- Bayer intends to lay off hundreds of employees at a California manufacturing plant as part of a restructuring effort aimed at better positioning the German drugmaker's hemophilia business.
- The August approval of recombinant factor VIII therapy Jivi brought Bayer's roster of marketed hemophilia treatments to three. Yet that portfolio is putting pressure on Bayer to make manufacturing more efficient.
- "Our transition into commercial production with three products has resulted in the need for organizational changes to enable these efficiencies, and today we notified 227 employees that their positions were being eliminated as part of this reorganization," a company spokesperson said in an emailed statement to BioPharma Dive.
The layoffs, first reported by San Francisco news station KRON4, come as Bayer faces several threats within the hemophilia treatment landscape.
Its two other recombinant factor VIII therapies on the market, Kogenate and Kovaltry, suffered in recent quarters due to a planned termination agreement with a distribution partner. From January through June, the drugs brought in 427 million euros ($517 million), down 20% from the same period a year prior.
External challenges are present too. Though Jivi should help prop up Bayer's sales, it will still have a tough time keeping up with the disruptive potential of Roche's Hemlibra (emicizumab).
Roche late last year secured Food and Drug Administration approval for Hemlibra in hemophilia A patients with inhibitors, and expects to hear back on Oct. 4 whether regulators will permit it to be used for the rest of the hemophilia A population. Hemlibra's once-weekly administration also gives it a dosing advantage over almost all other treatments in the therapeutic class.
Bayer seems to believe Jivi's dosing schedule, which initially starts at twice a week but can later be extended to once-every five days (or even less frequent), has what it takes to compete in the hemophilia A market.
And at a higher level, Bayer execs mentioned on a recent earnings call that they foresee growth for all three of the company's hemophilia brands.
Wednesday's news, however, underscores that growing pains will be part of the process.
"The manufacturing processes for these products must also be robust and efficient to ensure product safety, reliable supply, and to remain competitive in support of new therapies that position the long term viability of the site," the Bayer spokesperson wrote in the email to BioPharma Dive.
Correction: A previous version of this article mistakenly stated Hemlibra won approval last year for hemophilia A patients without inhibitors.