Pipeline 2012: Pharma's Front-Runners

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Pipeline 2012: Pharma's Front-Runners
Pipeline 2012: Pharma's Front-Runners

Neurology

PRODUCTS GENERATING BUZZ

BG-12 Biogen Idec

Indication: Multiple sclerosis (Phase III)

What the clinical trials found: The Phase III Confirm data replicated the robust efficacy seen in the Define trial, with BG-12 reducing relapse rates by 44% for the twice-a-day administration. CONFIRM, while not designed as a head-to-head, had a Copaxone arm, and Copaxone had a lower-than-expected 29% reduction in relapse rate. The interferons are generally in the 30-50% range.

inThought Approvability Index and Comment: 84%. BG-12 is likely to become the preferred oral agent for MS, beating out Novartis's Gilenya (fingolimod) on safety and ease of use. BG-12 is also likely to take market share from Biogen and Élan's Tysabri (natalizumab). We expect neither BG-12 nor Gilenya to significantly impact the current market for interferons or Copaxone, at least until the agents have several years on the market without major safety issues. Estimated approval: July 2012 (Source: Wolters Kluwer inThought).

inThought revenue forecast: $2.1 billion in peak sales by 2018.

What the analysts are saying: BG-12 will be an important player, and the fact that it is looking better than Copaxone, which is the market leader and is a daily injection, bodes well for an oral product, even one that's not once-a-day. It's hitting on some unmet needs, including better safety and tolerability. Gilenya has had strong uptake, and we can expect BG-12, which doesn't have the monitoring issues of Gilenya, to have good uptake as well, especially if, down the road, it's placed in a first-line therapy position and challenges Copaxone. Biogen Idec already sells Avonex, the leading interferon product, and Tysabri, so its sales force has a solid reputation among neurologists. —Louise Gillis, assoc. VP, research & consulting, GfK HealthCare

Bapineuzumab Pfizer/Johnson & Johnson

Indication: Alzheimer's disease (Phase III)

What the clinical trials found: A Phase II study showed some signs of efficacy and higher risk of a form of brain swelling called vasogenic edema, at least in ApoE4 carriers. Radiographic data looking at bapineuzumab's effect on plaque were supportive of an effect but not overwhelmingly positive.

inThought Approvability Index and Comment: 33%. There is evidence that bapineuzumab, which targets A-beta amyloid plaque, slows the progression, but treatment prior to cognitive decline may be required for clinical benefit. Estimated approval: April 2014 (Source: Wolters Kluwer inThought).

inThought revenue forecast: $4.4 billion in peak sales by 2018

What the analysts are saying: Clinicians are intrigued by this drug's mechanism of action in preventing amyloid plaques from forming, or reducing those formed. But the jury is still out as to whether it translates to the silver bullet the market is looking for: something that halts disease progression. —Marite Talbergs, SVP, research & consulting, GfK HealthCare

KEY NEUROLOGY PRODUCTS IN THE PIPELINE

To see this extended list of other Neurology products in a separate window, click here.

Vicodin CR Abbott
Pain (Prereg.)

Pivlaz Actelion
Cerebro vasospasm (Ph. III)

TC-5214 AstraZeneca
Depression (Ph. III)

Amyvid Avid Radiopharma
Alzheimer's diagnosis (Prereg.)

Gammagard S/D Baxter
Alzheimer's disease (Ph. III)

BIIB 017 Biogen Idec
Multiple sclerosis (Ph. III)

Buprenorphine transmucosal BioDelivery
Pain (Ph. III)

Zenas BioMarin
Lambert-Eaton myasthenic syndrome (Ph. III)

BMS-214778 Bristol-Myers Squibb
Circadian rhythm sleep disorders (Ph. III)

Hydrocodone ER Cephalon
Pain (Ph. III)

Bupivacaine CR Durect Corp.
Postoperative pain (Ph. III)

Fosphenytoin CyDex Pharma
Status epilepticus (Ph. III)

EMD 1195686 EMD Serono
Parkinson's disease (Ph. III)

Perampanel Eisai
Epilepsy (Ph. III)

LY20140023 Eli Lilly
Schizophrenia (Ph. III)

Solanezumab Eli Lilly
Alzheimer's disease (Ph. III)

Cariprazine Forest
Schizophrenia/bipolar (Ph. III)

F3295 Forest
MDD (Ph. III)

Ampligen HemispherRx
Chronic fatigue synd. (Prereg.)

Ketoprofen transdermal Hisamitsu
Musculoskeletal pain (Ph. III)

Etodolac-lidocaine patch IL Pharma
Pain (Ph. III)

Baclofen XR Impax Labs
Muscle spasticity (Ph. III)

Fentanyl sublingual Insys
Cancer pain (Prereg.)

IP 880 Iroko
Pain (Ph. III)

Betamethasone/indometacin/methocarbamol Iroko Pharm
Pain (Ph. III)

Diclofenac inj. Javelin
Pain (Prereg.)

Ereska Javelin
Pain (Ph. III)

Rylomine Javelin
Post-op pain (Ph. III)

Dexpramipexole Knopp
ALS (Ph. III)

Istradefylline Kyowa Hakko
Parkinson's disease (Prereg.)

Carbamazepine IV Lundbeck
Epilepsy (Ph. III)

Dihydroergotamine inhalation Map Pharma
Migraine (Prereg.)

Carisoprodol SR Meda
Spasm (Ph. III)

Arcoxia Merck
Pain (Ph. III)

Bridion (suggamadex) Merck
Neuromuscular blockade (Ph. III)

MK-4305 Merck
Insomnia (Ph. III)

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

Indiplon Neurocrine Biosciences
Insomnia (Prereg.)

Sumatriptan transdermal NuPathe
Migraine (Prereg.)

Nabiximols Otsuka
Cancer pain (Ph. III)

Remoxy Pfizer
Pain, abuse-resistant (Prereg.)

Dimebon Pfizer
Alzheimer's, early stage (Ph. III)

Vanquix Pfizer
Epilepsy (Ph. III)

Naltrexone/oxycodone Pfizer
Pain, abuse-resistant (Ph. III)

MoxDuo QRx Pharma
Pain (Prereg.)

Ocrelizumab Roche/Genentech
Multiple sclerosis (Ph. III)

Lemtrada Sanofi
Multiple sclerosis (Ph. III)

Teriflunomide Sanofi
Multiple sclerosis (Prereg.)

Arbaclofen Seaside Therapeutics
Fragile X synd. (Ph. III)

Stedesa Sunovion
Epilespy (Ph. III)

Laquinimod Teva
Multiple sclerosis (Ph. III)

Brivaracetam UCB
Epilepsy (Ph. III)

Neupro UCB
Parkinson's disease (Ph. III)

Midazolam intranasal Upsher-Smith
Seizures (Ph. III)

Zohydro Zogenix
Pain (Ph. III)

Next page: Oncology products

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