Does it matter?

Does it matter?

Yesterday Novo Nordisk (NYSE: NVO) released results from their LEADER trial which by all accounts was very impressive. According to a company issued press release;

“Novo Nordisk today announced that Victoza® (liraglutide) significantly reduced the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo (95% confidence interval [CI]: 0.78; 0.97, p=0.01), when added to standard of care in 9,340 adults with type 2 diabetes at high CV risk.”

While shares of Novo initially rose on this news they have been sliding today as Lilly (NYSE: LLY) announced this morning additional data for their SGLT2 Jardiance. According to a company issued press release;

“New data showed Jardiance® (empagliflozin) reduced the risk for new-onset or worsening kidney disease by 39 percent versus placebo when added to standard of care in adults with type 2 diabetes with established cardiovascular disease.”

This follow on data comes from the EMPA-REG trial which also showed that Jardiance cut CV deaths by 38% and produced an overall relative risk reduction of 14%. By way of comparison the LEADER data showed Victoza cut CV deaths by 22%, and its relative risk reduction was 13%.  Some also noted that that the North American subgroup in the LEDAER trial did not show a significant effect on these metrics.

It’s unclear what impact this avalanche of data will have on the respective drugs. As ground breaking as EMPA-REG is, so far it has yet to translate into share gains for Lilly. The general consensus as we noted while in NOLA is that all SGLT2’s will show similar CV outcomes therefore making this a class effect.

This same belief is emerging that the LEADER data will be replicated by other GLP-1’s. Ironically this may benefit Lilly as they have a once-weekly GLP-1 Trulicity compared to Victoza which is taken once daily. GlaxoSmithKline (NYSE: GSK) also has a once-weekly Tanzeum while AstraZeneca (NYSE: AZN) has Bydureon which is also once-weekly. Novo soon will be joining this group with semaglutide.

So the question is as positive as the LEADER data is will it translate into share gains for Victoza. Will Novo run into the same issue Lilly is having where payors see no reason to make any changes based on data as payors see this as a class effect. Additionally, will physicians who prescribe these drugs see any reasons to make changes in their prescribing patterns based on this data. As we noted while in NOLA most physicians believe all SGLT2’s will produce CV benefits and therefore there is no reason to change prescribing patterns. Should this same belief take hold in the crowded GLP-1 category Victoza could run into the same problem as Jardiance, great data but no jump in share.

Some have looked at all this CV data as some sort of vindication for that crusading cardiologist Dr. Steven Nissen. According to an article posted by Forbes;

“The tests of the new diabetes drugs were birthed by one of the biggest controversies to hit the FDA: the accusation that the best-selling diabetes pill, GlaxoSmithKline’s Avandia, caused heart attacks. Steven Nissen, who launched the controversy with an analysis in the New England Journal of Medicine, suggested at an FDA meeting that what were needed were large studies of whether new diabetes drugs prevented heart attacks. These studies, which were attacked as a barrier to new products, are what are now delivering results.

“It is a triumph for evidence-based medicine,” Nissen says of the two trials. (He worked on the Victoza study.) “It is incredibly important for patients. It will stimulate industry to work even harder to try and find therapies that will affect cardiovascular mortality. It’s an amazing turnaround for a field that was stagnating.”

We agree that without the Avandia controversy these studies would may have never been done yet we’re not sure we agree with the good doctor. The fact is the diabetes drug field was not stagnating, at least not in terms of new product development. And given how this market is becoming a commodity market we’re also not sure that these CV studies would not have been done anyway as a way to differentiate one drug from another.

As we have noted previously there is a growing consensus that HbA1c is an incomplete gold standard, that it does not provide a clear enough picture. Thanks to Dr. Nissen CV studies have become the latest data point used to differentiate one drug from another. However, like A1C the CV data isn’t that valuable in terms of market share when payors and physicians believe the data will be replicated by all drugs in the class. This just strengthens our belief that diabetes drug companies will continue to add additional biomarkers to their clinical studies as a way to differentiate their offerings.

Basically the LEADER results are having the same impact as the EMPA-REG results forcing those without data to match or come close to a known data set. Johnson and Johnson (NYSE: JNJ) and AstraZeneca are in this position with their respective SGLT2’s while Lilly, AstraZeneca and GlaxoSmithKline are in this position for their respective GLP-1’s.

Our concern here is that we are about to get into a war over study design. This is exactly what happened when the good doctor came out with his now debunked meta-analysis. The fact is there is really no such thing as “hard” indisputable data. Study data isn’t like the final score in a game which reveals a clear winner and loser. Study data is open to interpretation it is not a final score. As we witnessed when the Avandia controversy was in full swing two experts can look at the exact same data set and come up with two very different conclusions. Our gut tells us that history will repeat itself.

Looked at stickily from a market share perspective this debate over data sets and study design favors those that don’t yet have “hard” data. On the flip side however it does put them under pressure to match or come close to matching a known data set. Meanwhile while we await this data payors and physicians will likely go with their gut until there is another data set to look at. Right now their gut is telling them when it comes to CV data it is a class effect for both SGLT2’s and GLP-1’s.

So we’re back to our original question in terms of market share will all this data, excuse the expression, move the needle for either Jardiance or Victoza. Just going by how Jardiance has done since the EMPA-REG data became known we would say no.

Ironically the real winners here aren’t Novo or Lilly but every diabetes patient using either an SGLT2 or GLP-1 and that’s not a bad thing. And quite frankly it’s about time patients started getting in the win column.