Drug Development / Overseas Portfolio

Sucampo Pharmaceuticals, Inc. (http://www.sucampo.com/)(SCMP)

Sucampo Pharmaceuticals Announces Positive Results from a Japanese Phase 2b Dose-Ranging Study of AMITIZA(R) for Chronic Idiopathic ConstipationData Reinforce AMITIZA's Safety and Efficacy Profile Pivotal Japanese Phase 3 Clinical Trials to Commence by Mid-2009 BETHESDA, MD--(BUSINESS WIRE)--
Sept. 18, 2008--Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced results of its phase 2b dose-ranging study of AMITIZA(R) (lubiprostone) in patients with Chronic Idiopathic Constipation (CIC), conducted in Japan. The study demonstrated a statistically significant increase in mean change in spontaneous bowel movements (SBM) from baseline after one week on treatment (p less than 0.0001), the study's primary endpoint, for patients taking AMITIZA 24 micrograms twice daily versus placebo.


Affymax Inc. (http://www.affymax.com/)(AFFY)

Affymax Announces Favorable Data Monitoring Committee Review of Phase 3 Hematide Program PALO ALTO, Calif., Aug 07, 2008 (BUSINESS WIRE) --
Affymax, Inc. (Nasdaq:AFFY) today announced that the independent Data Monitoring Committee (DMC), which provides oversight for the Phase 3 program for Hematide(TM), has completed its first review of the data and informed the company that the cumulative safety data generated thus far from the EMERALD and PEARL Phase 3 trials support continuation of the studies. In the Phase 3 program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis. "These are very important reviews by the DMC and we are pleased that the committee has recommended that the trials proceed," said Arlene M. Morris, president and chief executive officer of Affymax.
"We continue to make progress in enrollment of patients in the four Phase 3 trials and look forward to additional DMC reviews as more data are generated." The Phase 3 program, which consists of four trials, was initiated in October 2007. Recently, Affymax announced that enrollment is complete in PEARL 1, the first of those Phase 3 trials. The company continues to enroll in the other three studies and anticipates completion of enrollment by year end 2008.


OPKO Health Inc. ex-Acuity Pharmaceuticals, Inc. (http://www.opko.com/)

Newly Published Study Shows OPKO's siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye - Study Published in Journal Molecular Vision - - Results Show Good Distribution of Bevasiranib to Retina and RPE Cells after a Single Intravitreal Injection - MIAMI, June 3, 2008 /PRNewswire-FirstCall via COMTEX News Network/ --
OPKO Health, Inc. (Amex: OPK) today announced that a study published in the peer-reviewed journal Molecular Vision demonstrates that bevasiranib, its siRNA (small interfering RNA) agent is distributed throughout the eye, including extensive uptake into the retina. In two tissue distribution and pharmacokinetic studies in rabbits, results showed that bevasiranib was present in the retina and in targeted retinal pigment epithelium (RPE) cells following intravitreal injection.

Bevasiranib is a gene-silencing agent designed to shut down the production of vascular endothelial growth factor (VEGF), a primary cause of the new blood vessel growth, or neovascularization, associated with vision loss in patients with wet age-related macular degeneration, or wet AMD. The efficacy and safety of bevasiranib are currently being assessed in the COBALT study, an international Phase III trial for the treatment of wet AMD.
"Importantly, these data indicate that following intravitreal injection, bevasiranib distributes to the ocular structures relevant to the VEGF-induced neovascularization associated with vision loss in wet AMD, and we believe this animal data provides support for the use of bevasiranib in our ongoing pivotal Phase III trial for the treatment of wet AMD," said Samuel Reich, Executive Vice President of OPKO Ophthalmics. "It is noteworthy that bevasiranib was distributed to the RPE cells, since we believe that even a fraction of the tissue-associated bevasiranib entering the RPE cell is likely to be effective in specifically suppressing VEGF production."


FivePrime Therapeutics (http://www.fiveprime.com/)

Five Prime Initiates Phase 1 Clinical Trials of FP-1039 in Patients with Advanced Cancers SAN FRANCISCO, California
September 8, 2008. Five Prime Therapeutics, Inc today announced the first patient has been enrolled in a Phase I clinical trial of its investigational protein therapeutic, FP-1039, in patients with advanced solid tumors. FP-1039 is an FGFR1:Fc fusion protein shown in pre-clinical studies to inhibit angiogenesis and slow the growth of tumors.

May 20, 2008. Five Prime Therapeutics, Inc. and Pfizer Inc.(NYSE:PFE) today announced the initiation of a worldwide collaborative research and license agreement. The collaboration will focus on the discovery of antibody targets and novel therapeutic protein products to treat certain areas of cancer and diabetes. Under the collaboration, FivePrime will screen its comprehensive protein library in both cell-based assays and primary in vivo screens directed toward finding potential therapeutic protein products and antibody targets.


MacroGenics Inc. (http://www.macrogenics.com/)

Lilly and MacroGenics Announce Licensing and Collaboration Agreement
Lilly to Acquire Phase III Molecule Teplizumab for the Treatment of Type 1 Diabetes
Companies to Collaborate on the Development of Autoimmune Disease Treatments INDIANAPOLIS, IN and ROCKVILLE, MD
Eli Lilly and Company (NYSE:LLY) and MacroGenics, Inc. today announced that the two companies have entered into a global strategic alliance to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next generation anti-CD3 molecules for use in the treatment of autoimmune diseases. As part of the deal, Lilly will acquire the exclusive rights to the molecule. Teplizumab is currently being studied in the PROTEGE trial, a global pivotal Phase II/III clinical trial for individuals with recent-onset type 1 diabetes.

FibroGen, Inc. (http://www.fibrogen.com/)

FibroGen is a biotechnology-based drug discovery company.
FibroGen is focused on the discovery, development, and commercialization of new treatments for fibrosis, anemia, ischemia, and cancer based on our scientific leadership in tissue fibrosis and HIF biology. FibroGen also develops and produces recombinant human collagens and gelatins using unique production technology that provides the basis for our proprietary cosmetic dermal filler and biomaterials supply business.

FibroGen, Inc. (FibroGen) today announced it has completed an exclusive licensing agreement with Astellas Pharma Inc. (Astellas) that provides Astellas rights to certain FibroGen hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitors for development and marketing for the treatment of anemia in Europe, Commonwealth of Independent States (CIS), Middle East, and South Africa. These inhibitors include FG-2216 and FG-4592, currently in human clinical trials. FibroGen retains rights in the rest of the world except in Japan. The Japan rights were licensed previously to Astellas


Quark Pharmaceuticals, Inc. (http://www.quarkbiotech.com/)

Quark Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in DME

Fremont, California, July 30, 2008 Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNAi)-based therapeutics, today announced that its partner, Pfizer Inc, initiated patient dosing in a Phase II trial evaluating PF-4523655 (RTP801i-14) in patients with diabetic macular edema (DME). PF-4523655 is a novel siRNA drug candidate being co-developed by Quark and Pfizer. As part of the companies�f Global Licensing Agreement, the successful commencement of the trial triggers a milestone payment to Quark from Pfizer, a small percentage of which is payable by Quark to Silence Therapeutics and Alnylam as technology license milestone payments.

Quark Receives FDA Approval of IND For Kidney Transplant Quark Pharmaceuticals Receives FDA Approval of IND For Kidney Transplant siRNA Drug DGFi Quark�fs second siRNA drug delivered systemically
Fremont, California, June 25, 2008 Quark Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its siRNA drug candidate, DGFi, in kidney transplantation. The Company expects its Phase I/II clinical study for prevention/treatment of Delayed Graft Function (DGF) in kidney transplant patients to begin in the second half of 2008. DGFi is Quark's second product candidate to enter clinic trials that is systemically administered to patients. The first ever siRNA drug candidate to be delivered systemically in man was Quark's AKIi-5 which is in Phase I clinical trial for acute kidney injury. The Phase I/II will be a multi center study in which the safety and tolerability of escalating doses of DGFi by a single IV injection in renal transplant patients with DGF. Up to 204 adult kidney transplant recipients will be enrolled in this 2-part study.


Acologix, Inc. (http://www.acologix.com/)

Acologix strives to improve patients' lives by developing and commercializing innovative biopharmaceuticals targeting "osteo-renal"(bone and kidney) diseases. Acologix's deep expertise in mineral metabolism sciences is the key to solving major osteo-renal health problems. Periodontal disease, oral care, orthopedics, osteoporosis, chronic kidney disease and its secondary complications such as renal osteodystrophy and uremic pruritus represent significant underserved medical needs. Acologix is unique in its focus on these rapidly growing health care problems.


Acucela Inc. (http://www.acucela.com/home.html)

Acucela Inc. is a biotech company discovering new drug therapies for eye diseases. Neurodegenerative retinal diseases such as macular degeneration, Stargardt's disease, retinitis pigmentosa and glaucoma, significantly affect quality of life for over 50 million people worldwide, and there is a drastic lack of therapies available. Until now, ophthalmic drug discovery technologies have been very limited.
SEATTLE April, 2007 Acucela Inc., a Seattle based biotechnology company focused on discovery and development of treatments for blinding eye diseases, today announced the completion of a $25 million financing round. The round was led by several funds operated by SBI Investment Co., Ltd., who is wholly owned by SBI Holdings, Inc. which made its first significant investment in an American biotechnology company when it invested in Acucela in 2004. Otsuka Pharmaceutical Factory, Inc. has also participated in the financing round with $5M.


Dynogen Pharmaceuticals, Inc http://www.dynogen.com/

Dynogen is a biopharmaceutical company developing more effective drugs for gastrointestinal (GI) and genitourinary (GU) disorders, including irritable bowel syndrome (IBS) and overactive bladder (OAB). We focus on compounds that have previously been in the clinic and therefore have known safety and pharmacokinetic profiles. This approach, combined with the experience of the Dynogen team, enables our programs to be prioritized for near-term commercial potential, reduces the risk involved in clinical development, and has allowed Dynogen to rapidly build a high value development stage pipeline.
Today, we have three products in development for five indications:
DDP733 for the treatment of irritable bowel syndrome with constipation (IBS-c) and nocturnal gastroesophageal reflux disease (n-GERD);
DDP225 for the treatment of irritable bowel syndrome with diarrhea (IBS-d) and for the treatment of chronic functional vomiting (CFV); and
DDP200 for the treatment of OAB.
February 13, 2007 Dynogen Pharmaceuticals, Inc. today reported positive results of its randomized, double-blind, placebo controlled, parallel group Phase 2 trial of DDP733 in patients with irritable bowel syndrome with constipation (IBS-c).


BrainCells Inc. (http://www.braincellsinc.com/index.html)

BrainCells Inc. (BCI) (http://www.braincellsinc.com/index.html) is a biopharmaceutical company focused on the development of breakthrough small molecule therapeutics for diseases of the central nervous system (CNS). The Company's technology platform is based on pioneering research in the field of neurogenesis and recent discoveries linking neurogenesis to CNS disease states. BCI is using its neurogenesis technology platform to identify clinical-stage compounds, novel targets and compounds optimal for CNS indications. BCI is building a pipeline of clinical-stage programs to address unmet medical needs in the treatment of mood disorders, psychoses, cognition, brain repair syndromes and other CNS disorders.


AVEO (http://www.aveopharma.com/content/index.jsp)

AVEO is a biopharmaceutical company focused on the discovery and development of novel cancer therapeutics. AVEO is developing a pipeline of targeted therapies which address major unmet medical needs in the field of oncology. The Company utilizes its proprietary in vivo cancer models for the identification and validation of novel drug targets and to guide the development of its products. AVEO is located in Cambridge, Massachusetts.


Inotek (http://www.inotekcorp.com/)

Inotek Pharmaceuticals Corporation is a clinical-stage, drug development company founded in 1996. Inotek has a deep pipeline of small molecule compounds targeting the key biological processes involved in cell survival. The Company has built a robust small molecule chemistry expertise, leading to five distinct programs focused on DNA repair, cell necrosis and critical inflammatory pathways associated with tissue injury. Inotek is a leader in 'PARP inhibitors', a class of drugs that block the nuclear DNA repair enzyme poly (ADP-ribose) polymerase (PARP) and the Company is exploiting this target to develop therapeutics for a broad array of clinical applications. All of the Company's technologies were discovered and developed by Inotek researchers. Inotek has approximately 130 employees based in its corporate headquarters and main research laboratories in Beverly, Massachusetts and two operational sites in Israel. Inotek has a deep and diverse pipeline with three programs in clinical trials with ongoing Phase 1 trials for drugs which are targeting oncology, atrial fibrillation and other markets with significant unmet needs.


Drug Development / Domestic Portfolio

AnGesMG,Inc. (http://www.anges-mg.com/en/index.html)
Sep. 2002 Tokyo Stock Exchange Mothers(4563)



TransGenic Inc.(http://www.transgenic.co.jp/index_en.html)
Dec.2002 Tokyo Stock Exchange Mothers (2342)



MediBic(http://www.medibic.com/en/index.html)
Sep.2003 Tokyo Stock Exchange Mothers (2369)



MEDINET Co.,Ltd. (http://www.medinet-inc.co.jp/english/index.html)
Oct. 2003 Tokyo Stock Exchange Mothers (2370)


SHIN NIPPON BIOMEDICAL LABORATOREIS,LTD. (http://www.snbl.com/en/index.html)
Mar.2004 Tokyo Stock Exchange Mothers (2395)



TAKARA BIO Inc.(http://www.takara-bio.com/index.htm)
Dec.2004 Tokyo Stock Exchange Mothers (4974)



MediciNova Inc.(http://www.medicinova.com/)
Feb.2005 Osaka Stock Exchange Hercules (4875)


GNI Ltd.(http://www.gene-networks.com/english/index.html)
Aug.2007 Tokyo Stock Exchange Mothers (2160)



R-Tech Ueno, Ltd. (http://www.rtechueno.com/en/index.php)

OSAKA HERCULES(4573)
R-Tech Ueno is a medical technology company focused on research, development and manufacturing of innovative pharmaceutical products. Rescula(R) eye drops, our lead product, has been highly recognized by medical professionals and patients as a safe and effective medicine to treat ocular hypertension and glaucoma since its launch in 1994.
R-Tech Ueno will be a reliable partner in your pharmaceutical development projects by offering a broad range of medical technology services starting from optimization of drug candidates to the commercial production of the drug.


Institute of Medicinal Molecular Design,Inc. (IMMD) (http://www.immd.co.jp/en/index.html)

The Institute of Medicinal Molecular Design, Inc. (IMMD) was founded in March 1995 by Dr. Akiko Itai with the mission to contribute to the society by offering superior drug discovery technologies.
Dr. Akiko Itai is the former professor of the Faculty of Pharmaceutical Sciences in the University of Tokyo and internationally recognized for her novel methodologies of rational drug design. Since founded, we have improved rational drug design technologies and applied them in the discovery of new drugs. We believe our rational molecular design technology using original algorithms based on the study of protein-ligand interaction is one of the leading methods in the world.Currently, in addition to the core technology of rational molecular design, we are engaged in developing broader technologies for drug discovery including the next generation bioinformatics system KeyMolnet, and proceeding with our own drug discovery and development programs using such proprietary technologies.We are committed to developing breakthrough drugs and the platforms on which they are based, placing great importance on the value of basic science. itted to developing breakthrough drugs and the platforms on which they are based, placing great importance on the value of basic science.
2005/12/22 European Molecular Biology Laboratory (EMBL) licenses IMMD's KeyMolnet.
2005/11/18 The U. S. Food and Drug Administration to use IMMD's KeyMolnet by integration with FDA's ArrayTrack system for reviewing pharmacogenomic data.


NanoCarrier Co.,Ltd. (http://www.nanocarrier.co.jp/index_en.html)

NanoCarrier Co., Ltd. applies the manufacturing technology of ultrafine particles termed "micellar nanoparticles" which Professor Mitsuo Okano, Institute of Biomedical Engineering at Tokyo Women fs Medical University, Professor Kazunori Kataoka, Graduate School of Engineering at the University of Tokyo, and Dr. Masayuki Yokoyama, Kanagawa Academy of Science and Technology, proposed for the first time in the world. We are developing micellar nanoparticles to use them as carriers for drugs, such as anticancer agents. These micellar nanoparticles are block copolymers with amphiphilicity in which a hydrophilic polymer (polyethyleneglycol) and a hydrophobic polymer (polyamino acid derivative) are bound at the molecular level. After dispersing these block copolymers in water, they associate spontaneously and result in forming two-tier particles which clearly consist of the core (inner core) and shell (outer shell). This technology has drawn attention worldwide because it yields nanoparticles known as functional micellar nanoparticles.



BioOne Corporation (http://www.bioone.jp/english/index.html)

We are pleased to introduce INTERCEPT Blood System, an innovative and unique system to inactivate pathogens and lymphocytes in blood products, developed by Cerus Corporation


TMRC Co.,Ltd. http://www.tmrc.co.jp/en/business.html

TMRC Co., Ltd. provides CRO service (support for pharmaceutical development), as well as new drugs development service (in-house development), specializing in cancers.
CRO services
CRO stands for Contract Research Organization, which takes part in clinical trial operations conducted by pharmaceutical companies or other entities. We at TMRC Co., Ltd. provide monitoring, data management and other related operations specializing in cancers, to major pharmaceutical companies.


GreenPeptide Co., Ltd. http://www.green-peptide.com/english/index.php

We have already filed an Investigational New Drug Application (IND) with the Pharmaceuticals and Medical Devices Agency (PMDA), and have started Phase I trials of personalized peptide vaccines for advanced HRPC.
Our target prostate cancer patients are medically castrated, refractory to hormone and estramustine (EMP) treatment, and have the HLA-A24 phenotype. We are administering personalized peptide vaccines in combination with EMP to these patients in order to confirm the safety and efficacy of the treatment in Japan.
We also plan to carry out preclinical studies of personalized peptide vaccines for prostate cancer patients with the HLA-A2 phenotype, targeting the US and European market. Toxicity and formulation studies of these personalized peptide vaccines will be carried out in animals
We have also already filed an IND application with the PMDA and started Phase I trials of personalized peptide vaccines for treatment of malignant brain tumors (glioblastoma).
Our target patients are HLA-A24(+) and are refractory to initial treatment (radiation therapy or combination chemotherapy and radiation therapy after surgery). We are administering personalized peptide vaccines without any concomitant drugs to confirm the safety and efficacy of the peptide vaccine.


Perseus Proteomics Inc. (http://www.ppmx.com/en/index.html)

Based on novel protein expression technology developed at and transferred from the Laboratory for Systems Biology and Medicine (LSBM), a state-of-the-art division of the Research Center for Advanced Science and Technology (RCAST) at the University of Tokyo, Perseus Proteomics develops biotechnology-based antibody therapeutics and diagnostic biomarkers in collaboration with world-class scientists and clinicians at the University of Tokyo.


Argenes, Inc. (http://www.argenes.co.jp/english/index.html)

Argenes, Inc. is a Japanese bio-venture established in April 2004 focusing primarily on the development of novel biopharmaceuticals and molecular targeting therapeutics, including anti-rheumatoid arthritis (RA), and anti-osteoarthritis. Currently, our most innovatory prospective candidate for the treatment of RA is the drug anti-Fas mAb ARG098. We operate preclinical and clinical studies as well as manufacturer pharmaceuticals through managing of CRO and CMO. At Argenes, Inc. we continually seek to expand globally through creating alliances and through licensing out development rights and marketing rights.


AlphaGEN Co.,Ltd. http://www.alphagen.jp/index.html

siChimeraTM
The greatest challenges in siRNA drug development lie in in vivo stability, manufacturing cost, interferon induction and other adverse reactions, and patent-related issues. siChimeraTM is a technology founded by Kaoru Saigo of the University of Tokyo School of Science to address these issues (patent no. 3803318 granted 05/2006). We use this technology in our own siRNA drug discovery efforts. siChimeraTM uses chimera RNAi, in which both sense and antisene stands consist of DNA/RNA chimera.
*Angiogenic siRNA (for intermittent claudication, obstructive arteriosclerosis, and cardiac infarctions)
We are developing siRNA drugs targeting a control factor for HIF (hypoxia-inducible factor), which is one of the main factors involved in angiogenesis. We have found that siRNA can promote angiogenesis by inducing expression of several angiogenic factors simultaneously by preventing breakdown of HIF inside the cell. It is therefore expected that delivery of siRNA to disease-affected sites can efficiently induce angiogenesis, leading to a breakthrough in treatment for obstructive arteriosclerosis.


TSD Japan Inc. http://www.tsd-japan.co.jp/english/

Japanese Pharmaceutical Companies seeking in-licensing opportunities are suffering from:
1. Insufficient or unavailable data/information required for an in-house strategy conference.
2. Because the success rate in clinical development is low, it must finally be judged by examining results at the point of care.
3. Shortage of in-house development resources.
While they are interested in the compound, they cannot reach a decision because of insufficient information!
Solution of TSD Japan
1. Analyze what information is insufficient, although required, for an in-house strategy meeting by the potential Japanese licensee.
2. Carry out, with TSD's own resources, a minimal-scale clinical trial to get the results required for such an in-house meeting.
3. Propose a flexible partnering framework, such as an option contract containing risk sharing, for in-licensing negotiations.
They have been waiting for just such data to clear away their doubts about the compound.


CanBas Co., Ltd. (http://www.canbas.co.jp/)

CanBas was spun off of the research of three scientists from the Nagoya City Medical School and Fujita Health Medical School.
These scientists founded CanBas as a drug development biotech with help by angels and venture capitalists in 2000.
The company's core technologies include drugs that target the G2 checkpoint and a screening system to find selective abrogators of the G2 checkpoint.
CanBas is also developing techniques to best determine the specific drug sensitivity of individual cancers from a patient, to increase the probability of prescribing a successful drug regime.


Y's Therapeutics Co. Limited http://www.ysthera.com/index.html

Y's Therapeutics focuses on developing monoclonal antibody therapies and other molecular-targeted biological drugs for the treatment of inflammation-mediated diseases, cancer, and other unmet medical needs. We also have small molecule compounds in our R&D pipeline to diversify our portfolio.

Our R&D pipeline has six on-going projects. YSPSL is a recombinant molecule project, which prevents tissue damage around the blood vessel from inappropriate inflammation. YSCMA is a humanized monoclonal antibody project for solid tumors and hematological malignancies. YSAVA and YSTOP are projects in research stage targeting cancer. YSIL6 and YSTH2 are research projects targeting rheumatoid arthritis and inflammatory diseases respectively.


UMN Phrama Inc. (http://umnpharma.com/eng/index.html)

UMN-01, a novel anti-cancer product for which we have licensed exclusive worldwide rights, is a small molecule down-regulator of GRP78, a 78 kDa glucose regulated protein that belongs to the HSP70 family of heat shock proteins. GRP78 is induced in a wide variety of cancers, resulting in inhibition of apoptosis. Specifically under glucose deprivation, which can be observed in cancer tissues, UMN-01 restores apoptosis via GRP78 down-regulation at the transcriptional level. In mouse xenograft models UMN-01 has shown pharmacological efficacy against human stomach, pancreatic, and lung cancer. We are conducting preclinical studies and plan to start the first clinical study for the treatment of pancreatic cancer in late 2007.

UMN-02, for the treatment of pancreatitis, evolved from our own studies. We first identified a target molecule known to be related to the pathophysiology of pancreatitis. We then looked for small molecule candidates with existing pre-clinical and clinical data that could be repurposed for acute and chronic pancreatitis. We then secured necessary intellectual property rights through patents. We plan to conduct the Phase IIa study in the US from early 2007.

UMN-03 is a recombinant fusion protein, which neutralizes endogenous myostatin (growth and differentiation factor 8 or GDF-8), a protein whose role is to reduce the amount of muscle tissue that is formed. Substantial published data indicate that blocking the action of myostatin can promote extra muscle growth, thus providing potential therapeutic advantage for patients with muscular dystrophy. Furthermore, UMN-03 can reduce fat tissue and could thereby provide a new therapeutic approach for type II diabetes or obesity. We plan to start the first clinical study in early 2008.

UMN-05 is an in-licensed product from Protein Sciences Corporation and its trade mark in the US is FluBlOk(TM). The project includes two recombinant vaccines, TIV (trivalent inactivated influenza vaccine) and vaccine against avian influenza virus which may cause a pandemia. The current licensed influenza vaccines, which are produced in eggs, have various weak points such as the difficulty to use them in subjects allergic to eggs and the long period of time needed to produce them, while UMN-05 is produced in Protein Sciences patented insect cell lines and formulated in PBS without any preservatives or adjuvant. In the US, FluBlOk(TM) is expected to obtain market approval before the 2008/09 influenza season.


Dynavec Corporation (http://www.dnavec-corp.com/english/index_e.html)

3 Core Technologies
Our antecedent, DNAVEC Research Inc, has developed many technologies throughout 9 years of research and development. The 3 core technologies are given below. Our company has the exclusive rights of the patents.
Sendai Virus Vectors(SeV):
Suitable in a wide-range which includes gene therapy, gene vaccines, functional analysis of genes, and manufacturing of recombinant proteins as a cytoplasmic RNA vector
New pseudo-type Simian Immunodeficiency Virus (SIV):
The first practicable vector for use in respiratory systems in the world
Selective Amplifier Genes:
Artificial genes that improve the functions of vectors for use in blood disorders


Aqumen Biopharmaceuticals. (http://www.aqumen.jp/en/index.php)

The Company's current portfolio of compounds and technologies in the development pipeline includes: i) A0001, Ophthalmic Dye for Retinal Surgery ii) A0003, Novel treatments for Age-related Macular Degeneration (AMD). and iii)A0006 . Company is in negotiations to acquire rights to a Phase II program by year end 2007. The following diagram summarizes the important existing and anticipated clinical development milestones for each of the programs as they relate to their respective targeted applications:


D.Western Therapeutics Institute (http://www.dwti.co.jp/e/top.html)

Drug Western Method
=Our Original Patented Technology

The Drug Western Method examines what types of protein in the body were affected by the administered drug, and also examines the pharmacological effects caused by the drug administration. The structure and function of the protein can be revealed by isolating the protein gene that the drug affects and conducting the mapping of gene sequences.
Consequently, the molecular target of a new drug becomes identifiable. In other words, the way that the new drug works can be learned in advance.


GeneCare Research Institute Co., Ltd. (http://www.we-care-gene.com/en/index.html)




M's Science Corporation (http://www.m-sci.net/)

M's Science successfully navigated its way through the difficult phases of research & development in new seeds and acquisition of funds. Now the company is conducting a clinical study phase for several new drugs, all of which are expected to be blockbusters with a new mechanism of action. A Phase II clinical study in the USA will begin soon with our SA4503, sigma receptor agonist, for patients with depression and strokes. Also, we will be preparing a clinical study of HF10, attenuated herpes simplex virus, with cancer patients, in 2006. With my more than 10-years of experience in the USA and a 3-years career in top management in Quintiles, the largest CRO in the world, I am very much excited about this challenge of reaching our goal of establishing a high quality pharma bio company in Japan.



Regenerative Medicine

Japan Tissue Engineering Co., Ltd. (J-TEC) (http://www.jpte.co.jp/e/e_cont_index.html)

The technology for keratinocyte cultivation has been transferred to J-TEC by Professor Minoru Ueda of Nagoya University. J-TEC members have accumulated their ex-pertise under the guidance of Professor H.Green, who developed the technique, and clinical authority Dr. Michele De Luca, and possesses the skills to generate cultured epidermis using Green's technique to meet the highest global standards. By isolating keratinocytes from a 1-cm2 skin sample and culturing them as illustrated below, a sheet of cultured epidermis meas-uring around 1000 cm2 can be produced in around two weeks.


ArBlast Co., Ltd (http://www.arblast.jp/e/index.html)

ArBlast was established in December 2005. Using the collagen sheet obtained by processing the human amniotic membrane, it is a regenerative medicine venture that regenerates various tissues.
At present, ArBlast is engaged in the development of the refined collagen sheet derived from human amnion which is made from refining the human amnion and using this sheet as the basement membrane, cultured corneal epithelial cell sheet and cultured corneal endothelial sheet are being developed. The collagen sheet derived from human amnion has diverse immunological characteristics, and at present it is impossible to synthesize substitute collagen sheets. Furthermore, the amniotic membrane does not include blood vessel elements, making it possible to reduce rejection after transplant. This is a big benefit of the sheet. The sheet is suitable as culture basement membrane for different types of tissue. Even for independent use, its application in medical treatment is being considered.


CellSeed Inc. (http://www.cellseed.com/index-e.html)

Many fundamental technological innovations applied to regenerative medicine have been produced by academic institutions. CellSeed matured one of these "Cell-sheet engineering". Our vision is to develop "Cell-sheet medicine" utilizing "Cell-sheet engineering"for patients suffering from specific diseases difficult to cure by existing medical technology.
To achieve this business goal, we offer 1) Cell-sheet engineering technology to exploit to support tissue-based surgical therapies, transplantation, and fundamental science and discovery, and 2) High value-added laboratory consumables and novel equipment derived from our unique Bio-nano interface technology to support research leading to innovative bio-technology that ultimately will contribute to new discoveries and products.


BCS,Inc. (http://www.bcsinc.co.jp/en/index.htm)

Biotechnology, transplantation, and gene therapy are the most expected new medical technologies of today. Collaborated with Tokai University, we have developed the technology to generate composite cultured skin, a kind of tissue engineering and regenerative medicine. Ahead of others in the same trade, we have achieved successful cases of applying the composite cultured skin in treatment of patients with severe burn injury. We aim to enhance this technology and apply it to generate broader range of biomaterial, such as cartilage, born, or body organs in future. We will keep working for the further development of the new medical transplantation.


ReproCELL Incorporated (http://www.reprocell.com/en/index.html)

ReproCELL Inc. hopes to contribute to the development of new drug in Japan by utilizing monkey and human ES cells, providing training and consulting for medical industries after providing specialized training to technicians and researchers in handling skills and knowledge of primate ES cells, based on the experience accumulated at Nakatsuji research office at the Institute for Frontier Medical Science.


Platform Technologies

CellFree Sciences Co., Ltd(http://www.cfsciences.com/eg/index.html)

ENDEXT(R) Technology signifies the wheat germ cell-free protein synthesis technology that was developed by Professor Yaeta Endo of Ehime University. The wheat germ lysate produced by the new technology is free of translation inhibitors, and as a result, it permits remarkably stable in vitro protein synthesis: all that is needed for the synthesis is to add the target mRNA as well as the amino acids and other substrates to the lysate. The eukaryotic origin of the ENDEXT(R) wheat germ lysate has made it possible to produce a broad range of difficult-to-express proteins including not only those of microorganisms and higher forms of life but also artificial proteins. Pacific Northwest National Laboratory (PNNL), one of the nine national laboratories of the U.S. Department of Energy, employed the CFS automatic protein synthesizer GenDecoder1000. PNNL will use it to synthesize proteins required for Genomes to Life (GTL) program, whose focus is on the molecular machines of DOE-relevant microbes and their networking in living cells and microbial communities. GenDecoder1000 is capable of transcription and translation of 384 samples in an overnight campaign.


Carna Biosciences, Inc. (http://www.carnabio.com/english/)

Carna Biosciences has been studying the functions, mechanisms and signaling of protein kinases and EGF family molecules for their role in diseases such as cancer, inflammation and dermatitis.
We have cloned and classified over 500 varieties of protein kinase genes from the human genome by means of bioinformatics. By using knockout and transgenic mice, and RNAi technology, the company is attempting to clarify the functions of orphan protein kinases along with their implications in the pathogenesis of diseases, thereby providing novel drug targets.Regarding EGF molecules, Carna Biosciences has been studying the activation mechanisms, signaling pathway and physiological/pathological roles of these proteins, with the emphasis on HB-EGF. These growth factors are noted not only for their roles as growth factors but also for mediating the EGF receptor transactivation in GPCR-induced cell proliferation. It is becoming clear that EGF-mediated EGF receptor transactivation is implicated in the pathogenesis of diseases such as dermatitis, heart disease and cancer. Also, EGF family molecules are involved in steroid signal transduction. The activation and signaling pathways of these growth factors have drawn attention as new drug targets. Carna Biosciences has been characterizing these pathways in an attempt to identify new drug targets.


Nimura Genetic Solutions Co., Ltd. (http://www.ngs-lab.com/en/)

Our mission: Isolating diverse creatures including species indegenous to rainforests in Malaysia, exploring new compounds which lead development of new medicine conforming to CBD and building a predominant bio-resource collection, NGS will contribute to health and progress of bioindustries in international community.
To attain our mission, NGS has built a business infrastructure to provide our know-how through the collaboration with pharmaceutical companies.


Neo-Morgan Laboratory Inc. (http://www.neo-morgan.com/en/index-en.html)

We are a biotechnology company aimed to contribute to the society by using our proprietary technology that introduces mutations into organisms resulting in various selected characters. Our technology effectively works for the improvement of plants and microorganisms such as yeast and lactic bacteria. It improves the efficiency of producing products and enables us to achieve developed and useful compounds. We also focus on the full understanding of the mechanism that reveals the evolution of all organisms on earth.
The substantial difference in the fidelity of genomic replication between the leading strand and the lagging strand is advantageous in terms of evolution because it allows for greater diversity of genotypes while guaranteeing the genotypes that have occurred in the past. The application of this Disparity Theory by artificially increasing the difference in the fidelity between the leading strand and the lagging strand allows evolution to accelerate while avoiding extinction of the population.


PharmaDesign, Inc. (http://www.pharmadesign.co.jp/eng/)

PharmaDesign Inc. is a selective Genomic Drug Discovery venture company founded by professionals on bioinformatics and rational drug design.
We contribute to the health and welfare of people by devoting our latest genomic drug discovery technique to develop innovative medicines appropriate for individual needs.
We keep on making efforts everyday to achieve our motto, "A novel creation is generated by a dream, carried out by passion, and crystallized by a firm sense of mission."
We have developed three business areas, 1) drug discovery research, 2) contract research, and 3) tool product sales, supporting development process in genome drug discovery, from target search to drug discovery to clinical development.



Bio Matrix Research Institute (http://www.biomatrix.co.jp/eng/index.html)

BIO MATRIX RESEARCH (BMR), a bio-venture company launched by the Tokyo University of Science, conducts wide-ranging advanced research and is engaged in the development and commercialization unique products.
Scientific advances are the outgrowth of technological development. BMR develops technologies that support the technologies required for dynamic development in the fields of molecular biology, medicine, and pharmacology.
Completion of the Human Genome Project in 2003 suggests that the human genome is no longer a black box. The company's major goals are development and practical application of exhaustive analysis techniques, so the outcome of genomic analyses can be applied in research.


Medical Device & Others

MC Laboratory Inc. (http://www.mclab.co.jp/en/)

People today suffer from stress and disturbed eating habits which can increase wastes in blood and cause interrupted blood flow. MC FAN is a blood fluidity measurement device (blood fluidity analyzer) which simulates capillary vessels. When a blood sample is applied to the analyzer, the condition of the blood can be displayed on the TV monitor in real time.


Institute of Gene and Brain Science (http://www.ins-gbs.co.jp/en/index.html)

The Institute of Gene and Brain Science is a drug discovery venture company that was established by two physicians from the Keio University School of Medicine, in 2001 to translate their research results into the innovative therapy.
We are developing innovative drugs and therapeutic techniques for two disease areas (to refer the followings) based on the research and medical findings of the central nervous system and brain tumors obtained by Dr. Masahiro Toda, a neurosurgeon, in addition to the basic medical findings in the field of immunology.
- Regeneration of central nervous system for central nerve damage, disease (spinal cord injury, cerebral infarction etc.)
- Cancer immune therapy
In association with the Keio University School of Medicine, the Institute of GBS is a drug discovery venture company that takes full advantage of coordination between Keio and GBS and the ample resources accumulated through clinical studies. It is our mission that we provide innovative drug and therapeutic techniques for patients look forward to make a quality of life .


Use Techno Corporation (http://www.utcbanaba.com/)



ReqMed Company, Ltd. (http://www.reqmed.co.jp)



Pharma Frontier (http://www.pharmafrontier.co.jp/dnamicroarray.html)



Summit Glycoresearch Corporation (http://www.sgr.co.jp/english.html)



Lymphotec (http://www.lymphotec.co.jp/index.htm)



Oncorex Inc. (http://www.oncorex.co.jp/index.html)



Aspion (http://www.aspion.co.jp/index.html)



Biomaster (http://www.biomaster.jp/web_site/english/index.html)