EXHIBIT 2002
`EXHIBIT 2002
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`Cephalon Exhibit 2002
`Fresenius v. Cephalon
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`IPR2016-00098
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`Treanda New Drug Application for the Treatment of Chronic L... Page 1 of 4
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`Drugs.com
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`Know more. Re sure.
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`Treanda
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`Treatment for Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma
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`Update: Treanda Now FDA Approved - March 20, 2008
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`Treanda New Drug Application for the Treatment of Chronic
`Lymphocytic Leukemia Granted Priority Review Status by FDA
`FRAZER, Pa., December 03, 2007 /PRNewswire-FirstCall/ 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 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 2007 and the FDA will make a review decision by the end of March 2008.
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`"If approved, Treanda will make a meaningful difference as the first new CLL treatment option approved
`by the FDA since 2001 and could be available as soon as the second quarter of 2008," said Dr. Lesley
`Russell, Executive Vice President, Worldwide Medical and Regulatory 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 no adequate therapy exists. Priority review reduces the
`targeted NDA review time from 10 months to six months. FDA granted orphan drug status 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 product is approved for this indication.
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`About Treanda
`Treanda is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that this
`rationally designed hybrid acts in two ways to kill cancer cells. Treanda damages the DNA in cancer
`cells, which leads to the normal path of cell death (apoptosis). It also stops cancer cells 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. 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 indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals
`Ltd holds exclusive rights to develop and market bendamustine HCI in Japan and selected Asian
`countries.
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`Treanda in CLL
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`http://www.drugs.com/nda/treanda_071203.html (cid:9)
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`CEPHALON, INC. -- EXHIBIT 2002 0001
`1/19/2016
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`Treanda New Drug Application for the Treatment of Chronic L... Page 2 of 4
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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 safety and efficacy of bendamustine HCI, the active ingredient in
`Treanda, compared to chlorambucil in patients who were not previously treated for their disease.
`Chlorambucil, a chemotherapy drug, 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 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.
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`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 responsive to treatment with rituximab. This study also met
`its primary endpoints of overall response rate and median duration of response, while demonstrating a
`manageable tolerability profile. The company anticipates filing an NDA in the fourth quarter of 2007 for
`Treanda in patients with indolent NHL who failed treatment with rituximab. In addition, Cephalon has
`studied Treanda in combination with rituximab in patients with relapsed 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.
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`About Cephalon Oncology
`Cephalon Oncology is a strategic business unit focused on the development and commercialization of
`oncology products and resources for patients 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 the United States for the treatment of patients with
`relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule 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.
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`About Cephalon, Inc.
`Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World
`Economic Forum Community of Global Growth 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 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. Cephalon's European headquarters are located in Maisons-Alfort, France.
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`The company's proprietary products in the United States include: PROVIGIL (modafinil) Tablets [C-IV],
`FENTORA (fentanyl buccal tablet) [C-II], 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-II]. The company also markets numerous products internationally. Full
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`http://www.drugs.com/nda/treanda_071203.html (cid:9)
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`CEPHALON, INC. -- EXHIBIT 2002 0002
`1/19/2016
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`Treanda New Drug Application for the Treatment of Chronic L... Page 3 of 4
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`prescribing information on its U.S. products is available at http://www.cephalon.com or by calling
`1-800-896-5855.
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`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, 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; 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 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.
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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. csteele@cephalon.com cmerritt@cephalon.com
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`Web site: http://www.cephalon.com/
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`Company News On-Call: http://www.prnewswire.com/comp/134563.html /
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`Ticker Symbol: (NASDAQ-NMS:CEPH)
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`Terms and conditions of use apply
`Copyright © 2007 PR Newswire Association LLC. All rights reserved.
`A United Business Media Company
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`Posted: December 2007
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`Related Articles
`
`• Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-
`Hodgkin's Lymphoma - November 3, 2008
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`• Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic
`Lymphocytic Leukemia - March 20, 2008
`• FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-
`Hodgkin's Lymphoma - February 19, 2008
`• Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with
`Relapsed Indolent Non-Hodgkin's Lymphoma - January 2, 2008
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`http://www.drugs.com/nda/treanda_071203.html (cid:9)
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`CEPHALON, INC. -- EXHIBIT 2002 0003
`1/19/2016
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`Treanda New Drug Application for the Treatment of Chronic L... Page 4 of 4
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`• 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
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`Treanda (bendamustine hydrochloride) FDA Approval History
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`View comments
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`http://www.drugs.com/nda/treanda_071203.html (cid:9)
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`CEPHALON, INC. -- EXHIBIT 2002 0004
`1/19/2016