialists across Europe following approval, anticipated during 2005.
Celltech in-licensed the European rights to Xyrem from Orphan Medical in October
2003. Under the terms of the agreement, Celltech will be responsible for the
registration, sales and marketing of Xyrem in Europe. Celltech made a milestone
payment to Orphan Medical related to the European regulatory filing and will
make further payments tied to future product development milestones and sales
related milestones. Celltech will also pay Orphan a royalty on sales of the
product. The licensing agreement also provides Celltech with rights to negotiate
in regard to other potential future indications including fibromyalgia syndrome.
Ingelise Saunders, Celltech's Global Commercial Director, commented: "We are
pleased at having rapidly submitted our marketing authorisation application for
Xyrem in narcolepsy, in line with our expectations. Xyrem will be an important
product within our European specialist-focused commercial organisation. We are
looking forward to progressing our European submission and working with sleep
centres and physicians in order help fulfil the unmet medical need in patients
with this serious disorder."
| Contacts: | |||||
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 | ||||
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
Notes for editors
Narcolepsy
Narcolepsy is characterised by excessive daytime sleepiness, which can be
complicated by an irresistible tendency to fall asleep, even in unlikely
circumstances such as the middle of a conversation or at a meal.
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 expected dates for approval and launch of Xyrem
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, failure to obtain and maintain required approvals for products from
governmental authorities, unavailability of raw materials or other interruptions
in production or product distribution, fluctuations in currency exchange rates,
inability of the Company to market new products effectively, the failure of the
Company's development, manufacturing and marketing partners to perform their
contractual obligations 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 judgment 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.
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: 1 April, 2004