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

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PRODUCTS GENERATING BUZZ

NEUROLOGY
Solanezumab Eli Lilly
Indication: Alzheimer's disease (Phase III)
What the clinical trials found: In Phase III, secondary analysis of pooled data in patients with mild Alzheimer's found a significant benefit in cognition (34% reduction in cognitive decline). This could not be confirmed in a second trial. Side effects include lethargy, rash and angina.
inThought Comment: It's very unlikely the FDA will approve sola'  as-is. Lilly will have to do additional clinical trials, and those are inherently unpredictable. If Lilly doesn't have biomarkers supporting clinical effectiveness, we see sola' having a 50-50 shot, but it will take several years (Source: Symphony Health Solutions)
Revenue forecast: Our model assumes a 2017 launch for sola, with peak (2020) estimates of $2.5 billion. —Catherine Arnold, analyst, Credit Suisse
What the analysts are saying: Although the cognitive effect in mild patients was not confirmed, being able to show benefit to the patient in terms of daily living activities (as opposed to only showing reduction in proxy measures of improvement) is important to practitioners as it is understandable to patients and their caregivers. Given the millions of patients that are or will be afflicted with Alzheimer's, this may hold blockbuster potential. —Marite Talbergs, SVP, research and consulting, GfK HealthCare

ORPHAN DISEASE
Recombinant factor VIII Fc (rFVIIIFc)
Recombinant factor IX Fc (rFIXFc) Biogen Idec/Sobi

Indication: Hemophilia A (Phase III)
What the clinical trials found: In separate Phase III trials, rFVIIIFc and rFIXFc were effective in controlling and preventing bleeding, routine prophylaxis and perioperative management. The long-acting clotting factor products were generally well-tolerated.
inThought Approvability Index and Comment: 56%. The hemophilia drug-development space has gotten a lot more interesting, with many compelling products coming. The two Biogen drugs have generated really nice data and look like they will be quite successful. Estimated approval date: Dec. 2014 (Source: Symphony Health Solutions)
inThought revenue forecasts: rFVIIIFc: $825 million in 2018; rFIXFc: $419 million in 2018.
What the analysts are saying: Frequency of administration is a negative for existing agents and is thought to impact quality of life, so any decreases in required use will make these products more convenient. Hemophilia patients are often reluctant to switch therapies when something has been working, so uptake could be slow in established patients. But given that administration is a common complaint, it is logical to believe that some may clamor for a less-frequent treatment. —Michael Garcia, SVP, research and consulting, GfK HealthCare

OTHER KEY PRODUCTS IN THE PIPELINE

NEUROLOGY

Dexpramipexole Biogen Idec
ALS (Ph.III)

BG-12 Biogen Idec
Multiple sclerosis (Prereg.)

BIIB017 Biogen Idec
Multiple sclerosis (Ph.III)

Tasimelteon BMS
Insomnia (Ph.III)

Eslicarbazepine acetate Eisai
Partial epilepsies (Ph.III)

Perampanel Eisai
Tonic-clonic epilepsy (Ph.III)

Edivoxetine Eli Lilly
Major depressive disorder (Ph.III)

Cariprazine Forest
Bipolar disorder (Ph.III)

Levomilnacipran Forest
Major depressive disorder (Prereg.)

Preladenant/MK-3814 Merck
Parkinson's disease (Ph.III)

Suvorexant Merck
Insomnia (Prereg.)

Safinamide Pfizer
Parkinson's (Ph.III)

Tafamidis meglumine Pfizer
Amyloid polyneuropathy (Prereg.)

Bitopertin Roche
Schizophrenia (Ph.III)

Ocrelizumab Roche/Biogen
Multiple sclerosis (Ph.III)

ORPHAN DISEASES

BMN-110/GALNS BioMarin
Mucopolysaccharidosis (Ph.III)

Migalastat GSK
Fabry's disease (Ph.III)

Pasireotide Novartis
Acromegaly (Ph.III)

N8-GP/NN7088 Novo Nordisk
Hemophilia A (Ph.III)

N9-GP/NN7999 Novo Nordisk
Hemophilia B (Ph.III)

Turoctocog alfa Novo Nordisk
Hemophilia A (Prereg.)

Tafamidis meglumine Pfizer
Amyloid polyneuropathy (Prereg.)

Eliglustat Sanofi/Genzyme
Gaucher's disease (Ph.III)

Empagliflozin Sanofi/Genzyme
Gaucher's disease (Ph.II)

Arbaclofen Seaside Therapeutics
Fragile X syndrome (Ph.III)

Idebenone Takeda
Friedreich's ataxia (Ph.III)

Miglustat United Therapeutics
Niemann-Pick diseases (Prereg.)

RESPIRATORY

A 64077 Abbott
COPD (Ph.III)

300 IR Abbott/Stallergenes
Seasonal allergic rhinitis (Ph.III)

FX125L Boehringer Ingelheim
Inflammatory diseases (Ph.II)

Olodaterol/tiotropium bromide BI
COPD (Ph.III)

GSK-642444 GSK
COPD (Ph.III)

Mepolizumab GSK
Asthma (Ph.III)

Relvar/Breo GSK
COPD (Prereg.)

Seebri Breezhaler Novartis
COPD (Ph.III)

Lebrikizumab Roche
Asthma (Ph.III)

WOMEN'S HEALTH

Elagolix Abbott
Endometriosis (Ph.III)

Trebananib Amgen
Fallopian tube cancer (Ph.III)

Serada Depomed
Hot flashes (Prereg.)

Trabectedin J&J
Breast/ovarian cancer (Ph.III)

Vintafolide Merck
Ovarian cancer (Ph.III)

Corifollitropin alfa Merck
Female infertility (Ph.III)

V503 Merck
Cervical cancer prevention (Ph.III)

Conjugated estrogens/bazedoxifene Ligand Pfizer
Vasomotor symptoms (Ph.III)

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