August 31, 2016
By Mark Terry, Breaking News Staff


Stockholm, Sweden – Medivir AB (MVRBF) announced today that it plans to split the company into two independent companies.

Originally proposed in June, one of the entities would own Medivir’s commercial products portfolio. That group of drugs including a hepatitis C drug, Olysio, for which it has a partnership with Johnson & Johnson (JNJ). It also has a batch of drugs sold regionally that it picked up when it acquired BioPhausia in 2011. This first company is expected to be listed on the Nasdaq’s First North Premium.

The second company would be an independent biotech company that has MIV-711, a cathepsin K inhibitor the company is developing in a Phase II clinical trial for osteoarthritis. MIV-711 is the only drug in the Medivir clinical pipeline except for a Johnson & Johnson trial of Olysio as part of a triple combination treatment.

That trial was announced in May, and is a Phase IIb trial. It is evaluating the efficacy, safety and pharmacokinetics of AL-335, odalasvir and simeprevir in HCV patients. It will involve about 400 patients.

However, it does have MIV-802, a nucleotide NS5B polymerase inhibitor, in preclinical development. Earlier this month Medivir licensed exclusive rights to the hepatitis C drug from Boston-based Trek Therapeutics. Trek holds the rights to develop and commercialize the drug globally, excluding China, Taiwan, Hong Kong and Macau. BioPhausia, a Medivir subsidiary, holds commercial rights in the Nordics and specific Western European countries.

Medivir is eligible for various developmental milestones, as mid-teen royalties.

“We are pleased to have Trek Therapeutics as a partner with their deep knowledge of HCV drug development,” said Niklas Prager, Medivir’s chief executive officer, in a statement, “and their mission to make competitive treatments accessible to world populations.”

In addition to its HCV work, Medivir is developing therapeutics for HIV, respiratory syncytial virus, and hepatocellular carcinoma. So far they are all in preclinical development.

Medivir stated that, “The objective of the separation is to visualize the value of both the commercial operations and the pharmaceutical projects that make up the R&D portfolio.” It hopes to complete the breakup before the end of the year.

Medivir stock is currently trading for 65.75 SEK (Swedish Krona). Shares traded on Nov. 16, 2015 for 79.25 SEK, and dropped to 47.60 SEK on May 16, 2016, before it began to climb again.

Olysio is facing very stiff competition from Gilead Sciences (GILD)’s own hepatitis C franchise, which has had a major affect on Medivir stock. Overall, investors appear to be happy with the idea of the split. The original announcement pushed it up by about 30 percent, and since it announced confirmation of the split, it’s gone up another 6 percent.

The new company’s success probably depends on MIV-711. Medivir indicates it expects a data readout from the Phase II trial in the second half of 2017. They have a history of outlicensing drugs after Phase II, so if the new company continues with that strategy, it will have an effect on the company’s mid-year status. At this time, Medivir hasn’t disclosed financial information about the split.



Source: BioSpace