Active Biotech

Lund, Sweden

Active Biotech

Lund, Sweden

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News Article | May 18, 2017
Site: globenewswire.com

Active Biotech's Annual Report 2016 is now available för download at www.activebiotech.com. The Annual Report will only be digitally distributed. The English version will be available within short. For further information, please contact: Hans Kolam, CFO Tel. +46 (0)46 192044 About Active Biotech Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Anyara, cancer immunotherapy, previously in clinical Phase 1-2/3 development in patients with pancreatic-, lung- or renal cancer. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 14.30 am CET on May 18, 2017.


News Article | May 18, 2017
Site: globenewswire.com

Active Biotech's Annual Report 2016 is now available för download at www.activebiotech.com. The Annual Report will only be digitally distributed. The English version will be available within short. For further information, please contact: Hans Kolam, CFO Tel. +46 (0)46 192044 About Active Biotech Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Anyara, cancer immunotherapy, previously in clinical Phase 1-2/3 development in patients with pancreatic-, lung- or renal cancer. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 14.30 am CET on May 18, 2017.


News Article | May 17, 2017
Site: globenewswire.com

The Board of Directors of Active Biotech AB (publ) has issued a notice to the Annual General Meeting, which is to take place on Thursday, June 15, 2017, at 5 pm at Elite Hotel Ideon, Scheelevägen 27 in Lund, Sweden. Please see the attached notification, which is being announced within short in Svenska Dagbladet and Post- och Inrikes Tidningar. About Active Biotech Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Anyara, cancer immunotherapy, previously in clinical Phase 1-2/3 development in patients with pancreatic-, lung- or renal cancer. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit http://www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 am CET on May 17, 2017. The shareholders of Active Biotech AB (publ) are invited to the Annual General Meeting of shareholders to be held on Thursday, June 15, 2017, at 5.00 p.m. at Elite Hotel Ideon, Scheelevägen 27 in Lund, Sweden. ENTITLEMENT TO PARTICIPATE Shareholders who wish to participate in the Meeting must (i) be recorded in the register of shareholders maintained by Euroclear Sweden AB on Friday, June 9, 2017, and (ii) notify the Company of their intention to participate in the Meeting not later than on Friday, June 9, 2017. Shareholders who have trustee-registered their shares must re-register the shares in their own name to be entitled to participate in the Meeting. Such registration, which may be temporary, must be completed on Friday, June 9, 2017. Accordingly, shareholders must inform the trustee of this request in ample time prior to this date. There are a total of 96,824,320 shares and votes in Active Biotech. The Company holds no treasury shares. NOTICE OF PARTICIPATION Notice of participation in the Meeting can be made in writing to Active Biotech AB (publ), Attn: Susanne Jönsson, P.O. Box 724, SE-220 07 Lund, Sweden, by telephone +46 (0)46-19 20 00 or by e-mail to susanne.jonsson@activebiotech.com. The notice shall include name, personal/corporate identity number, number of shares held, daytime telephone number and, if applicable, the number of advisors (not more than two) that will accompany the shareholder at the Meeting. Shareholders represented by proxy shall issue a dated and signed power of attorney for the proxy. If the power of attorney is issued on behalf of a legal entity, a certified copy of a registration certificate or corresponding document shall be appended. The original power of attorney and, where applicable, the certificate should be submitted to the Company at the address indicated above well in advance of the Meeting. Proxy forms are provided at the Company's website, www.activebiotech.com, and sent to shareholders that so request. Disposition of the Company's profits or losses (item 10) The Board proposes that no dividend be paid and that the Company's accumulated loss be carried forward. Board of Directors, etc. (items 2, 12, 13 and 14) The Election Committee, comprising Mats Arnhög (Chairman of the Board), Johnny Sommarlund (MGA Holding) and Tomas Billing (Nordstjernan), proposes the following: Chairman of the Meeting: Attorney at law Erik Sjöman. Number of members and deputy members of the Board of Directors: four ordinary members with no deputies. Fees payable to the Board of Directors: unchanged SEK 250,000 to the Chairman of the Board and SEK 125,000 to each of the other Board members who are not employees of the Company. The fee payable to a member of the Board of Directors may, if agreed with Active Biotech, be invoiced through a company, whereby the invoiced fee shall be adjusted in order to obtain cost neutrality for Active Biotech. Board of Directors: re-election of Mats Arnhög, Magnhild Sandberg-Wollheim, Peter Sjöstrand and Peter Thelin. Chairman of the Board: re-election of Mats Arnhög. Number of auditors and deputy auditors: one auditor with no deputies. Fees payable to the auditor: in accordance with approved invoices within the scope of the tender. Auditors: re-election of KPMG AB. The proposal regarding auditor is in accordance with the recommendation by the Board of Directors. Election Committee (item 15) The Election Committee proposes that the Meeting assign the Chairman of the Board the task of convening an Election Committee, based on the ownership structure at the end of September 2017, comprising the Chairman of the Board and one representative of each of the three largest shareholders of the Company. The Election Committee shall remain in place until the following Election Committee has been appointed. If a member of the Election Committee no longer represents one of the three largest shareholders in the Company, the Election Committee is entitled to dismiss the member. In the event that a member of the Election Committee resigns or is dismissed, the Election Committee may appoint another representative of the major shareholders to replace such a member. The Election Committee shall perform its duties in accordance with the stipulations for Election Committees stated in the Swedish Code of Corporate Governance. Guidelines for remuneration of senior executives (item 16) The Board proposes guidelines principally entailing that the Company shall offer total remuneration on market terms, facilitating the recruitment and retention of competent senior executives. Remuneration of senior executives may comprise fixed salary, any variable salary, pensions and other benefits. The fixed salary shall take into consideration the individual's area of responsibility and experience. The variable salary shall, where applicable, depend on the individual's fulfillment of quantitative and qualitative goals. Pension benefits shall comprise defined-contribution schemes. For senior executives covered by the ITP plan, pension premiums shall correspond to the stipulations in the ITP plan. For other senior executives, pension premiums shall not exceed 25 percent of the fixed salary. The guidelines correspond to the principles applied to date. Share issue authorization (item 17) The Board proposes that the Meeting resolve to grant authorization to the Board, for a period that does not extend past the date of the next Annual General Meeting, on one or several occasions, with or without pre-emptive rights for shareholders, to resolve on the issue of new shares and/or convertibles. It should also be possible to make such an issue resolution stipulating in-kind payment, the right to offset debt or other conditions. The authorization may not be utilized to a greater extent than would enable a total of not more than nine million shares to be issued and/or arise through the conversion of convertibles issued with the support of the authorization. The purpose of the authorization is to enable the financing, commercialization and development of the Company's projects and to provide flexibility in commercial negotiations relating to partnerships. Amendment of the articles of association (item 18) The Board of Directors proposes that the shareholders' meeting resolves to amend the articles association so that the limits for the share capital (§ 4) are decreased from SEK 160,000,000 - 640,000,000 to SEK 500,000 - 2,000,000. Reduction of the share capital and statutory reserve (item 19) The Board of Directors proposes that the shareholders' meeting resolves on a reduction of the Company's share capital and statutory reserve in accordance with the following. (i) The share capital shall be reduced by approximately SEK 364,464,039 for allocation to unrestricted shareholders' equity. The reduction shall be made without cancellation of shares. (ii) The statutory reserve, which amounted to approximately SEK 118,870,784 as of 31 December 2016, shall be reduced by the same amount, approximately SEK 118,870,784, for allocation to unrestricted shareholders' equity. Following the reductions as set forth above, the share capital will amount to SEK 500,000, divided into 96,824,320 shares, and the statutory reserve will amount to SEK zero. The share's quota value will amount to approximately SEK  0.005. DOCUMENTATION, ETC. The Annual Report and other supporting resolution documentation will be held available at the Company's premises at Scheelevägen 22 in Lund, Sweden, and on the Company's website, www.activebiotech.com, not later than three weeks prior to the Meeting. The documents will be sent to shareholders who request a copy and specify their postal address. Shareholders are reminded of their right to request information under Chapter 7, Section 32 of the Swedish Companies Act. Lund, May 2017 The Board of Directors of Active Biotech AB (publ)


News Article | May 17, 2017
Site: globenewswire.com

The Board of Directors of Active Biotech AB (publ) has issued a notice to the Annual General Meeting, which is to take place on Thursday, June 15, 2017, at 5 pm at Elite Hotel Ideon, Scheelevägen 27 in Lund, Sweden. Please see the attached notification, which is being announced within short in Svenska Dagbladet and Post- och Inrikes Tidningar. About Active Biotech Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Anyara, cancer immunotherapy, previously in clinical Phase 1-2/3 development in patients with pancreatic-, lung- or renal cancer. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit http://www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 am CET on May 17, 2017. The shareholders of Active Biotech AB (publ) are invited to the Annual General Meeting of shareholders to be held on Thursday, June 15, 2017, at 5.00 p.m. at Elite Hotel Ideon, Scheelevägen 27 in Lund, Sweden. ENTITLEMENT TO PARTICIPATE Shareholders who wish to participate in the Meeting must (i) be recorded in the register of shareholders maintained by Euroclear Sweden AB on Friday, June 9, 2017, and (ii) notify the Company of their intention to participate in the Meeting not later than on Friday, June 9, 2017. Shareholders who have trustee-registered their shares must re-register the shares in their own name to be entitled to participate in the Meeting. Such registration, which may be temporary, must be completed on Friday, June 9, 2017. Accordingly, shareholders must inform the trustee of this request in ample time prior to this date. There are a total of 96,824,320 shares and votes in Active Biotech. The Company holds no treasury shares. NOTICE OF PARTICIPATION Notice of participation in the Meeting can be made in writing to Active Biotech AB (publ), Attn: Susanne Jönsson, P.O. Box 724, SE-220 07 Lund, Sweden, by telephone +46 (0)46-19 20 00 or by e-mail to susanne.jonsson@activebiotech.com. The notice shall include name, personal/corporate identity number, number of shares held, daytime telephone number and, if applicable, the number of advisors (not more than two) that will accompany the shareholder at the Meeting. Shareholders represented by proxy shall issue a dated and signed power of attorney for the proxy. If the power of attorney is issued on behalf of a legal entity, a certified copy of a registration certificate or corresponding document shall be appended. The original power of attorney and, where applicable, the certificate should be submitted to the Company at the address indicated above well in advance of the Meeting. Proxy forms are provided at the Company's website, www.activebiotech.com, and sent to shareholders that so request. Disposition of the Company's profits or losses (item 10) The Board proposes that no dividend be paid and that the Company's accumulated loss be carried forward. Board of Directors, etc. (items 2, 12, 13 and 14) The Election Committee, comprising Mats Arnhög (Chairman of the Board), Johnny Sommarlund (MGA Holding) and Tomas Billing (Nordstjernan), proposes the following: Chairman of the Meeting: Attorney at law Erik Sjöman. Number of members and deputy members of the Board of Directors: four ordinary members with no deputies. Fees payable to the Board of Directors: unchanged SEK 250,000 to the Chairman of the Board and SEK 125,000 to each of the other Board members who are not employees of the Company. The fee payable to a member of the Board of Directors may, if agreed with Active Biotech, be invoiced through a company, whereby the invoiced fee shall be adjusted in order to obtain cost neutrality for Active Biotech. Board of Directors: re-election of Mats Arnhög, Magnhild Sandberg-Wollheim, Peter Sjöstrand and Peter Thelin. Chairman of the Board: re-election of Mats Arnhög. Number of auditors and deputy auditors: one auditor with no deputies. Fees payable to the auditor: in accordance with approved invoices within the scope of the tender. Auditors: re-election of KPMG AB. The proposal regarding auditor is in accordance with the recommendation by the Board of Directors. Election Committee (item 15) The Election Committee proposes that the Meeting assign the Chairman of the Board the task of convening an Election Committee, based on the ownership structure at the end of September 2017, comprising the Chairman of the Board and one representative of each of the three largest shareholders of the Company. The Election Committee shall remain in place until the following Election Committee has been appointed. If a member of the Election Committee no longer represents one of the three largest shareholders in the Company, the Election Committee is entitled to dismiss the member. In the event that a member of the Election Committee resigns or is dismissed, the Election Committee may appoint another representative of the major shareholders to replace such a member. The Election Committee shall perform its duties in accordance with the stipulations for Election Committees stated in the Swedish Code of Corporate Governance. Guidelines for remuneration of senior executives (item 16) The Board proposes guidelines principally entailing that the Company shall offer total remuneration on market terms, facilitating the recruitment and retention of competent senior executives. Remuneration of senior executives may comprise fixed salary, any variable salary, pensions and other benefits. The fixed salary shall take into consideration the individual's area of responsibility and experience. The variable salary shall, where applicable, depend on the individual's fulfillment of quantitative and qualitative goals. Pension benefits shall comprise defined-contribution schemes. For senior executives covered by the ITP plan, pension premiums shall correspond to the stipulations in the ITP plan. For other senior executives, pension premiums shall not exceed 25 percent of the fixed salary. The guidelines correspond to the principles applied to date. Share issue authorization (item 17) The Board proposes that the Meeting resolve to grant authorization to the Board, for a period that does not extend past the date of the next Annual General Meeting, on one or several occasions, with or without pre-emptive rights for shareholders, to resolve on the issue of new shares and/or convertibles. It should also be possible to make such an issue resolution stipulating in-kind payment, the right to offset debt or other conditions. The authorization may not be utilized to a greater extent than would enable a total of not more than nine million shares to be issued and/or arise through the conversion of convertibles issued with the support of the authorization. The purpose of the authorization is to enable the financing, commercialization and development of the Company's projects and to provide flexibility in commercial negotiations relating to partnerships. Amendment of the articles of association (item 18) The Board of Directors proposes that the shareholders' meeting resolves to amend the articles association so that the limits for the share capital (§ 4) are decreased from SEK 160,000,000 - 640,000,000 to SEK 500,000 - 2,000,000. Reduction of the share capital and statutory reserve (item 19) The Board of Directors proposes that the shareholders' meeting resolves on a reduction of the Company's share capital and statutory reserve in accordance with the following. (i) The share capital shall be reduced by approximately SEK 364,464,039 for allocation to unrestricted shareholders' equity. The reduction shall be made without cancellation of shares. (ii) The statutory reserve, which amounted to approximately SEK 118,870,784 as of 31 December 2016, shall be reduced by the same amount, approximately SEK 118,870,784, for allocation to unrestricted shareholders' equity. Following the reductions as set forth above, the share capital will amount to SEK 500,000, divided into 96,824,320 shares, and the statutory reserve will amount to SEK zero. The share's quota value will amount to approximately SEK  0.005. DOCUMENTATION, ETC. The Annual Report and other supporting resolution documentation will be held available at the Company's premises at Scheelevägen 22 in Lund, Sweden, and on the Company's website, www.activebiotech.com, not later than three weeks prior to the Meeting. The documents will be sent to shareholders who request a copy and specify their postal address. Shareholders are reminded of their right to request information under Chapter 7, Section 32 of the Swedish Companies Act. Lund, May 2017 The Board of Directors of Active Biotech AB (publ)


JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced results from the CONCERTO trial in patients with relapsing-remitting multiple sclerosis (RRMS). The primary endpoint in CONCERTO -- the evaluation of laquinimod (0.6 mg/daily capsules) versus placebo to evaluate the time to Confirmed Disability Progression (CDP) after at least 3 months – was not met. (Hazard Ratio of 0.937, p = 0.7057). Other data details announced by the Company show that on the secondary endpoint which measured change in brain volume-- an indicator of disability progression over time-- compared to baseline was positive (40% improvement over placebo at month 15, p < 0.0001). Other encouraging results were seen on the secondary endpoint of time to first relapse (risk reduced by 28%; p = 0.0001) and the exploratory endpoint of annualized relapse rate (risk reduced by 25%; p=0.0001). As with the primary endpoint, secondary endpoints measuring time to CDP at 6 and 9 months did not reach significance. On the exploratory endpoint of reduction of the number of gadolinium-enhancing T1 lesions at month 15, laquinimod demonstrated a 30% reduction (p=0.004). “We have learned a great deal from the CONCERTO trial and we will continue our analysis of the data,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints which fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials.” The clinical safety profile of laquinimod 0.6 mg daily, which had been previously studied with over 12,000 patient-years of exposure, was confirmed in CONCERTO. Adverse events reported in 5% or more of CONCERTO patients taking 0.6 mg daily of laquinimod were headache (17%), nasopharyngitis (9%), back pain (7%), and arthralgia (5%). Teva continues to evaluate the potential of laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial. Complete data from the CONCERTO trial will be published in a scientific journal and presented at a future medical meeting. CONCERTO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with RRMS. The higher-dose (1.2 mg) arm of the trial was discontinued in January 2016. In addition to the primary outcome measure of time to CDP after at least 3 months as measured by change in EDSS, CONCERTO examined the impact of laquinimod (0.6 mg) on the secondary endpoints of change in brain volume from baseline to month 15, time to first confirmed relapse and CDP measured by EDSS after at least 6 and 9 months—all secondary endpoints as compared to placebo. Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing -remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal Phase 3 development for the treatment of relapsing remitting multiple sclerosis. Also, laquinimod is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8 pm CET on May 5, 2017. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Laquinimod, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.


Jerusalem & Lund Sweden, May 5, 2017 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced results from the CONCERTO trial in patients with relapsing-remitting multiple sclerosis (RRMS). The primary endpoint in CONCERTO -- the evaluation of laquinimod (0.6 mg/daily capsules) versus placebo to evaluate the time to Confirmed Disability Progression (CDP) after at least 3 months - was not met. (Hazard Ratio of 0.937, p = 0.7057). Other data details announced by the Company show that on the secondary endpoint which measured change in brain volume-- an indicator of disability progression over time-- compared to baseline was positive (40% improvement over placebo at month 15, p < 0.0001). Other encouraging results were seen on the secondary endpoint of time to first relapse (risk reduced by 28%; p = 0.0001) and the exploratory endpoint of annualized relapse rate (risk reduced by 25%; p=0.0001). As with the primary endpoint, secondary endpoints measuring time to CDP at 6 and 9 months did not reach significance. On the exploratory endpoint of reduction of the number of gadolinium-enhancing T1 lesions at month 15, laquinimod demonstrated a 30% reduction (p=0.004). "We have learned a great deal from the CONCERTO trial and we will continue our analysis of the data," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. "Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints which fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials." The clinical safety profile of laquinimod 0.6 mg daily, which had been previously studied with over 12,000 patient-years of exposure, was confirmed in CONCERTO. Adverse events reported in 5% or more of CONCERTO patients taking 0.6 mg daily of laquinimod were headache (17%), nasopharyngitis (9%), back pain (7%), and arthralgia (5%). Teva continues to evaluate the potential of laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial. Complete data from the CONCERTO trial will be published in a scientific journal and presented at a future medical meeting. About CONCERTO: CONCERTO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with RRMS. The higher-dose (1.2 mg) arm of the trial was discontinued in January 2016. In addition to the primary outcome measure of time to CDP after at least 3 months as measured by change in EDSS, CONCERTO examined the impact of laquinimod (0.6 mg) on the secondary endpoints of change in brain volume from baseline to month 15, time to first confirmed relapse and CDP measured by EDSS after at least 6 and 9 months-all secondary endpoints as compared to placebo. About Laquinimod Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. About Active Biotech Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal Phase 3 development for the treatment of relapsing remitting multiple sclerosis. Also, laquinimod is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8 pm CET on May 5, 2017. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Laquinimod, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 ("Annual Report"), including in the section captioned "Risk Factors," and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. # # #


Jerusalem & Lund Sweden, May 5, 2017 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced results from the CONCERTO trial in patients with relapsing-remitting multiple sclerosis (RRMS). The primary endpoint in CONCERTO -- the evaluation of laquinimod (0.6 mg/daily capsules) versus placebo to evaluate the time to Confirmed Disability Progression (CDP) after at least 3 months - was not met. (Hazard Ratio of 0.937, p = 0.7057). Other data details announced by the Company show that on the secondary endpoint which measured change in brain volume-- an indicator of disability progression over time-- compared to baseline was positive (40% improvement over placebo at month 15, p < 0.0001). Other encouraging results were seen on the secondary endpoint of time to first relapse (risk reduced by 28%; p = 0.0001) and the exploratory endpoint of annualized relapse rate (risk reduced by 25%; p=0.0001). As with the primary endpoint, secondary endpoints measuring time to CDP at 6 and 9 months did not reach significance. On the exploratory endpoint of reduction of the number of gadolinium-enhancing T1 lesions at month 15, laquinimod demonstrated a 30% reduction (p=0.004). "We have learned a great deal from the CONCERTO trial and we will continue our analysis of the data," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. "Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints which fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials." The clinical safety profile of laquinimod 0.6 mg daily, which had been previously studied with over 12,000 patient-years of exposure, was confirmed in CONCERTO. Adverse events reported in 5% or more of CONCERTO patients taking 0.6 mg daily of laquinimod were headache (17%), nasopharyngitis (9%), back pain (7%), and arthralgia (5%). Teva continues to evaluate the potential of laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial. Complete data from the CONCERTO trial will be published in a scientific journal and presented at a future medical meeting. About CONCERTO: CONCERTO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with RRMS. The higher-dose (1.2 mg) arm of the trial was discontinued in January 2016. In addition to the primary outcome measure of time to CDP after at least 3 months as measured by change in EDSS, CONCERTO examined the impact of laquinimod (0.6 mg) on the secondary endpoints of change in brain volume from baseline to month 15, time to first confirmed relapse and CDP measured by EDSS after at least 6 and 9 months-all secondary endpoints as compared to placebo. About Laquinimod Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. About Active Biotech Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal Phase 3 development for the treatment of relapsing remitting multiple sclerosis. Also, laquinimod is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit www.activebiotech.com for more information. This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8 pm CET on May 5, 2017. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Laquinimod, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 ("Annual Report"), including in the section captioned "Risk Factors," and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. # # #


Sennbro C.J.,Active Biotech | Knutsson M.,Ferring Pharmaceuticals A S | Van Amsterdam P.,Abbott Laboratories | Timmerman P.,Janssen Research and Development
Bioanalysis | Year: 2011

Background: In regulated bioanalysis, the need for partial validation when changing the counter ion of the anticoagulant is currently being debated within the bioanalytical community. To date, industry and the health authorities have not yet reached a consensus on this issue. The aim of the present study was to evaluate the impact of a change in counter ion when using the same anticoagulant on LC-MS/MS assay performance for a broad array of new chemical entities, compiling data generated at companies within the European Bioanalysis Forum (EBF). Results: In all, 15 EBF member companies provided experimental data on partial validation. In total, data from 42 LC-MS/MS assays were evaluated. The results show that a change in counter ion when using the same anticoagulant had no impact on assay performance. Conclusion: Based on these results and on conclusions from previous studies, the EBF recommends that in regulated bioanalysis, plasma samples containing different counter ions, but the same anticoagulant, should be regarded as equal matrices, thus removing any need for partial validation. © 2011 Future Science Ltd.


Foell D.,University Childrens Hospital Muenster | Foell D.,The Interdisciplinary Center | Wittkowski H.,University Childrens Hospital Muenster | Kessel C.,University Childrens Hospital Muenster | And 13 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2013

Rationale: S100A12 is overexpressed during inflammation and is a marker of inflammatory disease. Furthermore, it has been ascribed to thegroupofdamage- associated molecular pattern molecules that promote inflammation. However, the exact role of human S100A12 during early steps of immune activation and sepsis is only partially described thus far. Objectives: We analyzed the activation of human monocytes by granulocyte-derived S100A12 as a key function of early inflammatory processes and the development of sepsis. Methods: CirculatingS100A12wasdeterminedin patients with sepsis and in healthy subjects with experimental endotoxemia. The release of human S100A12 from granulocytes as well as the promotion of inflammation byactivation ofhumanmonocytesafter specific receptor interaction was investigated by a series of in vitro experiments. Measurements and Main Results: S100A12 rises during sepsis, and its expression and release from granulocytes is rapidly induced in vitro and in vivo by inflammatory challenge. A global gene expression analysis of S100A12-activated monocytes revealed that human S100A12 induces inflammatory gene expression. These effects are triggered by an interaction of S100A12 with Toll-like receptor 4 (TLR4). Blocking S100A12 binding to TLR4 onmonocytes or TLR4 expressing cell lines (HEK-TCM) abrogatestherespective inflammatorysignal. Onthecontrary,blocking S100A12 binding to its second proposed receptor (receptor for advanced glycation end products [RAGE]) has no significant effect on inflammatory signaling inmonocytes and RAGE-expressing HEK293 cells. Conclusions:Human S100A12 is an endogenousTLR4 ligand that inducesmonocyte activation, thereby acting as an amplifier of innate immunity during early inflammation and the development of sepsis. Copyright © 2013 by the American Thoracic Society.


Objective To assess the efficacy of paquinimod, a new immunomodulatory small molecule, in a murine lupus model, and to evaluate its pharmacokinetics and tolerability in systemic lupus erythematosus (SLE) patients at doses predicted to be efficacious and safe and determine the maximum tolerated dose. Methods The efficacy of paquinimod was studied in lupus-prone MRL-lpr/lpr mice and compared with that of established SLE treatments. Dose-response data and pharmacokinetic data were used to calculate effective and safe clinical doses of paquinimod. The pharmacokinetics and tolerability of paquinimod were evaluated in a phase Ib double-blind, placebo controlled, dose-ranging study in which cohorts of SLE patients received daily oral treatment for 12 weeks. Results Paquinimod treatment resulted in disease inhibition in MRL-lpr/lpr mice, comparable to that obtained with prednisolone and mycophenolate mofetil; prominent effects on disease manifestations and serologic markers and a steroid-sparing effect were observed. In patients with SLE, the pharmacokinetic properties of paquinimod were linear and well suitable for once-daily oral treatment. The majority of the adverse events (AEs) were mild or moderate, and transient. The most frequent AEs were arthralgia and myalgia, reported with the highest dose levels of paquinimod (4.5 mg/day and 6.0 mg/day). At the 4.5 mg/day dose level and higher, some AEs of severe intensity and serious adverse events were reported. Conclusion Paquinimod effectively inhibited disease and had a steroid-sparing effect in experimental lupus. Results from preclinical models together with pharmacokinetic data were successfully translated into a safe clinical dose range, and doses of up to 3.0 mg/day were well tolerated in the SLE patients. Taken together, the promising combined data from a murine model and human SLE support the future clinical development of paquinimod. Copyright © 2012 by the American College of Rheumatology.

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