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Australia

Brisbane-based Alchemia Merge with Melbourne-based Meditech

Brisbane-based biotech firm, Alchemia, and Melbourne-based Meditech Research are to merge via an off-market takeover bid by Alchemia for Meditech that values the latter company at A$16.9 million (US$12.4 million).

The companies said that by joining forces, they would create a substantial drug development company with an extensive pipeline of products, a strong financial position and an experienced management team. The companies also said that the merger w ould bring together tw o companies with technology platforms based on carbohydrates. Alchemia's chemistry expertise wou l d c o m p l e m e n t M e d i t e ch' s b i o l o g y e x p e r t i s e . M e d i t e ch' s s t r o n g p r e c l i n i c a l a n d c l i n i c a l e x p e r t i s e wo u l d a c c e l e ra t e t h e d e ve l o p m e n t o f A l ch e m i a ' s d r u g d i s c ove r y o p p o r t u n i t i e s .

Alchemia chief executive officer, Tracie Ramsdale, said that the combined group would have exceptional people, a high-quality product pipeline and innovative technology. "T he Alchemia board believes Meditech will be an excellent addition to Alchemia's growing drug development and discovery portfolio," Ramsdale said. Alchemia will offer Meditech shareholders one Alchemia share for every nine Meditech shares, valuing Meditech at A$16.9 million (US$12.4 million) based on Alchemia's 30-day volume- weighted average price of A$1.207 (US$0.885).

The merger proposal has the unanimous support of Meditec h directors, w ho intend t o r e c o m m e n d t h e o f f e r t o M e d i t e ch s h a r e h o l d e r s i n t h e a b s e n c e o f a s u p e r i o r p r o p o s a l . All directors who hold Meditech shares or options will accept Alchemia's offer in r e s p e c t o f t h e i r s h a r e h o l d i n g s a n d o p t i o n h o l d i n g s i n t h e a b s e n c e o f a s u p e r i o r p r o p o s a l .

Alchemia's offer is subject to standard conditions including Alchemia obtaining acceptances to provide it with relevant interests in more than 90% of the Meditech shares on issue. During the bid period, Alchemia will provide financial support for Meditech's ongoing operations in the form of a short-term secured loan of up to A$2 million (US$1.47 million). The two companies have also signed an agreement that provides for the payment of a A$160 000 (US$117 300) break fee by either company in certain circumstances, and a no-solicitation undertaking by Meditech.

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Meditech's assets in clinical trials are at an earlier stage of development than Alchemia's synthetic heparin. But they are significantly more advanced than Alchemia's other drug discovery opportunities. The pipeline of the combined companies would comprise synthetic heparin, one drug candidate in Phase 2 clinical trials, two candidates that have completed Phase 1 trials and another that is planned to start Phase 1 trials at the end of 2006.

Meditech has a product in Phase 2 clinical trials in metastatic colorectal cancer patients and two anti-cancer products that have satisfactorily completed Phase 1 trials. These products complement Alchemia's early and late-stage revenue-generating opportunities.

Meditech's chief executive officer, Dr Ian Nisbet, said the merger with Alchemia was consistent with Meditech's strategic plan and was a critical step in building a strong, internationally competitive biotech company.

"This offer substantiates the Meditech board's consistent view of the value of the company, its technology and its people. We will be working with Alchemia to ensure that this offer is put to shareholders as soon as possible," Nisbet said.

About Alchemia Contact Details: Alchemia was established in Australia in 1995 by three scientists, Professor Peter Andrews, Dr Tracie Ramsdale and Professor Istvan Toth. It was formed Alchemia to unlock the therapeutics potential of one of the Address: 3 Hi-Tech Court, Brisbane Technology Park, last remaining biological macromolecules with a Eight Mile Plains, Brisbane, significant untapped potential—the carbohydrate QLD 4113, Australia and its sugar buidling blocks. The company’s first Tel: +61 7 3340 0200 product was the synthetic heprain. It will be lauched in the market in 2008. Fax: +61 7 3340 0222 Email: [email protected] URL: www.alchemia.com About Meditech Meditech Research Limited is an Australian, development stage, biotechnology company focused on developing and commercializing drugs that improve the health and quality of life of patients with Contact Details: cancer and other chronic diseases. The company has internationally recognized expertise in carbohydrate Meditech Research Ltd based therapies, particularly products based upon the glycosaminoglycan, hyaluronic acid. Building Address: Tok Corporate Centre, Level 1, on this expertise, Meditech has created its patented 459 Toorak Road, Toorak, Victoria 3142 HyACT™ (Hyaluronic Acid Chemotransport Tel: +61 3 9296 2026 Technology) platform which it is applying to the Fax: +61 3 9296 2192 development of improved formulations of cytotoxic Email: [email protected] drugs. URL: www.mrl.com.au

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Australia

Imugene to Conduct Second Bird Flu Program

ydney-based Imugene Ltd will undertake a second bird flu vaccine program as part of its research on viral vector programs at the company's newly leased laboratory facility Sat La Trobe University, Melbourne, Australia. The company said that the research conducted at this laboratory would supplement its work carried out as part of an arrangement with the CSIRO. The CSIRO has been working under contract on vaccine candidates for the H5N1 strain of the virus with a particular focus on creating a vaccine for the broiler (meat bird) market. Imugene has now started a second bird flu vaccine program aimed at creating a vaccine for the egg layer and breeding bird market. This new vaccine research will be conducted at Imugene's new laboratory u n d e r t h e d i r e c t s u p e r v i s i o n o f I m u g e n e ' s ch i e f s c i e n t i f i c o f f i c e r, D r M i k e S h e p p a r d .

Layer birds and birds used for breeding stock for the broiler market require longer lasting immunity to diseases than broiler birds, which typically reach slaughter weight by 42–49 days of age. The vaccine designed for layers and breeders will use two antigens (rather than the single antigen used in the broiler vaccine) to elicit both antibody and cell mediated immunity.

Th e n e c e s s a r y g e n e s h ave b e e n s e l e c t e d a n d t h e y a r e b e i n g s y n t h e s i z e d i n E u r o p e . Imugene said it expected to receive these genes within the next 4–6 weeks, and they would then be inserted into the fowl adenovirus vector to create vaccine candidates.

About Immugene Ltd Contact Det ails: Imugene is an Australian company developing and commercializing a range of biological animal health products for the production and Imugene Ltd companion animal markets worldwide. The Address: Level 1, 14–20 Delhi Road, Imugene products improve the health and welfare North Ryde, NSW 2113, Australia of animals and reduce or eliminate the use of Tel: +61 2 9870 7330 chemicals and dr ugs, par ticularly antibiotics, in production animals. Fax: +61 2 9888 9338 Email: imngene.imugene.com URL: www.imugene.com.au

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Australia LCT and The Bionic Ear Institute Collaborate on Research to Improve Hearing Loss

About Living Cell Technologies iving Cell Technologies Limited has entered into Living Cell Technologies Ltd develops live cell therapy a collaborative agreement with The Bionic Ear products to treat life threatening human diseases. Listed on Institute, an internationally recognized not-for- the Australian Stock Exchange, it is a ver tically integrated L profit biomedical research organization, to improve company that operates globally through offices in Australia, Ne w Zealand and the United States. LCT focuses on the hearing outcomes for cochlear implant patients developing treatments where healthy living cells are injected through rehabilitation of the auditory nerve. into patients to replace or repair damaged tissue, without requiring the use of toxic dr ugs to prevent rejection. The company’s product por tfolio focuses on treatments for people Th e c o l l a b o ra t i o n w i l l c o m b i n e t h e p l a t f o r m with Huntington’s disease, insulin-dependent diabetes and tec hnologies of LCT with the expertise of The haemophilia. B i o n i c E a r I n s t i t u t e ’s wor l d - l e a d i n g s c i e n t i s t s a n d About Bionic Ear Institute their know-how with models of deafness, cochlear implant technology, and experience in cell delivery The Bionic Ear Institu te is a not-for-profit biomedical research organization based in Australia. The institute was t o t h e c o chl e a r. U n d e r t h e a g r e e m e n t , L C T h a s established to undertake vital research to assist in the ongoing the option to acquire an exclusi ve license to development of a device that would allow deaf people to hear. commercialize results of the collaboration. Grants The Australian Bionic Ear was pioneered by Professor Graeme Clark and his team at the University of Melbourne. Today, its are being targeted to assist in funding the program. researchers are world leaders in innovative biomedical research. The work of the Bionic Ear Institute contributes to improved “We’ve known that LCT’s technology will play a hearing for more than 70 000 severely and profoundly deaf significant role in enabling treatment of a variety of children and adults world wide. In addition to the research in hearing, research is being extended into areas such as spinal different conditions, but we are particularly excited cord repair, infection control for implantable devices and early a b o u t wo r k i n g w i t h o n e o f t h e wo r l d ’s l e a d i n g treatment of epileptic seizures. g r o u p s i n t o h e a r i n g l o s s ,” s a i d L C T C E O, D avi d Collinson. Contact Det ails: “Importantly, this strategic partnership will allow LCT L C T t o d e ve l o p a f u r t h e r p o r t f o l i o o p p o r t u n i t y, Address: Pacific Tower, Suite 2.11 / 737, without losing focus on mo ving our tw o lead Burwood Rd, Hawthorn VIC 3122, products to the clinic,” continued Mr Collinson. Australia Tel: +61 3 9813 5501 “ E n c a p s u l a t e d c e l l s m ay p r ov i d e a l o n g - t e r m Fax: +61 3 9813 5502 neuroprotection therapy to neurons of the inner ear Email: [email protected] to treat cochlear deficits,” said Associate Professor URL: www.lct.com.au Rob Shepherd, acting director, the Bionic Ear Institute. Contact Det ails: “The Bionic Ear Institute has been w orking The Bionic Ear Institute diligently on novel methods for rescuing auditory Address: 384-388 Albert St, East Melbourne, neurons and is very excited to combine this VIC 3002, Australia kno wledge with LCT’s encapsulation platform. Tel: +61 3 9667 7500 The resear c h will pro vide a significant insight Fax: +61 3 9667 7518 i n t o i m p r ov i n g h e a r i n g i m p a i r m e n t a n d p o s s i b l y Email: [email protected] r e h a b i l i t a t i n g t h e a u d i t o r y n e r ve,” s a i d A s s o c i a t e URL: www.bionicear.org Professor Shepherd.

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Australia

Norwood Abbey takes MIT's Needle Licence

e d i c a l t e chn o l o g i e s g r o u p N o r woo d A b b e y h a s s i g n e d a c o m m e rci a l - p h a s e license agreement with Massachusetts Institute of Technology (MIT) involving Mt h e u n iver s i t y ' s n e e d l e - f r e e d r u g d e l iver y s y s t e m a n d t h e m i c r o n e e d l e d r u g delivery system.

Norwood Abbey said the agreement provided it with an exclusive worldwide licence over all technological developments emerging from the contracted works programs. The license covers 10 patent families covering one issued US patent and some 50 applications.

I n r e t u r n , M I T w i l l e a r n a r oyal t y f r o m r e ven u e s g e n e rat e d by t h e p r o d u c t s whe n c o m me rc i a l iz e d . The Au s t ral i a n c om p a ny sa i d t h e n e e d l e -f r e e sy s t e m h a d p o te n t i a l applications in both human and veterinary fields.

Norwood decided to exercise its rights for a formal license over the technology as a result of the successful development of working prototypes, and a strong intellectual property position. Commercial discussions with a number of both human and veterinary pharmaceutical groups have recently started.

The human-use product is a small reusable handheld device of a similar size to a very small hairdryer, a little larger than an electric toothbrush. Drugs and vaccines are delivered using a single use disposable syringe. The product has been developed as a safe, low-cost alternative for needles and syringes and incorporates controllability of force and, therefore, control of the depth of delivery. The product is almost silent in operation.

MIT has recently conducted preliminary trials of the human use hand-held prototype device. In addition, MIT has successfully completed the first live animal studies using a prototype needle-free device for veterinary applications.

About Nor wood Abbey Contact Details: Nor wood Abbey specializes in developing and commercializing innovative projects and Norwood Abbey Ltd technologies that address significant unmet needs in the medical industr y. Nor wood aims to identify Address: 63 Wells Road Chelsea Heights, innovative research projects that are suppor ted by Victoria, 3196, Australia strong intellectual proper ty with the potential to Tel: +61 3 9782 7333 address significant market oppor tunities. Nor wood’s Fax: +61 3 9782 7334 strategy is to establish key strategic alliances and Email: [email protected] par tnerships with the objective of improving people’s lives. URL: www.norwoodabbey.com

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China Sinovac Biotech and LG Life Sciences Announce Distribution Agreement to Market Vaccines in China

inovac Biotech Ltd and LG Life Sciences Ltd, the leading pharmaceutical company in South Korea, announced that both companies have entered into an distribution agreement in which SSinovac will act as LGLS's exclusive distributor for its hepatitis B vaccine in China. “ S i g n i n g t h i s a g r e e m e n t i s t h e b e g i n n i n g o f S i n ovac ’s i n t e r n a t i o n a l c o o p e rat i o n w i t h vac c i n e suppliers. After a long, careful analysis, we are very pleased to begin this strategic relationship with LG Life Sciences,” said Mr Yin Weidong, CEO of Sinovac. Sinovac and LGLS signed a Letter of Intent to collaborate their international and China sector marketing efforts and vaccine supply. Based on previous studies, Sinovac believes Euvax B will compare favorably to vaccines in China. Mr Yin noted, “This agreement fits very well with our overall business strategy, once we successfully register EUVAX, we will have another sales revenue generator for Sinovac.”

“Partnering with Sinovac is an exceptional opportunity for LGLS to execute our business strategy; which is to secure global marketing capabilities,”said In-Chull Kim, PhD, President and CEO of LG Life Sciences. LG Life Sciences is exporting its Hepatitis B vaccine, EUVAX BTM, to more than 60 countries including UN-sponsored programs.

Dr. Kim continued, ‘”This market is important to us and we are confident in Sinovac’s registration and vaccine distribution capability in China.”

About LG Life Sciences Ltd LG Life Sciences Ltd (LGLS) is the leading pharmaceutical Contact Det ails: company in South Korea with a firm foundation in science and R&D. LGLS strives to improve the health and quality of life Sinovac of patients around the world through discover y, development Address: 39 Shangdi Xi Road, Haidian District, and marketing of innovative products, including medicine to Beijing, China fight various infectious diseases, diabetes and other chronic Tel: +268 562 3452 illnesses. LGLS maintains successful par tnerships with Fax: +268 562 3453 major pharmaceutical companies, augmenting its internal R&D and marketing capabilities. Email: [email protected] URL: www.sinovac.com About Sinovac Biotech Sinovac Biotech Ltd is a world leader in the research, development, manufacture and commercialization of vaccines for endemic and pandemic vir uses such as hepatitis and influenza, and for fast emerging vir uses Contact Det ails: such as pandemic influenza (bird flu) and SARS. The company's objective is to provide Chinese children with LG Life Science the best vaccines in the world, and let children in the Address: 17F East Bd, LG Twin Tower 20, world use vaccines made in China. Sinovac Biotech Ltd Yoido-dong, Young dungpo-gu Seoul is also known in China as Beijing Kexing Bioproducts. Korea, 150-721 Working closely with Chinese public health officials, Sinovac focuses on manufacturing and marketing human- Tel: +82 2 3773 7717 use vaccines and related products, and currently markets its Fax: +82 2 3773 7012 vaccine for Hepatitis A. Sinovac is the first and currently the URL: www.lgls.co.kr only company in the world to have been granted permission to begin clinical trials for a vaccine to prevent SARS

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India

Novavax and Bharat Biotech to Co-develop Flu Vaccine

S Va c c i n e d e vel o p e r N ovavax a n d I n d i a ' s B h a rat B i o t e ch I n t e r n a t i o n a l ( B B I L ) h ave announced a strategic alliance to pursue the rapid development of a pandemic influenza Uvaccine for India and other south Asian markets. Under the terms of the agreement, BBIL will fund 100% of the preclinical and clinical studies for these markets. It will assist in developing an efficient manufacturing process for the virus-like particle (VLP)-based influenza vaccine.

B BI L w il l b e re sp o ns ib l e fo r t he s a le a nd di st r ib ut io n o f t he vacc i ne i n I nd i a an d o th er surrounding countries, while Novavax will receive unrestricted access to all preclinical and clinical data that BBIL generates and they will also receive a double-digit royalty on all future sales located within BBIL's geographic territories.

Novavax's VLP vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. Viral proteins can self-assemble into VLPs when over-expressed in certain cells.

VLP technology has already been used in the development of hepatitis B and human papilloma virus vaccines, but the companies' arrangement will be the first time that VLP technology has been applied to create an influenza virus vaccine.

Novavax said the technology was a particularly good fit for addressing pandemic influenza because it obviated the reliance on the supply of embryonated eggs for the production of the vaccine. In addition, this technology can be used to rapidly create vaccines against emerging threats or new strains of existing pathogens.

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The alliance will be overseen by a steering committee chaired by Dr Richard Klausner, a former executive director of the Bill and Melinda Gates Foundation and former director of the US National Cancer Institute. Klausner is a special advisor to both the Indian Government and to Novavax.

BBIL chairman and managing director, Dr Krishna Ella, said the agreement between the companies was bigger than just a business deal. "It is an attempt to bring together capabilities of two different organizations across the world to address the global public health and economic threat posed by pandemic influenza," Ella said.

"Novavax's VLP technology is clearly one of the most effective in addressing emerging strains of the virus and BBIL's proven capabilities in process development, clinical development, and manufacturing infrastructure will help expedite the availability of a VLP-based vaccine for pandemic influenza to the Indian public and the world at large,” Ella continued.

As part of the strategic alliance between the Hyderabad-based Bharat Biotech and Pennsylvania-based Novavax to pursue the rapid development of pandemic influenza vaccine, the partners are planning to initiate multi-centric human trials in India and Europe. An estimated Rs 30 million (US$0.7 million) will be spent on the trials. Human trials will begin by the end of 2006. According to Dr Rahul Singhvi, president and CEO of Novavax, technologies that match and respond to strains is a major challenge to companies working on pandemic flu vaccines. Under the agreement, Bharat Biotech will fund all pre-clinical and clinical developments. They will be responsible for commercialization whereas Novavax will receive unrestricted access to all pre-clinical and clinical data and a royalty on all sales. Novavax is finding the potential to develop a single dose vaccine for pandemic flu.

About Novavax Contact Details: Novavax Inc is a specialty biopharmaceutical company engaged in the research, development and Bharat Biotech commercialization of proprietary products focused on drug delivery and biological technologies. Address: Genome Valley , Turkapally, Shamirpet Mandal, The company’s research is focused on developing Hyderabad, 78 Andhra Pradesh/India its technology platforms in drug delivery: micellar nanoparticle (MNP), Novasomes® and Sterisomes®, to Tel.: +040 2348 0567 enhance the delivery of FDA approved drugs to provide Fax: +040 2348 0560 patients with better clinical outcomes. URL: www.bharatbiotech.com About Bharat Biotech Bharat Biotech International Limited (BBIL/Bharat Biotech), Hyderabad, India, is a multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Contact Details: Bharat Biotech, established in the year 1996 by Dr Krishna M. Ella & Mrs Suchitra K. Ella as the founder directors, Novavax is engaged in developing next-generation vaccines and Address: 508 Lapp Road, biotherapeutics through innovative and collaborative research. Malvern, PA 19355, USA Tel: +484 913 1200 Fax: +484 913 0150 URL: www.novavax.com

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India

Perth-based Proteomics Partners with New Delhi-based TechnoConcept

erth-based Proteomics International has concluded a deal with New Delhi-based Te ch n o C o n c e p t wh e r e by t h e I n d i a n c o m p a ny w i l l b e c o m e t h e e x c l u s ive s u p p l i e r o f PProteomics' cutting-edge protein analysis services.

Proteomics' managing director Dr Richard Lipscombe said that the country's biotechnology i n d u s t r y was b o o m i n g , a n d t h e l o c a l c o m p a ny' s e x p o r t r e ve n u e f r o m I n d i a h a d i n c r e a s e d tenfold in the past year. This was a result that was expected to be improved upon this year.

"We have a great advantage in Perth being in the same practical time zone as India," Lipscombe said. "We can service the needs of India's booming biotech sector with services tailored to the needs of their major research institutes and biotechnology companies. TechnoConcept give us a great presence on the ground and we can both benefit from a solid trading relationship serving the needs of researchers all over India," he continuted.

The deal was brokered through Austrade and the WA Department of Industry and Resource's TradeStart program.

About TechnoConcept India Pte Ltd Contact Det ails: TechnoConcept takes pride in introducing itself as India’s premier technological vendor to the scientific community TechnoConcept India Pte Ltd involved in research in biotechnology for scientific instr uments, fine chemicals and scientific software. Address: 824/3, Sukhdev Nagar, Kotla Mubarakpur, About Proteomics International New Delhi – 110 003 The cornerstone of Proteomics International's strategy is the Tel : +91 11 24636224 use of state of the ar t technology to supply the pharmaceutical Fax: +91 11 24636223 and fine chemicals industr y with selected proteins that have inherent and demonstrable functionality thus providing a Email: [email protected] faster route to market. Proteomics International's capacity to URL: www.technoconcept-india.com analyze all the proteins of any living tissue opens up a spectr um of commercial oppor tunities. At the core are state-of-the-ar t mass spectrometr y and two dimensional gel electrophoresis, enabling the derivation of data that can be analyzed using bioinformatics techniques. Proteomics International seeks to Contact Det ails: explore ne w oppor tunities in proteomics and bioinformatics that will enhance its intellectual proper ty por tfolio. Proteomics International Address: Box 6064 East Perth, Western Australia 6892 Tel: +61 8 9312 3945 Fax: +61 8 9360 2856 URL: www.proteomics.com.au

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Japan

Japan’s Bioventures Today A-Cube Inc.

A-Cube’s Background

-Cube Inc. (A-Cube) was founded in June 2003 in San Francisco by Dr. Hisaaki Kawakatsu and Dr. Nobuyuki Ota. Both the Japanese medical researchers, based in the San Francisco Bay Area, Ahad an idea to design monoclonal antibodies which can detect activated disease causing proteins by using a proprietary computer simulation system. They hoped to use these monoclonal antibodies in research reagents, diagnostics and antibody-based drugs. Thus, they named their company A-Cube which means “Activated Antigen and Antibody”.

“Chopping off cancer cells like a butcher is already outdated. Future cancer treatments should be based on the mechanisms of occurrence,” said Dr. Ota, the co-founder and current CEO of A-Cube, when he was still studying in a high school. Firm in his belief that there is a future for new cancer treatments, Dr. Ota studied biophysics in Yale University, as biophysics was not a popular subject in Japan at that time. After obtaining his Ph.D. in Molecular Biophysics and Biochemistry from Yale University, Dr. Ota became a faculty member of the University of California, San Francisco (UCSF), where he met Dr. Kawakatsu.

C r e a t i n g a n t i b o d i e s a g a i n s t a t a r g e t p r o t e i n i s a n e x t r e m e l y c o s t - i n t e n s ive a n d t i m e - c o n s u m i n g process as it is difficult to know which peptides in a protein are the most antigenic and which peptides will produce the antibodies of interest. While Dr Kawakatsu was seeking an efficient method to create antibodies for antibody drugs, Dr. Ota found certain regularity in epitopes during his study in epitope analysis and protein database. Both of them later discovered an antibody which is able to recognize active and inactive cancer-related protein, Ras. Confident that this discovery will lead to an important product, Dr Kawakatsu and Dr Ota started their company, A-Cube.

A-Cube’s Technology

A-Cube developed two technologies, Linear Epitope Site Prediction (LESP) and a screening system, Conformational-Specific Monoclonal Selection (COSMOS). These technologies are efficient in creating monoclonal antibodies for target antigen, which was difficult to be produced with the existing methods. A-Cube has developed a novel simulation algorithm, LESP, to predict linear epitope sites for proteins using crystal structures. This algorithm is used to design antigen peptides and generate antibodies to distinguish the conformational changes of signaling proteins. LESP is a scoring function that incorporates the chemical properties of the epitope sites and the epitope propensity obtained from A-Cube’s epitope database.

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A-Cube’s Business

Clone 28, a mouse monoclonal antibody (mAb) that specifically recognizes active-forms of Src- family tyrosine kinases (Srcs), a type of cancer genes, was developed by Dr Kawakatsu with tremendous effort. Clone 28 is currently distributed and marketed through a US life science company, Biosource International Inc. Another pharmaceutical giant is currently conducting test evaluation of Clone 28 for use as a clinical trial reagent to select patients for cancer drug administration.

As a new business, A-Cube is using its new technologies to find out where the antibodies should target based on the three-dimensional structure of protein. It also uses its new technologies in deciding how to design the antigens and how to create such antibodies in an efficient way. More specifically, the process flow can be described as follows:

1. Obtain three dimensional structure data of target protein from pharmaceutical companies or research institutes. 2. By using novel LESP system, predict the antigenicity and design antigen peptide with three- dimensional information by comparing with the protein structure. 3. Synthesize peptide. 4. Immunize animals. 5. By using COSMOS screening system, select suitable monoclonal antibody.

A-Cube is planning to outsource processes 3 and 4 above to partner companies in the US.

Fig. 1 Inactive Src kinase structure with an output of epitope prediction.

Currently, A-Cub is developing conformation specific monoclonal antibodies for inactive Src kinase. Together with A-Cube’s antigen data base, amino acid sequences with high antigenicity are selected as antigen peptides for development of inactive specific monoclonal antibody. This antibody is expected to be a very powerful tool not only for understanding the mechanism of Src kinase, but also for evaluating accurately the efficacy of a Src kinase inhibitor as a cancer drug.

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A-Cube’s People

Ph.D. (Co-Founder and current Chief Executive Officer and Chief Scientific Officer) Nobuyuki Ota, After obtaining his Bachelor of Arts degree from Monmouth College in Illinois and his Ph.D. in Molecular Biophysics & Biochemistry from Yale University (Axel Brunger Lab), Dr Ota became a researcher in David Agard Lab, Department of Biochemistry and Biophysics, UCSF. He was actively involved in projects on ligand recognition by proteins, and he investigated the mechanisms of agonism and antagonism for estrogen receptors by multidisciplinary methods. He also developed a novel technique for predicting the binding mode of a flexible ligand in a flexible binding pocket called multi- conformation simulated annealing pseudo-crystallographic refinement (MCSA-PCR), which has been used by Elan Pharmaceutical Inc to design drugs against ß-secretase for Alzheimer’s disease. In addition, he has been developing a novel simulation method, Anisotropic Thermal Diffusion (ATD), to study an intramolecular signaling pathway.

Hisaaki Kawakatsu, Ph.D. (Co-Founder and former Chief Executive Officer) After obtaining his Bachelors of Science from Kyoto University and his Masters of Science and Ph.D. from Osaka University, Dr. Kawakatsu worked as a chief licensing officer in Nippon Shinyaku Pharmaceutical Co Ltd in Japan. A-Cube’s product, Clone 28, was discovered in his last project at Nippon Shinyaku. In October 1996, he started his study in the field of pulmonary diseases including fibrosis and emphysema at Dean Sheppard Lab, Department of Medicine, UCSF. He also served as a secretary in general for a non-profit Japanese biotechnology researcher networking organization, Japanese San Francisco Bay Area Seminar, from 2000 to 2005. In 2003, he won the best score in “Idea to IPO”, a venture competition organized by the UCSF and major venture companies in the US. He passed away on January 29, 2006.

Yoshiaki Yoshikuni, Ph.D. (Chief Financial Officer and Head of the Kyoto Office) After completing his Bachelor of Science and his Ph.D. from Kyoto University, Dr. Yoshikuni was appointed to several director positions in Nippon Shinyaku Pharmaceutical Co Ltd as well as the President of NS Pharma Inc, a U.S. subsidiary of Nippon Shinyaku. In January 2004, he joined Oxygenix Co., Ltd as a head of Kyoto Research Laboratory. He has a established wide network with scientists and business leaders through his activities as a board director in the New York Pharma Forum (1999-2002) and as a committee member in the U.S.-Japan Healthcare Study (1998-2002). His name appeared in Merck Index, which is the most authoritative encyclopedia for chemical substances. He isolated “1- deoxynojirimycin” from mulberry tree and reported its alpha-glucosidase inhibitory activity.

A-Cube’s business is also supported by other significant personnel including Dr. Dusko Ilic, Director, Quality Control; Dr. Takao Sakai, Consultant, Animal Model Development and Pathological Evaluation; Dr. Richard Wagner, Consultant, Business Development; Dr. Ryuichiro Ishitani, Consultant, Program Development; and Dr. Jeremie Roux, Consultant, Website and Assay Development.

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Antibody Drug Market As of July 2005, the number of antibody-based drugs approved by the US Food and Drug Administration (FDA) is 19. 25 other drugs are still under phase III trials. Among these antibody drugs are eight cancer drugs, a drug against epidermal growth factor receptor (EGFR) and a drug against vascular endothelial growth factor (VEGF). The antibody drug market has increased by 37% to US$5.4 billion from 2001 to 2002, and its market in the US is expected to hit US$16.7 billion by 2008. The antibody drug market in Japan is expected to be around 60 billion yen by 2015, a 440% increase from 2004.

A-Cube’s Future In April 2005, together with its partner company, Epitomics Inc, A-Cube has received its first Small Business Innovation Research (SBIR) grant approval from the US National Institute of Health (NIH). A-Cube plans to seek further opportunities for grants and revenues through its projects, namely Srcs, nuclear receptors, small GTPases, and receptor-type tyrosine kinases. With the opening of two branch offices in Tokyo and Kyoto, Japan in October 2005 and another laboratory in Burlingame, USA, in November 2005, A-Cube is ready to start service business as well to meet the high demand for antigen designing.

This article is contributed by JAIC Asia Holdings Pte Ltd as a part of collaboration with World Scientific Publishing Co Pte Ltd.

Contact Details:

A-Cube Inc. Address : 863 Mitten Road, Suite 103, Burlingame, CA 94010-1303, USA Tel : +1-650-703-7781 Fax : +1-415-664-3978 Email : [email protected] URL : www.acube.cc

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Singapore SGS Opens Up New Contract Analytical Laboratory for Quality Control Testing in Singapore

, t h e wor l d ' s l e a d i n g i n s p e c t i o n , ver i f i c a t i o n , t e s t i n g a n d c e r t i f i c a t i o n company, celebrated the opening of its new laboratory in Singapore. The SGSnew laboratory is dedicated to quality control testing of pharmaceuticals, biopharmaceuticals and medical devices. This laboratory expands SGS' Life Science Services business international network of currently 16 pharmaceutical Quality Control (QC) operations in North America, Europe and Asia.

“ The S i n g a p o r e a n Q C l a b o ra t o r y w i l l b e a c o r n e r s t o n e o f o u r g l o b a l s t ra t e g y f o r t h e L i f e S c i e n c e S e r v i c e s ( L S S ) g r o u p ” s a i d H e l g e B a s t i a n , e x e c u t ive v i c e p r e s i d e n t L S S . “ D u r i n g t h e l a s t yea r s , S i n g a p o r e b e c a m e a m a j o r p r o d u c t i o n h u b f o r p h a r m a c e u t i c a l s , biopharmaceuticals and medical devices. Man y of our clients in Europe and North America have established manufacturing capabilities there. As their partner, it was a clear decision to expand our network and set up this state-of-the art laboratory. Additionally, we believe the lab can provide services to the vibrant biotechnology community in Singapore, offering testing capabilities and regulatory knowledge that smaller companies might lack.”

“SGS’s QC labor atory fits in perfectly with our objecti v e of dev eloping a strong base of services providers and vendors that support biomedical manufacturers in Singapore,” s a i d D r B e h S wa n G i n , d i r e c t o r, S i n g a p o r e E c o n o m i c D e ve l o p m e n t B o a r d B i o m e d i c a l Sciences Group. “This will enable companies to focus on their core manufacturing r o l e s a n d l e ve ra g e o n t h i r d - p a r t y e x p e r t s f o r s u p p o r t s e r v i c e s a n d r e l a t e d a c t iv i t i e s .”

The 450 square-meter laboratory will offer high quality testing capabilities in analytical chemistry, microbiological testing, method development and validation, as well as stability studies. The laboratory was designed with the support and training of European and North American experts, using the vast knowledge of the SGS group. Operations are fully compliant w i t h G M P g u i d e l i n e s e n s u r i n g t h e s a m e h i g h q u a l i t y s t a n d a r d s S G S p r ovi d e s a r o u n d t h e world.

About SGS SGS is the world's leading inspection, verification, testing Contact Det ails: and cer tification company. SGS is recognized as the global benchmark for quality and integrity. With 42 000 employees, SGS SA SGS operates a network of about 1 000 offices and laboratories Address: 1 place des Alpes, around the world. P.O. Box 2152, 1211 Geneva 1, Switzerland Tel: +41 22 739 91 11 Fax: +41 22 739 98 86 URL: www.sgs.com

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