On January 31, 2012 Spectrum Pharmaceuticals (NasdaqGS: SPPI) reported that it has entered into a co-development and commercialization agreement with Hanmi Pharmaceutical Company for SPI-2012 (formerly known as "LAPS-GCSF"), a drug for the treatment of chemotherapy induced neutropenia based on Hanmi’s proprietary LAPSCOVERY Technology (Press release, Spectrum Pharmaceuticals, JAN 31, 2012, View Source [SID:1234508777]).

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Granulocyte colony-stimulating factor (GCSF) stimulates the production of white blood cells by the bone marrow. A recombinant form of GCSF is used in appropriate cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens to be given at full-dose and on schedule. Chemotherapy can cause myelosuppression and unacceptably low levels of white blood cells, making patients prone to infections, hospitalizations, and interruption of additional chemotherapy treatments. The worldwide market for GCSF-related drugs was over $5 billion in 2011.

LAPSCOVERY (Long Acting Protein/Peptide Discovery) is a platform technology that can be applied to various molecules including glycosylated proteins, modified or artificial peptides with unnatural amino acid sequences. LAPSCOVERY can select the optimal conjugation sites from the proteins or peptides to minimize the structural hindrance and maximize the pharmacological activity.

"We were very impressed by Hanmi’s platform technology and are delighted to add SPI-2012, our third biologic drug, to our mid-stage pipeline," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Early evidence suggests that there could be advantages of SPI-2012 over currently approved therapies in increasing the rate and intensity of neutrophil recovery. We believe this agreement is consistent with our strategy of acquiring promising drug candidates at reasonable upfront and developmental costs, while maintaining significant economics for our shareholders in the long-term."

"Spectrum Pharmaceuticals has a proven history in in-licensing, developing and commercializing drugs. As a result, we expect this collaboration to help significantly advance SPI-2012 through the clinical and regulatory pathways, and commercial success," said Dr. Gwan-Sun Lee, Chief Executive Officer and President of Hanmi Pharmaceuticals.

On January 30, 2012 Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, reported that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation (Press release, Cancer Research Technology, JAN 30, 2012, View Source [SID1234523521]). Erivedge is the first and only FDA-approved medicine for people with advanced forms of the most common skin cancer. It is being developed and will be commercialized by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech.

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GDC-0449, a first-in-class hedgehog pathway inhibitor, was initially identified as a developmentally related gene in drosophila at the London Research Institute (Phil Ingham in collaboration with Harvard scientists). CRT subsequently licensed Hedgehog IP to Curis in 1995.

Dr Keith Blundy, Cancer Research Technology’s CEO, said: "We’re delighted that Vismodegib has been approved by the FDA ahead of the March deadline. This announcement brings us a step closer to approval in Europe by the EMA.

"The target of this drug, a signalling pathway called hedgehog, was co-identified by a team of Cancer Research UK scientists in the 1990’s and it is a great example of how early basic research funded by the charity can be translated into patient benefit."

For more information, view the Curis press release.

On January 26, 2012 Celgene Corporation (NASDAQ: CELG) and Avila Therapeutics, Inc., a privately held biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, reported a definitive merger agreement under which Celgene Corporation will acquire Avila Therapeutics, Inc (Press release, Celgene
, JAN 26, 2012, View Source [SID1234517135]).

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The acquisition positions Celgene to expand its leading role in the future treatment of hematologic cancers with Avila’s AVL-292, a highly-selective Bruton’s tyrosine kinase (Btk) inhibitor, currently in phase I clinical development. In addition, Avila’s proprietary Avilomics Platform augments Celgene’s investment in the discovery and development of novel therapeutics for managing complex disorders.

"Avila Therapeutics is a remarkable company that is aligned with our commitment to improve the lives of patients worldwide through innovative science and disease-altering therapies," said Tom Daniel, M.D., President of Research and Early Development for Celgene Corporation. "In particular, we see Avila’s unique approach to protein silencing as an area of great promise for our research initiatives in hematology, oncology and immune-inflammatory diseases."

"Celgene and Avila are uniquely matched, both strategically and scientifically," said Katrine Bosley, Avila’s Chief Executive Officer. "Celgene’s global leadership in hematology and emerging franchise in immune-inflammatory diseases will accelerate and expand the clinical development of our Btk inhibitor program. Equally important, we value the high standards of creativity and rigor of Celgene’s scientists. We believe working together may accelerate the advancement of more innovative medicines from the Avilomics platform."

The transaction has been approved by the Board of Directors of each company and is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the merger agreement, Celgene will acquire Avila Therapeutics, Inc. for $350 million in cash, plus up to $195 million for milestones contingent upon the development and regulatory approval of AVL-292, as well as up to $380 million in potential milestone payments contingent upon the development and approval of candidates generated from the Avilomics platform. The acquisition of Avila Therapeutics, Inc. will be accounted for as a purchase transaction that Celgene expects to be completed during the first quarter of 2012. The Company anticipates the acquisition will be neutral to 2012 non-GAAP diluted earnings guidance.

On January 26, 2012 Cancer Research Technology, the commercial arm of Cancer Research UK, reported it has launched Acublate Limited, a spin-out company which will develop a next-generation High Intensity Focused Ultrasound (HIFU) surgery device to treat a range of solid tumour types (Press release, Acublate, JAN 26, 2012, http://commercial.cancerresearchuk.org/crt-spins-out-company-develop-cancer-surgery-machine-melt-tumours [SID1234523125]).

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HIFU is a highly precise non-invasive type of surgery which uses ultrasound energy to heat and destroy tumours while leaving surrounding healthy tissue intact. The treatment works with immediate benefit and has the potential to reduce side effects compared with current alternative treatments.

The Acublate device uses an advanced proprietary phased-array system – that is, it targets multiple points in the tumour at once. The system can be steered rapidly in 3D to target and destroy tumours.

It is expected that the device will significantly reduce HIFU treatment times and become a more effective and cheaper alternative to currently available HIFU therapies for the treatment of cancer and other chronic diseases.

Initially, the Acublate device will treat patients with bowel cancer that has spread to the liver. But the technology has the potential to treat a range of cancers.

Cancer Research UK, Imperial Innovations and Imperial College Healthcare NHS Trust funded the original research to develop the technology. The research was led by founding scientists physicist Professor Jeff Hand at Imperial College London and surgeon Professor Paul Abel at Imperial College London.

Cancer Research Technology, with others, has raised £145,000 to develop the clinical prototype which is expected to be ready within a year. Further funding will be required to run clinical trials of the equipment with the first clinical data expected within 24 months.

Cancer Research Technology, which owns the IP to the technology, is Acublate Limited’s major equity holder and will benefit from any future licence income

Tony Hickson, managing director technology transfer, at Imperial Innovations, said: "As the provider of commercialisation services to the Imperial College Healthcare Trust, Imperial Innovations is extremely pleased to see this cutting-edge treatment being developed by a Cancer Research UK spin-out, and, alongside the ICHT and CRT, has backed the idea, supporting the development of the prototype towards clinical trials."

Dr Keith Blundy, CRT’s CEO, said: "We’re delighted to be able to take the research into this exciting technology that Cancer Research UK helped fund onto the next stage. The HIFU technology currently approved for clinical use in the UK specifically targets prostate cancer but we hope the Acublate device will be able to treat most solid tumour types.

"It’s also expected to treat patients more quickly, more effectively and with fewer side effects than the current technology.

"We hope to have the first set of data from clinical trials using the equipment to treat bowel cancer that has spread to the liver, within two years."

(Press release, Cannabis Science, JAN 25, 2012, View Source [SID:1234505817])

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