Biomedical Engineering Reference
In-Depth Information
greatest success. We note that FPs targeting oncology in our
database focus on a wide range of cancers: 20% focus on the
four cancer indications with the highest success rates, while
no FP in our database focuses on the four least successful
cancer indications as a primary target (prostate, colorectal,
myelodysplastic syndromes, and nonsmall-cell lung cancer).
We note that both glioblastoma and melanoma are also
popular target oncology indications for the FPs in our
database, together accounting for 35% of the oncology target
indications.
In addition to oncology and autoimmune, hematology
and cardiovascular also accounted for seven (16%) of the
database of FPs in Phase II development and above. Perhaps,
the most interesting point to note about these FPs is
the diversity of their target indications, ranging across
thrombocytopenia, neutropenia, hemophilia, acute myocar-
dial infarction. These are serious medical conditions
characterized by a high unmet medical need, but are not
typically targeted by biologics such as mAbs, nucleic acid
therapeutics or therapeutic vaccines.
in—instead, FP drugs are selected based on factors such as
their individual efficacy and safety profiles, administration,
and pricing.
The typical evolution for an early-stage biotech market
such as therapeutic vaccines and nucleic acid therapeutics
is for early-stage developers to build a portfolio of biotech
drugs for which they have generated strong preclinical and
early-clinical trial data (usually up to Phase II, due to cash
constraints) and then search for licensing deals for the
most advanced candidates and/or those with the best
profile so that potential partners can help carry out
large-scale, costly Phase III trials and, where possible,
build up a marketing functionality. Looking exclusively at
FPs in Phase II clinical development (i.e., at the point that
candidates at the same stage from early-stage biotech
markets such as nucleic acid therapeutics and therapeutic
vaccines would usually start to be licensed), one-third of
the programs involve a Big Pharma/Big Biotech partner,
whileoverhalfarepartneredwitheitheraBigPharma/Big
Biotech company or another earlier-stage drug developer.
Thus,wethinkFPsareamorematuremarketthanthese
earlier-stage biotech markets. One reason for this is
potentially the same reason that could explain why Big
Pharma/Big Biotech do not have more than two FPs in
later-stage clinical development: that FPs are not seen as a
homologous technology that Big Pharma/Big Biotech feels
they lack access to; instead, each FP appears to be judged
on its own characteristics. Supporting this argument is our
view that FPs as a class have less of a need for a major Big
Pharma/Big Biotech licensing deal to “validate” the tech-
nological platform, and our view that there has not been a
wave of either FP licensing or major technology platform
company acquisitions by Big Pharma/Big Biotech.
Another factor likely restricting the acquisition of FP
companies to deals done to acquire a specific FP product
is that there are not FP technology platform companies
with a broad IP estate and a wide range of pipeline
candidates.
2.4.3 FPs Developers and Partners: Many Big
Pharma/Big Biotech Companies Have at Least
One FP in Phase II Development or Above
A few Big Pharma/Big Biotech companies dominate the
two mature biotech sectors: mAbs (e.g., Roche that has
mAb blockbusters such as Avastin and Rituxan) and
recombinant therapeutic proteins (e.g., recombinant insu-
lin is dominated by Sanofi-Aventis and Novo Nordisk,
whereas Amgen and Johnson & Johnson lead the recom-
binant erythropoietin market). While the FP market is
dominated by Enbrel, most Big Pharma/Big Biotech
companies (Amgen included) have only a small number
of FPs in Phase II and III development, compared to
the mAb market where for example Roche has 16
NME (new molecular entity) mAbs in Phase II and III
development alone.
Based on our database, many Big Pharma/Big Biotech
companies have at least one FP in clinical development,
with both the United States and European companies
having approximately an equal participation. However,
we could find few examples of major drug developers
with more than two FPs in Phase II and above active
clinical development. Moreover, unlike the mAbs market,
there are no FP technology platform companies that we
could identify which have been the focus of multiple
licensing deals with Big Pharma/Big Biotech companies
(e.g., compared to the mAb market, where such deals were
signed with “fully human” mAb platform companies such
as Medarex [now Bristol-Myers Squibb], Abgenix [now
Amgen], and CAT [now AstraZeneca]). Together, this
suggests that FPs are not viewed such as mAbs as a
technology platform for Big Pharma/Big Biotech to invest
2.4.4 FP Development: Less Attractive for
Earlier-Stage Drug Developers, but More Attractive
for Big Pharma Licensees
Compared to other drug classes, we think that FP devel-
opment could be less attractive for earlier-stage drug
developers due to higher operating costs (primarily
R&D costs) in the early stage than for other drug classes.
To some extent, the FP drug class becomes more attractive
for these developers if they are able to retain some of the
marketing rights. However, we think that FP licensing is
attractive for licensees due to a potentially stronger oper-
ating margin resulting from lower marketing spending
requirements and often higher prices and reimbursement
levels.
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