Alchemia Approaching Several Key Milestones in 2008
26 Fevereiro 2008 - 10:00AM
Business Wire
Alchemia Limited (�the Company�) (ASX:ACL) today announced its half
year results for the six months ended 31 December 2007. Dr Peter
Smith, Alchemia�s Chief Executive Officer and Managing Director,
today set out the significant progress the Company had made over
the reporting period to advance and de-risk the Company�s drug
discovery and delivery platforms, through the completion of a
number of highly important initiatives and milestones. The major
highlights for the period include: 1. � Fondaparinux Program on
Track to Deliver in 2009 � Generic fondaparinux remains on track
for approval around the end of calendar year ("CY") 2008, subject
to review times at the US Food and Drug Administration (FDA). --
Strong growth in Arixtra(R) sales up 87% to US$200 million, from
US$107 million in CY 2006. Once the FDA issue their final letter of
approval for the ACS indication (an approvable letter for ACS
(acute coronary syndromes) was issued early in 2007) this is likely
to have a positive impact on US sales of Arixtra. -- Alchemia
remains confident that its fondaparinux will be the sole generic
version of Arixtra. -- As the only synthetic molecule in the
heparin market, generic fondaparinux will not meet the same
regulatory hurdles that have delayed other generic heparins of
animal origin at the FDA. � 2. HyACT Technology Closer to Market �
In early 2008 the Company announced the results of its successful
pre-IND meeting with the FDA for the design of the pivotal Phase
III study for HA-irinotecan. This important milestone significantly
de-risks the program and increases the potential opportunities for
partnering and financing. The Company expects to file an IND
(Investigational New Drug Application) to commence pivotal clinical
trials of HA-irinotecan later this financial year. � 3. Other
Highlights � In addition Dr Smith noted the following key
achievements: -- Development of the VAST(TM) 'Universal Library'
(UL) remains on track for completion in 2009. The UL will comprise
in excess of 10,000 drug-like VAST(TM) molecules and is designed to
target the therapeutically rich area of G-protein coupled
receptors, GPCRs. -- The Company has undertaken successful screens
against several targets for two international drug development
companies using the Company's VAST(TM) compounds, with great
success and is currently developing focussed libraries for those
companies. -- Receipt of a key HyACT(R) patent granted in Europe
which underpins the HyACT(R) technology and the HA-irinotecan
product. Dr Smith was also delighted with the depth and calibre of
the industry experts attracted to the Company's Clinical Advisory
Board (CAB) and Scientific Advisory Board (SAB). The CAB comprises
experts with research and clinical experience in the field of
oncology, and advises on the clinical development of HyACT(R)
products. The SAB advises on disease targets for Alchemia's drug
discovery technology VAST(TM). � 4. Finances � For the six months
to 31 December 2007 Alchemia incurred a net loss after tax of $5.1
million (2006: $6.9 million). � Total revenue for the period was
$1.2 million, down from the previous period (2006: $2 million).
This decrease is due to the receipt of lower grant revenue and
other income. Grant revenue was down due to lower income received
from a Federal Government Commercial Ready Grant for the ACL16907
anticancer program. � Operating expenditure of $6.5 million was
lower than the corresponding period (2006: $9.1 million),
principally because of the reduction in R&D expenditure for the
period to $1.3 million compared with the previous period (2006:
$3.9 million). This is mainly due to the assumption of fondaparinux
manufacturing costs by Dr Reddys. � In July the Company
successfully completed a private placement of 19 million shares
which raised $14.7 million (net). US institutional interest in this
raise was strong and resulted in over 12 million of the shares
being placed into that market. The capital raising has
significantly strengthened Alchemia's balance sheet, with cash at
December 31 of $20.3 million. This should provide sufficient
funding to see the company through to receipt of fondaparinux
revenues in 2009. � 5. The 2008 Outlook � Commenting on the outlook
for the remainder of the financial year Dr Smith noted that the
company has a number of significant milestones ahead. "We will
continue to report on our progress with our oncology platform,
including preparations for Phase III clinical trials for
HA-irinotecan, partnering and development of other HyACT(R) based
products. For commercial reasons we are unable to give precise
guidance on the ANDA filing date for generic fondaparinux but
expect this event to substantially increase interest in the stock."
About Alchemia Limited � www.alchemia.com.au Alchemia is a drug
discovery and development Company founded on its chemistry
expertise. The Company�s lead program is fondaparinux (synthetic
heparin, a generic version of GlaxoSmithKline�s Arixtra�) which
will generate near term revenues and was recently partnered with Dr
Reddy�s Laboratories Inc. for the US market. Alchemia�s pipeline of
assets is built on two platform technologies: HyACT� (targeted
cancer delivery) and VASTTM (drug discovery). HA-irinotecan, for
the treatment of colorectal cancer, recently achieved positive
Phase II clinical trial results. Arixtra� is a registered trademark
of GlaxoSmithKline. VASTTM and HyACT� are trademarks of Alchemia
and Alchemia Oncology.
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