June 18, 2008 UMN Pharma initiates phase I/II trials for pandemic influenza vaccine manufactured from cell-culture, UMN-0501. UMN Pharma Inc. today announced initiation of phase I/II clinical trials in human subjects with UMN-0501, UMN's pandemic influenza vaccine. In Japan, this is the "first-in-man" clinical study of a pandemic influenza vaccine manufactured by cell-culture. The purpose of this clinical study is to assess safety and efficacy in 125 healthy adults aged 20-40. Study results will be obtained by the end of the year. News release PDF file.  (39K) In order to view this file, you will need to have the following plug-in installed.   June 10, 2008 UMN pandemic influenza vaccine, UMN-0501 designated as orphan drug. UMN Pharma Inc. today announced that UMN-0501, a novel vaccine being developed by UMN Pharma for pandemic influenza, has been granted orphan drug designation by the Ministry of Health, Labour and Welfare. UMN-0501 is a novel pandemic influenza vaccine manufactured from cell culture using recombinant protein rather than the traditional method that utilizes embryonated-egg culture. News release PDF file.  (72K) In order to view this file, you will need to have the following plug-in installed.   May 19, 2008 UMN Pharma presents at DIGESTIVE DESEASE WEEK 2008 in San Diego, California. Researchers from UMN Pharma Inc. presented pharmacological study results at the annual Digestive Disease Week conference demonstrating the impact of UMN-02, a specific 5HT-2A receptor antagonist, on choline-deficient ethionine-supplemented (CDE) diet-induced necrotizing acute pancreatitis in mice. This presentation showed that UMN-02 ameliorated severe necrotizing acute pancreatitis in mice by inhibiting key inflammatory responses. Based on these experimental results, we believe that UMN-02 could serve as a novel therapeutic for the treatment of acute pancreatitis. UMN-02 is a highly specific 5HT-2A receptor antagonist being developed by UMN Pharma Inc. for the treatment of acute pancreatitis. Further details about our presentation can be found in the conference proceedings from the DIGESTIVE DESEASE WEEK 2008.   April 30, 2008 UMN Pharma acquires factory site in Akita for the manufacturing of pandemic influenza vaccine. This acquisition will allow UMN Pharma to build a manufacturing facility for the production of UMN-0501, a pandemic influenza vaccine being developed by UMN Pharma that will begin Phase I/II clinical trials in June of this year. News release PDF file.  (74K) In order to view this file, you will need to have the following plug-in installed.   April 10, 2008 UMN Pharma announced initiation of phase I/II clinical trials for UMN-0501, UMN’s pandemic influenza vaccine. UMN Pharma Inc. (headquartered in Akita, President & CEO: Shuichi Kanazashi) today announced initiation of phase I/II clinical trials for UMN-0501, UMN’s pandemic influenza vaccine. Trials will begin in mid-June followed by the completion of necessary investigations for an IND filing as required by the PMDA (Pharmaceutical and Medical Devices Agency) based onPharmaceutical Affairs Law. The purpose of this clinical study is to assess safety, efficacy and appropriate dose for the IND product in healthy adults aged 20-40. News release PDF file.  (65K) In order to view this file, you will need to have the following plug-in installed.   April 2008 UMN Pharma appoints Mr. Masahiro Hayashi as a new Director of the company. Mr. Hayashi starts heading the business development division of UMN Pharma since April 2008. Further information can be found in the section of management team. -> Management Team   November 15, 2007 UMN Pharma appoints Dr. Kanazashi as UMN Pharma’s new President and CEO. Dr. Kanazashi replaces Yasunari Kashihara as the President and CEO of UMN Pharma. Previously, Dr. Kanazashi was the Chief Medical Officer of UMN Pharma and headed the R&D strategy division. Mr. Kashihara resigned as the President and CEO of the company on November 15, 2007. -> Management Team   October 27, 2007 The results of a pharmacological study on UMN-02 published in the Journal of Pharmacological Sciences. The results of pharmacological studies on UMN-02 published in the current volume of the Journal of Pharmacological Sciences, a leading Japanese academic journal, showed the involvement of 5-HT(2A) receptor activation in cerulein-induced acute pancreatitis in mice. The research paper follows a previous presentation at the annual meeting of the Japanese Pharmacological Society held in March, 2007 and strongly suggests potential efficacy of selective 5-HT(2A) antagonists in acute pancreatitis. References Possible Involvement of Endogenous 5-HT in Aggravation of Cerulein-Induced Acute Pancreatitis in Mice   October 26, 2007 UMN Pharma is awarded the research fund “Potential Verification Stage�Esponsored by Japan Science and Technology Agency. The research subject entitled “Discovery of new anticancer drugs targeting GRP78-related molecules induced by glucose-deprivation�Ehas been adopted as the “Potential Verification Stage�Eresearch program by the Japan Science and Technology Agency in reference to UMN-01. In collaboration with the Japanese Foundation of Cancer Research, UMN Pharma is exploring analogues that are superior to UMN-01, which is UMN’s original compound, in order to potentiate activity and improve safety. This research program is expected to add value to the UMN-01 Project.   October 16, 2007 UMN Pharma appoints Mr. Aburatani as the Company’s Advisor. Mr. Aburatani was the former Director of the company and had been heading the operations.   September 28, 2007 UMN Pharma appoints Mr. Yagi as the Company's board of directors. Mr.Yagi has been heading the clinical development division of the Company since September, 2007. Further information can be found in the section of management team. -> Management Team   September 1, 2007 UMN Pharma appoints Mr. Nakajima as the Company’s Advisor of the clinical development. Mr. Nakajima was the former Director of the company and had been heading the clinical development division.   August 14, 2007 UMN Pharma appoints Mr. Takagi as the Company's board of directors. Mr. Takagi has been heading the business development division of the Company since August 2007. Further information can be found in the section of management team. -> Management Team   June 14, 2007 UMN Pharma appoints Dr. Yamaguchi as the Company’s Chief Scientific Advisor. Dr. Yamaguchi was the former President and Chief Executive Officer of the company. Further information can be found in the section of management team. -> Management Team   April 17, 2007 UMN Pharma makes presentation at the annual meeting of the American Association for Cancer Research (AACR) held in Los Angeles, California in 2007. Researchers at UMN Pharma Inc. presented results from a microarray analysis of tumor tissue after the administration of UMN-01. In this study, mice bearing MKN74, stomach cancer cells, were administered UMN-01 and were subsequently studied using cDNA microarrayanalysis. Researchers found that intravenous injection of UMN-01 significantly suppressed tumor growth in this model. In addition, some probes or genes demonstrated interesting changes in their signature patterns with respect to the anti-tumor effect seen in the cDNA microarray analysis. Further details about our presentation can be found in the conference proceedings from the American Association of Cancer Research (AACR).   April 11, 2007 The result of a clinical study of FluBlØk (UMN-05) in the US is published in JAMA (The Journal of The American Medical Association). Dr. Treanor reported to JAMA (The Journal of The American Medical Association) the results of a randomized controlled trial with the purpose of determining the dose-related safety, immunogenicity, and protective efficacy of FluBlØk (UMN-05) produced in insect cells using recombinant baculoviruses. Participants in the study were randomly assigned to receive a single injection of placebo, FluBlØk; rHA0 vaccine containing hemagglutinin from influenza A/New Caledonia/20/99 (H1N1) and influenza B/Jiangsu/10/03 virus and hemagglutinin from influenza A/Wyoming/3/03 (H3N2) virus. The primary immunogenicity endpoints were the rate of 4-fold or greater increases in serum hemagglutinin inhibition antibody to each of the 3 components before and 28 days after inoculation. The pre-specified primary efficacy endpoint was culture-documented influenza illness, defined as development of influenza-like illness associated with influenza virus on a nasopharyngeal swab. As the result, authors observed that FluBlØk was safe and immunogenic in a healthy adult population. Though the sample size was small, FluBlØk prevented 100% of influenza infections. Furthermore, authors observed that FluBlØk as a hemagglutinin component vaccine without neuraminidase had enough ability to show the good efficacy.   March 15, 2007 UMN Pharma makes a presentation at the annual meeting of the Japanese Pharmacological Sciences held in Nagoya in 2007. Researchers from UMN Pharma Inc. presented results of pharmacological studies showing the involvement of 5-HT2A receptor activation on cerulein-induced acute pancreatitis in mice. This is the first report showing the importance of the 5-HT2A receptor in the pathogenesis of acute pancreatitis through the use of various types of 5-HT2 subtype specific receptor agonists and antagonists. Further details about our presentation can be found in the conference proceedings from the Japanese Pharmacological Sciences.   February 21, 2007 UMN Pharma completes $18.9 million Series C financing round, with participation of 20 investors. UMN Pharma Inc. raised $18.9 million in Series C financing round from 20 investors including JAFCO, NIF SMBC Ventures, Nomura Research & Advisory, SPARX Capital Partners, Rakuten Strategic Partners, CYBIRD Investment Partners, Pacific Rim Ventures, Nikko antfactory, Collabo SANGAKUKAN, Orix Capital, Yasuda Enterprise Development, The Dai-ichi Mutual Life Insurance, Tokyo Small and Medium Business Investment & Consultation, Nippon Venture Capital, New Frontier Partners, Mizuho Capital, Mitsubishi UFJ Capital, Nagoya Small and Medium Business Investment & Consultation and so on.   November 2, 2006 UMN Pharma signs a Biopharmaceutical Manufacturing Agreement with DSM Biologics. UMN Pharma Inc. and DSM Biologics signed a Biopharmaceutical Manufacturing Agreement based on the PER.C6® manufacturing platform. Under the terms of the agreement DSM Biologics will provide UMN Pharma with (a) full process development services, (b) full analytical development services and (c) cGMP manufacturing batches for UMN Pharma’s UMN-03 fusion protein. News release PDF file.  (31K) In order to view this file, you will need to have the following plug-in installed.   August 29, 2006 UMN Pharma signs a license agreement of UMN-05 with Protein Sciences Corporation. UMN Pharma Inc. signed a license agreement with Protein Sciences Corporation in the US This agreement allows UMN to use the exclusive rights of the development, manufacturing and sales of new recombinant influenza vaccines in Japan. News release PDF file.  (50K) In order to view this file, you will need to have the following plug-in installed.   March 10, 2006 UMN Pharma signs a research licensing agreement for UMN-03 with Crucell and DSM Biologics. UMN Pharma Inc. signed a research licensing agreement with Crucell N.V. and DSM Biologics in the Netherlands. This agreement allows UMN to use the PER.C6® cell line in the development and manufacturing of UMN-03. News release PDF file.  (417K) In order to view this file, you will need to have the following plug-in installed.   February 3, 2006 UMN Pharma completes $7.5 million Series B-2 financing round, with participation of 11 investors. UMN Pharma Inc. raised $7.5 million in Series B-2 financing round from 11 investors including Pacific Rim Ventures, Nomura Research & Advisory, NIF SMBC Ventures, SPARX Asset Management , Japan Asia Investment, Orix Capital, Tokyo Small and Medium Business Investment & Consultation, Mizuho Securities, Mizuho Capital, Nagoya Small and Medium Business Investment & Consultation, and Resona Capital.   October 17, 2005 UMN Pharma completes $1.1 million Series B-1 financing round, with participation of 3 venture capital firms. UMN Pharma Inc. raised $1.1 million in Series B-1 from 3 venture capitals, Pacific Rim Ventures, Nomura Research & Advisory and NIF SMBC Ventures.   July 22, 2005 UMN Pharma completes $0.9 million Series A round (second tranche), with participation of 2 venture capital firms. UMN Pharma Inc. raised $ 0.9 million in Series A round (second tranche) from 2 venture capitals, Pacific Rim Ventures and ASTEC.  This financing was provided by having achieved the second milestone set last November.   November~ December, 2004 UMN Pharma completes $0.9 million Series A round (first tranche), with participation of 2 venture capital firms. UMN Pharma Inc. raised $ 0.9 million in Series A round (first tranche) from 2 venture capitals, Pacific Rim Ventures and ASTEC.  In this round, we set two milestones and this financing was the first of them.