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Eirx Therapeutics (LSE:ERX) Focus Of The Month

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Overview

Eirx Therapeutics is a Cork-based drug discovery company, focusing on the identification and commercialisation of genomic targets associated with the biological process of programmed cell death (apoptosis). The company has chosen to concentrate on three key therapeutic areas, cancer, chronic inflammatory diseases and neurodegenerative disorders, all of which offer billion dollar market opportunities.

The company was founded in 1999 as a spin-out from Cork University and to date has raised circa 9 million to expand its research and development programs, such that it now employs 12 individuals and has a strong patent portfolio. The most recent funding was a 1.25 million placing, executed in conjunction with an introduction to AIM (Alternative Investment Market) in January 2004. This is the second Irish biotech company to list on AIM, the first being Dublin-based Alltracel, increasing Irelands profile as a centre of biotechnology excellence.

Eirx Therapeutics has currently signed three collaborative agreements and is in negotiations with several other biopharmaceutical companies. In addition, the company has already intimated that it intends to expand the company through a series of strategic acquisitions.



Apoptosis


The term apoptosis was first used in a paper by Kerr, Wyllie, and Currie (Brit J. Cancer 26:239) in 1972 to distinguish a morphologically distinctive form of cell death associated with normal physiology from necrosis, which was associated with acute injury to cells. Apoptosis is characterized by nuclear chromatin condensation, cytoplasmic shrinking, dilated endoplasmic reticulum, and membrane blebbing. Apoptotic death can be triggered by various stimuli, however, not all cells will necessarily die in response to the same stimulus.

Apoptosis is as essential to an organism as cell division. In human development, the selective destruction of cells through apoptosis is responsible for the formation of fingers and toes in a forming foetus and the establishment of neural pathways within the brain. Apoptosis is also necessary for killing cells that would otherwise cause damage to the organism, for example cells infected with viruses.

If the process of apoptosis is in some way defective and these cells are left unchecked, a variety of disorders may ensue. The inability to destroy certain immune cells may lead to autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and insulin dependent diabetes. Cells with DNA damage may become cancerous, or in the case of reproductive cells cause birth defects. Conversely, neurodegenerative disorders, such as Alzheimer's, Parkinson's and Huntington's diseases and stroke are associated with neuronal cell death caused by apoptosis.

Thus, the genes/proteins involved in the various apoptosis pathways are of increasing interest to the pharmaceutical industry as therapeutic targets, either through the use of inducers to initiate apoptosis or inhibitors to prevent apoptosis.


Technology


The structure and function of cells and ultimately of an organism, is dependent on a set of proteins. The protein complement encoded by the entire genome of an organism is referred to as the proteome. Proteins can be classified into various groups including, enzyme which catalyse reactions, antibodies, which are involved in the immune system, and signaling proteins which form complex pathways that mediate intracellular events such as apoptosis. Any mutations, either hereditary or spontaneous, in the genome can lead to the production of defective proteins and/or the incorrect regulation of gene expression, resulting in too much or too little of a protein being produced. Failure to produce the correct level of protein, at the right time and in the right place can have disastrous consequences and have been shown to be the underlying cause of numerous diseases.

Genomic studies have identified a plethora of genes directly and indirectly associated with both cell survival and apoptosis. However, many of these genes are incorrectly implicated in these processes, i.e."guilty by association". In order to eliminate genes associated but not causal to apoptosis, Eirx Therapeutics has developed a proprietary drug target discovery platform - ALIBI, which consists of a series of overlapping assays. By analysing temporal expression (i.e. when a gene is active compared with other apoptosis genes) and looking at the pathways associated with the gene products, Eirx Therapeutics is able to optimise the selection of target candidates. ALIBI is already being used as part of Eirx Therapeutics' research program, but is now being offered to third parties on a fee-for-service basis.



Research Pipeline


It is estimated that 70% of human diseases can be associated with defects in the apoptosis pathways. However, Eirx Therapeutics has chosen to initially focus on cancer, chronic inflammatory diseases and neurodegenerative disorders, as all of these markets offer significant commercial opportunities. Eirx Therapeutics looks to identify both the genes involved in the apoptosis pathway and the genes associated with their expression. The characterisation of these genes may ultimately lead to the diagnosis and treatment/prevention of certain diseases. Of the 15 patent applications filed, 7 are for specific genes associated with cancer or inflammation:





Market Opportunity


As detailed, Eirx Therapeutics main foci are cancer, inflammatory diseases and neurogenerative disorders.

Cancer: The many forms of this disease share a common element, in as much that malignant cells fail to undergo apoptosis, resulting in uncontrolled cell proliferation. The global market for branded cancer drugs was estimated to exceed $14 billion in 2000. This figure is expected to more than double by the end of this decade.

Inflammation: Caspase-1 plays a key role in the generation of two important pro-inflammatory cytokines (IL-1b and IL-18). These cytokines have been shown to be associated with a number of chronic diseases, such as asthma, rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and chronic obstructive pulmonary disease (COPD). In 2000 the global sales of asthma drugs was estimated to be between $7-10 billion, RA - $1.6 billion, IBD - $1 billion, with the treatment of COPD estimated to cost nearly $3 billion per annum.

Neurodegeneration: Conditions associated with premature cell death within the brain include Alzheimers and Parkinsons diseases. Global sales in 2000 for Alzheimers medication were estimated at just over $500 million. As the average age of mortality increases, due to better medication and standards of living, there is likely to be a dramatic increase in this market.

Although by targeting such large therapeutic markets, Eirx Therapeutics is maximising it commercial opportunities, it is still an early-stage company, which will out-license drug development pre-Phase I. Therefore, it would be meaningless to attempt to derive any valuation from the sales figures given above. When making its investment in Eirx Therapeutics, Billam Ag has taken a more realistic approach by evaluating the short to medium term potential of the research pipeline.



Business Model


The main source of revenue for Eirx Therapeutics will be milestone payments associated with out-licensed/partnered compounds. However, to reduce cash burn, Eirx Therapeutics will carry out contract research for third parties.





Commercial Partners


Eirx Therapeutic is currently working with three bio-pharmaceutical companies:


Regen Therapeutics (LSE:RGT) Service contract

SR Pharma (LSE:SPA) Research agreement-click for link to news story

OSI Pharmaceuticals (NASDAQ:OSIP) Currently evaluating several novel oncology targets with the option to license for drug discovery.
To date, the OSI Pharmaceutical deal represents the most exciting opportunity for Eirx Therapeutics, generating upfront access fees, consultancy fees and milestone payments totally up to $4.7 million per target based on successful commercialisation of a novel therapeutic. However, the company is in discussions with several other potential collaborators.

Pharmaceutical companies are increasingly interested in therapeutic agents that directly and selectively target the apoptosis process in humans cells. The table below gives examples of potential drugs undergoing clinical trials at present. The companies detailed can be viewed as competitors. However, given that Eirx Therapeutics are a target discovery company looking to out-license clinical development and the strength of their intellectual property portfolio, we are more inclined to view these companies as potential partners. Therefore, the level of interest in this field is encouraging.



Financial Statements


A summary of the key financial statements for the last 3 years are shown in the tables below:



Major Shareholders


Eirx Pharma is a life science investment company, which adopts a synergistic strategy in order to optimise its portfolio and drive shareholder value. Eirx Therapeutics is represent on the board of Eirx Pharma by and John Pool (Chairman of Eirx Therapeutics) and Peter Hoskins (CEO Eirx Pharma and advisor to Eirx Therapeutics). Shareholders of Eirx Pharma include institutions such as 3i Group, Enterprise Ireland and the University of Cork, as well as several investment companies and private individuals (see pie chart below):

http://www.billamag.net/focus-document-text.asp?FocusTextID=1

http://www.billamag.net/focus-document-text.asp?FocusTextID=1

Infinity Pharmaceuticals Announces Completion of Merger with Discovery Partners International
Wednesday September 13, 8:23 am ET
Conference Call Scheduled for 8:30 a.m. EDT (5:30 a.m. PDT) Thursday, September 14, 2006


CAMBRIDGE, Mass., Sept. 13 /PRNewswire-FirstCall/ -- Infinity Pharmaceuticals, Inc. (Nasdaq: INFI - News) announced today the completion of its previously announced merger with Discovery Partners International, Inc., or DPI. The newly-combined company will operate as Infinity Pharmaceuticals, Inc. under Infinity's management and will retain no Discovery Partners operations or programs. Infinity begins trading today on the NASDAQ Global Market under the symbol "INFI." The company will be hosting an investor conference call providing a business overview of the combined company and a discussion of its lead oncology programs on Thursday, September 14, 2006 at 8:30 a.m. EDT (5:30 a.m. PDT).
ADVERTISEMENT


"This merger with Discovery Partners gives Infinity the resources necessary to fully explore and expand the potential of our pipeline," said Steven H. Holtzman, chief executive officer of Infinity. "Infinity has the opportunity to create significant value for both patients and stockholders in the coming years."

"Through DPI's merger with Infinity, former DPI stockholders are benefiting from the value-creation potential of a company dedicated to becoming a leader in oncology drug discovery and development," added Michael C. Venuti, Ph.D., former acting chief executive officer of DPI who will continue as a director of the combined company. "With the financial resources provided in this transaction, we expect that Infinity will be well positioned to drive forward its pipeline of anti-cancer agents, creating both meaningful therapies for patients and substantial value for stockholders."

With the completion of the merger and Infinity's recently-announced collaboration with MedImmune, Inc., Infinity expects to have funds sufficient to support its current operating plan at least through December 31, 2009, in the absence of any new corporate development opportunities or financings.


Infinity's products in development include:
* IPI-504 (Hsp90 inhibitor) -- Infinity's lead novel, proprietary
anti-cancer product candidate has demonstrated in preclinical studies
the ability to potently and selectively inhibit Heat Shock Protein 90
(Hsp90), thereby killing cancer cells. In preclinical studies, IPI-504
has demonstrated broad potential to treat a variety of cancers as both a
single agent as well as in combination with existing anti-cancer drugs.
IPI-504 is currently delivered intravenously in a water-based
formulation and is being evaluated in two disease-focused Phase l
clinical trials in patients with relapsed, refractory multiple myeloma
and relapsed, refractory gastrointestinal stromal tumors (GIST). An oral
formulation of IPI-504 is in preclinical development. On August 28,
2006, Infinity entered into a worldwide alliance with MedImmune, Inc. to
jointly develop and commercialize drugs, including IPI-504, that target
Hsp90. Under the terms of the agreement, Infinity and MedImmune will
share equally the worldwide profits from the successful
commercialization of any products. Infinity also has an option to
co-promote such products in the U.S.
* Hedgehog cell-signaling pathway inhibitors -- The Hedgehog pathway is
normally active during embryonic development regulating tissue and organ
formation. Aberrant activation of the Hedgehog pathway in adults has
been implicated in many of the most deadly cancers. Infinity's Hedgehog
pathway inhibitors are novel, proprietary systemically-administered
agents that have demonstrated in preclinical studies the ability to
potently and selectively inhibit the Hedgehog pathway. Infinity's
Hedgehog pathway program is also being jointly developed and
commercialized under the worldwide alliance with MedImmune, Inc.,
whereby Infinity and MedImmune will share equally the worldwide profits
from the successful commercialization of any products. Infinity also has
an option to co-promote any such products in the U.S.
* Bcl family inhibitors -- The Bcl family of proteins (including Bcl-2 and
Bcl-xL) are key regulators of programmed cell death, or apoptosis.
Infinity's Bcl family inhibitors are currently in preclinical
development for use alone or in combination to sensitize a broad range
of solid tumors to currently available chemotherapeutics. In March 2006,
Infinity entered into an alliance with Novartis to collaboratively
discover, develop, and commercialize drugs targeting Bcl protein family
members for the treatment of a broad range of cancer indications.

Shares Outstanding and Ownership of Infinity
In connection with the merger, DPI effected a 4-to-1 reverse stock split of its common stock. As a result of the merger and the reverse stock split, the combined company has approximately 19.4 million shares issued and outstanding, of which approximately 66% are held by prior Infinity stockholders and approximately 34% are held by DPI stockholders.

Investor Conference Call Details

Infinity has scheduled an investor conference call providing a business overview of the combined company and a discussion of its lead oncology programs on Thursday, September 14, 2006 at 8:30 a.m. EDT (5:30 a.m. PDT). A live webcast of the conference call can be accessed on Infinity's website at http://www.ipi.com. The call can be accessed by dialing 1-800-289-0498 (domestic) or 1-913-981- 5539 (international) five minutes prior to the start time. An archived version of the webcast will be available on Infinity's website for 30 days.

Board of Directors

The combined company's board of directors includes nine members from the former Infinity board of directors and three continuing members from the DPI board of directors. The DPI directors who will continue on the board are Harry Hixson, Jr., Michael Venuti, and Herm Rosenman. The Infinity directors who will serve on the board of the combined company include: Steven Holtzman (Chair), Vicki Sato (lead outside director), Ronald Daniel, Anthony Evnin, Eric Lander, Patrick Lee, Arnold Levine, Frank Moss, and James Tananbaum.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

Forward Looking Statements

This release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements regarding the expected benefits of the merger of Infinity and DPI for stockholders of the combined company, the expectation that the merger will enable the combined company to be well positioned to drive forward its pipeline of anti-cancer agents and create substantial value for patients and stockholders, and the expectation that the combined company will have cash to support its current operating plan through at least December 31, 2009. Such statements are subject to numerous factors, risks, and uncertainties that may cause actual events or results to differ materially from the combined company's current expectations. For example, there can be no guarantee that any product candidate the combined company is developing will successfully complete necessary preclinical and clinical development phases, be approved for sale in any market or that, if approved, revenues from sales of such product will reach any specific level. In particular, management's expectations could be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the combined company's dependence on its collaborations with MedImmune and Novartis; the combined company's ability to obtain additional funding required to conduct its research, development, and commercialization activities; unplanned cash requirements and expenditures; and the company's ability to obtain, maintain, and enforce patent and other intellectual property protection for any products it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in DPI's registration statement on Form S-4, as amended, as filed with the Securities and Exchange Commission and DPI's other SEC reports.

Any forward-looking statements contained in this press release speak only as of the date hereof and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Discovery on Target 2006
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Dr. Finbarr Murphy, Managing Director, EiRx Therapeutics Ltd. is attending Discovery on Target 2006 in Boston from October 23-26, 2006 at the World Trade Center, Boston, MA, USA.
Dr. Murphy will take part in the Roundtable Buzz Session on Wednesday 25th and will also speak on "siRNA and the Problem of Getting What You Want" on Thursday 26th @ 11.35am.




For immediate release
6 September 2005








EIRX THERAPEUTICS PLC

("EiRx" or "THE COMPANY")



PRESENTATION TO BIOJAPAN INDUSTRY CONFERENCE



Cork, Ireland, 6th September 2005 On 7th September, Dr Colin Telfer, Group Chief Operating Officer at EiRx, is to present EiRx Therapeutics product pipeline and recent successes at the BioJapan World Business Forum, the Japanese pharmaceutical industrys prestigious annual conference being held this year in Yokohama.



Dr Telfer, who was recently appointed Group Chief Operating Officer, will address the conference at the invitation of the UK BioIndustry Association, as part of a seminar showcasing the UKs leading position in cancer drug discovery. His talk will include the first public account of the development of EiRxs EnPADTM drug screening technology and the discovery of new cancer drug candidates recently announced by the company. A copy of the presentation will be viewable on the companys website www.eirx.com.



Other UK companies presenting at the seminar include Antisoma and Oxford BioMedica, and a keynote speech will be given by Professor Paul Workman, Director of Cancer Research UKs Centre for Cancer Therapeutics.



Dr Telfer will also present EiRxs research and collaboration activities to an audience of industry executives in Osaka, and attend business partnering meetings with potential alliance partners in Tokyo.



Commenting on his upcoming activities, Dr Telfer said: The BIAs invitation demonstrates a clear recognition of the potential value of EiRxs contribution to current cancer drug research. I also hope to build relationships with our colleagues in the Japanese pharmaceutical industry, who represent the worlds second largest market for modern medicines.



For further information, please contact:



EiRx Therapeutics plc


John Pool, Chairman
01260 226529

Buchanan Communications


Tim Anderson / Mark Court / Mary-Jane Johnson
020 7466 5000

6th September

Dr Telfer will also present EiRxs research and collaboration activities to an audience of industry executives in Osaka, and attend business partnering meetings with potential alliance partners in Tokyo.

Ethnicity And Cancer Susceptibility
Main Category: Cancer / Oncology News
Article Date: 12 Sep 2006 - 22:00pm (PDT)
| email this article | printer friendly | view opinions | Article Also Appears In
Genetics





Researchers from the UCL Branch of the global Ludwig Institute for Cancer Research (LICR) have uncovered how a genetic variation present in ethnic groups from around the equator may influence cancer susceptibility. The findings published in Nature Genetics have implications for pharmacogenetics, the study of how inherited variations may affect drug metabolism and response, and present a target for future 'designer' cancer therapies.

The p53 tumor-suppressor protein removes damaged cells by a programmed cell death (apoptosis). When the p53 gene is mutated - as it is in approximately half of all human cancers - damaged cells do not die, but rather continue to grow and divide and eventually form a tumor. The two most common polymorphic forms of p53 are p53Pro72 and p53Arg72 and the distribution varies in different ethnic groups. The two forms differ by just one amino acid in the protein sequence. Several years ago, the LICR team discovered that the ability of p53 to control apoptosis is regulated by the ASPP family of proteins.

In this study, the investigators showed that the ASPP family preferentially regulates the p53Pro72 over p53Arg72 form. These results suggest that ASPP protein levels determine cancer susceptibility in people with the p53Pro72 form, the prevalence of which is linked closely to latitude.

According to Professor Xin Lu, the senior author of the study and Director of the LICR Branch, the occurrence of the p53Pro72 form is highest in ethnic populations from around the equator. "It's really interesting to speculate whether the increased exposure to DNA-damaging ultraviolet radiation has resulted in the need for a second level of p53-regulation. The results are important for furthering our understanding of how p53, the tumor suppressor, is regulated, and also offers intriguing hints about how these regulatory mechanisms might have evolved."

While speculations about how the mechanism evolved are largely academic at this stage, Professor Lu says the findings have practical applications for future cancer therapies and the growing field of pharmacogenetics. "It's not hard to imagine a scenario in the future where we might examine the p53 sequence of a cancer patient as part of tailoring an individualized therapeutic strategy. If the patient has p53Pro72, then she might get a specific therapy that alters ASPP protein levels to re-activate p53's anti-cancer function. If the patient has p53Arg72, we know the therapy would be less effective."

http://www.pipelinereview.com/joomla/content/view/6361/104/

Discovery on Target 2006
..................................................................................................................................
Dr. Finbarr Murphy, Managing Director, EiRx Therapeutics Ltd. is attending Discovery on Target 2006 in Boston from October 23-26, 2006 at the World Trade Center, Boston, MA, USA.
Dr. Murphy will take part in the Roundtable Buzz Session on Wednesday 25th and will also speak on "siRNA and the Problem of Getting What You Want" on Thursday 26th @ 11.35am.

read the link, its all about this

What we want now are upfront payments and a large deal!!

MGI phara results out wednesday news on milestone payment to ERX expected for its trial of ZYC300

MGI Pharma
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http://www.eirx.com/eirx_heading_images/Vaccine%20Antigens%20v2.0.pdf#search=%22mgi%20pharma%20zyc300%22

http://www.mgipharma.com/