BioWorld International Correspondent
As he put it himself, Medivir AB CEO Lars Adlersson had "two reasons to celebrate" Tuesday. The drug discovery company he leads had just signed its largest deal ever, a pact potentially worth €122 million with Boehringer Ingelheim GmbH to develop its candidate HIV drug MIV-310. It was also his 39th birthday.
Investors delivered the perfect present, lifting the Huddinge, Sweden, company's share price 30.1 percent to a two-year high of SEK114.5 on the Stockholm stock exchange.
The deal has a structure similar to the €86 million pact to develop MIV-210 the company entered with London-based GlaxoSmithKline plc less than two months ago. Both involve a nucleoside reverse transcript inhibitor (NRTI) and, as with the earlier agreement, Medivir has retained Nordic marketing rights to the compound. (See BioWorld International, May 28, 2003.)
The larger deal size this time around is a reflection of the fact that MIV-310 is in Phase II clinical trials, whereas MIV-210 is at the Phase I stage. Adlersson told a conference call audience that the company had also agreed to an up-front payment with Boehringer Ingelheim that was smaller than the €6 million it took from the GSK deal. The company generated additional cash recently by disposing of its CCS skincare products and pharmaceuticals business for SEK210 million (US$26.0 million), SEK85 million of which it will book as profit.
Boehringer Ingelheim, of Ingelheim, Germany, assumes responsibility for all pharmaceutical and clinical development of MIV-310 and will have marketing rights outside of the Nordic region. Medivir can earn additional payments as MIV-310 passes development and performance milestones, and would gain double-digit royalties on eventual product sales.
MIV-310 is in development for treating mutant HIV strains that are resistant to currently available NRTIs. According to Medivir, a recent study showed that up to 70 percent of the 1.4 million people with HIV infection in the industrialized world are resistant to at least one NRTI drug. In a four-week Phase IIa study, MIV-310 reduced viral load by 99 percent in HIV patients receiving between three and six other antiviral agents, said Medivir's vice president of pharmaceutical development, Johan Harmenberg. No side effects were reported at the administered dose of 7.5 mg/day, he said.
Medivir last year licensed out another anti-HIV compound, a non-nuceloside reverse transcriptase inhibitor (NNRTI), MV026048, to Basel, Switzerland-based F. Hoffmann-La Roche Ltd. (See BioWorld International, April 17, 2002.)
Another NNRTI drug, MIV-170, is undergoing lead optimization, while two other antivirals are entering Phase III clinical trials. MIV-606 (now RP-606), which is in development for shingles, is partnered with Reliant Pharmaceuticals, of Liberty Corner, N.J., while ME-609 is in development for labial herpes.
The company will retain an interest in viral polymerase inhibition, but it is increasingly looking elsewhere in its search for new drug candidates.
"The next step for Medivir is to become one of the world leaders in protease research," Adlersson told the conference call audience.
Rein Piir, chief financial officer and director of investor relations, told BioWorld International that the company plans to extend its protease inhibition program to all four protease families in the next 12 to 18 months. It will cost about SEK50 million to hire more scientific staff and to obtain the necessary compound libraries. "The skill isn't to have them. The skill is to use them correctly," he said.
The company has two preclinical protease inhibition programs under way. It has a collaboration with Peptimmune Inc., a subsidiary of Cambridge, Mass.-based Genzyme Corp., to find inhibitors of Cathepsin S for treating autoimmune disorders. That has been at the lead-optimization stage for the past two years, and is progressing toward clinical development, Piir said. The second program, which is focused on finding inhibitors of Cathepsin K for treatment of osteoporosis, is at an earlier stage of development.