2/27/2012

BASF & Bend Research Sign Bioavailability Agreement

BASF SE and Bend Research Inc. have signed an agreement to jointly evaluate and develop novel excipients to enhance the solubility and bioavailability of poorly soluble drugs.

The companies plan to combine their world-leading expertise in the development of new excipients and drug formulations to provide customers from the pharmaceutical industry with early access to the latest polymer innovations. The aim of this collaboration is to meet increasing challenges of poorly soluble APIs (BCS Class II and IV compounds); the initial focus will be on optimizing new vinylpyrrolidone-based copolymers being developed for the solubilization of poorly soluble APIs.

“We are excited about the opportunities this collaboration brings to us and our customers,” said Rod Ray, CEO of Bend Research. “It offers early access to a different set of chemistries and allows us to develop and test customer formulations based on new polymers. BASF has an impressive track record developing and launching novel excipients. This deal complements our recently announced collaboration on cellulosics because it gives us access to completely different chemistries.”

“We are glad to bring our in-depth knowledge of polymeric excipients into this collaboration – to jointly extend the current toolbox already comprising innovations like Soluplus,” said Ralf Fink, Vice President Global Marketing at BASF Pharma Ingredients & Services business unit. “Coupled with Bend Research’s outstanding strengths in formulation development, including spray-drying and hot-melt extrusion, we are in a unique position to address urgent solubility challenges. With this partnership, we help our customers with the development of drugs with poor bioavailability.”

BASF has extensive ingredient formulation and material science expertise, as well as world-class excipient products. Bend Research is the leading formulation development and technology firm in the field of spray-drying and has recently expanded capabilities in hot-melt extrusion. For more information, visit www.bendres.com or www.basf.com.

BioCellChallenge Launches First Universal Delivery System for Transporting Antibodies Into Live Cells

BioCellChallenge SAS recently announced the launch of a new delivery system, ImmunoCellin, which is designed to transport antibodies into live cells even in the presence of additives. The company has recently filed a patent for this pioneering technology.

Without a suitable nanocarrier, antibodies cannot cross the plasmic membrane of live cells unaided and reach their potential intracellular targets. ImmunoCellin delivers antibodies directly into live cells, without any particular advanced preparation. This system is especially effective in identifying new targets for future therapeutic treatments.

“Until now, cellular biology research projects have made little use of antibody transport into live cells largely because all the tools are not sufficiently effective to be used without a lot of preparation or re-engineering. However, there is particular benefit in introducing therapeutic antibodies to target the intracellular proteins involved in certain diseases, particularly in certain cancers,” explained Dr. Meunier, CEO of BioCellChallenge.

ImmunoCellin is a much more potent protein function inhibitor than siRNA. Using siRNA to prevent a protein from playing its role in the cell inhibits all the functions of that protein. With ImmunoCellin, however, monoclonal antibodies can be directed to a single region of the protein to interfere with a single molecular mechanism, meaning that a specific function of the protein can be determined with certainty. ImmunoCellin is therefore a powerful tool for developing a broader understanding of the inter-protein interactions, which form the basis of cell function.

ImmunoCellin is also particularly suitable for use in kinetic studies of intracellular protein localization in response to different stimuli. It can also directly interfere with protein traffic in the cytosol or the nucleus by targeting a localization signal, for example.

The reagent is very simple to use: a few microlitres of the reagent are mixed with a few micrograms of antibody and this mixture is then added to the cells. No other preparation is required. The lipid-based formulation encapsulates the antibodies, facilitating their passage through the membrane.

There is no covalent interaction between the transport system and the antibody. Once inside the cell, the system does not retain the antibody, which can then diffuse freely through the cytosol until it reaches its target. Beacuse no chemical coupling is required, there is no impact on the activity of the antibody. Finally, as this system is not inhibited by the presence of serum, in vivo approaches are also possible.

This new system is aimed particularly at pharmaceutical and biotechnology industry R&D teams working on therapeutic antibodies. Accordingly, BioCellChallenge is keen to develop partnerships with players in the pharmaceutical and biotechnology industry. The ImmunoCellin system is also particularly relevant to cellular and molecular research biologists worldwide. For more information, visit www.biocellchallenge.com.

Capsugel Launches New Dosage Form Solutions Business Unit

Capsugel recently announced the launch of its Dosage Form Solutions (DFS) business unit to address growing customer demand for innovative product development and commercial manufacturing in the healthcare industry. The DFS business unit will focus on the company’s growing expertise in lipid-based formulations, while continuing to expand its offerings in targeted release capsules.

“With the launch of the new DFS business unit, Capsugel builds on its heritage of delivering innovative, quality products and services in hard capsules, by advancing our expertise in product formulation and commercial finished product manufacturing,” said Guido Driesen, President & CEO of Capsugel. “DFS is well-positioned to help address our customers’ most pressing dosage form challenges of existing and new nutritional and pharmaceutical products.”

Amit Patel will serve as President of the DFS business unit from Capsugel’s headquarters in Morristown, NJ. Mr. Patel has extensive experience in the pharmaceutical industry, including generics and specialty pharmaceuticals. “Continuing to innovate and develop cutting-edge healthcare products is essential to maximizing the potential of the industry,” said Mr. Patel. “The DFS business unit uses our proprietary technology platforms to help bring improved products to the market faster for our customers. The platforms can enable various solid oral dosage product improvements, including bioavailability enhancement, optimal dosing for potent APIs, controlled release, stability improvement, and taste-masking.”

Over the past decade, Capsugel has developed a world-class portfolio of products, technologies, and intellectual property. DFS will leverage its proprietary technology platforms of lipid-based formulations and targeted release capsule formulation, R&D capabilities, and commercial manufacturing infrastructure to develop and manufacture products for customers. The business unit has operating sites in North America, Europe, and Asia, and has been involved with hundreds of products and projects for leading and emerging specialty, branded, and generic pharmaceutical customers, as well as those in the consumer health and nutritional segments.

Capsugel is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, liquid-filled, and vegetarian capsules, to product R&D, proprietary technology platforms, and commercial manufacturing solutions, Capsugel is at the forefront of innovation providing end-to-end support to customers from early formulation to final production. For more information about Capsugel, visit www.capsugel.com.

Dow Chemical & Cambrex Collaborate to Manufacture Drug Solubility Solution

Cambrex and The Dow Chemical Company recently executed an agreement for Cambrex to contract manufacture Dow Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) for Drug Solubility Enhancement.

This is the final step in building on the solubilization partnership that Dow and Bend Research announced in October 2012, and it will help Dow to commercially supply solubility enabling excipients. Construction has already begun on the new operational facility at Cambrex Karlskoga with commercial product availability set for year-end 2013.

“Dow’s polymer science and application expertise, coupled with Cambrex’s capabilities positions Dow for rapid entry into the market. The AFFINISOL product platform has excellent manufacturing flexibility to match the diverse excipients needs of our customers’ pipelines,” said Bob Maughon, Senior R&D Director for Dow.

“We are enthusiastic about bringing the first solution of our AFFINISOL product range to the market,” added Marc van Gerwen, Business Director for Dow. “This agreement demonstrates our ability to promptly address with material science the pharmaceutical industry’s most pressing need: advancing poorly soluble APIs to become therapeutically beneficial oral drug products.”

“We are proud to be part of this collaboration with Dow,” said Eric Neuffer, VP of Sales and Business Development for Cambrex. “This agreement between Dow and Cambrex further validates Cambrex’s commitment to finding solutions that offer our clients quality products and services to meet a market need. This has been a great partnership with both the Dow and Cambrex teams focused on achieving project goals and objectives in a timely manner.”

Cambrex Corporation is an innovative life sciences company that provides products, services, and technologies to accelerate the development and commercialization of small molecule therapeutics. The company offers APIs, advanced intermediates, and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances, and formulation of finished dosage form products. For more information, visit www.cambrex.com.

ProBioGen Signs Major Technology Deal for Therapeutic Antibody Platform

Another global pharma company has licensed ProBioGen’s GlymaxX ADCC-enhancement technology. The license covers the modification of the pharma’s antibody production platform for the generation of antibodies with enhanced potency. The continued licensing success demonstrates the industry’s endorsement of GlymaxX. The GlymaxX technology is highly versatile because it can be applied to any starter or production cell line. It allows both, the robust permanent modification of established antibody expression platforms, as well as the rapid conversion of existing antibody producer clones to produce ADCC-enhanced molecules.

The GlymaxX technology is based on the stable expression of a heterologous enzyme in the antibody producing cells. GlymaxX prevents antibody fucosylation almost completely, but moreover allows the exact adjustment of any desired fucosylation level through the controlled addition of fucose into the culture medium.

The license with an option for a commercial license covers the modification of the company’s antibody production platform and the generation of multiple antibodies with enhanced ADCC potency. Financial details are not disclosed. The technology can be licensed royalty-free, based on milestone-dependent license fees only.

The GlymaxX technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose is known to greatly enhance ADCC. The GlymaxX technology is based on the introduction of a gene for an enzyme that deflects the producer cells’ pathway of fucose biosynthesis. GlymaxX is universally applicable to different CHO hosts and other eukaryotic cell species, and it is simple and potent. GlymaxX can be rapidly applied in a few weeks to any existing antibody producer cell line, or can be introduced into entire animal cell expression platforms by modifying host cell lines. ProBioGen offers this technology royalty-free as service or as license to third parties.

ProBioGen is an internationally operating technology provider and Contract Development and Manufacturing Organization (CDMO) with almost 20 years of experience in cell culture, process development, and GMP-manufacturing. For more information, visit www.probiogen.de.

Quinten Identifies Synergistic Markers; Predicts Favorable Response to TNBC Treatment

Quinten recently announced the identification of two discriminating biological marker candidates that are indicative of a favorable response to treatment in women suffering from triple-negative breast cancer (TNBC). In the sub-group with both markers in combination, 86% of women responded to treatment with Panitumumab plus Fec 100, followed by Docetaxel, with complete disappearance of the tumor (equating to a full pathological response on Chevallier’s classification). Only 47% of women in the total population examined during Phase II testing showed a similar response to treatment.

Using its proprietary Q-Finder algorithm, Quinten analyzed 200 biological variables relating to samples taken from 47 TNBC patients, provided by the Centre Jean Perrin in Clermont-Ferrand, which is led by Professor J Dauplat. The biological markers that have been identified confirm and build on results already found by teams working at the center under Professor Nabholtz, who is responsible for the medical and clinical research departments and Professor Penault-Lorca, Head of Biopathology and Director of the 4677 ERTICa university research team (Equipe de recherche sur les traitements individualises du cancer [personalised cancer treatment research team]) at the University of Auvergne.

In cancers showing a mixed basal/luminal phenotype, among patients with an EFGR score of more than 80, combined with a cytokeratin 8/18 percentage in excess of 20, the response rate to treatment is almost double (1.83 times) the overall rate for women suffering from TNBC. These patients represent approximately 30% of women with TNBC.

TNBC accounts for around 15% of breast tumors. A breast tumor is said to be triple negative if less than 1% of its mass is made up of estrogen and progesterone receptor-carrying cells, and it exhibits no HER2 overexpression or amplification. These are found in around 13% of breast cancers. This type of cancer affects mainly younger women under the age of 50. In older women, it is often known as an “˜interval’ cancer, which is discovered between two routine screening mammograms, in which the most recent showed perfectly normal results. It is known to be an aggressive cancer, with 10-year survival rates of just 5% for basal phenotype TNBC (75% of all TNBC cases) and 62% for other TNBC cases. It is not unusual to see a rapid spread of pulmonary and cerebral metastases following conventional treatment, as the cancer cells spread through the bloodstream rather than the lymph ducts. There are few specific or targeted treatments available for TNBC at present.

“As far as we know, this is the first time that prognostic biological markers for a favorable response to this type of treatment have been discovered for TNBC. This discovery once again illustrates and confirms our ability to identify synergistic variable interactions that define specific high-benefit or high-risk sub-groups within a given population,” explains Alexandre Templier, CEO of Quinten. “This approach to personalized medicine has long been of interest to pharmaceutical laboratories. More recently, we have seen growing interest from academic teams. We help them to make the best possible use of their data.”

“We are delighted to have discovered this interaction between two markers that individually provide no information. It gives hope to women suffering from TNBC, as there are still very few treatments available. We will be able to select patients who have the greatest chance of responding to the treatment that we have implemented,” added Professor Jean-Marc Nabholtz of the Centre Jean Perrin. “A scientific paper is being drafted, and we are discussing the commencement of work to confirm this discovery.”

Quinten provides consulting services on strategy and operations to companies in the pharmaceutical, biotechnology, and cosmetics industries, with a particular focus on the exploitation of biomedical data. Due to its unique technology and proven know-how, Quinten extracts accurate and targeted information from these data in the form of directly implementable recommendations. For more information, visit www.quinten-france.com.