Chiasma Provides Corporate Update and Previews Expected 2021 Milestones

MYCAPSSA launch in US continuing to gain traction with physicians, patients, and payers

MYCAPSSA EMA submission for EU marketing approval on track for mid-2021 following positive results of MPOWERED Phase 3 clinical trial

NEEDHAM, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA as the first oral therapy for the treatment of acromegaly, today reviewed its 2020 accomplishments and previewed its anticipated 2021 corporate milestones.

2020 Key Highlights:

• MYCAPSSA Approved in the U.S. as the first and only oral somatostatin analog (SSA) for the long-term maintenance treatment of patients with acromegaly who responded to and tolerated treatment with octreotide or lanreotide.
  • Approval was based on the positive CHIASMA OPTIMAL Phase 3 trial results which were published in the Journal of Clinical Endocrinology & Metabolism and presented at the 2020 Endocrine Society Annual Meeting (ENDO) along with six other scientific posters relevant to MYCAPSSA.

• Commercial Launch of MYCAPSSA in the U.S. Late in the third quarter of 2020, Chiasma commenced the initial phase of the MYCAPSSA U.S. commercial launch with a focused salesforce calling on approximately one-third of key prescribing accounts. Chiasma progressed to the second phase of the launch at the beginning of 2021 with an expanded salesforce hired during the fourth quarter of 2020. Progression to the final phase of the launch with a full-strength salesforce is expected after market conditions improve beyond the COVID era.
  
  
• Early launch insights and progress:
  
  
  • Coverage of MYCAPSSA by multiple payers insuring approximately 150 million lives provides a solid foundation for MYCAPSSA uptake in 2021.
  • Positive and encouraging feedback on MYCAPSSA from endocrinologists and patients supports the company’s goal of ultimately becoming the standard of pharmacological care in acromegaly.
  • Preliminary (unaudited) net revenues for 2020 are expected to be between $0.9 and $1.1 million.  

• Reported Positive Data from CHIASMA OPTIMAL Open Label Extension. The efficacy and safety (tolerability) seen in the 1-year extension phase of the study (48 weeks) was similar to that seen in the 36-week core study period. The mean of the insulin-like growth factor 1 (IGF-1) levels for the population of all MYCAPSSA treated patients that completed the 36-week core CHIASMA OPTIMAL trial and continued into the open-label extension (OLE) (n=19) was maintained within normal limits at the end of the 48-week OLE period.