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PPL
Therapeutics and Bayer Announce Delay of Phase III AAT Trial
Edinburgh, Scotland
March 18, 2002
PPL Therapeutics and Bayer
Corporation, Biological Products Business Group, (Bayer Biological Products)
today announced a further delay of the start of the Phase III clinical trials of
PPL’s transgenically produced recombinant alpha-1 antitrypsin (recAAT) for the
treatment of alpha-1 antitrypsin deficiency (hereditary emphysema).
In 2001, a Phase II study was conducted to confirm the safety and tolerability
of an increased recAAT concentration administered via a new inhalation device.
After reviewing the preliminary data from the Phase II study, the FDA suggested
that further analysis be conducted in order to understand why a small number of
Phase II subjects did not complete the study. Analyses conducted over the past
few months were unfortunately inconclusive. As a result the companies have
decided to investigate possible factors that might have caused these subjects
not to complete the study. These include route of administration, dose, purity
and formulation related issues.
Commencement of the Phase III trial will await the completion of this work. The
companies expect this development to delay regulatory approval of recAAT until
2007. However, both companies are actively exploring approaches to shortening
the clinical development plan that could expedite the launch of the product.
Dr. Gunnar Riemann, Global Head of Bayer Biological Products, said, "Bayer
remains committed to recAAT, and its potential to greatly increase product
supply. Bayer’s long-standing commitment to this collaboration and to persons
with alpha-1 antitrypsin deficiency remains unwavering; we will continue our
efforts to provide safe and effective treatments to the alpha-1 community."
Geoff Cook, CEO of PPL, said, "PPL is disappointed to have to delay the
pivotal trial for this potentially break-through product that could improve the
lives of patients with alpha-1 antitrypsin deficiency. We are fully committed to
this project, and remain confident that we can meet these challenges."
RecAAT offers the potential to greatly increase AAT supply because it is not
dependent on the availability of human plasma. In addition, an aerosol
formulation of recAAT would allow delivery directly to the lungs via an
inhalation system intended to improve patient convenience and, thus, compliance.
About Bayer
In August 2000, Bayer Biological Products and PPL signed an agreement to develop
and market an aerosol formulation of recAAT. Under the agreement, Bayer is
responsible for clinical development and marketing. PPL is responsible for
exclusive product manufacturing.
Prolastin®, Alpha-1 Proteinase Inhibitor (Human), is currently the only product
available for the treatment of alpha-1 antitrypsin deficiency and is
manufactured by Bayer Biological Products. Company officials are eager to bring
the next generation of safe and effective treatments for this deficiency to
market. Complete prescribing information for Prolastin®, Alpha-1 Proteinase
Inhibitor (Human) is available at www.bayerdirect.com.
Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a
broad range of health care, life sciences, and chemical products that help
diagnose and treat diseases, purify water, preserve local landmarks, protect
crops, advance automobile safety and durability, and improve people’s lives.
Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in
2000 and is one of Fortune magazine’s Most Admired Companies. The company
employs 23,200 people. It is a member of the worldwide Bayer Group, a $29
billion international health care and chemicals group based in Leverkusen,
Germany.
The Bayer Group (BAYG.DE) stock is a component of the DAX, and is listed on
multiple foreign exchanges including the NYSE (BAY)
About PPL Therapeutics
1. PPL Therapeutics is a biopharmaceutical company, which is one of the
world’s leaders in the application of transgenic animal technologies to the
development and production of human proteins for therapeutic and nutritional
applications.
2. PPL’s patented transgenic production of human proteins involves the
introduction of copies of human DNA into the genetic material of another
species. The resulting transgenic animals express the human gene product
(protein) in the mammary gland allowing its collection and purification during
lactation. The technique, which offers the opportunity to produce human proteins
economically and in potentially unlimited quantities, is based on patented
technology developed by the Roslin Institute in the 1980s for which PPL holds an
exclusive licence.
3. PPL’s three lead products are AAT, fibrinogen, and bile salt stimulated
lipase (BSSL).
4. PPL is the only company to offer a wide range of animals for transgenic
protein production, including sheep, cows, rabbits, and pigs.
5. Further information on PPL, its products, and technologies can be found at: www.ppl-therapeutics.com
.
Forward-Looking Statements
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to substantial
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. The company assumes
no liability whatsoever to update these forward-looking statements or to conform
them to future events or developments.
Contact:
Geoff Cook, CEO
PPL Therapeutics plc
Telephone: +44 (0)131 440 4777
Tricia McKernan
Manager, Public Policy & Communications
Bayer Corporation
Telephone: +1 919-316-6349
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