Alchemia Approaching Several Key Milestones in 2008
Tue Feb 26, 8:22 AM
BRISBANE, Australia--(BUSINESS WIRE)--Alchemia Limited (“the Company”) (ASX: ACL.AX) 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:
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.
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.
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).
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.
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."
