The Pipeline Report 2013: Late-Stage Standouts

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The Pipeline Report 2013: Late-Stage Standouts
The Pipeline Report 2013: Late-Stage Standouts

Metabolic

PRODUCTS GENERATING BUZZ
Dapagliflozin Bristol-Myers Squibb/AstraZeneca
Indication: Type 2 diabetes (Preregistration); T1D (Ph.II)
What the clinical trials found: Lowers blood glucose levels, improves blood pressure and promotes weight reduction. The FDA raised concerns about bladder, breast cancer and liver risk, as well as cardiovascular issues.
inThought Approvability Index and Comment: 54%. In January FDA told BMS/AZ to collect more safety data, and now J&J's canagliflozin or Lilly/BI's empagliflozin are vying to be the first FDA-approved SGLT2 inhibitor. ADA data were reassuring, and dapa' will have a good shot when it goes back before FDA. Estimated approval: Jan. 2014 (Source: Symphony Health Solutions)
inThought revenue forecast: $609 million in annual sales by 2019.
What the analysts are saying: Cardiovascular risk underlies the way the FDA is looking at diabetes drugs (See: Avandia). On the other hand, there's a real need to help patients control blood-glucose and to control cardio-related co-morbidities. Clinical trials indicate that SGLT2s provide such benefit, but safety must be demonstrated. Results for J&J's canagliflozin (awaiting approval) indicate superior efficacy to dapa' in lowering HbA1C, without the same side effects. Dapa' may have been the first to go before the FDA, but there need to be more definitive statements on superiority and safety before we see a shakeout. —Dave Jacobson, SVP, Roper global diabetes group, GfK HealthCare

Tresiba (insulin degludec) Novo Nordisk
Indication: Type 2 diabetes (Preregistration); T1D (Prereg.)
What the clinical trials found: Trials among patients with type 2 diabetes suggested a 43% reduction in nighttime hypoglycemia vs. Sanofi's Lantus (seen mostly in one trial), longer duration and more flexible dosing times. The FDA has flagged cardio issues.
inThought Approvability Index and Comment: 79%. Novo Nordisk wants to leapfrog long-acting insulin Lantus, which is set to come off patent. But November's FDA advisory panel meeting cast some doubt on its timely approval and commercial success. Estimated approval: Jan. 2013 (Source: Symphony Health Solutions)  
inThought revenue forecast: $2.2 billion in annual sales in 2019.
What the analysts are saying: Tresiba—and sister product Ryzodeg, which includes a rapid-acting insulin—are designed for type 2s who need better post-prandial glucose control. [At press time, an FDA advisory panel voted 8-4 in favor of approval, but 12-0 that a large cardiovascular outcomes trial is needed to better define the potential cardiovascular signal seen in Phase III. Some also questioned its hypoglycemia benefit. –Ed.] While the cardio analysis can be done post marketing, US approval could be delayed (an October deadline already passed). Tresiba is also expected to initially cost more, and that could be an issue for existing insulin users—if Lantus is working for someone and there is a cost factor, why would the physician or patient switch? On the other hand, the cost may be offset by the potential of improved control of severe hypoglycemia, extended control over time and better compliance among new and existing insulin patients, if demonstrated. —Dave Jacobson, SVP, Roper global diabetes group, GfK HealthCare

OTHER KEY PRODUCTS IN THE PIPELINE

Bardoxolone methyl Abbott
Diabetic nephropathies (Ph.III)

Metreleptin Amylin
Lipodystrophy (Ph.III)

Lesinurad/RDEA-594 AstraZeneca
Gout (Ph.III)

Empagliflozin/BI 10773 BI/Lilly
Type 2 diabetes (Ph.III)

Insulin peglispro/LY2605541 BI/Lilly
Type 1/2 diabetes (Ph.III)

Linagliptin+pioglitazone BI/Lilly
Type 2 diabetes (Ph.III)

LY 2963016 (insulin glargine) BI/Lilly
Type 1/2 diabetes (Ph.III)

Metreleptin BMS/AZ
Lipodystrophy (Prereg.)
 
Arxxant/LY333531 Eli Lilly/Alcon
Diabetic macular edema (Prereg.)

Dulaglutide/LY2189265 Eli Lilly
Type 2 diabetes (Ph.III)

Syncria (albiglutide) GSK
Type 2 diabetes (Ph.III)

Canagliflozin J&J
Type 2 diabetes (Prereg.)

Afrezza MannKind
Type 1/2 diabetes (Ph.III)

Janacti/MK-0431C Merck
Type 2 diabetes (Ph.III)

MK-3102 Merck
Type 2 diabetes (Ph.III)

Galvus (vildagliptin) Novartis
Type 2 diabetes (Ph.III)

LCQ 908 Novartis
Hyperlipoproteinemia type I (Ph.III)

IDegLira Novo Nordisk
Type 2 diabetes (Ph.III)

Semaglutide Novo Nordisk
Type 2 diabetes (Ph.III)

Aleglitazar Roche
Type 2 diabetes (Ph.III)

Lixisenatide Sanofi
Type 2 diabetes (Prereg.)

Nesina (alogliptin) Takeda
Type 2 diabetes (Prereg.)

Mitiglinide Takeda
Type 2 diabetes (Prereg.)

TAK-875 Takeda
Type 2 diabetes (Ph.III)

Trelagliptin/SYR-472 Takeda
Type 2 diabetes (Ph.II)

Contrave Takeda/Orexigen
Obesity (Ph.III)

MABp1 XBiotech
Type 2 diabetes (Ph.II)
 
Beloranib Zafgen
Obesity (Ph.IIa)

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