Vectura has signed a development and licence agreement with Mundipharma International and a US independent associated company as the global development and commercialisation partner for the VR2076 (previously SKP-2076) pressurised Metered Dose Inhaler (pMDI) ICS/LABA/LAMA triple programme.
In December 2015, the companies entered into a feasibility and option agreement and following successful completion of the feasibility work, which Vectura was responsible for, Mundipharma and the US associated independent company have now confirmed they will exercise the option to develop and commercialise VR2076 initially in asthma.
The exercise of this option triggers a payment to Vectura of €1.5 million. The Group’s R&D investment guidance for 2016 and 2017, provided recently in its interim results statement in November, remains unchanged.
Further total potential milestone payments up to €46.5 million are receivable linked to development, regulatory and launch progress of the programme as well as royalties on any future net sales of the product.
The royalty rate on this novel product development programme, where Vectura has been responsible for the formulation development, is initially around a mid-single digit percentage but could increase depending on sales.
This agreement also includes the potential for further development of the triple combination treatment for chronic obstructive pulmonary disease (“COPD”).
If Mundipharma decides to develop the programme in COPD, Vectura is eligible for further potential milestones linked to the regulatory progress of the programme up to €20.0 million as well as royalties on any future net sales of the product. The royalty rate on net sales for the COPD indication product would be the same as the asthma indication product. In addition, Vectura will also receive one-off undisclosed sales milestones should net sales of both the asthma and COPD products achieve certain predetermined levels.
The first regulatory filings of VR2076 are planned in the EU for late 2022/early 2023.
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