Thursday, August 23, 2012

Medivir Hepatitis C Drug-TMC435(simeprevir) important component in future interferon-free treatments

Medivir – Investor relation – Press Release


CEO’s comment on the second quarter of 2012
“Good progress in all parts of the company” We continued to develop Medivir into a profitable Nordic pharmaceutical company, and made good progress in all parts of the company. Sales of original pharmaceuticals progressed as planned, and made continued stable progress in the second quarter. Parallel imports, through Cross Pharma, are operating on an expansive and fast-moving market where our experience and long-term commitment continued to create value.
TMC435 gained its generic name - simeprevir. Phase III trials on simeprevir continued as planned and new data presented in the period confirmed simeprevir’s good prospects of becoming an essential component in the optimal triple therapy for hepatitis C (HCV). Simeprevir’s competitive profile also engenders good hopes of an important role in future interferon-free therapies. Extensive phase II trials have demonstrated good safety and efficacy, not least in the hardest-to-treat patient groups where there is the greatest need for therapy.
The company’s proprietary projects progressed as planned. In May, phase I trials commenced on our in-house developed cathepsin K inhibitor MIV-711, for treating skeletal disorders. We also have strong hopes of being able to designate a nucleotide CD in our own early HCV projects before year-end. In June, we initiated a partnership with the Swedish University of Agricultural Sciences (SLU) in Uppsala on the development of new antibiotics against resistant bacteria, a project that is consistent with our strategy.
Simeprevir (TMC435) - Medivir’s protease inhibitor in clinical phase III for treating hepatitis C
Phase III trials on simeprevir progressed as planned during the period and we expect to be able to present initial data from these trials around the coming year-end. From extensive phase II trials, we know that simeprevir addresses needs in all patient groups effectively and safely, simultaneous with this compound being easy to administer, possible in a single day tablet dose. Good efficacy is especially important in the hardest-to treat and most severely affected patient groups. The strength of the results from treatment-naïve and treatment-experienced patients in phase IIb trials demonstrate that through its mechanism of action, simeprevir will be an important component in future interferon-free treatments.
Combination therapy is a prerequisite for realizing interferon and ribavirin-free treatments. In July, a phase II trial commenced designed to study combination treatment with simeprevir and daclatasvir from Bristol-Myers Squibb. This trial is another key step in collecting data for future combination therapies with simeprevir as a solid cornerstone. The combination trial in phase II on simeprevir and Gilead’s nucleotide inhibitor GS7977, which commenced at the beginning of the year, progressed well. We hope to be able to present the first partial results from this trial before year-end.
Hepatitis C projects in-house
Our own preclinical HCV projects progressed as planned in the second quarter. As previously, our goal is to be able to designate a CD in the nucleotide project before year-end.
Conference call for investors, analysts and the media
The Interim Report will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management.

Time: 2 p.m. (CET) on Thursday, 23 August 2012

Participant telephone numbers: Sweden +46 (0)8 505 204 24
Europe +44 (0) 20 3003 2666
USA +1 866 966 5335

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The conference call will also be streamed via a link from the website

Live Stream-

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