17th Jan 2005 16:30
HIV compound SPD754 out-licensed to anti-infectives specialist, Avexa Ltd Basingstoke, UK and Philadelphia, PA, US - 17 January 2005 - ShirePharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced todaythat it has out-licensed its HIV compound, SPD754, to Avexa Limited, apublicly-listed Australian specialty anti-infectives company.This is one of the final steps in Shire's divestment program - designed toensure focus on later stage pipeline investment in its core therapeutic areasof CNS, gastrointestinal and renal diseases. In the last 12 months, Shire hashad six projects in its core areas approved by regulators.Avexa will take on full responsibility for the worldwide development of SPD754in accordance with an agreed development plan. SPD754 is currently in Phase IIwith an anticipated launch target of 2009. Avexa has the right to commercializeSPD754 throughout the world, excluding North America (USA and Canada), whereShire retains the right to commercialize the product. An undisclosed reciprocalroyalty will be payable. Included in the deal and subject to subsequentsatisfaction of certain conditions , Shire will take a AUD$2 million equityposition in Avexa, subject to Avexa shareholder approval, and will also have anoption to acquire four million more shares following the successful completionof the Phase IIb trial.Says Matthew Emmens, Chief Executive of Shire:"Our strategic restructuring and divestment has progressed to plan, and theout-licensing of SPD754 to Avexa is another important step in this process andprovides us with greater R&D focus on our core markets. Avexa is an idealpartner for the product, having the skills and expertise to take this programforward and see it through to registration and approval in a timely manner. Atthe same time, we are able to retain a stake in the future value of theproduct. "Says Avexa Chief Executive Officer, Dr Julian Chick:"This is a great opportunity for Avexa. It recognises Avexa's particularexpertise and depth of experience of its management and scientific team in thecommercial development of drugs for HIV. We are competitive with the world'sbest in our understanding of this field. Our objective is to take the drug intoPhase III and for SPD754 to reach the market by 2009."For further information please contact:Investor Relations Clĩa Rosenfeld (UK and Europe) +44 1256 894 160 Brian Piper (US and Canada) +1 484 595 8252 Media Jessica Mann (UK and Europe) +44 1256 894 280 Matthew Cabrey (US) +1 484 595 8248 Notes to editorsFurther information on SPD754 and Avexa's intentionsSPD754 is a nucleoside analogue and part of a class of drugs known as NRTi.NRTis represent the major class of HIV therapeutics and the drugs of firstchoice in the treatment of HIV. Currently reverse transcriptase inhibitorsrepresent over 50% of the global sales of HIV drugs which in 2004 was in excessof US$6 billion.SPD754 has been shown to selectively inhibit the HIV replication enzyme reversetranscriptase and has successfully completed a Phase IIa trial. ImportantlySPD754 is under Investigational New Drug (IND) status and has receivedfast-track approval from the FDA in the USA helping to speed development. Avexais preparing SPD754 to enter a Phase IIb trial designed to demonstrate itsefficacy in HIV-infected patients that have demonstrated resistance to therapywith 3TC (Lamivudine), a first line HIV therapy. The Phase IIb trial willexamine two different doses of SPD754 and compare the drug to 3TC. This trialwill be conducted in Australia, with the first patient expected to be enrolledby the middle of this year and results due in the first quarter of 2006.Shire has previously conducted a Phase IIa trial with SPD754 in 63 HIV-infectedpatients who had not had prior exposure to HIV drugs. In this trial, SPD754showed a statistically significant, greater than 1.4 log decrease in viralload. A decrease in viral load is one of the primary measures used to benchmarkthe effectiveness of HIV drugs and a 1.4 log decrease is similar or greaterthan that achieved by other NRTis currently being sold on the marketdemonstrating the potential of SPD754 in the treatment of HIV.A successful outcome to this trial will assist Avexa in positioning SPD754 as asecond line NRTi therapy in the treatment of HIV, meaning that patients thatare no longer experiencing direct clinical benefit from 3TC therapy can beswitched to SPD754 as an ongoing HIV treatment alternative. Avexa believes thatthere is a need for new drugs that will treat the resistant virus selectedduring 3TC therapy.3TC as either a stand-alone or combination drug generates close to US$1 billionin global sales annually. Other NRTi drugs on the market in this class includeFTC (emtricitabine), Tenofovir and the combination (emtricitabine andTenofovir) Truvada.Shire Pharmaceuticals Group plcShire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceuticalcompany with a strategic focus on meeting the needs of the specialist physicianand currently focuses on developing projects and marketing products in theareas of central nervous system (CNS), gastrointestinal (GI), and renaldiseases. Shire has operations in the world's key pharmaceutical markets (US,Canada, UK, France, Italy, Spain and Germany) as well as a specialist drugdelivery unit in the US.For further information on Shire, please visit the Company's website: www.shire.comAbout AvexaAvexa Limited is a Melbourne-based biotechnology company with a focus onresearch and development of anti-infectives. The company is developing drugsfor the treatment of infectious diseases which have a significant unmet medicalneed. Avexa has dedicated resources and funding for its three key projects:antiviral drugs for HIV/AIDS and hepatitis, and an antibiotic alternative forantibiotic-resistant bacterial infections.For further information on Avexa, please visit the Company's website: www.avexa.com.auTHE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACTOF 1995Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, Shire's results could be materially affected. Therisks and uncertainties include, but are not limited to, risks associated withthe inherent uncertainty of pharmaceutical research, product development,manufacturing and commercialization, the impact of competitive products,including, but not limited to, the impact of those on Shire's Attention Deficit& Hyperactivity Disorder (ADHD) franchise, patents, including but not limitedto, legal challenges relating to Shire's ADHD franchise, government regulationand approval, including but not limited to the expected product approval datesof METHYPATCH⨠(methylphenidate), Shire's ability to secure new products fordevelopment, including, but not limited to, the execution of a bindingagreement with New River Pharmaceuticals Inc, the implementation of the currentreorganization and other risks and uncertainties detailed from time to time inShire's filings, including its Annual Report on Form 10-K for the year endedDecember 31, 2003, with the Securities and Exchange Commission.ENDRelated Shares:
Shire