It was yet another slow week for the biotech sector with very
few updates making an impact. Newsmakers included
Disappointing Data Pulls Down Can-Fite:
Can-Fite ended 2013 on a disappointing note with shares plunging
32.4% on data from a phase III study on CF101. CF101 failed to
achieve the primary as well as secondary endpoints in the study
that was conducted in patients with moderate-to-severe dry eye
Amgen's Romosozumab Fares Well in Mid-Stage
Amgen's shares were up 1.5% on positive data from a mid-stage
study on romosozumab. The study was conducted in postmenopausal
women with low bone mineral density (BMD). Treatment with
romosozumab for 12 months resulted in a significant increase in
BMD at the lumbar spine, total hip and femoral neck compared to
Moreover, exploratory analyses showed that BMD increased
significantly at the lumbar spine and hip compared to Fosamax and
Forteo (currently approved treatments). The data looks good but
it remains to be seen how romosozumab performs in ongoing phase
Priority Review for Cubist Drug:
The FDA agreed to review Cubist's experimental antibiotic
tedizolid phosphate (TR-701) on a priority basis. This means a
response should be out by Jun 20. Cubist is looking to get
tedizolid approved for the treatment of acute bacterial skin and
skin structure infections. The EU marketing application for the
antibiotic will be submitted in the first half of this year.
Cubist shares gained 1.3% on the news. Tedizolid became a part of
Cubist's pipeline following its Sep 2013 acquisition of
Patent Protection for Immunomedics (IMMU):
IMMU shares have been gaining steadily ever since the company
received additional patent protection for its antibody-drug
conjugates. This is good news for the company as the patents will
cover IMMU-132 and IMMU-130, both phase II oncology
Orphan Drug Status for NPS' Natpara: NPS
) shares inched up 2.1% with the company gaining orphan drug
status in Europe for Natpara for the treatment of
hypoparathyroidism. Natpara already has orphan drug status for
this indication in the U.S. where it is currently under FDA
review. Orphan drug status brings several incentives like
protocol assistance, scientific advice, and exclusivity once the
drug is on the market.
Last 6 Months
The Week So Far:
This week has turned out to be pretty eventful so far with
) shares soaring significantly.
Epizyme Shares Shoot Up:
Epizyme shares shot up a whopping 75.6% on the achievement of a
proof-of-concept milestone related to the development of
EPZ-5676. This triggered a $25 million milestone payment from
). 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
Pharmacyclics Gains on Imbruvica News:
With an Independent Data Monitoring Committee unanimously
recommending 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.
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 the company's lead pipeline
candidate, bavituximab, for second-line non-small cell lung
EU Nod for Abraxane Label Expansion:
Celgene's Abraxane gained EU approval for use as a first-line
treatment in patients suffering from metastatic pancreatic
cancer. It is to be used in combination with Gemzar. Approval was
expected as last year the Committee for Medicinal Products for
Human Use (CHMP) had issued a positive opinion regarding the
Synageva Wraps Up Patient Enrolment:
Synageva has finished enrolling patients far above its original
target in its phase III study (Acid Lipase Replacement
Investigating Safety and Efficacy - ARISE) on sebelipase alfa.
The study is being conducted in children and adults suffering
from lysosomal acid lipase deficiency. Top-line results from this
study will be out the second half of the year. Shares were up
FDA Action Date for Orexigen Drug:
The FDA issued an action date for Orexigen's obesity candidate,
Contrave. The agency will act on the company's regulatory
submission by Jun 10.
Pipeline Update from Intercept:
Intercept will be providing an update on its pipeline on Jan 9.
Information to look out for: updates on the completion of the
double-blind phase of the POISE study, top line data from the
OBADIAH and PESTO studies and milestones expected this year.
Intercept focuses on the development of novel bile acid
therapeutics for the treatment of chronic liver diseases.
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