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Oral Tysabri steps up to the plate
By Anna Lewcock
27/06/2007
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With a number of
companies competing in the race to develop the first oral treatment
option for multiple sclerosis, UCB and Biogen Idec's oral version of
the infamous Tysabri has entered Phase II trials.
The two companies' candidate, currently
going by the name CDP323, is an oral VLA-4 antagonist (as is
Tysabri) intended for the treatment of relapsing-remitting multiple sclerosis (MS). The Phase II trials are expected to yield results by the end of 2008.
Biogen Idec hopped on board to partner with UCB
in developing and commercialising the small molecule compound back in
October last year, following encouraging Phase I trials. The two
companies are initially investigating the compound for the treatment of
MS, but will also be considering its use in treating other autoimmune
disease indications.
UCB and Biogen are co-developing and
co-commercialising the compound, with all commercialisation costs and
profits to be shared equally. Over $200m (€149m) will be added to
UCB's coffers courtesy of the Biogen deal.
CDP323 is one of the
few oral alpha-4 integrin antagonists according to UCB, and it's hoped
that by tapping Biogen's expertise in multiple sclerosis the two
companies can come up with a competitive product.
Biogen is
already responsible for the market-leading MS drug worldwide, Avonex
(interferon beta-1a), which brought the company revenues of around
$1.7bn over 2006. However, the company ahs taken a few punches over
the last few years regarding an existing injectable MS treatment,
Tysabri (natalizumab).
Tysabri, also a VLA-4 antagonist, was
approved by the US Food and Drug Administration (FDA) for
relapsing-remitting forms of MS back in 2004, however was hastily
withdrawn three months later after several cases of patients developing
a life-threatening viral infection of the brain.
The occurrence
of progressive multifocal leukoencephalopathy (PML) in certain patients
held Tysabri of the market for a significant period of time, only
returning with stringent guidelines in June last year.
Damage to
Biogen and Tysabri partners Elan's potential revenues was significant,
with original analyst estimates for the treatment predicting annual
revenues of up to $3bn, but following its withdrawal and late relaunch
the drug only managed to generate $74m over 2006 - split between Elan
and Biogen.
Although the companies have initiated risk
management plans in the US and Europe to facilitate the correct use of
Tysabri, the firms clearly recognise that the damage have may have
already been done, with Biogen foreseeing "many rumours and speculation regarding Tysabri and suspected cases of PML" in the future.
Despite
the unfavourable aura surrounding the existing version of Tysabri, a
spokesperson for UCB told in-PharmaTechnologist.com that the two
companies "strongly believe an oral solution is worthwhile exploring," and that the product could potentially become one of the firm's bigger products.
A 24-hour oral formulation
of the drug could have significant advantages over the current monthly
version of Tysabri in that it could reduce the likelihood of PML taking
hold in a patient, as well as the more obvious non-invasive aspect of
drug administration.
It's perhaps unsurprising that Biogenis
hoping to catch the next big wave in MS treatment by successfully
producing an oral formulation whilst simultaneously reaffirming its
position in the MS market and hopefully demonstrating the safety of a
Tysabri-like treatment option.
In addition to this, the MS
market is growing fairly rapidly, and the first non-invasive oral
treatment to become available would earn itself a particularly
favourable position and at least a temporary monopoly while competitors
catch up.
Several firms are fighting to be the first on the
market with a non-invasive treatment option for MS sufferers. Only
earlier this month Teva and partners Active Biotech announced their
oral candidate was entering Phase II trials, and Novartis' hotly tipped
oral MS treatment (FTY720, fingolimod) is on track for submissions in
2009.
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