It’s been a good week for Grifols. Alongside the christening of a new manufacturing plant in Dublin Wednesday, the Spanish plasma specialist received a thumbs-up on its Rigel-partnered platelet disorder drug from a nearby cost watchdog in the U.K.
On the manufacturing front, Grifols' new factory will focus on purification and filling of the plasma protein albumin. The 183,000-square-foot site joins Grifols' existing Grange Castle manufacturing and supply hub just outside the Irish capital. Specifically, the upgrade triples filling capacity for Grifols' flexible container Albutein FlexBag, which the company pitches as a more convenient alternative to vials for storing and shipping albumin, as well as administering the therapy to patients.
Albumin is the most abundant protein found in plasma. It’s used to replace lost fluids, restore vital blood volume and treat diseases such as cirrhosis, Grifols explained in a release. Whether the protein is packaged in bags or vials, Grifols expects global albumin demand to spike roughly 5% each year over the next five years.
Grifols says it’s infused nearly 300 million euros ($293.3 million) into its Irish operations since it first set up shop there back in 2012. The company currently employs more than 300 workers at its Dublin site, and it expects to add another 200 heads or so “over the next couple of years,” according to the company’s release.
Dublin forms Grifols' fifth production site for essential plasma medicines, the company said. It also operates plants in Barcelona, Spain, and the U.S. The company has manufacturing sites in the works in Canada and Egypt, too, which are expected to come online in 2024 and 2025, respectively.
Crossing the Irish Sea, meanwhile, Britain’s National Institute for Health and Care Excellence has recommended Grifols and Rigel Pharmaceuticals’ fostamatinib for adults with chronic immune thrombocytopenia (ITP). The blessing specifically covers Grifols' spleen tyrosine kinase inhibitor in patients who haven’t responded to previous treatments.
The U.K. marks the latest leg of fostamatinib’s phased launch in Europe, where the drug goes by the name Tavlesse. In the U.S., where fostamatinib recently had an ill-fated run in the clinic for COVID-19, the autoimmune disease drug is approved in ITP as Tavalisse.
Chronic immune thrombocytopenia is a rare autoimmune disease that causes the body’s immune system to mistakenly attack platelets in the blood. Grifols touts Tavlesse as “the only targeted agent that works by protecting platelets from destruction.”
Outside the U.K., Tavlesse has already made its way to Czech, French, German, Italian, Norwegian and Spanish markets, Grifols said. The drug has also scored the backing of the Scottish Medicines Consortium.
Under a deal first struck with Rigel in 2019, Grifols has exclusive rights to fostamatinib in Europe and Turkey.
Rigel, for its part, gets stepped royalties from Grifols' territories and holds the rights to fostamatinib in certain regions outside Grifols' purview, such as the U.S.
As part of the original agreement, Grifols furnished Rigel with $30 million in upfront cash. Rigel was also in line to receive upward of $297.5 million in regulatory and commercial milestones, including a $20 million payout after the drug received its green light from the European Medicines Agency, the companies said back in 2019.