Dive Brief:
- Merck KGaA is investing 165 million Swiss francs, or about $166 million, over the next four years to expand its Aubonne, Switzerland site. This will grow its capacity for manufacturing biotech medicines.
- The facility will include new lines for aseptic filling for freeze-dried and liquid injectable formulations, along with new quality control labs. Once the expansion is completed, the Swiss site will be able to produce up to 27 million vials of injectable medicines per year.
- Construction is expected to complete in 2020, with the new quality control labs operational in 2021 and the new lines for aseptic filling up and running in 2023, following validation by regulatory authorities, German Merck stated.
Dive Insight:
Merck KGaA has been laying out extensive expansion plans over the last few months, with 1 billion euros ($1.4 billion) going into its global headquarters in Darmstadt, Germany over the next five years. The company has also said it will invest $70 million into the U.S. R&D hub in Billerica, Massachusetts, covering 145,000 square feet and expected to complete in 2021.
Its latest investment, the manufacturing expansion in Switzerland, focuses on biologics. The site will manufacture older drugs, such as Gonal-f (follitropin alfa) an infertility treatment, to newly-launched products such as Bavencio (avelumab), an immuno-oncology therapy.
Merck has trailed in immuno-oncology, with Bavencio having just two approved indications so far.
German Merck and partner Pfizer have been pushing forward in other indications, but not all of these have been successful. A couple of weeks ago, the collaborators discontinued a second ovarian cancer Phase 3 study, JAVELIN Ovarian PARP 100, after less than a year. Last year, the pharmas pulled JAVELIN Ovarian 200 after a different Phase 3 study failed to reach its primary endpoints.
Bavencio has also struggled in the clinic for other indications. The drug has previously failed late-stage studies in gastric cancer and non-small cell lung cancer.