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Tuesday, November 17, 2015 12:18:48 PM
Take a close watchful eye on little known biomedical Novocure (NVCR), whose novel anti-cancer therapy is catching Wall Street’s attention. Its stock has rallied robustly from a low of $15 a share on the day it went public on Oct. 7, 2015, to a high of $30.89 thereafter, before sliding on Nov. 16, to $22. At least one analyst, JMP Securities’ Michael G. King, sees the stock going much higher, rising to at least $43 a share before long.
Novocure went public at an inopportune time – on the day when many investors dumped the biotechnology group because of consumer outrage over the issue of overpriced drugs. As a result, shares of Novocure tumbled some 17% that day. But, no matter. The stock has since rebounded, driven up by the company’s novel product, Optune.
The Food and Drug Administration approved on Oct.5, 2015, Novocure’s lead product, Optune, for the treatment, in combination with temozolomide, of newly diagnosed glioblastoma, the most common type of primary malignant brain tumor. The FDA approval raises the company’s target patient population in the U.S. alone by nearly 70%, according to Novocure analysis.
“Our our sales and marketing team is now actively promoting Optune as a superior therapy for newly diagnosed glioblastoma, as we work to transform the standard of care,” says Asaf Danziger, chief executive officer of Novocure. Optune is the first FDA-approved therapy in more than a decade, he notes, to demonstrate statistically significant extension of survival in newly diagnosed glioblastoma patients.
Novocure points out that some 215 U.S. leading cancer centers have been certified to prescribe Optune as of Sept. 30, 2015, a 10% increase from the prior quarter.
There are nearly 10,000 new cases of primary glioblastoma and their treatment with Optune could help the company generate $1 billion in sales a year within three years, estimates Novocure. Since the company markets the product itself, FDA’s approval alone could mean $700 million-$800 million of profits annually in the U.S., or close to $10 a share, figures some analysts.
With Optune’s approval in the U.S., Europe and Japan, the sales opportunity from glioblastoma alone could be worth more than $2.5 billion, according to JP Morgan analyst Michael G. King. “With no similar therapeutic technologies in existence, or on the horizon, and demonstrated efficacy in combination with the standard of care, we believe tumor treating fields (TTFields), a new treatment modality in oncology, will become part of the new standard of care,” says King, who rates Novocure stock as “outperform.”The FDA approval of Optune “the company faces solid opportunities,” says the analyst.
He believes the company has a “unique business model with its first approved product, representing a hybrid between a device and a therapeutic.”
King, in a recent report to clients, says that the FDA approval of Optune positions the company to penetrate a large market opportunity in glioblastoma. Apart from its effort in seeking approval of Optune, Novocure also has five completed or ongoing phase 2 clinical studies, as well as nine completed pre-clinical studies on various drug candidates.
The FDA approval is being hailed as the most significant advance in brain cancer in more than 10 years and, says King, “should become part of the new reference standard.”
The two-year survival rate among patients treated with Optune in combination with temozolomide was 50% higher than in patients treated with temozolomide alone, according to Novocure’s estimate.
The company continues to work towards expanding its product pipeline. “We remain focused on advancing our clinical pipeline to evaluate the use of Tumor Testing Fields for a variety of additional solid tumors, including ongoing trials in brain metastases, pancreatic cancer, ovarian cancer, and mesotheloma,” says Bill Doyle, Novocure’s executive chairman.
He believes Novocure will “achieve significant growth as we drive adoption of Optune in newly diagnosed glioblastoma and work to transform the standard of care in our first indication.”
Indeed, some big investors believe that with FDA approval of Optune, Novocure has become “the unicorn investment in the treatment of cancer.”
http://www.forbes.com/sites/genemarcial/2015/11/17/novocures-novel-anti-cancer-therapy-catches-street-attention/
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