Lupin launches Ivabrad
has received Drug Controller General of India (DCGI) approval to launch Indias
first selective and specific sinus node I channel inhibitor; Ivabrad (ivabradine).
Ivabrad comes from Pinnacle, Lupins marketing division for specialty drugs
in India. Currently, it is now available in 5 mg and 7.5 mg tablets.
Lupins Ivabrad is a new and innovative approach for the treatment of symptomatic
chronic stable angina in CAD patients. Stable angina is a common and disabilitating
disease that significantly limits the quality of life of patients. It is observed
that the traditional heart rate-lowering agents reduce the myocardial contractility,
which is harmful when ventricular function is already impaired. As per ORG-IMS
estimates, Lupins cardiovascular drugs business is among the fastest growing
in the Indian market, with sales having grown from about Rs 130 crore, 2006-07
to over Rs 175 crore 2007-08.
Commenting on the launch, Dr Kamal Sharma, Managing Director Lupin, said, Ivabrad
offers doctors and heart patients in India a new and innovative approach for
the treatment of symptomatic chronic stable angina in coronary artery disease
(CAD) patients, a drug that will have a significant impact on the treatment
of cardiovascular diseases in India.
Sharma commented, Ivabrad is not only a testament to Lupins larger
goal of developing and delivering innovative, cost-effective quality drugs for
everybody but will also go a long way to further extend and strengthen our goodwill
and franchise with cardiologists, in keeping with our market leadership credentials
in the cardiovascular space.
Since the number of existing anti-anginal treatments have limitations and side
effects, therefore, there is a need for a drug which not only provides pure
heart rate reduction without impairing other cardiac functions but also improves
stable angina management.
Ivabrad is a new clinical entity and the first selective sinus node I channel
inhibitor which reduces heart rate while maintaining myocardial contractility
and atrioventricular (AV) conduction. It is a new alternative indicated in the
treatment of chronic stable angina pectoris in patients with normal sinus rhythm.
Shakti P Chakraborty, President, India Region Formulations, Lupin, said, Statistics
today suggest an alarming rise in lifestyle diseases in the next few years.
Heart diseases and heart attacks have already assumed epidemic proportions in
India over the past decade and treatments such as Ivabrad will go a long way
towards controlling these diseases, Chakraborty added.
According to the World Health Organization (WHO) of all ailments, the spurt
in cardiovascular diseases has been the most steep and rapid. While mortality
due to cardiovascular diseases has decreased by 60 percent in Japan and Finland,
50 percent in the US and 25 percent in Canada and Australia. It is projected
that mortality due to cardiac ailments will in fact increase by 100 percent
in India by 2015. The number of people suffering from heart disease and ailments
is expected to become 100 million by the year 2010.
Modernisation and changing lifestyles have contributed to the decline in the
average age, when a person may suffer from a heart attack from 40 years to 30
years. There has been an overall increase in coronary diseases from six percent
to 10 percent in the past decade. The increasing rate of heart diseases amongst
the youth is a serious concern as about five percent of the patients who undergo
angioplasty and other heart surgeries in the country fall under the age group
of 30-35 years.
The Beautiful studya large clinical trial undertaken in December
2004 was initiated to evaluate the morbidity-mortality benefits of ivabradine.
This involved a total of 10,917 coronary patients with left ventricular dysfunction
in 33 countries, and was followed up for a median duration of 19 months and
a maximum duration of 35 months. The study revealed that in coronary patients
with a heart rate of more than 70 bpm, ivabradine significantly reduces the
risk of coronary events by 22 percent, fatal and nonfatal myocardial infarction
by 36 percent and coronary revascularisation by 30 percent.
Currently, Lupin commands 5.03 percent of the market share of the same and Lupins
34.27 percent year-on-year growth has outperformed the domestic cardiovascular
market consistently. The cardiac market in India is estimated to be around Rs
3,600 crore with a growth rate of 18 percent, out of which the market for angina
is estimated to be more than Rs 900 crore.
The company has secured global leadership position in anti-TB and cephalosporins
and has a significant presence in the areas of cardiovascular (prils and statins),
diabetology, asthma and nonsteroidal anti-inflammatory drugs (NSAIDs). The companys
R&D endeavours have resulted in significant progress in its new chemical
entity (NCE) programme. The companys foray into advanced drug delivery
systems has resulted in the development of platform technologies that are being
used to develop value-added generic pharma.