The Fight Against Fat
This morning Arena
Pharmaceuticals (NASDAQ:ARNA) announced results from the BLOSSOM (Behavioral modification
and LOrcaserin Second Study for Obesity Management) trial for their weight loss
drug Lorcaserin. According to the company 63.2% of patients lost at least 5% of
their body weight, with 35.1% lost at least 10% of their body weight.
The drug
appeared to be fairly well tolerated with the three most common adverse events
being upper respiratory infection, nasopharyngitis and headache.
While the
company was pleased with the results and plans to move forward with the drug,
the results failed to impress investors as shares of Arena have fallen in pre-market
trading. Arena is not alone in the race to submit an obesity drug to the FDA as
Vivus Inc (NASDAQ:VVUS)
and Orexigen Therapeutics Inc (NASDAQ:OREX),
are also close to filing for regulatory approval of new obesity drugs. Also in this race is Novo Nordisk (NYSE:NVO)
and Amylin (NASDAQ:AMLN) with their GLP-1 compounds.
Just as
diabetes is growing at epidemic rates, obesity is major healthcare issue as it’s
estimated that more than two-thirds of Americans are obese. Many analysts
expect obesity drugs to quickly achieve blockbuster status given America’s
continuing battle against fat. Analysts
also see obesity drugs connecting with physicians who they believe will use the
drugs in a dual role as there is direct correlation between obesity and
diabetes.
The real
question is how the FDA will view these drugs. Already we have seen all the
companies involved in the fight against fat compile cardiovascular data as they
are anticipating that the FDA will view these drugs not just as treatments for
obesity. Diabetic Investor has speculated companies would position their
diabetes drugs as obesity drugs given the hard line taken by the FDA when it
comes to approving new diabetes drugs. Considering the type of data we’re
seeing from these studies it appears companies aren’t taking any chances and
want to ready for any issue thrown at them by the FDA.
Unlike other
drug categories Diabetic Investor does not believe there will be a huge
advantage for being first to market. Obesity drugs have a checkered history and
it’s likely the FDA will take their time during the approval process. Still
this is one huge opportunity and like the diabetes market competition will be fierce.
This could get very interesting, stay tuned.
