Last week turned out to be pretty eventful with
) shares soaring. But, the clear winner was
) which saw its shares gaining an impressive 281%.
Intercept Shares Skyrocket on Data:
Intercept stood out last week with its shares skyrocketing 281%
when a Data Safety Monitoring Board halted a mid-stage study
being conducted with obeticholic acid (OCA). OCA is being
evaluated in the FLINT study for the treatment of nonalcoholic
steatohepatitis (NASH) - a serious chronic liver disease caused
by excessive fat accumulation in the liver.
The study was stopped as the primary endpoint was met.
Usually, studies are stopped prematurely due to safety signals or
some other negative event. So the halting of a study due to
positive data is always welcome news and a major positive. With
no drugs currently approved for NASH, Intercept is well placed to
rule the market once OCA is approved.
About 12% of adults in the U.S. are estimated to have NASH
with 2.7% (more than 6 million) having progressed to advanced
liver disease or cirrhosis due to NASH. Not just that, the number
of liver transplants due to NASH has also gone up significantly
in the last few years. So, we could very well be looking at a
candidate with blockbuster potential.
Epizyme Shares Shoot Up:
Epizyme shares shot up 75.6% with the company achieving a
proof-of-concept milestone related to the development of
EPZ-5676. This means that Epizyme will get a $25 million
milestone payment from partner,
The company will also get a $4 million milestone payment under
its agreement with Glaxo regarding small molecule HMT inhibitors.
Epizyme now expects to exit 2013 with a cash balance of $145
million, significantly above the earlier forecast of $115
Fast Track Status for Peregrine's Bavituximab:
Peregrine Pharma's shares gained 14.5% on news that the FDA has
granted fast-track status to its lead pipeline candidate,
bavituximab, for second-line non-small cell lung cancer.
Bavituximab was recently moved into a phase III study (SUNRISE -
Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III
Fast-track designation means the development and review
process could be speedier with more frequent and timely
communication and meetings with the FDA. The candidate could also
be granted priority review.
PCYC's Imbruvica Continues to Impress:
Intercept was not the only company to receive a favorable
recommendation from a data monitoring committee last week. An
Independent Data Monitoring Committee unanimously recommended
that the phase III RESONATE study being conducted on
Pharmacyclic's leukemia drug, Imbruvica should be stopped early.
The company saw its shares gaining 19.8%.
This is a very positive development for the company as the
study met its primary and a key secondary goal. Imbruvica is
another drug with blockbuster potential.
Sangamo Soars on Biogen Deal:
Sangamo shares shot up 38.3% on the company's collaboration with
Biogen for the development of treatments for hemoglobinopathies,
which are genetic disorders resulting from the abnormal structure
or underproduction of hemoglobin. This deal not only provides
Sangamo with a strong partner in the form of Biogen, Sangamo also
stands to receive an upfront payment of $20 million and more than
$300 million on the achievement of milestones.
Biogen will also reimburse Sangamo for its internal and
external R&D costs. All in all, a good deal for Sangamo.
Last 6 Months
Will it be Third Time Lucky for OREX Drug?
The FDA issued an action date for
) obesity candidate, Contrave. The agency will act on the
company's regulatory submission by Jun 10. Will it prove to be
third time lucky for Contrave? Considering the encouraging LIGHT
study data, chances of approval look good. If approved, Orexigen
and partner Takeda will launch the drug in the second half of the
ITMN Prelim Results Look Good:
) shares shot up 9.5% with the company saying that Esbriet
revenues should come in at $70.2 million in 2013, up 168%.
Increased penetration in existing markets and launch in
additional countries drove performance. The strong performance
should continue in 2014.
DoJ Subpeona Overshadows AEGR Prelim Results:
) was another company that announced preliminary results last
week. Although the company reported that sales of its cholesterol
management drug, Juxtapid, will be in-line with the recently
provided guidance of $45 million - $50 million, this news was
overshadowed by the disclosure that the Department of Justice
(DoJ) has issued a subpoena asking the company to provide
documents related to the marketing and sale of the drug. Even the
company's 2014 guidance of global net product sales of $190
million - $210 million could not prevent the shares from
declining more than 10% on the DoJ investigation news.
NPS End the Week Up 12.3%:
) exited last week 12% higher with the company announcing an FDA
action date for Natpara for the treatment of hypoparathyroidism.
The FDA will issue a response by Oct 24. The company also
reported preliminary results and said it expects 2013 revenues
in-line with the guidance of $28 million - $32 million. NPS also
provided an encouraging outlook for Gattex sales in 2014.
MannKind Shares Slip:
) shares slipped 16.4% on news that its diabetes candidate,
Afrezza, will be reviewed by an FDA advisory panel on Apr 1. But
is this really bad news? The setting up of an advisory panel
actually gives the company a chance to address any concerns that
may be associated with the candidate.
The problem in this case is that the advisory panel meeting
will be held a mere fortnight before the FDA is expected to
deliver a response on the approval status of Afrezza. So, the
short gap between the panel date and the FDA action date may make
investors jittery as the FDA may very well push out the PDUFA
date in order to discuss the panel's recommendation.
The Week So Far:
This week, most biotech companies have been attending the
ongoing J.P. Morgan Annual Healthcare Conference where pipeline
updates, strategic goals and guidance for 2014 have been
Many companies have also been presenting preliminary results.
Celgene expects to deliver 2013 earnings of $5.96 per share, well
above current expectations. The company's long-term outlook also
) also 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 which have been doing very well.
Alnylam Shoots Up on Sanofi Deal:
Big pharma companies continue to show a lot of interest in
) 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. Alnylam
gained 40% on the news.
Lexicon to Reduce Headcount:
) will be cutting its headcount by about 45% as the company has
decided to focus only on late-stage programs. The company's CEO
will also be leaving.
ICPT Loses Some Ground:
Intercept, which saw its shares shoot up a whopping 281% last
week, gave back some of the gains this week on news that its CEO
said that the company may need support from a bigger player for
its experimental liver disease drug.
Regeneron's Eylea Keeps Impressing:
) 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%.
Chelsea's Northera on Approval Track?
) should see a huge boost in its share price as the FDA's
advisory panel has voted (16-1) in favor of approving Northera
for the treatment of symptomatic neurogenic orthostatic
hypotension in patients with primary autonomic failure
(Parkinson's disease, multiple system atrophy and pure autonomic
failure), dopamine beta hydroxylase deficiency and non-diabetic
For the remainder of this week, we expect more updates at the
J.P. Morgan conference as well as a few preliminary results.
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