Evotec & Roche to Develop Compound That Could Slow AD Progression

Evotec AG and Roche AG recently announced they have entered into an exclusive worldwide agreement for the development and commercialization of Evotec’s MAO-B inhibitor in patients with Alzheimer’s disease (AD).

Under the terms of the agreement, Roche will pay Evotec an up-front fee of $10 million. Evotec could receive further development and commercial milestone payments of up to $820 million as well as tiered double-digit royalties on sales. Roche will initiate studies in 2012 to demonstrate proof-of-concept and will be responsible for all clinical development, manufacturing, and commercialization activities.

Evotec’s compound (EVT 302) is a novel, potent inhibitor of monoamine oxidase type B (MAO-B), an enzyme that breaks down the chemical messenger dopamine in the brain and contributes to the production of free radicals. Free radicals are known to cause oxidative stress that may contribute to pathogenesis of AD as demonstrated by the up-regulation of MAO-B expression in the brain of AD patients. For these reasons, the selective MAO-B inhibitor is targeted to treat AD symptoms and potentially slow disease progression. The compound, which will be entering clinical studies in AD, was originally licensed from Roche to Evotec in 2006, and initially developed in another indication.

“Roche is committed to bringing innovative treatments to patients suffering from devastating neurodegenerative diseases, and is developing a number of approaches to tackle Alzheimer’s,” said Jean-Jacques Garaud, Head of Roche Pharma Research & Early Development. “The addition of EVT-302 to our CNS pipeline complements other approaches we are investigating including tau- and amyloid- targeted therapies.”

“We are delighted to have Roche as our strategic partner to fight Alzheimer’s disease,” added Dr. Werner Lanthaler, CEO of Evotec. “Their outstanding commitment to pharmaceutical innovation makes Roche the ideal partner to fight one of the biggest healthcare problems of our times.”

Foster Introduces Custom Drug Delivery Film & Rod

Foster Corporation, a PolyMedex Discovery Group company and leader in biomedical materials, recently announced it has introduced custom extruded film and rod from drug/polymer blends for implant, patch, and oral drug delivery applications. Working with customer-specified active pharmaceutical ingredients and a range of polymer formulations, including EVA, bioresorbable, and water-soluble polymers, Foster is able to support customers from formulation development through clinical production of advanced drug delivery systems.

Foster’s dedicated business unit for highly regulated materials, Delivery Science, specializes in blending polymers and active pharmaceutical ingredients with twin screw extrusion technology in a cGMP clean room environment. Traditionally, the company provided custom blends in pellet form for conversion into shapes used for drug delivery. These shapes included film for mucosal and transdermal patches, and rods for implantable drug delivery. Foster now also offers a range of custom film and rod extrusions for these applications.

Foster’s unique approach combines material blending with the direct extrusion shape forming process, which provides a significant advantage for polymers with active pharmaceutical ingredients.

“Many active pharmaceutical ingredients are temperature sensitive. Heat histories associated with multiple processes that risk degradation of the drug can severely limit a particular delivery platform,” said Tony Listro, Delivery Science Managing Director. “Direct extrusion removes a heat history associated with independent processing of film or rod for pre-compounded pellets, reducing the risk of degradation to the drug. Performing the entire process in a single cGMP-controlled facility consolidates supply and regulatory logistics.”

At the present time, Delivery Science can produce drug/polymer film in widths of 2 to 5.5 inches (50.8 to 139.7 mm) and thicknesses of 0.0012 to 0.0394 inches (0.03 to 1.00 mm), and solid rods ranging from 0.020 to 0.315 inches (0.508 to 8.0 mm).

Xcelience Expands CTS Manufacturing & Packaging

Xcelience, a leader in early drug development, has expanded clinical trial supplies manufacturing and packaging capabilities to include four new pieces of equipment and a new fully automated packaging line.

To complement existing expertise in matrix tablet delivery systems, Xcelience added a MG Futura (capsule-filling machine for powder and pellets), LCI Multi-granulator MG-55 (extruder), QJ-230T marumerizer (spheronizer), and wurster insert (bottom spray) to the existing Glatt GPCG-3 fluid bed processor. These new pieces enable production, coating, and encapsulation of MUDF delivery systems.

“The new MG Futura is a great example of our continued commitment to add state-of-the-art technology that delivers real value to our clients,” explains Theodore Koontz, Director of Operations. “The MG Futura improves upon production times, increases overall capacity, and expands upon our existing capabilities for powders, pellets, and powder micro-dosing for inhalation systems.”

In addition, Xcelience has added a fully automated packaging line (including ink-jet coding) for primary bottling of tablets and capsules. The new packaging line enhances the speed at which batches are packaged, shortens timelines, and enhances the ability to package larger batches of drug product.

Crescendo Bioscience Secures $56 Million

Crescendo Bioscience, a molecular diagnostics company developing quantitative biomarker tests for rheumatoid arthritis (RA) and other inflammatory diseases, recently announced it has completed a $31 million Series C equity financing and entered into a strategic investment agreement with Myriad Genetics for $25 million, raising a total of $56 million.

The $25 million investment by Myriad Genetics is non-dilutive capital that is structured as long term debt and is accompanied by a 3-year option to acquire Crescendo Bioscience for cash at a predetermined multiple of revenue based on the growth rate of Crescendo Bioscience at the time of option exercise. The option allows Crescendo Bioscience to continue to operate independently and may be exercised after Crescendo Bioscience attains a minimum revenue milestone.

Crescendo Bioscience is a leader in the development of molecular diagnostic tests for patients suffering from inflammatory autoimmune disorders, with its first products focused in rheumatoid arthritis. The company is committed to providing personalized diagnostic, prognostic, therapy selection, and monitoring tools for physicians to improve patient outcomes. Crescendo Bioscience’s initial product, Vectra DA, is the first blood-based molecular diagnostic test available that can determine the level of disease activity in patients with rheumatoid arthritis.

“This $56 million in funding exceeds our financing goals and is further validation of the unique market opportunity we are pursuing, the strength of our business model, and our early progress in penetrating this market,” said William A. Hagstrom, Chief Executive Officer, Crescendo Bioscience. “This funding will help us accelerate the commercialization of Vectra DA and expand our pipeline of molecular diagnostic products for rheumatoid arthritis and other inflammatory diseases.”

“As part of our focus on investing for future growth, we have identified Crescendo Bioscience as a franchise with strong potential; one that we believe will transform the management of chronic inflammatory diseases,” added Pete Meldrum, President and Chief Executive Officer of Myriad Genetics.

PerkinElmer to Acquire Caliper Life Sciences for $600 Million

PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment, recently announced it has signed a definitive agreement to acquire Caliper Life Sciences, Inc., a Hopkinton, Massachusetts-based leader in imaging and detection solutions for life sciences research, diagnostics, and environmental markets, for $10.50 per share, for a total net purchase price of approximately $600 million in cash.

“The acquisition of Caliper Life Sciences brings innovative molecular imaging and detection technologies to our portfolio, complementing our world-leading offerings in life science, diagnostics, environmental, and food markets,” said Robert F. Friel, Chairman and Chief Executive Officer, PerkinElmer. “The R&D, application expertise, and intellectual property of the combined organization will provide our customers with enhanced knowledge and services and a strong pipeline of innovation. Additionally, the proven leadership and talent of the Caliper team will be a strong addition to our organization.”

The combined technology platforms will expand PerkinElmer’s deep portfolio of solutions and services for global customers, including broader offerings for molecular, cellular, animal, and tissue imaging to enable translational medicine research; addition of a world-leading microfluidics platform for genomics and proteomics applications, for improved detection and screening through low sample use and efficiency; high-value sample preparation technologies for key scientific workflow areas such as Next Generation DNA Sequencing; more comprehensive solutions and services for identification of therapeutic response, biotherapeutics development, and biologics QA/QC; platform technology additions to drive expansion into attractive areas such as detection for environmental contaminants and food pathogens; and broadening services capabilities, leveraging multi-vendor asset management, custom research, and profiling for contaminants and adverse effects.

Thermo Scientific Introduces Chromatography Resource Centre

Thermo Fisher Scientific Inc., a world leader in serving science, recently introduced the web-based Thermo Scientific Chromatography Resource Centre (CRC), which provides application and method development information to help guide you through any HPLC and GC separation and sample preparation challenge. With a library of 6000 application notes, a comprehensive technical bibliography, and access to informative video animations and demonstrations, the CRC provides an invaluable reference guide for the chromatographer. Furthermore, you can easily download five of the most recent application notes produced using Thermo Scientific Accucore HPLC columns.

Visitors can benefit from the technical expertise and experience of Thermo Fisher Scientific by visiting the CRC and using the HPLC method development calculator, provided to smooth the transition between columns and techniques. In addition, the GC column selector tool, Thermo Scientific HyperSep SPE Applications Notebook, and the online Thermo Scientific Chromatography Columns and Consumables catalogue, provide you with all the resources necessary to optimize your chromatography applications.

For access to experience from expert chromatographers at Thermo Fisher Scientific, please visit www.thermoscientific.com/crc.

Thermo Fisher Scientific Inc.’s mission is to enable its customers to make the world healthier, cleaner, and safer. With revenues of nearly $11 billion, the company has approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals, and clinical diagnostic labs, universities, research institutions, and government agencies, as well as in environmental and process control industries.