Sweden
Sweden

Time filter

Source Type

The extension study of MIV-711 in patients with moderate knee osteoarthritis has now completed enrolment, having achieved its target of recruiting 50 patients. All patients in the extension study were recruited from the initial phase IIa study and receive 200mg MIV-711 once daily. The headline data from the initial study continues to be expected to be reported in the third quarter of 2017, and the headline data from both groups in the extension study are expected to be reported in the first half of 2018. The first objective of the extension study is to assess the safety, tolerability and efficacy of six additional months of treatment with MIV-711 in patients treated in the initial study for six months and who showed evidence of response. The initial study and the extension study together provide an opportunity to assess the effect of 12 months of treatment on the structure of the diseased knee. The other objective of the study is to explore the safety, tolerability and efficacy of six months of treatment with MIV-711 in patients who received placebo in the initial study and whose osteoarthritis worsened. These patients with rapid disease worsening may be in particular need of a disease-modifying treatment and the extension study provides a unique opportunity to study the effect of MIV-711 in this patient population. As part of the study, an independent DMC is periodically scheduled to review the accumulated safety data. Based on the present DMC review of all safety data including unblinded data from the initial study and data to date from the extension study, the DMC has recommended that the extension study should go ahead. This review constitutes the first of two planned DMC reviews during the extension study. "The DMC's recommendation to continue as planned is a positive outcome", says Christine Lind, CEO at Medivir. "The combined data from the MIV-711 phase IIa programme have the potential to show that MIV-711 is capable of modifying the course of osteoarthritis. This would be expected to generate significant interest from the pharmaceutical community as well as osteoarthritis patients and their doctors. We look forward delivering the data from these studies over the coming months and to continuing partnering discussions after completion of these studies." MIV-711 is being developed as a DMOAD, which is a drug intended to slow or reverse the progressive degeneration of joints affected by osteoarthritis. There are no DMOADs approved for use currently, and the standard of care for osteoarthritis patients is based on analgesics, with the potential for associated side effect risks such as gastrointestinal-bleeding and opioid dependency, and changes in life style. DMOADs for osteoarthritis therefore represent a very large and attractive market opportunity. Medivir estimates that the US market alone is greater than USD 6 billion annually for a drug that impacts disease progression, even if its use was restricted just to patient populations with moderate osteoarthritis in weight-bearing joints. For further information, please contact: This information is information that Medivir 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 persons set out above, at 08.30 CET on 9 June 2017. Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List. This information was brought to you by Cision http://news.cision.com http://news.cision.com/medivir/r/enrolment-completed-in-the-miv-711-osteoarthritis-extension-study-and-data-monitoring-committee-reco,c2284805 The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/medivir---enrolment-completed-in-the-miv-711-osteoarthritis-extension-study-and-data-monitoring-committee-recommendation-to-go-ahead-300471561.html


News Article | June 19, 2017
Site: www.prnewswire.com

John Öhd has been Medivir's Director, Clinical Research & Development since 2014, prior to which he was senior director of Experimental Medicine at Shire in Nyon, Switzerland. John has held various positions at AstraZeneca in Södertälje, Sweden, including group director for early development in cognitive and neurodegenerative disorders. He worked in cancer research initially at Lund University where he received a PhD in Experimental Pathology and subsequently at Karolinska Institute. John received his MD from Linköping University, and trained clinically at Karolinska University Hospital. For further information, please contact: Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List. This information was brought to you by Cision http://news.cision.com The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/medivir-appoints-john-ohd-as-chief-medical-officer-300475771.html


News Article | May 30, 2017
Site: www.prnewswire.com

"Medivir has transformed into an oncology-focused research and development company with a broad pipeline of attractive projects. Ola has been an instrumental part of the executive leadership team in creating the new company and I want to thank him for his contributions and wish him good luck in his future career," says Christine Lind, CEO of Medivir. "I have had a rewarding and instructive time at Medivir and the privilege to be involved in the most intense years of the company's changes. Medivir is on a new journey with a vision to improve life for cancer patients through the development of transformative drugs and thus this is a good time to transition", says Ola Burmark. A recruitment firm has been retained and the process of finding a successor has started. For further information, please contact: Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List. This information was brought to you by Cision http://news.cision.com http://news.cision.com/medivir/r/medivir-s-cfo-will-leave-his-position---successor-recruitment-underway,c2275672 The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/medivirs-cfo-will-leave-his-position---successor-recruitment-underway-300465213.html


Medivir AB (Nasdaq Stockholm: MVIR) today announces that the independent Data Monitoring Committee (DMC) has had its third meeting and recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on a review of unblinded safety data. The objective of MIV-711-201 is to evaluate the safety, tolerability and efficacy of six months of treatment with MIV-711 in patients with moderate knee osteoarthritis. As part of the study, an independent DMC is periodically scheduled to review the unblinded safety data from the trial. Based on the review of the accumulated safety data after the first 150 subjects had completed 3 months of treatment, the DMC has recommended that the phase IIa trial of osteoarthritis should continue without any modifications. It is expected that data from MIV-711-201 will be available in the third quarter of 2017 and that data from the extension study will be available in the first half of 2018. MIV-711 is being developed as a DMOAD, i.e. a drug to slow or reverse the progressive degeneration of joints affected by OA. There are no DMOADs approved for use currently, and the standard of care for OA patients is based on analgesics, with the potential for associated side effect risks such as GI-bleeding and opioid dependency, and changes in life style. DMOADs for osteoarthritis therefore represent a very large and attractive market opportunity. Medivir estimates that the US market alone is greater than USD 6 billion annually for a drug that impacts disease progression, even if its use was restricted just to patient populations with moderate osteoarthritis in weight-bearing joints. Further information on the trial planning and conduct can be found on www.clinicaltrials.gov with identifier NCT02705625. Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 8.30 CET on 8 December 2016. Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List. This information was brought to you by Cision http://news.cision.com


Medivir AB (Nasdaq Stockholm: MVIR) today announces that MIV-323 has been selected as a candidate drug (CD) from its fusion inhibitor project for the treatment of respiratory syncytial virus (RSV) infection, and has now entered non-clinical development. Human respiratory syncytial virus is the main viral cause of respiratory tract infection in infants, the elderly and the severely immunocompromised. Almost all children will have been infected with RSV by the time of their second birthday. It has been estimated that RSV resulted in around 33.8 million lower respiratory tract infections in children younger than 5 years in 2005, with 3.4 million requiring hospitalization and between 66,000 and 199,000 child deaths. Today only one drug is approved for therapeutic use – ribavirin – but its use is limited by a complex administration procedure, limited efficacy, high cost and severe side effects. A humanised monoclonal antibody is available for prophylactic use, but it is approved only for prevention of RSV infection in infants that are at very high risk of serious lower respiratory tract disease following infection by RSV. Patients urgently need new, safe and effective drug options for the treatment and prevention of RSV infection. Medivir AB entered a license agreement with Boehringer Ingelheim International GmbH for exclusive, global rights to a drug program for the treatment and prevention of RSV infection in August 2014. Under the terms of the agreement Medivir received an exclusive, global license to research, develop, manufacture and commercialise RSV drugs resulting from Boehringer Ingelheim's program. "RSV is respiratory pathogen that can cause life-threatening infections, especially in children, the elderly and the immunocompromised. It is a major, underserved disease area today, with no effective treatment available" said Richard Bethell, Medivir's CSO. "MIV-323 has outstanding potency against diverse RSV isolates and a class-leading preclinical pharmacokinetic and in vitro safety profile. Although Medivir will be focusing its R&D efforts in oncology going forward, we believe that MIV-323 is a CD with best-in-class potential and we look forward to enabling its development by a third party." For further information, please contact: Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 14.30 CET on 14 December 2016. Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List. This information was brought to you by Cision http://news.cision.com http://news.cision.com/medivir/r/medivir-s-fusion-inhibitor-for-the-treatment-of-respiratory-syncytial-virus-infection--miv-323--ente,c2150161 The following files are available for download:


PAOLI, Pa., Nov. 02, 2016 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (NASDAQ:TLOG) (“TetraLogic” or “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced that it has entered into an asset purchase agreement with Medivir AB (Nasdaq Stockholm:MVIR) (“Medivir”) to sell its SMAC mimetic program, including its clinical stage asset birinapant, and its topical HDAC inhibitor, SHAPE, to Medivir (the “Sale”).  In consideration Medivir is expected to pay $12 million in cash upon closing of the transaction as well as future milestones of up to $153 million based on the development and commercialization of TetraLogic’s product candidates and earn-out payments which become payable upon achievement of specified annual sales. The transaction, which was approved by the Board of Directors, is expected to close by the end of the fourth quarter of 2016.  Closing is subject to certain conditions, including the approval of TetraLogic’s shareholders and of the holders of TetraLogic’s convertible debt (“Senior Notes”). In connection with the Sale, the holders of the Senior Notes agreed to exchange $2.2 million in principal amount of the Senior Notes for 12,222,222 shares of newly issued convertible participating series A preferred stock, with certain preferential dividends and liquidation preferences.  Following this exchange, approximately $41.5 million in aggregate principal amount of Senior Notes will remain outstanding, plus accrued but unpaid interest on all Senior Notes. Each share of preferred stock will accrue dividends at the rate of 8%, payable in priority to any dividend or other distribution on the Common Stock.  The preferred stock will have voting rights equivalent to one share of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), and will vote on an as-converted basis as a single class with the holders of Common Stock. The holders of Senior Notes have agreed to vote their shares of preferred stock in support of the Sale. Shareholders of the Company holding approximately 17.48% of the outstanding shares of capital stock entitled to vote have signed voting agreements in support of the Sale.  Collectively therefore, holders of shares representing approximately 50.72% of the shares of capital stock entitled to vote will have agreed to vote their shares in favor of the Sale. Under its agreement with the holders of Senior Notes, the Company has agreed to use the $12 million cash proceeds received at closing of the Sale to redeem $12 million in aggregate principal amount of the Senior Notes then outstanding.  The holders of the Senior Notes have also agreed to extend the maturity date of the Senior Notes to June 15, 2024 and to receive interest payments in additional Senior Notes in lieu of cash. As a result of the Sale, the Company will be terminating all remaining employees, with all terminations expected to be completed no later than December 1, 2016. On November 2, 2016, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) that it determined to delist the Company’s Common Stock and that it will suspend trading of the Company’s Common Stock effective at the open of business on November 4, 2016. The Company’s Board of Directors determined, after careful consideration and in light of the Sale, that voluntarily delisting and deregistering is in the overall best interests of the Company and its shareholders. Factors that the Board of Directors considered include the inability of the Company to regain compliance with continued listing requirements of Nasdaq, the costs associated with satisfying its ongoing reporting obligations and the nominal trading price and limited trading activity of its Common Stock. In connection with the Sale, the Company is submitting a notice to Nasdaq of its intention to voluntarily delist its Common Stock, from The Nasdaq Global Market and to deregister its Common Stock under Section 12(b) of the Securities Exchange Act of 1934, as amended.  The Company intends to file a Notification of Removal from Listing and/or Registration on Form 25 with the Securities Exchange Commission (“SEC”) as soon as permissible thereafter unless previously filed by Nasdaq and expects that the Common Stock will cease to be listed on The Nasdaq Global Market 10 days after the filing of Form 25. The Company previously reported that it had received notice from Nasdaq informing the Company that it was not in compliance with (i) the minimum Market Value of Listed Securities requirements set forth in Nasdaq Listing Rule 5450(b)(2)(A); (ii) the $1.00 Minimum Bid Price requirement as set forth in Nasdaq Listing Rule 5450(a)(1); and (iii) the minimum $15 million market value of publicly-held shares requirement set forth in Nasdaq Listing Rule 5450(b)(2)(C).  Following a hearing before the Nasdaq hearing panel (“Panel”) to appeal a delisting determination by Nasdaq, the Company received notice that the Panel granted the Company’s request for continued listing on The Nasdaq Global Market subject to certain conditions, including completion of a conversion of its Senior Notes into equity of the Company by October 15, 2016 (the “Restructuring”).  On October 18, 2016, the Company received notice that the Panel had granted the Company’s request for an extension till October 31, 2016 for completion of the Restructuring. Some of the statements in this press release and other written and oral statements made from time to time by TetraLogic and its representatives are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include statements regarding the closing of the Sale, the exchange of the Senior Notes into preferred stock, cost savings and other benefits expected to be derived from the delisting and deregistration and the intent and belief or current expectations of TetraLogic and its management team. Such statements may be identified by the use of words like “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “seek”, the negative of these terms or other comparable terminology. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. For example, there can be no assurances that TetraLogic will successfully complete the Sale or the exchange of the Senior Notes.  Investors should read carefully the factors described in the “Risk Factors” section of TetraLogic’s filings with the SEC, including TetraLogic’s Form 10-K for the year ended December 31, 2015, for information regarding risk factors that could affect TetraLogic’s results. The forward-looking statements contained in this press release speak only as of the date of this press release and TetraLogic undertakes no obligation to publicly update any forward-looking statements to reflect changes in information, events or circumstances after the date of this press release, unless required by law. This press release is being made in respect of the Sale. The proposed Sale will be submitted to the shareholder of the Company for their consideration. In connection with the proposed Sale, the Company will file a proxy statement with the SEC.  This press release does not constitute a solicitation of any vote or proxy from any shareholder of the Company. INVESTORS ARE URGED TO READ THE PROXY STATEMENT CAREFULLY AND IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER RELEVANT DOCUMENTS OR MATERIALS FILED OR TO BE FILED WITH THE SEC OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE SALE. The final proxy statement will be mailed to the Company’s shareholders. In addition, the proxy statement and other documents will be available free of charge at the SEC’s internet website, www.sec.gov. When available, the proxy statement and other pertinent documents also may be obtained free of charge at the Company’s website, http://tetralogicpharma.com/, or by directing a written request to TetraLogic Pharmaceuticals Corporation, Attn: Secretary, in writing, at P.O. Box 1305, Paoli, PA 19301. The Company and its directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposed Sale. Information about the Company’s directors and executive officers is included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 16, 2016 and the proxy statement for the Company’s 2015 annual meeting of shareholders, filed with the SEC on April 28, 2016. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement relating to the proposed Sale when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.


News Article | February 24, 2017
Site: www.prnewswire.com

STOCKHOLM, Feb 24, 2017 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announced the Nomination Committee's proposal for a new Board of Directors that will be submitted to the 2017 Annual General Meeting. The 2016-2017 Nomination Committee comprises representatives of the...


News Article | March 3, 2017
Site: www.prnewswire.com

STOCKHOLM, Mar 03, 2017 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announces the result of Medivir's voluntary redemption programme. The redemption programme comprised a total of 6,738,655 shares in Medivir. Upon completion of the application period, a total of...


STOCKHOLM, Sweden, Dec 8, 2016 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR)today announces that the independent Data Monitoring Committee (DMC) has had its third meeting and recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on...


News Article | November 3, 2016
Site: www.businesswire.com

HUDDINGE, Sweden--(BUSINESS WIRE)--Medivir (STO:MVIRB) will be conducting an analyst and investor conference call/webcast today 3 November, at 14.30 CET. Niklas Prager CEO, Ola Burmark CFO and Richard Bethell CSO will be presenting and will be available for questions relating to the recent agreement to acquire two clinical stage oncology programs from Tetralogic Pharmaceuticals Corporation. To join the conference call, please dial:Sweden +46 (0)8 566 426 96Europe +44 20 300 898 17USA +1 855 831

Loading Medivir collaborators
Loading Medivir collaborators