Thursday, June 13, 2013

Can Cadila's Lipaglyn replace Statins in diabetes patients?

Cadila Healthcare's Lipaglyn is the first dual PPAR agonist to be approved anywhere in the world.  Many dual PPAR agonists have gone into late stage development in past, but were discontinued for safety issues. Although Cadila has not disclosed any data, but according to them, the compound does not have any of the safety issues that have led to discontinuation of  other PPAR agonists. In the past, Edema, weight gain, renal  and CV safety concerns have led to discontinuation of dual PPAR agonists. The prominent compounds that were discontinued were Galida / tesaglitazar (AstraZeneca) and Muraglitazar (Bristol-Myers).


With Statins being implicated to cause diabetes, can Lipaglyn replace them in diabetes patients

With Lipaglyn being an alpha agonist predominantly, we guess Lipaglyn would be potent from a lipid management perspective, but as far as HbA1C reduction is concerned, the efficacy is likely to be mild.  Hence the potential competitor to Lipaglyn would be statin. In the recent past statins have been implicated to cause new onset diabetes and also increase glucose levels. In such a a scenario, it would be interesting to see whether Lipaglyn gains acceptance in diabetes patients as a lipid management agent. With 70-80% diabetics having confounding dyslipidemia, the market potential is huge, but acceptance would largely depend on two things

1) Relative efficacy of Lipaglyn versus Statins in diabetes patients in terms of lipid management
2) In a price sensitive market like India, Pricing would be of utmost importance


 Partnering Prospects

With regard to partnering in the US, the prospects may not be very bright as developing a dual PPAR agonist would involve guzzling loads of cash. We see better chances for Cadila to find a partner for Japan and China where hurdles are not as high. This is evident by the fact that many Japanese companies have not chosen to develop their SGLT2 inhibitors in the US and EU, although they have filed for approval in Japan.

 The two most significant hurdles for developing this in the US being
1) USFDA requires a carcinogenicity study on any dual PPAR agonist that needs to be tested on humans. We are not aware if Cadila has been able to complete the same so far.
2) USFDA would also require a CV safety study, which would need to be conducted in a large population size and across the world. Not many companies would be willing to invest in such a large study, especially when they have seen so many failures in the same class in the past.
Only a large global pharma MNC would dare to take this forward. We believe Merck, AstraZeneca / Bristol-Myers may dare to take this forward. 

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