Novo Nordisk has made an agreement to acquire the US and Canadian rights to Macrilen from Strongbridge Biopharm. The company has also entered into a research collaboration focusing on the discovery of novel treatments for obesity and its associated metabolic pathologies.

Macrilen (macimorelin), an enhancer of growth hormone secretion and the first and only FDA-approved oral product indicated for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare endocrine disorder, was approved by the FDA in December 2017 and FDA has granted Macrilen orphan drug exclusivity in the US. Macrilen was launched in the US in July 2018.

With the acquisition of Macrilen, Novo Nordisk can further leverage its scientific and commercial expertise and commitment to the growth disorders community, it states.

USD 145 million

Novo Nordisk will pay USD 145 million to Strongbridge as well as tiered royalties related to sales of Macrilen. In addition, Strongbridge’s current field organisation will continue to promote Macrilen in the US for up to three-year agreement. Novo Nordisk’s existing biopharm field force will also support the commercialisation of Macrilen.

As part of the partnership with Strongbridge, Novo Nordisk will acquire newly issued Strongbridge shares representing approximately 10% of the outstanding shares of Strongbridge at a share price of USD 7 per share, corresponding to an investment of approximately USD 37 million.

“The acquisition of Macrilen is in line with the strategy for our biopharm business with growth being driven by both organic and bolt-on initiatives. Macrilen is highly complementary to Norditropin and will allow Novo Nordisk to assist physicians and patients in the diagnosis as well as treatment of patients with growth hormone deficiency,” said Jesper Brandgaard, Executive vice president and Head of Biopharm and Legal affairs, Novo Nordisk.

The transaction is expected to close in December 2018 and is subject to US regulatory approval.

Collaboration with Embark Biotech

The research collaboration between Embark Biotech and Novo Nordisk will focus on the discovery of novel treatments for obesity and its associated metabolic pathologies through mechanisms that increase energy expenditure.

The research platform of Embark Biotech, a recent spin-out from Center for Basic Metabolic Research at University of Copenhagen, builds on insights into receptors that stimulate energy expenditure without triggering the sympathetic nervous system (the ‘fight-or-flight’ response). The aim of the collaboration is to develop novel drug candidates that help people with obesity lose weight by burning off excess energy instead of storing it as fat. The potential addition of energy expenditure drugs would make a meaningful difference in the treatment of obesity. The work behind the research platform and the spin-out of Embark Biotech has been supported by Novo Seeds and the Novo Nordisk Foundation since 2016.

Next-generation anti-obesity therapies

As part of the collaboration agreement, Embark will receive research support for activities conducted in the collaboration, and Novo Nordisk has an option to license exclusive worldwide rights to develop and commercialize products discovered in the collaboration.

“We are excited to get started on this project which aims at developing next- generation anti-obesity therapies,” says Marcus Schindler, senior vice president of Global Drug Discovery in Novo Nordisk. “There is a huge unmet medical need for treatment of obesity. While more than 650 million people are currently living with obesity, it is rarely acknowledged, diagnosed or treated as a serious chronic and complex disease. We believe that Novo Nordisk and Embark together have both the capability and capacity to explore this new mechanism of action.”

Photo of Jesper Brandgaard, Executive Vice President, Biopharm and Legal Affairs, Novo Nordisk