BioWorld International Correspondent

Medivir AB last week entered its largest drug development deal to date, a pact worth up to €86 million with GlaxoSmithKline plc to develop its HIV drug MIV-210. The news sent the Huddinge, Sweden-based company's share price soaring by almost 50 percent during trading on the Stockholm Stock Exchange last week.

"We have managed to close a deal with yet another key player in the HIV area, GlaxoSmithKline, and I am delighted," CEO and President Lars Adlersson told a conference call audience. Medivir will receive an up-front payment of €6 million, plus milestones worth up to €80 million should MIV-210, a nucleoside analogue reverse transcriptase inhibitor (NRTI) in Phase I clinical trials, reach the market.

London-based GSK takes on all development costs and gains worldwide marketing rights apart from the Nordic territories, which Medivir retained. "This fits well with our strategy to, in the future, set up our own sales and marketing organization in this geographical area," Adlersson said. Medivir also would receive royalties on GSK product sales.

MIV-210, a prodrug of 3' fluoro gramacine, acts as a viral DNA chain terminator. It is selectively incorporated into the growing viral DNA chain by the enzyme reverse transcriptase and then disrupts further polymerization, while having no effect on human DNA synthesis. It originally was under development as a candidate treatment for hepatitis B infection - and GSK retains rights to that indication as well - but it is now being positioned primarily as an HIV therapy because of the greater accessibility of that market.

In particular, MIV-210 is being developed as a treatment for HIV strains resistant to other NRTIs currently available. Cell culture studies indicate that it has a unique resistance profile, Medivir's vice president of pharmaceutical development, Johan Harmenberg, said in the conference call.

Medivir has another NRTI in development for multiply resistant HIV strains, MIV-310, which is in Phase II clinical trials. The two compounds target different mutant strains, however.

"So they're pretty much complementary rather than competing," Medivir's chief financial officer and vice president of investor relations, Rein Piir, told BioWorld International. That compound is also on the auction block. "We are ready to go. We are in advanced discussions with different potential partners," he said.

Medivir has two other programs with partners at present. Last year, it licensed another HIV drug, a non-nucleoside reverse transcriptase inhibitor called MV026048, to F. Hoffmann-La Roche Ltd., of Basel, Switzerland, in a deal worth up to US$42 million. It also partnered a candidate shingles treatment, MIV-606, with Reliant Pharmaceuticals LLC, of Liberty Corner, N.J., last year. That is now proceeding to Phase III trials. Another development-stage compound, ME-609, has completed Phase II trials, but further partnering negotiations are on hold pending additional work Medivir is undertaking to strengthen its patent position.

Prior to securing the current deal, Medivir had about SEK115 million (US$14.8 million) in cash, Piir said. However, the company has no plans to seek additional support from the financial markets, as its skin care and pharmaceutical products subsidiary, CCS AB, is cash-flow positive and prospects for additional research collaborations and outlicensing deals are positive. "We are not aiming for any share issue. We are not even thinking about it," Piir said.