The usual regulatory and other updates from the biotech sector
were overshadowed last week by the highly awaited annual meeting of
the American Society of Clinical Oncology (ASCO). The meeting, held
in Chicago from May 30 - Jun 3, provides companies with a platform
to showcase their data to scientists, physicians, the investment
community and others.
As expected, a main area of focus this year was immuno-oncology
which has been attracting a lot of interest. Immuno-oncology
therapies have the potential to change the treatment paradigm for
cancer -- they use the natural capability of the patient's own
immune system to fight the cancer. Several deals have been signed
in the recent past between companies developing immuno-oncology
Outside the immuno-oncology area, impressive data was presented
by companies like
). Here's a look at some of the biotech companies that made waves
at ASCO 2014.
Pharmacyclics' Imbruvica Continues to Impress:
Pharmacyclics was there at ASCO with data on Imbruvica from several
studies. But the standout data was from the phase III RESONATE
study - a head-to-head comparison between Imbruvica and
GlaxoSmithKline's Arzerra. Patients with previously treated chronic
lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
experienced a significant improvement in progression free survival
(PFS), overall survival (OS) and overall response rate (ORR) when
treated with Imbruvica.
Imbruvica, which has blockbuster potential, delivered sales of
$56.2 million in its first full quarter on the market. It is being
developed for a wide range of tumor types and label expansion would
bring in additional revenues.
) Showcases Idelalisib Data:
Gilead presented a second interim analysis of a phase III study
evaluating idelalisib and Rituxan for relapsed CLL -significant
improvement in PFS and ORR compared to placebo plus Rituxan, with
acceptable safety was observed. Idelalisib is under priority review
for this indication with a response expected by Aug 6.
Chances of gaining approval look high considering the data on
Solid Data on AbbVie's Experimental Leukemia Drug:
AbbVie's experimental leukemia drug, ABT-199/GDC-0199, continues to
impress. An overall response rate of 84% was seen in
relapsed/refractory CLL patients treated with ABT-199/GDC-0199 plus
Rituxan in a phase Ib study. The data looks good and bodes well for
the continued development of the candidate.ABT-199/GDC-0199 is
currently in pivotal phase II and phase III studies for several
types of cancer.
AbbVie also presented preliminary results from an ongoing phase
I study on ABT-414, which is being evaluated for glioblastoma
multiforme, the most common and aggressive type of brain
Amgen and Celgene were also at ASCO this year.
Last 6 Months
*As of May 30, 2014
InterMune Resubmits Esbriet NDA:
InterMune resubmitted the NDA for its lung disease drug, Esbriet.
Esbriet is already approved in the EU and approval in the U.S.
would boost sales of the drug significantly. Esbriet sales were
$70.3 million in 2013. Six month review would allow the company to
launch in the U.S. in the first quarter of 2015, provided it gains
This is InterMune's second attempt to gain FDA approval - the
FDA had issued a complete response letter in Mar 2010 and had asked
the company to conduct an additional phase III study to support the
candidate's efficacy. InterMune conducted the phase III ASCEND
study and saw its shares skyrocketing on the results. The results
are compelling enough for the company to succeed in gaining FDA
Immuno-Oncology Deals Continue:
Immuno-oncology continues to attract more deals with
) tying up with Bristol-Myers Squibb. The companies will evaluate
the safety, tolerability and preliminary efficacy of a combination
of Bristol-Myers' PD-1 immune checkpoint inhibitor, nivolumab, and
Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor,
INCB24360, in a phase I/II study.
This is the second immuno-oncology focused deal to be signed by
Incyte in the last couple of weeks, the first one being with
AstraZeneca. Bristol-Myers has also been pretty active on this
front with this being the third such deal to be announced in the
last few days.
Provectus Plunges as FDA Says No Breakthrough Therapy
Provectus' shares plunged 62.9% on news that the FDA will not
assign Breakthrough Therapy status to the company's oncology
candidate, PV-10. The agency said that the data on the basis of
which the status was sought was not sufficient to show improvement
over existing treatments. The company was seeking the status for
the treatment of locally advanced cutaneous melanoma, which meets
the FDA's criteria of a serious or life-threatening disease or
Fast Track Status for Intercept's OCA:
The FDA granted fast track status to Intercept's obeticholic acid
(OCA) for the treatment of patients with primary biliary cirrhosis.
The company expects to file for approval in the first half of 2015.
Shares were up 3.9% - fast track status could speed up the
development and review process.
Array Ties Up with
Array and Biogen are collaborating for the discovery and
development of novel kinase inhibitors for the treatment of
The Week So Far:
) Clears the Air about Acquisition Rumors
: NPSP shot up 13.4% last week on rumors that Shire is interested
in acquiring the company for about $4 billion. However, earlier
this week, NPSP made it clear that it has not been in talks with
) Slumps on Safety Concerns:
Clovis Oncology's shares slumped 19.9% on safety concerns about its
experimental lung cancer treatment, CO-1686.
Incyte's Immunotherapy Looks Promising:
Incyte presented encouraging data on its immunotherapy
Puma Plummets on Data:
Puma's shares plunged 25.3% on data from a breast cancer study on
Partial Clinical Hold on Ariad Study Lifted:
Ariad received some good news with the FDA lifting a partial
clinical hold on the company's phase II study of Iclusig in
patients with refractory metastatic and/or unresectable
gastrointestinal stromal tumors (GIST).
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