Pharmaceutical Commerce - May/June 2017 - 14

are, well, very similar to innovator biologics!
To facilitate biosimilars' speed to market,
we did develop some cell line banks and
documentation packages for about a dozen
key products to give our customers a head
start. In fact, some of these have already
been first-to-market in different countries.
We also provide the sophisticated analytical
services required to progress a biosimilar
de ve lopment pro g r am successful ly,
especially bio-assays and characterization
expertise. And finally, we provide fill-finish
services for biosimilar injectables.


Catalent has been very big in
softgel capsules, and with the
recent acquisition of Accucaps,
is even more deeply invested. Does the
pharma industry make the best use of
this drug-delivery technology today,
or are there lots of products that could
be more commercially successful if
they were in capsule versions? What
guidance can you give to drug developers
contemplating capsule formulations?

Softgels are well established and familiar
to most people who've taken a vitamin,
mineral or supplement (VMS). Catalent
is well established as the largest provider
overall, and the largest prescription softgel
provider too-approximately 90% of
softgel NDAs over the last 25 years have
been made at Catalent. So our ability to
keep our customers happy by resolving their
technical formulation challenges, providing
novel consumer health formulations, and
reliably supplying end patient/consumer
demand is obviously important. The

addition of Accucaps brings us a new range
of Canadian customers, and a tenured
group of softgel experts; it also expands our
capacity and capabilities to meet consumer
health demand in North America and
Established doesn't mean complacent
however, and we are developing technologies
that will keep softgels at the forefront of
consumer health and pharmaceutical
markets, and applicable to the treatment
of more conditions. We know that softgels
are preferred by patients because they are
familiar, are often easier to swallow than
hard tablets and capsules, and because
patients perceive a faster onset of action.
Partly driven by this acceptance and softgels'
proven status, our pharmaceutical and
biopharmaceutical customers are working
with us to solve some long-standing
formulation and delivery challenges. The
most exciting applications perhaps are in
the ability to orally deliver macromolecules
in lipid-based formulations, offering a noninvasive alternative to injections.
Continuing innovations in plant-based
shells, the marketing benefits of which were
perhaps more immediately obvious to VMS
businesses looking to avoid animal-based
products and serve customers with products
perceived as healthier or that overcome
religious or dietary restrictions, gave us the
genesis of our OptiShell technology that we
are now applying to prescription medicines
to formulate at higher temperatures, and
to fill solid and semi-solid formulations.
Last year, we were gratified that FDA had
approved the first treatment to employ
this plant-based technology, which had
been developed and now being produced

a t C a t a l e n t's p re m i e r p re s c r i p t i o n
manufacturing site in St. Petersburg, Fl.
This ground-breaking product also employs
the first-ever extended-release formulation
in softgel form.
Lipid formulation is one of the
technologies we incorporate into
OptiForm® Solution Suite, a service that's
resonating with pharma partners who are
struggling with the challenge of progressing
the huge proportion, as many as nine out
of ten, poorly soluble new chemical entities
coming out of discovery. The service
employs a parallel, science-based screening
process to characterize development
candidates, and recommend formulation
approaches that are best suited to the
molecule and delivery target. We can take a
technology-neutral approach that considers
particle-size reduction, spray drying, hot
melt extrusion, salt screening, and lipidbased formulation, and, in 12 weeks, deliver
materials for ongoing development, and
present a thorough technical report. Our
customers have used it to rescue molecules
that have hit apparently insurmountable
development barriers at later stages.


Given the breadth of Catalent's
involvement with leading smallmolecule, biologic and generic
manufacturers, as well as working
with many biopharma startups, the
company has a powerful perspective
on the industry overall. What, in your
opinion, is the industry doing right, and
what is it doing wrong today? Are there
recurring problems among Catalent
clients that you wish could go away?

T h e i n du s t r y f a ce s a g re a t m a ny
challenges today. Returns on investment
from R&D in the largest companies are, on
average, below their cost of capital, largely
due to the cost of drug failures in research
and development. Products that do secure
regulatory approval face strong challenges
to market access and reimbursement,
which works best when their drugs are
designed to offer clearly differentiated
patient outcomes versus current treatments.
And manufacturing operations are often
configured for yesterday's products instead
of tomorrow's pipelines.
These factors bring unique opportunities
to Catalent to help resolve at least a portion
of these challenges, if the customer is
willing to partner strategically with us.
We've been investing in predictive molecule
and formulation design technologies
since 2007, and market-leading expertise
in development services, both of which
can improve the potential for success of
individual R&D programs. The concepts
of patient-focused drug design, which
we've been actively pioneering, combined
with our range of advanced deliver y
technologies, can help extend clinical
differentiation of new drugs. And-as 70
billion doses produced each year proves-
manufacturing products reliably is what
we do, every hour of every day. And we
actively invest to meet the future needs of
the industry, from flexible and continuous
manufacturing options, to "right-sized"
biomanufacturing capacity.

Health plan managers seek more information on drug utilization
EMD Serono Specialty Digest finds they struggle over 'ensuring clinically appropriate use'
EMD Serono's Specialty Digest polls health plan
managers (this year: 58 plans representing 173 million
lives) on their challenges, accomplishments and
opportunities in managing the use of specialty drugs
among their insured lives. Besides growing dramatically
(specialty products now represent 20% of the US' drug
spend), specialties are driving the growth of the specialty
pharmacy channel and transforming industry's market
access practices.
This year, the Digest's polling finds that ensuring
clinically appropriate use and managing the cost and
services for oncology are the top challenges. Further
examination shows that 48% of plan managers believe
that their clinical use review has been their most successful
action; but only 3% say that their control of oncology
spending has been a top success.
Fair approaches
EMD Serono identifies four categories of benefit
management by payers: network management and
reimbursement; utilization and clinical management;
benefit design; and distribution and ancillary services.

Network management is complicated by the fact that 45%
of reimbursements are fulfilled as a medical rather than
a pharmaceutical benefit. Networks include outpatient
hospital services, but 53% of plan managers say that
the hospitals' pricing is not competitive, and 48% of
respondents include a 'site-of-care redirection' program to
control the medical benefit costs.
On the utilization/clinical front, 16% of plans now
have at least one outcomes-based contract with a drug
manufacturer, and an additional 26% expect to have such
contracts in the next year. Among therapies, those for
inflammatory conditions were the one with the highest
number of outcomes-based contracts currently or within
the next 12 months.
For distribution and dispensing, 50% of plans use
multiple SPs, differentiating among therapy classes to
get the best service for each class. Across the board,
respondents rated quality of services a few fractions higher
than last year, with successful dispensing being rated the
top-quality service (4.1 on a 1-to-5 scale). While 66% of
plans do their own internal reporting on pharmacy benefit
data, 83% do their own for medical benefit data, indicating

14 Visit our website at May | June 2017

a lack of satisfaction with the quality of reporting from SPs
and other external providers.
On benefit design, a slightly higher percentage of plans
(25%) require coinsurance payments from patients, as
compared to 22% in 2015 (mean average).
The EMD Serono Specialty Digest is available at

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2017

Table of Contents
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Pharmaceutical Commerce - May/June 2017 - Table of Contents
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Pharmaceutical Commerce - May/June 2017 - Cover4