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Alchemia Limited Provides Company Update


May 22, 2013 - Brisbane, Australia


  • $2.4M fondaparinux profit share recorded for quarter ending 31 March 2013
  • Establishment of a collaboration with Merck Serono SA to support an investigator led Phase II Trial of HA-Irinotecan and Erbitux®
  • Third Independent Data Safety Monitoring Board (DSMB) review concludes Alchemia's HA-Irinotecan pivotal Phase III clinical trial should continue as planned
  • AstraZeneca collaboration well underway, with first project meeting

Australian drug development company Alchemia Limited (ASX: ACL) today anounced the following updates regarding its marketed anticoagulant, fondaparinux; subsidary, Audeo's, HyACT platform; as well as its internal VAST drug discovery platform.

Fondaparinux Profit Share

Alchemia's international marketing partner Dr Reddy's Laboratories Limited (DRL) has reported net sales for the quarter ending 31 March 2013 to be $8.8m, resulting in a profit share of $2.35m due to Alchemia. Alchemia will receive US$1.85M following its contribution of $0.5m to the agreed activities to improve yields and cost of goods (as previously disclosed). The reduced level of profit for the quarter is primarily a result of seasonal buying patterns which have meant that volumes in the first two months of the quarter (January and February 2013) have been significantly lower than prior months. The sales volumes for March showed a return to high levels, however, albeit at slightly weaker prices than the previous quarter.

Alchemia and Merck Serono Collaboration

Alchemia and Merck Serono have agreed to collaborate by supporting the initiation of a new clinical trial of HA-Irinotecan which will be conducted by Peter Gibbs, Associate Professor at the Walter and Eliza Hall Institute of Medical Research.

The collaboration between Alchemia and Merck Serono begins with an investigator-led Phase II clinical trial of Alchemia's HA-Irinotecan in combination with Merck Serono's leading therapeutic antibody, Erbitux® (cetuximab), for patients with metastatic colorectal cancer (mCRC). Initial patient enrolment is expected by Q3 2013. Approximately 45 patients, who are candidates for second-line treatment of mCRC, are to be enrolled at six to ten sites around Australia with the trial scheduled to run for approximately 24 months.

If Alchemia's current HA-Irinotecan Phase III clinical trial (NCT01290783) is successful, and the drug obtains health authority approval for use in irinotecan-containing chemotherapy regimens, there is the possibility that HA-Irinotecan will progressively replace the current form of irinotecan used by oncologists. According to current treatment guidelines 50-60% of mCRC patients should be considered for treatment with chemotherapeutic drugs, such as irinotecan, in combination with the therapeutic antibody, Erbitux. The Phase II study led by Dr. Gibbs is intended to generate data supporting the clinical use of HA-Irinotecan with Erbitux in the treatment of mCRC. Specifically, this study will primarily evaluate the safety of Alchemia's lead HyACT drug, HA-Irinotecan, as part of the FOLFIRI treatment regimen, in combination with Merck Serono's Erbitux.

Associate Professor Gibbs will be the Principal Investigator responsible for conduct of the study, with support from both Alchemia and Merck Serono. "This clinical trial is highly relevant to the current standard practice in the treatment of mCRC patients," said Dr. Gibbs. "By conducting this trial we expect to generate data demonstrating that HA-Irinotecan when administered as part of the FOLFIRI regimen, is safe to use in combination with Erbitux. This will enable oncologists to feel confident in prescribing Alchemia's drug as a safe and potentially more effective alternative to irinotecan in combination chemotherapy regimens."

Alchemia's Chief Scientific Officer, Dr Tracey Brown, commented, "We are excited about this collaboration with Merck Serono and expect to see further clinical evidence of the efficacy and safety of Alchemia's lead anti-cancer product, HA-Irinotecan. Alchemia's clinical development team is pleased that this clinical collaboration provides external validation and recognition of the potential for HA-Irinotecan to replace irinotecan in current mCRC treatment regimens, when used in combination with the antibody, Erbitux."

Third Review of Data by Data Safety and Monitoring Board (DSMB) for HA-Irinotecan Pivotal Phase III Trial

The Data Safety Monitoring Board (DSMB) has met for the third time and provided feedback on the pivotal HA-Irinotecan Phase III trial currently underway. In this third data review, the DSMB again recommended continuation after consideration of all the available clinical data. Data reviewed included the safety data from 408 metastatic colorectal cancer patients who had been randomized and received at least one treatment of HA-Irinotecan or irinotecan, each delivered as part of the FOLFIRI (5-Fluourouracil, leucovorin and irinotecan) regimen.

In 2012, the DSMB initially reviewed the trial after the first 20 patients received at least two cycles of study drug, then again six months later. In both instances the recommendation was to continue the trial as planned. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent and the patient population under study. When reviewing a clinical trial, a DSMB can ultimately recommend continuation, modification or termination of the clinical trial.

"We are happy to report progress on a number of projects across the Company," said Charles Walker, Alchemia's Chief Executive Officer. "Today's announcements are illustrative of our diverse and balanced portfolio. Although quarterly profits for fondaparinux were down sequentially due largely to seasonality, we are encouraged to see volumes for the month of March returning to one of the highest levels we've seen to date. In addition, our new collaboration with Merck Serono for HA-Irinotecan further validates the exceptional value potential of our Hy-ACT platform. We are excited to continue to support growth across our asset classes, and are pleased to report that our Phase III trial of HA-Irinotecan will proceed on track with no concerns over safety based on a third meeting of the DSMB. We look forward to updating the market on progress as we continue to advance across our asset portfolio."

About Alchemia - www.alchemia.com.au

Alchemia is a drug development company with late stage oncology product pipeline (Phase II and III), and an FDA approved drug ("Fondaparinux").

Fondaparinux (a generic version of GlaxoSmithKline's Arixtra®) is an injectable anticoagulant approved in the US for the prevention and treatment of deep vein thrombosis (DVT) after knee or hip surgery. The ANDA for generic fondaparinux was approved by the US FDA in July 2011 and launched in the US by marketing partner Dr Reddy's Laboratories. Alchemia received its first profits from sales of Fondaparinux in August 2012.

In addition, Alchemia has a drug discovery platform technology VAST® which is based on the Company's chemistry expertise. VAST is run on a business model designed to limit use of cash expenditure through the use of partnerships and government grants. Alchemia has projects running with academic institutions, a collaboration with AstraZeneca AB, and evaluation underway with global pharmaceutical partners.

Contact
Alchemia Limited
Charles Walker
Chief Executive Officer
Alchemia Limited
Tel: +61 7 3340 0200

Media enquiries, Australia:
Emma Power or Rudi Michelson
Monsoon Communications
+613 9620 3333
emmap@monsoon.com.au

Investor Relations USA:
Laura Forman
Blueprint Life Science Group
+1 415 375 3340 Ext. 103
lforman@bplifescience.com

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