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`Page 1 of 4
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`Active Biotech and Ipsen announce their decision to
`discontinue the development of tasquinimod in
`prostate cancer
`
`April 16, 2015 01:19 ET | Source: Active Biotech
`
`LUND, Sweden and PARIS, April 16, 2015 (GLOBE NEWSWIRE) -- Active Biotech (NASDAQ STOCKHOLM: ACTI)
`and Ipsen (Euronext: IPN; ADR: IPSEY) today announced top line results of the 10TASQ10 study. While the study
`showed that tasquinimod reduced the risk of radiographic cancer progression or death compared to placebo (rPFS,
`HR=0.69, CI 95%: 0.60 - 0.80) in patients with metastatic castration resistant prostate cancer (mCRPC) who have not
`received chemotherapy, tasquinimod did not extend overall survival (OS, HR=1.09, CI 95%: 0.94 - 1.28).
`
`Efficacy results together with preliminary safety data do not support positive benefit risk balance in this population.
`Therefore the companies have decided to discontinue all studies in prostate cancer. Full results will be presented at an
`upcoming scientific conference.
`
`Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: "We are disappointed for prostate cancer
`patients. Ipsen remains strongly committed to oncology. We are grateful to the clinicians, caregivers, patients and their
`families who were involved in this study."
`
`Professor Tomas Leanderson, President and Chief Executive Officer of Active Biotech stated: "The outcome of
`the 10TASQ10 study is a major disappointment based on the promising phase II results. However, the data at hand is
`unambiguous and cannot motivate further development of tasquinimod in this patient population. I want to thank the
`clinicians, caregivers, patients and their families who were involved in this study."
`
`Ipsen and Active Biotech are in communication with trial investigators, ethics committees and the relevant regulatory
`authorities, to provide them with updated and current information in compliance with local regulations. The companies
`are working with trial investigators and local regulatory authorities to ensure that patients who participated in the
`tasquinimod trials are transitioned to appropriate therapies so that trial participants receive appropriate care.
`
`About tasquinimod
`
`Tasquinimod is a novel oral immunotherapy that targets the tumor microenvironment by binding to S100A9 and
`modulating regulatory myeloid cell functions, exerting immunomodulatory, anti-angiogenic and anti-metastatic
`properties. Today the development of tasquinimod principally has been focused on the treatment of prostate cancer,
`but early clinical studies in other cancer indications are performed.
`
`About the 10TASQ10 trial
`
`The 10TASQ10 trial is a randomized, double-blind, placebo-controlled, global Phase III clinical trial evaluating
`tasquinimod in patients with metastatic castration resistant prostate cancer (mCRPC) who have not yet received
`chemotherapy. The aim of the 10TASQ10 study is to confirm tasquinimod's efficacy, with radiological Progression Free
`Survival (rPFS) as primary endpoint and overall survival (OS) as key secondary endpoint. The Phase III 10TASQ10
`trial met its enrollment target in December 2012 with more than 1,200 randomized patients as planned in the clinical
`protocol.
`
`https://globenewswire.com/news-release/2015/04/16/724977/
`
`
`
`JANSSEN EXHIBIT 2074
`Mylan v. Janssen IPR2016-01332
`
`
`
`Active Biotech and Ipsen announce their decision to discontinue the development of tasquinimod in prostate c...
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`Page 2 of 4
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`About Active Biotech
`
`Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative
`diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique
`immunomodulatory properties for the treatment of multiple sclerosis, and tasquinimod, an oral immunomodulatory, anti-
`metastatic substance for the treatment of prostate cancer. The objective of the preclinical ISI project is to produce new,
`patentable chemical compounds for treatment of diseases in the company's focus areas. Please visit
`www.activebiotech.com for more information.
`
`About Ipsen
`
`Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.2 billion in 2014. Ipsen sells
`more than 20 drugs in more than 115 countries, with a direct commercial presence in 30 countries. Ipsen's ambition is
`to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is
`supported by 3 franchises: neurology, endocrinology and urology-oncology. Ipsen's commitment to oncology is
`exemplified through its growing portfolio of key therapies improving the care of patients suffering from prostate cancer,
`bladder cancer or neuro-endocrine tumors. Ipsen also has a significant presence in primary care. Moreover, the Group
`has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological
`platforms, peptides and toxins, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis,
`France; Slough/Oxford, UK; Cambridge, US). In 2014, R&D expenditure totaled close to €187 million, representing
`about 15% of Group sales. The Group has more than 4,500 employees worldwide. Ipsen's shares are traded on
`segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the "Service de Règlement
`Différé" ("SRD"). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American
`Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol
`IPSEY. For more information on Ipsen, visit www.ipsen.com.
`
`Ipsen Forward Looking Statements
`
`The forward-looking statements, objectives and targets contained herein are based on the Group's management
`strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that
`may cause actual results, performance or events to differ materially from those anticipated herein. All of the above
`risks could affect the Group's future ability to achieve its financial targets, which were set assuming reasonable
`macroeconomic conditions based on the information available today. Use of the words "believes," "anticipates" and
`"expects" and similar expressions are intended to identify forward-looking statements, including the Group's
`expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described
`in this document were prepared without taking into account external growth assumptions and potential future
`acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as
`reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not
`exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain
`risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up
`never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons.
`The Group must face or might face competition from generic products that might translate into a loss of market share.
`Furthermore, the Research and Development process involves several stages each of which involves the substantial
`risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in
`which it has invested significant sums. Therefore, the Group cannot be certain that favourable results obtained during
`pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient
`to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will
`receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying
`assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set
`forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry
`conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations;
`the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost
`
`https://globenewswire.com/news-release/2015/04/16/724977/10129220/en/Active-Biotech-and-Ipsen-announce...
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`9/30/2016
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`containment; technological advances, new products and patents attained by competitors; challenges inherent in new
`product development, including obtaining regulatory approval; the Group's ability to accurately predict future market
`conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk;
`dependence on the effectiveness of the Group's patents and other protections for innovative products; and the
`exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to
`develop and market some of its products which could potentially generate substantial royalties; these partners could
`behave in such ways which could cause damage to the Group's activities and financial results. The Group cannot be
`certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A
`default by any of the Group's partners could generate lower revenues than expected. Such situations could have a
`negative impact on the Group's business, financial position or performance. The Group expressly disclaims any
`obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this
`press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements
`are based, unless so required by applicable law. The Group's business is subject to the risk factors outlined in its
`registration documents filed with the French Autorité des Marchés Financiers.
`
`Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities Market Act:
`
`This press release contains certain forward-looking statements. Such forward-looking statements involve known and
`unknown risks, uncertainties and other important factors that could cause the actual results, performance or
`achievements of the company, or industry results, to differ materially from any future results, performance or
`achievement implied by the forward-looking statements. The company does not undertake any obligation to update or
`publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in
`expectations after the date of this press release.
`
`For further information:
`
`Active Biotech
`
`Hans Kolam, CFO
`Tomas Leanderson, President & CEO
`Tel: +46 46 19 20 44
`Tel: +46 46 19 20 95
`E-mail: tomas.leanderson@activebiotech.com E-mail: hans.kolam@activebiotech.com
`
`Ipsen
`
`Media
`
`Didier Véron
`Senior Vice-Président, Public Affairs
`and Communication
`Tel.: +33 (0)1 58 33 51 16
`Fax: +33 (0)1 58 33 50 58
`E-mail: didier.veron@ipsen.com
`
`Financial Community
`
`Brigitte Le Guennec
`Corporate External Communication Manager
`
`Tel.: +33 (0)1 58 33 51 17
`Fax: +33 (0)1 58 33 50 58
`E-mail : brigitte.le.guennec@ipsen.com
`
`Stéphane Durant des Aulnois
`Vice-Président, Investor Relations
`Tel.: +33 (0)1 58 33 60 09
`
`Thomas Peny-Coblentz, CFA
`Investor Relations Deputy Director
`Tel.: +33 (0)1 58 33 56 36
`
`https://globenewswire.com/news-release/2015/04/16/724977/10129220/en/Active-Biotech-and-Ipsen-announce...
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`9/30/2016
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`Fax: +33 (0)1 58 33 50 63
`Fax: +33 (0)1 58 33 50 63
`E-mail: stephane.durant.des.aulnois@ipsen.com E-mail: thomas.peny-coblentz@ipsen.com
`
`Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish
`Securities Market Act. This information was provided to the media for publication 7:00 am. CET on 16 April 2015.
`
`Active Biotech and Ipsen announce their decision to discontinue http://hugin.info/1002/R/1911619/682119.pdf
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`HUG#1911619
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`https://globenewswire.com/news-release/2015/04/16/724977/10129220/en/Active-Biotech-and-Ipsen-announce...
`
`9/30/2016
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