Last week, several biotech companies attended the J.P. Morgan
Annual Healthcare Conference where pipeline updates, strategic
goals and guidance for 2014 were presented. Many companies also
presented preliminary results.
) Impresses with Prelim Results & Outlook:
Celgene expects to deliver 2013 earnings of $5.96 per share, well
above expectations. Total net product sales are expected to come
in at $6.4 billion, up 18%. 2014 guidance also surpassed
Moreover, the company's long-term outlook looks good with
Celgene raising its product sales targets as well as earnings
outlook for 2015 and 2017.
) Hits 52-Week High:
Jazz hit a 52-week high last week after it presented a strong
outlook at the J.P. Morgan conference and announced the
acquisition of global development, manufacturing and commercial
rights to ADX-N05 from Aerial BioPharma. ADX-N05 is being
developed for the treatment of excessive daytime sleepiness in
patients suffering from narcolepsy.
Meanwhile, Jazz expects to cross the $1 billion revenue mark
in 2014, driven by continued growth of existing products and new
) Spikes on Study Data:
Sarepta's shares jumped 40.1% on 120-week data from a phase IIb
study being conducted on its experimental drug, eteplirsen, for
Duchenne muscular dystrophy. This is the long-term extension
phase of the study which had met its primary endpoint at week 48.
Patients on the experimental drug continued to show stability in
walking ability. Investors are now eagerly awaiting an update on
the company's plans for phase III development.
) Continues to Attract Big Pharma:
Big pharma companies continue to show a lot of interest in
Alnylam - Sanofi expanded its agreement with the company for the
development of rare genetic diseases. Genzyme, Sanofi's
subsidiary, will acquire a 12% stake in Alnylam through a $700
million investment. This deal validates Alnylam's technology,
ensures continued pipeline progress and provides the company with
a pile of cash. Alnylam's shares shot up 40.9% on the news.
) Eylea Worth Keeping an Eye On:
Regeneron was also there at the J.P. Morgan conference where the
company said that it expects Eylea's fourth quarter sales to be
about $400 million and $1.4 billion in 2013. Importantly, Eylea
continues to represent significant growth potential in the form
of additional indications and continued uptake for approved
indications. Shares were up 11.8%.
Regeneron has also signed up with health care giant, Bayer,
for the joint development of a PDGFR (Platelet Derived Growth
Factor Receptor Beta) beta antibody. The companies intend to
explore the possibility of combining this antibody with Eylea for
the treatment of wet age-related macular degeneration.
Regeneron will split development costs with Bayer and will get
an upfront payment of $25.5 million as well as milestone
payments. Moreover, U.S. commercialization rights remain
exclusively with Regeneron. Will the companies be able to
re-create the success they have enjoyed with Eylea? Given
their successful track record with Eylea, confidence levels
Last 6 Months
) Scores EU Approval for Sovaldi:
The EU approved Gilead's hepatitis C virus (HCV) infection
treatment, Sovaldi. Sovaldi's approval, while expected, is an
important event for Gilead as well as HCV patients in the EU who
have postponed treatment as they await the launch of a better
therapy. Sovaldi basically represents a new HCV treatment
paradigm - high cure rates, a short treatment period and
reduction/elimination of the need for interferon injections. The
EU market is huge with about 9 million people carrying the
infection. Sovaldi, a potential blockbuster product, is already
approved in the U.S.
) Teams Up with Moderna:
Alexion is teaming up with Moderna Therapeutics for the discovery
and development of messenger RNA Therapeutics (mRNA) for the
treatment of rare diseases, Alexion's focus area. The mRNA
Therapeutics platform could help fasten the development and
manufacture of treatments for several rare diseases that cannot
be treated with existing technologies.
) Back with Iclusig:
ARIAD has re-launched Iclusig in the U.S. after the product was
temporarily suspended a few months back due to safety issues.
Iclusig is back with a revised label, a boxed warning and a REMS
plan. The question remains whether Iclusig will be able to bounce
back and pick up where it left. Sales in the third quarter of
2013 were $16.7 million.
Will Provenge Sales Continue to Improve?
) reported a sequential improvement in Provenge sales and saw its
shares jump 9%. But will this be enough to regain confidence in
the product's prospects? Remember, the prostate cancer market has
several strong treatments like Zytiga and Xtandi.
The Week So Far:
) Woes Continue:
Amarin's shares lost 23.8% on news that the Special Protocol
Assessment for the ANCHOR study for Vascepa will not be
Orphan Drug Status for Alexion Drug:
The FDA granted orphan drug status to Soliris for the prevention
of delayed graft function (DGF) in renal transplant patients.
) Strikes Deal for Pre-Clinical Compounds:
BioMarin is making an upfront payment of $2 million to Repligen
Corp. for the latter's histone deacetylase inhibitor (HDACi)
library and related intellectual property.
Later this week,
) will be reporting fourth quarter results. Want the latest
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