Alnylam Pharmaceuticals Inc
(
ALNY
) recently announced its goal for the next two years (2013 and
2014) regarding its key "Alnylam 5x15" pipeline and partner
program.
Alnylam's core product strategy, 'Alnylam 5x15,' was
introduced in January 2011. It aims to develop RNA (ribo nucleic
acid) interference (RNAi) therapeutic products for the treatment
of genetically defined diseases addressing major unmet medical
needs.
Alnylam plans to advance its familial amyloidotic
polyneuropathy (FAP) candidate, ALN-TTR02, into phase III
clinical trials. We note that the candidate is currently in a
phase II study, with results expected in mid-2013. Positive
results from the phase II study would allow Alnylam to move the
candidate into phase III development later this year.
Alnylam also intends to commence an open-label extension study
on ALN-TTR02 in mid-2013 as a long-term treatment for patients
participating in the ongoing phase II study. Periodic updates on
the results from the extension study will be provided from
2014.
The company has a partnership with Genzyme, a
Sanofi
(
SNY
) company, to commercialize the candidate in Japan and other
countries in Asia, whereas Alnylam will commercialize the
candidate in other parts of the world.
The company expects to complete phase I study on another
candidate ALN-TTRsc, being developed for the treatment of
patients suffering from familial amyloidotic cardiomyopathy
(FAC). The company plans to move the candidate into pilot phase
II study in late 2013. The company expects to initiate a phase
III study on the candidate in 2014 after the successful phase II
results.
Alnylam also plans to expand its 'Alnylam 5x15' pipeline with
ALN-AT3 and ALN-AS1, which are being developed for the treatment
of hemophilia and rare bleeding disorders (RBD) and acute
intermittent porphyria (AIP), respectively. Alnylam also has
plans to advance additional programs in 'Alnylam 5x15' through
various partnership deals.
The company also plans to advance its support partner based
programs in RNAi therapeutics. The company is developing
ALN-RSV01 for the treatment of respiratory syncytial virus (RSV)
infection and ALN-VSP for the treatment of liver cancer, through
partnerships.
Our Take
We remain positive on the company's effort to develop its RNAi
therapeutic products. We expect investor focus to remain on
Alnylam's pipeline. The company has collaborated with several
companies including
GlaxoSmithKline plc
(
GSK
), Sanofi,
AstraZeneca
(
AZN
) and
Biogen Idec
(
BIIB
) for microRNA therapeutics.
We currently have a Neutral recommendation on Alnylam. The
stock carries a Zacks #3 Rank (Hold). However, other pharma
stocks such as
Targacept, Inc
(
TRGT
) and
Repligen Corporation
(
RGEN
) carry a Zacks #1 Rank (Strong Buy).
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