While Big Pharma companies have equivocated about whether to pull drug production from the U.K. because of Brexit, CDMO Almac quickly went out and did something about it. It obtained a site in the EU and is now investing about $30 million on upgrades.
Based in Northern Ireland—part of the U.K.—Almac has secured a site 40 minutes away in Dundalk, Ireland, part of the EU. It says EU regulators have recently inspected the site for clinical trial and commercial production.
It now intends to invest £30 million ($41.6 million) to add a quality-control laboratory, commercial drug packaging facility and a 79,000-square-foot EU distribution center for clinical trial supply. It said the expansion will more than triple the manufacturing footprint at the European campus, which it says is slated to be operating by January 2019.
“The announcement today of further expansion will ensure our current and future clients receive a seamless solution with access to the EU marketplace,” Almac CEO Alan Armstrong said in a statement. “Crucially, this will ensure an uninterrupted service provision through any uncertainty Brexit may bring.”
Drugmakers in the EU have been warning of drug supply chaos if the U.K. and European Commission can’t strike a specific deal covering the approval of medicines before their governmental divorce. About 45 million packages of drugs move from the U.K. to the EU each year and 37 million in the other direction, a European Federation of Pharmaceutical Industries and Associations survey found.
GlaxoSmithKline and AstraZeneca, the U.K.’s largest and second-largest drugmakers, have urged the two sides to make sure the pharma issues get resolved ahead of the split but are making contingency plans just in case. AZ’s Pascal Soriot, for example, declared a hiatus on any significant manufacturing investments in the country until there is more light around what the split will mean for pharma.
By Eric Palmer
Source: Fierce Pharma
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy. The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older.
Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm could create a new closed-loop system for largely hands-off diabetes management.
Apnimed started the year by bagging nearly $80 million in extended series C funds and the momentum has kept up, with the sleep-apnea-focused biotech nailing its goals in a phase 2 study. “For those who cannot tolerate current treatments, AD109 has the potential to be a convenient, oral pill that could improve people’s quality of life both at night and during the day.”