A Medical Device Daily

Photocure (Oslo, Norway), a developer and of devices and pharmaceuticals for the photodynamic treatment and diagnosis of different types of cancer, said that its board has decided to de-merge PCI Biotech, its cancer-focused, drug-delivery subsidiary.

Following the completion of the de-merger process, PCI Biotech will seek a listing on the Oslo Stock Exchange.

Kjetil Hestdal, president/CEO of Photocure, said that the move is “an important step for both Photocure and PCI Biotech. By executing this planned de-merger, we will allow both companies to focus on their respective strengths in the treatment and diagnosis of cancer and in drug delivery.”

Photocure currently owns 91.4% of the shares in PCI Biotech, with the remaining shares owned by Radium Hospital Research Foundation, 6.9%, and the employees of PCI Biotech, 1.7%.

As a result of the de-merger, Photocure shareholders will receive one share in PCI Biotech for every share they own in Photocure.

Photocure said PCI Biotech has developed “a unique method for the light-directed drug delivery of therapeutic molecules directly into tumor cells.” It said this internal delivery of drugs “has the potential to enhance the efficacy of current approaches to the treatment of cancer.”

The technology, called photochemical internalization (PCI), can be used both for existing anti-cancer drugs and for emerging treatments, such as gene therapy using siRNA, and as such is of increasing interest in the pharmaceutical and biotech industry, Phoytocure said.

The board of Photocure said it made the de-merger decision for two primary reasons: PCI Biotech’s focus on drug delivery is “clearly distinct” from Photocure’s existing and future business opportunities; and Photocure believes that de-merging PCI Biotech will give PCI Biotech the best possible opportunity to develop its drug-delivery technology and “to release the value that this creates to shareholders.”

Photocure said the de-merger will enable it to “focus entirely” on its commercial ambitions and the development of its R&D pipeline.

PCI Biotech has been a subsidiary of Photocure since 2000, and the company said that it has built”a solid technology platform, generated significant pre-clinical documentation and established a strong intellectual property position.”

The soon-to-be separate company said it will launch the first clinical proof-of-concept study in 2008 to evaluate the ability of its technology to deliver an established anti-cancer agent into tumor cells.

Photocure’s board will prepare a plan for the de-merger that will be sent to each shareholder during 1Q08, with the plan on the agenda for a general shareholder meeting one month after distribution to the shareholders. After the general meeting, there will be a two-month creditor notice period before the de-merger can be executed.

Personal genome service is launched

deCODE genetics (Reykjavik, Iceland) reported the launch of deCODEme, which it characterized as “a pioneering service that enables individuals to get a detailed look at their own genome.”

The company, a pioneer in applying human genetics to develop drugs and diagnostics for common diseases, said that through their subscriptions to deCODEme, individuals “can learn what you DNA says about your ancestry, your body — traits such as hair and eye color — as well as whether you may have genetic variants that have been associated with higher or lower-than-average risk of a range of common diseases.” It said that the information will be “continually updated” as new discoveries are made.

deCODE said subscribers will create a secure, password-controlled personal account. Then, a few weeks after sending in a simple cheek swab, “customers will receive expert analysis of more than a million key variants across their genome, accessible through an easy-to-use and intuitive user interface.”

“We are pleased to ... launch this groundbreaking service,” said CEO Kari Stefansson, MD, PhD. “You have the opportunity to take advantage of the best that science has to offer when you learn about disease risks associated with your genetic variations and ancestry.”

The company said that, in more than a decade of research, it has analyzed the genomes of hundreds of thousands of people from around the world, “developing an unrivaled track record in gene discovery, in systems for genetic analysis, as well as data and privacy protection.”

The introductory price of a subscription to deCODEme is under $1,000.

Transgenomic to sell for BioView in Europe

BioView (Rehovot, Israel) and Transgenomic (Omaha, Nebraska) have formed an agreement allowing Transgenomic to distribute BioView’s family of scanning and analysis workstations in selected Western European countries, including the Scandinavian region.

Transgenomic’s European sales and support organization will market, sell and service the instruments. The products include the Duet, Allegro and Accord automated workstations for the scanning and classification of cells via fluorescence in situ hybridization and brightlight microscopy. The results of the scan are reviewed on the BioView Solo offline workstation for the final report.

The BioView products are for in vitro diagnostic use as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern and shape.

The companies said the products have applications for testing in hematological disorders, breast cancer studies for Her-2 neu gene amplification, bladder cancer screening and follow-up using the Vysis UroVysion Bladder Cancer Recurrence Kit, and prenatal and postnatal genetic testing.

Dr. Opher Shapira, president and CEO of BioView, said that the agreement is an opportunity for BioView to expand its market penetration in Europe in an efficient manner.

“Transgenomic,” he said, “has a reputation [among] its European customer base for providing superior service and support. Following our success in the U.S. market, we believe that this agreement with Transgenomic will help establish us in a similar manner in the Western European and Scandinavian countries covered by this agreement.”

Craig Tuttle, president/CEO of Transgenomic, said, “These sophisticated imaging systems will complement our Hanabi Metaphase Chromosome Harvester and spreader products and further expand our sales and service reach into cytogenetics and pathology laboratories across Europe.”