EXPERT SUPPORT FOR KARO BIO'S STRATEGIC ROUTE FOR EPROTIROME

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 (http://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