Medivir comments on the patent approval
The European Patent Office has approved Medivir’s patent application for combining fostrox and Lenvima to treat hepatocellular carcinoma (HCC) and liver metastases from other cancers. The patent runs until April 2041 and thus secures market exclusivity for a key part of the commercialisation phase. We contacted Medivir’s CEO Jens Lindberg for a comment.
The patent notice follows positive final data from Medivirs phase Ib/IIa study, presented at the EASL Liver Cancer Summit earlier this year – watch an interview with Dr. Jeff Evans, one of the study’s investigators, here – and arrives as the company gears up for its upcoming phase IIb study.
The patent is a vital part ofMedivir’s strategy to protect the combination of fostroxacitabine bralpamide (fostrox) and lenvatinib (Lenvima), along with other clinically relevant fostrox combinations, especially for liver cancer patients who have run out of treatment options.
Towards phase IIb studies
Primary liver cancer ranks among the deadliest cancers worldwide, with hepatocellular carcinoma (HCC) making up most cases. For patients whose first-line treatment fails, the outlook is grim – there are no approved alternatives. Fostrox targets the liver directly, killing tumour cells while sparing healthy ones, a feature Medivir believes could pave the way for future market approval.
In November 2024, Medivir completed its phase Ib/IIa study combining fostrox with Lenvima. The results were impressive: patients saw a median time to disease progression of nearly 11 months and a 24 per cent response rate – far better than past second-line outcomes. Now, the company is set to launch a phase IIb study in partnership with pharmaceutical giant Eisai, which is providing Lenvima. Already approved by the FDA in the US, the study aims to confirm the combination’s potential.
“Given that the European Patent Office is highly respected and other patent authorities often follow its lead, we look forward to further approvals of this important patent.” – Jens Lindberg, CEO of Medivir
Comments from the CEO
According to the company’s CEO, Jens Lindberg, the new patent, together with the fostrox composition of matter patent, is a key part of Medivir’s strategy to protect clinically relevant combinations with fostrox for liver cancer.
We contacted Jens for an additional comment.
What does the patent approval mean for the continued development of fostrox?
– This type of patent is of tremendous value for fostrox. Since fostrox is a liver-targeted drug with a clear focus on specifically treating liver cancer, this kind of method-of-use patent provides significantly stronger protection than it would for drugs with a broader range of applications. It means the effective patent term extends beyond the basic composition-of-matter patent for the fostrox molecule. Given that the European Patent Office is highly respected and other patent authorities often follow its lead, we look forward to further approvals of this important patent.
The patent protection extends to 2041. When do you hope to launch the drug on the market?
– With the design of our planned phase IIb study for the fostrox + Lenvima combination, our ambition is to apply for Breakthrough Therapy Designation and initiate the process for an Accelerated Approval if the outcome is positive. This patent approval significantly extends the duration of patent protection, and as a result, this extended protection creates tremendous commercial value upon approval and commercialisation. The commercial value of a drug is almost always greatest just before its patent expires, so being able to extend the period of market exclusivity by several years is extremely valuable.
Can you talk about the rest of the patent portfolio?
– With fostrox, we have built a robust patent portfolio. The core patent for fostrox was approved earlier in all major countries and regions. In addition, we have also applied for and received approval for combination patents with other commonly used drugs in the field of liver cancer, such as sorafenib and regorafenib. On top of this, fostrox is also approved as an Orphan Drug in the US and Europe, which provides additional patent protection. Together with the combination patent for fostrox + Lenvima, this creates a strong patent portfolio for fostrox.
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