Sangamo BioSciences gets mention as competitor in Bayer expansion article

Of course we were told the hemophilia program would happen much faster than has actually transpired. As Ed Lanphier says, " in the next 12, 18, 24 months". Who can wait that long while management continues to exercise their very generous options?

The 80,000-square-foot structure on the southern edge of Bayer’s East Bay campus actually is part of a long-range strategy by the subgroup of Germany-based drug giant Bayer AG. That plan has focused on upgrading facilities for research, development, manufacturing and testing so-called Factor VIII replacement products that help hemophilia patients control the bleeding disorder.

Factor VIII is a blood-clotting protein, and about one in every 5,000 boys is born with a defect in a gene that encodes the protein, causing hemophilia A.

Bayer will break ground on the new testing facility this month, said Joerg Heidrich, Bayer’s senior vice president for biotech product supply and site head for Bayer in Berkeley. Construction is expected to be completed in 2017.

The testing building, which will replace an older facility, won’t mean more Bayer jobs at the company's Berkeley campus, but there will be an undisclosed number of construction-related jobs.

What's more, company officials stressed, the project shows Bayer’s commitment to the Bay Area and to developing new products for hemophilia A patients and other people with blood disorders.
“It’s a great story for the Bay Area,” Heidrich said. “The research is done in Mission Bay and the development and manufacturing are done on the Berkeley site.”

In all, Bayer has invested more than a half-billion dollars into its Berkeley facility over the past decade, Heidrich said, including a $100 million manufacturing expansion started in 2009.

Bayer already makes and tests Kogenate FS, a Factor VIII product approved in 2000, at its Berkeley facility. Kogenate was the company's second-best-selling product last year at about $1.1 billion, following the blood thinner Xarelto.

Kogenate FS costs about $1,000 per dose.

But Bayer's two-decade-old Kogenate franchise is getting squeezed by Factor VIII treatments that allow patients to dose less often. What's more, experimental gene therapies, which could fix the genetic defect with a single treatment, are progressing toward in-human studies.

Those competitors include Richmond's Sangamo BioSciences Inc. (NASDAQ: SGMO) and partner Shire plc.

As a result, Bayer has been busy pushing its own next-generation Factor VIII products through the clinical trial process.

"This is really the beginning of a much broader story that starts in factor replacement," said Dr. David Weinreich, Bayer's head of global development, specialty medicine.

Bayer in December filed for Food and Drug Administration approval of its latest experimental hemophila drug, called Kovaltry. A long-acting treatment that could allow hemophilia A patients to be dosed once a week, rather than once every four days or so, also has hurdled a late-stage trial.

Bayer's Berkeley site has made batches of Kovaltry as well as damoctocog — the experimental long-acting drug — for clinical trials.

If Kovaltry is approved by the FDA, which could occur next year, Bayer will make and test commercial batches of it and Kogenate FS in Berkeley. Those products could be shipped to some 80 other countries.

"It's simply a brick-and-mortar thing," Weinreich said about the new testing facility. "When you fill it up, you have to put more bricks and mortar into it."