What Now?

What Now?

It’s official MannKind (NASDAQ: MNKD) has regained the rights to Afrezza. According to a company issued press release;

“MannKind Corporation (NASDAQ: MNKD) (TASE:MNKD) has assumed responsibility for the worldwide development and commercialization of Afrezza® (insulin human) Inhalation Powder from Sanofi, effective today, in a transition that ensures patients will not experience any interruption in their treatment. Under terms of the transfer agreement, Sanofi will continue to distribute Afrezza from its existing inventory until MannKind begins to distribute Afrezza during the third quarter.”

The big question is now what? Just what can MannKind do alone that they could not do when they were partnered with our wine drinking friends in France? Perhaps a bigger question given the precarious state of their finances, can they survive long enough to find another partner and/or additional capital. It’s an equally intriguing question as why anyone would want to partner with MannKind, when they can just let nature take its course, have the company file for bankruptcy and then scoop up Afrezza for pennies on the dollar.

Even under that scenario it’s very difficult to see Afrezza ever reaching the lofty heights once projected by the many overzealous analysts who bought into the MannKind malarkey. Keep in mind that many of the analysts were projecting sales in the billion dollar plus range, falling hook line and sinker for the MannKind Sanofi (NYSE: SNY) manure that Afrezza would succeed because it was inhaled rather than injected. That Afrezza would not suffer the same fate as Exubera that it would not end up being a $4 billion disaster.

And we are just loving how the MannKind zealots, especially those on Twitter, who at one time were singing long and loud how great it was that Sanofi was partnered with MannKind, are now thrilled that cash starved MannKind now has Afrezza back. Listen we’ll say this about these zealots they are very passionate yet this passion is blinding the realities of the situation.

The reality is this even if MannKind somehow found a partner and/or additional capital this would only delay not derail the inevitable. This would not solve Afrezza cost of goods issue, it would not solve poor formulary position, it would not lower Afrezza sales and marketing costs – the bottom line here is that about the only thing a new partner and or additional capital would do is transfer a problem that once belonged to Sanofi and MannKind to someone else and MannKind.

From the beginning we have stated that Afrezza was nothing more than a niche product, reaching sales in the millions NOT billions. From the beginning we stated that Afrezza had many hurdles to overcome, hurdles that would hurt sales. From the beginning we were clear, crystal clear, that Sanofi was the WRONG and WORST partner they could have picked. From the beginning we predicted that try as they might they would not avoid the fate that doomed Exubera.

We don’t mention this to gloat as honestly we take no comfort in the fact we were 100% right. The truth is there are patients using Afrezza and it is helping them manage their diabetes more effectively.  The truth is Afrezza does work and there is a place for the drug in the treatment regimen. Yet Afrezza is the posterchild for why the commercial aspects of a drug matters. We just love it when all these people say this isn’t about money, this is about helping patients. Well my friends wonder how the patients who are using Afrezza feel this moment as they drug they are using is about to be taken away because it was a COMMERCIAL not THERAPUTIC failure.

There is a reason we call this the BUSINESS of diabetes. There are reasons why we stress that as promising as some of these new drugs and whiz bang devices look, there must be a sustainable business model if they are actually going to help patients. It does not help patients at all when a drug like Afrezza is pulled from the market. It does not help advance diabetes management in any way when companies like Sanofi mismanage, and we are being overly kind today, a product like Afrezza.

So we have a message for all the MannKind supporters, those on Twitter and in the blogosphere, those who seem to believe that money does not matter, how do you feel today.  How does it feel to have the drug you’re taking that’s helping you be taken away? How do MannKind shareholders feel as they watch their investment sink into the abyss? Did anything good come of this, did anyone benefit from how poorly Sanofi handled Afrezza?

Time to wake up and get with the program, the business aspects matter and they directly impact patients.