Biotech Stock Roundup: Gilead, Pharmacyclics Impress at ASCOGILD INCY BIIB ABBV PCYC CLVS NPSP
ZacksTrade Now 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 treatments.
Outside the immuno-oncology area, impressive data was presented by companies like Pharmacyclics (PCYC - Analyst Report) and AbbVie (ABBV - Analyst Report). 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.
Gilead (GILD - Analyst Report) 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 the candidate.
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 cancer.
Amgen and Celgene were also at ASCO this year.
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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 FDA approval.
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 approval.
Immuno-Oncology Deals Continue: Immuno-oncology continues to attract more deals with Incyte (INCY - Analyst Report) 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 Status: 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 condition.
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 Biogen (BIIB - Analyst Report): Array and Biogen are collaborating for the discovery and development of novel kinase inhibitors for the treatment of autoimmune disorders.