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Product Update at PPL Therapeutics on AAT and Fibrin 1 May 18, 2002
Recombinant Alpha-1-Antiptrypsin (RecAAT) On 5 December 2001, PPL Therapeutics plc (PPL) indicated that Bayer and PPL had delayed the start of their Phase III clinical trial evaluating PPL’s transgenically produced recombinant alpha-1-antitrypsin (recAAT) for the treatment of alpha-1-antitrypsin deficiency (hereditary emphysema). The delay provided time for PPL and its partner in the development of this product, Bayer Biological Products (Bayer BP), to conduct additional analyses of Phase II study data focussing on subjects who did not complete the trial. Today the two companies announce a further delay to the start of the Phase III trials as follows: PPL Therapeutics and Bayer Announce Delay of Phase III AAT Trial 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: Geoff Cook, CEO of PPL, said: 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. Forward-Looking Statements
Fibrin Sealant PPL’s single component fibrin sealant, Fibrin I, which is used to arrest bleeding and seal wounds, offers a number of advantages over existing fibrin sealants including ease of use, its ability to reduce the severity and incidence of post-surgical adhesions and simplicity of manufacturing. PPL is developing this product from human plasma in the first instance as this offers the fastest route to market. A transgenically derived product will be developed as a second generation product. The plasma derived product has undergone a successful evaluation programme including process development, formulation and pre-clinical proof-of-concept testing. Currently, PPL is partnered with Smith & Nephew for certain indications and is in discussions with a number of other companies for further indications. A recent EU directive, which comes into force in June 2002, will allow, PPL believes, Fibrin I to be developed as a device rather than as a medicine. This should significantly reduce the regulatory risk and simplify clinical trials. It is expected to gain product approval in 2005 and PPL is working with the appropriate bodies to get this underway as quickly as possible. The current market for surgical sealants, which includes fibrin sealants as well as other tissue sealant technologies, is estimated to be close to $300 million and is expected to grow to greater than $600 million in the next 5 years. In addition, with its anti-adhesive properties, Fibrin I has the potential to capture a significant portion of the $600 million market for stand-alone anti-adhesives. Contract Manufacturing Opportunities Financial Implications to PPL of the above: About Bayer 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) For more information contact: Financial PR Enquiries: Notes to Editors:
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