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Bayer Expands Hemophilia Portfolio
Phase 1 clinical testing expected to commence in third quarter of 2008 / Transaction includes license to Maxygen's novel biotechnology research platform
Leverkusen / Redwood City, California, USA, July 2, 2008 - Bayer HealthCare is
expanding its commitment to hemophilia with the acquisition of Maxygen's
hemophilia program assets, including a next-generation recombinant Factor VIIa
protein known as MAXY-VII. The lead therapeutic candidate is expected to enter
Phase 1 clinical testing in the third quarter of 2008. The total transaction is
valued at US-Dollar 90 million upfront with a final, potential milestone
payment of US-Dollar 30 million. This agreement includes a license to use
Maxygen's MolecularBreedingTM technology, a novel research platform, for
exploiting gene targets.
Hemophilia is an inherited bleeding disorder caused by deficient or defective
blood coagulation proteins. Roughly 20 to 30 percent of patients with
hemophilia develop antibodies - or inhibitors - to current therapies. In these
instances a Factor VIIa is used to bypass inhibitors and help these individuals
to form clots. MAXY-VII is a next generation Factor VIIa clotting factor that
may offer an improved dosing regimen and safety profile. The addition of a
development candidate for patients with clotting factor inhibitors could
further build Bayer's leadership position in hemophilia care where it offers
the recombinant Factor VIII product, Kogenate® (antihemophilic factor
[recombinant]). The company has a strong development program dedicated to
hemophilia including ongoing clinical investigations into long-acting forms of
Kogenate.
"MAXY-VII has the potential to be an important expansion of therapeutic options
for people living with hemophilia and we are pleased to add this to our global
development portfolio. The agreement fits into our growth strategy for our
specialty pharmaceutical business and builds on our expertise in the
commercialization and manufacturing of protein therapeutics," said Dr. Gunnar
Riemann, member of the Executive Committee of Bayer HealthCare. "Our scientists
are actively collaborating with researchers in academia and biotechnology firms
to leverage novel research platforms. Access to Maxygen's MolecularBreedingTM
technology provides us with another tool to expand our product pipeline."
"This agreement allows Maxygen to capture significant value from this
preclinical asset, and puts MAXY-VII in the hands of the hemophilia leader,"
said Russell Howard, chief executive officer of Maxygen. "MAXY-VII has the
potential to become the world's first approved shuffled protein therapeutic, a
milestone that is likely to open up many more opportunities for Maxygen's
technology. Bayer is the ideal company to move the MAXY-VII program toward that
goal."
Bayer also receives a non-exclusive license to use Maxygen's MolecularBreedingTM
technology for a broad set of genes for its internal use in its specialty
pharmaceutical business. In addition, Bayer receives exclusive rights to use
the technology for 30 specified gene targets in areas of strategic business
interest. This novel platform allows scientists to exploit gene variation that
can result in unique drug targets or novel therapeutic protein candidates.
About MAXY-VII and Hemophilia
MAXY-VII is designed to be an improved Factor VIIa for the treatment of
hemophilia patients. Hemophilia is an inherited bleeding disorder characterized
by prolonged or spontaneous bleeding, especially into the muscles, joints or
internal organs. The disease is caused by deficient or defective blood
coagulation proteins, known as factor VIII or IX. The most common form of the
disease is hemophilia A, or classic hemophilia, in which the clotting factor
VIII is either deficient or defective. Hemophilia B is characterized by
deficient or defective factor IX. According to the World Federation of
Hemophilia, about 1 in 10,000 people is born with hemophilia A and 1 in 50,000
people is born with hemophilia B. At some point in time, roughly 20 to 30
percent of patients develop antibodies to these replacement factors (frequently
referred to as inhibitors).
About the MolecularBreedingTM Directed Evolution Platform
MolecularBreeding, also known as gene shuffling, is an iterative process of
recombination and selection. The products of these recombined genes (proteins)
are then screened for the targeted drug properties. This novel platform allows
scientists to exploit gene variation that can result in unique drug targets or
novel therapeutic protein candidates.
About Kogenate® FS/KOGENATE® Bayer
Kogenate®FS (Antihemophilic Factor [Recombinant]) / KOGENATE® Bayer
(Recombinant Coagulation Factor VIII [octocog alfa]) is a recombinant factor
VIII treatment indicated for the treatment of hemophilia A. The safety,
efficacy and overall reliability of the Kogenate line of products are based on
20 years of clinical experience. Clinical data shows that Kogenate provided
excellent hemostatic control, was well tolerated, and has a proven safety
profile in patients with hemophilia A. Kogenate is manufactured at Bayer's
state-of-the-art biotechnology facility in Berkeley, California. The most
frequently reported adverse events were local injection site reactions,
dizziness and rash. Known intolerance or allergic reactions to constituents of
the preparation is a contraindication to the use of Kogenate. Known
hypersensitivity to mouse or hamster protein may be a contraindication to the
use of Kogenate.
About Maxygen, Inc.
Maxygen is a biopharmaceutical company focused on developing improved versions
of protein drugs. Maxygen looks for opportunities where its proprietary protein
modification technologies can address significant therapeutic needs. Maxygen's
approach to drug discovery and development leverages the established
development and regulatory paths of approved drugs. Find more information at
www.maxygen.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
