Welcome!

News Feed Item

Alchemia Announces Half-Year Results for Period Ended 31 December 2013

BRISBANE, AUSTRALIA -- (Marketwired) -- 02/18/14 -- Alchemia Limited, (ASX: ACL) a drug discovery and development company, is pleased to announce its half year results for the six months ended 31 December 2013.

Highlights for the first half of the financial year include:

  • Total revenue of $5.0 million for the six months ended 31 December 2013
  • $4.7 million in fondaparinux profit share payments for the period
  • Cash receipts of $8.8 million in R&D tax incentives received in period due to R&D spend incurred in the previous financial year
  • Cash balance of $16.4 million as at 31 December 2013.

Generic fondaparinux

For the half year ended 31 December 2013, the Company reports that under the collaboration, development and marketing agreement with Alchemia's commercial partner, Dr Reddy's Laboratories, profits of $4.7 million were payable to Alchemia Limited. This amount is in lieu of sales made by Dr Reddy's Laboratories of Alchemia's fondaparinux in the US and takes into account the payment of $1.1 million to Dr Reddy's Laboratories by Alchemia Limited for agreed activities to improve yields and cost of goods.

Alchemia Oncology
Over the six-month period, Alchemia continued to treat patients in the Company's pivotal Phase III clinical trial of HA-Irinotecan in metastatic colorectal cancer (mCRC). The primary objective of the Phase III study is to demonstrate that HA-Irinotecan is superior to Irinotecan in its effect on Progression Free Survival (PFS). The primary endpoint of this trial will be reached when 350 patients have experienced disease progression or death.

The trial has recruited patients with 2nd or 3rd line metastatic colorectal cancer (mCRC) where patients are randomised to receive either FOLFIRI (a combination of the cancer drugs 5-FU, leucovorin and irinotecan) or FOLF(HA)-Iri in which irinotecan is replaced with Alchemia's proprietary formulation, HA-Irinotecan.

A brief study outline is as follows:

  • 415 second-line metastatic colorectal cancer patients, randomised and double-blinded: neither the patient nor clinician knows which treatment is being administered;
  • Half of patients will receive Alchemia's HA-Irinotecan in combination with 5-fluorouracil and leucovorin (test arm) and half will receive unmodified irinotecan with 5-fluorouracil and leucovorin (control arm);
  • 76 sites in Australia, the UK, Russia, Ukraine, Bulgaria, Poland and Serbia;
  • Primary endpoint of progression-free survival where the statistical assumptions are based on FOLF(HA)-Iri providing a minimum of a six week improvement in PFS compared with the control arm;
  • Primary endpoint assessed after disease progression or death in 350 patients

In addition, Alchemia has initiated an investigator-led Phase II clinical trial of HA-Irinotecan in combination with carboplatin in small cell lung cancer. Currently 27 patients have been enrolled in the study and in October of 2013, interim results were presented at the 15th World Conference of Lung Cancer in Sydney, showing that HA-Irinotecan in combination with carboplatin is safe to administer and that there are early encouraging signs of clinical activity.

Another significant advancement in the clinical development of HA-Irinotecan was achieved in May of 2013 when Alchemia and Merck Serono agreed to collaborate by supporting the initiation of a new investigator-led clinical trial of HA-Irinotecan in combination with Merck Serono's leading therapeutic antibody, Erbitux® (cetuximab), for patients with metastatic colorectal cancer (mCRC). Up to 50 patients who are candidates for second-line treatment of mCRC, will to be enrolled at six to ten sites around Australia with the trial scheduled to run for approximately 24 months. This trial is currently in the organisational stage and recruitment is expected to begin in the first half of calendar year 2014.

Alchemia's oncology programs, including HA-irinotecan, are all based on its proprietary HyACT® technology for targeting cancer therapies to tumours. The HyACT drug delivery platform presents the Company with multiple product opportunities as we believe that HyACT may be able to improve the delivery of a range of chemotherapeutic agents to cancer cells and boost drug efficacy without increasing side effects. The technology has applications ranging from small molecule cytotoxics to much larger biologics, such as monoclonal antibodies. Due to the versatility of this platform, Alchemia is seeking to further deploy this technology to improve the treatment and survival of patients with cancer.

Drug Discovery

Alchemia's VAST technology utilises pyranose as a scaffold to generate novel molecules that are more diverse and complex in shape than the typical compounds used in drug discovery. Using these chemistries the Company has developed an array of compounds it refers to as, "Diversity Scanning Array" (DSA), which represents approximately 14,000 pyranose-based compounds that systematically arrange typical binding groups in a broad range of possible three-dimensional orientations. This array has the ability to identify the shape and functional requirements of molecules that modulate a target.

On the basis of this technology, Alchemia established a multi-target drug discovery collaboration with AstraZeneca AB in April of 2013, where Astra Zeneca will apply the technology across a variety of therapeutic areas including oncology, respiratory, cardiovascular, metabolism, infection and neuroscience. This collaboration will exploit the unique shape diversity provided by DSA and versatility offered by VAST to approach difficult therapeutic targets in innovative ways. Following the signing of the agreement, a copy of the DSA has been transferred to AstraZeneca AB and high throughput screening campaigns are ongoing on several targets.

Alchemia has also put in place strong collaborations with the Institute for Molecular Biosciences (University of Queensland) to discover novel inhibitors of selected ion channels and with the Monash Institute for Pharmaceutical Science to discover novel allosteric modulators of the Family B G-protein coupled receptors. These collaborations aim to discover new treatments for pain, chronic obstructive pulmonary disease and type II diabetes. The collaborations are supported by government grants, which help fund specialised biology teams in the respective institutes, fully focussed on the collaborative drug discovery efforts. These types of collaborations maximise the use of the VAST platform in a highly cost efficient manner.

Financials

The Group reported a net loss of $5.5 million for the six months ended 31 December 2013, an improvement from its $5.9 million loss for the six months ended 31 December 2012.

Total income for the period was $5.0 million, a decrease of $4.4 million from the previous period (2013: $9.4 million), during which the Group received $4.5 million R&D tax incentive income.

Operating expenses of $10.7 million were lower than the corresponding period of $15.5 million). The reduction in Administrative and Corporate Costs of $1.9 million was mainly related to the costs associated with the deferment of the demerger and listing of Audeo Oncology, Inc., which was expensed in December of 2012. The reduction in costs associated with conducting the HA-Irinotecan Phase III trial in patients with mCRC of $3.5 million relates to a significant spend in the six months to 31 December 2012 due to the registrational trial.

Over the course of the reporting period, Alchemia has seen a significant net increase in cash balances, (including cash, cash equivalents and term deposits) from $6.1 million as at 31 December 2012 to $16.4 million as at 31 December 2013. Cash balance in the period was boosted by cash receipts of $5.9 million royalty payments from Dr Reddy's and $8.8 million from R&D tax incentives versus operating expenditure of just $11.2 million.

The group acquired capital items totalling $0.2 million during the period, up from $0.1 million in the prior year period.

About Alchemia Limited - www.alchemia.com.au

Alchemia is a drug discovery and development company marketing FDA approved fondaparinux, an injectible antithrombotic in the US, as well as other major markets via partner Dr. Reddy's Laboratories. The Company is also developing a late stage oncology product pipeline with multiple ongoing trials through its proprietary HyACT drug delivery platform, which targets anti-cancer drugs to solid tumours. Lead asset HA-Irinotecan is in a pivotal Phase III clinical trial for the treatment of metastatic colorectal cancer. HA-Irinotecan is also in two Phase II investigator-led trials, one of which is in collaboration with Merck Serono combining HA-Irinotecan with Erbitux® (cetuximab). Alchemia is also exploring additional small molecule drug discovery targets via an internal discovery platform VAST, based on the Company's deep chemistry expertise. The VAST technology is being developed in collaboration with leading academic institutions and is partnered with AstraZeneca AB.

Erbitux® is a trademark of Merck KGaA.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, will discuss how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technol...
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
New Relic, Inc. has announced a set of new features across the New Relic Software Analytics Cloud that offer IT operations teams increased visibility, and the ability to diagnose and resolve performance problems quickly. The new features further IT operations teams’ ability to leverage data and analytics, as well as drive collaboration and a common, shared understanding between teams. Software teams are under pressure to resolve performance issues quickly and improve availability, as the comple...
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, will draw upon their own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He will also discuss the implementation of microservices in data and applicat...
Join IBM June 8 at 18th Cloud Expo at the Javits Center in New York City, NY, and learn how to innovate like a startup and scale for the enterprise. You need to deliver quality applications faster and cheaper, attract and retain customers with an engaging experience across devices, and seamlessly integrate your enterprise systems. And you can't take 12 months to do it.
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
As you respond to increasing requests for new analytics, you need fast and flexible technology in your arsenal so that you can deploy the right workload to the right platform for the need at hand. Do you need self-service and fast time to value? Do you have data and application control and privacy needs, along with strict SLAs to meet? IBM dashDB™ is data warehouse technology powered by in-memory computing and in-database analytics that are designed for fast results, scalability and more.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...