| Research Triangle Park, N.C. (January 31,
2003)
Bayer Biological Products (BP) is poised to move forward successfully. Bayer AG announced earlier today that Bayer and Aventis had agreed not to pursue their plans to create a joint venture in the field of biological products. Based upon anticipated growth in product sales, a robust research and development program, and a commitment to the patient communities it serves, Bayer BP will continue to hold a leadership position in the biological products industry.
"Our product pipeline is the deepest in the industry, and demand for our products continues to grow," said Dr. Gunnar Riemann, executive vice president, Bayer Corporation, and president, Bayer BP Division. "Furthermore, Bayer has secured an ample supply of plasma to meet our production requirements and we have several long-term agreements in place with suppliers. We will build on these relationships to ensure continued supply. Most importantly, our commitment to the patients we serve remains unwavering. Our focus will continue to be on providing reliable supplies of the safest possible products."
Dr. Riemann reiterated that three pillars of Bayer BP business will contribute to a successful future: sales growth for current products, research and development, and commitment to the patient communities it serves.
Sales Growth Anticipated in Current Product Portfolio
The company's range of life-saving, blood plasma-derived biological products includes: Gamimune® N 10%/Polyglobin® 10% for the treatment of immune deficiency disorders and Prolastin® for the treatment of congenital emphysema. In addition, it manufactures Kogenate® FS/KOGENATE® Bayer, recombinant Factor VIII product for the treatment of hemophilia A.
"We achieved a significant profitability improvement in 2002. We expect Kogenate to continue its growth in 2003 and beyond, and believe that Prolastin volume will also increase," said Dr. Riemann. "Additionally, Gamimune N sales continue to be healthy and we are anticipating the imminent global launch of our next generation IGIV."
Submitted for regulatory approval under the trade name Gamunex™ in the United States, Canada, and Germany, Bayer BP's next generation immune globulin intravenous (IGIV) product introduces a breakthrough purification process, Caprylate/Chromatography, designed to establish new standards in product purity and supply reliability. Gamunex™ is the first newly developed IGIV product to be submitted to the Food and Drug Administration (FDA) in over a decade and its production process differs significantly from traditional IGIV manufacturing processes that are based on methods first introduced in the 1940s and 50s.
To support the approval for Gamunex™, Bayer BP undertook an unprecedented licensure-relevant clinical trial program, including the largest-ever series of trials involving patients with primary immune deficiency. Of special importance were the powered and comparative (IGIV-C versus Gamimune® N) trials, which are expected to "demonstrate for the first time that different production methods lead to different clinical outcomes," said Dr. Riemann, referring to Bayer's new state-of-the-art manufacturing facility in Clayton, North Carolina.
Research & Development
Products in development consist of several investigational therapies for treating alpha-1 antitrypsin deficiency, including intravenous and inhalation treatments. Other pipeline products include a factor IX gene therapy, several thrombolytic agents, and a treatment for idiopathic thrombocytopenic purpura.
Bayer BP has formed strategic collaborations with numerous companies in support of its research and development efforts. An agreement with Avigen offers the option of exclusive worldwide marketing and distribution rights to Bayer for Avigen"s Coagulin-B™ gene therapy treatment in development for hemophilia B.
Bayer BP and PPL Therapeutics plc are working together to develop a transgenically produced recombinant alpha-1 antitrypsin (recAAT) replacement therapy that offers the potential to greatly increase supply of AAT. An aerosol formulation of recAAT would allow delivery directly to the lungs via a novel inhalation system.
Additionally, Bayer BP has acquired the rights for a promising new organizational tool, a special handheld computer designed to help people with hemophilia maintain product information, track and report home treatments, access educational materials, and communicate with health care providers.
"Through our own innovative research and our numerous strategic partnerships, we have the deepest pipeline of products
in the biological products industry," said Mike Fournel, senior vice president, research & development, for the Biological Products Division. "We are excited about our ability to continue to innovate and to deliver safe and reliable products to our patient communities."
Commitment to Patient Communities
As a global leader in biological products, Bayer BP demonstrates its global corporate citizenship by taking an active role to support community infrastructure and enhance the quality of life for the patient communities it serves. Through its contributions of financial and human resources, Bayer BP has created a variety of novel and education programs, including: Parents Empowering Parents, a grassroots training program for families of children with hemophilia; a three-year grant to Johns Hopkins Hospital Children's Center to create an Immune Deficiency Foundation Center for Primary Immunodeficiencies; sponsorship programs for local and regional Hemophilia Summer Camps; grants supporting programs and services provided by the Alpha One Foundation; financial support of the National Hemophilia Foundation's It’s Time for a Cure research campaign to find a cure for hemophilia, and the Bayer Hemophilia Awards Program in support of research and patient and professional advocacy education.
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 material
differences between the actual future results, financial situation, development or performance of the company, and the estimates given
here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities
and Exchange Commission (including our Form 20-F).
The company assumes no liability whatsoever to update these forward-looking statements
or to conform them to future events or developments.
About Bayer
Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of health care, crop protection, polymer,
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 2001,
and is one of Fortune magazine's Most Admired Companies. The company employs 21,500 people. It is a member of the worldwide Bayer Group, a
$27 billion international health care and chemicals group based in Leverkusen, Germany. The Bayer Group stock is a component of the DAX
and is listed on the New York Stock Exchange (ticker symbol: BAY).
Contact:
Tricia McKernan
Bayer Biological Products
+1-(0)919/316-6316
E-mail: tricia.mckernan.b@bayer.com
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