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[Invisible.Empire]

Martinsried, 24. Juni 2005. Wie das pharmazeutische Unternehmen Cephalon mitteilt, hat das schweizerische Heilmittelinstitut Swissmedic die Zulassung für Actiq® zur Therapie von Durchbruchschmerzen bei Tumorpatienten erteilt. Das schnell wirksame oral-transmukosale Fentanyl-Präparat wird in der Schweiz über die Globopharm AG ausgeliefert.

Actiq® ist ein Fentanyl-Stick, bei dem das Fentanylcitrat in eine Matrix eingebettet und an einem Kunststoffapplikator angebracht ist. Durch Reiben des Sticks an der Mundschleimhaut löst sich die Matrix auf und das Fentanyl wird kontinuierlich innerhalb von 15 Minuten freigesetzt. Aufgrund der schnellen transmukosalen Resorption gelangt der Wirkstoff unter Umgehung des First-Pass-Effekts innerhalb weniger Minuten an den Wirkort, so dass bereits innerhalb der ersten fünf Minuten nach Applikation eine schmerzstillende Wirkung erwartet werden kann. Die Ergebnisse einer doppelblinden, placebokontrollierten Studie zeigen, dass Actiq® genauso schnell analgetisch wirkt wie intravenös verabreichtes Morphin (Lichtor et al., Anesth. Anal. 1999). Auch die Stärke der Schmerzlinderung ist mit i.v. Morphin vergleichbar, was sich in der Gesamtbeurteilung durch die Patienten widerspiegelt (Coluzzi et al., Pain 2001).

Mehr als die Hälfte der Tumorpatienten leidet trotz fachgerechter Einstellung auf eine ansonsten effektive Opioidtherapie unter Durchbruchschmerzen. Diese Schmerzspitzen sind charakterisiert durch ein plötzliches, meist unvorhersehbares Auftreten, eine hohe Schmerzintensität und eine relativ kurze Dauer von durchschnittlich ca. 30 Minuten. Zur Behandlung werden bislang nicht retardierte Opioide, beispielsweise Morphin in Form von Tabletten oder Tropfen, eingesetzt. Diese Substanzen erreichen ihre maximale Wirkung nach oraler Gabe jedoch erst nach 30-90 Minuten, so dass die analgetische Wirkung erst gegen Ende einer Durchbruchschmerzepisode einsetzt.

[Magnet]

[posting]17.862.994 von Invisible.Empire am 12.09.05 12:18:40[/posting]24. Juni 2005

[Invisible.Empire]

Cephalon Receives FDA Approval to Market Sugar-Free Formulation of ACTIQ(R)


FRAZER, Pa., Sept. 12 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that it has received an approval letter from the U.S. Food and Drug Administration (FDA) to market a new sugar-free formulation of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The sugar-free formulation, which is bioequivalent to the currently available product, will be marketed for the same indication as ACTIQ using the same name.

"With this approval, we will move forward with our plans to launch the sugar-free formulation of ACTIQ in the first half of 2006," said Dr. Paul Blake, Executive Vice President, Worldwide Medical & Regulatory Operations. "We are pleased that we are able to offer one more treatment option to cancer patients with breakthrough pain."

ACTIQ

ACTIQ is the first medication approved for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ACTIQ contains a strong pain-relieving medication (an opioid analgesic) called fentanyl that is used to treat breakthrough cancer pain in patients with malignancies who are taking and who are tolerant to around-the-clock opioid medication for their underlying moderate-to-severe persistent cancer pain. ACTIQ is a single-use medicated lozenge, attached to a handle, which delivers fentanyl as the unit is moved along the inside lining of the cheeks.

The most serious adverse effects associated with all opioids are respiratory depression (potentially leading to apnea and respiratory arrest), circulatory depression, hypotension, and shock. All patients should be followed for symptoms of respiratory depression. The most common side effects observed in ACTIQ clinical trials were tiredness, nausea, vomiting, and dizziness. Frequently, however, these adverse events will cease or decrease in intensity with continued use of ACTIQ, as the patient is titrated to the proper dose.

[Invisible.Empire]

Cephalon Files New Drug Application for OraVescent(R) Fentanyl for the Management of Breakthrough Pain in Cancer Patients


FRAZER, Pa., Sept. 6 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a fentanyl effervescent buccal tablet for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent pain.

The tablet delivers the opioid fentanyl through the oral mucosa utilizing a proprietary enhanced absorption technology, OraVescent, developed by CIMA LABS INC., a wholly-owned subsidiary of Cephalon. Upon approval, Cephalon intends to commercialize OraVescent fentanyl (OVF) in multiple dosage strengths (100, 200, 400, 600, and 800 micrograms). The medication will be listed as a Schedule II controlled substance.

"Expanding our pain care franchise is integral to Cephalon`s growth strategy," said Dr. Paul Blake, Executive Vice President, Worldwide Medical & Regulatory Operations. "With OVF, we build on our expertise in breakthrough pain to bring innovation to a clinically important, but often inadequately managed, component of chronic pain."

This NDA, submitted on schedule, is the fourth of five new product opportunities that Cephalon is pursuing over a 15-month period. A supplemental New Drug Application (sNDA) for ATTENACE(TM) (modafinil) Tablets [C-IV], for the treatment of attention-deficit / hyperactivity disorder in children and adolescents, and an NDA for NUVIGIL(TM) (armodafinil) Tablets [C- IV], for excessive sleepiness, were submitted for FDA review in December 2004 and March 2005, respectively. Cephalon recently entered into an agreement to develop and commercialize naltrexone long-acting injection for the treatment of alcohol dependence with Alkermes, Inc., which submitted an NDA for the product in March 2005. Cephalon also is conducting a Phase 3 clinical trial of GABITRIL(R) (tiagabine hydrochloride) as a treatment for generalized anxiety disorder.

The NDA submitted for OVF includes results from 13 studies. The pivotal double-blind, placebo-controlled, variable-dose study assessed the safety and efficacy of OVF compared with placebo in opioid-tolerant cancer patients with breakthrough pain. Patients treated with OVF showed a statistically significant improvement on the primary endpoint, the Sum of Pain Intensity Differences through 30 minutes (SPID30) (p <0.01). Interim safety analyses from three on-going Phase 3 trials in opioid-tolerant patients as well as pharmacokinetic data from nine clinical pharmacology studies are included in the submission. Safety data from 360 patients participating in the Phase 3 studies demonstrated that OVF was generally well tolerated.

Cephalon has drawn on its experience with ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] to develop a comprehensive Risk Minimization Action Plan (RiskMAP) for OVF, which was submitted with the NDA. FDA considers RiskMAPs integral to the commercialization and safe use of opioids.

About Breakthrough Pain in Cancer Patients

Pain is a primary symptom reported by cancer patients. Of those taking chronic opioid medication for their persistent pain, an estimated 64 to 86 percent experience breakthrough cancer pain. Breakthrough pain is a sudden flare of pain that "breaks through" the relief provided by the pain medication taken around-the-clock to treat underlying persistent pain. The typical episode in cancer patients may peak in as little as three to five minutes, with up to four flares a day. Flares of breakthrough pain are typically severe in intensity and may be excruciating. They often come on suddenly or may be related to a specific activity ("incident pain"). Breakthrough pain can be caused by the cancer itself, treatment, or other cancer-related conditions.

[Bernd13090]

kann das einer mal in wenigen sätzen erklären... positiv oder negativ ???

[Ramses2I]

denke im großen und ganzen das die meldungen vom 6. bzw. 12 september positiv zu werten sind.

wie mir cephalon auf anfrage mitgeteilt hat, ist geplant
ACTIQ in der ersten und OraVescent in der zweiten jahreshälfte 2006 auf den markt zu bringen.

beide mittel sollen wohl gegen schmerzen bei krebspatienten eingesetzt werden.

Grüße
Ramses2I

[Invisible.Empire]

FDA Extends PDUFA Date for VIVITREX(R) to December 30, 2005; Cephalon and Alkermes Continue to Anticipate VIVITREX Launch in First Half of 2006


FRAZER, Pa. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 20, 2005--Cephalon, Inc. (Nasdaq: CEPH) and Alkermes, Inc. (Nasdaq: ALKS) announced today that they have received notification from the United States Food and Drug Administration (FDA) that the agency has extended the action date to December 30, 2005 for its priority review of the New Drug Application (NDA) for VIVITREX(R) (naltrexone long-acting injection) for the treatment of alcohol dependence. The original action date under the Prescription Drug User Fee Act (PDUFA) for the VIVITREX NDA was September 30, 2005. The companies continue to anticipate the launch of VIVITREX in the first half of 2006.

The extension is a result of the FDA classifying a recent response by Alkermes as a major amendment to the NDA, which permits the FDA to extend the action date by 90 days under PDUFA regulations.

" We will continue to work closely with the FDA to assist them in the completion of the review of the application in a timely manner," stated Richard Pops, CEO of Alkermes. " This extension does not affect our plans for the timing of the commercial launch of VIVITREX."

" We have made great progress in developing commercial launch plans for VIVITREX and remain on schedule for a product launch in the first half of 2006," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon.

In June 2005, Cephalon and Alkermes entered into an agreement to develop and commercialize VIVITREX in the United States for the treatment of alcohol dependence.

[Ramses2I]

2005 Full Year Guidance
Product sales $1.20-1.25 billion
Adjusted diluted earnings per share $2.70-$2.85



Third Quarter 2005 Earnings Conference Call Tuesday, November 1, 2005, 4:30 p.m. U.S. EST

FRAZER, Pa., Sept. 29 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) has scheduled its regular quarterly earnings conference call covering third quarter 2005 results for 4:30 p.m. EST on Tuesday, November 1, 2005.

November 1, 2005 Schedule

4:00 p.m. EST Q3 2005 results will be distributed by PR Newswire

4:20 p.m. EST To participate in the conference call, dial 1-913-981-5581 and refer to Conference Code Number 3189624

4:30 p.m. EST Conference call begins promptly.

Simultaneous Webcast

The public may access a live webcast of the conference call from the Events page of the Investor Information section of the company`s website, http://www.cephalon.com. Please click on the link and follow the prompts for registration and access.

If you are unable to listen to the live broadcast, an audio or webcast replay of the call will be available approximately two hours after the event until Midnight EST, November 8, 2005. To listen to the audio replay, dial 1-888-203-1112 and use the Conference Code Number 3189624.

Additional information presented on the conference call may be made available on the Investor page of the company`s website.

SOURCE Cephalon, Inc.

CONTACT: Robert S. (Chip) Merritt, Cephalon, [phone], [e-mail]

[Invisible.Empire]

FRAZER, Pa., Oct 21, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) to market SPARLON(TM) (modafinil) Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents ages six through 17. The company submitted a supplemental new drug application (sNDA) to FDA in December 2004.

"SPARLON is distinct from all currently available ADHD therapies," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations. "We are excited to offer physicians and families a potential new option in the treatment of ADHD and are working closely with the FDA to obtain final approval."

Cephalon expects to launch SPARLON, a proprietary dosage form of modafinil, in early 2006 subject to final FDA approval. In August 2005, Cephalon announced an agreement with McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc. to co-promote SPARLON.

Cephalon also presented for the first time results of integrated analyses of efficacy and safety data from its three pivotal trials evaluating SPARLON Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents at a major medical meeting of child and adolescent psychiatrists in Toronto. The three Phase 3 studies in which more than 600 children and adolescents (ages six through 17) with ADHD were randomized to treatment with SPARLON or placebo included two identically designed nine-week, flexible-dosage studies and one seven-week, fixed-dosage study. Patients treated with SPARLON experienced significant improvement compared to placebo as early as the first week, with continued improvement during titration and dose maintenance.

In the clinical trials, SPARLON was generally well tolerated and discontinuation rates due to adverse events were not significantly different from placebo. The most common adverse events associated with SPARLON were generally mild to moderate in nature and included insomnia, headache and decreased appetite. Insomnia and decreased appetite generally occurred upon initiation of treatment and often resolved with continued treatment.

Data from these three trials were submitted to the FDA for evaluation as part of the sNDA.

SPARLON

SPARLON is a new formulation and proprietary dosage strength of modafinil, the active ingredient in PROVIGIL(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. PROVIGIL is not approved to treat ADHD and is available only in 100 mg and 200 mg strengths. If approved, SPARLON is expected to be available in early 2006.


The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and TRISENOX(R) (arsenic trioxide) injection and more than 20 products internationally. Full prescribing information for all 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 scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, including the results of the SPARLON clinical trials, prospects for final regulatory approval of SPARLON, including the anticipated timetable for the launch of the product, manufacturing development and capabilities, market prospects for its products, particularly with respect to SPARLON 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.

Media: Jenifer Antonacci, [phone], [e-mail], or Investors: Robert (Chip) Merritt, [phone], [e-mail], both of Cephalon