Alchemia Announces Successful Pre-IND Meeting With the US FDA

Clear and Rapid Path to Market for HAIrinotecan (HyCAMP)*

  • Single pivotal clinical trial required for approval
  • Clear path for clinical development, with primary endpoint agreed
  • IND application to be filed shortly
  • Important milestone offers increased partnering potential

BRISBANE, Australia--()--Australian drug developer, Alchemia Limited (ASX:ACL), today announced agreement on the HA-irinotecan clinical development program, following a pre-investigational new drug (pre-IND) meeting with the United States (US) Food & Drug Administration (FDA).

Chief Executive, Dr Peter Smith, said that the company was delighted with the outcome of the discussions. Alchemia now has a very clear path to market for HA-irinotecan following on from the highly successful Phase II clinical trial completed last year. During our pre-IND meeting with the FDA, the agency agreed on the proposed pivotal trial design and we will file our IND application to begin the trial in the very near future. This is a major milestone for Alchemia.

The proposed study will enroll around 400 patients with metastatic colorectal cancer who have failed previous treatments. Half of the patients will receive Alchemias HA-irinotecan in combination with Erbitux® whilst the control arm will receive unmodified irinotecan plus Erbitux®. The primary endpoint will be progression-free survival (PFS). The study will be double-blinded such that the patient and the clinician will not know which treatment is being administered.

Alchemia plans to seek approval for HA-irinotecan in the US through the 505(b)(2) NDA regulatory route. The 505(b)(2) process is designed to save time and money as compared to a full NDA (new drug application). HA-irinotecan qualifies for the 505(b)(2) route since it is a new formulation of a currently approved drug, irinotecan.

* Alchemia is currently in the process of determining the brand name for HyCAMP due to the potential for confusion with GlaxoSmithKlines anticancer drug Hycamtin®. Until the name is finalized the company will in future refer to the product as HA-irinotecan. The generic name will be hyaluronan-irinotecan solution for infusion.

About Alchemia Limited www.alchemia.com.au

Alchemia is a drug discovery and development Company founded on its chemistry expertise. The Companys lead program is fondaparinux (synthetic heparin, a generic version of GlaxoSmithKlines Arixtra®) which is expected to generate near term revenues for the company in 2009 and was recently partnered with Dr Reddys Laboratories Inc. for the US market. Alchemias 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.

About HA-irinotecan (HyCAMP)

HA-irinotecan is Alchemia's most advanced anticancer product. It is produced with HyACT technology which combines the chemotherapeutic drug irinotecan (Pfizer's Camptosar®) with hyaluronic acid (HA). In May 2007, Alchemia reported results from a Phase II clinical trial. HA-irinotecan not only allowed more cycles of therapy to be administered to cancer patients, but also produced a statistically significant increase in disease control and more than a doubling in progression free survival. Alchemia acknowledges the financial support of NovoZymes Biopolymer A/S for the clinical study.

About Pre-IND Meetings - www.fda.gov/cder/handbook/premtg.htm

Prior to clinical studies, the sponsor needs evidence that the compound is biologically active, and both the sponsor and the FDA need data showing that the drug is reasonably safe for initial administration to humans. Under FDA requirements, the sponsor usually must first submit data showing that the drug is reasonably safe for use in initial, small-scale clinical studies. Pre-clinical meetings are conducted with the appropriate review division that would review the drug marketing application and these meetings are typically requested by the sponsor of a drug. Meetings at such an early stage in the process are useful opportunities for open discussion about testing phases, data requirements, and any scientific issues that may need to be resolved prior to IND submission. At these meetings, the sponsor and FDA discuss and agree upon the design of the animal studies needed to initiate human testing.

ERBITUX® (Cetuximab) is prescribed to colorectal cancer patients whose cancer has metastasised. The drug is administered in combination with Camptosar® (irinotecan) to patients whose cancer has progressed after receiving chemotherapy with Camptosar®. ERBITUX® is also indicated for the treatment of a certain type of head and neck cancer.

Arixtra(R) and Hycamtin(R) are registered trademarks of
GlaxoSmithKline.
VAST(TM), HyCAMP and HyACT(R) are trademarks of Alchemia and Alchemia
Oncology.
ERBITUX(R) is a registered trademark of ImClone Systems Incorporated.

Contacts

Alchemia Limited
Dr Pete Smith, +61 7 33400200
Chief Executive Officer
Mr David Green, +61 7 33400200
Chief Financial Officer
enquiries@alchemia.com.au
www.alchemia.com

Contacts

Alchemia Limited
Dr Pete Smith, +61 7 33400200
Chief Executive Officer
Mr David Green, +61 7 33400200
Chief Financial Officer
enquiries@alchemia.com.au
www.alchemia.com