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.
Celgene (CELG) 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 expectations.
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.
Jazz (JAZZ) 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 product launches.
Sarepta (SRPT) 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.
Alnylam (ALNY) 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.
Regeneron’s (REGN) 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 remain high.
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Gilead (GILD) 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.
Alexion (ALXN) 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.
ARIAD (ARIA) 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? Dendreon (DNDN) 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:
Amarin’s (AMRN) Woes Continue: Amarin’s shares lost 23.8% on news that the Special Protocol Assessment for the ANCHOR study for Vascepa will not be re-instated.
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.
BioMarin (BMRN) 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.
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