MELBOURNE, AUSTRALIA--(Marketwire - February 20, 2008) -
-- ATL1102 Licensed to Teva Pharmaceutical Industries Ltd.
-- ANP to Complete Current Phase IIa Trial -- Results Due Mid-Year
-- Teva to Fund and Perform All Future Development of ATL1102 Beyond
Current Trial
Antisense Therapeutics Ltd. (
ASX:
ANP) announced on February 11, 2008 that
the Company had entered into an exclusive, world-wide license agreement
with Teva Pharmaceutical Industries Ltd. (Teva), a top 20 global
pharmaceutical company, to develop and commercialize ATL1102, a drug
discovered by Isis Pharmaceuticals Inc. (
NASDAQ:
ISIS) and licensed to ANP.
Under the terms of the agreement, ANP will receive an initial US$2 million
up-front payment. ANP also has the potential to receive payments related to
the continued clinical development of ATL1102 for MS upon certain future
development milestones, with more significant milestone payments for entry
into the market, and sales targets in particular territories. The License
includes potential milestone payments of up to US$100 million for the MS
indication which is contingent upon completion of R&D, successful
commercialization and meeting certain sales milestones, and bears inherent
risks as does all pharmaceutical R&D. Teva would fund and perform all
future development of ATL1102 beyond the current trial, should they decide
to continue beyond that point.
If ANP fails to meet a particular development milestone regarding
completion of the current ongoing, fully enrolled Phase IIa study by the
agreed date in mid 2008, Teva may terminate the agreement and receive a
US$2 million termination fee.
Royalties are payable on net sales of ATL1102 are in the low double digit
range and are tiered according to annual net sales achieved. The agreement
also provides an option for Teva to in-license ATL1102 as an aerosol drug
for asthma.
Under a separate Collaboration and License Agreement between ANP and Isis
Pharmaceuticals Inc., ANP pays Isis one third of sublicense fees and
milestone payments received from Teva, as well as a percentage of any
royalties ANP receives.
ANP's Managing Director Mark Diamond said, "We are delighted to have signed
this significant licensing deal with one of the world's leading
pharmaceutical companies. Clinical stage deals such as this are subject to
very stringent selection criteria and we are particularly pleased that Teva
has recognized the drug's commercial potential. Teva is a company with
tremendous expertise in developing drugs, and is our partner of choice."
ANP will continue to manage and fund the current Phase IIa clinical trial
in relapsing-remitting MS patients, which is on track for completion of
dosing, unblinding of the clinical trial, and reporting of results in mid
2008.
Antisense Therapeutics makes no representations with respect to the outcome
of the Phase IIa trial and, like all other clinical trials in
pharmaceutical R&D, there are inherent risks in terms of clinical outcomes,
efficacy, cost and timeframes. As such, no assurance can be given that
ANP's drug development efforts will translate to successful
commercialization.
Background Information
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of
VLA-4 (Very Late Antigen-4), and is currently in Phase IIa clinical trials
as a treatment for MS. In inflammation, white blood cells (leukocytes) move
out of the bloodstream into the inflamed tissue, for example, the CNS in
MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent
white blood cells from entering sites of inflammation, thereby halting
progression of the disease. VLA-4 is a clinically validated target in the
treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive
effects in a number of animal models of inflammatory disease including MS
(Myers et al. J Neuroimmunol 160, p12-24, 2005).
Multiple sclerosis is a life long chronic disease of the central nervous
system which is believed to affect as many as 2.5 million people worldwide.
Global drug sales for MS exceeded US$5 billion in 2005 and are expected to
grow with the introduction of novel treatment options. There remains a high
demand for more effective and better tolerated treatments.
Antisense Therapeutics Limited (
ASX:
ANP) is an Australian publicly listed
biopharmaceutical drug discovery and development company. Its mission is to
create, develop and commercialize antisense pharmaceuticals for large unmet
markets. ANP has two drugs in development and two drugs in pre-clinical
research. Its lead drug, ATL1102, is in the advanced stages of a Phase IIa
trial as a potential treatment of multiple sclerosis. Website:
www.antisense.com.au
Isis Pharmaceuticals, Inc. (
NASDAQ:
ISIS) is exploiting its expertise in
RNA to discover and develop novel drugs for its product pipeline and for
its partners. The Company has successfully commercialized the world's first
antisense drug and has 18 drugs in development. Isis' drug development
programs are focused on treating cardiovascular and metabolic diseases.
Isis' partners are developing drugs for a wide variety of diseases. Ibis
Biosciences, Inc., Isis' wholly owned subsidiary, is developing and
commercializing the Ibis T5000™ Biosensor System, a revolutionary system
to identify infectious organisms.
Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused
on the discovery, development and commercialization of microRNA
therapeutics. As an innovator in RNA-based drug discovery and development,
Isis is the owner or exclusive licensee of over 1,500 issued patents
worldwide. Additional information about Isis is available at
http://www.isispharm.com.
Contact Information: Contact Information:
US Investors:
Andrea Costa
The Global Consulting Group
(646) 284-9461
acosta@hfgcg.com
Company:
Mark Diamond
Managing Director
+61 3 9827 8999