looks promising......

ASX/Media Announcement
Avexa in-licenses Phase II HIV drug from Shire and prepares
Phase IIb trial
18 January 2005
Research and development biotechnology company Avexa Limited (ASX: AVX) today
announced that it has in-licensed the Phase II HIV drug – SPD754 – from global
specialty pharmaceutical company Shire Pharmaceuticals Group plc (LSE: SHP,
NASDAQ: SHPGY, TSX: SHQ).
SPD754, a nucleoside reverse transcriptase inhibitor (NRTi), has already successfully
completed a Phase IIa trial in 63 HIV-infected patients. Avexa is on schedule to initiate
the Phase IIb trial, with results expected in the first quarter 2006. Avexa research
indicates that there is a need for new drugs that will treat the resistant virus emerging
during 3TC therapy (a first line anti-HIV treatment) and SPD754 will be developed to
target this market. SPD754 is expected to be on the market by 2009, potentially
providing Avexa with significant revenues.
“Avexa has in-licensed this later stage product because of its potential to generate
significant revenues and to reduce the overall risk involved in drug development for our
shareholders,” said Avexa Chief Executive Officer, Dr Julian Chick. “This is a great
opportunity for Avexa. It recognises Avexa’s particular expertise and depth of
experience of its management and scientific team in the commercial development of
drugs for HIV. We are competitive with the world’s best in our understanding of this
field.”
“The rates of success for late stage HIV projects are very high. According to a US
Bureau of Economics 2003 paper, all 29 HIV drugs that entered Phase III between
1989 and 2002 made it to market. On the assumption that SPD754 is successful in the
Phase IIb study; our objective is to take the drug into Phase III and for SPD754 to reach
the market by 2009.”
Says Matthew Emmens, Chief Executive of Shire:
“Avexa is an ideal partner for the product, having the skills and expertise to take this
program forward and see it through to registration and approval in a timely manner.”
The in-licensing of SPD754 will not affect the progress of existing Avexa programs. In
fact, the strengthening of Avexa’s internal clinical capabilities will complement the
clinical phases of these programs, in particular Avexa’s HIV integrase inhibitor program.
Assuming SPD754 reaches the market in the time frame outlined, the revenue
generated will enable Avexa to retain more value from its existing programs, and allow
Avexa to build a portfolio of products.
SPD754 is under Investigational New Drug status and has received fast-track approval
from the US Food and Drug Administration.
The Clinical Trial
SPD754 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 first choice in the
treatment of HIV. Currently reverse transcriptase inhibitors represent over 50% of the
global sales of HIV drugs which in 2004 was in excess of US$6 billion.
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SPD754 has been shown to selectively inhibit the HIV replication enzyme reverse
transcriptase and has successfully completed a Phase IIa trial. Importantly SPD754 is
under Investigational New Drug (IND) status and has received fast-track approval from
the FDA in the USA helping to speed development. Avexa is preparing SPD754 to
enter a Phase IIb trial designed to demonstrate its efficacy in HIV-infected patients that
have demonstrated resistance to therapy with 3TC (Lamivudine), a first line HIV
therapy. The Phase IIb trial will examine two different doses of SPD754 and compare
the drug to 3TC. This trial will be conducted in Australia, with the first patient expected
to be enrolled by 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-infected
patients who had not had prior exposure to HIV drugs. In this trial, SPD754 showed a
statistically significant, greater than 1.4 log10 (25 fold) decrease in viral load. A decrease
in viral load is one of the primary measures used to benchmark the effectiveness of HIV
drugs and a 1.4 log decrease is similar or greater than that achieved by other NRTis
currently being sold on the market demonstrating the potential of SPD754 in the
treatment of HIV.
Avexa intends to differentiate SPD754 from other marketed NTRis in the marketplace
by conducting a Phase IIb trial which is focused on demonstrating the effectiveness of
SPD754 in patients that have shown resistance to therapy with 3TC. 3TC as either a
stand-alone or combination drug generates close to US$1 billion in global sales
annually. Other NRTi drugs on the market in this class include FTC (emtricitabine),
Tenofovir and the combination (emtricitabine and Tenofovir) Truvada.
A successful outcome to this trial will assist Avexa in positioning SPD754 as a second
line NRTi therapy in the treatment of HIV, meaning that patients that are no longer
experiencing direct clinical benefit from 3TC therapy can be switched to SPD754 as an
ongoing HIV treatment alternative. Avexa believes that there is a need for new drugs
that will treat the resistant virus selected during 3TC therapy.
Terms of the Agreement
By in-licensing SPD754 Avexa takes on full responsibility for the worldwide
development of the drug in accordance with an agreed development plan. Included in
the deal, subject to shareholder approval, and the subsequent satisfaction of certain
conditions, Shire will take a AUD$2 million equity position in Avexa and will also have
an option to acquire 4 million more shares following the successful completion of the
Phase IIb trial. Avexa has the right to market SPD754 throughout the world, excluding
North America where Shire retains the right to market the product. An undisclosed
reciprocal royalty will be payable. Avexa is not obliged to make any milestone
payments to Shire as SPD754 progresses towards the market. The development and
commercialisation of SPD754 will be overseen by a Development Committee with joint
representation from Avexa and Shire.
Avexa has retained Wilson HTM Corporate Finance to assist in raising the capital
required for the Phase IIb development of SPD754 which will likely provide an
opportunity for new and existing shareholders to invest in the company and this later
stage project.
For more information:
Dr Julian Chick Jane Cotter Lisa Springer
Chief Executive Officer Oxygen Financial PR Wilson HTM
Avexa Limited +61 438 775 997 +61 2 8247 6624
+61 3 9208 4300
www.avexa.com.au
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About Avexa
Avexa Limited is an ASX listed, Melbourne-based biotechnology company with a focus
on research and development of anti-infectives. The company is developing drugs for
the treatment of infectious diseases which have a significant unmet medical need.
Avexa has dedicated resources and funding for its three key projects: antiviral drugs for
HIV/AIDS and hepatitis, and an antibiotic alternative for antibiotic-resistant bacterial
infections. Avexa has followed the ASX Code of Best Practice for Biotechnology
Companies in preparing this announcement.
About Shire Pharmaceuticals
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company
with a strategic focus on meeting the needs of the specialist physician and currently
focuses on developing projects and marketing products in the areas of central nervous
system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the
world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and
Germany) as well as a specialist drug delivery unit in the US. For more information on
Shire, please visit www.shire.com