Pharmacyclics, J&J get FDA shortcut for cancer drug

The classification of ibrutinib as a breakthrough therapy could mean speedy approval by the agency.

By Minyanville.com Feb 13, 2013 1:45PM
Doctor sitting in office with patient talking and smiling copyright Paul Bradbury, OJO Images, Getty ImagesPharmacyclics (PCYC) says its experimental drug for a pair of rare blood cancers received a new designation from U.S. officials that potentially sets it up for a quick approval. The news sent Pharmacyclics shares higher Wednesday.

Pharmacyclics and development partner Johnson & Johnson (JNJ) won the classification "breakthrough therapy" by the Food and Drug Administration for the oral drug ibrutinib as a single treatment for two cancers. That means the FDA will accept early clinical evidence showing that the drug is a big improvement over existing treatments.

Hopes for approval of the drug are already high. Shares of Pharmacyclics are up more than 200% in the past year and the company has amassed a $5 billion market cap. The stock rose another 7% to $75.24 in early trading Wednesday. Shares of Johnson & Johnson were little changed at $75.72 in morning trading. That stock is up 17% over the past year.

The companies said they hoped to file for FDA approval of their drug for mantle cell lymphoma this year. It's not clear when they'll file for market clearance of the treatment for patients with another cancer known as Waldenstrom's macroglobulinemia. The drug for use in these two cancers is in the middle stages of study historically needed for approval. Both cancers are rare types of non-Hodgkin lymphoma.

"This is a historic moment in oncology," Pharmacyclics CEO Robert Duggan says in a statement. "This compound entered the clinic in 2009 and has demonstrated tremendous clinical progress over the past four years."

Pharmacyclics plans to talk more about its drugs in development during a quarterly conference call scheduled for Thursday at 4:30 p.m. ET. Access the conference here.

Vertex Pharmaceuticals (VRTX) said last month that the FDA granted the breakthrough therapy tag to the company’s cystic fibrosis drug Kalydeco. The drug is approved for children with a certain genetic mutation but Vertex is studying the medicine for broader use. The FDA designated the drug twice as a breakthrough product for use as a single medicine and in combination with another experimental drug.

Shares of Vertex are up 27% over the past year, trading at $46.03 Wednesday morning.

The new breakthrough classification for experimental medicines was put into law as part of the 2012 Food and Drug Administration Safety and Innovation Act.   

More From Minyanville
Tags: JNJPCYC
0Comments

DATA PROVIDERS

Copyright © 2013 Microsoft. All rights reserved.

Quotes are real-time for NASDAQ, NYSE and AMEX. See delay times for other exchanges.

Fundamental company data and historical chart data provided by Thomson Reuters (click for restrictions). Real-time quotes provided by BATS Exchange. Real-time index quotes and delayed quotes supplied by Interactive Data Real-Time Services. Fund summary, fund performance and dividend data provided by Morningstar Inc. Analyst recommendations provided by Zacks Investment Research. StockScouter data provided by Verus Analytics. IPO data provided by Hoover's Inc. Index membership data provided by SIX Financial Information.

Japanese stock price data provided by Nomura Research Institute Ltd.; quotes delayed 20 minutes. Canadian fund data provided by CANNEX Financial Exchanges Ltd.

STOCK SCOUTER

StockScouter rates stocks from 1 to 10, with 10 being the best, using a system of advanced mathematics to determine a stock's expected risk and return. Ratings are displayed on a bell curve, meaning there will be fewer ratings of 1 and 10 and far more of 4 through 7.

127
127 rated 1
269
269 rated 2
463
463 rated 3
586
586 rated 4
657
657 rated 5
616
616 rated 6
644
644 rated 7
431
431 rated 8
263
263 rated 9
138
138 rated 10
12345678910

Top Picks

SYMBOLNAMERATING
COPConocoPhillips10
NWSNews Ord Shs Class B10
YHOOYahoo! Inc10
TJXTJX Companies Inc9
AMXAmerica Movil ADR Rep 20 Ord Shs Series L9
More

LATEST POSTS

Scary story: the 2013 market looks like 1987

All hail the bull market, which ended the week with a big rally. But it also is starting to look a little like 1987, which suffered an epic blow-out.

Fidelity Brokerage Services, Member NYSE, SIPC. (c) 2011 FMR LLC. All rights reserved

VIDEO ON MSN MONEY

ABOUT

Top Stocks provides analysis about the most noteworthy stocks in the market each day, combining some of the best content from around the MSN Money site and the rest of the Web.

Contributors include professional investors and journalists affiliated with MSN Money.

Follow us on Twitter @topstocksmsn.