The Luckiest Drug EVER

The Luckiest Drug EVER

Yesterday the FDA issued a safety communication which added warning labels for two DPP4’s, Onglyza from AstraZeneca (NYSE: AZN) and Nesina from Takeda. It should be noted that the FDA did NOT include the current DPP4 market leader Januvia from Merck (NYSE: MRK) in this communication. A fact which just extends Januvia’s incredible streak of good luck. (More on this in a moment.)

This news should help Merck fend off Astra and Takeda as both were becoming more aggressive with payors. Although Januvia is a mega-blockbuster and the clear leader in the DPP4 category, Astra, Takeda and Lilly (NYSE: LLY) who also has a DPP4, were using price as a weapon to gain share therefore forcing Merck to either match the price or risk share erosion. Until these new warnings came out payors just assumed that all DPP4’s did the same thing the same way.

A thought that was reinforced back in August when the FDA when labels for all DPP4’s would have to be adjusted to include a warning over severe and disabling joint pain.

Yet these warnings are different and not just because Januvia is not included, these warnings are related to adverse cardiovascular events. Everyone knows this is a hot button issue of the FDA ever since that crusading cardiologist Dr. Steven Nissen began his quest to get Avandia off the market. The reality is payors cannot ignore these warnings they cannot claim that all DPP4’s, do the same thing the same way. This give Merck a powerful weapon to use with payors.

This news should also send a strong warning to Johnson and Johnson (NYSE: JNJ) and Astra as both have SGLT2’s which have ongoing cardiovascular trials. As everyone knows Lilly came out with great cardiovascular data for their SGLT2 Jardiance. The general consensus in the medical community is that Invokana from JNJ and Farxiga from Astra will show similar results, that this is a class effect. That all SGLT2’s, do the same thing the same way. Something that JNJ is really hoping for as they are the current leader in this category and don’t want to be at a disadvantage against Jardiance.

What this data for Onglyza and Nesina shows that even though these drugs are both in the DPP4 category their method of action and ingredients produce different outcomes than Januvia. Or put simply they don’t all do the same thing the same way, there are real and important differences. Something that wasn’t expected for just as the medical community believes all SGLT2’s will show cardiovascular benefits they also believed all DPP4’s would produce similar cardiovascular results. Well it’s obvious the medical community got it wrong with DPP4’s and since we do not have the data from JNJ or Astra for their SGLT2’s the possibility exists they won’t show the same results as Jardiance.

Should it turn out that neither Invokana or Farxiga show the benefits seen with Jardiance, it could turn the SGLT2 category upside down and give Lilly a major boost.

Still this news continues one of the luckiest streaks ever in diabetes drug history.  The reality is Januvia got every conceivable break in the book and Merck to their credit didn’t drop the ball. Back when Januvia hit the market Merck was in desperate need of a blockbuster. Amylin was launching Byetta and the other DPP4 was stalled at the FDA. The launch also came right on top of the Avandia controversy when physicians were actively looking for an Avandia and Actos replacements. To help matters Amylin who was then partnered with Lilly was busy screwing up the launch of Byetta.

Although it seems improbable today given how well Januvia has done, back in the day the drug was known as Junknuvia as the data for the drug wasn’t all that impressive. That when used as a monotherapy and not in conjunction with metformin it really didn’t do much. About the only thing the drug appeared to have going for it was it wasn’t associated with any notable adverse events, which seemed to make sense as looking at the data it really didn’t have much benefit either. The general thought back then was Byetta was a better option when the data was compared.

Yet as luck would have it the perfect storm came along and the rest as they say is history.  So kudos to Merck for not screwing up the luck that has come their way. A streak that is continuing.