LIPAGLYN - The world’s first drug for treating diabetic dyslipidemiacombines lipid and glucose lowering effects in one single molecule.
Triglycerides, The ignored twin of cholesterol in Lipids
Times of India, Mumbai Edition, Thursday, February 5, 2015
Mumbai: If cholesterol is the don of lipids (LDL-low density lipoprotein) then triglycerides (TG) is his major domo. TGs are the end products of digestion and breakdown of a fatty meal. When you think of fat being stored in your hips and belly you’re thinking of TGs. This leaves a special place for HDL (high density lipoprotein) cholesterol which is the good component.
Whilst the white and black races are flooded with a surge of LDL cholesterol, there is a majority amongst the Indians who carry the increased triglyceride gene. TGs often abound more than the traditionally treacherous LDL and this, either isolated or when associated with low HDL, forms a typically lethal lipid pattern. Indeed it is a dangerous precursor for making the blood thick and leads to the deposition of fats within arteries.
If desirable levels are < 140mg/dl, abnormal patterns amongst such Indians range from 200-500 and some patients even exceed this. Unfortunately high sugars are known to accompany high TGs, so the poor diabetic takes a double hit. This deranged lipid pattern being genetic, is seen to persist even in second and third generation Indians, whose families migrated half a century ago, proving that it is not the environment or habits that incite this elevation.. Like cholesterol, eating of fatty foods definitely enhances TGs but interestingly even the intake of starchy products (rice, potatoes etc) can add to TGs.
Statins are the wonder antilipid agents. However, whilst they lower the other cholesterol components, their action on TGs is not that potent and a lot of patients have a residual surfeit of TGs despite taking optimum doses of statins. Heretofore unsuccessful in the quest for a drug to reduce TGs, a lot has been tried and tested. Fenofibrate, nicotinic acid, omega 3 acids etc are often used but have not attained the desired goal. A new group of compounds– the glitazaars are now seen as the best in tackling this lipid fraction successfully.
Proudly in this “make in India” age, Saroglitazar, (saaro in Gujrati means good) the first of this group to be invented and manufactured in Ahmedabad and made available in 2013, has displayed great potency in reducing TGs. As if God sent, it also mildly reduces sugar and thus has been seen to be extremely useful in the diabetic. Medically it is mandatory to reduce cardiovascular mortality from lipids especially in the diabetic who has his hands (blood??) full of potential risks.
You can take an Indian out of India but not India out of Indian so, the TGs-riddled Indian gene is important to recognize and treat early. To ensure accurate determination of TGs, a minimum eight-hour fasting is required. Prudent dietary measures can also assist in curbing it. Unlike cholesterol, TG burnout with brisk exercise is possible and should be co-opted.
So next time you think of fats, get the full picture, for in the underworld of lipids, often the “Khamoshiyan” of the TGs speak louder than cholesterol.
(Dr Hemant Thacker is a consultant physician & cardio-metabolic specialist attached to south Mumbai hospitals. (Email:firstname.lastname@example.org)
DNA, September 16, 2014
After India success, Cadila to take innovator drug to US
Mumbai: Cadila Healthcare will soon start filings for approval of its innovator drug Lipaglyn in advanced markets such as the US and Europe.
The drug has garnered a patients base of 50,000 in India within the first year of its launch.
Ganesh Nayak, chief operating officer and executive director, Cadila Healthcare, told dna, "We launched Lipaglyn in the country on September 16 last year and we have till date 50,000 satisfied patients using the product. We have around 3,000 diabetologists, cardiologists and physicians. For us, this forms a good database. Now, we can take this product to the world."
Lipaglyn, to be used to treat diabetic dyslipidemia and hypertriglyceridemia in Type II diabetes, is the first new chemical entity (NCE) discovered and developed indigenously by an Indian pharma company. This drug has a unique dual action of working on both glycemic control and the lipid controls.
Nayak said the three biggest markets globally are the US, Europe and Japan. "We will simultaneously start filing in these markets and the regulatory process will start within the next few months. Within the next three to five years we would bring in our lipaglyn at the global level in terms of sales and marketing. Japan will take a little more time since there are some technical requirements in that market. Also to market in these places, we might look at different modules of selling this product there," he added.
In another development, Zydus Wellness, a subsidiary of the Ahmedabad-based Cadila Healthcare, recently launched a corporate social responsibility (CSR) initiative called 'Donate your Calories'.
This campaign has been initiated by Zydus Wellness' leading brand SugarFree (a low-calorie sugar substitute). The aim is to promote healthy eating and to save sugar calories by converting to a healthier choice, and the calories saved will then be donated to underprivileged children.
"This is a part of our CSR initiatives. We have tied up with an NGO called Akshaya Patra which feeds 14-15 lakh school children everyday. From "donate your calories", whatever will be the amount of calories saved will be donated to this NGO in terms of monetary proceeds. Initially, the initiative will be for a three-month period, that is, from October to December, and depending on its success we will review it. Our target is to save 300 crore of calories within these first three months," Nayak said.
Zydus pioneers a breakthrough with LIPAGLYN, India’s first NCE to reach the market
India, September 16, 2013
LipaglynTM - India’s first NCE launched in the market
Three months after announcing its breakthrough in research, the Zydus Group has launched LipaglynTM, a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia and Hypertriglyceridemia in type 2 diabetes, not controlled by statins alone. LipaglynTM will be available across India and can be prescribed by cardiologists, diabetologists and general physicians. The therapy is priced at Rs. 25.90 per tablet.
The therapy is marketed by Zydus Discovery, a new division launched to exclusively market the original research products of the group’s research pipeline, the first being LipaglynTM . With a strength of 200 people, the division also has regional medical advisors to support the scientific promotion of discovery research products. The launch of LipaglynTM begins with a series of CMEs and scientific symposia to highlight the gaps in the current management of diabetes and the unmet healthcare need of Diabetic Dyslipidemia.
Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the triglycerides, a decrease in the "good" high-density lipoprotein (HDL) cholesterol and may have elevated levels of the "bad" low-density lipoprotein (LDL) cholesterol and total cholesterol concentration in the blood. Optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL. LipaglynTM , is the first therapy to be approved for this condition.
Speaking on the occasion, Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus Cadila said, “It’s a great milestone for Indian pharmaceutical research today as LipaglynTM completes its journey from the lab to the market. LipaglynTM has opened up a new path in the care and management of diabetes and its complications and I believe this is just the beginning of India’s contribution to the world of pharma research.”
Research has shown that diabetes is one of the major risk factors of CVD. Globally, 3 out every 4 patients suffering from diabetes also suffer from dyslipidemia. India has a population of nearly 65 million diabetics and 77 million pre-diabetics and of this, an estimated 55 million people currently suffer from diabetic dyslipidemia. In dyslipidemia patients with diabetes, CV risk is heightened by 3-4 times as compared to people without diabetes. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD.
Discovered by the Zydus Research Centre, the dedicated NCE research arm of the Zydus group, LipaglynTM is a best-in-class innovation. A team of 400 research scientists at ZRC designed a unique cellular mechanism of action following an extensive structure-activity relationship study.
As a dual PPAR agonist, LipaglynTM has a predominant affinity to PPAR alpha and moderate affinity to PPAR gamma. This two-pronged, dual action helps in a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c), thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients. LipaglynTM has a superior safety profile. With a non-renal route of elimination, LipaglynTM has no adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious. LipaglynTM is recommended for once daily administration as a 4 mg tablet.
Zydus Discovery will offer a dedicated LipaglynTM support programme to patients and caregivers. The programme shall provide counselling and support through toll-free helpline numbers and online support through its website www.Lipaglyn.com.
India, September 16, 2013
- • LipaglynTM is the first Glitazar to be approved in the world and is the first NCE discovered and developed indigenously by an Indian Pharma Company
- • The drug has been approved for launch in India by the Drug Controller General of India (DCGI)
- • Over 80% of all diabetic patients are estimated to be suffering from diabetic dyslipidemia. There are more than 350 million diabetics globally – so the people suffering from diabetic dyslipidemia could be around 300 million
- • With 20 discovery research programmes under various stages of clinical development, the group invests over 7% of its turnover in research
- • At group’s state-of-the-art research arm, the Zydus Research Centre, over 400 research scientists are engaged in NCE research alone
The Zydus Group announced a breakthrough in its research efforts with LipaglynTM (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia or Hypertriglyceridemia in type 2 diabetes, not controlled by statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, LipaglynTM is the first Glitazar to be approved anywhere in the world.
“LipaglynTM provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control,” said Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus Cadila. "It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realized this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the field of drug discovery,” Mr. Patel added.
Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the "bad" low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the "good" high-density lipoprotein (HDL) cholesterol concentration in the blood. Optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL. LipaglynTM , a non-thiazolidinedione, is the first therapy to be approved for this condition.
World over, it is estimated that 30% of all deaths occur due to cardiovascular diseases (CVD). In India, one out of every five persons is at serious risk of developing CVD. Research has shown that diabetes is one of the major risk factors of CVD. India has a population of nearly 65 million diabetics and 77 million pre-diabetics. 85 - 97% of the diabetes patients suffer from dyslipidemia or lipid abnormalities. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD.
Discovered by the Zydus Research Centre, the dedicated NCE research arm of the Zydus group, LipaglynTM is a best-in-class innovation, designed to have a unique cellular mechanism of action following an extensive structure-activity relationship study initiated in the year 2000. LipaglynTM has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily. The molecule has shown beneficial effects on lipids and glycemic control without side effects. This molecule underwent extensive pre-clinical characterisation and the IND was submitted in the year 2004.
As a part of the clinical development programme, extensive Phase-I, Phase-II and Phase-III clinical trials were conducted to evaluate the phamacokinetics, pharmacodynamics, efficacy and safety of LipaglynTM. The new drug application for LipaglynTM was based on a comprehensive clinical development programme spanning eight years.
Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetes patients showed that the 4 mg dose of LipaglynTM led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients.
In the second Phase III study, LipaglynTM was studied in diabetic dyslipidemic patients insufficiently controlled with statin therapy. The results from this study confirmed that LipaglynTM had a pronounced beneficial effect on both the lipid and glycemic parameters in these subjects.
In both the studies, LipaglynTM was well tolerated and had a better safety profile than the comparators. Importantly LipaglynTM has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious. LipaglynTM is recommended for once daily administration as 4 mg tablets.
Zydus will offer a dedicated LipaglynTM support programme to patients and caregivers. The programme shall provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time.
About Zydus Cadila
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. From a turnover of Rs. 250 crore in 1995, the group posted revenues of over Rs. 6300 crore in FY2013. With 20 discovery research programmes under various stages of clinical development, the group invests over 7% of its turnover in research. At the group’s state-of-the-art research arm, the Zydus Research Centre, over 400 research scientists are engaged in NCE research alone. The group employs over 15,000 people worldwide and is dedicated to creating healthier communities globally. It aims to be a leading global healthcare provider with a robust product pipeline; achieve sales of over $3 billion by 2015 and be a research-based pharmaceutical company by 2020.
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