Thursday, August 22, 2013

Market Potential of Lipaglyn - Lipaglyn can replace use of fibrates in diabetes Patients?

Zydus Cadila Lipaglyn which has been approved for treatment of diabetic dyslipidemia is expected to be launched soon.  About 80 percent of the diabetes patients have confounding condition of dyslipidemia. The market size is huge, but  with regard to what share Lipaglyn can capture, it is important to understand the extent of benefit of Lipaglyn has on glucose lowering and lipid control. 

Based on available data points, we see Lipaglyn to be positioned primarily as a Triglyceride reduction and HDL raising agent for diabetes patients. Currently Fenofibrates are the standard of care for treating high triglycerides in diabetes patients.  Lipaglyn being predominantly a PPAR alpha agonist, it is likely to be very potent in the reduction of Triglycerides and increasing HDL levels.  

Lipaglyn may be developed for Additional Indications

PPAR alpha agonists stimulate mitochondrial FA beta-oxidation in vivo in both liver and muscle. With no kidney or liver safety issues observed in the trials, we believe Zydus would also be looking to develop this drug for treatment of Hypertriglyceridemia and Non Alcholic Steatohepatitis (NASH).  Through this mechanism, Lipaglyn increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity). The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPARa also induces an increase in the synthesis of apoproteins A-I, A-II and HDL-cholesterol.

Competition with Fenofibrates

Elevated TG is a common phenomenon observed with diabetes patients. The key advantage of Lipaglyn over Fenofibrates is that it can offer glucose reduction along with significant TG reduction, while fenofibrates do not have an impact on glucose levels. If priced appropriately, Lipaglyn can replace use of fenofibrates in India.

Global Potential for Lipaglyn

From a global launch perspective, we expect Zydus to develop the drug for Hypertriglyceridemia and Non Alcholic Steatohepatitis, while a development for Diabetes may not be financially feasible, as the hurdles are very high. The USFDA requires a large CV outcome study, along with carcionogenicity data before allowing human trials. Also with Roche suffering a recent setback for their dual PPAR agonist (aleglitazar), the sentiments on this class have further worsened, which will leave little bargaining power with Zydus as far as partnering with global pharma is concerned.

The best part with Zydus drug Lipaglyn is that it is not eliminated through kidneys, decline in EGFR (increase in creatinine levels) will not be an issue, as it has been found with Roche's aleglitazar and other dual PPAR agonist which have failed in the past. Hence we believe Lipaglyn if developed on a global scale, it truly has the potential to be a game changer for Zydus Cadila.

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