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Shared Strengths: The Merck And
Schering Pipelines
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For a company that has takes
pride in the strength of its R&D organization,
Merck's late-stage pipeline has needed an infusion
for some time. High-risk products such as Cordaptive
and the CETP inhibitor anaceptrapib have suffered
clinical setbacks while drugs like the CB-1
antagonist taranabant have been outright failures,
leaving a thin Phase III pipeline (1"The
Pink Sheet" Oct. 6, 2008, p. 22). The proposed
acquisition of Schering-Plough brings Merck some of
what it needs - a range of late-stage opportunities
that round out the Whitehouse, NJ-based drugmaker's
existing portfolio, strengthening its positions in
neuroscience and respiratory drugs. Thanks to
Schering, the company will have three pending NME
products at FDA this year, where it previously had
none. It also gives Merck potential blockbuster drugs
if TRA and bocepravir deliver in clinical trials.
Much of the credit for Schering's pipeline goes to
CEO Fred Hassan, who has focused on rebuilding that
pharma's pipeline via licensing and acquisition. In
particular, the 2007 takeover of Organon BioSciences,
which central nervous system and women's health
assets, was critical to Merck's desire to purchase
the company. Organon assets now comprise
three-quarters of Schering's pipeline. Here's a
closer look at the combined Merck-Schering pipeline,
with an emphasis on novel products or combinations in
mid- to late-stage development.
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Status
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Merck
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Schering-Plough
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ONCOLOGY
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Phase III
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Deforolimus, oral mTOR
inhibitor for metastatic soft tissue and bone
sarcomas (partnered with Ariad) [filing in
2010]
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None
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Phase II
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MK-0646, anti-IFG-1r antibody
for various cancers (from Pierre Fabre)
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Robatumumab, anti-IGF-Ir
antibody for various cancers, including Ewing's
sarcoma;
Two cell-cycle inhibitors (CDK
inhibitor and CHK-1 inhibitor) for various
cancers;
Rolapitant, NK-1 inhibitor for
chemotherapy-induced nausea and vomiting
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CARDIOVASCULAR
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Phase III
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Rolofylline (MK-7418/KW3902),
adenosine A1 antagonist for acute heart failure (from
Kyowa Hakko, via NovaCardia) [filing in 2009];
MK-0524A and B
(laropiprant/niacin, Tredaptive,
formerly Cordaptive) for
atherosclerosis [re-filing in 2012 after outcomes
trial completed];
Anacetrapib (MK-0859), CETP
inhibitor for atherosclerosis [filing beyond
2014]
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Thrombin Receptor Antagonist
for acute coronary syndrome and secondary prevention
of ischemic events;
Acadesine, injectable adenosine
regulating agent for prevention of
ischemia-reperfusion injury during CABG (in-licensed
from Pericor)
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Phase II
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MK-1903 for
atherosclerosis;
MK-6213 for
atherosclerosis
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None
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IMMUNOLOGY
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Pending
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None
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Golimumab, humanized monoclonal
antibody against tumor necrosis factor-alfa for
rheumatoid arthritis, ankylosing spondylitis and
psoriatic arthritis (partnered with Johnson &
Johnson)
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DIABETES
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Phase III
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MK-0431C (combination of
Januvia (sitagliptin) and pioglitazone)
[filing in 2011]
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None
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Phase II
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MK-0893;
MK-0941;
MK-8245
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None
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INFECTIOUS DISEASE
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Phase III
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V503, a 9-valent vaccine for
human papillomavirus [filing in 2012]
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Boceprevir, protease inhibitor
for hepatitis C;
Vicriviroc, oral chemokine CCR5
co-receptor antagonist for treatment-experienced
HIV
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Phase II
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Three compounds (including
V710, an S. aureus vaccine with Intercell, starting
Phase III in 2009 and filing in 2011)
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SCH 900518, protease inhibitor
for hepatitis C;
Topical antifungal for
onychomycosis (in-licensed from Anacor);
Pleconaril for prevention of
common cold (also for asthma exacerbations)
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NEUROLOGIC AND PSYCHIATRIC
CONDITIONS
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Pending
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None
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Asenapine
(Saphris), atypical antipsychotic for
treatment of schizophrenia and bipolar mania disorder
(from Organon)
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Phase III
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Telcagepant, oral calcitonin
gene-related peptide receptor antagonist for migraine
[filing in 2009]
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Esmirtazapine, serotonin and
histamine receptor antagonist for primary insomnia
(also for hot flashes) (from Organon)
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Phase II
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One neurologic compound;
One insomnia compound;
One compound for psychiatric
disease
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AMPAkine, glutaminergic for
attention deficit/hyperactivity disorder and
depression (from Cortex, via Organon)
ORG-25935, glycine uptake
inhibitor for alcohol dependence and schizophrenia
(from Organon);
Preladenant for Parkinson's
disease
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RESPIRATORY/ALLERGY
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Phase III
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None
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Mometasone/formoterol combination for
asthma and COPD (partnered with Novartis)
Allergy immunotherapy for grass pollen
allergies (from ALK-Abello)
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Phase II
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MK-0476C
MK-0633, once-daily 5-LO
inhibitor for asthma and COPD [moving into Phase III
in 2009, filing in 2011]
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CXCR2 chemokine receptor
antagonist for COPD;
Mometasone / oxymetazoline for
allergic rhinitis;
Pleconaril for asthma
exacerbations (also for common cold);
QAB 149 (LABA) / mometasone
combination for asthma and COPD
Allergy immunotherapies for
dust mite allergies and for ragweed allergies (from
ALK-Abello)
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OSTEOPOROSIS AND WOMEN'S HEALTH
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Pending
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None
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Corifollitropin alfa for
assisted reproduction, in Europe (from
Organon)
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Phase III
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Odanacatib, cathespin K
inhibitor for treatment of osteoporosis [filing in
2012]
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Esmirtazapine for hot flashes
(also for insomnia) (from Organon);
NOMAC/E2 (nomegestrol acetate
and estrogen estradiol) combination oral
contraceptive (in-licensed from Theramex, via
Organon)
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Phase II
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MK-5442/JTT-305 bone growth
stimulator for treatment of osteoporosis (partnered
with Japan Tobacco)
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None
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OTHER
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Pending
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None
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Sugammadex, selective relaxant
binding agent to reverse neuromuscular blockade
following surgical procedures
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Phase II
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MK-2866 for sarcopenia
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n/a
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