The Pipeline Report 2014: Class Seekers

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The Pipeline Report 2014: Class Seekers
The Pipeline Report 2014: Class Seekers

Metabolic

PRODUCTS GENERATING BUZZ

LY 2963016 (insulin glargine biosimilar) Eli Lilly/Boehringer Ingelheim
Indication: Type 1/2 diabetes (Ph. III)
What the clinical trials found: Several studies were conducted using current insulin glargine as the comparator, including one Ph. III trial when administered with oral diabetic medications in patients with T2D, another when given in combination with mealtime insulin lispro (Humalog) in patients with T1D.
CS Approvability Index and inThought Comment: 45%. This insulin glargine product was already filed in the EU as a true biosimilar of Sanofi's Lantus basal insulin. This will be a test case for biosimilars. The question is not approvability but how much of a discount they apply—our model has 30%—and how much can it disrupt the current branded drug.
Credit Suisse revenue forecast: $1.4 billion in annual sales by 2020
What the analysts are saying: The annual Roper Diabetes study of 2,000 patients suggests that Lantus will be hard to dislodge. If physicians and patients believe they've got something equivalent that's safe and effective, there seems to be opportunity. But the educational investment would need to be high. Lilly has the advantage of being a leader in the market. But most patients in our study are under the care of PCPs, who don't have a lot of time to invest in education. It's also unclear what will distinguish their product from Lantus. —Mary McBride, president, GfK Roper Diabetes

Dulaglutide Eli Lilly
Indication: Type 2 diabetes (Pre-reg.)
What the clinical trials found: Superior HbA1c reductions vs. placebo and vs. exenatide (AWARD-1), vs. metformin (AWARD-3) and vs. sitagliptin (AWARD-5); significant weight loss vs. sitagliptin, and similar weight loss to patients taking comparators in the other two trials. Mild-to-moderate nausea was the most common AE reported.
Credit Suisse Approvability Index and inThought Comment: 50%. We already have a bunch of GLP-1s on the market, but it will be interesting to see how these formulations get used with insulin. Obviously the once-a-week version is similar to AZ/BMS's Bydureon and might have some advantages in terms of injectability and needle size. Estimated launch: 2014 (Source: Credit Suisse)
Credit Suisse revenue forecast: $806 million in global annual sales by 2020
What the analysts are saying: Since if you're on a GLP-1, our data show, you're more likely to see an endo—and endo's are a small proportion of prescribers—the chances of it being widely prescribed are more limited. (In our data, 5-6% of patients are on a GLP-1.) It's difficult to know how it will be priced. Lilly is still waiting for results from AWARD-6 (with Victoza as the comparator), so if they can show superiority, then with its once-weekly dosing, it would be in a good position. —Mary McBride, president, GfK Roper Diabetes

Dapagliflozin BMS/AZ
Indication: Type 2 diabetes (Pre-reg.)
What the clinical trials found: New Ph. III data showed dapagliflozin added to metformin and sulfonylurea, at 24 weeks, reduced HbA1c -0.86% vs. -0.17% in the placebo group; reduction in mean body weight was -2.65 kg at week 24 vs. -0.58 kg in patients who received placebo. Rate of urinary tract infection: 6.4% for dapagliflozin vs. 6.4% for placebo.
CS Approvability Index and inThought Comment: 50% (US). Two oral SGLT2 inhibitors from BMS and J&J were neck-and-neck in clinical development. BMS's was supposed to get approved first but got a CRL from the FDA in January 2012 requesting more data. Invokana (cangliflozin) was approved first, and its launch has been good. As far as we can tell, the clinical distinction between dapa' and cana' is minimal. It will be a question of how much an additional SGLT2 can expand the market and whether they can compete. The next PDUFA date is Jan. 11, 2014. Estimated approval: 2014 (Source: Credit Suisse)
Credit Suisse revenue forecast: $1.6 billion by 2020
What the analysts are saying: The new Ph. III data showing it to be effective as an add-on to metformin and sulfonylurea in terms of A1c reduction, combined with weight reduction and BP control, is advantageous. It looks like it's on the road to approval. If it reaches market, it's likely to be prescribed second- or third-line, competing with DPP-4s and GLP-1s. Kidney disease will not be a huge factor; not many T2D patients are reporting it. —Mary McBride, president, GfK Roper Diabetes

OTHER KEY PRODUCTS IN THE PIPELINE

SaxaDapa FDC AZ
Diabetes (Ph. III)

Empagliflozin BI/Lilly
Diabetes (Ph. III)

Albiglutide GSK
Diabetes (Ph. III)

Omarigliptin Merck
Diabetes (Ph. III)

Tresiba Novo Nordisk
T1/2 diabetes (Pre-reg.)

Ryzodeg Novo Nordisk
T1/2 diabetes (Pre-reg.)

NovoThirteen (rFXIII) Novo Nordisk
Congenital deficiency (Pre-reg.)

IDegLira Novo Nordisk
Diabetes (Pre-reg.)

FIAsp Novo Nordisk
Diabetes (Ph. III)

Semaglutide Novo Nordisk
Diabetes (Ph. III)

U300 Sanofi
T1/2 diabetes (Ph. III)

Lyxumia Sanofi
Diabetes (Ph. III)

Contrave Takeda
Obesity (Pre-reg.)

TAK-875 Takeda
Diabetes (Ph. III)

DIAPep Teva
Diabetes (Ph. III)

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