With Copaxone and Avonex generating global sales of
$4.3 billion and $3 billion for Teva and Biogen Idec, respectively, in
2013, it is not surprising to see both companies implementing life-cycle
management strategies in the key US market. The performance of the two
products has been shaped by the uptake of newer oral agents in recent
years and competition may intensify further if the FDA approves one or
more generic versions of Copaxone later in 2014.
Success
in prolonging the commercial longevity of Copaxone is arguably a more
pressing concern for Teva but the company has made a strong start over
the past six weeks in converting patients to a higher dosage formulation
of Copaxone, which is dosed three-times a week (3TW) versus once daily.
According
to IMS data, around 48 percent of new Copaxone prescriptions are now
being filled with the 3TW version, as are 18 percent of total Copaxone
prescriptions. Analysts appear to have been surprised at this rapid
uptake, although a number of earlier Physician Views polls run by
FirstWord did support the view that Teva would meet its expectations.
Sentiment towards the strategy now appears to be shifting, however, with
Citi's Liav Abraham noting on Friday that the company is on track to
better its switch strategy, which in turn could be shrinking the market
opportunity for generics.
Assuming that at least one
generic Copaxone product launches later this year in the US (Teva
continues to implement a multi-pronged strategy to prevent such an
occurrence) the key question concerns how rapidly the branded version
will lose market share. Based on key opinion leader (KOL) feedback,
Abraham argues that branded revenues will be "stickier" than consensus
forecasts currently anticipate, despite strategies implemented by payers
- see ViewPoints: Analyst focus group points to increasing payer
pressure in multiple sclerosis market ahead of potential generic
Copaxone entry.
Some earlier feedback from neurologists
polled by FirstWord indicates an alternative view, however, while
payers are likely to play a key role in shaping the dynamics of the
market. To gain more clarity on this issue - and given that 3TW Copaxone
has now been available for six weeks - FirstWord is polling US
neurologists this week to ascertain what percentage shares they
anticipate generic Copaxone to achieve (in both new/switch and existing
patients) and what impact the availability of 3TW Copaxone will have on
this trend.
The advent of generic Copaxone will likely
have a broader impact on other MS therapies, which at least partially
explains why Biogen Idec has developed Plegridy, a version of Avonex
that can also be dosed less frequently - potentially once-a-month.
The
FDA announced last week a three-month delay to its review of the drug,
which now has a PDUFA data in August. With no additional data requested
from Biogen Idec, a number of analysts have speculated that that the
delay could concern the dosing schedule for Plegridy, which appears to
be notably more effective when dosed once every two weeks rather than
once monthly.
Biogen Idec may possess the fastest
growing MS drug franchise in the form of its oral treatment Tecfidera,
but retaining a strong portfolio of therapies supported by Avonex and
Tysabri has been recognised as a key element of the company's strategy
in this market moving forward. Thus, this week's Physician Views poll is
also asking US-based neurologists how they expect to be using Plegridy
by the end of its initial 12-month period on the market assuming
approval is secured.
To recap, this week's poll will ask US-based neurologists...
-
What percentage of existing Copaxone patients (either receiving the
once-daily or three-times weekly version) they estimate will have been
switched to a generic version 12 months after it becomes available?
-
What percentage of new patients receiving Copaxone they would estimate
are being prescribed a generic version 12 months after it becomes
available?
- To what extent they anticipate that exposure to the
three-times weekly version of Copaxone will act as a material deterrent
among patients who are 'encouraged' by payers to switch to a generic
version once it becomes available (even if this it means the patient
paying a higher co-pay/utilises a co-pay scheme for the branded
version)?
- What percentage of total MS patients they would estimate prescribing Plegridy to after 12 months of availability?
- What percentage of new patients they would estimate prescribing Plegridy to after 12 months of availability?
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