4/28/2018
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`Genentech: Press Releases
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`Monday,Dec 9, 1996
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`IDEC Pharmaceuticals and Genentech Announce Positive Final Results
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`Results Of Phase II Combination Trial Also Reported
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`Orlando-- December9, 1996 --
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`IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) and Genentech, Inc. (NYSE: GNE) have
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`announcedpositive final results from a pivotal PhaseIIItrial of IDEC-C2B8 asa single agent
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`therapy for relapsed low gradeorfollicular non-Hodgkin's lymphoma. Thetrial, conducted in a
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`total of 166 patients, confirmed the antibody's overall responserate andsafety profile as seen in
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`an earlier Phase II study. The companiesadditionally reportedfinal results from a Phase II
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`combinationtrial of IDEC- C2B8 and CHOP chemotherapy. Results of bothtrials are being
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`presentedtodaybyclinical investigators Myron Czuczman, M.D.of the Roswell Park Cancer
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`Institute and Peter McLaughlin, M.D. of the M.D. Anderson CancerCenter at the annual meeting
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`of the American Society of Hematology (ASH)heldinthiscity.
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`In PhaseIII openlabel, single arm testing of IDEC-C2B8asa single agent therapeutic, each of the
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`patients participating at over 30 trial centers received four infusions of the antibody on an
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`outpatient basis during a 22-day period. Of 151 evaluable patients, 76 responded to treatment
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`with IDEC-C2B8, for an overall responserate of 50%. Nine of these responses were complete
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`responses (6%) and 67 were partial responses (44%). At over nine months' median followup,the
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`median time to disease progression for respondersfollowing treatment with IDEC-C2B8has not
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`yet been reached. Of the responding patients, 70% remain in remission. Patients continue to be
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`followed.
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`The adverse events associated with IDEC-C2B8 were mostly infusion-related. These side effects
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`consist primarily of mild to moderateflu-like symptoms(e.g., fevers, chills) and occur with
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`greatest frequency uponinitial administration. The symptomsare limited in duration to the
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`period of infusion, may be ameliorated with oral acetaminophen and diphenhydramine and
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`decreasesignificantly in frequency with subsequentinfusions.
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`As a matterofscientific interest, patients were also monitored for the presence of a tumor marker
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`gene knownin medical research as Bcl-2. Results presented at ASH revealed that the tumor
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`Genentech: Press Releases
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`marker genereverted to negative in the peripheral blood of over 70% of the patients who were
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`positive at baseline, and in the bone marrow of over 50% of patients who werepositive at
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`baseline. Researchers have previously reported clearanceof this marker from bone marrowwith
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`marrow transplantation regimens incorporating 'ex vivo' marrow purging and only rarely with
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`chemotherapy regimens. However,theclinical significance of Bcl-2 conversion has not yet been
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`determined.
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`"IDEC-C2B8has completedall PhaseIII clinical testing in support of regulatory filing and we are
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`very gratified by the results we have seen for this agent to date," said Antonio J. Grillo-Lopez,
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`M.D., IDEC's seniorvice president of medical and regulatory affairs. "We have confirmed IDEC-
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`C2B8's potential as an effective, alternative therapy with limited toxicity for patients with B-cell
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`lymphoma. Basedontheseresults, we expectto file a Biological License Application for IDEC-
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`C2B8as a single agent therapy for relapsed patients with low gradeorfollicular non-Hodgkin's
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`lymphomainthefirst half of 1997."
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`IDEC and Genentech arealso investigating the use of IDEC-C2B8in combination with other
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`therapies for lymphomaandreportedpositive results in a Phase II open label, single arm trial
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`combining IDEC-C2B8 with CHOP chemotherapy(a standard regimen of cyclophosphamide,
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`doxorubicin,vincristine and prednisone). In thistrial, patients with low gradeorfollicular
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`lymphomareceived six doses of IDEC-C2B8 over 21 weeks. Within this sametime period, they
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`also received six cycles of CHOP chemotherapy.Of the 35 patients completingall treatments, 35
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`respondedto treatment, for an overall response rate of 100%. Twenty-twopatients (63%)
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`achieved a complete response and 13 (3%) achieved a partial response. Patients tolerated the
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`combination of IDEC-C2B8 and CHOPwell; adverse events did not exceed those routinely
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`observed with CHOPaloneor those associated with IDEC-C2B8alone, indicating compatibility of
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`the two therapies.
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`"Based on the limited toxicity and patient responserates observed to date for IDEC-C2B8 asa
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`single agent therapeutic, Genentech and IDEC are committed to exploring further uses for IDEC-
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`C2B8, both as a frontline therapy, and in combination with other anti-cancer treatments," said
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`Sue Hellmann, M.D., Genentechvice president, medical affairs. "Genentech is currently
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`conducting a study of IDEC-C2B8in combination with chemotherapyin patients with
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`intermediate grade disease and additional combination therapytrials are planned."
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`Genentech: Press Releases
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`B-cell lymphomasare malignancies of the body's antibody-producing immunesystem cells. Non-
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`Hodgkin's lymphomascurrently afflict roughly 225,000 Americans, with over 50,000 new
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`diagnoses expectedthis year. Low grade andfollicular lymphomas comprise about 65% of the
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`total lymphoma. prevalencein the United States.
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`IDEC-C2B8is a monoclonal antibodythatis therapeutically active on its own and does not
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`require the attachmentof radioisotopes ortoxinsto elicit its anti-tumoreffect. The antibody
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`targets a protein (the CD20 antigen) that is expressed on the surface of matureB cells and on B-
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`cell tumors, but not on B-cell precursors or other body tissues. IDEC-C2B8 worksby binding to
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`its target antigen and recruiting the patient's natural defenses to attack and kill both malignant
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`and normal matureBcells. In trials to date, the normalB cells regenerate from stem cells and
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`return to normal levels within months following treatment with IDEC-C2B8.In addition, clinical
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`results to date have shown that IDEC-C2B8does notexhibit any significant toxicities that overlap
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`with those produced by chemotherapyorhigh doseradiation. Thus, treatment with IDEC-C2B8
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`has not precluded patients from receiving subsequent chemotherapeutic treatments. In addition,
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`IDEC-C2B8is administered over 22 days, versus the four- to eight-month course required for
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`most conventional chemotherapies.
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`IDEC and Genentech are developing IDEC-C2B8in collaboration with F.Hoffmann-La Roche,
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`Ltd. of Switzerland and Zenyaku Kogyo Co.Ltd. of Japan. Genentech,Inc.is a leading
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`international biotechnology companythat discovers, develops, manufactures and markets human
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`pharmaceuticals for significant unmet medical needs. The company has headquarters in South
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`San Francisco, California and is traded on the New YorkandPacific Stock Exchanges under the
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`symbol GNE.
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`IDEC Pharmaceuticals focuses on developing targeted immunotherapies for the treatment of
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`cancer and autoimmunediseases. IDEC's products are primarily designed to act through immune
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`mechanismsand offer greater specificity of action, longer therapeutic effect and lowertoxicity
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`thanis typical of existing therapies. All of IDEC's products are designed for administration in
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`outpatient settings, providing the opportunity to reduce overall treatmentcosts.
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`IDEC Pharmaceuticals’ press releases and are available at no charge through PR Newswire's
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`"Company NewsOnCall" fax service. For a menu of IDEC's current press releases and quarterly
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`reportsor to retrieve a specific release, call (800) 758-5804, ext. 432581 or internet
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`http: //www.prnewswire.com.
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`4/28/2018
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`Genentech: Press Releases
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`The statements madeinthis press release contain certain forward looking statementsthat involve
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`a numberofrisks and uncertainties. Actual events or results may differ from the company's
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`expectations. In addition to the matters describedin this press release, timelinesforclinical
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`ongoingactivity are subject to change, results of pendingor futureclinical trials cannot be
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`accurately predicted and decisions by the FDA and otherregulatory agencies, as well as the risk
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`factors listed from timeto time in the company's SECfilings, including but not limitedto its
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`Annual Reports on Form 10-K for the year ended December31, 1995, and form S-3 filed May 3,
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`1996, mayaffect the actual results achieved by the company.
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`IDEC Pharmaceuticals is a registered U.S. trademark of the company. The company headquarters
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`is located at 11011 Torreyana. Road, San Diego, CA 92121.
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`CONTACT:Connie Matsui of IDPH, 619-550-8656; or Laura Leber of GNE, 415-225-5759.
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`## HF
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`https:/Awww.gene.com/media/press-releases/4800/1 996-1 2-09/idec-pharmaceuticals-and-genentech-annou
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`IPR2017-01122
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