日本経済新聞 2003/8/30

富士写が乳がん診断薬 独社と蛍光造影剤開発     
シェーリング発表
 2009年にも商用生産へ

 富士写真フイルムは医療用造影剤大手の
独シェーリングと共同で、乳がんの早期発見を容易にする蛍光造影剤を開発した。人体に投与するがん用蛍光造影剤として初の商用生産を目指し、2009年をめどに医療用診断薬分野に参入する。富士写が複写機事業以外の技術開発で他社と連携するのは珍しく、今後は提携戦略を強化し新規事業の開拓を加速する考えだ。
 蛍光造影剤は人体内部の細胞の観察や遺伝子解析などの画像診断をする際に、蛍光色素で明暗を強調して見えやすくする薬剤。提携では富士写の感光材料技術とシェーリングの造影剤技術を融合。従来のエックス線診断では見つけにくいがん細胞だけを浮かび上がらせる毒性のない蛍光造影剤を開発した。
 蛍光造影剤を血液投与した人の乳房に、人体を透過観察しやすい波長700-1000ナノ(ナノは10億分の1)メートルのレーザー光を当てると、がん細胞部分だけが光る。シェーリングは今年6月に世界初の臨床試験を実施、これまでに乳がんの疑いがある女性4人に投与して病巣発見に成功し、副作用などはなかったという。来年6月までに40人を対象に臨床試験を行い、その後医療用試薬の認可取得を進める。
 エックス線診断ではがん部位と通常の細胞の見分けがつかない場合も多いため、疑われる部位に針を刺して細胞を採取して診断することも多い。新技術では針を刺さずに見分けられ、またエックス線被ばくも避けられる。
 富士写では将来の乳がん診断手法として需要が広がるとみて、医薬認可が取れた後に事業化する方針だ。

古森杜長に聞く M&Aで技術取り込む

 技術開発で独自路線を堅持してきた富士写真フイルムが、提携重視の戦略へかじを切り始めた。6月に最高経営責任者(CEO)を兼務し、経営改革を進める古森重隆社長に聞いた。

− これからの技術開発の方向性は。
 「デジタル技術と既存技術が入り乱れ、当社の強みが発揮できる画像・情報の事業分野も広がっている。従来は独自開発にこだわっていたが、今後は液晶などの電子材料や光学分野を中心に、企業の合併・買収(M&A)や提携によって新規事業の種となる外部技術を素早く取り込む。研究開発では新研究所の設立など、世の中の二ーズに合った形へ再編も進める」

ー デジタル化で従来の収益源だったフィルムなどが苦戦している。
 「フィルムの低迷は厳しいが、フィルム写真技術はまだ発展途上で改良余地は十分にある。当社には写真文化を守る責務がある。デジタルもアナログも同時に育て、事業に結びつけたい」

ー 経営改革の重点課題は。
 「研究者では役員待遇のフェロー制度を導入するなど、社員の4割を占める技術系人材の新たな活用も模索している。約300社ある連結対象会社を200社に絞り込むなどの合理化を進める一方で、組織の活性化と若手の能力教育は怠らず強化していく」


August 28, 2003 Schering

Schering's innovative method for breast cancer detection shows first positive results in clinical phase I study

Schering AG, Germany announced today the start of the clinical phase I trial for a new breast cancer detection method, which is expected to offer the advantage of a sensitive and radiation-free diagnosis. The technology combines the existing near-infrared imaging method (optical mammography) with a special fluorescent dye, which was
jointly developed by Schering and Fuji Photo Film Co., Ltd.,.

First results with this new type of contrast agent, SF64, in women with suspected breast cancer have shown good safety and tolerability. In all patients examined so far, tumors could be clearly delineated.

Breast cancer is one of the most frequently causes of death in women and early as well as precise diagnosis is crucial for successful therapy, said Professor Gunter Stock, Member of the Board of Executive Directors, responsible for research and development. Besides other advantages, this innovative method offers a radiation-free, cost-effective diagnosis and could avoid straining biopsies in many cases. We expect finalization of the study by mid 2004.

The development of optical mammography with a fluorescent dye should offer a suitable method of breast imaging to women who are difficult to assess because of dense breasts or who have an inconclusive X-ray mammogram. One potential of this new method could be to drastically reduce the numbers of breast biopsies that only show age related tissue changes but no breast cancer. Furthermore, women with an increased genetic risk of breast cancer could potentially benefit from this new development. These women are at risk to develop breast cancer at a young age.

Optical mammography may offer a sensitive diagnosing and screening method for this patient group without the ionising radiation and discomfort associated with X-ray mammography, explains Dr. Thomas Moesta, principal investigator of the fluorescent based optical contrast agent at the Robert-Rossle Clinic of the Berlin Charite Hospital. After intravenous injection of the fluorescent dye, the breast is examined using laser light of near infrared wavelength, in order to identify the tumor."

The study
Post menopausal women with suspected breast cancer participate in the clinical trial of optical mammography, to evaluate the new fluorescent dye SF64, which was co-developed by Schering and Fuji Photo Film Co., Ltd., a leading imaging company with strong background in fine chemical technology including fluorescence dyes, in conjunction with the proprietary Computed Tomography Laser Breast Imaging (CTLMR) system, newly developed by
Imaging Diagnostic Systems, Inc., Plantation, Florida.

The Phase I trial will include 40 post menopausal women and is embedded in a common activity between the Max Delbrueck Centre for Molecular Medicine, the Charite, and the Helios Klinikum Buch, all in Berlin, for the advancement of Optical Methods for Tumor Detection. So far four patients were examined, and in all of them tumors could be clearly delineated.

Furthermore, the trial demonstrated good safety and tolerability of SF64 at the first dose level. Now, tests will also include different dosage levels.

Optical mammography
Optical mammography is based on the penetration of near-infrared (NIR) light into tissue. By using the CTLM system the new contrast agent SF64 provides a unique fluorescent signal that may help doctors to better detect breast cancer in women with dense breasts or inconclusive results in X-ray mammography.

Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Diagnostics&Radiopharmaceuticals, Dermatology as well as Specialized Therapeutics for disabling diseases in the fields of the central nervous system, oncology and cardiovascular system. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work


Imaging Diagnostic Systems, Inc.   http://www.imds.com/

Located in Plantation, Florida, Imaging Diagnostic Systems, Inc. (IDSI) is a medical technology company engaged in the research and development of a non-invasive breast imaging system. IDSI is a pioneer in the field of medical optical imaging and has made major strides in the early diagnosis of breast abnormalities. Since the Companys inception in early 1994, IDSI has developed a revolutionary breast imaging device, named Computed Tomography Laser Breast Imaging (CTLMR) that utilizes state-of-the-art laser technology and proprietary algorithms to create three dimensional cross sectional images of the breast without the use of x-rays and compression.

Recognizing that a non-invasive painless breast imaging system would be a benefit for the consumer and the medical industry, IDSI placed its primary focus in an area of a enormous concern: breast cancer. With over 800,000 biopsies preformed each year and 700,000 of those resulting in normal findings, a need for a breast imaging system that was not limited by age, density, or size was evident.

Imaging Diagnostic Systems, Inc. has entered the final stages of the FDA Pre-Market approval process for its CTLMR patented breast imaging system. The company has received the CE Marking, UL listing, and ISO 9002 certification, enabling sales in the international markets.


日本経済新聞 2003/9/2           Tranzyme発表

新日本科学 開発期間を短縮 米バイオに出資 新薬を共同研究

 新薬開発試験の受託最大手、
新日本科学(鹿児島県吉田町、永田良一社長)は米国のバイオベンチャー、トランザイム(ノースカロライナ州)と資本・業務提携した。トランザイムに100万ドルを出資、同社の遺伝子改変動物を効率的に生産する技術を活用しゲノム(全遺伝情報)創薬を共同研究する。新薬開発期間の短縮につなげる。
 トランザイムが第三者割当増資で発行した株式(1株1ドル)を100万株引き受け、同社の発行済み株式総数の約11%を取得した。新日本科学は出資を機に、米現地法人のSNBLUSA(ワシントン州)を窓口にして共同研究を進める。
トランザイムは1999年の設立。視聴覚や脳など知覚神経に関する疾病治療薬の開発を得意にする。同社が中核に据えるのは、特定の遺伝子を動物細胞の中にある胚の中心部ではなく、胚の膜と膜の外を包む透明帯の間に送り込み遺伝子改変動物を生産する技術。
 これによりマウスのような小動物だけでなく、大型実験動物でも高い成功率で遺伝子を改変できるようになる。改変のコストも従来方法より大幅に削減できるようになったという。
 前臨床試験の受託事業などを通じて、大型実験動物を使った新薬開発に豊富なノウハウを持つ新日本科学はこの技術に注目。両社の技術を結び合わせて、遺伝子改変動物と正常な動物との間での新薬候補物質の効き目の違い、副作用の有無などを効率的に突き止め、新薬開発を加速する。
 新日本科学は2003年中にも株式公開を予定している。武田薬品工業ともゲノム解析を共同研究するなど事業領域の拡大に取り組んでいる。「今回のトランザイムとの提携で1年後には一定の成果を上げたい」。(永田杜長)と話している。


新日本科学 Shin Nippon Biomedical Laboratories (SNBL)     http://www.snbl.co.jp/

 新日本科学は、1957年に我が国初の受託研究機関として鹿児島に誕生し、今年で45周年を迎えます。現在では医薬品開発過程における「安全性研究」から「臨床薬理研究」、さらに「臨床開発」の受託まで一貫した“製薬メーカーへのサポート体制”が確立され、新日本科学グループとして従業員数1000名を有する国内最大規模の医薬品開発受託機関に成長しました。これもひとえに皆様方の暖かいご支援とご指導の賜物と衷心より感謝申し上げます。
 新日本科学グループは、日本国内に留まらず、欧米や中国に現地法人を設立して、総合力と信頼性、そして確実性を世界に向けて発信し、最新の設備と確かな技術であらゆる疾患分野の創薬ニーズにお応えしています。

主要業務

研究受託事業
  国際的視野で行われる新薬開発は、ますますスピードアップが重要なファクターとなってきました。新日本科学グループでは、国内はもとより、グローバルな製薬会社からの研究を受託し、新薬開発のサポート体制を確立しています。 研究受託事業は、45年以上の経験と実績を誇る「安全性研究受託部門」、臨床第I相試験を受託する「臨床薬理研究受託部門」、そして臨床第II・III相試験におけるモニタリング業務や臨床統計解析、薬事コンサルティングを行う「臨床開発受託部門」の3部門で協働しています。
   
  ●安全性研究受託部門
新薬のヒトへの安全性を外挿したり、薬物動態を調べたりする部門です。「安全性研究所」は鹿児島県吉田町に、「薬物代謝分析センター」は和歌山県海南市にあり、毒性学・薬理学・病理学・生化学・微生物学・遺伝子工学・薬物代謝学等の専門家があらゆる角度から医薬品の安全性を探求しています。米国ワシントン州シアトル市郊外には、海外での安全性研究拠点として「SNBL USA, Ltd.」があり、新日本科学グループの国際的展開を担っています。

●臨床薬理研究受託部門
臨床薬理研究受託部門を担う株式会社新日本科学臨床薬理研究所は、提携先の医療機関CPC クリニ ック(鹿児島)と協働して臨床第I相試験を実施しています。新規事業部門のSMO事業本部(神戸)では、独自の研修システムで教育したCRC(治験コーディネーター)を各地の提携先の医療機関に派遣して、質の高いスピーディーな治験を実施する支援体制づくりを行っています。今後の国際共同治験の実施に向けて、複数の国立大学とその地域医療機関や医師会とコンソーシアムの結束をはかり、治験の円滑な推進をはかっています。

●臨床開発受託部門
臨床開発受託部門では、充実した社内教育制度により訓練されたCRA(モニター)によるモニタリング業務に加えて、製薬会社で豊かな経験を積んだ専門家によるメディカルライティングや薬事コンサルティングが主な業務です。従来、臨床薬理研究部門で受託していた統計解析とデータマネージメントも臨床開発受託部門で実施されるようになり、充実した環境が整備されています。また、海外からの顧客に応える体制づくりも進み、国際共同治験の実施も視野に入ってきました。
   
トランスレーショナルリサーチ事業
  国内外の大学やベンチャー企業など、優れた発想や卓越した才能を持ち、当社の企業理念を共有で
きる研究者を支援したい、そして世界に通用するビジネスモデルとして育てたい。そんな私たちの企業姿勢を形にしたのがトランスレーショナルリサーチ事業です。日本ばかりでなく、国際的視野で事業を展開。すでに大学研究者らと共同で設立した事業や合弁会社が、ベンチャービジネスとして成果をあげつつあります。
   
業務提携
  私たちは、医療機関や大学などの研究施設と業務提携を行っています。そのひとつが、メリーランド州立大学(ボルチモア)との合弁会社University Medicines International, LLCで、合衆国で初めての州立大学と民間企業との合弁会社として知られ、新しいビジネスモデルとしても欧米で注目を集めています。

 


トランザイム(株)

           FindBioVenture http://www.findbioventure.com/html/vdata/20412-03.html

名称 トランザイム(株) ファイル No. 20412-3
主題 トランザイム社は応用ゲノム分析、タンパク質分析、薬剤開発に独自の技術を開発している。
概容 トランザイム社の技術は、臨床的に関連のある生物系において、遺伝子の機能やタンパク質の発現を研究することを可能とするものである。TExT(テキスト:商標、Tranz Expression Technologyの略)は、任意の組織から得た分割中または分化後の哺乳動物細胞において遺伝子を効率的に発現させる方法である。トランザイム社のやり方では、様々な一次及び樹立細胞培養物、器官培養物、生きた動物の器官などにおいて、高レベルのタンパク質を空間的・時間的に調節して発現させることができる。レンチウイルスの遺伝特性に基づく同社のTranzVector(トランズベクター:商標)技術は、遺伝物質を染色体に取り込むものである。宿主は、送り込まれた遺伝子を自身のDNA複製の一部として発現する。レンチウイルスは、複製細胞又は休止細胞のDNA中に入り込む能力があることから、他の遺伝子送達法よりずっと有利となる。トランザイム社のTranzAssay(トランズアッセイ:商標)はTExTとTranzVectorを使って、現在薬剤発見に使用されているスクリーニング法に対して、細胞ベースの高性能分析系を組み立てる。同社はまず、嚢胞性線維症、眼病、神経障害、抗ウイルス療法、がんの分野での薬剤発見を促進することに焦点を当てている。トランザイム社は既得及び出願中合わせて8つの米国特許を持つと共に、8つの国際特許出願を持つ。
掲載日 4.12.2002

Tranzyme  www.tranzyme.com

Overview
Tranzyme is a drug discovery and development company uniquely focused on the treatment of diseases associated with the neurosensory system including the eye, the ear and the brain. Tranzyme has developed a proprietary functional biology platform based on gene delivery and controlled expression from in vitro to ex vivo to in vivo.
The Company
s proprietary technology addresses critical needs in the drug discovery process by introducing high quality biology and providing a seamless transition through all phases of the discovery process. Tranzyme is leveraging its technology through partnerships and internal programs to drive the discovery and development of novel therapeutics. The Company has already established over a dozen strategic partnerships around the world and has secured access to a number of important therapeutic targets for neurosensory diseases. Tranzyme is initially focused on neuroprotection in diseases like macular degeneration, glaucoma, and hearing loss.

Technology
TranzVector
TM: Tranzymes gene transfer technology based on lentivirus genetics. TranzVector has the ability to integrate into the DNA of all types of mammalian cells regardless of whether the cells are multiplying or resting. Thus, target genes can be delivered to cells of great commercial interest, including stem cells, cardiovascular cells, endothelial cells, neurons, retinal cells, and others. Once genes are delivered by TranzVector, the cells have long-term expression of the integrated genetic material.

TExT
TM: Tranz Expression Technology. Tranzymes gene expression technology that permits high-level, spatially- and temporally-regulated expression of genes in a variety of primary and established cell cultures, in organ cultures, and in organs of live animals. The breadth of applications for this technology includes expression of proteins in clinically relevant cell types for specialized assays, gene function discovery, target validation and animal model development.

TranzAssay
TM: Tranzymes assay development and drug discovery technology. Reporter systems and event screens are used to detect specific stimuli such as activation of signal transduction pathways, proteolysis, and viral transcription and replication. TranzAssay systems use multiple components and regulatory sequences that often require delivery of a set of genes on separate TranzVectors (in trans), resulting in the optimal and regulated expression of the component genes.

TranzEmbryo
TM: Tranzymes revolutionary technology to create genetically modified (transgenic) animals.
This technology combines TranzVector and TExT platforms to clone genes of interest into animal embryos. TranzEmbryo enables the creation of animal models of disease in virtually any mammalian species with extremely high (>50%) success rate.

DNA-Directed RNAi: The combination of gene silencing technology (RNAi) and Tranzyme's gene delivery and expression technology offers a revolutionary means of producing gene
knockdownsquickly and efficiently.
The combined technologies will be ideal for both in vitro and in vivo applications and will fast track the discovery and validation of drug targets. Tranzyme
s technology enables siRNA to be delivered in the form of DNA, thus bypassing inefficiencies inherent in delivering RNA per se, ensuring long-term expression, an attribute of particular value in the design of animal models for drug discovery.

Research & Development
Neurosensory Drug Discovery: Tranzyme is building an intellectual property portfolio of novel therapeutic targets and lead compounds for applications in diseases associated with the neurosensory system, including the eye, the ear, and the brain. The Company will initially focus on neuroprotective mechanisms in diseases like macular degeneration, glaucoma, diabetic retinopathy and hearing loss. Tranzyme
s strategy is to:
* Enter into partnerships with companies interested in the CNS area
* Seek rights to targets and compound libraries for neurosensory indications
* Build specialized biological assays and animal models for neurosensory diseases
* Screen compound libraries, late-stage therapeutics and approved drugs for potential neurosensory indications

Gene Function & Target Validation: The combination of gene delivery and gene silencing (RNAi) technologies provide a vertical integration of the discovery process from in vitro to ex vivo to in vivo, to facilitate the understanding of gene function, provide target validation and develop highly-specific assays for drug discovery. Tranzymes technologies also permit the co-expression of interacting proteins in a variety of mammalian cells as the final validation of the relevance of the protein interactions.

Assay Development & Drug Discovery: Tranzyme
s technologies are being used to build assay systems that regulate delivered gene(s) to closely mimic the biological setting. These assays will be used to can compound libraries against the gene of interest using a clinically relevant cell line. Tranzyme is initially focusing efforts on accelerating drug discovery in neurosensory diseases, neurodegenerative disorders, cystic fibrosis, and anti-HIV agents.

Protein Expression: Tranzyme
s technologies are being used for rapid high-level expression of properly folded proteins in cell types that naturally express the protein of interest. These proteins are likely to be superior to proteins expressed in heterologous systems such as bacteria, yeast and insect cells, and are potential drug targets in biochemical assays. Tranzyme has successfully expressed soluble, secreted and integral membrane proteins including GPCR's, ABC transporters, proteases, deacetylases, kinases, nucleotide sugar transporters, and sulfate transporters.

Animal Models: The study of the neurosensory system and the brain is limited by the lack of genetically modified animal models for target validation, assay design and library screening. Tranzyme is applying its TranzEmbryo technology in the creation of animal models in mammalian species that could not be subjected previously to genetic manipulation because of the limitations of embryo transformation. Such animals include guinea pigs, rabbits, ferrets and hamsters, which have particular relevance in modeling the neurosensory system.

Corporate Partnerships
Tranzyme has established over a dozen industry partnerships around the world. The Company has been a proven partner for a number of biotechnology and pharmaceutical companies focused on diseases of the brain such as Alzheimer
s disease, Parkinsons disease, Huntingtons disease and stroke.

Gene Function & Target Validation: In August 2001, Tranzyme signed an agreement with NeoGenesis Drug Discovery, Inc. in the areas of gene expression and protein function discovery. In October 2001, Tranzyme entered into a broad collaboration with the University of Utah Genome Center to jointly develop gene libraries for gene function discovery and subsequent target validation.

In February 2003, Tranzyme entered into a collaboration agreement with Benitec, Ltd. (Queensland, Australia), a leader in high throughput gene silencing technology. Tranzyme and Benitec will jointly develop and market their gene silencing and gene delivery technologies. The combined technologies provide a revolutionary means of producing gene
knockdownsquickly and efficiently, ideal for both in vitro and in vivo applications. The collaboration will target the pharmaceutical industry and facilitate the discovery and validation of drug targets.
The companies will also develop proprietary targets using the combined technology for future joint drug discovery and commercialization.

Assay Development & Drug Discovery: In October 2001, Tranzyme announced a partnership with the Cystic Fibrosis Foundation Therapeutics, Inc., a non-profit affiliate of the Cystic Fibrosis Foundation, to develop novel cell lines to be used for cystic fibrosis (CF) drug discovery. Tranzyme will use its gene delivery and expression technology to establish immortalized human bronchial epithelial cell lines derived from normal individuals and CF patients expressing varying levels of either mutant or wild-type CFTR genes. The resulting cell lines will be available to the CF research community for screening and drug discovery as well as for Tranzyme
s internal drug discovery programs.
In February 2002, Tranzyme announced the formation of a joint collaboration with Gemin X Biotechnologies, Inc., (Montreal, Quebec) to discover new drugs for the treatment of neurological disorders using Gemin X
s proprietary apoptosis-regulating gene technologies. These genes are expected to have significant utility in treating diseases in which excess apoptosis is the etiologic factor including stroke, head trauma, Alzheimers disease and neurosensory diseases. Tranzyme will develop cell-based assays and animal models expressing mutant and wild-type versions of the gene in order to validate its function. Gemin X and Tranzyme will then use the cell-based assays and animal models to screen small molecule drugs designed by Gemin X.
In May 2002, Tranzyme announced a license agreement and multi-year research collaboration with Quark Biotech, Inc. (QBI). QBI is an established genomics-based drug discovery company working in a variety of disease indications. QBI is licensing Tranzyme
s platform technologies to further their R&D programs in gene function discovery, target validation and lead identification. QBI is providing research funding and will make milestone and royalty payments, as well as an equity investment in Tranzyme. Tranzyme gains access to certain proprietary targets, which the Company can develop for its neurosensory drug discovery program.
Also in May 2002, Tranzyme entered into a partnership with Targacept, Inc. to develop a novel bioassay for CNS drug discovery. The novel cell-based assay will express nicotinic acetylcholine receptors provided by Targacept. These receptors are implicated in a variety of neurodegenerative diseases. The bioassay will be critical for discovering compounds that have a neuroprotective function. Tranzyme will retain rights to develop and utilize the bioassay for its internal neurosensory drug discovery efforts.
In September 2002, Tranzyme announced a strategic alliance with BD Technologies (Becton, Dickinson & Co.), which is expected to lead to the development and commercialization of novel products for drug discovery as well as cell and tissue engineering. BD Technologies will access Tranzyme
s proprietary gene delivery and expression technologies and explore the utility of Tranzymes technologies in specific cell types of interest. BD Technologies will have rights to market products resulting from the use of Tranzyme technology, with Tranzyme receiving a fee from the sale of each product. In addition, Tranzyme gains access to undisclosed intellectual property for its internal drug discovery programs.
In March 2003, Tranzyme was awarded funding from the Institute for the Study of Aging to develop cellular and animal model systems for Alzheimer
s disease (AD). Tranzyme will use its proprietary TranzVector gene delivery system to create neuronal cell lines expressing single or multiple AD-related genes for use in high-throughput assays of beta-amyloid production. Using similar technology, Tranzyme will create rapid and inexpensive non-transgenic mouse models for AD drug discovery. In addition, Tranzyme will create a transgenic rat model for AD.

Protein Expression: Tranzyme is working with Active Pass Pharmaceuticals, Inc. and others to deliver ABC transporter genes into various mammalian cell lines and to express and purify the resulting proteins using tranz expression technology (TExT).

Genetically Modified Animals: Tranzyme has entered into a partnership to develop TranzEmbryo technology with Ozgene Pty, Ltd. (Canning Vale, WA, Australia). Ozgene will employ TranzEmbryo to create genetically modified mice and rats for the global research market.


June 5, 2003 Tranzyme        解説

Tranzyme Receives Equity Investment from the Biggest Japanese CRO, SNBL Group

Tranzyme, Inc., a drug discovery company focused on the diseases of the neurosensory system, announced today that it received an equity investment from Shin Nippon Biomedical Laboratories (SNBL) Group of Tokyo , Japan . The SNBL Group is investing US $1 million in Tranzyme stock. In addition to the equity investment, the two companies have initiated discussions to establish a broad strategic alliance. Additional terms of the investment were not disclosed.

SNBL was established in 1957 as the first pharmaceutical contract research organization (CRO) in Japan . Since that time SNBL has evolved into an international full service CRO, offering quality research services at every stage of the drug development process. Today, SNBL is Japan
s largest CRO and has an international presence with operations in the US and Europe . SNBL offers services from exploratory drug efficacy and safety testing, through clinical development, to submission and beyond.

We made this equity investment in Tranzyme because we are impressed by their unique focus on diseases of the neurosensory system, areas in which SNBL Group has considerable internal expertise,commented Ryoichi Nagata, M.D., Ph.D., President and CEO of SNBL Group. In addition, we are confident in the management's ability to leverage their expertise to establish valuable drug discovery partnerships. We see potential synergies with Tranzymes drug discovery efforts as the SNBL Group has state-of-the-art proteomics technology (NanoSolution, Inc.) and a unique nasal drug delivery system (Translational Research, Ltd.).

The proceeds from this financing will go towards accelerating Tranzymes drug discovery programs in the neurosensory area. Through its current industry partnerships, Tranzyme has secured access to druggable targets and compound libraries that have potential implications in diseases associated with vision, hearing, balance, taste and smell. This financing will provide the capital needed to refine the unique neurosensory assay systems required for these targets thereby enhancing the screening of therapeutic candidates.

The relationship with SNBL will allow Tranzyme to advance its business objectives on several fronts,said Vipin K. Garg, Ph.D., President & CEO of Tranzyme, Inc. In addition to providing financial resources, SNBL brings comprehensive GLP pre-clinical testing and development capabilities that meet global regulatory standards. These capabilities will be critical to Tranzyme as we identify our own lead compounds and progress them towards clinical development during the next year.

Shin Nippon Biomedical Laboratories (SNBL) Group was founded in 1957 and is recognized as the first and foremost Contract Research Organization (CRO) in Japan with both preclinical and clinical capabilities. Based on a preclinical foundation, the Group now offers full-service worldwide drug development capabilities, providing the pharmaceutical and biotechnology industries with the highest quality research services available at every stage of the drug development process, from early phase discovery through to post marketing stage. The Group has expanded beyond CRO operations to include NanoSolution, Inc. and Translational Research, Ltd. NanoSolution, Inc. offers high-speed nanoscale proteomic analysis in post-genome research, using a direct nanoflow HPLC system with the worlds highest throughput. Translational Research, Ltd. provides impetus and support for research at universities and private enterprises and utilizes SNBLs internal preclinical and clinical capabilities to lead drug development through licensing to the pharmaceutical sector. Its first application is in the field of intranasal insulin delivery system. For more information about SNBL Group visit www.snbl.com.

Tranzyme, Inc. is a privately held drug discovery and development company uniquely focused on the treatment of diseases associated with the neurosensory system including the eye, the ear and the brain. Tranzyme has developed a proprietary functional biology platform for compound screening and drug discovery. Tranzyme is leveraging its technology through partnerships and internal programs to drive the discovery and development of novel therapeutics. The Company has already established a dozen strategic partnerships around the world and has secured access to a number of important therapeutic targets for neurosensory diseases. For more information about Tranzyme visit
www.tranzyme.com


2003/09/03 杏林製薬

ディスカバリーパートナーズインターナショナルインク(DPI社)との探索研究委託契約について

 杏林製薬株式会社(社長荻原郁夫)は、この度、
リード探索およびリード最適化に関する受託研究機関であるディスカバリーパートナーズインターナショナルインク(社長・COO Taylor Crouch)と創薬シーズの探索における委託研究契約を締結いたしました。
 同契約に基づき、DPI社はアレルギー領域における医薬品候補化合物を探索するスクリーニング系の確立を行うとともに、DPI社が保有する大量の化合物ライブラリーから候補化合物をスクリーニング検出し、杏林製薬(株)に提供します。杏林製薬(株)は提供された候補化合物から開発化合物を選択しリード最適化研究を行うことで、効率的な創薬を目指します。なお、候補化合物に関する工業所有権および商業化の全世界における独占的実施権は、杏林製薬に帰属いたします。

 DPI社はグローバルに医薬品探索サービスを提供する受託研究機関で、転写因子の核内移行アッセイ系の確立などリード探索におけるスクリーニングシステムの構築および短期間での高速スクリーニングについて最先端の技術とノウハウを有しています。

 当社はフランチャイズマネジメント戦略の中で、R&D領域を3領域に集中化・重点化しております。アレルギー領域は当社の重点研究領域であり、今回の探索研究を通じて創薬シーズの早期発掘によりアレルギー領域における創薬研究の効率化とスピードアップにつながるものと期待しております。

<参考資料>
● ディスカバリーパートナーズインターナショナル社の概要

会社名 :Discovery Partners International, Inc.
代表者 :Taylor Crouch (President & COO)
所在地 :San Diego, California(米国カリフォルニア州サンディエゴ)
設立 :1995年
従業員 :236名
売上高 :$41.3MM
株式 :2000年7月NASDAQ上場

リード最適化研究   http://www.fuji-ric.co.jp/report/200305/topics1.html

ゲノム情報の充実やITの活用による新しい創薬法への期待

ヒトゲノムドラフト配列が公表されて以降、ゲノム情報を活用したバイオテクノロジーに関する研究開発が世界全体で活発化している。バイオテクノロジーが利用される分野としては農業、食品、環境といったものもあるが、もっとも重要な目標は、副作用が少なく効果の高い薬の開発であることは言を待たない。

そもそも病気というのは、体内に存在する何らかのタンパク質の機能が亢進あるいは減退している状態と考えられる。薬がこのような状態のタンパク質に結合し、そのタンパク質の機能を阻害あるいは促進することにより、薬の作用が惹起される。したがって、創薬の基本的なステップはおおよそ次のようなものになる。

[A] 病気の機序の理解・薬のターゲットとなるタンパク質の同定
[B] ターゲットタンパク質と結合する化合物候補(リード化合物とよばれる)の探索および最適化
[C] 薬物動態(体内における吸収、分布、代謝、排出)や毒性などの前臨床試験・臨床試験

ゲノムは「生命の設計図」ともいわれるように、タンパク質の1次構造(アミノ酸配列)を規定する遺伝子の集合である。ゲノム創薬とは、このゲノムの情報を土台として上記の創薬の各ステップの高度化・効率化をはかることを指す。たとえばステップ[A]においては、ある疾病の患者と健常者の遺伝子情報をマイクロサテライトやSNPs(一塩基多型)といった多型情報として抽出し、相関をとることにより、その疾病の原因となる遺伝子を特定することが可能となる(ゲノムワイド相関解析)。

さらに、そのような手法により特定されたターゲットタンパク質に対し、大量の化合物との結合強度を測る実験を繰り返し、リード化合物を探索、さらには最適化することができる(ステップ[B])。あるいはまた、事前に個々の薬物の代謝にかかわる遺伝子多型を同定し(ステップ[C])、患者の多型情報に合わせて薬を処方するテーラーメイド医療などが可能となる。


Discovery Partners International    http://www.discoverypartners.com/

Discovery Partners International, Inc. (Nasdaq: DPII) is a leader in drug discovery collaborations. DPI offers integrated services, products, and systems that span the drug discovery continuum, including target characterization, targeted and screening-library design and synthesis, high throughput and high content screening, lead generation and optimization, gene expression analysis, and protein crystallization. DPI has actively contributed to dozens of drug discovery collaborations, working on many of the most promising new biological target areas for the biotech and pharmaceutical industries. Discovery Partners International is headquartered in San Diego, California and has operations in the United States and Europe.

Operational Structure
Discovery Partners is organized into three discovery units, working closely together to support the discovery process from target validation through to optimize leads for IND submission. The company's units comprise the following:

Integrated Drug Discovery: Focused on executing multi-disciplinary collaborations aimed at discovering and optimizing new therapeutic drug leads. This unit specializes in: Lead finding (utilizing high throughput, high content, and in silico screening); Lead optimization (utilizing medicinal chemistry, biology, and computational modeling inputs); and, In vitro toxicology (utilizing our Xenometrics gene expression profiling technologies).
Discovery Chemistry: Comprising the former ChemRx organization, dedicated to providing outsourced chemistry capabilities to the pharmaceutical and biotech industries and to fulfilling the chemistry needs of DPI's IDD customers. This unit regularly provides custom, novel chemistry libraries of drug-like compounds, designed, synthesized, purified, and scaled to meet specific industry lead finding requirements.
Discovery Systems: Comprising IRORI combinatorial chemistry products, Crystal Farm
automated crystal incubation systems, ARCSultra-high throughput screening systems, and related services designed to enable our customers to transfer or acquire our technologies to enhance their own internal capabilities in drug discovery.