Novo Nordisk is off and running with its launch for oral semaglutide, a Type 2 diabetes med carrying blockbuster expectations. But the company also sees potential new uses for its oral delivery platform, and it’s bolstering its manufacturing network to support its forays in that direction.
The Danish drugmaker said Wednesday it expects to spend around 8 billion Danish kroner ($1.3 billion) on capital projects in 2021 as it gears up to add capacity for active pharmaceutical ingredients. That spending will help advance its oral drug delivery work, Chief Financial Officer Karsten Munk Knudsen said on a conference call with analysts.
The capital spending boost, up from around 6 billion Danish kroner ($1 billion) historically, is based on “positive pipeline progression,” Knudsen said on the call, noting that the drugmaker is gearing up for a high-dose oral semaglutide trial.
The trial is “high priority” because the company wants “to be out in the marketplace with the high efficacy oral biologic, whatever the dose becomes, that is superior to what we could expect to see from competition,” Novo’s departing chief scientific officer Mads Krogsgaard Thomsen said on the call.
Aside from the high-dose oral semaglutide trial in diabetes, the company is also planning a phase 3 study of the drug in Alzheimer’s disease. In all, the “reason why we are upgrading our capacity is basically to meet the potential demand on some of these pipeline projects and also potential pipeline projects on the same platform, which are not publicly disclosed at this point in time,” Thomsen said.
The capital spending boost comes as Novo wraps up a major expansion in the U.S. In 2016, the company laid out a plan for a $2 billion API site in Clayton, North Carolina, for oral semaglutide and other medicines. The facility, which was expected to employ 700 people, is an expansion to an existing Novo plant there.
On Wednesday’s call, Knudsen said the North Carolina project is in the “final phases” before Novo submits the site to the FDA for review. Construction companies have mostly left the site, he said, and quality approvals are pending before the first stages of production can start.
Aside from that project, Novo in 2019 purchased a pill plant in Treyburn, North Carolina, from beleaguered Purdue Pharma. A Novo spokesman said at the time the company “wanted to establish tablet production capacity in the U.S. in order to build a domestic supply chain for oral semaglutide and future oral medicines.” The location made sense considering its proximity to Clayton, he added.
Of course, since Novo announced those supply chain moves, the company has scored a U.S. approval for oral semaglutide, now known as Rybelsus. The company’s launch has come amid the COVID-19 pandemic, but, in 2020, the med’s sales grew to $300 million. Novo has so far negotiated around 90% market access, and around 80% of prescriptions for the medicine are new to the GLP-1 class, execs said on Wednesday’s call.
by Eric Sagonowsky
Source: fiercepharma.com
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