Other indications
Xerclear®
Therapy area
Episodic treatment of recurrent labial herpes to reduce the progression of cold sore episodes to ulcerative lesions.
In phase
Xerclear was approved by the US FDA on 31 July 2009 for marketing and sales in US.
In October 2009 the European regulatory authorities approved marketing authorisation for Xerclear in 14 European countries.
Indication texts in US and EU
Competitive edge Label in USA – "Acyclovir and Hydrocortisone Cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time"
Competitive edge Label in Europe – "Treatment of early signs and symptoms of recurrent herpes labialis (cold sores) to reduce the progression of cold sore episodes to ulcerative lesions in immunocompetent adults and adolescents (12 years of age and older)"
TMC435 (protease inhibitor)
Disease area
Treatment of chronic hepatitis C virus (HCV) infection.
Phase
This project is in phase 3. Interim data from phase 2b studies showed very positive results in terms of treatment effect and tolerability/ safety. Phase 3 trials on treatment-naive patients (QUEST1 and QUEST2) and relapsers (PROMISE) have commenced based on these results. Enrolment for these studies was completed in August 2011.
Competitive edge
TMC435 is an HCV NS3/4A protease inhibitor with very potent antiviral activity in patients infected with HCV. Can be administered in a low, single daily dose, and to date, has been very safe and tolerable, i.e. did not give rise to any additional adverse events when administered in addition to standard of care (SoC). Has high potential to reduce total treatment times because 83% of patients in the phase 2b study were able to discontinue all treatment after 24 weeks instead of 48 weeks.
Project data
- Collaboration with Tibotec since 2004.
- Phase 3 studies ongoing.
- Excellent antiviral activity and tolerability in patients infected
with HCV. - PK profile enabling single daily dose.
- Several series of potent inhibitors have been developed, offering the prospects of developing backups.
TMC649128 (HCV POL)
Disease area
Treatment of chronic hepatitis C virus (HCV) infection.
Phase
Phase 1b studies have recently commenced.
Competitive edge
TMC649128 is a nucleoside NS5B polymerase inhibitor, which has demonstrated good effect against several HCV genotypes in in vitro preclinical studies, and a high genetic barrier to resistance development. This profile makes developing TMC649128 in combination with other direct-acting HCV antivirals attractive.
Project data
- Collaboration with Ortho Biotech Products LP, an associated company of Tibotec, since May 2008.
- Phase 1b studies ongoing.
- TMC649128 has a high genetic barrier against resistance development and has proven active against several HCV genotypes in vitro.
Cathepsin K inhibitor
Disease area
Skeletal disorders such as osteoporosis, osteoarthritis and bone metastases.
Phase
Two candidate drugs (CDs) have been designated, MIV-710 and MIV-711, with MIV-711 in preclinical development.
Competitive edge
Cathepsin K inhibitor achieves a marked reduction of bone degradation without affecting bone formation, which is expected to result in greater skeletal strength. Rapid onset of activity against bone resorption is a major competitive edge over pharmaceuticals commonly prescribed at present. Very good preclinical pharmacokinetics offer the prospects of a low dose and single daily treatment.
Project data
- Highly potent and selective cathepsin K inhibitor, which effectively inhibits bone resorption.
- Important bone formation process is unaffected.
- Long effect duration in preclinical models.
HIV PI
Disease area
Protease inhibitor for treating patients with HIV.
Phase
Preclinical optimization in collaboration with Tibotec, Johnson & Johnson.
Competitive edge
HIV protease inhibitor with highly potent antiviral effect against wild-type and multiresistant virus.
Project data
- Collaboration with Tibotec Pharmaceuticals Ltd. since 30 June 2006.
- Inhibitor with highly potent activity against wild-type HIV and multiresistant virus.
Cathepsin S
Disease area
Neuropathic pain and rheumatoid arthritis.
Phase
Late preclinical optimization phase.
Competitive edge
Cathepsin S inhibitor have a new mechanism for treating neuropathic pain and offer the potential for rapid onset and improved effect with fewer adverse events than current treatment principles.
Project data
- Highly potent compounds with high selectivity and good pharmacokinetic characteristics have been identified.
- Medivir-developed Cathepsin S inhibitor compounds have been evaluated in preclinical models of neuropathic pain and rheumatoid arthritis with positive outcomes.
Valomaciklovir (MIV-606)
Disease area
NRTI against shingles (herpes zoster) and post-herpetic neuralgia (PHN). Also active against other herpes viruses.
Phase
Phase 2b study (herpes zoster) and phase 2a study (mononucleosis) completed.
Competitive edge
Phase 2b results indicate a reduction of PHN related to shingles and that a single daily dose is as effective as SoC, which is administered three times daily.
Licensee
Epiphany Bioscienses.
Lagociclovir (MIV-210)
Disease area
NRTI for treating chronic infection with the hepatitis B virus (HBV).
Phase
Completed phase 1 study.
Competitive edge
Effective against multiresistant HIV and HBV that have become resistant to other pharmaceuticals on the market. Highly potent effect in in vivo hepatitis model. Good pharmacokinetic characteristics in phase 1 and effect against multiresistant HIV in pilot study.
Licensee
Daewoong has licensed MIV-210 for China, South Korea, Japan and Taiwan and is responsible for clinical development of MIV-210 as a potential hepatitis B pharmaceutical.
MIV-410
Disease area
Disease area
NRTI for treating patients with multiresistant HIV and cytomegalovirus infections in immuno-deficient patients.
Phase
In preclinical development.
Competitive edge
Potent NRTI with a new inhibition mechanism. This project is in preclinical development.
Licensee
Presidio Pharmaceuticals.
Dengue fever
Prophylactic treatment of dengue fever for inhabitants of regions subject to outbreaks and for travelers to regions where dengue is present. This treatment is also intended to reduce the risk of developing the more serious complications (hemorrhagic dengue), which can lead to internal hemorrhaging and hemorrhagic shock.
Phase
Early research phase.
Competitive edge
No pharmaceuticals against dengue are currently available on the market.
Project data
Collaboration with Janssen Pharmaceutica.
