EXHIBIT 2002
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`EXHIBIT 2002EXHIBIT 2002
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`CEPHALON, INC. -- EXHIBIT 2002 0001
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`M) Drugs.com
`M) Drugs.com
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`Know more. Be su re.
`Know more. Be su re.
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`Treanda
`Treanda
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`Treatment for Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma Treatment for Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma
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`Update: Treanda Now FDA Approved - March 20, 2008
`Update: Treanda Now FDA Approved - March 20, 2008
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`Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted
`Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted
`Priority Review Status by FDA
`Priority Review Status by FDA
`FRAZER, Pa., December 03, 2007 /PRNewswire-FirstCalli — Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA}
`FRAZER, Pa., December 03, 2007 /PRNewswire-FirstCalli — Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA}
`has accepted and granted priority review designation to the Treanda (bendamustine HCI) New Drug Application (NDA) for the first-line treatment
`has accepted and granted priority review designation to the Treanda (bendamustine HCI) New Drug Application (NDA) for the first-line treatment
`of patients with chronic lymphocytic leukemia (CLL). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new
`of patients with chronic lymphocytic leukemia (CLL). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new
`cases diagnosed every year in the United States. Cephalon filed the Treanda NDA for CLL in September 2607 and the FDA will make a review
`cases diagnosed every year in the United States. Cephalon filed the Treanda NDA for CLL in September 2607 and the FDA will make a review
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`decision by the end of March 2008_ decision by the end of March 2008_
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`proved, Treanda will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be
`proved, Treanda will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be
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`able as soon as the second quarter E3' of 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory able as soon as the second quarter E3' of 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory
`Operations.
`Operations.
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`The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where
`The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where
`no adequate therapy exists_ Priority review reduces the targeted NDA review time from 10 months to six months_ FDA granted orphan drug status
`no adequate therapy exists_ Priority review reduces the targeted NDA review time from 10 months to six months_ FDA granted orphan drug status
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`for Treanda for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the United States, if the for Treanda for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the United States, if the
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`product is approved for this indication. product is approved for this indication.
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`About Treanda About Treanda
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`Treanda is a rationally designed purine analogIalkylator hybrid. Preclinical data demonstrate that this rationally designed hybrid acts in two ways to Treanda is a rationally designed purine analogIalkylator hybrid. Preclinical data demonstrate that this rationally designed hybrid acts in two ways to
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`kill cancer cells et. Treanda damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis)_ It also stops cancer cells kill cancer cells et. Treanda damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis)_ It also stops cancer cells
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`from dividing to create new cancer cells. This dual-action of Treanda may be attributable to its unique chemical design_ from dividing to create new cancer cells. This dual-action of Treanda may be attributable to its unique chemical design_
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`Cephalon holds exclusive rights to market and develop Treanda in the United States. Treanda is licensed from Astellas Pharma GmbH_
`Cephalon holds exclusive rights to market and develop Treanda in the United States. Treanda is licensed from Astellas Pharma GmbH_
`Bendamustine HCI, the active ingredient in Treanda, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited,
`Bendamustine HCI, the active ingredient in Treanda, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited,
`under the tradename RIBOMUSTIN_ In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for
`under the tradename RIBOMUSTIN_ In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for
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`indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCI in Japan indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCI in Japan
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`and selected Asian countries_ and selected Asian countries_
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`Treanda in CLL Treanda in CLL
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`The Treanda NDA for the treatment of patients with CLL is based on a large, international multi-center Phase 3 clinical trial that evaluated the The Treanda NDA for the treatment of patients with CLL is based on a large, international multi-center Phase 3 clinical trial that evaluated the
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`safety and efficacy of bendamustine HCI, the active ingredient in Treanda, compared to chlorambucil in patients who were not previously treated for safety and efficacy of bendamustine HCI, the active ingredient in Treanda, compared to chlorambucil in patients who were not previously treated for
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`their disease. Chlorambucil, a chemotherapy drug 2' is FDA-approved as a first-line therapy for patients with CLL. In the pivotal trial, bendamustine their disease. Chlorambucil, a chemotherapy drug 2' is FDA-approved as a first-line therapy for patients with CLL. In the pivotal trial, bendamustine
`HCI met both primary endpoints — overall response rate and progression-free survival — and demonstrated a manageable tolerability profile. The
`HCI met both primary endpoints — overall response rate and progression-free survival — and demonstrated a manageable tolerability profile. The
`company anticipates that results from this study will be released at the American Society of Hematology (ASH) annual meeting, which begins on
`company anticipates that results from this study will be released at the American Society of Hematology (ASH) annual meeting, which begins on
`December 8, 2007 in Atlanta, Georgia.
`December 8, 2007 in Atlanta, Georgia.
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`Treanda in NHL
`Treanda in NHL
`The company has also studied Treanda for the treatment of patients with indolent non-Hodgkin's lymphoma (NHL} whose cancer is no longer
`The company has also studied Treanda for the treatment of patients with indolent non-Hodgkin's lymphoma (NHL} whose cancer is no longer
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`responsive to treatment with rituximab. This study also met its primary endpoints of overall response rate and median duration of response, while responsive to treatment with rituximab. This study also met its primary endpoints of overall response rate and median duration of response, while
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`demonstrating a manageable tolerability profile. The company anticipates filing an NDA in the fourth quarter r3 of 2007 for Treanda in patients with demonstrating a manageable tolerability profile. The company anticipates filing an NDA in the fourth quarter r3 of 2007 for Treanda in patients with
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`indolent NHL who failed treatment with rituximab. In addition, Cephalon has studied Treanda in combination with rituximab in patients with relapsed indolent NHL who failed treatment with rituximab. In addition, Cephalon has studied Treanda in combination with rituximab in patients with relapsed
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`indolent and mantle cell NHL Results from these studies of Treanda as monotherapy and in combination will be presented at medical meetings indolent and mantle cell NHL Results from these studies of Treanda as monotherapy and in combination will be presented at medical meetings
`later this year.
`later this year.
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`About Cephalon Oncology
`About Cephalon Oncology
`Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients
`Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients
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`and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds_ In addition to and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds_ In addition to
`Treanda, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX (arsenic trioxide) Injection, a product approved in
`Treanda, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX (arsenic trioxide) Injection, a product approved in
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`the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule
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`inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia. inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.
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`In Europe, Cephalon markets three additional oncology products in 19 countries_ In Europe, Cephalon markets three additional oncology products in 19 countries_
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`CEPHALON, INC. -- EXHIBIT 2002 0001
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`About Cephalon, Inc.
`About Cephalon, Inc.
`Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World Economic Forum Community of Global Growth
`Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World Economic Forum Community of Global Growth
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`Companies. For 20 years, the company has been dedicated to the discovery, development and commercialization of innovative products in four Companies. For 20 years, the company has been dedicated to the discovery, development and commercialization of innovative products in four
`core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs
`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 Europa U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices,
`approximately 3,000 people in the United States and Europa 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. Cephalon's
`laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's
`European headquarters are located in Maisons-Alfort, Franca
`European headquarters are located in Maisons-Alfort, Franca
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`The company's proprietary products in the United States include: PROVIGIL (modafinil) Tablets [C-IV], FENTORA (fentanyl buccal tablet) [C-I1], The company's proprietary products in the United States include: PROVIGIL (modafinil) Tablets [C-IV], FENTORA (fentanyl buccal tablet) [C-I1],
`TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL (naltrexone for extended-release injectable
`TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL (naltrexone for extended-release injectable
`suspension), GABITRIL (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ (oral transmucosal fentanyl citrate) [C-I1].
`suspension), GABITRIL (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ (oral transmucosal fentanyl citrate) [C-I1].
`The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at
`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 1-860-896-5855-
`http://www.cephalon.com or by calling 1-860-896-5855-
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`fn addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking
`fn 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
`statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific
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`progress on its research programs- development of potential pharmaceutical products, including the results of any clinical programs with respect to progress on its research programs- development of potential pharmaceutical products, including the results of any clinical programs with respect to
`Treanda or the timing or acceptance of any current or future filings for regulatory approval of Treanda or other Cephalon Oncology compounds;
`Treanda or the timing or acceptance of any current or future filings for regulatory approval of Treanda or other Cephalon Oncology compounds;
`interpretation of clinical results, particularly with respect to the Treanda clinical trials. manufacturing development and capabilities. market prospects
`interpretation of clinical results, particularly with respect to the Treanda clinical trials. 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
`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
`forward-looking statements by the use of words in the statements such as "anticipate," ''estimate," ''expect," "project," 'intend" "plan," "believe" or
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`other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these
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`forward-looking statements due to general financial, economic regulatory and political conditions affecting the biotechnology and pharmaceutical forward-looking statements due to general financial, economic regulatory and political conditions affecting the biotechnology and pharmaceutical
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`industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K 10-0 and 10-K filed industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K 10-0 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
`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
`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.
`publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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`CONTACT: Media. Candace Steele. +1-610-727-6231„ orfor Investors, Robert (Chip) Merritt, +1-610-738-6376„ both of Cephalon, Inc-CONTACT: Media. Candace Steele. +1-610-727-6231„ orfor Investors, Robert (Chip) Merritt, +1-610-738-6376„ both of Cephalon, Inc-
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`csteele@cephalon.com cmerritt@cephalon.com csteele@cephalon.com cmerritt@cephalon.com
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`Web site: http://wwN.cephalon.coml
`Web site: http://wwN.cephalon.coml
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`Company News On-Call: httpliwww.prnewswire.comicompf134563.htm1
`Company News On-Call: httpliwww.prnewswire.comicompf134563.htm1
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`Ticker Symbol: (NASDAQ-NMS:CEPH)
`Ticker Symbol: (NASDAQ-NMS:CEPH)
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`Terms and conditions of use apply
`Terms and conditions of use apply
`Copyright © 2007 PR Newswire Association LLC. All rights reserved.
`Copyright © 2007 PR Newswire Association LLC. All rights reserved.
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`A United Business Media Company A United Business Media Company
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`Posted: December 2007 Posted: December 2007
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`Related Articles Related Articles
`
`• Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma - November 3,
`• Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma - November 3,
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`2068 2068
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`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia - March 20, 2008
`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia - March 20, 2008
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`• FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma - February 19, 2008
`• FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma - February 19, 2008
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`• Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's
`• Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's
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`Lymphoma - January 2, 2008 Lymphoma - January 2, 2008
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`Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic Lymphocytic Leukemia - September 21, 2007
`Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic Lymphocytic Leukemia - September 21, 2007
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`• Cephalon Announces Plans for New NDA Filing for Treanda - June 28.2007
`• Cephalon Announces Plans for New NDA Filing for Treanda - June 28.2007
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`Treanda (bendamustine hydrochloride) FDA Approval History Treanda (bendamustine hydrochloride) FDA Approval History
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`CEPHALON, INC. -- EXHIBIT 2002 0002