Type of information: Licensing agreement
Compound: US and Canadian rights to Macrilen™ (macimorelin)
Company: Novo Nordisk (Denmark) Strongbridge Biopharma (Ireland)
Therapeutic area: Rare diseases - Endocrine diseases - Hormonal diseases
Type agreement: licensing
- hormone-release stimulating peptide. Macimorelin is growth hormone secretagogue receptor agonist. It stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in blood samples over ninety minutes after oral administration of macimorelin for the assessment of growth hormone deficiency.
- This prescription oral test has been granted orphan drug designation in the US, as the first and only FDA-approved oral growth hormone secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency (AGHD), a rare endocrine disorder. In an open-label, randomised, cross-over trial with 154 people, Macrilen™ was shown to diagnose AGHD accurately when comparing the diagnostic agreement between Macrilen™ and the benchmark, Insulin Tolerance Test (ITT).
Disease: adult growth hormone deficiency (AGHD)
- • On October 31, 2018, Strongbridge Biopharma announced that the company has entered into an agreement for Novo Nordisk to acquire the rights to Macrilen™ (macimorelin) in the US and Canada. This acquisition will expand Novo Nordisk's biopharm business. Macrilen™ was launched in the US in July 2018. With the acquisition of Macrilen™, 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.
- 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™. The transaction is expected to close in December 2018 and is subject to US regulatory approval.
- Strongbridge will receive an upfront payment of $145 million from Novo Nordisk for the U.S. and Canadian rights to Macrilen™;
- Strongbridge will receive tiered royalties related to the sales of Macrilen™ through 2027.
- Novo Nordisk will leverage and fund Strongbridge’s rare endocrine commercial field organization for Macrilen™ for up to three years.
- In addition, Novo Nordisk will purchase approximately 5,242,000 ordinary shares of Strongbridge Biopharma plc at a purchase price of $7.00 per share, representing a premium to the most recent market close share price. This investment will result in gross proceeds of $36.7 million to Strongbridge.