Here we go again

Here we go again

According to a press release issued by Roche today; “Roche announced today that results from the first five Phase III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose (blood sugar) in these studies. Roche’s taspoglutide, the first weekly human GLP-1 analogue in late stage development may improve treatment options for patients with type 2 diabetes.”

As has become standard for Roche we get all the hype and none of the data. According to the company the reason for this lack of any real data is they want to be able to present the data at upcoming conferences like the ADA in June. These company officials claim that if they were to release any real data the ADA would not allow them to present a more detailed review of this data at the conference.

Given that Diabetic Investor has been reporting on GLP-1’s since their inception we can state that this claim being made by Roche holds about as much water as a spaghetti strainer. All anyone has to do is go back and look at the various press releases from Amylin (NASDAQ:AMLN) when Byetta or Byetta LAR was in clinical trials or do the same with Novo Nordisk (NYSE:NVO) and their recently approved GLP-1 Victoza®.

Roche continues to live in fantasy land believing that everyone will take them on their word that tasoglutide is the greatest thing since sliced bread and soft soap. Based on earlier tasoglutide data, real data that is, presented at previous conferences tasoglutide has many of the same characteristics as other GLP-1’s and frankly there was nothing all that spectacular that made tasoglutide stand out.

While it possible that as they do more studies something has changed, we doubt that, but if this truly is the case why not back up the claim with some real data. The fact is releasing data, any data for that matter, wouldn’t prevent the company from making a more detailed presentation at the ADA conference.  

Diabetic Investor can’t say we’re all that surprised by Roche as they have been consistent and truly believe that outlets like Diabetic Investor will buy into their explanation. As Karl Popper once noted; “Ignorance is not simple lack of knowledge but an active aversion to knowledge, the refusal to know, issuing from cowardice, pride or laziness of mind.”

The real news coming out of this press release, since there really wasn’t any news reveled in the press release, is just how important the GLP-1 category is becoming. As Diabetic Investor has been reporting GLP-1 therapy has the potential to change the paradigm for the treatment of Type 2 diabetes. Roche, Sanofi-Aventis (NYSE:SNY), GlaxoSmithKline (NYSE:GSK), Lilly (NYSE:LLY) and just about anyone else in diabetes knows this which is why you can’t swing a dead cat without hitting a company who has a GLP-1 in their pipeline. The fact is everyone is chasing Amylin and Lilly and their once-a-week GLP-1 Byetta LAR awaiting approval from the FDA on March 5th. 

It should speak volumes just how paradigm changing LAR could be by the amount of rumors circulating about LAR’s PUDFA date being delayed. Based on everything that Diabetic Investor sees no reason for delay and the FDA could actually make an approval announcement before March 5th.  Unlike Novo Nordisk, LAR is not a new drug but rather a line extension. Given that current version of Byetta has been on the market for nearly five years and is being used by more than one million patients, the FDA has more than enough data to make a decision on LAR.

It’s worth noting that unlike Victoza® which was the subject of an FDA panel meeting, the FDA has not asked the same for LAR. Nor has the agency given any indication that they need additional information from Amylin. While it is possible there could be delay all the facts point to LAR meeting its PUDFA date. But when it comes to all these rumors about delays Wall Street is like many members of the media who don’t let the facts get in the way of what they see as a juicy story.  A story that Diabetic Investor believes is being helped by Amylin’s competitors who continue to talk out of both sides of their mouth when it comes to GLP-1’s.

Considering that we are just 22 days away from March 5th, we’ll soon see who’s right and who’s not. Unlike others Diabetic Investor prefers to look at the facts and not the speculation. As it stands today all the facts point to LAR meeting its PUDFA date. As Aldous Huxley said; “Facts do not cease to exist because they are ignored.”