The Battle for Supremacy in the GLP-1 Market

The Battle for Supremacy in the GLP-1 Market

Tonight while many people will be watching the NBA Finals another heavyweight battle will take place here in San Francisco. At 5pm PST Novo Nordisk (NYSE:NVO) will be holding their investor presentation highlighting their GLP-1 Liraglutide This event will be quickly followed by Amylin (NASDAQ:AMLN) who will be conducting their investor presentation at 7pm PST. Although Amylin already has Byetta, their GLP-1, firmly established in the market the big news everyone is waiting for is when their once-a-week version of Byetta, Byetta LAR, will be submitted to the FDA.

Following the Amylin and Novo events this evening will be Roche who will present data on their GLP-1 drug Monday at 6:30pm PST.

It is not an understatement to say that of all the events scheduled here at the conference none are bigger than these three presentations. The fact of the matter is GLP-1 technology has the potential to be a multi-billion dollar market and its adoption will have far reaching implications for the entire diabetes market both drugs and devices.

The actions of Novo Nordisk illustrate just how important this market is and provide a glimpse into just how far companies will go to gain an edge over the competition. Prior to the start of the conference everyone was well aware of the previously mentioned events, which abstracts would be presented and what data would be released. However, Novo surprised everyone when on Friday morning they issued a press release with the headline; “Clinical study shows liraglutide provides statistically significantly better blood glucose control than exenatide” (exenatide = Byetta). The study referred to is the LEAD™ 6 study which compared liraglutide to Byetta. According to the press release

“Patients treated with liraglutide achieved a reduction in HbA1c of more than 1.1 percentage points, compared to a reduction in HbA1c of less than 0.8 percentage points in the exenatide group, a difference which was statistically significant.”

“Both patients treated with liraglutide and patients treated with exenatide lost on average around 3 kg during the course of the study, with a trend towards more weight loss in the liraglutide group.”

“The most frequently reported adverse event for both liraglutide and exenatide was nausea at a level of around 25% (percent of all study participants reporting nausea at least once). In the liraglutide group, the percentage of patients reporting nausea in each week fell to low single-digit numbers after 8–10 weeks, similar to the level observed in a background population. In the exenatide group, the level after 8-10 weeks of treatment remained at the level of 10%.”

Here is what the press release didn’t mention, the complete data set from LEAD™6 won’t be released for almost another year. Basically Novo was saying liraglutide was better than Byetta without allowing anyone to see the full data set. Without this critical information no one could question the validity of Novo’s claim. We know nothing about dropout rates, methodology or patient breakdown.

Think of how the medical community would react if the researchers involved in the Advance or Accord trials stated, “Intensive glucose management is better than standard glucose management. We’ve seen the data, that’s what it says, we’re not going to show you the data- trust us this is what it says.” The uproar would send shockwaves throughout the convention center and likely cause a riot by this normally docile group of attendees.

What makes Novo’s action even more disturbing is they knew Amylin’s data for LAR was great but because of the news embargo no one could write anything about it until the embargo lifted the following day at 9am PST. Making matters worse, prior to the conference Novo told the press that there would be no major announcements prior to their scheduled events. With their bush league tactics Novo was deliberately trying to control the news flow, damage Amylin’s share price and steal Amylin’s thunder.

Sure enough there was the Novo CEO on Bloomberg and Amylin’s shares got hammered off nearly 10% for the day.

To their credit Amylin remained professional and did not immediately lift the embargo so everyone could write about the LAR data. Nor did they publicly condemn Novo’s unprofessional behavior to release selected bites of information and not the full data set. Taking the high road Amylin knew that although their shares would suffer in the short term, investors would be more than pleased with LAR’s data.

And just what does the data say:

Type 2 patients treated with Byetta LAR showed dramatic improvement in A1c -1.9% from baseline compared to patients on Byetta who’s A1c dropped 1.5% from baseline. Patients in both groups lost weight, an average of 8 pounds, and nearly 80% (77%) of patients using Byetta LAR achieved an A1c of 7% or less. The ADA defines a patient under good control when their A1c is 7% or below.

The bottom line here is not only does Byetta LAR outperform liraglutide, it’s once a week administration will make it the preferred choice by physicians. The facts, backed by all the released data, clearly show that Byetta LAR is superior to liraglutide. This may be tough news for Novo to take but the facts speak for themselves.

Diabetic Investor is disappointed in Novo’s unprofessional behavior as it is unworthy of what was a great company. There was no reason to use underhanded tactics as liraglutide is a good drug and does have a place in the market. Although it will not be as successful as Byetta LAR, the drug will do quite well given the move towards GLP-1 therapy in the Type 2 patient population.

Novo really has no one but themselves to blame as they are once again late to market with a good drug. This happened once already with Detemir and has happened again with liraglutide. It’s Novo’s own fault that they took too long to get liraglutide to the FDA allowing Byetta free rein in the GLP-1 market. Shame on Novo for once again being late to market and their unprofessional behavior. Frankly the company owes the entire diabetes community an apology.

David Kliff
Diabetic Investor
847-634-4646 fax
224-715-3761 mobile