Big News Day

Big News Day

The ADA conference does not officially begin until this Friday yet today we have seen a host of news in the diabetes sector. The most recent news hitting the wires came from Lilly (NYSE:LLY) who has agreed to sell their Humulin insulin line co-branded with Wal Mart (NYSE:WMT), the world’s largest retailer. According to a company issued press release; “Beginning in mid-September, Lilly’s Humulin(R) brand of insulin will be available in Walmart pharmacies across the U.S. under the dual-branded name Humulin(R) ReliOn(R), including 10 mL vials of Humulin(R) R U-100, Humulin(R) N, and Humulin(R) 70/30 formulations.”

Although this agreement does not cover Lilly’s newer more advanced insulin, Humalog®, it does speak to Wal Mart’s focus on providing lower cost therapy options. It is also not the first time Wal Mart has partnered with an insulin company as the retailer has partnered with Novo Nordisk (NYSE:NVO) in the past.

Speaking of Novo the company announced today they are reinitiating their Phase 3 obesity program for liraglutide. According to a company issued press release; “Following the US approval of Victoza® for the treatment of type 2 diabetes, Novo Nordisk has been in dialogue with the FDA regarding the further progression of the development programme investigating the potential of liraglutide within obesity. Based on the feedback from the FDA, Novo Nordisk now plans to re-initiate the global phase 3 programme in the first half of 2011 in clinical trials comprising approximately 5,000 patients.”

Also jumping into the fray is Johnson and Johnson (NYSE:JNJ) who announced the signing of two deals in the diabetes drug space. The first was with Diaymd Medical AB, a Swedish company that is conducting late-stage clinical tests on a drug, which is designed to prevent further destruction of pancreatic islet cells, delay or prevent disease progression and other related complications.

The second deal was with Metabolex Inc. who has potential Type 2 diabetes drugs in preclinical development.

Finally we had some clinical data from Astra Zeneca (NYSE:AZN) and Bristol Myers Squibb (NYSE:BMS) on their type 2 drug Dapagliflozin. According to a study published in the online version of Diabetes Care; “Dapagliflozin lowered hyperglycemia in treatment-naïve patients with newly diagnosed type 2 diabetes. The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for type 2 diabetes.”

Taking a closer look of the study it should noted that according to the authors; “This was a 24-week parallel-group, double-blind, placebo controlled phase 3 trial. Patients with glycosylated hemoglobin (A1C) 7.0-10% (n=485) were randomly assigned to one of 7 arms to receive once-daily placebo or dapagliflozin 2.5, 5 or 10 mg once-daily in the morning (main cohort) or evening (exploratory cohort). Patients with A1C 10.1-12% (high-A1C exploratory cohort; n=73) were randomly assigned 1:1 to receive blinded treatment with a morning dose of dapagliflozin 5 or 10 mg/day. Primary endpoint was change from baseline in A1C in the main cohort, statistically tested using an analysis of covariance.

Results In the main cohort, mean A1C changes from baseline at week 24 were -0.23% with placebo and -0.58%, -0.77% (P=0.0005 vs placebo), and -0.89% (P<0.0001 vs placebo) with dapagliflozin 2.5, 5, and 10 mg, respectively. Signs, symptoms and other reports suggestive of urinary tract infections and genital infection were more frequently noted in the dapagliflozin arms. There were no major episodes of hypoglycemia. Data from exploratory cohorts were consistent with these results.”

While some may say that lowering A1C, .58%, .77% and .89% is significant, Diabetic Investor is not overly impressed with these results as they are on par with other already approved medications on the market. We we’re even less impressed when you consider the baseline A1C of study participants. It should also be noted that other medications on the market and under development have shown superior A1C lowering in treatment naïve patients.

Based on this news today Diabetic Investor sees several trends developing that will likely be reinforced at ADA. First, the Lilly – Wal Mart news demonstrates how the economy impacts diabetes management. While Humulin is not a bad insulin, all available data indicates the newer insulin analogues are superior. However this superior performance does come with a higher price tag and in today’s poor economy not all patients can afford superior treatment options. Or put another way, while they would like the best available drugs these drugs are not always affordable.

Second, Novo is seeking new life for Victoza® as they know Bydureon will soon be on the market. They also know that Roche just announced their once-weekly GLP-1 is delayed at least another 12 to 18 months, which allows them time to develop the once-weekly version of Victoza. Realizing that Bydureon will likely own the diabetes indication for a long acting GLP-1 and that the obesity market is as large, if not larger, than the diabetes market they could reposition Victoza and salvage this drug which has been handicapped by a black-box warning and poor formulary coverage.

JN J, like Roche, is not currently known for their diabetes drugs but has a strong presence in the device market. As Diabetic Investor has noted on several occasions the future outlook for the device side, whether its blood glucose monitors or insulin pumps is rather bleak while there is plenty of upside developing better therapy options. The company already has a presence in the diabetes market and could use their existing sales force to reach the important primary care physician market, the physicians who treat nearly 80% of the diabetes patient population.

Finally the news from Bristol and Astra Zeneca while hardly earth-shattering does point to another trend in the diabetes drug arena. Everyone realizes that for type 2 patients in particular, patients and the physicians that treat them are in desperate need for better therapy options. They also understand that FDA has become overly conservative in their approach to approving new medications as efficacy is no longer the primary factor when approving new drugs. Due to the Avandia controversy the FDA is placing adverse event profiles on par with efficacy. The black box given to Victoza is the just the latest example of how conservative the FDA has become.

Lastly, while there has been no public acknowledgment of this Diabetic Investor believes we are headed for a system where cost-effectiveness will figure into the drug approval process. Just as the British has NICE, it’s only a matter of time given the rising cost of healthcare that America develops our own version of NICE.  The simple fact is there are too many me too drugs on the market and we don’t need multiple drugs in the same category that do exactly the same thing. While the drug companies would beg to differ do we really need multiple DPP-IV on the market or three short-acting insulin analogues?

As today’s news indicates we’re in for one exciting ADA – let the fun begin.