Now that Lilly (NYSE:LLY) has officially split with Amylin (NASDAQ:AMLN), preferring instead their ill-advised partnership with Boehringer Ingelheim as their way back to relevance in diabetes, the two companies are now desperately trying to prove that the drugs coming out of this alliance really do make a difference; too bad their own data proves otherwise. Just yesterday more study data was released for their lead product Tradjenta™, which basically concluded what Diabetic Investor has been saying all along this is a rather lackluster late to market me-too drug that offers no compelling advantage over its competition one of which just so happens is a mega-blockbuster.
In one study the companies state; “Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced results of a 24-week open label arm of a phase III study for linagliptin in initial combination with metformin, which showed meaningful reductions in blood glucose for adults with Type 2 Diabetes (T2D).” Just how meaningful? According to the study; “Linagliptin was compared with glimepiride in T2D patients for whom metformin was inappropriate due to intolerance or contraindication. HbA1c levels in patients treated with linagliptin remained stable from 7.5% at week 18 to 7.4% at week 52.” Now we don’t mean to be picky here but by our way thinking keeping a patient’s HbA1c stable while admirable is hardly the goal, which buy our way thinking is to improve and lower HbA1c.
But wait there’s more as the study states; “Initial combination therapy of linagliptin with metformin resulted in mean HbA1c reductions of –3.7% in poorly controlled patients after 24 weeks.” Again we hate to be picky here, yet a reduction of HbA1c of less than 4% after 24 weeks isn’t something to brag about especially when you compare that performance to their well-established competition. This performance looks even worse when you compare the drug to Byetta, Victoza or the clinical data for Bydureon. True this is not an apple to apples comparison however these are drugs Tradjenta competes against.
Looking at other data the companies has released, we now understand why they call the results “meaningful” rather than significant, a word that will never be associated with Tradjenta. Even the geniuses at Lilly and BI, not known for being the most realistic bunch, must look at this collection of data and wonder just what the heck they were thinking when this partnership was put together. From the beginning of this ill-advised partnership Diabetic Investor was skeptical how it could possibly succeed when the drugs involved in the deal where nothing more than a collection of me-too, copycat, late to market drugs that offered no compelling advantage over established competitors. The deal looked even stranger, which is saying something, when you looked at the data set for Bydureon, a drug that has the potential to change the treatment paradigm for Type 2 diabetes.
So Lilly and BI are now stuck with a drug that really has no place in the market and must jump over two competitors, one of which is a mega-blockbuster, to gain traction. This is after spending millions to promote the drug putting the Tradjenta name on anything that moved. Perhaps the most unbelievable aspect over what’s quickly turning into one of the bigger disasters in diabetes drug history, the companies continue to believe that by some miracle they will be able to recoup their investment in Tradjenta. Being realistic, a foreign concept to the folks at Lilly and BI, it will take more than a miracle to save this dog of a drug. And frankly that’s an insult to dogs’ everywhere, who are not only loyal companions but also can measure a patients glucose levels.
Monday will be the much anticipated Lilly diabetes town hall meeting, many believe the company will announce further cut backs in their diabetes sales force, which makes sense since these unfortunate folks don’t have much of anything to sell. The company which fired the first shot in what has become a price war in the short-acting insulin market, is now reeling from that decision as Novo Nordisk (NYSE:NVO) has decided to fight fire with fire. The pipeline is basically worthless and soon they will have to watch Bydureon hit the market. Looking over the various analysts’ estimates for Bydureon sales, Lilly once again will have missed the boat in the diabetes space and perhaps lost any chance of once again becoming a relevant player in the space.
The company has hitched their wagon to the BI partnership and their flagship product Tradjenta is sinking faster than the Titanic. And unlike the Titanic story which became a blockbuster movie, the Lilly story will become a case study of how to turn gold into sand. We can just see it now “Trajunkta the ship that sank Lilly diabetes.”