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

NEW YORK, May 18, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced its 2016 UK Annual Report and Accounts and notice of its Annual General Meeting have been posted to shareholders and will shortly be available for download from the Company’s website at www.motifbio.com. This follows the announcement made by the Company on May 2, 2017 via RNS of the publication of its financial results for the year ended December 31, 2016 and the filing of its US Annual Report on Form 20-F with the US Securities and Exchange Commission. The Company's Annual General Meeting is to be held at 2:00 pm BST on June 15, 2017 at the offices of DLA Piper UK LLP at 3 Noble St, London EC2V 7EE, United Kingdom. This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014 and has been released by Robert Dickey IV, Chief Financial Officer, on behalf of the Company. Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 1,000 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients. Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having announced the topline results from the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


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

NEW YORK, May 18, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced its 2016 UK Annual Report and Accounts and notice of its Annual General Meeting have been posted to shareholders and will shortly be available for download from the Company’s website at www.motifbio.com. This follows the announcement made by the Company on May 2, 2017 via RNS of the publication of its financial results for the year ended December 31, 2016 and the filing of its US Annual Report on Form 20-F with the US Securities and Exchange Commission. The Company's Annual General Meeting is to be held at 2:00 pm BST on June 15, 2017 at the offices of DLA Piper UK LLP at 3 Noble St, London EC2V 7EE, United Kingdom. This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014 and has been released by Robert Dickey IV, Chief Financial Officer, on behalf of the Company. Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 1,000 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients. Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having announced the topline results from the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


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

NEW YORK, May 18, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced its 2016 UK Annual Report and Accounts and notice of its Annual General Meeting have been posted to shareholders and will shortly be available for download from the Company’s website at www.motifbio.com. This follows the announcement made by the Company on May 2, 2017 via RNS of the publication of its financial results for the year ended December 31, 2016 and the filing of its US Annual Report on Form 20-F with the US Securities and Exchange Commission. The Company's Annual General Meeting is to be held at 2:00 pm BST on June 15, 2017 at the offices of DLA Piper UK LLP at 3 Noble St, London EC2V 7EE, United Kingdom. This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014 and has been released by Robert Dickey IV, Chief Financial Officer, on behalf of the Company. Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 1,000 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients. Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having announced the topline results from the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


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

NEW YORK, May 18, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced its 2016 UK Annual Report and Accounts and notice of its Annual General Meeting have been posted to shareholders and will shortly be available for download from the Company’s website at www.motifbio.com. This follows the announcement made by the Company on May 2, 2017 via RNS of the publication of its financial results for the year ended December 31, 2016 and the filing of its US Annual Report on Form 20-F with the US Securities and Exchange Commission. The Company's Annual General Meeting is to be held at 2:00 pm BST on June 15, 2017 at the offices of DLA Piper UK LLP at 3 Noble St, London EC2V 7EE, United Kingdom. This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014 and has been released by Robert Dickey IV, Chief Financial Officer, on behalf of the Company. Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 1,000 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients. Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having announced the topline results from the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


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

NEW YORK, May 18, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced its 2016 UK Annual Report and Accounts and notice of its Annual General Meeting have been posted to shareholders and will shortly be available for download from the Company’s website at www.motifbio.com. This follows the announcement made by the Company on May 2, 2017 via RNS of the publication of its financial results for the year ended December 31, 2016 and the filing of its US Annual Report on Form 20-F with the US Securities and Exchange Commission. The Company's Annual General Meeting is to be held at 2:00 pm BST on June 15, 2017 at the offices of DLA Piper UK LLP at 3 Noble St, London EC2V 7EE, United Kingdom. This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014 and has been released by Robert Dickey IV, Chief Financial Officer, on behalf of the Company. Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 1,000 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients. Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having announced the topline results from the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


Gordon Nardell Q.C.,39 Essex Street | Simpson P.,DLA Piper UK LLP
Journal of Planning and Environment Law | Year: 2011

The articles examines the implications of recent caselaw on the species protection provisions of the habitats directive. The Habitats Directive and the Wild Birds Directive together set out a system of protection across the European Union for the conservation of nature. The Habitats Directive was first implemented in England, Wales and Scotland by the Conservation (Natural Habitats) Regulations 1994 (1994 Regulations). The Supreme Court was doubtless concerned that the Court of Appeal's reading of article 12(1)(b) involved importing constraints that are unsupported by the language of the provision. The issue is of particular importance in the frequently encountered scenario where, although EPS are present in the vicinity of proposed development, there is no relevant Natura 2000 site attracting the operation of regulation 61. It is submitted that planning conditions relating to compensatory measures are not appropriate where those measures can be secured adequately by NE or WAG through the regulation 53 licensing process.


Hicks V.A.,Upper Tribunal Lands Chamber | Sage R.,DAC Beachcroft Claims Ltd. | Wright M.,DLA Piper UK LLP
Journal of Planning and Environment Law | Year: 2015

The article discusses the decision made by an upper tribunal in the case 'Mrs Violet Ann Hicks versus The Coal Authority.' Mrs Hicks is currently the sole freehold owner of the subject property and lives there with her husband and son In her witness statement, she said that when she and her husband purchased it, together with about 40ha of land in May 1973, the substantial farmhouse was in need of complete modernization. These works were undertaken between then and December 1974 when she moved in. She said that despite the need for refurbishment, there was no significant damage to any part of the farmhouse and she could not recall any damage occurring prior to noticing severe cracking in May 2007.


Van Eecke P.,University of Antwerp | Truyens M.,DLA Piper UK LLP
Computer Law and Security Review | Year: 2010

This article discusses the complex relationship between social networks and the EU Data Protection Directive (95/46/EC). After a concise introduction to the general privacy impact of social networks, it discusses how the Directive applies to users and operators of social networks and social network applications. Particular attention is drawn to the scope of the Directive (including the "household" exception), the obligations imposed on data controllers, the interpretation of the Directive by Working Party 29, as well as the difficulties that are encountered when applying the aging Directive to the technological reality of today's social networks. © 2010 Patrick Van Eecke & Maarten Truyens. Published by Elsevier Ltd. All rights reserved.


Bore J.,DLA Piper UK LLP
Biochemist | Year: 2012

The single dramatic episode that led to the now familiar body of legislation regulating the manufacture and supply of medicines in the United Kingdom was the thalidomide tragedy that played out in the early 1960s. The limb deformities in children born to mothers who had taken thalidomide as a treatment to prevent morning sickness early in their pregnancy were readily reproducible in tests in rabbits. But tests in appropriate species had reportedly not been carried out before thalidomide was marketed worldwide. There were proportionately fewer cases of thalidomide-induced deformities in the USA because the drug had not been marketed there, although it had been used by women in clinical trials. The federal Food and Drug Administration (FDA) had taken a more cautious approach requiring additional evidence of safety in pregnant women. © 2012 The Biochemical Society.


Burden K.,DLA Piper UK LLP
Computer Law and Security Review | Year: 2016

This is the latest edition of the DLA Piper column on developments in EU law relating to IP, IT and telecommunications. This news article summarises recent developments that are considered important for practitioners, students and academics in a wide range of information technology, e-commerce, telecommunications and intellectual property areas. It cannot be exhaustive but intends to address the important points. This is a hard copy reference guide, but links to outside web sites are included where possible. No responsibility is assumed for the accuracy of information contained in these links. © 2016 DLA Piper UK LLP. Published by Elsevier Ltd. All rights reserved.

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