On January 28, 2014 ARIAD and Specialised Therapeutics Australia Pty Ltd (STA), a specialty pharmaceutical company, reported that ARIAD has granted STA exclusive rights to commercialize Iclusig (ponatinib) in Australia in patients with Philadelphia-positive (Ph+) leukemias (Press release Ariad, JAN 28, 2014, View Source;p=RssLanding&cat=news&id=1894128 [SID:1234500155]).

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Under the terms of the agreement, STA will be responsible for obtaining marketing authorization and pricing and reimbursement approval of Iclusig and assisting ARIAD in regulatory filings for Iclusig in Australia. STA will book sales of Iclusig to pharmacies and other distributors, while ARIAD will supply packaged drug to STA. The term of the agreement is seven years from the first commercial sale of Iclusig following reimbursement approval. At the conclusion of the term, ARIAD will have the option to take over commercialization of Iclusig in Australia or to extend the agreement with STA.

"This agreement illustrates how we plan to make Iclusig available to patients in geographies where we do not anticipate setting up our own commercial activities near term," said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "STA has a proven track-record in oncology marketing and market access in Australia and is successfully distributing several important oncology brands in this region."

ARIAD submitted a marketing application for Iclusig in the third quarter of 2013 to the Therapeutic Goods Administration (TGA) in Australia. Marketing approval and commercial launch of Iclusig are expected in the fourth quarter of 2014. Prior to launch, ARIAD and STA will collaborate to make Iclusig available to patients with refractory chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL) under a Special Access Program.

"Iclusig is as an important cancer medicine for patients with difficult-to-treat CML or Ph+ ALL who have few options available to them," said Carlo Montagner, chief executive officer at STA. "We look forward to a successful collaboration with ARIAD providing refractory CML patients in Australia with a new highly effective treatment option."

According to the Australian Institute of Health and Welfare, there are more than 1,500 patients in Australia being treated for CML and approximately 290 patients are newly diagnosed with the disease each year.

"Some patients with this disease build resistance to current therapies and eventually run low on treatment options," said Professor Timothy Hughes, Consulting Haematologist at the Royal Adelaide Hospital and one of the PACE trial investigators. "I anticipate that Iclusig will be a valuable new therapy for adult patients with refractory CML."

About Iclusig (ponatinib)

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) is a biopharmaceutical company dedicated to working with leading pharmaceutical companies worldwide to provide acute care therapies for high unmet medical needs to people living in Australia and New Zealand. The STA therapeutic portfolio and pipeline at present encompasses oncology, hematology, ophthalmology and infectious diseases. STA also has interests in the therapeutic areas of respiratory, dermatology, endocrinology and central nervous system (CNS).

On January 27, 2014 Pfizer reported top-line results from two randomized Phase III studies of the irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced non-small cell lung cancer (NSCLC) (Press release Pfizer, JAN 27, 2014, View Source [SID:1234500281]).

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Both trials evaluated dacomitinib in populations of previously treated patients with advanced NSCLC. The ARCHER 1009 trial (NCT01360554), which included patients previously treated with chemotherapy (second/third line), did not meet its objective of demonstrating statistically significant improvement in progression-free survival (PFS) when compared with the EGFR inhibitor erlotinib.

In addition, the NCIC CTG BR.26 trial, which included patients with advanced NSCLC after standard therapy with both chemotherapy and an EGFR tyrosine kinase inhibitor had failed, did not meet its objective of prolonging overall survival (OS) versus placebo.
An ongoing, third Phase III trial, ARCHER 1050 (NCT01774721), is evaluating PFS of dacomitinib in a different patient population than was studied in ARCHER 1009 and BR26. ARCHER 1050 compares dacomitinib versus gefitinib in treatment-naïve (without prior treatment) patients with EGFR-mutant advanced NSCLC. The results are expected in 2015.
In both studies, the adverse events observed for dacomitinib generally were consistent with its known adverse event profile. Full efficacy and safety data from ARCHER 1009 and BR.26 will be submitted for presentation at an upcoming medical meeting.

On January 23, 2014 Sun Pharma Advanced Research Company reported that it has received the approval of the Drug Controller General of India (DGCI) for its medicine for treatment of breast cancer (Press release, Sun Pharma Advanced Research, JAN 23, 2014, View Source [SID1234556401]).

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The medicine, Paclitaxel Injection Concentrate for Nanodispersion (PICN), was found to be equally effective and safe when compared to Abraxane in a clinical study in metastatic breast cancer patients, the company said in a statement.

"PICN is approved in India for both the 260mg/m2 and 95mg/m2 doses to be administered every 3 weeks," it said, adding, the medicine offers the convenience of a quick and easy one-step dilution and infusion preparation for healthcare professionals.

PICN can be administered in a short 30 minute infusion and unlike conventional Paclitaxel formulations it does not require pre-medication with steroids and anti-histamines and does not lead to any significant hypersensitivity reaction in patients.

On January 22, 2014 Cancer Research Technology reported that an innovative screening technology that tags compounds with unique strands of DNA – like barcodes – will be used to assess up to a billion prototype drug molecules for anti-cancer activity, under a collaboration between the Institute of Cancer Research, London, Cancer Research Technology (CRT) and Denmark-based drug discovery company Nuevolution A/S (Press release, Cancer Research Technology, JAN 22, 2014, View Source [SID1234523231]).

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Researchers will use Nuevolution’s novel screening technology, Chemetics, to screen libraries of DNA-tagged compounds to identify those that act on a key protein in the stress response pathway, which has an important role in cancer cell survival and resistance to cancer treatments.

The collaboration will give scientists at The Institute of Cancer Research (ICR) access to data from screens of Nuevolution’s proprietary library of small-molecule compounds, each of which is tagged with a unique strand of DNA – marking it like a barcode. Up to a billion compounds will be assessed, with the successful hit compounds identifiable through their DNA tag. This state-of the-art screening technology allows potent drug leads to be identified quickly, accurately and from very large and complex compound mixtures.

The three-way deal between the ICR, Nuevolution and CRT, the commercial arm of Cancer Research UK, builds on a previous collaboration between CRT and Nuevolution, which aimed to identify drug leads that block the activity of several challenging cancer targets of therapeutic interest.

Under the new deal the Cancer Research UK Cancer Therapeutics Unit at the ICR and Nuevolution will collaborate to screen a key target within the stress response pathway using Nuevolution’s Chemetics technology. Researchers from the Cancer Research UK Cancer Therapeutics Unit at the ICR will provide detailed insights and scientific expertise on the specific stress pathway target as well as their extensive experience in cancer drug discovery and development. In addition, they will use their cancer biology and molecular pharmacology expertise to validate prototype drug molecules identified by the Chemetics screening.

The parties have an option to co-develop promising compounds arising from this collaboration. The agreement is open-ended and allows for the screening of additional targets if the collaboration is successful.

Professor Paul Workman, deputy chief executive of The Institute of Cancer Research, London, and director of the Cancer Research UK Cancer Therapeutics Unit said: "The stress response pathway plays a key role in allowing cancer cells to survive and to develop drug resistance – so it is increasingly being seen as an exciting source of future drug targets.

"But for some of these targets it is technically very challenging to identify prototype small molecule drugs. The new collaboration between the ICR, Cancer Research Technology and Nuevolution will allow us to screen very rapidly and efficiently for compounds that are able to bind to a key component of the stress response pathway that we have identified as especially important, and could help us to identify new drug candidates far more quickly than would otherwise be the case. By working in partnership we can accelerate the potential for patient benefit."

Thomas Franch, CSO, Nuevolution A/S said: "We are delighted to enter this project and to expand our present collaborations with ICR and CRT. The project will address a highly challenging target for which small molecule compounds is not easily identified using conventional screening methods. We hope to identify lead compounds using the Chemetics technology and look forward to moving this exciting project forward together with the world-leading team at ICR".

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said: "Our role is to build global industry-academic partnerships to bring the best technologies and expertise together to develop new treatments for cancer patients – ultimately saving more lives from the disease. This exciting international collaboration combines global expertise and resources to exploit the untapped biology of the stress response pathway.

"This work will accelerate the identification of potential new cancer drugs though an innovative approach to scan for DNA ‘barcode’ tags on promising new molecules – extending the existing relationship between Nuevolution and CRT."

On January 21, 2014 PIQUR Therapeutics AG, focused on the discovery and development of innovative anti-cancer drugs, reported that it has successfully completed the Series A financing round (Press release, PIQUR Therapeutics, JAN 21, 2014, View Source [SID1234527276]). The private placement was rapidly oversubscribed. Subscribers include existing shareholders as well as new investors from the life science industry.

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Dr. Vladimir Cmiljanovic, CEO and co-founder of PIQUR, commented: "We are delighted by the trust of investors in our company. In particular, we successfully attracted further distinguished individuals from the life science industry as investors. The successful round of funding has encouraged us in our determination to continue pursuing our corporate strategy. The funds that have been procured secure the cost of the first clinical studies with our lead compound PQR309."

PIQUR has received approval from the authorities in Switzerland and UK to conduct the clinical Phase I study with PQR309. This study will assess the safety in cancer patients, and will help determine the ideal dosage. On January 2, 2014, PQR309 was administered to the first patient at the University Hospital in Basel. "For PIQUR, the very first administration of PQR309 represents an important milestone in clinical development. First results of the study are expected to be released before the end of 2014," said Prof. Dr. Richard Herrmann, Chief Medical Officer of PIQUR.

Also of crucial importance for the future development of the company is the broadening of the license agreement with the University of Basel. The license agreement with the University of Basel was previously limited to the field of cancer, and has now been extended to a broad range of promising clinical indications. "The expansion of the license agreement is very important for the progress and development of our company. We now have the unlimited freedom to assess the therapeutic benefit of PQR309 and all other research programs in other therapeutic fields, such as immunology, neurology and ophthalmology," pronounced Prof. Dr. Bernd Giese, Chairman of the Board of Directors.

To turn cancer into a manageable disease
PIQUR aims to help turn cancer into a manageable disease. Despite significant advances in the fight against cancer, there remains a high unmet medical need for therapies that not only prolong patients’ survival but also significantly improve quality of life. PIQUR targets both PI3K (phosphoinositide 3-kinase) and mTOR (mammalian target of rapamycin), two key signaling molecules that are vital to several essential biological processes, such as cell proliferation and survival, making inhibition of the target attractive for cancer therapy.

PIQUR’s differentiation is the level of innovation with its unique, proprietary fragment and scaffold libraries, as well as cellular technology platforms, and their excellent products with novel, dual-acting ‘strong PI3K plus fine-tuned mTOR’ inhibitors that address the given challenges, meeting therapeutic, tolerance and galenic needs.