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

Infectious Disease

PRODUCTS GENERATING BUZZ
ABT-450/r+-267+-333+ribavirin Abbott Labs
Indication: Hepatitis C virus (Phase III)
What the clinical trials found: This non-nucleotide, oral regimen achieved a 97.5% SVR12 in GT1, therapy-naïve patients and 93% SVR in null responders, in Phase IIb. Ribavarin and boosted ritonavir were required to achieve 90%+SVR. Safety appeared consistent with standard of care.
inThought Approvability Index and Comment: 66%. Even though GS-7977 (see below) is the frontrunner in the hep. C pipeline, there is more than enough room for several different regimens to be successful. Abbott's and others will find a clinical niche. Estimated approval: July 2015 (Source: Symphony Health Solutions)
inThought revenue forecast: $1.1 billion in peak annual sales by 2019.

Dolutegravir GlaxoSmithKline/Pfizer/Shionogi
Indication: HIV/AIDS (Phase III)
What the clinical trials found: 88% of patients taking integrase inhibitor dolutegravir plus GSK's Epzicom produced virological suppression at 48 weeks, vs. 81% of those taking Gilead's Atripla in Phase III. Positive safety results have been reported.
Revenue forecast: £857 million ($1.4 billion) in annual sales in 2016, says Bernstein's Tim Anderson.
What the analysts are saying: KOLs are especially intrigued by dolutegravir's once-daily dosing and attractive resistance profile. In trials, naïve patients who failed dolutegravir did not develop resistance to integrase or nucleoside reverse transcriptase inhibitors. So dolutegravir may be able to meet an unmet need for a sturdier integrase inhibitor with a higher barrier to resistance. A dolutegravir+Epzicom regimen demonstrated superior tolerability to Atripla in treatment-naïve patients, especially with respect to CNS side effects. If co-formulated, tolerability could also give dolutegravir/Epzicom a potential edge over Stribild, which features elvitegravir but is burdened by cobicistat's side-effect profile. —Mimi Doi, PhD, JD, assoc. VP, GfK HealthCare

Sofosbuvir/GS-7977 Gilead Sciences
Indication: Hepatitis C virus (Phase III)
What the clinical trials found: 100% with genotype 1 infection taking this nucleotide drug with Gilead's NS5A inhibitor GS-5885 achieved SVR4, in the Phase II ELECTRON study of 25 patients. The safety profile was acceptable.
inThought Approvability Index and Comment: 60%. ‘7977 is the most promising hep. C drug in development but has a lot to live up to to justify the nearly $11 billion Gilead paid for Pharmasset. Estimated approval: March 2015 (Source: Symphony Health Solutions)
inThought revenue forecast: $2.1 billion in peak annual sales by 2019.
What the analysts are saying: GS-7977 thus far appears to successfully combine very high efficacy with a relatively clean side effect profile. Its oral administration is also seen as far superior to current therapies that are given as weekly injections. Currently, the drug is on track for a late 2014 approval, assuming no safety concerns emerge. Safety will be key given that this has so far been the biggest stumbling block for some of Gilead's competitors developing all-oral HCV treatments. —Marite Talbergs, SVP, research and consulting, GfK HealthCare

OTHER KEY PRODUCTS IN THE PIPELINE

Motavizumab Abbott Labs
RSV (Ph.III)

Peramivir BioCryst
Influenza A virus H1N1 (Ph.III)

Asunaprevir+daclatasvir BMS
Hepatitis C (Ph.III)

BMS 914143 BMS
Hepatitis B/C (Ph.III)

Faldaprevir/BI 201335+BI 207127 Boehringer Ingelheim
Hepatitis C (Ph.III)

Oritavancin/LY 333328 Eli Lilly
Gram-positive infections (Ph.III)

Avibactam/ceftazidime Forest
Gram-negative infections (Ph.III)

GSK 2282512A GSK
Influenza virus vaccine (Prereg.)

GSK 2321138A GSK
Influenza virus vaccine (Prereg.)

Meningococcal vaccine GSK
Groups ACYW-135 conjugate (Ph.III)

MMR vaccine GSK
MMR (Ph.III)

NB 001 GSK
Herpes simplex virus (Ph.III)

Rifaximin GSK
Clostridium infections (Ph.III)

Varicella zoster vaccine GSK
Varicella zoster virus (Ph.III)

Bedaquiline/TMC207 J&J
Tuberculosis (Prereg.)

Simeprevir J&J
Hepatitis C (Ph.III)

Actoxumab/bezlotoxumab/MK-3415A Merck
Clostridium infections (Ph.III)

Thymalfasin Merck
Hepatitis B (Ph.III)

V 503 Merck
HPV infection (Ph.III)

V 212 Merck
Herpes zoster (Ph.III)

V 419 Merck/Sanofi Pasteur
Hib-DTaP-hepatitis-B-poliovirus vaccine (Ph.III)

Delamanid/OPC 67683 Otsuka
Tuberculosis (Ph.III)

DTaP vaccine adult Sanofi
(Ph.III)

ChimeriVax Sanofi
Dengue fever vaccine (Ph.II)

DTaP-poliovirus vaccine
Sanofi Pasteur (Ph.III)

Japanese encephalitis vaccine
Sanofi Pasteur (Ph.III)

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