Orexo’s (STO:ORX) partner in Japan, Kyowa Hakko Kirin, has obtained positive phase III results in Japan for KW-2246, which is approved for the treatment of breakthrough pain in cancer patients and marketed under the brand AbstralTM in Europe. Kyowa Hakko Kirin will now proceed with preparations for a new-drug application for KW-2246 in Japan for use in continuous pain management of acute cancer pain (breakthrough pain).

Orexo announces that Kyowa Hakko Kirin, Orexo’s partner in Japan, today confirms that it has obtained positive clinical phase III results for KW-2246 in Japan. The clinical study results revealed a statistically significant difference between KW-2246 and the placebo, and clinical effectiveness was confirmed. In addition, with regard to safety, no unacceptable side effects were found during the clinical study period.

Kyowa Hakko Kirin will now proceed with the preparations for a new-drug application for KW-2246 in Japan. According to the market research institute Datamonitor, the Japanese market for opioids is one of the largest markets in the world (Datamonitor 2008, Commercial and Pipeline Insight: Opioids).

Torbjorn Bjerke, President and CEO of Orexo, comments: “The positive phase III results in Japan are an important milestone for our successful collaboration with Kyowa Hakko Kirin. This marks another important step in the international development of AbstralTM and strengthening Orexo in the process of becoming a profitable pharmaceutical company”.

Trial design

The clinical study was conducted using a crossover design involving a double-blind placebo-controlled trial, targeting patients to whom an opioid analgesic was administered at fixed intervals for intermediate to severe cancer pain and who use a morphine preparation for breakthrough pain, and a non-blind controlled trial with a morphine preparation.

About Abstral

Abstral is a fast-dissolving tablet for sub-lingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. It is based on Orexo’s unique and patented sublingual tablet technology in which a rapidly dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral is sold in Sweden, UK and Germany and is ready for launch in France. In Sweden, Abstral is sold through Orexo’s and ProStrakan’s joint venture, ProStrakan AB. The product is being prepared for registration in Japan and in the US the clinical phase III is finalized.

License agreements have been signed with Kyowa Hakko Kirin for Japan and with ProStrakan for EU and the US. Distribution agreements regarding Abstral for Russia and the CIS, Bulgaria and Rumania have been signed with Gedeon Richter. A distribution agreement has been signed with Hospira for the Southeast Asian market. For the Chinese market, Orexo has signed a distribution agreement with NovaMed, and for the Israeli market Orexo has signed a distribution agreement with Neopharm.

About Kyowa Hakko Kirin

Kyowa Hakko Kirin Co., Ltd. is engaged in the manufacturing and marketing of medical products and pharmaceuticals. As the parent company of the Kyowa Hakko Kirin Group, it manages the business activities in the Bio-Chemicals and Chemicals segments with the Pharmaceuticals segment as its core business. More information can be found at http://www.kyowa-kirin.co.jp/english/index.html.

Source
Orexo

It may be possible to improve impaired attention after stroke - which could aid recovery - according to research reported in Stroke: Journal of the American Heart Association.

Impaired attention is the most prominent stroke-related neuropsychological change and is reported in at least 46 percent and as many as 92 percent of stroke survivors, said Suzanne L. Barker-Collo, Ph.D., a senior lecturer and neuropsychologist at the University of Auckland in New Zealand.

Impaired attention can reduce cognitive productivity and the ability to focus on tasks. It’s key to re-learning motor skills.

In the first full-scale single-blinded, randomized clinical trial using Attention Process Training (APT), 78 stroke survivors were randomized to receive APT or standard rehabilitation care. APT is designed to improve the ability to maintain attention, as well as to shift attention (such as when having a conversation with more than one person) and to attend to more than one thing at a time. It’s been used successfully in people after traumatic brain injuries but hasn’t been tested in stroke patients.

Researchers tested participants in four aspects of attention - sustained, selective, divided and alternating - as well as visual and auditory aspects of attention. Patients receiving APT had up to 30 hours of individual training, in one-hour sessions for four weeks. They received on average 14 hours of training.

Researchers said people who underwent APT had a significantly greater improvement on a test of attention than those who received standard care. At six months, those who had APT had an average improvement of 2.49 standard deviations higher than standard care patients on “full-scale attention scores.”

The improvement in attention didn’t correlate with significant improvements in outcomes, but researchers said six months may not be enough time to gauge the impact of improved attention.
Differences on other measures of attention and broader outcomes were not significant.

Early identification and rehabilitation of attention should be part of stroke rehabilitation because APT is a viable and effective way to improve attention deficits after stroke, said the researchers, who recommend more research on the issue.

See the manuscript for co-authors and author disclosures. The New Zealand Health Research Council funded the study.

Source:
Bridgette McNeill

American Heart Association

SNM’s Clinical Trials Network have announced that several leading commercial providers of PET radiopharmaceuticals in Europe have registered their manufacturing sites with the network. SNM’s Clinical Trials Network is an initiative designed to address the need for streamlined drug discovery through the integration of imaging biomarkers into multi-center clinical trials.

According to Michael M. Graham, M.D., Ph.D., SNM President and co-chair of the Clinical Trials Network, “SNM is very pleased to have the support of Advanced Accelerator Applications, Erigal Limited and IBA Molecular. Their participation in the network will afford European clinical trial sites the option to obtain investigational imaging agents like FLT from a commercial provider instead of having to produce it themselves.” These commercial manufacturers represent 27 PET manufacturing sites in Europe.

The SNM Clinical Trials Network has received investigational new drug (IND) status for the use of FLT in multicenter studies. The goal of the network is to receive multicenter IND status for additional imaging biomarkers over time. Each imaging site that participates in a study using an SNM multicenter IND will need to demonstrate that the biomarker for the study is manufactured in a manner consistent with FDA standards. Now, in place of submitting detailed information about in-house production methods, sites will have the option to purchase investigational biomarkers from a commercial manufacturer with a drug master file (DMF) on file with the FDA. Advanced Accelerator Applications, Erigal Limited and IBA Molecular have all expressed interest in participating in future multicenter clinical trials under SNM INDs. Participation in any specific trial will require that these manufacturers have chemistry, manufacturing and control (CMC) information on file with the FDA for the investigational imaging biomarker being used in that trial.

“We hope that having commercial PET radiopharmaceutical producers supply investigational agents will further improve the level of standardization in imaging biomarker production. But this in no way reduces the need for single site produced biomarkers. We need both,” said Dr. Graham.

Having commercial availability of IND PET drugs for use in clinical trials for future therapeutic agents will also greatly enhance the number of sites that have access to biomarkers like FLT and may increase the number of sites able to participate in these studies. SNM hopes that increased availability of sites to support clinical trials work will help drug developers better match imaging sites with targeted patient populations and may also speed the time to completion of trials by including more sites in each clinical trial.

There are currently 201 manufacturing sites registered with the network worldwide, with 23% located in European regions. SNM is pleased to have the support of all major U.S. multi-site PET manufacturers in the network registry as well, including Cardinal Health, IBA Molecular and PETNet Solutions.

Source:
Amy Shaw

Society of Nuclear Medicine