On July 22, 2008 Following a thorough review that concluded late yesterday, the Board of Progen Pharmaceuticals Limited reported that it had discontinued the PI-88 phase 3 study in liver cancer (Press release, Progen, JUL 24, 2008, View Source [SID1234519617]). Progen confirmed its strategic direction to develop its existing portfolio of compounds and the company will actively seek to acquire additional compounds and opportunities through Merger & Acquisition activity.

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The strategic review was triggered by a recent accumulation of a number of factors that impacted the commercial return for the phase 3 PATHWAY trial.

The trial is unlikely to meet the forecast patient recruitment timetable and further significant delays were expected due to:

— slower than expected regulatory processes in China, Korea and Vietnam;

— slower than expected initiation of clinical sites;

— slower than expected recruitment of patients into active sites; and

— the recent launch of a competitive phase 3 trial, assessing Bayer/Onyx Nexavar(R) in the same indication.
Due to a lack of a global partner willing to meaningfully develop and commercialise PI-88, the commercial opportunity is much less than previously expected. Without a significant global partner contributing, Progen will be less able to expand into additional indications and exploit all potential PI-88 commercial opportunities.
These aspects would have delayed market entry significantly and seriously impacted on the commercial return of the phase 3 PATHWAY trial.
The next step is that Progen will seek expressions of interest in PI-88, at a regional level, initially from amongst those parties that had entered into Non-Disclosure Agreements and Due Diligence on PI-88.
The PI-88 trial had been facilitated through external agencies, and had resulted in 23 sites being opened for patient recruitment and 12 patients from 5 recruitment centres having been recruited to date. Existing patients receiving PI-88 will continue to receive the drug if they wish to do so, subject to regulatory approval. External costs of the trial in FY2008 are estimated at $9.8m. The cost of discontinuing this trial is estimated to be less than $4.0m.
As part of the strategic review, Progen has determined that the current phase 2b melanoma trial, will be completed but no further development in melanoma by Progen is anticipated at this stage. This trial is expected be finalised at an estimated additional cost of $300,000.
In addition, and as part of the strategic review, the Company has also decided to terminate further development of its phase 1 compound PI-166, based on a recent commercial assessment of the market and the approval of Nexavar(R) in this indication.
The Board of Progen has determined that it will increase its focus on the further development of molecules with high potential value.
Progen will focus its resources on aggressively pursuing its other compounds in development PG11047 (phase 1), the 500 series (late preclinical) and the epigenetics platform (early preclinical).
— Progen has previously announced the phase 1 trial of compound PG11047, for patients with advanced cancers, which had been the subject of an earlier phase 1 trial. This extended trial is already showing positive tolerability/dosing profiles.
— The 500 series is currently undergoing scale-up manufacture and animal safety studies.
— The Board of Progen has confirmed that it will continue to expand its gene expression modification – epigenetic – compounds platform, added to Progen’s technology platform through the CellGate acquisition.
In parallel, the Company will be actively pursuing merger and acquisition opportunities to expand its clinical stage pipeline.
Given its strong cash position, Progen will aggressively pursue M&A activities. As part of this process, Progen will announce in the next weeks the appointment of corporate advisers to assist with the identification of and initial discussion with potential acquisitions in Australia and the United States.
Cash Position as at 30 June 2008: $76.7m, excluding creditors and accruals of $6.2m (unaudited).

About Progen: Progen Pharmaceuticals is a globally focused biotechnology company committed to the discovery, development and commercialization of small molecule pharmaceuticals primarily for the treatment of cancer. Progen has built a focus and strength in anti-cancer drug discovery and development. Progen targets the multiple mechanisms of cancer across its three technology platforms, angiogenesis, epigenetics and cell proliferation. Progen has operations in Australia and the US.

On July 9, 2008 ValiRx plc (AIM:VAL, ‘ValiRx’), the cancer therapeutics and diagnostics company, reported it has secured a one year exclusive evaluation license from Cancer Research Technology Limited ("CRT") to a potentially significant new prostate cancer compound that has been shown in preclinical testing to successfully arrest prostate cancer growth in vivo (Press release, Cancer Research Technology, JUL 9, 2008, View Source [SID1234523377]). During the evaluation period ValiRx has an exclusive option to acquire worldwide exclusive rights in the cancer field.

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The Directors believe the compound – to be called VAL 201 – has the potential to add significant value to the Company in the near to mid-term as it has already been shown in preclinical trials to stop the growth of prostate cancer in situations where tumours are unresponsive to other treatments.

Currently, prostate cancer is the most common cancer amongst men with 35,000 men being diagnosed and 10,000 deaths each year in the UK. The estimated value of the global prostate cancer market is approximately USD3 billion.

Under the terms of the agreement with CRT, ValiRx will be responsible for performing the pre-clinical regulatory development of VAL 201 in readiness for entry into human trials. Once the option has been exercised, ValiRx will receive an exclusive licence to the compound and control the commercialisation and the process thereafter.

Satu Vainikka, CEO of ValiRx, commented: "This agreement extends further our relationship with Cancer Research Technology and expands our portfolio of late pre-clinical compunds."

Dr Phil L’Huillier, CRT’s director of business management, said: "We are very pleased to enter into an agreement for ValiRx to take forward into preclinical development this promising compound for the potential treatment of men with hormone resistant prostate cancer."

On June 9, 2008 Astex Therapeutics Limited ("Astex") reported that Astex and Janssen Pharmaceutica have entered into a research alliance focused on the research, development and commercialisation of novel drugs for the treatment of cancer (Press release, Astex Pharmaceuticals, JUN 9, 2008, View Source [SID1234535125]). The new agreement grants Janssen Pharmaceutica a worldwide exclusive license to compounds arising from Astex’s novel FGFR inhibitor programme, and the parties are also to establish a new drug discovery alliance focused on the identification of novel inhibitors against a further two cancer drug targets. The highly selective FGFR inhibitors were discovered using Astex’s proprietary fragment-based drug discovery platform, Pyramid, which will also be employed to drive the new drug discovery programme. Since 2004 Astex has used Pyramid to generate one new cancer drug candidate for clinical development each year.

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Under the terms of the agreement, Ortho Biotech Research & Development, the research and development arm of Janssen Pharmaceutica, will be responsible for completing all of the pre-clinical and clinical development of all products arising from the collaboration and for their commercialisation globally. The agreement also grants Astex an option to co-commercialise FGFR products developed under the collaboration in the USA.

The agreement provides for an upfront payment and equity investment in Astex, plus committed research funding, totalling $37.4 million over a two year period, as well as downstream development and regulatory milestones relating to all three programmes. Astex will also receive tiered, double digit, royalties on sales of FGFR inhibitor products discovered and developed under the collaboration and additional royalties on new products generated under the other research programmes. Total payments under the collaboration, excluding royalties, could be worth over $500 million to Astex, assuming one product from each programme is successfully commercialised in all territories.

Harren Jhoti, Chief Executive Officer of Astex Therapeutics, said, "This is another landmark agreement for Astex, and we are delighted to be working with one of the global leaders in oncology drug development on this discovery alliance. This partnership is another testament to Astex’s position as the leader in fragment-based drug discovery and the productivity generated by our platform."

On May 28, 2008 DRAXIS Health Inc. ("DRAXIS") reported the completion of the statutory arrangement under which all of DRAXIS’ common shares have been acquired by an indirect wholly-owned subsidiary of Jubilant Organosys Ltd for US$6.00 per common share (Press release, Draxis Health, MAY 28, 2008, View Source [SID:1234510741]). As a result, DRAXIS common stock is expected to cease trading on the NASDAQ Global Market and on the Toronto Stock Exchange at market close on Thursday, May 29, 2008, and will no longer be listed on these stock exchanges.

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Payment of the cash consideration will be made by Computershare Investor Services.

DRAXIS shareholders who possess physical stock certificates have received instructions and a letter of transmittal by mail from Computershare Investor Services concerning how and where to forward their certificates for payment. For shares held in "street name" by a broker, bank or other nominee, shareholders will not need to take any action to have shares converted into cash, as this will be carried out by the broker, bank or other nominee. Questions about the payment of proceeds should be directed to the appropriate broker, bank or other nominee.

On May 21, 2008 Thermo Fisher Scientific, the world leader in serving science, reported that Cancer Research Technology (CRT) has purchased 2,000 Maybridge Fragments as the foundation of its new fragment screening library(Press release, Cancer Research Technology, MAY 21, 2008, View Source [SID1234523378]). Wholly owned by the internationally renowned charity, Cancer Research UK, CRT is a specialist oncology-focused development and commercialisation company. Selected for its high quality, the Maybridge Fragment Collection will be used in CRT’s established Discovery Laboratories in London and Cambridge, for fragment-based screening, a key technology to accelerate the identification of drug leads against novel cancer targets.

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"Having reviewed several vendor catalogues with a focus on fragment collections for a discrete selection of heterocyclic small molecules with suitable properties, we ultimately chose the Maybridge Fragment Collection due to its superior overall fit to our requirements," explained Dr. Martin Swarbrick, Group Leader, Medicinal Chemistry, at CRT. "A good fit to ‘Rule-of-Three’ principles for physicochemical properties was essential, as well as lead-likeness and ‘drug-ability’."

Other key features of the Maybridge Fragment collection that influenced the CRT selection process include its high compound purity and chemical diversity, which is supported by related synthons elsewhere in the Maybridge catalogue. The availability of related building blocks featuring the same fragments from Maybridge stock facilitates the rapid construction of a library around chosen core fragments for hit-to-lead work and further optimisation.

"Other factors in our decision to purchase the Maybridge Fragment selection were their immediate and reliable availability for prompt follow up work, as well as the favourable pricing," added Swarbrick.

"We are very proud to have been selected by such an eminent cancer technology transfer company due to the quality, diversity and flexibility of our Fragment Collection," said Dr.Mick Durrant, Director of Business Development for Maybridge products at Thermo Fisher Scientific. "We pride ourselves on our choice of off-the-shelf collections and the ability to pick from our carefully selected fragment lists. This enables our customers to create their own bespoke libraries, giving them both convenience and complete control over their fragment screening programmes to ultimately accelerate lead generation."

The Maybridge Fragment collection is a convenient source of pre-selected, high quality building blocks which is a distillation of Maybridge’s combined expertise in heterocyclic compound design. Over 30,000 compounds have been assembled to form a pool from which researchers can build their own customised fragment libraries. This collection has been selected for purity, low molecular weight and absence of inappropriate functionality. All compounds are easily re-supplied and available custom weighed in mgs or µmols.

Many of the Maybridge Fragments are fully "Rule-of-Three" compliant, which means that the physicochemical properties of these fragments are optimal; therefore increasing the probability of future "hit" successes. Consequently, Maybridge Fragments provide an ideal starting point for a lead optimisation drug discovery programme and the ultimate evolution of a new molecule in the drug discovery process.