EXPERT SUPPORT FOR KARO BIO’S STRATEGIC ROUTE FOR EPROTIROME

​STOCKHOLM, Sweden, August 27, 2010. Karo Bio held a well attended seminar on Thursday. Professors Steven E. Nissen and Paul J.P. Kastelein together with
Dr Jens Kristensen, Karo Bio’s Chief Medical Officer, presented and discussed the rationale in the selected development route for eprotirome and the medical need for more effective treatments of dyslipidemia in high-risk patients with heterozygous familial hypercholesterolemia (HeFH).

John J.P. Kastelein is Professor of Medicine and Chairman of the Department of Vascular Medicine at Academic Medical Center in Amsterdam, Netherlands, and will be the principal investigator for the clinical trial of eprotirome in HeFH. Steven E. Nissen is Professor of Medicine and Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic in Ohio, USA, and will chair the clinical program’s steering committee. 

Professor Kastelein provided both an introduction to HeFH, its diagnosis and treatment and shared his insights into clinical testing of pharmaceuticals for HeFH. According to Kastelein, HeFH is the most common hereditary metabolic disorder and should not be regarded as a small indication. Kastelein believes current assumptions about prevalence to be underestimated. 

Patients with HeFH suffer from dyslipidemia already from early age and in his studies of HeFH patients, Kastelein has observed an average age at death of 38 years in male patients that have not started treatment in early adulthood. He considers there to be ample room for drugs that lower LDL cholesterol in HeFH patients, since the major part of the patients (79 percent) do not reach treatment goals with currently available treatments. Kastelein therefore sees eprotirome as an opportunity that can bring new and efficient treatment a step further. 

Professor Nissen discussed the regulatory landscape for dyslipidemia drugs and highlighted the clinical need for a new drug for HeFH patients. Nissen agreed that there are large benefits in bringing down the levels of LDL cholesterol in HeFH patients as early as possible. Commenting on the identification of HeFH patients, he said that in practice the condition is often diagnosed based on high LDL levels, rather than genetic testing. 

In response to a question from the audience about the decision to perform the trials in Europe, Nissen pointed to the benefits of utilizing the network of sites with identified patients from Professor Kastelein’s previous studies in the field. He also believes the regulatory path in Europe to be less complex than in the USA. 

Professor Nissen pointed out that his and professor Kastelein’s major responsibility, as physicians and scientists, is to ensure that the upcoming study contains high quality data. 

Karo Bio’s Chief Medical Officer Jens Kristensen presented the clinical phase III program that is designed to evaluate eprotirome’s safety profile at longer treatment regimens, as well as its efficacy profile in HeFH patients. Kristensen revealed that program will involve two larger groups, one with 625 HeFH patients and one with 500 high-risk patients. 

Karo Bio’s CEO Fredrik Lindgren concluded the seminar: “It seems we have succeeded in gathering several kinds of stakeholders, both on stage and in the audience, with a common interest to see eprotirome make it into clinical practice for the benefit of patients.” 

Highlights of the presentations from the seminar will be available in on www.karobio.com from Friday, August 27, 2010.
 

For further information please contact
Fredrik Lindgren, CEO
Mobile: +46 705 616 177 

Erika Söderberg Johnson, CFO
Mobile: +46 70 720 48 20 

About eprotirome
The thyroid hormone is one of the body’s own ways of regulating lipids in the blood. This effect is exercised in the liver. Eprotirome is a novel, liver-selective thyroid hormone receptor agonist for the treatment of dyslipidemia. Eprotirome’s profile is unique. In one single compound, powerful reductions of several independent risk factors for the development of atherosclerotic cardiovascular diseases are combined. 

About heterozygous familial hypercholesterolemia (HeFH)
HeFH is a hereditary condition where patients suffer from very high blood lipid levels already in early years. HeFH patients are therefore a high-risk group for cardiovascular disease. The prevalence is estimated to between 1 of 350 to 1 of 500 people globally. In total, it is Karo Bio’s estimation that there are about 1 million patients in Europe alone, and as many in the US and Japan combined. Like other dyslipidemia patients, HeFH patients are mainly treated with statins. Only about 20-30% of the patients reach their treatment goals. Today, the degree of diagnosis of HeFH is about 15%, which is expected to grow substantially when existing gene tests and DNA mapping are becoming more recurrent. 

About Karo Bio
Karo Bio is a pharmaceutical company focused on the research and development of innovative drugs for unmet medical needs. Karo Bio’s vision is to become a pharmaceutical company with sustainable profitability, products on the market and a competitive project portfolio. 

Karo Bio runs a number of development projects within the indication areas cardiovascular and metabolic diseases, neuropsychiatry, inflammation, cancer and women’s health. An important foundation for the company’s activities is the unique knowledge around nuclear receptors as target proteins for the development of novel pharmaceuticals, as well as the related mechanisms of action. Important processes and competences within the company are structurally based research, drug discovery, preclinical and clinical development, and medical and regulatory expertise. 

Kar Bio has the capability to take selected compounds for niche indications through the whole development chain, while compounds addressing large patient groups require development collaborations or out-licensing at some stage in the process. In addition to the proprietary projects, Karo Bio has three strategic collaborations with international pharmaceutical companies. 

Karo Bio, headquartered in Huddinge, has 70 employees, and is listed on NASDAQ OMX Stockholm since 1998 (Reuters: KARO.ST). 

This press release is also available online at: www.karobio.com and www.newsroom.cision.com