Exubera Update
14 October 2005 - 10:49PM
UK Regulatory
RNS Number:6952S
Bespak PLC
14 October 2005
For immediate release 14 October 2005
Bespak plc
Welcomes Positive Opinion on Exubera(R)
Bespak plc (LSE: BPK), a leader in specialty medical devices, is pleased to note
that Pfizer Inc announced yesterday that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Evaluations Agency (EMEA) has
issued a positive opinion recommending the approval of Exubera(R) inhaleable
insulin for the treatment of type 1 and type 2 diabetes in adults.
The proposed therapeutic indication for Exubera(R) is for the treatment of adult
patients with type 2 diabetes not adequately controlled with oral antidiabetic
agents and requiring insulin therapy; and for the treatment of adult patients
with type 1 diabetes, in addition to long or intermediate acting subcutaneous
insulin, for whom the potential benefits of adding inhaled insulin outweigh the
potential safety concerns.
Exubera(R), which is the product of a joint-development program between Pfizer
and sanofi-aventis, is an inhaled rapidly acting insulin that is inhaled into
the lungs prior to eating, using a proprietary inhalation device and powdered
insulin formulation developed by Nektar Therapeutics. The product represents a
major advance in insulin delivery and will be the first non-injectable form of
insulin available since the discovery of the drug in the 1920s.
Bespak, in conjunction with Nektar, has developed the production process and
will manufacture the proprietary inhalation device for Exubera(R).
Exubera(R) was filed with the US Food & Drug Administration (FDA) on 2nd March
2005, and an FDA advisory committee recommended the approval of Exubera(R) on
8th September for the treatment of adults with type 1 and 2 diabetes. Pfizer
awaits the approval by the FDA in the US as well as approval by the European
Commission.
It is anticipated that once fully launched, Exubera(R) will be a significant
source of revenue growth for Bespak's Device & Manufacturing Services division.
Mark Throdahl, Bespak's Chief Executive, said: "We are delighted by this
recommendation from the CHMP, which moves us closer to European regulatory
approval of this important new treatment for diabetes."
For further information please call:
Bespak plc
Mark Throdahl - Chief Executive +44 (0) 20 1908 552 600
Martin Hopcroft - Group Finance Director
Buchanan Communications +44 (0) 20 7466 5000
Tim Thompson / Mark Court / Mary-Jane Johnson
Notes for Editors:
About Bespak plc
Bespak, a specialty medical devices company, is at the forefront of developing
new delivery systems for the pharmaceutical industry. The company has a product
range covering metered dose inhalers, dry powder devices, actuators and
compliance aids. The company also develops and manufactures drug delivery
devices for leading global pharmaceutical companies. The group, which has
facilities in King's Lynn and Milton Keynes in the UK, is a public company
quoted on the Official list of the London Stock Exchange (LSE: BPK). For more
information, please visit www.bespak.com.
About diabetes
It is estimated that nearly 180 million people worldwide suffer from diabetes,
and the number is expected to rise to 300 million people in the next 20 years.
Currently, diabetes and its complications account for more than $100 billion in
healthcare costs annually in the United States.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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