Novo Nordisk expands its biopharm business with the acquisition of the US and Canadian rights to Macrilen (TM)

Novo Nordisk announced the expansion of its biopharm business with an agreement to acquire the US and Canadian rights to Macrilen(TM) (macimorelin), the first and only FDA-approved oral growth hormone receptor indicated for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare endocrine disorder, from Strongbridge Biopharma Plc.

Diagnosis of growth hormone deficiency is time consuming and a considerable burden for both patients and health care providers. By enabling a fast and deeper roll out of Macrilen(TM), Novo Nordisk can address a significant unmet medical need. Macrilen(TM) was approved by the US Food and Drug Administration (FDA) in December 2017 and FDA has granted Macrilen(TM) orphan drug exclusivity in the US. Macrilen(TM) was launched in the US in July 2018. With the acquisition of Macrilen(TM), Novo Nordisk can further leverage its long-standing scientific and commercial expertise and commitment to the growth disorders community. As a partner to the endocrinology community Novo Nordisk is committed to raising awareness of growth disorders and advancing patient care.

Novo Nordisk will pay USD 145 million to Strongbridge as well as tiered royalties related to sales of Macrilen(TM). In addition, Strongbridge’s current field organisation will continue to promote Macrilen(TM) in the US for up to three-year agreement. Novo Nordisk’s existing biopharm field force will also support the commercialisation of Macrilen(TM). 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(TM) is in line with the strategy for our biopharm business with growth being driven by both organic and bolt-on initiatives. Macrilen(TM) 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.

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