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Aug 1- Aug 7

Aug 1: FDA Approves Keppra(R) Intravenous Formulation

Today UCB announced that the U.S. Food and Drug Administration (FDA) has approved Keppra® (levetiracetam) injection 500mg/5mL (100mg/mL) for use as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Keppra® injection is an alternative for patients when oral administration is temporarily not feasible; it must be diluted prior to use and administered as a 15-minute intravenous infusion.

'The addition of new intravenous formulations extend the treatment spectrum for patients with epilepsy allowing therapy to be individualized to particular clinical situations.' said Orrin Devinsky, Professor of Neurology, Neurosurgery and Psychiatry, Comprehensive Epilepsy Center, New York University, US. He continued, 'The FDA approval of the intravenous formulation for Keppra® provides a welcome new option for U.S. physicians and patients.'

Troy Cox, President CNS Operations, UCB said 'This U.S. approval closely follows the European approval of the IV formulation for Keppra® earlier this year. Keppra® is now the only newer anti-epileptic drug available in the U.S. and Europe with both oral and intravenous formulations.'

In March 2006 the European Commission approved the use of Keppra® 100 mg/mL concentrate for solution for intravenous infusion for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children four years of age and older with epilepsy.

Keppra® is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

Aug 2: Novo Nordisk Sues Pfizer for Patent Infringement

Novo Nordisk (NYSE:NVO ) announced today that the company filed a lawsuit against Pfizer claiming that Pfizer's product Exubera® infringes patents owned by Novo Nordisk. The patents cover inhaled insulin treatment for diabetes.

The lawsuit, filed in United States Federal Court in the Southern District of New York, alleges that Pfizer willfully infringed the patents and seeks compensatory damages. Novo Nordisk also announced it intends to file a motion for preliminary injunction seeking a court order that would prohibit Pfizer from continuing its unlawful conduct while the lawsuit is in progress.

"Novo Nordisk has been leading the fight against diabetes for more than 80 years," said Jim Shehan, vice president and general counsel of Novo Nordisk Inc. "We are the only company in the industry with a complete portfolio of insulin analogues to help patients achieve improved control at any stage of their diabetes. We have been able to realize this accomplishment because the patent system enables pioneering companies like ours to continue innovating and pushing for progress in the fight against diseases like diabetes.

"The patents we are asserting are for groundbreaking research on new approaches to treat diabetes," he added. "As all research-based companies recognize, patent protection is necessary to safeguard the investment that biomedical research requires."

Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women.

Aug 7: Collagen Matrix, Inc. Receives FDA 510(k) Clearance for Collagen Nerve Wrap

Collagen Matrix, Inc. announced today that it has received FDA's 510(k) clearance of its Collagen Nerve Wrap indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.

Collagen Nerve Wrap is a resorbable collagen matrix that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Collagen Nerve Wrap is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Collagen Nerve Wrap is an easy to handle, soft, pliable, nonfriable, porous collagen matrix. The proprietary design of the product allows Collagen Nerve Wrap to be spread open for easy placement over the injured nerve and to maintain closure without sutures. Collagen Nerve Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.

"As we continue our advanced research and development in the area of peripheral nerve repair under the NIH-funded bioactive nerve guide project for long gap nerve injuries, the Collagen Nerve Wrap product line addresses an immediate clinical need in the area of crush injuries or short gap nerve injuries. This regulatory clearance further demonstrates our commitment to the area of peripheral nerve repair," said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix.

Collagen Matrix, Inc. is a leader in the design and engineering of collagen-based extracellular matrices for tissue and organ repair and regeneration. Since its inception in 1997, the Company has received many government grants for the development of collagen-based matrix products in the areas of neurological, vascular, urological, and orthopedic tissue regeneration applications. The Company currently manufactures collagen-based finished medical devices in the areas of neurosurgery, oral surgery, orthopedic-spine surgery, and wound care.

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