The Pipeline Report 2014: Class Seekers

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



Secukinumab Novartis

Indication: Ankylosing spondylitis/plaque psoriasis/psoriatic arthritis/RA (Phase III)
What the clinical trials found: In a Ph.-III trial of patients with moderate-to-severe plaque psoriasis, PASI 90 rate seen at week 52 was 65% and 33% in the secukinumab 300mg and Enbrel groups, respectively (statistically significant). AE incidence similar for both drugs.
inThought Approvability Index and Comment: 85%. This monoclonal antibody inhibits the IL-17A receptor, thought to be very important in immune response and, for reasons we don't completely understand, secukinumab is a game-changing drug in psoriasis that doesn't do much in RA and works about the same as other drugs in psioriatic arthritis. It seems to do the trick in psoriasis, where clinicians measure efficacy by seeing how many patients achieve a 50% clearance in the amount of rash on their body—PASI 50. J&J's Stelara raised the standard to PASI 75. But IL-17s are so good that they bypass that and require PASI 90. Scientists are starting to measure PASI 100, which in the world of drug development is as close to a cure as you can get. If someone had gotten up at a dermatology meeting five years ago and talked about PASI 100, they would have been laughed off the stage. Amgen and Lilly each have IL-17s that look to be just as good as Novartis's in psoriasis. This probably will get approved in psoriatic arthritis but not for RA, as it's not much better than the TNF inhibitors for that disease. Expected launch: 2014, psoriasis (Source: Credit Suisse)
Credit Suisse revenue forecast: $1.5 billion in annual global sales by 2020.

Eloctate (recombinant factor VIII Fc) Biogen Idec/Sobi

Indication: Hemophilia A (Pre-registration)
inThought Comment: In partnership with Swedish Orphan Biovitrum AB (Sobi), Biogen Idec has two long-acting recombinant coagulation factors for the treatment of hemophilia A and B, Eloctate and Alprolix, respectively. Eloctate (rFVIIIFc) is poised to be approved next year. This continues to be a very active area, with several new drugs coming from Baxter and Sanofi, as well.
What the analysts are saying: Eloctate is currently under FDA review with potential approval in 1Q14 (PDUFA date in March 2014). Biogen Idec noted that it's planning for a mid-2014 commercial launch of Eloctate in the US (~90 days approval delay). Sobi has noted <1 year FDA delay for Eloctate would not impact its EU approval timeline. For Alprolix (rFIXFc) for hemophilia B, FDA approval is expected in 1Q14, as well. For Sobi territories (ex-US), Phase III pediatric data for Eloctate/Alprolix are on track for 1H14/2H14, respectively. —Eun Yang, equity analyst, Jefferies


Brodalumab/AMG-827 Amgen
Psoriasis (Ph.III)

Romosozumab/AMG-785 Amgen
Postmeno. Osteo. (Ph.III)

Brodalumab AZ
Psoriasis (Ph.III)

Lesinurad AZ
Gout (Ph.III)

Apremilast Celgene
Psoriatic arthritis (Pre-reg.)
Psoriasis (Ph.III)

Baricitinib Eli Lilly

Ixekizumab Eli Lilly
Psoriasis (Ph.III)

Tabalumab Eli Lilly
Lupus (Ph.III)

Sirukumab GSK/J&J

Vercirnon GSK
Crohn's (Ph.III)

Tildrakizumab/MK-3222 Merck
Psoriasis (Ph.III)

AIN457 Novartis
Psoriasis (Ph.III)

Sarilumab Sanofi

Fedratinib Sanofi
Myelofibrosis (Ph.III)

Vedolizumab Takeda
Ulcerative colitis (Pre-reg.)

Drisapersen GSK

2696273 GSK

Migalastat GSK
Fabry (Ph.III)

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

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

AFQ056 Novartis
Fragile X synd. (Ph.III)

Tafamidis meglumine Pfizer
TFAP (Pre-reg.)

Cerdelga Sanofi
Gaucher (Pre-reg.)

Lumacaftor Vertex
Cystic fibrosis (Ph.III)


Mepolizumab GSK
Asthma (Ph.III)

Fluticasone furoate (685698) GSK
Asthma (Ph.III)

Anoro Ellipta GSK
COPD (Pre-reg.)

MK-7243 Merck
Allergy (Pre-reg.)

MK-3641 Merck
Allergy (Pre-reg.)

Lebrikizumab/RG3637 Roche
Severe asthma (Ph.III)

Octreotide/RG3806 Roche
Acromegaly (Ph.III)

Elagolix AbbVie
Endometriosis (Ph.III)

NOMAC/MK-8175A Merck
Contraception (Ph.III)

MK-8962 Merck
Fertility (Ph.III)

Viviant Pfizer
Osteo. (Pre-reg.)

Bazedoxifene-conjug estro. Pfizer
Vasomotor sympt. (Pre-reg.)

Page 7 of 7