14 May 2019
Chiasma and Lonza Announce Progression of Oral Octreotide Capsules Development and Definitive Commercial Supply Agreement
  • Chiasma recently completed enrollment of its CHIASMA OPTIMAL Phase 3 clinical trial of octreotide capsules, the first potential oral somatostatin analog for the maintenance treatment of acromegaly
  • Chiasma is developing octreotide capsules utilizing the company's proprietary Transient Permeability Enhancer technology in combination with Lonza's liquid-filled hard capsule technology
  • Lonza will continue its long-term relationship with Chiasma for the development and anticipated commercial manufacture of encapsulated octreotide at Lonza's Edinburgh (UK) site

Waltham, MA (USA) and Basel (CH), 14 May 2019 – Chiasma, Inc. (NASDAQ: CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, and Lonza (SWX:LONN) today announced that the companies have entered into a commercial supply agreement for Chiasma's oral somatostatin analog candidate, conditionally trade named MYCAPSSA®.

Chiasma is conducting a Phase 3 clinical trial under a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration for its octreotide capsules product candidate, MYCAPSSA®, for the maintenance therapy of adult patients with acromegaly. If approved, Chiasma believes MYCAPSSA will be the first oral somatostatin analog for the treatment of acromegaly, a disorder that typically develops when a benign tumor of the pituitary gland produces too much growth hormone.

Chiasma and Lonza have signed a manufacturing contract to support the anticipated launch and ongoing commercial supply of MYCAPSSA® at Lonza's Edinburgh (UK) site. The agreement extends a collaboration between the two companies that has been in place since 2012.

Octreotide acetate is currently only available by injection for patients suffering from acromegaly. MYCAPPSA uses Chiasma's proprietary Transient Permeability Enhancer technology (TPE®) to produce the octreotide capsules formulation manufactured using Lonza's liquid-filled hard capsule technology (LFHC). As part of the collaboration, Chiasma and Lonza jointly invested in specialized milling equipment, large-scale LFHC coating equipment and in-house printing capabilities to support the processing, filling, and other manufacturing activities performed by Lonza for MYCAPSSA manufacturing.

“Extending our partnership with Chiasma demonstrates our commitment to supporting innovator companies from early phases through to commercial supply,” said Dr. Christian Dowdeswell, VP and Head of Dosage Forms & Delivery Systems, Lonza Pharma & Biotech. “Chiasma's technology when combined with Lonza's delivery systems has the potential to improve the treatment options for adult patients with acromegaly.”

The Phase 3 trial, referred to as CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), is a global, randomized, double-blind, placebo-controlled, nine-month trial. Top-line data is expected during the third quarter of 2019. Assuming positive CHIASMA OPTIMAL data, an NDA submission for MYCAPSSA is expected by year-end 2019.

“We believe MYCAPSSA, if approved, will potentially become a standard of care for the maintenance treatment of adults suffering from acromegaly,” said Mark Fitzpatrick, President and Chief Executive Officer of Chiasma. “Lonza-Edinburgh has been a valuable partner helping us advance this specialized drug product from development through clinical trial manufacture and to potential commercialization, and we look forward to continuing this mutually beneficial relationship.”