Press release

Medivir’s MIV-818 obtains the International Nonproprietary Name fostroxacitabine bralpamide

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the World Health Organization (WHO) has selected the International Nonproprietary Name (INN) fostroxacitabine bralpamide as the official generic name for the company's patented candidate drug MIV-818, which is in clinical development in primary liver cancer.

Medivir's main project, fostroxacitabine bralpamide (MIV-818), is the company’s proprietary candidate drug with a unique mechanism of action, which makes fostroxacitabine bralpamide attractive to be combined with a multitude of other drugs for the treatment of hepatocellular carcinoma (HCC). In the ongoing study, fostroxacitabine bralpamide is administered in two different combinations, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor.

- ”We are now able to use a generic name for our candidate drug, and for us that is an important step towards a product for the treatment of HCC” said Magnus Christensen, interim CEO and CFO of Medivir.

For further information, please contact:
Magnus Christensen, Interim CEO and CFO, Medivir AB
Phone: +46 (0)8 5468 3100

About fostroxacitabine bralpamide
Fostroxacitabine bralpamide (also named MIV-818) is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostroxacitabine bralpamide has completed a phase 1b monotherapy study, and a combination study in HCC was recently initiated.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (MIV-818), a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. 
Collaborations and partnerships are important parts of Medivir’s business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list.