Sydney, Australia, 29 October 2010 – Novotech has announced initiation of three Phase Ib oncology trials at sites in Australia and New Zealand to test the safety, efficacy and pharmacokinetics of client OncoMed’s humanized monoclonal antibody product designed to target cancer stem cells.

Novotech, a leading Australian contract research organization, employing cutting edge technologies in electronic data capture and clinical trial management systems, will manage the trials for OncoMed.

Three separate trials will recruit patients with pancreatic cancer, advanced colorectal cancer, and non-squamous non-small cell lung cancer (NSCLC).

Dr. Steve Benner, Senior Vice President and Chief Medical Officer of OncoMed  Pharmaceuticals, a Redwood City, California based biotechnology company said Novotech was appointed for its local regulatory knowledge and site selection and data management expertise.  “We have been very impressed with our colleagues at Novotech and look forward to collaborating closely with them on these important trials,” said Dr. Benner.

Novotech CEO Alek Safarian said the Novotech team, has initiated the trials and enrollment has begun.

OncoMed Pharmaceuticals is a US-based clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastases. A leader in cancer stem cell research, the company has established a library of antibodies  to cancer stem cell proteins associated with tumors such as pancreatic, breast, colorectal and lung cancers. OncoMed’s lead candidate, OMP-21M18 is currently in Phase Ib clinical trials and has a pipeline of several preclinical product candidates targeting multiple cancer stem cell pathways.

About Novotech

Headquartered in Sydney with a regional hub in Malaysia, Novotech is focused on the Asia Pacific region with operations in nine countries including India and South Korea. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area. As the largest independent CRO based in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Since 2006, Novotech has been recognized as Australia’s leading CRO by Frost & Sullivan in its Asia Pacific Excellence in Healthcare awards. For more information, please visit www.novotech-cro.com.

News Facts

• Novotech, the largest independent clinical research organisation in Australia, has selected Oracle’s Siebel Clinical Trial Management System to support the company’s complete spectrum of clinical drug development and research.
• Novotech works with leading biotechnology and pharmaceutical companies to bring new healthcare products to the global market by offering a broad range of compliant clinical services. The company is headquartered in Australia with operations in India, New Zealand, South Korea and across Southeast Asia. The company has helped global customers conduct trials across a population base of more than 1.5 billion people in the Australasian region alone from first human exposure through to completion of Phase III trials.
• Novotech has been running a bespoke system to manage their clinical trial operations.  Over time, the business has grown and expanded across the Asia Pacific rim. The existing system did not accommodate the evolving business needs of Novotech as it lacked scalability and flexibility.
• In order to support the company’s continued growth and an increasingly complex business, Novotech needed a system that was robust and could grow with their operations.
• Novotech selected Siebel Clinical Trial Management because it met the organisation’s present needs, is a recognised leader and is built on open standards allowing the company to integrate other business applications, such as its financial system.
• Siebel Clinical Trial Management will also serve as a centralised repository for all investigators to collect and track relevant information about research, including personal profiles to disease specialities. Information will be readily available to manage clinical trials at different tiers – local, regional and global.
• Siebel Clinical Trial Management will offer a consistent view of the clinical trials undertaken by Novotech and provide up to date information on clinical trial statuses across the organisation. Furthermore, Siebel Clinical Trial Management will provide a common platform that will assist Novotech to conduct their activities to achieve operational efficiencies.
• In addition to managing the end-to-end trial management process, Siebel Clinical Trial Management will assist to provide timely and accurate reports and dashboards to support tactical and strategic decision making.
• Novotech expects to see improved process efficiencies, better trial quality and lower trial costs from the implementation. Plans are underway to integrate Siebel Clinical with Novotech’s finance system. This will help streamline the business and support real time and accurate reporting, enabling traceability and auditability, and helping reduce the risk of errors due to manually entered information.

Supporting Quotes

• “As we continue to expand, we need a system that can grow with our business operations and support our ability to run successful clinical trials across the globe. Novotech’s investment in this field with industry leading technology systems like Oracle’s Siebel Clinical showcases our efforts to be recognised as a world-class CRO, “said Alek Safarian, CEO Novotech Australia.
• “Oracle’s Siebel Clinical Trial Management System is a proven solution for managing successful clinical trials. We are pleased that Novotech recognises the benefits it provides in supporting the company’s ongoing and future clinical drug development and research,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences.

Supporting Resources

• Siebel Clinical Trial Management System
• Oracle in Life Sciences
• Oracle Health Sciences on Twitter
• Join the Oracle Health Sciences Community on Facebook

About Novotech

Headquartered in Sydney with a regional hub in Malaysia, Novotech is focused on the Asia Pacific region with operations in nine countries including India and South Korea. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area. As the largest independent CRO based in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organisations in the region. Since 2006, Novotech has been recognised as Australia’s leading CRO by Frost & Sullivan in its Asia Pacific Excellence in Healthcare awards. For more information, please visit www.novotech-cro.com.

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Media contact:

Susan Fitzpatrick
DatelineMedia Group
Australian office: +61 2 9006 1614
USA office: +1650 7985238
EMAIL: susan@dmgpr.com

New operations in Malaysia, Singapore, Thailand, and Philippines

Sydney, Oct 27, 2009 – Leading Australian contract clinical research company Novotech announced today that it was expanding into four new Asian markets with the establishment of a management hub in Kuala Lumpur, Malaysia.

Novotech CEO Alek Safarian said the time was right to expand further to accommodate Novotech’s client demands for patient recruitment, and cost effective, high quality clinical research.

Novotech’s newest operations will involve a regional management hub based in Malaysia covering a presence in Singapore, Thailand and Philippines. Novotech already has a joint venture presence in India and an office in Korea.

“A sizable patient population, transparent regulatory environment, time zone compatibility with the Australian headquarters and Government and clinical sector support for research all make the region very attractive,” said Safarian.

Safarian said growth predictions for outsourced clinical trials in Asia are strong and the company expects to generate more than 50% of its revenues from outside Australia in three to five years.

“We are well advanced with planning with this initiative.  Our Malaysian office will be fully operational during the current quarter, with the other countries coming online towards the end of the year,” said Safarian.

Internationally recognized as a leading CRO in the region, Novotech announced in June that it had been awarded a total of 23 new multi-centre phase II and III clinical studies during the height of the global financial crisis, further strengthening the growing importance of the Asia Pacific region for clinical drug development.

These included trials focusing on oncology, ophthalmology, central nervous system, cardiovascular, endocrinology and musculoskeletal diseases.

“The majority of these studies involve US and European-based biotechnology companies, some of whom are repeat clients of Novotech, and will run between now and 2014,” said Safarian.

“There’s an increasing momentum building behind drug developers looking at the Asia-Pacific region for their R&D programs.

“Given Australia’s long history of involvement in global clinical trials, the country is ideally placed to be a gateway for expansion of clinical trial activity in the region as a whole.”

About Novotech
Headquartered in Sydney, Novotech is focused on the Australasian region but has worldwide reach through the company’s network of strategic partners.

As the largest independent CRO in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region.

In the past year, Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, has expanded rapidly into Asia bringing its global reputation for high quality service and regional expertise to this growth area.

Novotech has been recognized as Australia’s leading CRO by Frost & Sullivan for the past two years.

www.novotech-cro.com

Media contact:
Susan Fitzpatrick
DatelineMedia Group
Australian office: +61 2 9006 1614
EMAIL: susan[at]datelinemedia.com

Novotech announced the win at BIO 2008, San Diego.

According to Frost & Sullivan, Novotech has demonstrated it can “manage multiple
projects of almost any size across the globe”.

In the past year, Novotech, described by Frost & Sullivan as the best in its industry class
for Australia based CROs, has expanded rapidly into Asia bringing its global reputation
for high quality service and regional expertise to this growth area.

Alek Safarian, Novotech CEO, said much of the company’s research work was for
leading-edge treatments in oncology and cardiovascular disease.

According to Frost & Sullivan analyst Ms Sohini Mitra, Manager of HealthCare Practice
Asia Pacific: “The company’s significant revenue increase between 2005 and 2007 has
stemmed mainly from their investment in IT capabilities.”

“These investments, along with geographic expansion and enhanced capabilities in the
area of biometrics have enabled the company to manage multiple projects of almost any
size across the globe.”

“Novotech’s focus on enhancing its Clinical Trial Management System (CTMS)
technology, potential acquisitions and geographic expansion, position the company
favourably to exhibit strong growth in the future.”

Safarian said the range of skills and technology infrastructure Novotech has been
investing in for years fits perfectly the service delivery expectations of overseas
sponsors.

“We also have world leaders in health and medical research right here in Australia which
is one of the key reasons sponsors choose Australia for sophisticated clinical research,”
he said.

Following the company’s expansion to the US, Novotech attracted investment from two
leading biotech venture firms BioPacificVentures and Co-Investor Capital Partners. This
investment gives Novotech the capability to execute on its aggressive expansion plans
internationally.

Novotech came out on top against its competitors after being evaluated on key criteria
including excellence in one or more of the following criteria:

• Revenue and market-share growth
• Geographical and service expansion
• Company’s strategy to strengthen position
• Technological innovation and leadership

According to Frost & Sullivan in addition: “The company is perceived to exhibit
outstanding management and consistent growth. The company must offer high quality
products and/or services and have positive social and economic impact on local and
national communities. The company should have proven expertise in taking advantage
of market changes by capturing and solidifying market presence, or through execution of
innovative strategies within the existing competitive landscape.”

About the 2008 Frost & Sullivan Excellence in Healthcare Awards – Australia
Clinical Research Organization Of The Year
The Frost & Sullivan Award for Australian Contract Research Organization of the Year is
presented each year to the company that has demonstrated unparalleled excellence
within its industry, growth and performance across Asia Pacific in 2007. The Award is
based on factors including the company’s business development, revenue growth and
market potential, geographical and service expansion and company’s strategy to
strengthen position within a particular Frost & Sullivan Industry Research Group (IRG).
This company is perceived to exhibit outstanding management and consistent growth.
The company must offer high quality products and/or services and have positive social
and economic impact on local and national communities. The company should have
proven expertise in taking advantage of market changes by capturing and solidifying
market presence, or through execution of innovative strategies within the existing
competitive landscape.

About Novotech
Headquartered in Sydney, Novotech is focused on the Australian and New Zealand
markets but has worldwide reach through the company’s subsidiary in the United
Kingdom and its US and Asian operations.

As the largest independent CRO in Australia, Novotech offers a level of flexibility and
local knowledge that is unmatched among other contract research organizations in the
region. Novotech’s US operations make it uniquely positioned to offer trials across the
two countries, providing the benefits of Australia’s highly regarded cost-effective clinical
trial capabilities, and at the same time take advantage of access to the much larger US
market for rapid patient enrolment – a service that has to date only been available via
large global CROs at higher overhead costs.

www.novotech-cro.com