The Pipeline Report 2014: Class Seekers

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

Infectious Disease

PRODUCTS GENERATING BUZZ

ABT-450/r + -267 + -333 AbbVie
Indication: Hepatitis C (Ph. III)
What the clinical trials found: The INF- and RBV-free regimen ABT-450/r + -267 produced SVR12 rates of 95% in GT-1b treatment-naïve patients and 90% in null responders in Ph. IIb. SVR12 rates in those two cohorts hit 99% and 93%, respectively, among GT-1 patients taking the -333-containing regimen.
inThought Comment: This INF-free regimen combining non-nucleoside inhibitor NS5B (-333) with an NS5A inhibitor (-267) and protease inhibitor (-450) looks good perhaps for certain genotypes of HCV, and perhaps those refractory to Gilead's sofosbuvir (see below). Estimated launch: 2015 (Source: Symphony Health Solutions)
Credit Suisse revenue forecast: $1 billion in global annual sales by 2020
What the physicians are saying: Some potentially would like one regimen for all patients, but specialists might find more value in products for certain subtypes—an efficacious product in a subset of patients with easier dosing or containing fewer products overall. But AbbVie will be late to the game and have some work to do. —Rishi Dalsania, consultant, GfK HealthCare

Simeprevir Janssen
Indication: Hepatitis C (Pre-reg.)
What the clinical trials found: In GT-1a patients with the Q80K polymorphism (48% of those in two Phase III trials), SVR12 rates were 58% in the treatment group and 55% in the control group (statistically insignificant), vs. 84% in the segment without this polymorphism.
inThought Approvability Index and Comment: 90%. This small-molecule protease inhibitor (PI), specifically for GT-1 and -4 HCV infections, earned a unanimous vote from an FDA ad-com panel in October for GT-1 and should also get approved this year in an INF- and RBV-containing regimen. It's a small improvement over the existing PIs from Vertex and Merck, but could get a second life as part of an all-oral J&J regimen in 2014/15. Estimated launch: Jan. 2014 (Source: Symphony Health Solutions)
inThought revenue forecast: $637 million in global annual sales by 2016
What the physicians are saying: The Q80K matter, called out in October by the FDA ad-com panel, is an additional condition physicians would have to screen for, and could have a negative impact on perception. It will be interesting to see how they will approach this issue. —Rishi Dalsania, consultant, GfK HealthCare

Sofosbuvir Gilead
Indication: Hepatitis C virus (Pre-reg.)
What the clinical trials found: 95% of GT-2s achieved SVR12, 56% of GT-3s, in the Ph. III FISSION trial of treatment-naïve patients taking sofosbuvir + RBV; vs. 78% and 63%, respectively, in a group taking INF + RBV. No serious or severe cardiac AEs seen.
inThought Approvability Index and Comment: 90% (as part of an all-oral regimen in 2014). In October an FDA ad-com panel voted 15-0 in favor of approving this NS5B polymerase inhibitor without INF for GT-2 and -3 patients, and 15-0 for use along with INF (and RBV) in GT-1 and -4 infections. Its PDUFA date is Dec. 8, 2013, but the “real” approval will come when it's likely to get approved in an all-oral regimen with NS5A protein inhibitor ledipasvir. Estimated approval: Dec. 2013 (Source: Symphony Health Solutions)
inThought revenue forecast: $2.3 billion in global annual sales by 2016
What the physicians are saying: Sofosbuvir + RBV will likely be the first all-oral regimen to reach market, but for GT-2 and -3 at first—accounting for roughly 15% of the US HCV market. More anticipated is sofosbuvir + ledipasvir, a one-pill-a-day combo with which 95% of patients with the more common GT-1 achieved SVR12. It's also shown to be effective without ribavirin. Physicians want to get rid of RBV, because it's a burden from a pill standpoint and leads to anemia. ­—Rishi Dalsania, consultant, GfK HealthCare

OTHER KEY PRODUCTS IN THE PIPELINE

ABT-072 AbbVie
HCV (Ph. III)

Certolizumab AstraZeneca
Spondylitis (Pre-reg.)

Amikacin inhal. Bayer
Gram-neg. inf. (Ph. III)

Deleobuvir/BI 207127 Boehringer Ingelheim
Hep. C (Ph. III)

Faldaprevir/BI 201335 ­Boehringer Ingelheim
Hep. C (Ph. III)

Daclatasvir BMS
Virology (Ph. III)

Asunaprevir BMS
Virology (Ph. III)

Peginterferon lambda-1a BMS
Virology (Ph. III)

Ceftolozane/tazobactam Cubist
Gram-neg. inf./UTIs (Ph. III)

Cobicistat/darunavir Gilead
HIV/AIDS (Ph. III)

Ledipasvir/GS-5885 Gilead
HCV (Ph. III)

Zoster vaccine GSK
Herpes zoster (Ph. III)

Tivicay + Epzicom GSK
HIV infections (Pre-reg.)

GSK805 J&J
HCV (Ph. III)

TMC647055 J&J
HCV (Ph. III)

MK-3415A Merck
C. diff. inf. (Ph. III)

Vaniprevir/MK-7009 Merck
Hep. C (Ph. III)

V212 Merck
Herpes zoster (Ph. III)

V503 Merck
HPV vaccine (Ph. III)

MnB rLP2086 Pfizer
Meningitis B vacc. (Ph. III)

C. diff vaccine Sanofi
Prophylaxis (Ph. III)

Eravacycline Tetraphase
Infections (Ph. III)

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