A Medical Device Daily

Smith & Nephew Orthopaedics Trauma & Clinical Therapies (S&N; Memphis, Tennessee) and Q-MED (Uppsala, Sweden) said that they have formed an alliance to develop Q-MED's technology for the production of stabilized non-animal hyaluronic acid, NASHA, for the management of osteoarthritis (OA) in joints and to explore other orthopedic and disease applications.

The companies have entered into a licensing and supply agreement under which Q-MED has granted S&N the global exclusive right to market and distribute Durolane and other products intended for the management of orthopedic conditions and diseases.

Q-MED will manufacture all products developed, and S&N will focus on, and bear the costs for, the clinical development, registration and commercialization of new products.

Durolane is the first single-injection hyaluronic acid therapy for the treatment of OA of the hip and knee, the companies said. It has been approved for the treatment of OA in the knee in Europe since 2001, and for the treatment of OA of both the knee and hip in Europe and Canada since 2004.

Q-MED submitted a premarket approval application to the FDA in March.

In other agreements news:

• MicroDose Technologies (Monmouth Junction, New Jersey), a private drug delivery systems company, reported entering into a multi-product development and licensing agreement with Novartis (Summit, New Jersey) for the MicroDose dry powder inhaler (DPI), following an exploratory study performed with the MicroDose DPI.

Including an initial payment, MicroDose could receive up to $125 million in milestones for the successful development of the first five products. In addition, Novartis will pay MicroDose development costs and royalties on product sales, and Novartis will fund the necessary development, manufacturing and marketing costs for all products. In return, Novartis will receive exclusive rights to the MicroDose inhaler technology for its respiratory products.

• Biocare Medical (Concord, California) and VWR International have entered an alliance to support the marketing of Biocare reagents and equipment in immunohistochemistry (IHC) clinical diagnostic and research markets.

Biocare benefits from the “breadth and expertise” of VWR sales representatives in the U.S. and significant presence in other countries to help identify qualified leads for Biocare's Nemesis Automated Immunostainer and accompanying state-of-the-art IHC reagent line. Biocare will then take the lead and provide the necessary technical demonstration and training to produce IHC stains.

• Cordis (Miami Lakes, Florida) and ClearStream Technologies Group (Wexford, Ireland) reported that the two companies have signed an agreement whereby Cordis will distribute ClearStream's most advanced percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, which Cordis will market under the name Crescendo PTCA Balloon Dilation Catheter.

The companies expect the Crescendo Balloon will be commercially available by the end of third quarter of this year. It will be available in all countries except the U.S., Japan and Canada.

• Epigenomics (Berlin/Seattle), a molecular diagnostics company developing tests based on DNA methylation, reported that Affymetrix (Santa Clara, California) has granted it non-exclusive access to its microarray technology to develop and market microarray-based in vitro diagnostic tests for oncology and other indications.

The agreement complements Epigenomics' previously reported strategic alliance with Qiagen (Venlo, the Netherlands) for sample preparation.

Together, with the Affymetrix arrays and DNA analysis instrumentation, Epigenomics can now provide a complete platform for its pathology tests based on its proprietary DNA methylation methods.

The first products based on this platform will be pathology tests in prostate and breast cancer.

As the first example, Epigenomics is planning to transfer its Molecular Classification Test (MCT) for prostate cancer onto the Affymetrix platform to use it in the pivotal clinical trial for FDA approval of the assay, which is scheduled to start next year.

• Moda Technology Partners (Moda; Fort Washington, Pennsylvania), a software company that provides mobile data acquisition solutions to the pharmaceutical manufacturing industry and BD Diagnostics (Baltimore), a segment of BD (Becton, Dickinson and Co.) and a provider of products used for environmental monitoring, food pathogen testing, and biopharmaceutical fermentation media, reported the signing of a cooperative marketing agreement.

The agreement is intended to effectively leverage BD's bar-coded sample collection media and Moda's environmental monitoring solution, Moda-EM to ensure product safety within biopharmaceutical manufacturing facilities.