It was a busy week as well as weekend for the biotech sector.
Highlights from last week include the approval of
) hepatitis C virus (HCV) treatment, Sovaldi, and that of
) Xiaflex (Peyronie's disease), a collaboration between
) and positive data on
) experimental cancer drug.
Meanwhile, with the annual meeting of the American Society of
Hematology (ASH) kicking off during the weekend, several
companies were in attendance presenting data on their approved as
well as experimental drugs.
Sovaldi Approval Ushers in New HCV Treatment
Last week, Gilead's blockbuster hopeful, Sovaldi, was approved in
the U.S. for HCV. With approval being largely expected, shares
inched up 1.6%. FDA approval of Sovaldi also resulted in Moody's
Investors Service revising its rating outlook on Gilead to
positive from stable.
Sovaldi is an important product not only for Gilead but also
for HCV patients who have postponed treatment as they await the
launch of a better therapy. Sovaldi has many factors that should
work in its favor - high cure rates, a short treatment period and
reduction/elimination of the need for interferon injections. It
has the potential to change the treatment paradigm in the HCV
Following Sovaldi's approval, there has been a lot of buzz
regarding Gilead's pricing of the drug. Each pill is priced at
$1,000 which means that a 12-week treatment period would cost
about $84K. However, the company is providing a copay assistance
Given the broad label of the product and the pent-up demand
for new treatments, uptake should be rapid despite the pricing.
Sovaldi should bring in multi-billion dollar sales for
AUXL Jumps on Xiaflex Label Expansion:
Auxilium's shares soared 11.95% with the FDA approving Xiaflex
for an additional indication. Xiaflex, which is currently
marketed for Dupuytren's Contracture, gained approval for
Peyronie's disease. Hopefully, approval for the additional
indication will boost Xiaflex sales which are yet to pick up
OncoMed Shoots Up on Celgene Deal:
Biotech major Celgene inked a deal with OncoMed for the joint
development and commercialization of up to six anti-cancer stem
cell candidates from OncoMed's biologics pipeline. OncoMed shares
jumped 97.9% on the news. The deal is a major achievement for
OncoMed which went public earlier this year in July. Celgene also
benefits as it has acquired an anti-cancer stem cell pipeline by
investing $177.25 million for now.
I-SPY Positive for Puma:
Shares of Puma Biotechnology soared more than 68% on positive
top-line results from the phase II I-SPY 2 study on lead pipeline
candidate, neratinib. The strong results from the phase II study
conducted in breast cancer patients bode well for late-stage
Biogen Dips Slightly on Regulatory Delay:
Biogen shares were down 1.3% with the FDA action date for its
hemophilia B candidate, Alprolix, being pushed back by three
months, which means the company will most likely be able to
launch Alprolix later in the first half of 2014 provided it gains
approval. This is the second delay being faced by Biogen where
its hemophilia pipeline is concerned.
AMBI Plunges on Regulatory Update:
) hopes of filing for accelerated approval for its experimental
drug for relapsed/refractory acute myeloid leukemia were dashed
with the FDA saying that a phase III study on quizartinib will
have to be conducted in order to file for approval. Not so good
news for Ambit as this will push up costs and push out the
potential approval/launch date for the drug. Not surprisingly,
shares were down 33.1% on the news.
Last 6 Months
Conatus and Immunomedics Gain on Orphan Drug Status:
Shares of Conatus Pharmaceuticals were up 18.1% after the FDA
granted Orphan Drug Status to experimental drug, emricasan.
Immunomedics got the same designation for its antibody-drug
conjugate IMMU-132 for the treatment of small cell lung
EMA Takes A Closer Look at Iclusig:
Ariad's shares lost 10.9% on news that the European Medicines
Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is
conducting a further in-depth review of the risk/benefit profile
of leukemia drug Iclusig. Earlier, EU regulators had recommended
that Iclusig could remain on the market though tough restrictions
would be imposed for continued marketing of the product.
Lexicon Slips on Phase II Data:
Lexicon Pharmaceuticals' pipeline candidate, LX1033, failed to
achieve statistical significance in the primary endpoint of a
phase II study for diarrhea-predominant irritable bowel syndrome
(IBS-d). Shares were down 4.7%.
The Week So Far:
Several biotech companies presented data on approved drugs as
well as pipeline candidates at the annual ASH meeting (Dec 7 -
10). Companies that were in the limelight thanks to encouraging
data include Celgene,
) and Geron.
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