Bayer HealthCare is expanding its commitment to haemophilia with the acquisition of Maxygen's haemophilia programme 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.

According to a Bayer press release, 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 MolecularBreeding technology, a novel research platform, for exploiting gene targets.

Haemophilia is an inherited bleeding disorder caused by deficient or defective blood coagulation proteins. Roughly 20 to 30 percent of patients with haemophilia 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 haemophilia care where it offers the recombinant Factor VIII product, Kogenate (antihaemophilic factor [recombinant]). The company has a strong development program dedicated to haemophilia 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 haemophilia 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 MolecularBreeding 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 haemophilia 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 MolecularBreeding 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.

MAXY-VII is designed to be an improved Factor VIIa for the treatment of haemophilia patients. Haemophilia 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 haemophilia A, or classic haemophilia, in which the clotting factor VIII is either deficient or defective. Haemophilia B is characterized by deficient or defective factor IX. According to the World Federation of Haemophilia, about 1 in 10,000 people is born with haemophilia A and 1 in 50,000 people is born with haemophilia B. At some point in time, roughly 20 to 30 percent of patients develop antibodies to these replacement factors (frequently referred to as inhibitors).

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.