Navigation Links
Cephalon's EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer Pain

FRAZER, Pa. and MAISONS-ALFORT, France, Jan. 24 /PRNewswire-FirstCall/ -- Cephalon, Inc., (Nasdaq: CEPH) announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion regarding EFFENTORA(TM), the company's fentanyl buccal tablet pain medication. In March 2007, Cephalon submitted the EFFENTORA European new drug application for the treatment of breakthrough pain in adult cancer patients who are already receiving maintenance opioid therapy for chronic cancer pain. The CHMP recommendation for EFFENTORA will now be forwarded to the European Commission for final marketing approval, which typically occurs within 60 to 90 days.

"We believe this product, once approved, will be an exciting addition to our European product portfolio and will provide a tremendous benefit to patients suffering from breakthrough cancer pain," said Alain Aragues, President Cephalon Europe. "Cephalon is committed to bringing innovative medications to the European market and we are delighted to receive this positive opinion for EFFENTORA from the CHMP."

The prevalence of cancer in Europe is estimated at approximately 2.9 million patients according to the most recent report from GLOBOCAN, a worldwide database of cancer statistics. A large majority of these patients will experience breakthrough cancer pain, a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent chronic pain. Patients experience intense transient flares of pain that interrupt, or "break through," their background persistent pain. Breakthrough pain is characterized by its rapid onset, moderate-to-severe intensity and a relatively short duration. In cancer, the onset of a breakthrough pain episode is often sudden, reaching peak intensity within three minutes with a median duration of 30 minutes and an average of four episodes per day. Episodes may occur during a specific activity or incident or spontaneously with no apparent cause.

In September 2006, the fentanyl buccal tablet formulation was approved in the United States under the trade name FENTORA(R) (fentanyl buccal tablet) [C-II].

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development, and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at or by calling 1-800-896-5855.

Cephalon Europe

Cephalon has a growing presence in Europe, with more than 800 of its 3,000 employees located in various countries. Cephalon's European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Two manufacturing plants are located in Mitry-Mory and Nevers, France. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries as well as Scandinavia. Cephalon Europe markets more than 30 products in four therapeutic areas: central nervous system, pain, primary care, and oncology.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval, including with respect to final marketing approval of EFFENTORA by the European Commission; manufacturing development and capabilities; market prospects for its products; sales, adjusted net income and basic adjusted income per common share guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

SOURCE Cephalon, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Neptune Technologies receives GRAS notification in the United States
2. 012 Smile.Communications Receives License to Provide Endpoint Network Services
3. Video and Photo: Tekturna HCT(R), a Single-tablet Combination of Tekturna(R)* and a Diuretic, Receives US Approval for Treatment of High Blood Pressure
4. SDCRM Receives Highest Score in Three of Four Categories from CIRM on Part I of Major Facilities Grant Application
5. Biosensors Receives CE Mark Approval for Its BioMatrix(R) Drug-Eluting Coronary Stent System
6. Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer
7. Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral Iclaprim
8. Genta Receives Notice of Non-Compliance With NASDAQ Rule
9. Texas Boy Receives Wheelchair From New Hampshire Couples Recently Deceased Granddaughter
10. Harborview Medical Center in Seattle Receives Prestigious $100,000 Foster G. McGaw Prize for Excellence in Community Service
11. EaglePicher Technologies Receives Battery Power Products and Technologys First Annual Innova Award
Post Your Comments:
(Date:11/24/2015)... 2015  PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI ) ... president and chief executive officer, will present at the 27 ... New York City . The presentation will ... 2015 at 9:30 a.m. EST. and ... at least 15 minutes prior to the presentation to allow ...
(Date:11/24/2015)... According to two new studies, fewer men are having PSA ... doctors, scientists, and public health experts have been pushing for ... being done, will there be more men dying of ... "Despite the efforts made in regards to early detection for ... of death in men, killing approximately 27,500 men this year. ...
(Date:11/23/2015)... 2015 China Cord Blood Corporation (NYSE: ... of cord blood collection, laboratory testing, hematopoietic stem cell ... preliminary unaudited financial results for the second quarter and ... 2015. --> --> ... for the second quarter of fiscal 2016 increased by ...
(Date:11/23/2015)... , November 23, 2015 ... to develop daclatasvir for 112 ... countries   --> --> ... for a hepatitis C medicine, signing an agreement with Bristol-Myers ... to help cure multiple genotypes of the HCV virus.  The ...
Breaking Biology Technology:
(Date:11/10/2015)... YORK , Nov. 10, 2015 ... to behavioral biometrics that helps to identify and ... fraud. Signature is considered as the secure and ... the identification of a particular individual because each ... more accurate results especially when dynamic signature of ...
(Date:11/9/2015)... 9, 2015  Synaptics Inc. (NASDAQ: SYNA ), ... broader entry into the automotive market with a comprehensive ... pace of consumer electronics human interface innovation. Synaptics, industry-leading ... for the automotive industry and will be implemented in ... Europe , Japan , and ...
(Date:11/2/2015)...  SRI International has been awarded a contract of ... to the National Cancer Institute (NCI) PREVENT Cancer Program ... modern testing and support facilities, and analytical instrumentation to ... studies to evaluate potential cancer prevention drugs. ... Drug Development Program is an NCI-supported pipeline to bring ...
Breaking Biology News(10 mins):