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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