Re Agreement
GlaxoSmithKline PLC
29 October 2001
Issued: London and Toronto, October 29th, 2001
GlaxoSmithKline and Biovail Sign Licensing Agreements For Once Daily
Formulation of Wellbutrin and Distribution Rights for Zovirax Ointment
& Cream
GlaxoSmithKline plc (GSK) and Biovail Corporation (NYSE, TSE:BVF) today
announce that Biovail has licensed to GSK a novel controlled-release,
once-daily formulation of bupropion hydrochloride (HCI) for sales and
distribution on a world-wide basis, excluding Canada.
Bupropion HCI, which is marketed for the treatment of depression as Wellbutrin
SR by GSK, is currently sold in a sustained-release, twice daily, dosage
format. Under the terms of the Wellbutrin Once Daily agreement, Biovail will
manufacture and supply the product to GSK for a share of the future sales of
the product. GSK and Biovail will co-promote Wellbutrin SR and, Biovail will
have the option to co-promote Wellbutrin Once Daily upon approval, in the
United States. GSK and Biovail intend to file a New Drug Application (NDA) for
Wellbutrin Once Daily with the United States Food and Drug Administration
(FDA) during the first half 2002.
In addition, Biovail has acquired exclusive promotion and distribution rights
for Zovirax Ointment for the United States and Puerto Rico. Under the terms of
the agreement, GSK will manufacture and supply Zovirax Ointment and Zovirax
Cream to Biovail and, in return, Biovail will pay GSK $133 million for certain
rights to the products, subject to certain conditions. Biovail will begin
promotional efforts related to Zovirax Ointment in January 2002 and intends to
launch Zovirax Cream upon FDA approval. In order to gain FDA approval for
Zovirax Cream, GSK will work with the FDA to reinstate a New Drug Application
(NDA) previously filed by the company for the product. GSK will also conduct a
paediatric Phase IV study for Zovirax Cream.
Commenting on the agreements, Dr Jean-Pierre Garnier, Chief Executive Officer,
GlaxoSmithKline said: 'This agreement with Biovail represents a further
strengthening of our late stage product development pipeline and is indicative
of our intention to become the partner of choice for those companies wishing
to maximise the commercial potential of their products and increase their
global presence. The new Wellbutrin Once Daily will offer physicians greater
prescribing flexibility, the potential for improved patient convenience and
compliance as well as a modified drug release profile.'
Eugene Melnyk, Chairman of the Board, Biovail Corporation commented: 'Our
agreements with GlaxoSmithKline are the latest example of Biovail's stated
mission of continuing to grow and expand our base business and to capitalise
on the opportunities that our rich and deep pipeline of controlled-release and
FlashDoseO products represent. Our new association with GlaxoSmithKline for
the licensing and promotion of Wellbutrin Once Daily and Wellbutrin SR and,
the acquisition of US distribution rights for Zovirax topical products,
further demonstrates our commitment to building Biovail into one of North
America's premier developers and marketers of pharmaceutical products.'
The transaction will be notified under the Hart Scott Rodino pre-merger
notification program, and will become effective only upon approval of the
transaction by the US Federal Trade Commission.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer.
Biovail Corporation is an international full-service pharmaceutical company,
engaged in the formulation, clinical testing, registration, manufacture, sale
and promotion of pharmaceutical products utilising advanced drug delivery
technologies.
--Ends--
Enquiries:
UK Media enquiries Martin Sutton (020) 8966 8372
Philip Thomson (020) 8966 8372
Alan Chandler (020) 8966 8372
US Media enquiries Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
European Analyst/Investor enquiries Jennie Younger (020) 8966 8378
Duncan Learmouth (020) 8966 5961
Anita Kidgell (020) 8966 8369
US Analyst/Investor enquiries Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation
Reform Act of 1995, the Company cautions investors that any forward-looking
statements or projections made by the Company, including those made in this
Announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect the
Group's operations are described under Risk Factors in the Operating and
Financial Review and Prospects in the Company's Annual Report on Form 20-F for
2000, filed with the US Securities and Exchange Commission.
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