Lonza to manufacture oral somatostatin analogue MYCAPSSA drug candidate in the UK

The Swiss CDMO has signed an advance commercial supply agreement with Chiasma, the US-based biopharma company

Octreotide acetate is currently only available by injection for patients suffering from acromegaly

Chiasma, the US-based biopharmaceutical company, and Swiss drug contractor Lonza have entered into a commercial supply agreement for MYCAPSSA, Chiasma’s oral somatostatin analogue candidate.

The agreement extends collaboration between the two companies in place since 2012.

Headquartered in Massachusetts, Chiasma is conducting a Phase-3 clinical trial under a Special Protocol Assessment agreement reached with the US Food and Drug Administration (FDA) for the drug. MYCAPSSA has been formulated for the maintenance therapy of adult patients with acromegaly.

If approved, Chiasma believes MYCAPSSA will be the first oral somatostatin analogue for the treatment of acromegaly, a disorder that typically develops when a benign tumour of the pituitary gland produces too much growth hormone.

As part of the deal, Chiasma and Lonza have signed a manufacturing contract to support the anticipated launch and ongoing commercial supply of MYCAPSSA. The contract will see Lonza manufacture the drug at the Edinburgh site in the UK.

“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.

He added: “Chiasma’s technology when combined with Lonza’s delivery system has the potential to improve the treatment options for adult patients with acromegaly.”

Octreotide acetate is currently only available by injection for patients suffering from acromegaly.

Octreotide capsules formulation

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).

The collaboration will see Chiasma and Lonza jointly invest in specialised 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.

Clinical trials

The Phase-3 trial — referred to as CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centres)— is a global, randomised, 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," Fitzpatrick concluded.

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