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 $145 Million and Tiered Royalty Stream from Novo Nordisk ~

~ Novo Nordisk to Purchase Approximately 5.2 Million Ordinary Shares of Strongbridge Biopharma plc at Purchase Price of $7.00 per Share, Resulting in Gross Proceeds of $36.7 Million ~

~ Strongbridge’s Current MACRILEN Field Organization will Continue to Promote the Product in the U.S. Under a Three-Year Agreement with Novo Nordisk ~

~ Strongbridge to Host Conference Call Today at 9:15 a.m. ET to Discuss the Transaction Details and Third Quarter Financial Results and Corporate Highlights ~

DUBLIN, Ireland and TREVOSE, PA, USA I October 31, 2018 I Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the Company has entered into an agreement for Novo Nordisk to acquire the rights to MACRILEN™ (macimorelin) in the United States (U.S.) and Canada. MACRILEN is the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD).

“We are proud to enter into this MACRILEN agreement with Novo Nordisk, a global leader in endocrinology, as it aligns with our strategic objective to maximize the potential of MACRILEN while we continue to prepare for the potential regulatory approval of RECORLEV™ (levoketoconazole),” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “The upfront payment and equity investment from Novo Nordisk will significantly strengthen the Company’s overall financial position and marks a tremendous step forward in Strongbridge’s continued evolution as a company dedicated to rare diseases,” Pauls added.

Terms of the agreement include that:

  • 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; and
  • 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.

These transactions are expected to close in December 2018. MTS Securities, LLC served as Strongbridge’s transaction advisor.

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

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 Cushing's syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation.  Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The Company’s rare neuromuscular franchise includes KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.

1. Monson JP, Brooke AM, Akker S. Adult growth hormone deficiency. In: De Groot L, Chrousos G, Dungan K, et al (eds). Endotext [online]. South Dartmouth, MA; MDText.com, Inc: 2000. https://www.ncbi.nlm.nih.gov/books/NBK278982/. Accessed January 16, 2018.
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 January 15, 2018.
4. Fukuda I, Hizuka N, Muraoka T, Ichihara A. Neurol Med Chir (Tokyo). 2014;54(8):599-605.

SOURCE: Strongbridge Biopharma

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