Proposed acquisition of specialist formulation company Formulytica
Melbourne, 21 June 2023: Opal Biosciences Limited (“Opal”) is pleased to announce its proposed merger with specialist company, Formulytica Pty Ltd (“Formulytica”). Opal and Formulytica have partnered to establish a new sterile pharmaceutical development and manufacturing facility. The new facility will be focused on small scale product manufacture of sterile liquid products for clinical trial and personalised medicine treatment.
The objective of the new merged business will be to serve the needs of local and overseas groups who need manufacture of research stage products for testing in preclinical and early stage (Phase I/IIa) clinical studies and for some precision medicine treatment development e.g. individually tailored cancer vaccines.
Formulytica is recognised internationally for its strengths in formulation development (topical applications and injectables). Formulytica will continue to operate its fee-for-service business under its own internationally recognised brand. It will service local and international clients and in addition continue to gain royalties from its own in-house innovative technologies, some of which have already been outlicenced and commercialised.
Opal’s Managing Director, Julie Phillips said, “Australia is a growing and highly attractive jurisdiction to conduct clinical trials. On 1 April 2022 the new R&D Tax Incentive determination[1] for clinical trials came into effect. This determination means clinical trials are automatically eligible for the R&D tax incentive. This will grow the ecosystem significantly by attracting even more overseas clinical trials. However, currently in Australia, the necessary capabilities and infrastructure for small scale sterile liquid injectable and vaccine manufacturing and fill/finish are scarce. Our plan will transform and grow Opal.”
Formulytica’s Dr Richard Buchta said “We welcome this opportunity to join with Opal and both our companies recognise the enormous opportunity the current environment for conduct of clinical trials in Australia presents to grow our business further. Australian companies would prefer to have more of their formulation and development work conducted onshore for their preclinical and clinical trials”.
The transaction will be effective on the completion of a capital raising. Opal will then acquire all the shares of Formulytica to form a wholly-owned subsidiary and any existing debt within Formulytica will be converted to equity. Formulytica’s Peter Cox and Dr Richard Buchta will then join the Opal board. The details of the capital raising will be announced shortly.
[1] https://business.gov.au/news/r-and-d-tax-incentive-determination-for-clinical-trials
