Is GSK in or out?

Is GSK in or out?

Yesterday GlaxoSmithKline (NYSE:GSK) announced additional results from their Harmony studies for their once-weekly GLP-1 albiglutide. According to a company issued press release;

“In Harmony 6, the second of the phase III ‘Harmony’ studies to complete, albiglutide was compared to preprandial insulin, each administered on top of long-acting insulin glargine.  In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint.

Results showed a reduction in HbA1c from baseline of 0.82% for patients receiving albiglutide compared to a reduction of 0.66% for preprandial lispro insulin (p<0.0001 for non-inferiority).  Weight change from baseline was -0.73kg in the albiglutide arm and +0.81kg in the preprandial lispro insulin arm (p<0.0001 for treatment difference).  The most common adverse events observed more frequently in the albiglutide arm than the comparator arm, in this 52 week study, were gastrointestinal in nature; nausea (13% for albiglutide versus 2.1% for preprandial lispro insulin) and vomiting (7% for albiglutide versus 1.4% for preprandial lispro insulin). “

Based on this data the company now feels they can move forward with albiglutide, although no specific date was given in the release it appears the earliest albiglutide would go to the FDA is 2014.

Given this is the wacky world of diabetes where anything can happen and usually does, it’s a pretty good bet that based on this news GSK should no longer be considered a possible buyer of Amylin (NASDAQ:AMLN). Some had speculated that GSK, who is desperate to get back into diabetes, might make a run for Amylin now that the company is officially in play and Diabetic Investor believes had the data from these studies been less than hoped for an Amylin bid was a real possibility. Still we would not completely rule out a bid as GSK must be wondering whether they’ll be facing the same situation Bristol Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) did when they launched Onglyza well after Januvia had established itself in the marketplace.

The harsh reality for GSK is no matter how good albiglutide may be time is not on their side. Even if they can get the drug to the FDA by 2014, Amylin will have more than a two year head start with Bydureon and making matters even more difficult by the time the FDA gets around to approving albiglutide, the Bydureon pen delivery system will be well established in the marketplace as well. Perhaps this is why GSK is taking a page from the Novo Nordisk (NYSE:NVO) playbook and building a robust data set for the drug.  For reasons that elude Diabetic Investor companies that are second to market with a me-too copycat drug spend far too much effort on building a huge data set and far too little time on factors that would actually get a patient/physician to switch from Bydureon to a competing therapy.

This is particularly true with the GLP-1 class of drugs where study data has become very predictable as nearly every GLP-1 has proven to be effective at lowering HbA1c, producing weight loss and the most common side effects being nausea and vomiting.  This class of drugs has also shown to produce little if any severe hypoglycemic events, another plus. Considering that all GLP-1 are injected and that it’s only a matter of time before we move from once-weekly dosing to once-monthly, Diabetic Investor believes that cost and delivery systems will determine the winner for GLP-1 supremacy.

It’s about time everyone begin to realize that GLP-1’s aren’t going away anytime soon and that they will not only adversely impact sales of insulin but have the potential to turn the entire type 2 drug category upside down. This is the reason there is so much interest in Amylin as everyone knows that more than ever being first to market provides a huge advantage. All one needs to do is look at Januvia to see this. Add in the unpredictability of the FDA and it’s easy to see why the bidding for Amylin could become very exciting. The simple truth is we no longer live in a world where we’ll see something like what we experienced when Avandia and Actos came to market within weeks of each other; quite frankly the FDA just isn’t working that way anymore. This more conservative and methodical approach by the FDA has created a huge advantage for any drug which is first to market.

GSK knows all this which is why we wouldn’t rule them out of the Amylin bidding just yet.  While it looks like they aren’t interested, looks as we all know can be deceiving.