On October 16, 2007 Perlegen Sciences, Inc., The University of Cambridge, Cancer Research Technology Ltd (CRT) and its parent organization, Cancer Research UK, reported that Perlegen has obtained an exclusive commercial license from Cambridge Enterprise Limited, the commercialisation office of Cambridge University, to the breast cancer markers identified through collaborative research between the parties that was previously announced in February, 2005 (Press release, Cancer Research Technology, OCT 16, 2007, View Source [SID1234523384]).

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The study identified novel breast cancer susceptibility markers that are present in approximately 20% of UK breast cancer cases. By comparison, previously identified genetic variants, for example in the genes BRCA1 and BRCA2, are much rarer, occurring in less than 5% of breast cancer cases.

Although common, these risk alleles (forms of DNA sequence at a specific location) confer somewhat less overall risk than other described markers, doubling breast cancer risk in cases which have two copies of the variants versus those with none.

Pursuant to the terms of the license agreement, Perlegen will commercialize a diagnostic test, either directly or through a sub-license agreement with a third party. Cambridge University and CRT will share in any financial returns. In addition, Cambridge University may provide non-commercial licenses to academic researchers.

The results of the collaboration were published in June 2007 in the scientific journal Nature: "Genome-wide association study identifies novel breast cancer susceptibility loci" by Douglas F. Easton et al. More than one million women are diagnosed annually with breast cancer. The near term diagnostic, and possibly longer term therapeutic, application of these findings could benefit breast cancer patients through improvements in prevention, earlier detection and ultimately treatment of breast cancer.

The study that yielded these markers, the most comprehensive study of breast cancer genetics ever conducted, was based on reading the DNA of over 50,000 women. The samples used in the study were coordinated by the researchers at Cambridge University through a variety of clinical collaborators around the globe. Perlegen genotyped the anonymised samples to determine the genetic variation in each sample. Funding was provided by Cancer Research UK, the parent organization of CRT.

"We are pleased that the collaborative effort between Cambridge University, Perlegen, all those who provided DNA samples to the study, and Cancer Research UK which provided funding support, has led to increased knowledge of the genetic basis of breast cancer," said Prof. Bruce Ponder, Director of the Cancer Research UK Cambridge Research Institute, Head of the Department of Oncology, and Co-Director of Strangeways Research Laboratory, University of Cambridge.

"The next step for this research is to translate our greater understanding of the genetic basis of the disease into new technologies that will directly benefit breast cancer patients," commented Dr. Keith Blundy, Chief Executive Officer of CRT.

"We look forward to further developments in this field, which together with today’s important findings, will hold the promise of improving the health care for the many women with these novel susceptibility genetic markers," said Dr. Bryan Walser, Chief Executive Officer of Perlegen Sciences.

Dr. Iain Thomas, Head of Life Sciences at Cambridge Enterprise Limited added: "One in nine women in the UK will be diagnosed with breast cancer. We hope the results of this study will make an important difference for many of these women. We’re delighted to have entered into this commercial license with Perlegen Sciences."

On September 3, 2007 Vernalis plc reported the achievement of a milestone under the company’s joint research and development collaboration with Novartis on the oncology target Hsp90 (Press release, Cancer Research Technology, SEP 3, 2007, View Source [SID1234523385]). The milestone payment was triggered by the start of Phase I clinical trials of a Vernalis compound in a range of solid tumours and liquid cancers.

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The Vernalis Hsp90 programme is the result of a collaboration established in March 2002 with CRT and The Institute of Cancer Research, building on studies funded by The ICR, Cancer Research UK and Wellcome Trust. Under the agreement, Vernalis will pay CRT and The ICR a proportion of its revenues from the agreement with Novartis. The original press release from Vernalis can be viewed here.

On August 22, 2007 Antisoma plc has reported that its single arm phase II trial of ASA404 in non-small cell lung cancer has produced positive final results (Press release, Cancer Research Technology, AUG 22, 2007, View Source [SID1234523386]). In particular, survival data support the findings from an earlier, randomised study in which addition of ASA404 to standard chemotherapy produced one of the largest increases in median survival ever reported in lung cancer.

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Findings from the trial will be presented by Dr Mark McKeage of the Auckland Cancer Centre, New Zealand, on 5 September at the World Lung Cancer Conference in Seoul, Korea.

ASA404 (formerly known as AS1404; DMXAA) is a small-molecule vascular disrupting agent which targets the blood vessels that nourish tumours. The drug was discovered by Professors Bruce Baguley and William Denny and their teams at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand, and initially licensed by Cancer Research Technology (CRT) to Antisoma in August 2001. Worldwide rights to the drug were licensed by Antisoma to Novartis AG in April 2007. Novartis plan to start enrolment of patients into a phase III trial in early 2008.

The original press release from Antisoma can be viewed here.

Advanced Viral Research has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On Aug 7, 2007 Integra LifeSciences Holdings Corporation (Nasdaq:IART) ("Integra") and IsoTis, Inc. (Nasdaq:ISOT) ("IsoTis") reported a definitive agreement whereby Integra would acquire IsoTis in an all cash transaction (Press release, Integra LifeSciences, AUG 7, 2007, View Source [SID:1234510753]). This strategic combination, unanimously approved by the Board of Directors of IsoTis, will create a global leader in regenerative medicine. The transaction is expected to be completed in the fourth calendar quarter of 2007. The transaction offers a number of potential strategic benefits to Integra:

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* Combination creates comprehensive orthobiologics portfolio
* Combined company to have one of the largest sales organizations
focused on orthobiologics in the United States
* Extensive channel coverage in neurosurgery, spine and extremity
reconstruction markets expected to drive cross-selling opportunities
and enhanced revenue growth

Upon closing, IsoTis, Inc. will become a wholly-owned subsidiary of Integra. Integra will be one of the largest companies in the world focused on advanced technology in orthobiologics and will have a product portfolio that encompasses some of the largest and most trusted orthobiologic brands, such as INTEGRA(R) Dermal Regeneration Template, DuraGen(R) Dural Graft Matrix, Integra Mozaik(TM) Osteoconductive Scaffold, NeuraGen(R) Nerve Guide and the Accell family of demineralized bone matrix products, DynaGraft(R)II and OrthoBlast(R) II. The combined company will have operations in North America and Europe with more than 2,000 employees, including approximately 300 sales and service professionals and over 500 employees in Europe.

Under the terms of the merger agreement, IsoTis shareholders will receive $7.25 in cash for each share of IsoTis common stock they own, which represents total consideration of approximately $51 million, plus debt to be repaid at closing.

"This combination brings together two well-respected industry leaders in the regenerative medicine marketplace," said Stuart Essig, Integra’s Chief Executive Officer. "Both Integra and IsoTis provide some of the most advanced technology addressing surgeons’ needs. By combining our companies’ complementary, best-in-class products and technologies, we expect to drive enhanced revenue growth and value creation. Integra has a track record of successfully executing on and integrating strategic transactions and we expect to realize the benefits of this combination in both our top line growth and earnings per share over the long term."

Pieter Wolters, IsoTis’ President and Chief Executive Officer, said, " We believe this transaction enables both IsoTis and Integra to reach our shared goal of improving patient outcomes in an innovative, cost-effective manner. We are very excited about the benefits this combination of industry leaders will provide to shareholders, employees, business partners, physicians and patients."

Benefits of the Combination

Comprehensive orthobiologic product portfolio using best-in-class technology. Both Integra’s and IsoTis’ products are recognized as best-in-class. The combined company will be uniquely positioned to offer a comprehensive orthobiologic product portfolio.

Extensive channel coverage. The merged company will have one of the largest sales and service organizations focused on orthobiologics in the United States. IsoTis distributes its products through a network of independent distributor agents in the United States, which Integra intends to build upon, a network of international stocking distributors, and private label partners. Integra has direct sales organizations focused on neurosurgery, extremity reconstruction, spinal surgery and general surgery, with over 250 direct sales reps in the United States and over 50 sales professionals in Europe. Integra intends to integrate IsoTis’ domestic and international sales and marketing organization and its global network of independent orthopedics distributors into its own sales efforts and leverage this expanded distribution.

Cross-selling opportunities. By leveraging the combined company’s product offering and broader channel coverage, Integra and IsoTis expect to drive cross-selling opportunities across the organization, increasing penetration of key customer segments such as neurosurgery, spine, extremity, trauma and reconstructive surgery. These initiatives are expected to enhance revenue growth over the long term.

Expanded international presence. The merged company will benefit from a broader global platform with direct selling organizations in North America and Europe. Today, approximately 25 percent of Integra’s and IsoTis’ combined revenues are generated internationally. The companies expect to increase growth in international revenues by capitalizing on the increased scope and scale created by this transaction, which will include an international direct sales and service team of over 75 associates and 200 distribution partners selling in over 100 countries.

Cost savings. Excluding transaction related costs and charges, the combined organization is expected to generate recurring cost savings from enhanced efficiency in manufacturing, purchasing, administrative, research and sales and marketing efforts.

Integra Guidance for 2008

The companies expect to initiate programs that are expected to enhance revenue growth in the long term. Concurrent with the signing of the merger agreement, the companies have announced a strategic alliance whereby Integra will sell on a private label basis IsoTis’ DynaGraft(R) II and OrthoBlast(R) II demineralized bone matrix products through its Integra NeuroSciences and Integra Extremity Reconstruction direct sales organizations in the United States.

IsoTis has recently announced its intention to wind down its European operations. This process has begun and IsoTis expects to achieve pre-tax savings of approximately $3-$5 million per year from these actions. After elimination of its European entities and facilities, IsoTis will maintain research and manufacturing operations at a single site in Irvine, California.

"While the transaction will be dilutive to reported earnings for several quarters as we restructure the business, we expect the restructuring activities surrounding the IsoTis acquisition to generate projected pre-tax cost savings of approximately $9 to $11 million per year for 2008 and beyond, as compared to IsoTis’ historical 2006 results," said Stuart M. Essig, Integra’s President and Chief Executive Officer. "Substantial savings will come from the reduction of public company costs, duplicative board and executive management costs, redundant insurance costs, and reduced advisory, legal and accounting fees. Additionally, by the end of 2008, Integra expects to complete the integration of IsoTis’ marketing, product development, administrative and logistics functions into Integra’s existing infrastructure and generate additional cost savings."

Integra expects to incur pre-tax charges related to these activities of approximately $3 to $5 million. These charges are expected to be incurred during the fourth quarter of 2007 and the first half of 2008, depending upon the actual closing date of the transaction.

Upon the closing of the transaction, Integra will provide more detailed guidance regarding the financial aspects of the transaction and its expected impact on Integra’s future financial results.

Timing and Approvals

The transaction is subject to approval of IsoTis’ shareholders, as well as other closing conditions and approvals. The transaction is expected to close in the fourth calendar quarter of 2007.

Advisors

In connection with the transaction, Thomas Weisel Partners is acting as exclusive financial advisor to IsoTis, and provided a fairness opinion to the IsoTis Board of Directors. Latham & Watkins LLP is legal counsel for IsoTis. Willkie Farr & Gallagher LLP is legal counsel for Integra.