Strongbridge Biopharma plc Enters into Agreement for Novo Nordisk to Acquire the U.S. and Canadian Rights to MACRILEN™ (macimorelin)
~ Strongbridge to Receive Upfront Payment of
~ Strongbridge’s Current MACRILEN™
~ Strongbridge to Host Conference Call Today at
“We are proud to enter into this MACRILEN agreement with
Terms of the agreement include that:
- Strongbridge will receive an upfront payment of
$145 millionfrom Novo Nordiskfor the U.S. and Canadian rights to MACRILEN;
- Strongbridge will receive tiered royalties related to the sales of MACRILEN through 2027; and
Novo Nordiskwill leverage and fund Strongbridge’s rare endocrine commercial field organization for MACRILEN for up to three years.
These transactions are expected to close in
Conference Call Details
Strongbridge will host a conference call on Wednesday, October 31 at 9:15 a.m. ET. To access the live call, dial 844-285-7153 (domestic) or 478-219-0180 (international) with conference ID 9775249. The conference call will also be audio webcast from the Company’s website at www.strongbridgebio.com under the “Investor/Webcasts and Presentations” section. A replay of the call will be made available for one week following the conference call. To hear a replay of the call, dial 855-859-2056 (domestic) or 404-537-3406 (international) with conference ID 9775249.
About Adult Growth Hormone Deficiency (AGHD)
AGHD is a rare disorder associated with increased morbidity and mortality1,2 There are more than 50,000 adults with a growth hormone (GH) deficiency diagnosis in the U.S.1 People who have AGHD can include those who were GH deficient as children and become adults with AGHD, or adults who become GH deficient. In adults, GH deficiency can develop when the pituitary gland or hypothalamus is damaged due, for example, to tumors, surgery, radiation or traumatic brain injury (TBI).3 If left undiagnosed, AGHD may lead to increased risk for premature mortality, significant morbidities, including an increase in body fat, increased rate of fractures, a decrease in muscle mass, dyslipidemia, weakness and fatigue, cardiovascular disease, osteoporosis, and impaired psychological well-being such as isolation, anxiety, or depression.1,3 Except in the presence of multiple other pityitary hormone deficiencies, AGHD cannot be diagnosed by routine blood or other tests; growth hormone stimulation testing is required to diagnose AGHD.4
Important Safety Information
What is MACRILEN™?
MACRILEN (pronounced ma-kri-len) (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).
What should you know about MACRILEN?
- Taking MACRILEN with certain other medications may cause irregular changes to your heart rhythm. Before taking MACRILEN, tell your healthcare provider about all your medications, as you may need to temporarily stop taking some medications before you take MACRILEN.
- Some medications may cause a false positive result when taken with MACRILEN. Before taking MACRILEN, tell your healthcare provider about all the medications you take, including growth hormone.
- Tell your healthcare provider if you were recently diagnosed with hypothalamic disease, as this can cause a false negative result with MACRILEN.
- You will need to fast (go without food) for at least 8 hours before taking MACRILEN.
What are the most common side effects with MACRILEN?
The most common side effects in 3%-5% of patients were changed sense of taste, dizziness, headache, fatigue, nausea, and hunger.
These are not all of the possible side effects of MACRILEN. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the
Please see Full Prescribing Information.
About Strongbridge Biopharma
Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge's rare endocrine franchise includes RECORLEV™ (levoketoconazole), a cortisol synthesis inhibitor currently being studied in Phase 3 clinical studies for the treatment of endogenous
This press release contains forward-looking statements within the meaning of the federal securities laws. The words "anticipate," "estimate," "expect," "intend," "may," "plan," "potential," "project," "target," "will," "would," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to the potential regulatory approval of RECORLEV, Strongbridge's strategy, plans, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients. Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K for the year ended December 31, 2017 and subsequent filings with the SEC. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.
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1. Monson JP, Brooke AM, Akker S. Adult growth hormone deficiency. In: De Groot L, Chrousos G, Dungan K, et al (eds). Endotext [online].
2. Gupta V. Adult growth hormone deficiency. Indian J Endocrinol Metab. 2011;15(Suppl 3):S197-S202.
3. Bujanova J, Cummings MH. Drug review: Management of growth hormone deficiency in adults. Prescriber. 2015. http://onlinelibrary.wiley.com/doi/10.1002/psb.1422/pdf. Accessed
4. Fukuda I, Hizuka N, Muraoka T, Ichihara A. Neurol Med Chir (
Source: Strongbridge Biopharma plc