"On the Lipaglyn Launch……"

Pankaj Patel
Chairman and MD, Zydus Cadila
There is unmet healthcare need for a single drug with a dual action which single-handedly can control the dyslipidemia and provide glycemic benefits without side-effects.
Pankaj Patel, Chairman and MD, Zydus Cadila in an exclusive interview with Ananya Sen answers all you wanted to know about Lipaglyn.

Why was the need for a single molecule to control diabetic hyperlipidemia felt? Why couldn't the condition be dealt well with two separate drugs each for hyperlipidemia and diabetic control?
We can no longer look at dyslipidemia and diabetes in isolation and deal will them separately as research suggests that nearly 90 percent of all diabetics also suffer from dyslipidemia.

There is a gap currently in the treatment of diabetic dyslipidemia. For example PPAR alpha agonists like Fenofibrate which is required in a high dose of 160 mg to control only hypertriglyceridemia and has the drawbacks of renal/liver/muscle toxicity and when combined with statins in conditions where statins alone are not sufficient. The risk of myopathy with this combination increases further.

Diabetes control with Metformin alone may work in some, but not in all cases . The addition of sulfonylureas - poses risk of hypoglycemia. The addition of PPAR gama agonists like Pioglitazone can lead to weight-gain, edema and also have other side effects. Similarly, the incretins and insulin also have their drawbacks.

So there is unmet healthcare need for a single drug with a dual action which single-handedly can control the dyslipidemia and provide glycemic benefits without side-effects. Lipaglyn addresses this unmet need with its predominant PPAR Alpha and moderate PPAR Gamma action and an excellent safety profile. Lipaglyn is effective in reducing triglyceride levels, LDL cholesterol, total cholesterol and increases HDL Levels.

It also provides glycemic benefits like reduction in fasting plasma glucose and HbA1c. The clinical studies have shown that there is no weight gain associated with Lipaglyn, no edema, no cardiovascular adverse events and no potential for liver, kidney and muscle toxicity. Its dual pronged action and excellent safety profile make it a novel drug.

Are there any contraindications associated with the drug? Are its metabolites toxic? What is its route of elimination?
Lipaglyn has a non-renal route of elimination and is eliminated through the hepato-billary route. The absolute contraindication is hypersensitivity to any component of tab Lipaglyn.

Caution in case of pregnancy (Category C) is advised; Lipaglyn is not meant for the pediatric age group; excretion in breast milk is not known and should be avoided during lactation. It should not be given in combination with PPAR alpha agonists (fenofibrate - fibrates) or PPAR gama agonists (pioglitazone-TZDs).

What about the issue of carcinogenicity? Has its safety in this respect been proved?
Two-year carcinogenicity study of Saroglitazar was conducted in Wistar rats. No potential carcinogenic concern for humans was identified, which was further confirmed by a mechanistic study in non-human primates employing molecular biomarkers.

Does the drug show additional indications other than those stated ? LIPAGLYN has been approved for the treatment of diabetic dyslipidemia and hypertriglyceridemia with Type 2 diabetes mellitus not controlled by statin therapy alone. Trials are on for its use in Non-Alcoholic Steatohepatitis (NASH) and HIV-induced lipodystrophy.

When will Lipaglyn hit the Indian market?
We are planning to launch the drug in mid September this year.

What are your thoughts on the Patent Protection of Lipaglyn?
Lipaglyn is fully patent protected. A number of patents have been filed in all countries worldwide under the Patent Cooperation Treaty.

How are you planning to price the product in India and globally ?
In India, Lipaglyn has been priced much lower than any other NCE at Rs 25.90 . As far as the global pricing is concerned it is too early to discuss this .

Has the drug been filed for approval outside the Indian market? Which are those?
We have initiated the process for approvals in various regulated and emerging markets.

Have you partnered with other companies to launch your product outside the Indian market?
Not as yet but we are open to partnerships to market Lipaglyn in global markets.

What are your expectations from Lipaglyn in terms of its revenue generation potential?
Lipaglyn has the potential to become a blockbuster drug. Currently the market potential of drugs indicated for this therapy is USD 30 billion. We are planning to achieve Rs 100 crores in first three years of launch in India.

How many new products do you plan to launch by the end of 2020 ?
We have a robust NCE pipeline and hope to bring 2-3 more drugs to the market by 2020. In addition to this we are also developing our vaccines and biologics portfolio.