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Cephalon, Inc.  (CEPH)
Other Ticker:  
 
    Sector  Consumer Non Cyclical    Industry Legacy
   Industry Legacy
   Sector  Consumer Non Cyclical
 


Cephalon, Inc. Segments

 
PROVIGIL
   34.4 % of total Revenue
GABITRIL
   1.36 % of total Revenue
Total CNS
   45.51 % of total Revenue
ACTIQ
   4.11 % of total Revenue
Generic OTFC
   0.82 % of total Revenue
FENTORA
   7.04 % of total Revenue
AMRIX
   1.86 % of total Revenue
Total Pain
   19.26 % of total Revenue
Oncology
   21.74 % of total Revenue
Other
   13.49 % of total Revenue
 

Business Segments (June 30. 2011)
Revenues
(in millions $)
II. Quarter
%
(of total Revenues)
(June 30. 2011)
Income
(in millions $)
II. Quarter
%
(Profit Margin)
PROVIGIL
251.15 34.4 % 0.00 -
GABITRIL
9.93 1.36 % 0.00 -
Total CNS
332.25 45.51 % 0.00 -
ACTIQ
29.99 4.11 % 0.00 -
Generic OTFC
6.02 0.82 % 0.00 -
FENTORA
51.43 7.04 % 0.00 -
AMRIX
13.55 1.86 % 0.00 -
Total Pain
140.63 19.26 % 0.00 -
Oncology
158.75 21.74 % 0.00 -
Other
98.47 13.49 % 0.00 -
Total
730.10 100 % 0.00 -

• View Income Statement • View Competition by Segment • View Annual Report

Growth rates by Segment (June 30. 2011)
Y/Y Revenue
%
II. Quarter
Q/Q Revenue
%
(June 30. 2011)
Y/Y Income
%
II. Quarter
Q/Q Income
%
PROVIGIL
-11.83 % -2.81 % - -
GABITRIL
-18.22 % -18.12 % - -
Total CNS
-1.68 % -0.73 % - -
ACTIQ
5.1 % 6.53 % - -
Generic OTFC
-47.85 % -33.34 % - -
FENTORA
15.51 % 10.83 % - -
AMRIX
-52.52 % -41.15 % - -
Total Pain
24.3 % 7.73 % - -
Oncology
22.2 % 6.44 % - -
Other
-25.09 % -19.05 % - -
Total
2.48 % -0.8 % - -

• View Growth rates • View Competitors Segment Growth • View Market Share

To get more information on Cephalon's PROVIGIL, GABITRIL, Total CNS, ACTIQ, Generic OTFC, FENTORA, AMRIX, Total Pain, Oncology, Other, Total segment. Select each division with the arrow.

  Cephalon's

Business Segments Description



CENTRAL NERVOUS SYSTEM DISORDERS

Our CNS disorders portfolio includes three FDA-approved products, two of which are currently marketed: PROVIGIL, for improving wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, OSA/HS and SWSD and GABITRIL, for use as adjunctive therapy in the treatment of partial seizures in epileptic patients. NUVIGIL is approved by the FDA for the same labeled indications as PROVIGIL and we currently are planning to launch the product around 2010.

Modafinil Products

PROVIGIL

Modafinil, the active ingredient in PROVIGIL, is the first in a new class of wakefulness-promoting agents. While its exact mechanism of action remains to be fully elucidated, modafinil appears to act selectively in regions of the brain believed to regulate normal sleep and wakefulness. The FDA approved PROVIGIL to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, and we launched the product in the United States in February 1999. In January 2004, we received FDA approval to expand the label for PROVIGIL to include improving wakefulness in patients with excessive sleepiness associated with OSA/HS and SWSD. In clinical studies, PROVIGIL was generally well-tolerated, with a low incidence of adverse events relative to placebo. The most commonly observed adverse events were headache, infection, nausea, nervousness, anxiety and insomnia.

Outside of the U.S., modafinil currently is approved in more than 30 countries, including France, the United Kingdom, Ireland, Italy and Germany, for the treatment of excessive daytime sleepiness associated with narcolepsy. In certain of these countries, we also have approval to market modafinil to treat excessive daytime sleepiness in patients with OSA/HS and/or SWSD.

NUVIGIL

An important focus of our modafinil strategy has been the development of next-generation compounds, including NUVIGIL, a single-isomer formulation of modafinil. In June 2007, we received FDA approval to market NUVIGIL with the same labeled indications as PROVIGIL. We currently are planning to transition our wakefulness franchise to NUVIGIL around 2010, prior to the April 2012 license effectiveness dates under the generic settlement agreements related to PROVIGIL. In clinical studies, NUVIGIL was generally well-tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

We are conducting further clinical studies of NUVIGIL in a variety of areas. If the results of these studies are positive, our plan is to seek an expansion of the labeled indications for NUVIGIL. To that end, we are planning to study NUVIGIL in cancer-related fatigue; we also expect to initiate clinical studies of NUVIGIL in excessive sleepiness associated with jet lag disorder, traumatic brain injury, restless legs syndrome and remitted major depressive disorder, initiate a Phase 2b study related to "negative" symptoms in patients with schizophrenia and to continue clinical studies in bi-polar depression.

GABITRIL

GABITRIL is a selective GABA (gamma-aminobutyric acid) reuptake inhibitor approved for use as adjunctive therapy in the treatment of partial seizures in epileptic patients. Epilepsy is a chronic disorder characterized by seizures that cause sudden, involuntary, time-limited alteration in behavior, including changes in motor activities, autonomic functions, consciousness or sensations, and accompanied by an abnormal electrical discharge in the brain. We currently have worldwide product rights to GABITRIL, excluding Canada and Latin America, and we market GABITRIL in the United States, France, the United Kingdom and Germany, among other countries. We have one third-party manufacturer of the active drug substance in GABITRIL and finished commercial supplies of the product in the United States and one third-party manufacturer of the active drug substance and finished commercial supplies outside the United States.

PAIN

Our pain therapeutics portfolio currently includes four marketed products in the United States. Three of these products, FENTORA, ACTIQ, and generic OTFC, focus on treating breakthrough cancer pain in opioid-tolerant patients. One of the most challenging components of cancer pain is breakthrough pain. Breakthrough pain is a transitory flare of moderate to severe pain that "breaks through" the medication patients use to control their persistent pain. Breakthrough cancer pain typically develops rapidly, can reach maximum intensity in three to five minutes and typically lasts for 30 to 60 minutes. Breakthrough pain may be related to a specific activity, or may occur spontaneously and unpredictably. Cancer patients who suffer from breakthrough pain may suffer a number of episodes every day. Breakthrough pain can have a profound impact on an individual's physical and psychological well-being and is often associated with a more severe and difficult to treat pain condition.

We also market AMRIX, a once-a-day, extended-release version of cyclobenzaprine hydrochloride, the active ingredient in the brand FLEXERIL®. AMRIX is indicated for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

FENTORA

We received FDA approval of FENTORA in late September 2006 and launched the product in the United States in early October. FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. FENTORA is the first and only buccal tablet approved for this indication.

We have focused our clinical strategy on studying FENTORA in opioid-tolerant patients with breakthrough pain associated with other conditions, including neuropathic pain and back pain. In October 2006, January 2007 and August 2007, we announced positive data from three Phase 3 clinical trials of FENTORA and in November 2007 we submitted a sNDA to the FDA seeking approval to market FENTORA for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions. The FDA has set September 13, 2008 as the action date for its review of this sNDA and has indicated that it will hold an Advisory Committee meeting in May 2008 to discuss this sNDA. In March 2007, we filed a marketing application with the European Agency for the Evaluation of Medicinal Products for a fentanyl effervescent buccal tablet for the same indication as FENTORA, which if approved will be sold under the trade name EFFENTORA in the EU. We anticipate final regulatory approval of EFFENTORA in the second quarter of 2008. If approved, the centralized filing of this application would allow us to market EFFENTORA in 29 European countries.

FENTORA delivers fentanyl, a powerful, Schedule II opioid analgesic, through the oral mucosa (the lining of the mouth) utilizing our proprietary, enhanced absorption technology, ORAVESCENT®. The sugar-free FENTORA tablet is placed between the upper cheek and gum above a rear molar tooth. When it comes into contact with saliva, FENTORA's delivery system generates a reaction leading to the release of carbon dioxide. It is believed that transient pH changes accompanying this reaction may optimize how well the tablet dissolves and how quickly the medicine passes across the buccal mucosa.

In clinical trials, FENTORA was generally well tolerated. Most adverse events occurring with FENTORA are typical opioid side effects. The most serious adverse events associated with all opioids are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. The most common (greater or equal to 10 percent) adverse events observed in clinical trials of FENTORA in patients with cancer were nausea, vomiting, application site abnormalities, fatigue, anemia, dizziness, constipation, edema, asthenia, dehydration, and headache. In clinical trials in patients with other chronic pain conditions, the most common (greater or equal to 10 percent) adverse events were nausea, vomiting, back pain, dizziness, headache, and somnolence. Application site adverse events were reported in 12 percent of patients. Most side effects were mild to moderate in severity.

ACTIQ/Generic OTFC

ACTIQ is approved in the United States for the management of breakthrough cancer pain in opioid tolerant patients. It was approved by the FDA in November 1998 and was launched in the United States in March 1999. Following our acquisition of Anesta Corp. in October 2000, we relaunched ACTIQ in February 2001. In October 2002, we reacquired rights to ACTIQ in 12 countries, principally in Europe, from Elan Pharma International Limited.

ACTIQ uses an oral transmucosal delivery system ("OTS®") to deliver fentanyl citrate, a powerful, Schedule II opioid analgesic. The OTS delivery system consists of a drug matrix that is mounted on a handle. It is designed to achieve rapid absorption of fentanyl through the oral mucosa and into the bloodstream, with pain relief that may begin within 15 minutes. ACTIQ is available in six dosage strengths to allow individualization of dosing. Side effects of ACTIQ are typical of opioid products and include somnolence, nausea, vomiting and dizziness. The greatest risk from improper use of ACTIQ, as with all opioid-based products, is the potential for respiratory depression, which can be life-threatening. We market ACTIQ under a comprehensive risk management program of educational and safe use messages that inform health care professionals, patients and their families of proper use, storage, handling and disposal of the product.

AMRIX

In August 2007, we acquired the North American rights to AMRIX from ECR. Two dosage strengths of AMRIX (15 mg and 30 mg) were approved in February 2007 by the FDA for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. With convenient, once-daily dosing, AMRIX provides relief from muscle spasm comparable to that with cyclobenzaprine hydrochloride taken three times daily. We made the product available in the United States in October 2007 and commenced a full U.S. launch in November 2007. In February 2008, we entered into an agreement with a contract sales provider to add 120 sales representatives to our field sales team detailing AMRIX. AMRIX is intended for use up to two or three weeks. The most common side effects of AMRIX in Phase 3 clinical trials were dry mouth, dizziness, fatigue, constipation, nausea and dyspepsia.

 

   

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