Januvia passes, Afrezza on deck
Yesterday Merck (NYSE:MRK) besides releasing first quarter results announced preliminary results from the Tecos trail. Tecos was designed to gauge the cardiovascular impact of Januvia, a drug which had nearly $4 billion in sales last year. According to the company Januvia met the primary goal of showing comparable cardiovascular safety versus a placebo. Moreover, the drug did not demonstrate an increased risk of hospitalization rates for heart failure.
This news was well received on Wall Street where many analysts were concerned after AstraZeneca (NYSE:AZN) released results for their cardiovascular study for Onglyza. A study which noted that Onglyza may adversely impact cardiovascular outcomes and based on a recent FDA panel meeting on the subject will likely result in label changes for the drug. Given the results of Tecos it would seem unlikely the FDA would require any label changes for Januvia. We will gain greater clarity when Merck releases detailed results of Tecos at the upcoming American Diabetes Association Annual Scientific Sessions in early June.
Now that this issue has been put to bed, at least for the moment, one has to wonder how our good friend that crusading cardiologist Dr. Steven Nissen feels today. Is he taking some perverse pride in the fact that due to his ambush of Avandia that every diabetes drug company must conduct additional time-consuming very expensive studies to prove that their particular medication does not lead to adverse cardiovascular events? Is he proud of the fact that doctors can no longer feel comfortable prescribing any new medication? Does he jump for joy that because of his attack on Avandia the approval process for new diabetes drugs has forever changed and not for the better?
At least for the moment Merck, the millions of patients taking Januvia and their physicians can rest easy. That is until the good doctor and his minions find something new to go after. Let’s just hope they find another disease state to go after as they have caused enough damage in diabetes.
Turning our attention to another drug targeted at patients with Type 2 diabetes, tomorrow could be a red letter day for Afrezza as Sanofi (NYSE:SNY) reports first quarter results. It’s unclear at the moment whether our wine drinking friends will disclose any sales numbers for Afrezza but you can take it to the bank management will face multiple questions on the subject.
As we have been reporting Diabetic Investor cannot recall any new diabetes drug that has generated such passionate views. Looking over the various sales estimates, many of which have been lowered by analysts, even if Sanofi does disclose results for Afrezza its likely this debate will only intensify.
Diabetic Investor besides being interested in what’s said or not about Afrezza will be paying close to attention to another new Sanofi drug, Toujeo. Another drug which is likely to come under the microscope.
Yet the most intriguing aspect of tomorrows call is that it will be the first earnings call since Olivier Brandicourt officially became CEO. The question is will Olivier reveal any new strategies, will he provide investors with a sense of where he wants to take the company or will he deflect questions due to the fact he’s been on the job for such a short time.
Whatever happens tomorrow one thing is guaranteed no matter what’s said or what’s not said MannKind (NASDAQ:MNKD) zealots will rationalize any bad news and over-hype any good news. They will continue to believe that Afrezza is the greatest thing to happen to diabetes since the discovery of insulin. They will continue to confuse patient reviews of Afrezza with the business of diabetes.
The fact is, it’s still early in the game for Afrezza and truth be told we really won’t know how the drug is doing for another few quarters. That won’t stop the debate or make either side less passionate which quite frankly that isn’t a bad thing.