3/29/2011

Champions Biotechnology Announces Technology Collaboration With Cephalon

Champions Biotechnology, Inc. recently announced the signing of a technology collaboration agreement with Cephalon, Inc. in which Champions will conduct low passage Tumorgraft studies on two proprietary chemical compounds, CEP-32496, an inhibitor of mutant B-Raf, and CEP-37440, a selective dual ALK-FAK inhibitor, provided by Cephalon to determine the activity or response in potential clinical indications. The results of these studies will be used to inform the future clinical development path of these compounds.

Cephalon will pay Champions an initiation fee of $1.39 million and will, under certain conditions, also pay Champions various amounts upon achieving certain milestones. Potential milestone payments under the agreement total $27 million. In addition, under certain conditions, Cephalon will pay Champions royalties on any commercialized products developed under the agreement.

“This is our largest Translational Oncology Services contract to date and provides us with a great foundation for strong revenue growth for our next fiscal year,” said Guy Malchi, Champion’s Head of Corporate Development. “We are very excited to be partnering with an innovative company like Cephalon that can utilize our technology to improve the process of oncology drug development. The potential for future milestone and royalty payments in these contracts will allow us to capture a portion of the financial upside our technology generates for our customers. We hope this is just the beginning of a productive and long-term partnership between our companies.”

“Our collaboration with Champions Biotechnology significantly complements our oncology discovery capabilities by providing wider access to more clinically relevant and predictive preclinical oncology models,” added Jeffry Vaught, Cephalon’s Executive Vice President for R&D. In addition, Champions’ technology platform will enable us to more effectively select the subsets of specific human cancers most likely to respond to our novel targeted therapeutic agents and identify the underlying cancer genotypes associated with drug sensitivity and resistance to chemotherapeutics.”

Champions Biotechnology, Inc. is engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs. The company’s Tumorgraft Technology Platform is a novel approach to personalizing cancer care based upon the implantation of human tumors in immune-deficient mice followed by propagation of the resulting engraftments, or Tumorgrafts, in a manner that preserves the biological characteristics of the original human tumor.

The company believes these Tumorgrafts closely reflect human cancer biology, and their response to drugs is predictive of clinical outcomes in cancer patients. The company offers personalized Tumorgraft development, drug studies, and genome sequencing as part of its POS whereby physicians can evaluate the effects of cancer drugs on their patients’ Tumorgrafts and understand the genetic make-up of their patient’s tumor, enabling them to better select treatment regimens that may be efficacious to the patient.

The company’s Tumorgraft Technology Platform is also used to provide Translational Oncology Solutions, or TOS, (previously referred to as Preclinical eValuation services) to leading pharmaceutical and biotechnology customers. This technology can evaluate tumor sensitivity/resistance to various single, combination standard, and novel chemotherapy agents and could lead to a faster and less-expensive path for drug development. TOS also includes biomarker discovery and the identification of novel drug combinations. In addition, the company provides to oncologists and their patients expert tumor panels to analyze medical records and test results, to assist in understanding conventional and experimental options and to identify and arrange for testing, analysis, and study of the patients’ cancer tissues, as appropriate.

Drug Delivery International Seeks to Recruit Scientists

Drug Delivery International (DDi) is on the hunt for a clutch of world-class scientists as it embarks on an aggressive growth drive. And as it recruits the top talent, it will also build up job numbers among sales and support staff.

Glasgow-based DDi, established only at the start of 2011, is projecting first-year turnover of at least $700,000 as it focuses on collaborative research, licensing agreements, and breakthroughs into the lucrative Asian and Far Eastern markets.

Dr. Carol Thomson, the Chief Operating Officer who is in charge of the day-to-day running of the ambitious new company, said that DDi also intends to develop its own intellectual property and to take products through research and development to clinical trials under its own steam.

“DDi has taken the first steps toward building a strong portfolio of growth potential products, and we are actively seeking at least four scientists with first-class pharmaceutical pedigrees to help us take the company to the next stage.”

For Dr. Thomson, born in Glasgow, the launch of DDi as a new contender in the intensely competitive international pharma sector is the latest stage in an already glittering career in management in the science sector. Her first degree at Glasgow University was in genetics, an interest sparked by school biology lessons where she was taught the concept of Mendelian Inheritance. The intellectually driven young geneticist worked her summers in prestigious labs up and down the country working spheres as diverse as genetics of parasites and cancer genetics as well as assisting the world-renowned Professor James Scott – founder and first Head of the Institute of Genetics and Genomics – with research into lipids in heart disease at the Hammersmith Hospital.

She completed her Doctorate with Professor Sir Gordon Duff at the University of Sheffield, investigating genetic factors in rheumatoid arthritis and then followed these successes with intensive post-doctoral work on immuno-genetics. However, she said, around this time she began to realize that she was ready for challenges other than focused lab work and joined Thomson Reuters, where she managed teams indexing and abstracting patents in the Pharmaceutical Patents Business Unit of the World Patents Index.

“I was with this large organization for 7 years, and I enormously enjoyed the combination of management and science – both disciplines that require focus, drive, intellectual rigor, and integrity,” she said.

Dr. Thomson then joined the University of Strathclyde in a Business Development Manager role and subsequently as Research Policy Manager, where she became involved in a Scottish Enterprise Proof of Concept fund project looking at the potential of chronotherapeutic – or time-delayed – drug delivery. This led, with the involvement of respected pharmacists Professor Howard Stevens and Professor Alex Mullen, to the establishment of DDi, which has already seized the chance to license three University of Strathclyde patents with the potential to create significant medical benefits across the world.

DDi – sister company of Bio-Images Research, which has just announced a major expansion into Asia – plans to further develop the technologies for licensing to pharmaceutical or generic companies and is actively seeking to become involved in collaborative research with interested parties. The patents are in the area of controlled drug release and have been demonstrated in the therapeutic areas of cardiovascular disease, pain management, and sleep. As a result of the licensing agreement, DDi has already entered into early stage discussions with a global pharmaceutical company to secure a collaborative research agreement with an option to license a controlled-release drug formulation for pain control.

“As we take on more scientists, employment opportunities in other areas of the company will also increase dramatically,” said Dr. Thomson. “Our growth plans are aggressive, focused, and have considerable significance for the future health of the Scottish pharmaceutical sector.”

Unigene’s Oral Peptide Drug Delivery Technology Validated

Unigene Laboratories, Inc., a leader in the design, delivery, manufacture, and development of peptide-based therapeutics, recently announced that the statistically significant top-line results released by its licensee, Tarsa Therapeutics, validate its proprietary oral peptide drug delivery technology. The ORACAL study achieved its primary endpoint, and the results support Tarsa’s plans for an NDA submission to the FDA targeted before the end of 2011. The study design and endpoints were agreed with the FDA through a formalized Special Protocol Assessment (SPA) process. Tarsa also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2012.

“The positive results from the Phase III oral calcitonin trial represent the second game-changing event for the New Unigene since launching our turn-around strategy last quarter,” said Ashleigh Palmer, Unigene’s President and Chief Executive Officer. “The successful outcome of this study not only validates our propriety oral peptide delivery technology and state-of-the-art recombinant manufacturing capabilities, but highlights our overall competence in the peptide sector. Our mission is to become nothing less than the pre-eminent peptide powerhouse.”

The ORACAL study is a Phase III multinational, randomized, double-blind, double-dummy placebo-controlled trial of oral recombinant salmon calcitonin compared to commercially available synthetic salmon calcitonin administered by nasal spray. The ORACAL study’s primary endpoint was the percent change in lumbar spine bone mineral density (BMD) after 1 year of treatment. The results of the study demonstrated that oral salmon calcitonin was significantly superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing BMD at the lumbar spine after 1 year of treatment. The trial enrolled 565 postmenopausal women with established osteoporosis in six countries. The trial also assessed the tolerability of oral calcitonin, which was similar to that of calcitonin administered by nasal spray and to placebo. Tarsa expects that the full data from the study will be presented in a prestigious, peer-reviewed forum in the second half of 2011.

“The positive Phase III results confirm our belief that Unigene’s oral drug delivery technology leads the industry,” said Dr. Nozer Mehta, Vice President, Biological Research and Development. “Our internally developed calcitonin tablet formulation now has the potential to be the first oral calcitonin to reach the market and will provide patients with a once-a-day easy-to-use osteoporosis therapy. Furthermore, these results give added confidence for our ongoing development programs and feasibility studies using our propriety oral drug delivery technology.”

Calcitonin is approved for the treatment of postmenopausal osteoporosis, but its use has been limited by the fact that it is currently available only in intranasal and injectable forms. The efficacy of this oral calcitonin tablet formulation in delivering the desired blood levels of calcitonin and reducing levels of biomarkers of bone resorption has been demonstrated by Unigene in prior clinical studies.

In 2009, Unigene licensed its proprietary late-stage oral calcitonin program to Tarsa Therapeutics, a venture-financed company founded to conduct Phase III clinical testing and oversee commercialization arrangements for the oral calcitonin product. Tarsa owns exclusive development and worldwide commercialization rights to Unigene’s oral calcitonin product, with the exception of China. Unigene currently owns a 26% stake in Tarsa, subject to the potential for further dilution, and is eligible to receive sales-related milestone payments and royalties on worldwide sales.

Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture, and development of peptide-based therapeutics. The company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence platform.

MethylGene Announces $34.5 Million Financing to Develop Oncology & Antifungal Drugs

MethylGene Inc. recently announced its intention to complete a private placement of $34.5 million. Institutional investors participating in the offering include a fund managed by Baker Bros. Advisors, LLC, Tavistock Life Sciences, a fund managed by OrbiMed Advisors LLC, funds managed by QVT Financial LP and Tang Capital Partners, LP. Current shareholders ProQuest Investments III, LP and Fonds de solidarité FTQ will also be participating in the offering.

“I’m very pleased to announce this financing and am particularly gratified by the high-caliber life science investors we attracted. I also want to thank our current investors for their continuing support,” said Mr. Charles Grubsztajn, President and Chief Executive Officer. “The proceeds of this financing will provide us with sufficient capital to advance our two primary product candidates into Phase II clinical trials in specific indications that we believe will offer the most benefit to patients and value to shareholders. With the appropriate resources now in place, we look forward to implementing our strategic plan.”

The proceeds from the offering will be used to advance MGCD265 into Phase II clinical trials in non-small cell lung and other cancer indications. In addition, the company will also be advancing MGCD290 into Phase II clinical trials in vulvovaginal candidiasis (VVC). With the proceeds from this offering and based on the current clinical development and operating plans, the company’s cash runway is expected to extend into 2014.

MethylGene Inc. is a clinical-stage biopharmaceutical company that develops novel therapeutics for cancer and infectious disease. The company’s lead product candidates include: MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase I/II clinical trials for solid tumor cancers and MGCD290, a fungal Hos2 inhibitor, for use in combination with fluconazole for fungal infections, which has completed Phase I clinical studies. The company’s partners include Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc.

Seattle Genetics Announces Antibody-Drug Conjugate Collaboration With Abbott Laboratories

Seattle Genetics, Inc. recently announced it has entered into a collaboration agreement with Abbott under which Abbott will pay an upfront fee of $8 million for rights to utilize Seattle Genetics’ antibody-drug conjugate (ADC) technology with antibodies to a single oncology target.

“We are pleased to collaborate with Abbott on our ADC technology given their position as one of the world’s leading pharmaceutical companies and their demonstrated commitment to both biologic and oncology therapeutics,” said Eric L. Dobmeier, Chief Business Officer of Seattle Genetics. “This is the second ADC collaboration with a multinational pharmaceutical company that we have announced this year, further illustrating the important role that our ADC technology is poised to play in the treatment of many types of cancer.”

Abbott is responsible for research, product development, manufacturing, and commercialization of any ADC products under the collaboration. Pending achievement of certain development, regulatory, and commercial milestones, Seattle Genetics is eligible to receive from Abbott up to approximately $200 million in milestone payments, as well as royalties on worldwide net sales of any resulting ADC products. Seattle Genetics also will receive annual maintenance fees and research support payments for assistance provided to Abbott under the collaboration.

ADCs are monoclonal antibodies that selectively deliver potent anti-cancer agents to tumor cells. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic, highly potent cell-killing agents called auristatins (such as MMAE and MMAF) and stable linker systems that attach auristatin to the antibody. Seattle Genetics’ novel linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

Seattle Genetics has 11 active ADC collaborations and has generated more than $155 million from ADC licensing deals to date. There are currently 11 ADCs in clinical development across both internal and collaborator pipelines using Seattle Genetics’ technology.

Seattle Genetics is a clinical stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company submitted a Biologics License Application to the US FDA for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma in February 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer, and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab.

Procter & Gamble & TEVA Form Consumer Healthcare Partnership

The Procter & Gamble Company and Teva Pharmaceutical Industries Ltd. recently announced the signing of a master agreement to create a partnership in consumer healthcare by bringing together both companies’ existing OTC medicines and complementary capabilities to accelerate growth.

This new business model combines P&G’s strong brand-building, consumer-led innovation and go-to-market capabilities with Teva’s broad geographic reach, its experience in R&D, regulatory, and manufacturing and its extensive portfolio of products.

“This unique partnership positions P&G and Teva to be a leading player in the consumer healthcare industry,” said Bob McDonald, Chairman of the Board, President, and Chief Executive Officer of P&G. “This is a remarkable opportunity to accelerate growth for both companies’ OTC businesses. Together, we will serve more consumers in more parts of the world, more completely, by increasing access to high-quality, affordable OTC medicines.”

“We are extremely pleased to be joining forces with Procter & Gamble, a world leader in brand building and innovative go-to-market capabilities,” said Shlomo Yanai, Teva’s President and Chief Executive Officer. “This partnership will create value by immediately expanding the number of channels and geographies in which each company’s OTC products will be sold. Together, we will develop a new platform with the potential to reshape the entire global OTC market.”

The partnership will include a joint venture that combines the companies’ OTC businesses in all markets outside of North America. The markets included in the joint venture generated sales of more than $1 billion in 2010. Teva will provide access to its unparalleled portfolio of medicines and global R&D and manufacturing expertise and infrastructure. As part of the partnership, the companies intend for Teva to take global responsibility for manufacturing to supply the joint venture markets and P&G’s existing North American business.

OTC healthcare medicines offer significant growth potential for both companies in developed and emerging markets. The companies expect to stimulate faster growth in the nearly $200-billion OTC market as the global population continues to age, consumers increasingly focus on quality-of-life and wellness and more consumers personally manage their family’s healthcare choices and rely on trusted brands. In addition, economies in emerging markets continue to grow quickly, and consumers are gaining purchasing power. All of these factors will contribute to continued strong growth of the global consumer healthcare market.

This partnership will enable both companies to generate greater value from their existing OTC businesses. By broadening its OTC product offerings, Teva will further strengthen its position with major pharmacy customers around the world. For P&G, the partnership will accelerate global expansion of its leading OTC brands, such as Vicks, Metamucil, and Pepto-Bismol. In addition, the partnership will exploit opportunities to develop Rx-to-OTC switches to create new trusted brands to be marketed worldwide, including in North America. The transaction is expected to close in the fall of 2011 subject to receipt of required regulatory approvals.