NEEDHAM, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical firm using its supply platform expertise to develop and commercialize oral therapies to enhance the lives of sufferers with uncommon illnesses at present handled with burdensome and painful injections, as evidenced by its current phased launch of MYCAPSSA® as the primary oral remedy for the therapy of acromegaly, in the present day introduced the hiring of John Doyle as its new Chief Monetary Officer, efficient in the present day. As beforehand reported, Mark Fitzpatrick, Chiasma’s present President and Principal Monetary Officer, will stay with the corporate in a consulting position by June 30, 2021 to assist facilitate a transition of duties to Mr. Doyle. Previous to becoming a member of Chiasma, Mr. Doyle served as Vice President of Finance and Investor Relations at Verastem, Inc.
“It’s my pleasure to welcome John to Chiasma, and I consider he’ll make a right away affect as we proceed to execute on our U.S. business launch of MYCAPSSA,” said Raj Kannan, chief government officer of Chiasma. “John brings a longtime observe document of management and success, and I sit up for working with him in realizing the complete potential of Chiasma.”
“I might additionally prefer to thank Mark Fitzpatrick for his devoted service to Chiasma since becoming a member of the corporate in 2015. Mark has served in quite a lot of management roles, together with as Chief Government Officer, and his many important contributions have enabled our potential future success. On behalf of your entire Chiasma workforce, I want Mark the easiest in his future endeavors,” Mr. Kannan added.
“I used to be drawn to Chiasma due to the corporate’s unwavering dedication to carry MYCAPSSA to sufferers within the U.S. and globally, probably enhancing the lives of sufferers affected by acromegaly,” said Mr. Doyle. “As an early commercial-stage firm, I can’t consider a extra thrilling time to affix the Chiasma workforce, and I sit up for contributing to the corporate’s business and monetary objectives.”
Mr. Doyle joins Chiasma from Verastem, Inc., a publicly traded biopharmaceutical firm, the place he most just lately served as Vice President of Finance and Investor Relations. Previous to becoming a member of Verastem in February 2018, he served as Head of Monetary Planning & Evaluation at SimpliVity Corp., a software program firm that was acquired by Hewlett Packard Enterprises in February 2017. Earlier than that, Mr. Doyle was Director of Enterprise Unit Monetary Planning & Evaluation, Early Section Division, at PAREXEL, a publicly traded pharmaceutical contract analysis group. Earlier in his profession, he served in more and more senior monetary planning and evaluation roles at Hologic, Inc., a publicly traded supplier of medical diagnostic, surgical and imaging merchandise. Mr. Doyle holds a B.S. in finance from the College of Massachusetts.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term upkeep therapy in acromegaly sufferers who’ve responded to and tolerated therapy with octreotide or lanreotide.
Hypersensitivity to octreotide or any of the parts of MYCAPSSA. Anaphylactoid reactions, together with anaphylactic shock, have been reported in sufferers receiving octreotide.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
MYCAPSSA may cause issues with the gallbladder. Monitor sufferers periodically. Discontinue if issues of cholelithiasis are suspected.
Blood sugar, thyroid ranges, and vitamin B12 ranges ought to be monitored and handled accordingly.
Bradycardia, arrhythmia, or conduction abnormalities might happen. Remedy with medication which have bradycardia results might must be adjusted.
The commonest adversarial reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose elevated, vomiting, stomach discomfort, dyspepsia, sinusitis, and osteoarthritis.
The next medication require monitoring and potential dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic medication, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and medicines primarily metabolized by CYP3A4. Counsel ladies to make use of another non-hormonal technique of contraception or a back-up technique when MYCAPSSA is used with mixed oral contraceptives.
Sufferers taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA might require elevated dosages of MYCAPSSA.
Advise premenopausal females of the potential for an unintended being pregnant.
To report SUSPECTED ADVERSE REACTIONS, contact the product info division at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The total Prescribing Data for MYCAPSSA is obtainable at www.MYCAPSSA.com.
Acromegaly sometimes develops when a benign tumor of the pituitary gland produces an excessive amount of progress hormone, in the end resulting in important well being issues. Widespread options of acromegaly are facial modifications, intense complications, joint ache, impaired imaginative and prescient and enlargement of the palms, toes, tongue and inside organs. Critical well being circumstances related to the development of acromegaly embody sort 2 diabetes, hypertension, respiratory problems and cardiac and cerebrovascular illness. Chiasma estimates that roughly 8,000 grownup acromegaly sufferers are chronically handled with somatostatin analog injections in the US.
Chiasma is a commercial-stage biopharmaceutical firm targeted on creating and commercializing oral therapies to enhance the lives of sufferers who face challenges related to their present therapies for uncommon and severe power illnesses. Using its Transient Permeability Enhancer (TPE®) expertise platform, Chiasma seeks to develop oral drugs which can be at present accessible solely as injections. In June 2020, Chiasma obtained FDA approval of MYCAPSSA for long-term upkeep remedy in acromegaly sufferers who’ve responded to and tolerated therapy with octreotide or lanreotide. MYCAPSSA, the primary and solely oral somatostatin analog accepted by the FDA, is obtainable for business sale. Chiasma is headquartered in Needham, MA with an entirely owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered emblems of Chiasma. For extra info, please go to the corporate’s web site at www.chiasma.com.
This launch comprises “forward-looking statements” throughout the which means of the Personal Securities Litigation Reform Act of 1995, together with, however not restricted to, statements concerning the potential business success of MYCAPSSA. Such statements are topic to quite a few necessary elements, dangers and uncertainties, lots of that are past the corporate’s management, that will trigger precise occasions or outcomes to vary materially from the corporate’s present expectations. Administration’s expectations and, due to this fact, any forward-looking statements on this press launch could possibly be affected by dangers and uncertainties. For a dialogue of those dangers and uncertainties, and different necessary elements, any of which may trigger the corporate’s precise outcomes to vary from these contained within the forward-looking statements, see the part entitled “Danger Elements” in Chiasma’s Quarterly Report on Type 10-Q for the quarter ended September 30, 2020, and in subsequent filings with the Securities and Change Fee. All info on this press launch is as of the date of the discharge, and Chiasma undertakes no responsibility to replace this info until required by regulation.
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