IPR Biotechnology
October 2006
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Previous Issues

Across Blood-Brain Barrier

Raptor Pharmaceutical Inc, wholly-owned subsidiary of Raptor Pharmaceuticals Corp has signed a research collaboration agreement with Dr William Mobley, Professor of Neurology and Neurological Sciences at the Stanford School of Medicine and Director, Neuroscience Institute at Stanford.

Dr Mobley's laboratory studies the signaling biology of neutrotrophic factors in the normal brain and in animal models of neurodegenerative disorders, such as Alzheimer's disease and Down syndrome.

According to the research collaboration agreement, Dr. Mobley's lab will study the utility of the company's proprietary Receptor-Associated Protein ("RAP") vectors, collectively referred to as Neuro Trans(TM), as potential transporters of intravenously administered therapeutics across the blood-brain barrier. Dr Mobley appreciated Raptor's support of research into this important therapentic area. The ability to deliver potential therapeutic compounds across the blood-brain barrier would be an exciting medical advance in the treatment of neurodegenerative diseases. Dr Mobley's laboratory tested Raptor's approach to the delivery of therapeutic proteins, such as Nerve Growth Factor or NGF, to the brain.

(Raptor Pharmacentical Corp, Aug 1, 2006)
Agreement for Bio-Implants

Arthro Kinetics plc, the pioneer orthopaedics company dedicated to regenerating joint mobility and spinal disc function, has announced a strategic alliance with Australian Biotechnologies Pty Ltd, Sydney, to manufacture and distribute advanced bio-implant products in Australia and New Zealand. In addition, a secondary agreement has been signed that allows the company to produce the implants at the Australian Biotechnologies facility for export into South East Asian countries, enabling the company to offer a cost competitive solution for this rapidly expanding region.

Australian Biotechnologies manufactures and engineers innovative human tissue-based products to repair and promote natural healing of human bone and other tissues. It has become the first privately owned bone and tissue processing facility in Australia and is owned by a Consortium of Australian Orthopedic Surgeons and two founding directors. It will introduce advanced processing techniques in partnership with leading international commercial partners to give Australian surgeons access to the most current technology for bone and tissue based products.

For Australian Biotechnologies, the key to their success in production of bone based products is to secure long term availability of donated human tissue. Australia operates differently to other countries in relation to donated human bone and tissue.Australian Biotechnologies has recently negotiated a long term agreement with the New South Wales Government for the management and processing of the state’s supply of donor bone.

During the initial 3-year term of the agreement, Arthro Kinetics expects this collaboration to generate €3 million in revenues for the initial CaReS product alone. In addition, the companies plan to collaborate on all future biological implants developed by Arthro Kinetics.

(Arthro Kinetics plc , July 31,2006)
Collaboration on Short-Acting Aptamers

On August 1, 2006 Archemix Corp and Nuvelo, Inc, announced that they have expanded their collaboration agreement. Under the new agreement, which replaces the existing 50/50 collaboration, Archemix will be responsible for the discovery of short-acting aptamers targeting the coagulation cascade for use in acute cardiovascular procedures, and Nuvelo will be responsible for the development and worldwide commercialization of these apatmers.

Under the new collaboration agreement, Nuvelo will make an initial upfront payment to Archemix of $4.0 million and, under certain circumstances may invest up to $10.0 million in Archemix’s common stock upon an initial public offering. Nuvelo will also fund Archemix research in the area of short-acting aptamers for the next three years at a minimum of $5.25 million. In addition, Archemix may receive payments totaling up to $35.0 million per development compound on the achievement of specified development and regulatory milestones, along with potential royalty payments based on sales of licensed compounds.

(Archemix Corp & Nuvelo, Inc Aug 1, 2006)
Development of PARP Inhibitors

Genentech, Inc.and Inotek Pharmaceuticals Corporation have entered into an exclusive golbal collaboration to discover, develop, manufacture and commercialize inhibitors of poly (ADP-ribose) polymerase (PARP) for the potential treatment of cancer. PARP is a nuclear enzyme within cells that directs the repair of damaged DNA via the activation and recruitment of DNA repair enzymes and has applications for the treatment of oncology and cardiovascular conditions.

Under the terms of the agreement, Genentech will make an upfront payment of $20 million to Inotek. Genentech will pay Inotek royalties based on the net amount of any sales of Inotek’s lead PARP Inhibitor. It will also provide funding to utilize Inotek’s small molecule chemistry expertise as part of a multi-year collaborative research program.

Additionally, Genentech has retained an option to develop and commercialize Inotek’s PARP inhibitors to prevent cell death and complications associated with various acute cardiovascular conditions and procedures. Inotek has retained an option to co-promote PARP inhibitors in the acute cardiovascular field in the United States with Genentech.

(Genentech, Inc.and Inotek Pharmaceuticals Corporation, July 25, 2006)
Novel Therapeutic Products

Pharmacopeia, Inc, is famous to develop therapeutics to address significant medical needs using company's proprietary technologies and processes. On May 23, 2006, the company announced the formation of a drug discovery, development and commercialization alliance with a leading global biopharmaceutical company, Cephalon Inc. The financial terms of the agreement call for Cephalon to pay Pharmacopeia an up-front program access fee of $15 million.

The primary objective of the alliance is to identify active molecules and bring them forward to clinical proof of concept, yielding novel candidates for drug development in various therapeutic areas. Under the terms of the agreement, Cephalon will be responsible for identifying promising compounds. The companies will then work collaboratively to advance the lead compounds to clinical candidates. Pharmacopeia will be principally responsible for medicinal chemistry and primary biology, while Cephalon will provide further biology support as required by the collaboration.

Upon nomination, if any, of clinical candidates, Cephalon will be primarily responsible for their development and commercialization. Pharmacopeia retains an option to develop candidates from the collaboration, subject to Cephalon’s agreement. For each clinical candidate advanced under the collaboration, the developing company will make clinical, regulatory and sales milestone payments to the non-developing company. Further, the company commercializing each resulting product will pay the non-commercializing company up to double-digit royalties based on the sales level achieved.

(Pharmacopeia, Inc, May 23, 2006)
Pain-Treatment Drug  

Pozen, Inc, is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and patient convenience. On the other hand, AstraZeneca is one of the world's leading pharmaceutical companies with healthcare seovices. Pozen has signed an exclusive global collaboration agreement with AstraZeneca for co-development and commercialization of proprietary fixed dose combination of the proton pump inhibitor (PPI) esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID).

Under the terms of the agreement, AstraZeneca will pay POZEN an upfront fee totaling $40 million with potential aggregate milestone payments of $160 million for certain development and regulatory milestones; and $175 million of potential sales performance milestones, if certain thresholds are achieved. Royalties will be paid on net sales on a tiered royalty structure that ranges from mid-single digits to mid-teens. POZEN will be responsible for the development and filing of the New Drug Application (NDA) in the United States, while AstraZeneca will have full responsibility for development activities outside of the US as well as all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. AstraZeneca will also be responsible for all non-US regulatory filings. The collaboration is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

(POZEN , Inc. Aug 2, 2006)