|By Marketwired .||
|February 18, 2014 06:00 AM EST||
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.
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.
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.
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.
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.
Chief Executive Officer
Tel: +61 7 3340 0200
Alchemia Limited Investor Relations
Tel: +61 4 0959 6164
Investor Relations USA
Blueprint Life Science Group
+1 415 375 3340 Ext. 103
Media enquiries, Australia
Emma Power or Rudi Michelson
+61 3 9620 3333
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
Dec. 11, 2016 07:00 AM EST Reads: 473
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
Dec. 11, 2016 06:45 AM EST Reads: 2,300
President Obama recently announced the launch of a new national awareness campaign to "encourage more Americans to move beyond passwords – adding an extra layer of security like a fingerprint or codes sent to your cellphone." The shift from single passwords to multi-factor authentication couldn’t be timelier or more strategic. This session will focus on why passwords alone are no longer effective, and why the time to act is now. In his session at 19th Cloud Expo, Chris Webber, security strateg...
Dec. 11, 2016 05:45 AM EST Reads: 731
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Dec. 11, 2016 05:30 AM EST Reads: 725
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 05:00 AM EST Reads: 1,179
"We are a leader in the market space called network visibility solutions - it enables monitoring tools and Big Data analysis to access the data and be able to see the performance," explained Shay Morag, VP of Sales and Marketing at Niagara Networks, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 04:45 AM EST Reads: 670
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 11, 2016 04:30 AM EST Reads: 882
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
Dec. 11, 2016 03:30 AM EST Reads: 1,160
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Dec. 11, 2016 03:00 AM EST Reads: 807
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
Dec. 11, 2016 02:45 AM EST Reads: 1,806
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
Dec. 11, 2016 02:45 AM EST Reads: 920
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 02:30 AM EST Reads: 1,313
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
Dec. 11, 2016 02:30 AM EST Reads: 1,070
"We are a custom software development, engineering firm. We specialize in cloud applications from helping customers that have on-premise applications migrating to the cloud, to helping customers design brand new apps in the cloud. And we specialize in mobile apps," explained Peter Di Stefano, Vice President of Marketing at Impiger Technologies, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 01:45 AM EST Reads: 762
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 11, 2016 01:45 AM EST Reads: 4,060