Livazo(R) (Pitavastatin), A Statin With Beneficial Effects On Lipid Fractions Associated With Heart Disease, Launches In Lebanon

Kowa Pharmaceutical Europe welcomes the first regional launch of its
statin, Livazo (pitavastatin) in Lebanon, where it will be marketed by
Beirut-based Algorithm, under an exclusive license.


Aimed at patients with primary hyperlipidemia and / or mixed
dyslipidemia,(1) Lebanon will be the first market for Livazo outside the Far
East and the USA. Algorithm will launch Livazo in the rest of the Middle East
and North Africa from 2012 onwards.


Livazo is a potent statin that combines effective control on
LDL-cholesterol (LDL-C) and triglycerides (TG), long-term incremental
HDL-cholesterol (HDL-C) increase and, due to its novel structure, is less
likely to have drug-drug interactions.(2) Its effectiveness has been
demonstrated in several Phase III clinical studies:


- Livazo safely and effectively reduced LDL-C and achieved European
Atherosclerosis Society (EAS) guideline targets in the majority of
patients with primary hyperlipidemia or mixed dyslipidemia, similar
to reductions seen with atorvastatin(3) and simvastatin(4)


- Livazo 2 mg and 4 mg demonstrated comparable efficacy to commonly
prescribed statins with 2 mg Livazo demonstrating statistically
significant superior efficacy compared with simvastatin 20 mg in
lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C)
and total cholesterol (TC)(4)


- Livazo effectively reduced LDL-C in the elderly(5) and also improved
LDL-C and other parameters of lipid metabolism in patients at higher
cardiovascular risk(2)


- Livazo was superior to pravastatin in improving LDL-C in elderly
patients (65 years)(5)


- Livazo demonstrated a gradual and sustained increase in HDL-C over the
long-term, supported by data from a 52 week extension study(6)


"We welcome innovative treatments such as Livazo, which not only lowers
LDL-C effectively but also addresses HDL residual risk and so has the
potential to increase the proportion of patients achieving treatment
targets," said Professor Ibrahim Salti, Professor of Medicine and Head of the
Division of Endocrinology and Metabolism at the American University of Beirut
in Lebanon. "Pitavastatin has shown good efficacy in metabolic syndrome
patients without effect on HbA1C levels, as well as in elderly patients. The
low drug-drug interaction makes it an attractive option for clinically
complex patients on multiple medications."


High cholesterol levels are a major risk factor for heart disease, the
number one cause of death globally.(7) In Lebanon, about one sixth of all
adults has high blood cholesterol, but only two fifths of these receive
medical treatment for it.(8)


The overall safety and tolerability of pitavastatin are consistent with
other commonly prescribed statins. In Phase III studies comparing
pitavastatin with atorvastatin(3), simvastatin(4) and pravastatin(5), the
overall safety profile of pitavastatin was demonstrated, with low incidences
of adverse events. All three doses of pitavastatin (1, 2 and 4 mg)
demonstrated a comparable safety profile to 10, 20 and 40 mg of
pravastatin(5), which is considered to be the statin least likely to cause
adverse drug reactions or drug-drug interactions. Additionally, pitavastatin
has demonstrated a long-term safety profile (to 52 weeks),(6) comparable to
that of simvastatin or atorvastatin.(9,10)















Drummond Paris, President of Kowa Research Europe, said: "The launch of
Livazo in Lebanon represents a milestone for Kowa as our first product in
this region. It will be the first of many launches in Europe, the Middle East
and North Africa during 2011. We are keen to offer the benefits of Livazo to
patients across the globe."


References


1. Livazo Summary of Product Characteristics


2. Ose L. Pitavastatin: finding its place in therapy. Ther Adv Chronic
Dis. 2011. Published online before print. January 26, 2011, doi:
10.1177/2040622310389227


3. Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin
compared with atorvastatin in primary hypercholesterolemia or
combined dyslipidemia. Clin. Lipidol. 2009;4:291-302


4. Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin
with simvastatin in primary hypercholesterolaemia or combined
dyslipidaemia. Curr Med Res Opin 2009;25: 2755-64


5. Stender S, Hounslow N. Robust efficacy of pitavastatin and comparable
safety to pravastatin. Atherosclerosis Suppl. 2009; 10:e945


6. Ose L, Budinski D, Hounslow N, Arneson V: Long-term treatment with
pitavastatin is effective and well tolerated by patients with primary
hypercholesterolemia or combined dyslipidemia. Atherosclerosis 2010;
202-208


7. World Health Organization. Cardiovascular diseases fact sheet.
Accessed on 14 February, 2011.
See here.


8. Rady, A. Is lifestyle affecting the risk of non-communicable diseases
in Lebanon? Human & Health 2010;13:15-17


9. Data on file (study 309)


10. Data on file (study 310)


About Livazo


Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor
of HMG-CoA reductase used for primary hypercholesterolemia and combined
dyslipidemia. Pitavastatin has a unique cyclopropyl group on the base
structure common to the statin class. Since its 2003 launch in Japan,
pitavastatin has accumulated millions of patient-years of exposure. Many of
these patients have co-morbidities and are taking multiple medications. Kowa
received FDA approval of pitavastatin (Livalo(R)) for the treatment of
primary hyperlipidemia or mixed dyslipidemia in August 2009 and it was
launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in
August 2008 using the decentralised authorisation procedure and received
regulatory approval in mid 2010. In much of Europe, pitavastatin will be
marketed by Recordati. Pitavastatin will be available in three dosage
strengths (1 mg, 2 mg and 4 mg).


*1. Co-marketing by the two companies under one brand name, Livalo. The
annual sales of Livalo tablets in Japan reached $520 million in 2010.


*2 Kowa (Shanghai) Pharma Consulting Co. Ltd., a wholly-owned subsidiary
of Kowa, is obtaining and providing information to physicians and hospitals
in China to ensure proper use of pitavastatin.


*3 In the United States, Kowa Pharmaceuticals America, Inc. (Headquarters
in Alabama, US), a wholly-owned subsidiary of Kowa, sell and market
pitavastatin with a co-promotion partner, Eli Lilly (Headquarters in Indiana,
US).


*4 In Europe, pitavastatin will be distributed by Kowa Pharmaceutical
Europe Co. Ltd. (Headquarters in Wokingham, UK), a wholly-owned subsidiary of
Kowa, and Recordati (Headquarters in Milan, Italy), a partner distributor.


About Algorithm


Algorithm, pharmaceutical manufacturer based in Lebanon, aims
at being the trusted regional partner to medical and patient communities and
is committed to delivering quality care in pharmaceutical therapies. It
operates in the Middle East and North Africa region with a product portfolio
consisting of innovative products as well as differentiated generics,
focusing mainly on the following therapeutic areas: cardiology,
endocrinology, neurology, gynaecology and urology. Algorithm has built
partnerships with many international companies, amongst which is Kowa.