Pharmaceutical Executive Magazine Features RaQualia:

December Issue Cover Story Highlights the Company’s Venture Model

RaQualia Pharma Inc. (RaQualia) announced today that Pharmaceutical Executive Magazine featured the company in the cover story of its December 2011 issue. The article is entitled, “RaQualia’s New Spin on the Startup” and was written by the magazine’s Editor-in-Chief William Looney. The piece discusses RaQualia’s genesis as a new venture and its collaboration-centric model. Looney focuses on what makes the company unique and the implications for both Japan and the industry:

RaQualia is not just another small-cap enterprise struggling to build a product portfolio with other peoples' funds. The additive element is the pressure its very presence places on the conventional wisdom that Japan lacks an entrepreneurial culture, where new ideas fail because the only choice is between the "salary man" culture of bureaucratic malaise or the "samurai code" of winner take all. RaQualia is carving out a third way focused on teamwork, trust, and partnered collaboration to achieve a level of R&D productivity that exceeds what has been possible in Japanese life sciences to date…the RaQualia model poses a subtle challenge to its industry peers—and to Japanese industrial policy writ large. The question is whether Japan's best days as a pace-setter in medicines innovation are behind it. Or is RaQualia a breakthrough precedent that must be allowed to succeed?

Excerpt from “RaQualia’s New Spin on the Startup,” Pharmaceutical Executive, December 2011

Upon the article’s release, RaQualia President and CEO Dr. Atsushi Nagahisa commented, “we are honored and delighted to be featured in Pharmaceutical Executive magazine, a thought leader in our industry. This piece is a very nice way to end the year. 2011 has been a year of tremendous productivity for RaQualia and our pipeline, and we look forward to next year with great anticipation.”

For more details on the article, please see:

http://pharmexec.findpharma.com/pharmexec/Leadership+Column/RaQualias-New-Spin-on-the-Startup/ArticleStandard/Article/detail/752341?contextCategoryId=48158

RaQualia Pharma Inc. (RaQualia) [JASDAQ Growth: 4579] announced today that President & CEO Atsushi Nagahisa was chosen by Pharmaceutical Executive Magazine as one of 30 leaders who have shaped the global pharmaceutical industry over the past 30 years.  The list includes individuals from various disciplines within the life sciences, including scientists, administrators, industry leaders, and public policy makers.  The cover feature appears in the October 2011 issue, commemorating the magazine’s 30th anniversary as a premier publication in the biopharmaceutical sector.

In response to this selection, Dr. Nagahisa said, “It is a tremendous honor to be included in a list with so many people whom I have admired for many years.  I am very grateful to have the opportunity to pursue innovation in the life sciences.  Every single day brings opportunities to try to help patients who are waiting for new and better therapies.”

The complete list of 30 is below for your reference:

Dr. Francis Collins, Director, National Institutes of Health
Dr. P. Roy Vagelos, Chairman Emeritus, Merck
Fernand Sauer, First Director General, European Medicines Agency
Sir Michael Rawlins, Chairman, UK National Institute for Health and Clinical Excellence
Dr. Mark McClellan, Director, Engelberg Center for Health Reform, Brookings Institution
Henry Waxman (D-California), Member, U.S. House of Representatives
Dr. Janet Woodcock, Director, FDA Center for Drug Evaluation and Research
Yasuchika Hasegawa, President & CEO, Takeda Pharmaceutical Co.

Dr. Harvey Bale, Jr., former Director General, IFPMA
Dr. Carlos Morel, Director for Technical Development in Health, Oswaldo Cruz Foundation
Dr. Henry Grabowski, Professor of Economics, Duke University
Jean-Claude Labrune, Chairman & CEO, Cegedim Group
Andrew Witty, Chairman & CEO, GlaxoSmithKline
Dr. Atsushi Nagahisa, President & CEO, RaQualia Pharma Inc.

Fred Frank, Vice Chairman, P.J. Solomon Co.
Dennis Gillings, Chairman & CEO, Quintiles Transnational Corp.
Dr. Peter Piot, Director, London School of Hygiene and Tropical Medicine
Angus Russell, CEO, Shire
Dr. Jane Henney, Former FDA Commissioner
Dr. Antonio Gotto, Dean, Weill Cornell Medical College
Sir Martin Sorrell, CEO, WPP
Y.K. Hamied, Chairman, Cipla

Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group
Josef von Rickenbach, President & CEO, Parexel
Dr. Napoleone Ferrara, Research Fellow, Genentech
Martin Wygod, Chairman, WebMD
Robert Seidman, Former Chief Pharmacy Officer, Wellpoint
Abbey Meyers, Founder, National Organization of Rare Disorders
Candan Karabagli, CEO, Abdi Ibrahim A.S.

Dr. Daniel Vasella, Chairman, Novartis 

The article on Dr. Nagahisa appears on page 68 of the magazine and can be downloaded as a pdf here.

Pharmaceutical Executive Magazine can be found at the following link: http://pharmexec.findpharma.com/

About RaQualia:
RaQualia Pharma Inc. engages in the discovery, development and marketing of clinical and pre-clinical drug candidates for highly-unmet medical needs including Pain, Inflammation, Cancer, Auto-immune, Alzheimer’s, and GI Diseases.  RaQualia’s vision is to bring people hope, health and happiness with new medicines. For further information, please visit us at www.raqualia.com.

####

RaQualia Pharma Inc. today announced that Dr. Atsushi Nagahisa, President & CEO, will present at the BioCentury NewsMakers in the Biotech Industry Conference on October 21, 2011 at 9:00 AM (Eastern time) in New York City.  The presentation will be webcast and can be accessed by the following URL.

Dr. Atsushi Nagahisa, President of RaQualia Pharma Inc. will chair the special session 8 of 10th International Bio Forum & Bio Expo Japan held on June 29 to July 1, 2011 at Tokyo Big Site.

URL for Bio Expo Japan: http://www.bio-expo.jp/en/Home/

RaQualia Receives Approval to List on JASDAQ

June 16, 2011 – RaQualia Pharma Inc. (RaQualia) announced today that it received approval to list its shares on the Osaka Securities Exchange JASDAQ Growth Market. The Company’s common shares are expected to be listed and begin trading on July 20, 2011. RaQualia’s Board of Directors decided on March 14, 2011 to temporarily postpone its planned listing due to the Tohoku-Pacific Ocean Earthquake of March 11 and its impact on the stock market, but the company has continued its preparations since then.

Contact

RaQualia Pharma Inc.

Kazuhiro Ikeda

E-mail: ask@raqualia.com

RaQualia Pharma Inc. announces the below executive appointment following its Shareholders Meeting and Board Meeting held on March 30th, 2011.

RaQualia Receives Approval to List on JASDAQ

February 21, 2011 – RaQualia Pharma Inc., announced that it received approval today to list its shares on the Osaka Securities Exchange JASDAQ Growth Market. The Company’s common shares are expected to be listed and begin trading on March 25, 2011.

Contact

RaQualia Pharma Inc.

Kazuhiro Ikeda

E-mail: ask@raqualia.com

RaQualia Grants a Non-Exclusive Patent License to Shire AG
For the Use of Ghrelin Receptor Agonist

February 16, 2011 – RaQualia Pharma Inc. today announced that it has agreed to license non-exclusive rights in the United States for the use of Ghrelin Receptor Agonist to Shire AG (Switzerland) for the treatment of human gastrointestinal disease. The license is effective as of February 7, 2011.

Under the terms of the agreement, RaQualia will receive an upfront payment as well as royalties on sales.

Contact

RaQualia Pharma Inc.

Tim Kendall

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

RaQualia Announces Collaboration and License Agreement
With Lilly for Pain Treatments

December 21, 2010 – RaQualia Pharma Inc. (RaQualia), headquartered in Aichi, Japan, a drug discovery and development company with innovative research capabilities, today announced that it has entered into a worldwide collaboration and licensing agreement with Eli Lilly and Company (Lilly), a global pharmaceutical company headquartered in Indianapolis, Indiana, United States. The partnership will initially focus on discovering and developing pre-clinical compounds for a specific ion channel target that could lead to new pain treatments.

“We are very pleased to be joining our efforts with those of Lilly to discover and develop innovative analgesic drugs,” stated Atsushi Nagahisa, Ph.D., President and CEO of RaQualia. “We have made excellent progress in our discovery programs at RaQualia and look forward to working with Lilly’s exceptional development and commercialization capabilities to bring new pain medicines to patients.”

Under the terms of the agreement, the two companies will collaborate to screen, optimize and develop drug candidates. RaQualia will provide pharmacology, medicinal chemistry, and core expertise in drug discovery, in addition to expertise in producing high quality development candidates. Lilly will contribute capabilities in drug development and will conduct preclinical and clinical development studies. Lilly will have exclusive, worldwide rights to commercialize products that result from the collaboration. In addition to an undisclosed upfront payment, RaQualia will be eligible to receive potential research and development, regulatory and commercialization milestone payments totaling up to $172M from the collaboration, as well as royalties on net sales.

Contact

RaQualia Pharma Inc.

Tim Kendall / Satoko Saito

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

RAQUALIA ANNOUNCES AGREEMENT WITH DURATA THERAPEUTICS
FOR JAPANESE RIGHTS TO DALBAVANCIN

RaQualia Pharma Inc (RaQualia), a biopharmaceutical company based in Aichi, Japan announced today that it has entered into an agreement with Durata Therapeutics (Durata), a specialist biopharmaceutical company based in Morristown, New Jersey.

Under the terms of the agreement, Durata obtained RaQualia’s Japanese rights to develop and commercialize of dalbavancin, a novel next-generation lipoglycopeptide antibiotic for the treatment of patients infected with methicillin-resistant Staphylococcus aureus (MRSA). Durata already holds the rights to develop and commercialize dalbavancin outside Japan. This agreement enables Durata to implement a global development strategy for the product. In exchange for the Japanese rights to dalbavancin, RaQualia will receive an upfront payment, development milestones and royalties on sales in Japan.

About Durata Therapeutics

Durata Therapeutics is a biopharmaceutical company addressing the growing need for new antibiotics to treat infectious diseases. Durata’s lead product candidate, dalbavancin, is in late-stage clinical development, and the Company also has two antibiotic programs in earlier-stage, preclinical research. Durata is supported by a premier team of venture capital organizations – New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.

For more information on Durata and the Company’s programs, please visit http://www.duratatherapeutics.com.

About RaQualia

RaQualia Pharma Inc. is an innovative life science company engaging in the discovery, development and marketing of clinical and pre-clinical candidates for unmet medical needs worldwide. For additional information, please visit www.raqualia.com

Contact

RaQualia Pharma Inc.

Tim Kendall / Satoko Saito

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

RaQualia Pharma Inc. announced the below executive appointment following its Shareholders Meeting and Board Meeting held on October 28th, 2010.

September 6, 2010 – CJ CheilJedang Co. (CJ), CEO: Jinsoo Kim, 5-ga, Namdaemun-ro, Jung-gu, Seoul, 100-749, Korea, and RaQualia Pharma Inc. (RaQualia), CEO: Atsushi Nagahisa, 5-2, Taketoyo, Aichi 470-2341, Japan, today announced the signing of a Licensing Agreement, granting CJ exclusive rights to RaQualia’s Acid Pump Antagonists (RQ-00000004, RQ-00000774).

Under the terms of the agreement, CJ will have Korea and China rights to develop and commercialize RQ-00000004 and RQ-00000774. In return, RaQualia will receive an upfront payment from CJ and is eligible to receive development milestones and royalties on sales of products commercialized under the license.

Both companies signed a Memorandum of Understanding to establish a strategic alliance in the area of innovative gastrointestinal therapies on June 7, 2010.

About Acid Pump Antagonist (RQ-00000004, RQ-00000774)

RQ-00000004 and RQ-00000774 are novel potassium competitive acid pump antagonists (APAs) that inhibit the binding of potassium ion to H+/K+-ATPase. This mechanism of action is fundamentally different from that of proton-pump-inhibitors (PPIs) and it enables more rapid onset of maximum suppression and longer duration of action if an appropriate pharmacokinetic profile is obtained. APAs are expected to improve Gastro-Esophageal Reflux Diseases (GERD) symptom control not adequately addressed by PPI therapy, and have potentials for the treatment of peptic ulcer and other acid-related GI disorders.

　Currently, a Phase 1 study is in progress in the US for RQ-00000004, and a backup compound RQ-00000774 is in pre-clinical development.

Contact

・CJ CheilJedang Co.

Sangman Ahn / Sungbin Cho

Phone: +81-3-3519-3452

Fax: +81-3-3580-1055

E-mail: bean@cj.net

・RaQualia Pharma Inc.

Taisuke Inagaki / Satoko Saito

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

Aichi, Japan August 5, 2010 – Maruishi Pharmaceutical Co., Ltd. (Maruishi) and RaQualia Pharma Inc. (RaQualia) today announced the signing of a License Agreement, granting exclusive rights to Maruishi for RaQualia’s EP₄ Antagonist (RQ-00000007) for the treatment of post-operative and cancer-related pain.

Under the terms of the agreement, Maruishi will have Japan and East Asia rights to develop and commercialize the intravenous formulation of RQ-00000007. In return, RaQualia will receive an upfront payment from Maruishi and is eligible to receive development milestones and royalties on sales of products commercialized under the license.

About RQ-00000007

RQ-00000007 is a potent and selective EP₄ antagonist, which is expected to offer a new treatment option for the management of acute pain conditions. The intravenous formulation of RQ-00000007 will provide fast onset for the treatment of pain following major surgery. RQ-00000007 has the potential to be used in combination therapy with opioid analgesics. This may reduce opioid usage, decrease the risk of side effects, and significantly improve the quality of life for patients.

In addition to the acute pain indication, RaQualia is developing RQ-00000007 as a new, innovative therapy for the treatment of chronic pain, cancer, and autoimmune diseases.

About Maruishi

Maruishi Pharmaceutical Co., Ltd. was founded in 1888 and is headquartered in Osaka, Japan. It develops and markets a variety of pharmaceutical products, particularly anesthetics and disinfectants. For more information, please visit www.maruishi-pharm.co.jp.

About RaQualia

RaQualia Pharma Inc. engages in discovery, development and marketing of clinical and pre-clinical drug candidates. RaQualia’s vision is to bring people hope, health and happiness with new medicines. For further information, please visit us at www.raqualia.co.jp.

Contact

・Maruishi Pharmaceutical Co.,Ltd.

Hideharu Tominaga / Kaoru Nagata

Phone: +81 6 6964 3150

Fax: +81 6 6965 6060

E-mail: strat_prod_planning@maruishi-pharm.co.jp

・RaQualia Pharma Inc.

Tim Kendall / Satoko Saito

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

RaQualia made a poster presentation on RQ-00000009, a 5-HT4 partial agonist, at Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) 2010, held in Hawaii on July 10 – 15, 2010.

[Summary]

RQ-00000009 penetrated into brain effectively and significantly improved memory and cognitive deficit in rodent models.   In addition, RQ-00000009 decreased brain cortex β-amyloid proteins in Tg2576 mice.  The projected efficacy dose of RQ-00000009 for Alzheimer’s disease therapy is 1 mg once-a-day.  These results strongly supported that RQ-00000009 has a high potential as the Alzheimer’s disease therapeutic.

The poster is available at the following link:

5-HT₄ partial agonist (RQ-00000009)（PDF file：642KB）

Contact

•Business Development: Taisuke Inagaki

•Phone: +81 569 84 0700

Dr. Toshinori Yamamoto won the 2010 Incentive Award from the Japanese Society of Toxicology (JSOT) and made an award lecture under the title of "Studies on the Toxicity-related Expression Changes of Proteins and Endogenous Metabolites." at the 37th annual meeting of the JSOT 2010 held in Okinawa from June 16th to 18th, 2010.

[Summary of his accomplishment]

Dr. Yamamoto has successfully implemented Toxicopanomics technologies (a collective designation for “-omics”, such as Toxicogenomics, Toxicoproteomics and Metabolomics) into investigational toxicology research, and investigated how toxicological responses induce perturbations of molecular factors globally. His research regarding hepatotoxicity and testicular toxicity suggested that the expression changes in molecular factors may enable the prediction of subsequent potential toxicity at early phase. Dr. Yamamoto believes that a series of molecular toxicology studies using Toxicopanomics technologies could help identify novel toxicological biomarkers based on the mechanism of toxicity, and eventually enhance early evaluations on drug safety field.

Dr. Yamamoto has been also awarded the JSOT Tanabe Awards (The Best Publication Award) in 2006, 2007, and 2008.

]]> http://www.raqualia.com/topics/80.html http://www.raqualia.com/80#comments Fri, 16 Jul 2010 13:22:56 +0000 http://p2test.raqualia.com/?p=80 http://www.raqualia.com/topics/75.html http://www.raqualia.com/75#comments Wed, 30 Jun 2010 13:20:19 +0000 http://p2test.raqualia.com/?p=75 Pfizer Japan Inc. exercised its Share Options and made payment of JPY 308.7M.

June 29th, 2010 – RaQualia today announced that Pfizer Japan Inc. exercised its share options and made payment of JPY 308.7M in exchange for additional equity in RaQualia Pharma Inc.

Contact

•Sanshiro Horii

•Phone: +81 569 84 0700

]]> http://www.raqualia.com/ir/127.html http://www.raqualia.com/127#comments Tue, 08 Jun 2010 01:29:33 +0000 http://p2test.raqualia.com/?p=127 CJ CheilJedang Co. and RaQualia Pharma Inc.
Establish Strategic Partnership

Aichi, Japan June 8^th, 2010 – CJ CheilJedang Co. (CJ), CEO: Jinsoo Kim, 5-ga, Namdaemun-ro, Jung-gu, Seoul, Korea 100-749, and RaQualia Pharma Inc. (RaQualia), CEO: Atsushi Nagahisa, 5-2, Taketoyo, Aichi 470-2341, Japan, today announced the signing of an agreement to negotiate in good faith to establish a strategic alliance in the area of innovative gastrointestinal therapies, beginning with RaQualia’s novel clinical candidate for markets in Korea and other countries in East Asia.

Leveraging CJ’s expertise in commercialization and RaQualia’s expertise in innovative R&D of new pharmaceuticals, we believe that this alliance will deliver important medicines to patients in Korea and the East Asia region. The two parties intend to complete the first of a series of license agreements by the end of August 2010.

Contact

・CJ CheilJedang Co.

Sangman Ahn / Sungbin Cho

Phone: +81-3-3519-3452

Fax: +81-3-3580-1055

E-mail: bean@cj.net

・RaQualia Pharma Inc.

Taisuke Inagaki / Satoko Saito

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

]]> http://www.raqualia.com/ir/125.html http://www.raqualia.com/125#comments Mon, 31 May 2010 00:41:25 +0000 http://p2test.raqualia.com/?p=125 MARUISHI PHARMACEUTICAL CO., LTD. AND RAQUALIA PHARMA INC.
SIGN LETTER OF INTENT FOR EP₄ ANTAGONIST (RQ-00000007)

Aichi, Japan May 31, 2010 – Maruishi Pharmaceutical Co.,Ltd. (Maruishi) and RaQualia Pharma Inc. (RaQualia) today announced the signing of a Letter of Intent (“LOI”), granting exclusive rights to Maruishi for RaQualia’s EP₄ Antagonist (RQ-00000007) for the treatment of post-operative and cancer-related pain.

Under the LOI, Maruishi will have Japan and East Asia rights to develop and commercialize the intravenous formulation of RQ-00000007. The two parties intend to complete a license agreement by the end of August 2010.

About RQ-00000007

RQ-00000007 is a potent and selective EP₄ antagonist, which is expected to offer a new treatment option for the management of acute pain conditions. The intravenous formulation of RQ-00000007 will provide fast onset for the treatment of pain following major surgery. RQ-00000007 has the potential to be used in combination therapy with opioid analgesics. This may reduce opioid usage, decrease the risk of side effects, and significantly improve the quality of life for patients.

In addition to the acute pain indication, RaQualia is developing RQ-00000007 as a new, innovative therapy for the treatment of chronic pain, cancer, and autoimmune diseases.

About RaQualia

RaQualia Pharma Inc. engages in discovery, development and marketing of clinical and pre-clinical drug candidates. RaQualia’s vision is to bring people hope, health and happiness with new medicines.

About Maruishi

Maruishi Pharmaceutical Co.,Ltd. was founded in 1888 and is headquartered in Osaka, Japan. It develops and markets a variety of pharmaceutical products, particularly anesthetics and disinfectants. Information about Maruishi can be found on the world wide web at www.maruishi-pharm.co.jp.

Contact

・Maruishi Pharmaceutical Co.,Ltd.

Hideharu Tominaga / Kaoru Nagata

Phone: +81 6 6964 3150

Fax: +81 6 6965 6060

E-mail: strat_prod_planning@maruishi-pharm.co.jp

・RaQualia Pharma Inc.

Tim Kendall / Satoko Saito

Phone: +81 569 84 0700

Fax: +81 569 74 1381

E-mail: ask@raqualia.com

]]> http://www.raqualia.com/topics/72.html http://www.raqualia.com/72#comments Fri, 28 May 2010 13:19:45 +0000 http://p2test.raqualia.com/?p=72 http://www.raqualia.com/topics/67.html http://www.raqualia.com/67#comments Fri, 28 May 2010 13:15:00 +0000 http://p2test.raqualia.com/?p=67 http://www.raqualia.com/topics/65.html http://www.raqualia.com/65#comments Wed, 26 May 2010 13:09:40 +0000 http://p2test.raqualia.com/?p=65 http://www.raqualia.com/topics/63.html http://www.raqualia.com/63#comments Tue, 27 Apr 2010 13:05:45 +0000 http://p2test.raqualia.com/?p=63 RaQualia to exhibit at Digestive Disease Week
at 8:00 AM – 5:00 PM on May 5th, 2010
Ernest N Morial Convention Center, New Orleans, USA

Poster Title：

“Characterization of a novel, potent, and selective small molecule motilin receptor agonist, RQ-00201894”
Note: This presentation has been selected as “Poster and ePoster of Distinction during Digestive Disease Week.”

Summary：

Background: Gastroprokinetic agents have been awaited in the market as an additional option for the treatment of functional upper gastrointestinal disorders. Motilin is one of the well-recognized endogeneous peptide hormones that regulate Phase III of the migrating motor complex (MMC). Erythromycin, a macrolide antibiotic, is known as a motilin receptor agonist, and studies have shown that erythromycin is capable of accelerating gastric emptying in normal subjects and patients with gastroparesis. RQ-00201894 is a novel small molecule having a motilin receptor agonistic activity. In the present investigations, we have characterized the in vitro pharmacology of RQ-00201894. Furthermore, we assessed the effects of orally administered RQ-00201894 on gastric motility and gastric emptying in conscious dogs and monkeys.

Results: RQ-00201894 potently activated the human motilin receptor with an EC50 value of 0.2 nM in beta-lactamase assay, and also showed >100-fold selectivity against more than 70 GPCRs, ion channels, and enzymes. In vivo, oral administration of RQ-00201894 dose-dependently induced a band of strong contractions in the gastric antrum and duodenum in fasting dogs. The motor index of the gastric antrum was increased by RQ-00201894 in a dose-dependent manner. In dog acetaminophen (APAP) model, RQ-00201894 induced dose dependent increase in peak plasma APAP and decrease in time to peak plasma APAP. In addition, RQ-00201894 increased the area under the curve from 0 to 45 min after dosing (AUC0-45) of APAP. Gastric emptying studies in cynomolgus monkeys were also conducted to show that orally administrated RQ-00201894 accelerated gastric emptying.
Conclusion: RQ-00201894 exhibited highly selective and potent agonistic activity against the human motilin receptor. RQ-00201894 induced MMC-like contractions in the upper gastrointestinal tract. In addition, RQ-00201894 accelerated gastric emptying in conscious dogs and monkeys. These profiles suggest a therapeutic potential of RQ-00201894 for functional GI disorders such as gastroesophageal reflux disease, functional dyspepsia and diabetic gastroparesi

Contact

•E-mail: ask@raqualia.com

•Phone: +81 569 84 0700

]]> http://www.raqualia.com/topics/60.html http://www.raqualia.com/60#comments Tue, 27 Apr 2010 13:04:56 +0000 http://p2test.raqualia.com/?p=60 http://www.raqualia.com/topics/57.html http://www.raqualia.com/57#comments Tue, 13 Apr 2010 13:00:50 +0000 http://p2test.raqualia.com/?p=57 RaQualia Appoints New Board Members and Management Team

RaQualia Pharma Inc. announced the appointment of new board members and its management team, effective April 1st, 2010.

Board of Directors
Representative Director	Atsushi Nagahisa
Director	Hiroki Narita
Director	Hiro Mizuno
Director	Akimitsu Hirai
Director	Susumu Tsuchiya
Statutory Auditor
Statutory Auditor	Hisaharu Inoue
Statutory Auditor	Yasushi Honma
Statutory Auditor	Hisaji Agata
Management
Senior Vice President	Shinichi Koizumi
Senior Vice President	Susumu Tsuchiya
Senior Vice President	Akihiro Furuta
Senior Vice President	Tomoko Nii
Vice President	Naoki Tani
Vice President	Sanshiro Horii
Vice President	Taisuke Inagaki
Vice President	Kazuhiro Ikeda
Vice President	Kiichiro Kawada

]]> http://www.raqualia.com/topics/55.html http://www.raqualia.com/55#comments Tue, 02 Mar 2010 12:59:00 +0000 http://p2test.raqualia.com/?p=55 http://www.raqualia.com/topics/52.html http://www.raqualia.com/52#comments Mon, 14 Dec 2009 12:58:03 +0000 http://p2test.raqualia.com/?p=52 RQ-00203078 (TRPM8) is highlighted in Thomson Pharma’s Overnight Report

RaQualia’s poster presentation at Neuroscience 2009 was published in Thomson Pharma’s IDdb Meeting Report 2009, Oct. 17-21.

A new selective TRPM8 antagonist

Shuzo Watanabe of RaQualia Pharma presented a poster on RQ-00203078, a new selective TRPM8 antagonist in preclinical development for the potential treatment of cold allodynia in patients with neuropathic pain. Previous studies have shown that TRPM8-deficient mice do not display temperature discrimination or hypersensitivity to cold following nerve injury or inflammation, suggesting that TRPM8 is a useful target for cold allodynia. In preclinical rat studies, RQ-00203078 was shown to significantly attenuate cold allodynia at subcutaneous
doses of 10 mg/kg and reduce chronic-constriction injury-induced static allodynia. The
compound also demonstrated a superior safety profile over pregabalin. At doses up to 100
mg/kg, RQ-00203078 displayed no significant effect on beam walking, a motor performance
indicator. In in vitro studies, it showed potent antagonistic activity against human TRPM8.

Poster: TRPM8 Antagonist(RQ-00203078)（PDF file：610KB）

LINK to Thomson Pharma (User ID and Password are required)：

• Society for Neuroscience – 39th Annual Meeting (Part I) – OVERNIGHT REPORT

Contact

•Business Development: Tim Kendall

•Phone: +81 569 84 0700

RaQualia’s poster presentation on TRPM8 Antagonist at Neuroscience 2009 (Chicago, October 17 – 21, 2009) is now available at the following link.

Poster: TRPM8 Antagonist(RQ-00203078)（PDF file：610KB）

Contact

•Business Development: Tim Kendall

•Phone: +81 569 84 0700

RaQualia’s poster presentations at DDW 2009 (summaries below) were published in Thomson Pharma’s IDdb Meeting Report 2009, May 30 – June 4

In vivo results for RQ-00000004

Masaomi Taijimi (RaQualia) presented data from a preclinical study characterizing the pharmacology of the acid pump antagonist (APA) RQ-00000004 and comparing it revaprazan, which is currently on the market. RQ-00000004 and revaprazan had respective IC50 values of 0.47 and 0.69 microM for porcine H+/K+ ATPase. The compound demonstrated no species differences for porcine, canine and human gastric H+/K+-ATPase. In in vitro inhibition assays RQ-00000004 was more potent than revaprazan. The compound dose-dependently inhibited gastric acid secretion in Heidenhain pouch dogs with a long duration of action. The dogs were treated with oral doses of the compound following histamine-induced gastric secretion. Complete inhibition of secretion was observed at 1 mg/kg. Oral administration of revaprazan (1 and 3 mg/kg) also inhibited secretion, although complete secretion was not observed even at 3 mg/kg. RQ-00000004 was effective over 20 h with maximal efficacy observed within the first few hours of single dosing, indicating its immediate acting effect.

Poster: In vivo results for RQ-00000004（PDF file：886KB）

Preclinical findings revealed for RQ-00000010

Preclinical findings revealed for RQ-00000010 Toshinori Yamamoto of RaQualia Pharma, spun-out from Pfizer, displayed new findings for RQ-00000010, a 5-HT 4 partial agonist being investigated for the potential treatment of GERD. Dr Yamamoto believes the compound’s low side-effect profile makes it a promising candidate to enter clinical development. In a dog clonidine-induced gastroparesis model, gastric emptying was significantly accelerated following the administration of the lowest dose of RQ-00000010 (0.1 microg/kg po). In safety pharmacology studies in vivo at doses of up to 30 microg/kg, there was no prolongation of QTc interval. The compound had Ki values of 0.87 and 1.8 nM for the human and dog recombinant 5-HT 4d receptors, respectively. In cell-based cAMP accumulation assays, RQ-00000010 had an EC50 value of 0.74 nM for the human 5-HT 4d receptor. The compound is expected to enter clinical development in 2010.

Poster: Preclinical findings revealed for RQ-00000010（PDF file：1705KB）

LINK to Thomson Pharma：

• Digestive Disease Week 2009 (Part III) – OVERNIGHT REPORT
• Digestive Disease Week 2009 (Part II) – OVERNIGHT REPORT

Contact

•Business Development: Tim Kendall

•Phone: +81 569 84 0700

Poster 1：

The Novel 5-HT4 Receptor Partial Agonist RQ-00000010 Enhances a Rate of Gastric Emptying in Dog Without QT Interval Prolongation

Summary：

There is a significant medical need for the treatment of Gastroesophageal reflux disease (GERD). However, currently no medicine with gastroprokinetic mechanism is available for GERD treatment, after the withdrawal of cisapride due to CV issues. RQ-00000010 is a selective 5-HT4 receptor partial agonist pursued as a gastroprokinetic agent for the treatment of GERD. RQ-00000010 displayed high affinity on the dog and human recombinant 5-HT4 receptor and potent agonistic activity against the human 5-HT4 receptor. In in vivo, RQ-00000010 demonstrated strong enhancement in both gastric motility and gastric emptying. In vitro, binding affinity to human ether-a-go-go-related gene (HERG) was evaluated and found that RQ-00000010 had over 40,000-fold safety margin against QT interval prolongation risk. Moreover, in vivo safety pharmacology study showed no prolongation of QTc interval with RQ-00000010 (safety margin: >100-fold). In conclusion, RQ-00000010 exhibited desirable efficacy and safety profiles in vitro and in vivo, and potential as a next generation of gastroprokinetics in which there is low risk of cardiovascular toxicity related to QT interval prolongation.

Poster 2：

Identification and Characterization of a Novel, Potent, and Selective Acid Pump Antagonist, RQ-00000004

Summary：

Proton pump inhibitors (PPIs) are widely used for the treatment of acid-related diseases, such as peptic ulcer and gastroesophageal reflux (GERD). However, patients on PPIs only achieve an incomplete response to the therapy and/or may suffer from nocturnal reflux and nocturnal heartburn. Therefore, a new type of acid suppressants is needed and much attention has been paid to research a reversible K-competitive acid pump antagonist (APA). RQ-00000004 is a highly selective, potent, reversible and K+-competitive inhibitor of the gastric H+/K+-ATPase with no species differences among porcine, canine, and human enzymes. Further characterization of RQ-00000004 for the therapeutic potential treatment of acid related diseases is ongoing.

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