Navigation Links
Cephalon Concludes All Outstanding Federal and State Government Investigations into the Company's Sales and Promotional Practices
Date:9/29/2008

Company Finalizes Previously Announced Agreement with U.S. Attorney's Office for Eastern District of Pennsylvania and U.S. Department of Justice

Settles State Cases with Connecticut and Massachusetts

FRAZER, Pa., Sept. 29 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today it has finalized a previously announced agreement in principle with the U.S. Attorney's Office for the Eastern District of Pennsylvania, the U.S. Department of Justice and various other federal agencies. The Company also reached separate agreements with the Attorneys General of the states of Connecticut and Massachusetts to settle related investigations into the company's sales and promotional practices. The initial investigations began in 2004 and involved three of the company's nine proprietary products in the United States -- Actiq(R) (oral transmucosal fentanyl citrate) [C-II], Provigil(R) (modafinil) Tablets [C-IV], and GabitRil(R) (tiagabine hydrochloride). Cephalon fully cooperated with all governmental entities throughout these investigations.

Under the previously disclosed terms of the federal settlement, Cephalon will pay the $425 million reserved in 2007 plus an estimated $12 million in accrued interest expense, plead guilty to a single misdemeanor violation of the U. S. Food, Drug, and Cosmetic Act, and enter into a five-year Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the U.S. Department of Health and Human Services. The guilty plea is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.

"We are pleased to have these long-standing matters behind us, while preserving our ability to participate in all federal and state health care programs, thereby maintaining the access of patients in those programs to our medications," stated Jerry Pappert, Executive Vice President and General Counsel, and a former Attorney General of the Commonwealth of Pennsylvania.

"We believe our existing compliance policies and procedures already address the majority of the requirements outlined in the CIA and that the strong compliance infrastructure now in place has improved the accountability of our employees and the transparency of our actions," said Valli Baldassano, Executive Vice President and Chief Compliance Officer. A copy of the CIA can be found at: http://oig.hhs.gov/fraud/cia/index.html.

Cephalon also settled its two outstanding state government investigations for a total of $6.85 million. In its settlement with the Connecticut Attorney General and Commissioner of Consumer Protection, Cephalon agreed to a $6.15 million payment, which includes a contribution of $3.8 million to the Connecticut Department of Public Health to fund state cancer initiatives and $200,000 to fund an electronic prescription monitoring program. In addition, the company agreed to a payment of $700,000 to settle an investigation with the Attorney General of the Commonwealth of Massachusetts. Four hundred fifty ($450) thousand dollars of that payment will be used to benefit consumers in Massachusetts and for comprehensive cancer initiatives.

"We are particularly satisfied that the largest share of the payments made to settle the state Attorney General investigations are for programs and initiatives consistent with our commitment to patients," added Cephalon General Counsel Pappert. "These contributions are aligned with our commitment to the oncology community and our emerging oncology business."

Cephalon has posted a set of Frequently Asked Questions about these settlements on its website at http://www.cephalon.com/media/on-the-record/

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. 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 European headquarters are located in Maisons-Alfort, France.

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

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 approval by the U.S. District Court of the guilty plea; continued ability to participate in government health care programs; expectations regarding the company's compliance programs and policies; anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings 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. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Cephalon, Inc. Announces Agreement to Acquire AMRIX, A Once-Daily Extended-Release Muscle Relaxant
3. Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA
4. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
5. Cephalon Quarterly Conference Call Invitation
6. Cephalon Announces Strong Third Quarter Financial Results
7. Cephalon Submits Supplemental New Drug Application for FENTORA
8. Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkins Lymphoma
9. Cephalon Presentation Slides for the 26th Annual JPMorgan Healthcare Conference Now Available
10. Cephalons EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer Pain
11. Cephalon Provides Update on Regulatory Status of the FENTORA Supplemental New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/23/2017)... ... August 23, 2017 , ... Having proven that ... South African bio-technology company, Green Cell Technologies® (GCT®), has turned its ... directly challenging current outdated ‘pressing’ methods, ushering in a new era of modern, ...
(Date:8/23/2017)... ... August 23, 2017 , ... ... and academic medical centers. The network provides members nationally scaled infrastructure and support ... biologics and restrictive payer agreements so members can provide continuity of care for ...
(Date:8/22/2017)... ... August 22, 2017 , ... KBioBox is pleased to ... the extended GUIDE-Seq ananlysis. KBioBox has adapted their core technology and direct alignment ... with easy to understand reports, extended indel analysis, and translocation analysis. , “The ...
(Date:8/21/2017)... MI (PRWEB) , ... August 21, 2017 , ... ... Awards: Healthcare Edition 2017. The awards recognize medical centers that have implemented innovative ... their efficiency of patient care protocols, competitive advantages, financial impact/value, and market need. ...
Breaking Biology Technology:
(Date:4/11/2017)... Research and Markets has announced the addition of the "Global ... ... at a CAGR of 30.37% during the period 2017-2021. ... based on an in-depth market analysis with inputs from industry experts. ... the coming years. The report also includes a discussion of the ...
(Date:4/11/2017)... MELBOURNE, Florida , April 11, 2017 ... "Company"), a security technology company, announces the appointment of independent ... John Bendheim to its Board of Directors, furthering the ... ... behalf of NXT-ID, we look forward to their guidance and ...
(Date:4/5/2017)... 5, 2017  The Allen Institute for Cell Science ... a one-of-a-kind portal and dynamic digital window into the ... the first application of deep learning to create predictive ... lines and a growing suite of powerful tools. The ... and future publicly available resources created and shared by ...
Breaking Biology News(10 mins):