RE: Circular12 Jul 2019 00:40
Recent business development of the Group
The first commercial sale of FortacinTM took place in the first quarter of 2018 in Italy, France, Spain, Germany and Portugal. A total of EUR 4.1 million (approximately US$4.7 million) was duly received by the Group from Recordati during FY2018. The Group now looks forward to working towards receiving further payments under its licence agreement with Recordati, pursuant to which the Group is eligible to receive remaining payments of up to EUR 33.0 million (approximately US$37.8 million) plus royalties after achieving certain milestones related to the European roll-out.
New out licencing deals were also signed in December 2018 in respect of out licencing FortacinTM to (i) Wanbang Pharmaceutical; and (ii) Orient EuroPharma in respect of the rights to commercialise FortacinTM in selected territories in Asia. Pursuant to these licencing agreements, the Group will be eligible to receive payments of up to a total amount of US$39.5 million, excluding royalties after achieving certain milestones related to the roll-out.
Subsequent to year ended 31 December 2018, Recordati launched FortacinTM in the United Kingdom in February 2019, with planned launches in Romania and Greece to follow later in 2019 and it will be rolled out in the other countries over the coming years.
In parallel with the European and Asian roll-out efforts of FortacinTM, the Group has further progressed the approval process with The Food and Drug Administration of the United States Department of Health and Human Services (the “FDA”). In this respect, the Phase II validation study of FortacinTM in respect of the FDA approval process was officially registered in July 2018, with the phase II clinical trial estimated to complete by first quarter of 2020. On the assumption that the trial is sufficient to convince the FDA that the Premature Ejaculation Bothersome Evaluation Questionnaire serves as an appropriate measure for support of a label claim, pivotal Phase III work could commence in the first quarter of 2021, with New Drug Application submission possible in first quarter of 2022, giving a Prescription Drug User Fee Act date in 2022.
According to the Management, while FortacinTM has only now been in the market for a relatively short period of time, the Group sees its potential to create a steady stream of recurring cash flow leading to profitability for the Group in the coming years and remains excited about the future prospects for the Group and the Shareholders. The Group will (i) continue to pursue the successful commercialisation of FortacinTM as quickly as possible, with the European roll-out with Recordati successfully launched in March 2018, as well as in the remaining key markets for out licencing FortacinTM in the US, the Middle East and Latin America; and (ii) continue with its existing strategy of pursuing strategic and value-led investments in the healthcare and life sciences sectors.
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