Significant events during Q2
-- Olysio (simeprevir) was approved within the EU for the treatment of adults with hepatitis C genotype 1 and 4 infection, and was launched by Medivir in Sweden, Denmark, Norway and Finland.
-- Adasuve was launched in Sweden, Norway, Finland and Denmark.
-- A supplemental New Drug Application for simeprevir in combination with sofosbuvir was submitted to the US FDA.
-- Final phase II COSMOS study data of simeprevir in combination with sofosbuvir was presented at EASL.
-- Two phase III trials evaluating combination treatment with simeprevir and sofosbuvir were initiated.
-- A new Board of Directors was elected at Medivir's Annual General Meeting and Birgitta Stymne G�ransson was elected Chairman of the Board.
-- Suscard was re-launched into the Swedish market.
Significant events after the end of Q2
-- U.S. FDA granted Priority Review for simeprevir in combination with sofosbuvir supplementary New Drug Application.
-- Respiratory Syncytial Virus drug program was licensed from Boehringer Ingelheim.
-- Medivir's Board of Directors has appointed Niklas Prager as new President and CEO of Medivir effective 1 September 2014.
* All figures refer to the Group, unless otherwise stated. Comparisons in the Interim Report are, unless otherwise stated, with the corresponding period in 2013. Cross Pharma was divested from the Group on 30 June 2013.
The CEO's comments on Q2 2014
Medivir launched Olysio (simeprevir) in the Nordic region and received SEK 500.7 million in royalty income
We can now look back on a very successful quarter, both in terms of revenues and of results and activities. Medivir's royalty income for the period from the global sales of simeprevir totalled SEK 500.7 million, demonstrating the continued strong growth in Janssen's sales of simeprevir during the second quarter.
The period saw our most important market launch to date with the launch of simeprevir, which is marketed under the name of Olysio in the Nordic region. In May, the European Commission granted marketing approval for the pharmaceutical for the treatment of adult patients with chronic hepatitis C, and physicians in all of the Nordic countries have since begun prescribing Olysio, primarily as an interferon- and ribavirin-free combination treatment with Sovaldi (sofosbuvir).
The marketing authorisation in Europe is an important milestone in our history and it provides clear confirmation of Medivir's successful research and technological platform on which to base our development of protease inhibitors. It also provides proof that Medivir has the ability to collaborate successfully with global pharmaceutical partners, which is a key prerequisite if we are to achieve sustainable profitability. Revenues from our Nordic pharmaceutical sales totalled SEK 62.9 million, SEK 21.7 million of which derived from sales of Olysio and SEK 41.2 million from sales of other pharmaceuticals. Sales of other pharmaceuticals continued stable in relation to the comparison quarter.
Our partner, Janssen, initiated two interferon-free phase III trials in April, in order to continue its development of interferon-free treatments for hepatitis C. These trials will treat patients with a combination of simeprevir and sofosbuvir for 8 or 12 weeks. Janssen also submitted a supplementary New Drug Application for simeprevir in combination with sofosbuvir to the US FDA. The application is based on data from the phase II study, COSMOS, and it is an important component of the efforts to enhance simeprevir's competitiveness in the US market.
The past quarter also saw the launch in the Nordic region of the new pharmaceutical, Adasuve, for the treatment of agitation in patients with schizophrenia or bipolar disorder. Adasuve is the first inhalable treatment for agitation. We also re-launched Suscard in the Swedish market. Suscard is a pharmaceutical for the treatment of angina pectoris - one of the Western World's most common cardiac diseases. The pharmaceutical has been unavailable in Sweden for the past two years, during which time demand for the treatment from patients and physicians alike has been substantial.
The addition of innovative specialist pharmaceuticals to the Nordic product portfolio is part of Medivir's commercial strategy, and the launches of Olysio and Adasuve are important steps in this direction.
Medivir's in-house research and development projects involving cathepsin K and S and the nucleotide project are continuing to progress according to plan and we are continuously evaluating potential partnership strategies. We strengthened our R&D portfolio in August when we licensed a Respiratory Syncytial Virus drug program from Boehringer Ingelheim. Under the terms of the agreement Medivir receives an exclusive, global license to research, develop, manufacture and commercialise future RSV drugs.
On 1 September, I will be handing the baton on to Niklas Prager. I am proud of what we have achieved together at Medivir during my time as the Group's President & CEO, and I wish Niklas and all of his colleagues every success with what I am sure will be their continued successful development of the company.
President & CEO
Conference call for investors, analysts and the media
The Interim Report for the second quarter of 2014 will be presented by Medivir's CEO, Maris Hartmanis, and members of the management group.
Time: Thursday, 21 August 2014 at 14.00 (CET).
Sweden +46 (0)8 519 990 30
Europe +44 (0)20 766 020 77
USA +1 877 788 9023
The conference call will also be streamed via a link on the website: www.medivir.com
The Interim Report for January-September will be published on 20 November 2014.
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