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EUSA Pharma

FDA approves Erwinaze to treat a form of leukemia

By EUSA Pharma, Press Release
Press Release.

 

The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

Acute lymphoblastic leukemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow.

Erwinaze is injected directly into the muscle three times a week and works by breaking down one of the body’s protein building blocks (the amino acid, asparagine) that is present in the blood, and is necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze.

“The approval of Erwinaze underscores the FDA’s commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs using novel trial endpoints”

said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Erwinaze was evaluated in one clinical trial of 58 patients. Additional safety data was collected from the Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in both studies were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions.

In the trial to support efficacy, the main outcome (endpoint) was the measurement of the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival. All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing.

Side effects associated with Erwinaze treatment include serious allergic reactions (anaphylaxis), inflammation of the pancreas (pancreatitis), high blood levels of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar (hyperglycemia).

Prior to Erwinaze’s approval there were two asparagine specific enzyme products – Elspar (asparaginase injection) and Oncaspar (pegaspargase) – approved by FDA to treat patients with ALL. Both of these products are E. coli derived.

Erwinaze has been designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the U.S.

Erwinaze is manufactured by EUSA Pharma Inc. of Langhorne, Pa.

EUSA Pharma Announces FDA Approval Of Orphan Drug ERWINAZE™ For Treatment Of Acute Lymphoblastic Leukemia

By EUSA Pharma, Press Release
Press Release.

 

Langhorne, PA and Oxford, UK – 18 November 2011 – EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE™ (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase. ERWINAZE will be available to patients throughout the United States immediately.

ALL is the most common form of childhood cancer, with approximately 2,900 patients under the age of 20 diagnosed in the USA each year [1]. It is also one of the most curable forms of cancer,with remission rates in treated children of over 95% and 75 – 85% surviving at least five years without recurrence of leukemia [1]. Treatment involves a number of stages and drugs, and typically includes asparaginase as an essential component of current protocols. ERWINAZE isindicated as an integral part of a multi-agent regimen for the treatment of ALL patients who develop hypersensitivity to current products derived from E. coli, and is therefore the first and only approved treatment option available for patients with hypersensitivity to standard-of-care treatment with pegaspargase. An estimated 15 – 20% of ALL patients develop hypersensitivity to E. coliderived asparaginase, representing approximately 450 – 600 children in the United States eachyear [2].

“Treatment with asparaginase is a vital and life-saving therapy for thousands of patients, mostly children, with acute lymphoblastic leukemia each year. Unfortunately, a number of these patients develop hypersensitivity to asparaginases derived from E. coli, including pegaspargase, and are unable to complete the recommended course of treatment. The approval of ERWINAZE is an important advance because it is the only treatment option that can enable these patients to continue and complete their full course of therapy,”

said Stephen E Sallan MD, Chief of Staff,Dana-Farber Cancer Institute and Professor of Pediatrics, Harvard Medical School.

“Today’s approval of ERWINAZE highlights EUSA’s ongoing commitment to the oncology field, and the treatment of patients affected by orphan diseases. We are grateful to our partners at the UK Health Protection Agency, our investigators and employees, and to the Food and Drug Administration for their dedication to this effort and for helping us make ERWINAZE available to the hundreds of patients who can benefit from it each year,”

said Dr Tim Corn, EUSA Pharma’s Chief Medical Officer.

Commenting on the news, Bryan Morton, President and Chief Executive Officer of EUSA Pharma, said, “The approval of ERWINAZE marks a major milestone for EUSA, and represents the culmination of many years of work. Launching ERWINAZE to sit alongside our existing portfolio of specialty products is also a major strategic milestone for the company, as this is the first treatment EUSA has developed internally. This achievement represents a transformation for the company, signaling our transition into a specialty development as well as commercialization organization.”

The ERWINAZE approval is based on the results of clinical studies in 630 ALL patients. In the pivotal efficacy study conducted in 58 subjects, 100% of evaluable patients achieved the asparaginase activity primary endpoint.

EUSA will offer a patient assistance program to help expand access to ERWINAZE for patients who lack health insurance or meet certain other criteria. For further information about ERWINAZE and full prescribing information visit www.erwinaze.com.

About ERWINAZE

ERWINAZE is an asparaginase enzyme that depletes the level of asparagine in the bloodstream.

Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Asparaginase products are derived from bacteria,and approximately 15 – 20% of patients develop hypersensitivity to modern products derived from Escherichia coli, preventing their continued treatment [2]. ERWINAZE, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments. ERWINAZE was originally discovered by the UK Health Protection Agency, and the assays for the US Biologics License Application were conducted by AIBioTech, Richmond, Virginia.

Selected Important Risk Information
Contraindications: History of serious hypersensitivity reactions, including anaphylaxis, to Erwinaze; History of serious pancreatitis, thrombosis or hemorrhagic events with prior Lasparaginase therapy.

Warnings and Precautions: Discontinue Erwinaze if serious hypersensitivity reactions, includinganaphylaxis, or severe or hemorrhagic pancreatitis occur. Warnings include: monitor glucose(intolerance may not be reversible; insulin may be needed for hyperglycemia); thrombosis and hemorrhage: discontinue until resolved. Do not use in lactating women and use in pregnant women only if clearly needed.

Common Adverse Reactions 1%: Serious hypersensitivity including anaphylaxis, pancreatitis, and abnormal transaminases, coagulation abnormalities (thrombosis, hemorrhage), nausea, vomiting, and hyperglycemia.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the US, a pan-European presence and a wider distribution network in numerous additional territories. EUSA currently has a total of 10 specialist hospital products,which are sold in over 80 countries globally*. These include Erwinase®/Erwinaze™ and Kidrolase®for the treatment of acute lymphoblastic leukemia, Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp® G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. The company also has several products in late-stage development.

EUSA Pharma to Acquire US Specialty Oncology Company Cytogen

By EUSA Pharma, Press Release
Press Release.

 

  • Acquisition of US infrastructure completes build of EUSA’s transatlantic commercialization platform

  • $22.6 million acquisition expands EUSA’s product portfolio

  • EUSA raises over $50 million to fund acquisition and other investments

11 March 2008: Doylestown PA, USA and Oxford, UK – EUSA Pharma Inc (‘EUSA’), a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has entered into a definitive agreement to acquire all the outstanding shares of Cytogen Corporation (NASDAQ: CYTO) for $22.6 million. Cytogen is a specialty pharmaceutical company with three oncology and pain control products on the American market, a specialist US sales force and an established commercial infrastructure. To meet the acquisition consideration, and fund further investments, EUSA Pharma has concurrently raised over $50 million in an investment round, led by TVM Capital, an international venture capital firm.

“The acquisition of Cytogen is of great strategic importance for EUSA as it completes the building of our transatlantic commercialization infrastructure, as well as fitting perfectly with our focus on oncology and pain control,” said Bryan Morton, Chief Executive of EUSA Pharma. “Over the last 18 months EUSA has built a strong European organization covering over 20 countries and marketing a portfolio of six specialty pharmaceuticals. Cytogen’s products and US infrastructure are the ideal complement to our business, offering us the opportunity to commercialize a rapidly growing portfolio of medicines on both sides of the Atlantic.”

Commenting on the acquisition, Rolf Stahel, Chairman of EUSA Pharma, said,

“The acquisition of Cytogen marks a step change in the growth of EUSA and completes the foundations of a world-class specialty pharmaceutical company. This transaction will transform our business, putting in place a truly transatlantic growth platform, and positioning the company as the partner of choice for future acquisitions and specialty product in-licensing.”

The acquisition of Cytogen brings to the enlarged EUSA group an established US commercial organization with a 40-strong specialist oncology sales force and three marketed products.

Caphosol® is a supersaturated calcium phosphate rinse indicated for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, and for the treatment of xerostomia.
ProstaScint® is a monoclonal antibody-based agent used to image the extent and spread of prostate cancer.
Quadramet® is a radiopharmaceutical for the treatment of pain in patients whose cancer has spread to the bones.

The enlarged group will have broad sales and marketing capabilities, via direct sales forces in the US and across Europe, and through distribution partners in a number of territories including Canada, South America and Asia. EUSA will have a portfolio of nine marketed medicines and five late-stage development products. The acquisition of Cytogen provides EUSA with the capabilities to commercialize a number of these medicines on both sides of the Atlantic.

In addition, the enlarged group’s transatlantic infrastructure provides the company with a strategic growth platform to exploit additional products through acquisition and in-licensing. With its highly focused business model, EUSA will have the opportunity to compete effectively with major players, making it an attractive partner for companies seeking specialist transatlantic commercial and late-stage development expertise.

Under the terms of the all-cash merger agreement Cytogen shareholders will receive $0.62 per share, representing a 35% premium on the company’s share price at the close of trading on 10 March 2008, and valuing the company at $22.6 million.

The Cytogen Board has approved the cash merger agreement and resolved to recommend that the company’s shareholders adopt the agreement. Completion of the acquisition is conditional on the approval of a majority of Cytogen’s shareholders and fulfillment of certain pre-closing conditions. Upon completion, EUSA intends to apply to delist all Cytogen’s issued shares from the NASDAQ stock exchange.

To meet the consideration for the acquisition, provide working capital to integrate and refocus the Cytogen organization and undertake further investments, EUSA Pharma has raised over $50 million in an investment fundraising. This investment round, which is conditional on the completion of the Cytogen acquisition, is led by TVM Capital and supported by EUSA’s existing investors, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest.

During 2007, Cytogen’s revenues totaled $20.2 million, with the company making a net loss of $25.7 million for the year. At the end of December 2007 the company held cash and cash equivalents totaling $8.9 million. During 2007, Cytogen began a program to refocus its strategy, reduce costs and promote its products more effectively by building on its expertise in the oncology field. EUSA intends to accelerate this initiative and rapidly drive the business to profitability, while retaining the strengths of the Cytogen organization.

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has six products on the market, including the antibiotic surgical implant Collatamp® G, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, and Rapydan®, a rapid-onset anesthetic patch which recently received Europe-wide approval. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant* for local post-surgical pain control.

Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising TVM Capital, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest. Since its foundation, the company has raised over $225 million in addition to the fund raising announced today, and completed several significant transactions, including the acquisitions of Talisker Pharma Ltd, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company has established commercial infrastructure in the US, a pan-European presence covering over 20 countries and a wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing within its specialist areas of medical and geographic focus, in line with its ambitious target to create a rapidly growing $1 billion company by the beginning of the next decade.

*CollaRx® is a registered trademark of Innocoll Technologies Ltd.

EUSA Pharma out-licenses Preclinical-stage Human Antibody to GlaxoSmithKline for up to $44 million plus Royalities

By EUSA Pharma, Press Release
Press Release.

 

Doylestown PA, USA and Oxford, UK – 18 February 2008 – EUSA Pharma Inc (‘EUSA’), a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has out-licensed the exclusive world-wide rights to its preclinical-stage human anti-interleukin-6 antibody to GlaxoSmithKline (GSK) for a consideration of up to $44 million, comprising an upfront fee and development milestones, plus royalties on future sales. As part of the agreement EUSA will pay approximately 50% of the overall consideration to its development partner for the antibody, Vaccinex Inc. GSK will fund and conduct all future development, production and commercialization of the product.

Interleukin-6 is a pro-inflammatory cytokine and B-cell growth factor and acts as a resistance factor to standard chemotherapy. EUSA’s product, OP-R003, is the first fully human anti-interleukin-6 antibody, with target indications in oncology and inflammatory diseases. OP-R003 is derived from a first generation murine antibody, elsilimomab, which has achieved promising clinical results as a lymphoma therapy. As a fully human antibody, OP-R003 has the potential to offer improved tolerability and a superior safety profile.

EUSA acquired OP-R003 as part of the company’s 2007 acquisition of OPi SA. OPi had previously entered a collaboration with Vaccinex, a specialist antibody discovery and development company, to optimize and develop OP-R003 as a therapy for rheumatoid arthritis and lymphoma.

“The out-licensing of this early-stage antibody is another strategic milestone for EUSA, as we continue to focus our business on marketed and late-stage products in the oncology, pain control and critical care areas,”

said Bryan Morton, Chief Executive of EUSA Pharma.

Commenting on the acquisition, Brian McVeigh, GSK’s Worldwide Business Development Director of M&A Strategy and Transactions, said,

“Interleukin-6 is increasingly recognized as an important biological target in a range of diseases, and consequently OP-R003 has great potential to meet a number of unmet medical needs.”

Advent Venture Partners invests in $175m financing round for EUSA Pharma Inc, new transatlantic specialty pharmaceutical company

By EUSA Pharma, Press Release
Press Release.

 

Thursday 1 March 2007 – EUSA Pharma Inc, a new transatlantic specialty pharmaceutical company focused on developing and marketing products for the hospital market both in Europe and the United States, announces the agreed acquisition of OPi SA (“OPi”), an integrated biopharmaceutical company. The acquisition will create a strong platform on which to build a significant transatlantic business. The acquisition is being funded with finance from a syndicate led by Essex Woodlands and 3i including, Goldman Sachs, Advent Venture Partners, NeoMed and NovaQuest.

OPi, which is headquartered in Lyon, France, develops and markets worldwide a range of specialty pharma drugs aimed at treating patients suffering from rare and severe diseases. Its primary focus is onco-haematology, with two drugs approved for the treatment of acute lymphoblastic leukaemia, Erwinase® (crisantaspase) and Kidrolase® (L-asparaginase). OPi is also active in other therapeutic areas, with commercialised hospital products targeting rare and severe diseases, and has a R&D portfolio including monoclonal antibodies at various stages of development.

Reasons for the Acquisition

EUSA Pharma’s strategy is to build a portfolio of products in oncology, pain and critical care, and to create a balanced company in the EU and USA, as reflected in the Company’s name. The acquisition of OPi gives EUSA Pharma an accelerated scale up providing the Company with an established infrastructure in Europe, plus product sales and rights in both the EU and the USA. OPi has four products in the market, a further two products in clinical development and a fully human anti-IL6 mAb in preclinical development. In 2006, OPi achieved sales of $23 million, a growth of 69% on 2005, and was profitable. EUSA Pharma has identified opportunities to add value through optimisation of current activities and an increased focus on commercial activities.

Background on EUSA Pharma

EUSA Pharma was founded in May 2006 by Bryan Morton with $53 million funding from Essex Woodlands. In July 2006, EUSA Pharma acquired a private company, Talisker Pharma. The acquisition included Rapydan™ and two development stage CNS products, one targeted at schizophrenia and one at Alzheimer’s disease. Rapydan™ is a rapid-onset anaesthetic patch which achieved regulatory approval in Sweden in January and is already marketed in the USA by Endo under the brand name Synera™. EUSA Pharma now expects Rapydan™ to be approved across Europe, including in the UK, France and Germany, beginning in the third quarter of 2007. The key differentiator of Rapydan™ is the inclusion in the patch of a heating element which aids the speed of onset and penetration of the anaesthesia. Rapydan™ represents EUSA Pharma’s first entry into the pain market.

The EUSA Pharma Executive Management and Board

EUSA Pharma’s management team has a solid track record of managing operations within global pharmaceutical companies. Bryan Morton, previously of Merck & Co Inc and founder of Zeneus Pharma, is President and Chief Executive. Jim Phillips, founder of Talisker, previously an international executive with Novartis, joined the EUSA Board as EU President in July 2006. Rolf Stahel, previously Chief Executive of Shire Pharmaceuticals, which he led from being a small private company to a FTSE 100 company worth $3.2 billion in nine years, is Chairman of the Group. Goran Ando, previously Chief Executive of Celltech Group, and Bill Crouse, a former J&J Executive and Managing Director of Healthcare Ventures, join the Board as Non-executive Directors. Petri Vainio joined the Board as Non-executive Director in May 2006 representing the founder Investor Essex Woodlands. Gilles Alberici, currently CEO of OPi, Andrew Fraser of 3i and Raj Parekh of Advent Venture Partners will also join the Board of EUSA as Non-executive Directors upon completion of the acquisition.

David Cook, Finance Director, was most recently with Zeneus Pharma as Group Financial Controller and then acting Chief Financial Officer. Dr Tim Corn is the Company’s Chief Medical Officer. Dr Corn was previously with Glaxo, MHRA, Elan and Zeneus Pharma. Zoe Evans, Legal Counsel and Company Secretary, has previous experience with companies in the sector including PowderJect Pharmaceuticals, Chiron Vaccines, Zeneus Pharma and Cephalon.

Bryan Morton, Chief Executive of EUSA Pharma, said:

“We have launched EUSA Pharma with a strong team and a clear strategy to become a significant transatlantic specialty pharma company. This acquisition gives EUSA an accelerated scale up: OPi has an outstanding R&D approach with some unique products in the market and the pipeline, but we will be able to bring a strong focus to commercial operations and plans.

We believe that the combination of EUSA Pharma and OPi is a strong platform for rapid growth. The Company plans to make more acquisitions to add further value in pursuit of our goal of becoming a $1 billion company.”

Gilles Alberici, Founder and Chief Executive of OPi, said:

“The team at OPi has successfully developed a number of attractive products and this is the right time to hand over the reins to a team ideally positioned to drive commercial operations to the next level, while maintaining a targeted R&D focus in specialised therapeutic areas. This is viewed as a significant leap towards the creation of a world class specialty pharma company. The acquisition also offers our investors a suitable exit and just reward for their support over the years. I have every confidence that the combined business has an exciting future.”

Rolf Stahel, Chairman of EUSA Pharma, said:

“The EUSA Pharma management team has worked extremely hard since the company was formed and that work has culminated in today’s acquisition. This marks the turning point in EUSA Pharma’s young and impressive history and gives us a strong base on which to build a fully integrated transatlantic specialty pharma company.”

For further information

EUSA Pharma Inc:

Bryan Morton, Chief Executive
Tel: +44 (0) 1865 338335
Fax: +44 (0) 1865 338105

Dr Jim Phillips, EU President & SVP Corporate Business Development,
Tel: +44 (0) 1483 549083
Fax: +44 (0) 1483 549100

OPi SA:

Gilles Alberici c/o Elizabeth Guichard, Tel: +33 (0) 4 37 49 8597, Fax: +33 (0) 4 37 49 8599, www.orphan-opi.com

Financial Dynamics:
Tel: +44 (0) 207 831 3113,
Fax: +44 (0) 207 242 8695,
Julia Philips, Ben Brewerton, Emma Thompson

Synera™ is a trademark of Zars, Inc

Rapydan™ is a trademark of EUSA Pharma (Europe) Ltd.


Notes to Editors

Business Strategy:

EUSA Pharma Inc is a transatlantic specialty pharmaceutical company focused on developing and marketing innovative products for the worldwide hospital market. The company was formally launched with the acquisition of OPi SA, in March 2007.

EUSA Pharma aims to create a $1 billion company by building a portfolio of products in the fields of oncology, pain and critical care, and to create a balanced company in the EU and USA. It will seek to in-licence, develop and market late-stage compounds.

The Company has an active partnering approach to take advantage of the opportunities presented by its outstanding infrastructure and capabilities. In addition, EUSA Pharma will seek to licence out portfolio products not in its core therapeutic areas such as its early stage CNS products, and to partner or out-licence its fully human anti-IL6 mAb in inflammatory diseases.

Following the acquisition of OPi, EUSA Pharma has four products in the market plus three products in clinical development and three products in preclinical development. EUSA Pharma’s management team has a proven track record of marketing within global pharmaceutical companies and an entrepreneurial edge in the creation of new pharmaceutical businesses.

Board and Management Team: Bryan Morton, President and Chief Executive, has a BSc in Pharmacology from Aberdeen University and an MBA from Durham University. He began his pharmaceutical career in sales and has held positions in medical information, marketing, sales management, business development and general management during a 29 year career in the healthcare industry largely with Merck and Co. Inc. and Bristol Myers Squibb. He has lived and worked in UK, USA, Australia and Belgium and in 2003 founded Zeneus Pharma through the acquisition of Elan’s European sales and marketing business. Backed by Apax, this venture resulted in the sale of Zeneus to Cephalon in late 2005 after two highly successful years of profitable operation. Bryan founded EUSA Pharma in May 2006 backed by Essex Woodlands.

Rolf Stahel, Chairman, worked for 27 years with Wellcome plc in Switzerland, Italy, Thailand, Singapore and the UK. As Regional Director, based in Singapore, he was responsible for 18 Pacific Rim countries. His last position with Wellcome was Director of Group Marketing, based in London and Beckenham, covering Group Strategy, R&D portfolio evaluation, marketing of existing and new products, and business development. Mr Stahel joined Shire Pharmaceuticals in March 1994 as its Chief Executive. At that time the company was privately held and had an estimated value of approximately $30m, revenues of $3m and 50 employees. In his nine years at the company he implemented six mergers and acquisitions transforming Shire into a FTSE 100 company with a market capitalisation of approximately $3.2bn, revenues of $ 1.1bn, and 1800 employees.

Mr Stahel is currently Chairman of Chesyl Pharma Ltd, Newron Pharmaceuticals SpA, and Deputy Chairman of Cosmo Pharmaceuticals SpA. He was also Chairman of PowderMed Ltd. from February 2005 until its sale to Pfizer Inc in November 2006.

Dr. Jim Phillips, President Europe & SVP Corporate Business Development, is a Medical Doctor and holds an MBA. Jim has previously held senior positions at both Johnson & Johnson and Novartis. He has worked in sales, medical & marketing, business development and general management with global board responsibilities. Jim led the buyout of Lifegard Technologies from J&J in 2000 and left Novartis to become interim CEO to Bone Medical Ltd, and led the successful IPO of that company in Australia in 2004.

In 2003 Jim founded and led Talisker Pharma Ltd, a specialty pharma company backed in 2005 by Endeavour Ventures. The Company was acquired by EUSA Pharma in mid-2006.

Dr. Petri Vainio, Non-executive Director, is a Managing Director of Essex Woodlands Health Ventures, one of the world’s largest and most established health care venture capital firms with nearly $2 billion of capital under management. Essex Woodlands invests world-wide in leading private companies in pharmaceuticals, biotechnology, medical technology and health care services. The Managing Directors of Essex Woodlands work closely with their portfolio companies as lead investors to build significant shareholder value over a period of several years.

Previously, Dr. Vainio served over 10 years as General Partner and leader of the health care investment practice at Sierra Ventures, a leading Silicon Valley venture capital firm with over $1 billion of capital under management. During his career, Dr. Vainio has served as a founding investor and board member of over twenty health care companies, most of which have become NASDAQ-listed or have been acquired by publicly-listed corporations. Dr. Vainio has helped these companies raise over $1 billion in venture capital financing and reach an aggregate market value of over $5 billion.

Dr. Gilles Alberici, Non-executive Director, brings 20 years of experience in the European pharmaceutical industry to the Board of EUSA Pharma. Gilles obtained his PharmD (1981) from Paris University and was then resident and researcher in immunology in one of France’s leading academic research hospitals, Institut Gustave-Roussy, where he received his PhD in 1985. He is the author of over 40 publications and 4 issued patents.

Gilles has also served as Development and Manufacturing Director of biological agents in the Mérieux Group. In 1994, he founded and led IMTIX, a Pasteur-Mérieux business unit, bringing Thymoglobulin (rabbit ATG) to more than 50 markets. He was also President of IMTIX-SangStat, the European affiliate of SangStat. In September 1999 Gilles founded OPi SA. From the time of the Company’s inception Gilles served as President and CEO of OPi SA and its subsidiaries.

Dr. Göran Ando, Non-executive Director, is Chairman of Novexel SA and Inion Oy, and Vice Chairman of Novo Nordisk A/S and S*Bio Pte Ltd. He is also a Non-executive Director of Enzon Pharmaceuticals, NicOx S.A., A-Bio Pharma Pte Ltd, Bio*One Capital Pte Ltd and Novo A/S. Dr Ando was previously Chief Executive of Celltech Group from April 2003. He joined Celltech from Pharmacia (Pfizer) where from 1995 he was Executive Vice President and President of R&D with additional responsibilities for manufacturing, IT, business development and M&A.

Prior to this, Dr Ando spent six years at Glaxo Group starting in 1989 as Medical Director, moving to Deputy R & D Director and then R & D Director. He was a member of the Group Executive Committee. Born in Sweden, Dr Ando is a Specialist in General Medicine and is a Founding Fellow of the American College of Rheumatology in the US.

William (Bill) Crouse, Non-executive Director, is Managing Director and a General Partner of HealthCare Ventures, one of the world’s largest venture capital firms specializing in biotechnology. HealthCare Ventures creates, finances, manages and builds high science biopharmaceutical companies. The company has led the strategic development and management of more than 90 companies with a combined market capitalization of greater than $50 billion in important and emerging fields such as genetic therapy, genomic sciences, and organ and cellular transplantation.

Mr. Crouse maintains extensive contacts with major pharmaceutical and biotechnology companies and has assisted HealthCare Venture’s portfolio companies in initiating and negotiating collaborative agreements which have resulted in more than $3 billion of funding to those companies. He has over forty years of experience in the pharmaceutical and diagnostics industry in general management, international operations, strategic planning, licensing, acquisitions, new product development, and sales and marketing. Prior to joining HealthCare Ventures, he was Worldwide President of Ortho Diagnostic Systems and a Vice President of Johnson & Johnson International from 1987 to 1993.

Andrew Fraser, Non-executive Director, is a Partner at 3i, a world leading private equity and venture capital company. 3i’s Venture Capital team invests in scaleable, ambitious technology and healthcare businesses, managing investments across Europe, US, Asia and Israel, valued at over $1.5bn.

Raj Parekh, Non-executive Director, is a General Partner at Advent Ventures which is one of the most experienced technology venture firms in Europe. He has over 20 years of experience in the Biopharmaceutical industry, and has acted as Chairman or Director of several European and US Biotechnology Companies. Established in 1981, Advent invests in both the Life Sciences and Information and Communication Technology. Advent Ventures has $1 billion under management from institutional investors across Europe and the US.

Dr. Tim Corn, Chief Medical Officer, qualified in medicine at King’s College Hospital, London after having gained a Master’s degree in biochemistry. Following training in neuropsychiatry, he became consultant and senior lecturer at the Maudsley Hospital, London and is the author of more than 50 scientific publications. He was elected Fellow of the Faculty of Pharmaceutical Medicine in 1996.

Tim has held senior clinical and regulatory positions at GlaxoWellcome, MSD Research Laboratories, Athena Neuroscience and Elan as well as in the UK regulatory agency. He has played a key role in seven regulatory approvals in Europe. Most recently he was Chief Medical Officer at Zeneus Pharma.

David Cook, Finance Director, graduated with a degree in Chemistry from The University of Oxford in 1990. He qualified as a chartered accountant (Institute of Chartered Accountants of England and Wales) in 1993. David worked for PricewaterhouseCoopers from 1991-2004 in both the UK and Australia in a variety of roles including audit, transaction services and management consultancy.

David joined Zeneus Pharma in 2004 as Group Financial Controller before joining EUSA Pharma in late October 2006 as Finance Director.

Zoe Evans, Legal Counsel & Company Secretary, graduated with a law degree and was called to the Bar by the Middle Temple in October 1999. She is also a fully qualified chartered secretary and an associate member of the Institute of Chartered Secretaries and Administrators.

Zoe began her legal career within the pharmaceutical industry when she joined PowderJect Pharmaceuticals Plc in 2001 as legal counsel and assistant company secretary and has since worked with Chiron, Zeneus Pharma and Cephalon as legal counsel and company secretary before joining EUSA Pharma.