EXHIBIT 2005
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`EXHIBIT 2005EXHIBIT 2005
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`Cephalon Exhibit 2005
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`Cephalon Exhibit 2005Cephalon Exhibit 2005
`Fresenius v. Cephalon
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`Fresenius v. CephalonFresenius v. Cephalon
`IPR2016-00111
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`lPR2016-00111 lPR2016-00111
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`Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent ... Page 1 of 4
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`Drugszorn
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`Know more. Re cure.
`
`Cephalon Receives FDA Approval for Treanda to
`Treat Patients with Relapsed Indolent Non-Hodgkin's
`Lymphoma
`
`FRAZER, Pa., Oct. 31, 2008 /PRNewswire-FirstCall/ Cephalon, Inc. today announced that the U.S.
`Food and Drug Administration (FDA) has approved Treanda (bendamustine hydrochloride) for Injection
`for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed
`during or within six months of treatment with rituximab or a rituximab-containing regimen. The data
`supporting the FDA approval show that Treanda is effective, has a tolerable side effect profile in
`patients with indolent NHL and that treatment results in a high durable response rate. In March of this
`year, Treanda received approval for the treatment of patients with chronic lymphocytic leukemia, the
`most common form of leukemia in the United States.
`
`Indolent NHL, a subset of non-Hodgkin's lymphoma, is a slow growing but serious cancer of the
`lymphatic system that is not curable with currently available treatments. Patients with indolent NHL are
`prone to multiple relapses after initial therapy. According to the National Cancer Institute, an estimated
`30,000 people in the United States will be diagnosed this year with indolent NHL.
`
`"Because most patients with indolent non-Hodgkin's lymphoma eventually become resistant to existing
`treatments, new treatment options like Treanda are needed to improve patient outcome," stated Dr.
`Bruce Cheson, Professor of Medicine at Georgetown University Hospital 0, Washington, D.C. and
`Treanda clinical investigator. "The Treanda pivotal trial shows that it is an effective and well-tolerated
`chemotherapy that offers a delay in disease progression for more than nine months."
`
`According to Dr. Lesley Russell, Executive Vice President and Chief Medical d' Officer, Cephalon, "We
`are excited about this second FDA approval for Treanda in 2008. This approval of Treanda for indolent
`non-Hodgkin's lymphoma is a significant milestone in our development of a diverse oncology portfolio
`of products that improve patient outcomes."
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`The FDA approval is supported by a pivotal trial of 100 patients with indolent B-cell NHL who had
`progressed during or within six months of treatment with a regimen that included rituximab. The pivotal
`study demonstrated that patients had a high response rate to treatment with Treanda, and these
`responses to the treatment were durable. The results from the pivotal study showed that treatment with
`Treanda as a single agent resulted in an overall response rate of 74 percent, which means that after
`treatment, the cancer diminished or disappeared in approximately three out of four patients.
`Additionally, patient response to treatment in the pivotal study lasted a median of 9.2 months and
`patients remained alive and their disease did not progress for a median of 9.3 months.
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`The safety of Treanda is also supported by a secondary monotherapy study. In the pivotal and
`secondary studies for Treanda in indolent NHL, the most common non-hematologic adverse reactions
`(frequency > 15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough,
`headache, weight decrease, dyspnea, rash and stomatitis. The most common hematologic
`abnormalities (frequency >15%) are lymphopenia, leukopenia, anemia, thrombocytopenia and
`neutropenia.
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`In addition to its proven efficacy and tolerable side effect profile, Treanda has a convenient dosing
`schedule as a treatment for indolent NHL. An intravenous infusion takes 60 minutes and can be
`administered in an outpatient setting, reducing the time it takes for patients to be treated. The
`recommended dose for indolent NHL is 120 mg/m2 administered on days one and two of a 21-day
`cycle, for up to eight cycles.
`
`About Treanda
`
`Treanda is a novel treatment with a unique chemical structure that is synthesized to combine an
`alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of
`Treanda remains unknown, Treanda may act in two distinct ways to kill cancer cells. Preclinical studies
`suggest that Treanda may lead to cell death by a process known as apoptosis (programmed cell death)
`as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic
`catastrophe (a non-apoptotic pathway),
`
`Cephalon holds exclusive rights to market and develop Treanda in the United States. Treanda is
`licensed from Astellas Deutschland GmbH. Bendamustine HCI, the active ingredient in Treanda, is
`marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited. In
`Germany, bendamustine 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 select Asia Pacific Rim countries.
`
`About Cephalon Oncology
`
`Cephalon, a leading biopharmaceutical company, is building a diversified portfolio of oncology products
`that represents a comprehensive approach to extend and enhance the lives of patients with cancer.
`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(R)
`(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.
`
`In Europe, Cephalon markets three additional oncology products in 19 countries.
`
`About Cephalon, Inc.
`
`Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company 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. The
`company's European headquarters are located in Maisons-Alfort, France.
`
`The company's proprietary products in the United States include: PROVIGIL (modafinil) Tablets [C-IV],
`FENTORA (fentanyl buccal tablet) [C-II], TRISENOX injection, Treanda, AMRIX (cyclobenzaprine
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`http://www.drugs.com/newdrugs/cephalon-receives-fda-approval-treanda-patients-relapsed... 1/20/2016
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`Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent ... Page 3 of 4
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`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 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 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 approval of any current or future filings for regulatory
`approval of Treanda or other Cephalon compounds; interpretation of clinical results, particularly with
`respect to the Treanda clinical trials; manufacturing development and capabilities; market prospects for
`its products, including the anticipated availability of Treanda in the United States or the benefits
`Treanda may provide; 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 O. The Private
`Securities Litigation Reform Act of 1995 permits this discussion.
`
`SOURCE Cephalon, Inc.
`-0- 10/31/2008
`/CONTACT: Media, Candace Steele, +1-610-727-6231, csteele@cephalon.com,
`or Investors, Robert (Chip) Merritt, +1-610-738-6376, cmerritt@cephalon.com,
`both of Cephalon, Inc./
`/Company News On-Call: http://www.prnewswire.com/comp/134563.html/
`/Web site: http://www.cephalon.com /
`(CEPH)
`
`CO: Cephalon, Inc.; U.S. Food and Drug Administration; FDA
`ST: Pennsylvania
`IN: HEA MTC
`SU: FDA
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`BP-AM
`NEF059 --
`9046 10/31/2008 16:55 EDT http://www.prnewswire.com
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`Posted: November 2008
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`http://www.drugs.com/newdrugs/cephalon-receives-fda-approval-treanda-patients-relapsed... 1/20/2016
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`Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent ... Page 4 of 4
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`Related Articles:
`
`• 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
`
`• Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted
`Priority Review Status by FDA - December 3, 2007
`
`• Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic
`Lymphocytic Leukemia - September 21, 2007
`
`• Cephalon Announces Plans for New NDA Filing for Treanda - June 28, 2007
`
`Treanda (bendamustine hydrochloride) FDA Approval History
`
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`CEPHALON, INC. -- EXHIBIT 2005 0004