The Pipeline Report 2014: Class Seekers

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

Neurology

PRODUCTS GENERATING BUZZ

Edivoxetine Eli Lilly
Indication: Major depressive disorder (Ph. III)
Credit Suisse Approvability Index and Comment: 60%. A small-molecule selective norepinephrine reuptake inhibitor for the oral treatment of depressive disorders and attention deficit hyperactivity disorder (ADHD). Estimated launch: 2015 (Source: Credit Suisse)
Credit Suisse revenue forecast: $918 million in annual global sales by 2020
What the analysts are saying: Edivoxetine has been perceived positively by physicians in general with predicted uptake expected to be high among treatment-resistant MDD patients. Due to the crowded anti-depressant market, this makes it more significant. More recent additions to treat-severe depression have included anti-psychotics, which are associated with a poor side-effect profile. Edivoxetine works as an SSRI, a class which is generally perceived more favorably by psychiatrists treating depression. There haven't been too many additions to the market of late, with the exception of Lundbeck's vortioxetine (which is also indicated for GAD). Edivoxetine could be a favorable choice. —Thomas Russell, GfK HealthCare

Lemtrada (alemtuzumab) Sanofi
Indication: MS (Pre-reg.)
What the clinical trials found: Ph.-III CARE-MS I and CARE-MS II trials—comparing Lemtrada with Merck/EMD Serono's Rebif—showed significant improvement over Rebif. In November, FDA reviewers objected to the design of these studies. It was generally well-tolerated except for some serious AEs: immune thrombocytopenia (ITP), thyroid disorders and some associated with INF.
inThought Approvability Index and Comment: 50% (MS). The drug did better than expected at November's FDA panel, based on the briefing documents. It has the advantage of being a drug where you take a course of treatment and then, in the best case, you're cured of MS. The bad thing is that it might give you a different autoimmune disease, like ITP. Lemtrada would have had a very bright outlook five years ago…not so much now because there are so many other good options. And the real Catch-22 is that it doesn't seem to work as well in people with advanced disease. Estimated launch: 2014 (Source: Symphony Health Solutions).
Credit Suisse revenue forecast: $1 billion in global annual sales by 2020
What the analysts are saying: Early reads were that efficacy is quite good. Side-effect issues will cause physicians and patients to think long and hard about whether the benefits outweigh potential risks. Our research shows 40% of doctors identify the drug unaided, 75-80% when given a list. They talk about efficacy, but almost as frequently about safety concerns. When asked what proportion of their patients they would consider to be good candidates for Lemtrada, they say about 10%. —Paul Wojciak, research director, GfK HealthCare

Plegridy (PEG-interferon-β-1a) Biogen Idec
Indication: MS (Pre-reg.)
What the clinical trials found: New data analyses from year one of the two-year, Ph.-III ADVANCE study showed absence of measured disease activity (no relapse rate, disease progression or lesions) was significantly higher with Plegridy: 34% in a two-week dosing arm and 22% in a four-week dosing arm, vs. 15% in the placebo arm. Overall AE incidence was similar to placebo.
inThought Approvability Index and Comment: 80%. It may be just a long-acting form of Avonex, Biogen's other beta interferon (and in a subcutaneous form vs. Avonex's intramuscular injection). That said, it's better to have less-frequent dosing. We haven't seen Rebif or Betaseron come along with better formulations, so maybe this will get used quite a bit. This version also protects Biogen against biosimilars and gives them a distinct advantage over the other two rivals. Estimated launch: late 2014 (Source: Symphony Health Solutions)
inThought revenue forecast: $450 million in global annual sales by 2018
What the analysts are saying: The message Biogen is sending on Plegridy is that this will reduce the treatment burden for patients through fewer, less-painful injections, with the efficacy of Avonex, a drug doctors are very familiar with. Unaided, only 30% of neurologists are aware of Plegridy, but when given a list of products, awareness increases to 75-80%. Also, a large majority anticipate that, as a result of prescribing Plegridy, they will decrease use of Avonex. The other thing they're asking is how much more expensive this will be. —Paul Wojciak, research director, GfK HealthCare

OTHER KEY PRODUCTS IN THE PIPELINE

Daclizumab AbbVie
MS (Ph. III)

Levodopa/carbidopa Intestinal gel AbbVie
Parkinson's (Ph. III)

Diprivan AZ
Anesthetic (Ph. III)

Naloxegol AZ
Opioid-induced const. (Ph. III)
 
Cariprazine Forest
Schizophrenia/bipolar (Pre-reg.)

Patrome (IPX066) GSK
Parkinson's (Pre-reg.)

Suvorexant Merck
Insomnia (Pre-reg.)

OPC-34712 Otsuka
MDD/schiz./ADHD (Ph. III)

Remoxy Pfizer
Pain (Pre-reg.)

ALO-02 Pfizer
Pain (Ph. III)

Tanezumab Pfizer
OA (Ph. III)

Ocrelizumab/RG1594 Roche
MS (Ph. III)

Bitopertin/RG1678 Roche
Psychotic disorders (Ph. III)

Laquinimod Teva
MS (Ph. III)

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