Stop the bleeding

LEVERKUSEN, Germany—In a deal worth up to $120 million, Bayer HealthCare last month acquired the hemophilia program assets of Maxygen Inc., a biopharmaceutical company focused on developing improved versions of protein drugs, as well as a license to use Maxygen's MolecularBreeding technology, a novel research platform for exploiting gene targets.

According to Bayer, the acquisition will expand its commitment to hemophilia by adding MAXY-VII, Maxygen's lead therapeutic candidate for the treatment of hemophilia, to its portfolio. The deal includes a license to use Maxygen's MolecularBreeding technology for a broad set of genes in Bayer's specialty pharmaceutical business. In addition, Bayer receives exclusive rights to use the technology for 30 specified gene targets in areas of strategic business interest. The total transaction is valued at $90 million upfront with a final, potential milestone payment of $30 million.

Mike Mathews, head of global strategic marketing for Bayer's hematology business, says MAXY-VII, a next-generation recombinant Factor VIIa protein that is expected to enter Phase I clinical testing in the third quarter of this year, has significant market potential. Roughly 20 percent to 30 percent of patients with hemophilia develop antibodies to current therapies. In these instances, a Factor VIIa is used to bypass inhibitors and help hemophiliacs to form clots.

"Today, the Factor VIIa market is estimated at about $1 billion," Mathews says. "Developing a product that has the potential to be superior to current offerings may provide patients with a better choice. We're excited to bring this product candidate into our hemophilia portfolio."

Bayer will not be the first pharma to house MAXY-VII in its portfolio. Previously, Maxygen co-developed the candidate with Roche Holding AG for the off-label treatment of acute bleeding conditions associated with blunt trauma. But in early 2007, when the parties could not establish an animal model intended to provide preclinical de-risking of the program, Roche gave it back to Maxygen.

"Roche did add a lot of value to the program, but we turned on a dime and took a drug that had been developed for acute, off-label indications and went back to its original label indication for hemophilia," says Maxygen CEO Russell Howard. "Bayer knows this territory very well, and the deal we have consummated will be the best one for hemophiliacs."

Howard says Bayer's resources will help Maxygen overcome some of MAXY-VII's current deficiencies, namely its expense.

"There is clear competition in this market, but the hemophilia population doesn't use drugs like this as much as they could or should because of financial concerns," Howard says. "Novo Nordisk sells one vial of its NovoSeven Coagulation Factor VIIa for $10,000, and the average hemophilia patient may need two to four of those doses per episode. The possibility of expanding and marketing this drug is so expensive, especially in the United States, where healthcare is not uniform. We're hoping Bayer will be able to expand this drug to give better coverage to people with this disease."

Mathews adds that Maxygen's Molecular Breeding technology provides Bayer with a larger library of novel variants in which to discover protein therapeutics, increasing Bayer's chances of discovering highly optimized, best-in-class molecules.

"Taking the example of MAXY-VII, it is possible that an improved version of FVIIa could have been derived using classical protein engineering techniques, but by creating all possible combinations of variants in this key region of FVIIa, the shuffling technology led to the identification of what we believe is the most highly optimized variant. This was done in a timeframe that would not have been feasible with the standard technologies," Mathews says. DDN