Why Lilly is right to diversify their diabetes business against Byetta

The lawsuit by Amylin against Lilly shows what can happen there are high sales expectations for a drug but these expectations don’t take into account the realities of the market.   Byetta was approved by the FDA in 2005 to help diabetics control type 2 diabetes when other medications could not.  However Byetta sales declined on a sequential basis largely because of missteps in marketing.

Byetta requires a twice daily injection 60 minutes before breakfast and dinner.  However with today’s busy schedules how many people can actually plan their meal times ?  But the real problems for Byetta started with buzz around to issues: the nausea it causes and the possibility of pancreatitis.

To counter the issue around pancreatic problems clinical data presented at the 70th annual American Diabetes Association convention,  held in late June,  served to reinforce current physician prescribing habits — which favor competitive agents from Novo Nordisk and Merck.   Amylin and Lilly’s presentations at ADA 2010 showed Byetta treated patients were at no higher risk for renal or pancreatic problems than existing treatments — including, Merck’s oral Januvia and Novo Nordisk’s in-kind Victoza injection therapy.   The data did help allay outstanding safety concerns clouding all three drugs.  Unfortunately, with no new sense of urgency for Byetta use all Amylin and Lilly accomplished was to provide additional reasons to prescribe competitive agents Januvia and Victoza, as both challengers  are easier to use for type-2 diabetes patients — once-daily dosing versus twice-daily.

In addition  both offer lower incidences of nausea (reason most commonly given by patients who discontinue their Byetta therapy).  Early on, Merck sales reps — either directly or indirectly — referenced Januvia as the “oral Byetta” – similar control of blood glucose, but with more convenient dosing, one pill a day without regard to meals versus twice-daily subcutaneous injections (one hour before morning and evening meals).

Wolters Kluwer analyst Ben Weintraub noted in an October 2009 report,:“What’s Holding Back Byetta,”

That patients tend to stop using Byetta sooner than other diabetes medicines. Analyzing data on 1.5 million U.S. diabetics followed from January 2008 – January 2009, Weintraub uncovered the following persistency trend: The average time on therapy for Byetta is 192 days, compared to 223 days for Januvia and 245 days for Janumet. Interestingly, the problem with Byetta is not an early drop-off, as might be expected due to nausea issues that generally resolve in the first couple months. Rather, the Byetta persistency curve follows other diabetes drugs until about six months, where it begins to drop off more sharply than the other drugs.Weintraub postulated that twice-daily injections could be a larger contributor to stopping Byetta use than GI adverse events.

So what are the key learning(s) here ?

(1) People prefer oral medications to medications that need to be injected unless you can clearly communicate a superior benefit of injecting the medication.

(2) Drugs that require people to learn to administer them vs. easy to administer drugs (oral) are already at a disadvantage. It’s harder to change patient behavior.

(3) HCP’s want drugs where patients will be compliant vs. drugs where they are not likely to be compliant.

(4) Don’t do head to head studies against competitors that show you are all on an even playing field if you don’t have clear differentiation in benefits.

(5) Amylin and Lilly did little to counter the online buzz of diabetics around nausea and pancreatitis.  The diabetic community online is one the most vibrant and engaged patient communities.