Sector News

Novo Nordisk plots $1.3B in spending as it expands API production—and advances new oral meds

February 5, 2021
Life sciences

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

comments closed

Related News

October 23, 2021

Novo Nordisk teams with CVS Health on obesity support program ahead of Wegovy DTC launch

Life sciences

As Novo Nordisk gears up to disrupt the obesity market with its newly approved weight-loss drug Wegovy, it is teaming with retail pharmacy giant CVS Health on a new education and nutrition coaching program for people taking anti-obesity meds.

October 23, 2021

GSK-backed Atreca inks license with Gates Medical Research Institute for malaria monoclonal antibody

Life sciences

The terms of the deal were undisclosed, but Atreca received $6 million from the Gates Foundation in 2012 to discover potential treatments for malaria, tuberculosis and HIV. The foundation has also given grant money to other biopharmas exploring malaria treatments, including Exscientia, which secured $4.2 million last year for such work.

October 23, 2021

A record number of biotechs are going public. Here’s how they’re performing.

Life sciences

At the start of the last decade, the IPO markets weren’t receptive to biotech companies. But by 2013, public investment was pouring into the industry, drawn by scientific advances and boosted by the newfound interest of a broader range of investors. Ever since, biotechs and their backers have ridden a multi-year boom. Keep track of them as they happen with this database.

Send this to a friend