| • | | Presentation of MPOWERED Phase 3 Data at Medical Conferences and Publication in a Peer Reviewed Medical Journal. Chiasma expects to present MPOWERED Phase 3 data analyses at upcoming endocrinology scientific meetings in spring and in fall 2021 and submit the results of the MPOWERED trial to a peer-reviewed journal for expected publication in 2021. |
| • | | 2021 Financial Guidance. Operating expense for the full year 2021 is expected to be in a range of $80 million to $90 million, including estimated stock-based compensation expense in a range of $5 million to $6 million. This guidance is based on the company’s current U.S. commercial plans and excludes expenditure for potential EU launch preparations of MYCAPSSA and potential additional new product development programs. |
2021 LifeSci Advisors Corporate Access Event
Chiasma management will be available to meet with institutional investors and analysts virtually at the 2021 LifeSci Advisors Corporate Access Event on January 7-8 and 11-14.
About MYCAPSSA
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
CONTRAINDICATIONS
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
ADVERSE REACTIONS
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
DRUG INTERACTIONS
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.