10/30/2012
Arthritis Signifies a Vast Untouched Market, Finds Frost & Sullivan
Tumor necrosis factor (TNF) inhibitors are currently the only therapeutic class available to psoriatic arthritis (PsA) patients in need of additional therapy beyond standard of care. This represents a significant unmet need for alternative therapies for TNF inhibitor refractory patients.
New analysis from Frost & Sullivan’s (http://www.healthcare.frost.com) United States Market for Psoriatic Arthritis Pharmacotherapy research finds that psoriatic arthritis pharmacotherapeutics prescribed as add-on therapies to standard background therapy earned revenues of approximately $751.5 million in 2011. Frost & Sullivan estimates this to reach $1.3 billion in 2017.
If you are interested in more information on this research, please send an email to Britni Myers, Corporate Communications, at britni.myers@frost.com, with your full name, company name, job title, telephone number, company email address, company website, city, state, and country.
TNF inhibitors, a well-established drug class, have laid the groundwork for the next-generation of effective disease-modifying antirheumatic drugs and biologics with improved safety and efficacy profiles. The development of novel therapies for this complex disease, however, is hindered by several factors, such as an incompletely understood pathogenesis and a perception that PsA is a milder disease than rheumatoid arthritis. In addition, dermatologists may be less inclined than rheumatologists to prescribe biologics, hindering acceptance of these valuable treatments within the physician community. Consequently, TNF inhibitors are likely to continue as the first line of treatment for PsA, initially limiting the uptake of new agents to second line use.
“While some TNF inhibitors that are effective in rheumatoid arthritis are also effective in PsA, patients with moderate-to-severe forms of the disease may not always respond to them,” said Frost & Sullivan Senior Industry Analyst Debbie Toscano. “This creates a strong need for alternative therapies.”
To improve their therapies’ commercial acceptance, pharmaceutical companies need to raise the level of disease awareness and alter the perception of the potential severity of PsA. In addition, robust data supporting the clinical benefits of new agents in comparison with TNF inhibitors can help to overcome the entrenchment of this class and win over payers, prescribers, and patients.
“With the impending launch of three new therapies for the treatment of PsA in 2014, the awareness of PsA is expected to increase substantially,” noted Toscano. “This will renew interest in PsA, as patients and physicians will finally be presented with alternative treatments.”
United States Market for Psoriatic Arthritis Pharmacotherapy is part of the Life Sciences Growth Partnership Services program, which also includes research in the following markets: United States Market for Rheumatoid Arthritis Pharmacotherapy, United States Rheumatic Diseases Therapeutics Market, United States Market for Ankylosing Spondylitis Pharmacotherapy, and United States Rheumatoid Arthritis Market: Assessment of Biologics and New Treatments. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants. For more information, visit www.frost.com.
Fuisz Pharma Announces Patented Film Formulations
Fuisz Pharma recently announced a patented film formulation for enhanced drug delivery performance. The seminal patent for this technology issued as United States Patent No. 8,241,661 (Biocompatible Film with Variable Cross-Sectional Properties).
“It is understood that bi-layer film compositions can offer improved buccal absorption characteristics by retarding the drug that is lost to salivary flow and thereby is swallowed and diverted to the GI tract,” said Joseph Fuisz Esq., managing member for Fuisz Pharma. “Such drug is naturally not available for absorption at the intended buccal delivery site.”
“At the same time, manufacturing two films one for the drug and a second for a backing layer and laminating said films is more difficult and costly than making a single film,” he added. “What this announcement deals with and what is strongly covered by the issued patent claims of the ‘661 patent is the intentional formation of hydrophobic domains in the top of a monolayer film. These hydrophobic domains retard the dissolution of the top section of the film, thereby precluding loss of drug to salivary flow. This offers the benefit of improved buccal performance with easier manufacturing and freedom to operate with respect to certain bi-layer patents.”
Richard C. Fuisz, MD, said, “Bottom line here is that we have bi-layer functionality in a single layer cast film. In addition, by employing physical laws of miscibility and density, the way is open for more than one drug and/or for different release rates. It is to be decided whether this patent is licensed or utilized by Fuisz.”
Fuisz Pharma is a private pharmaceutical technology company originated by the Fuiszes. The Fuiszes have made substantial contributions in drug delivery, including orally dissolving tablets and novel particle coating systems at Fuisz Technologies; inventing and developing thin film drug delivery technologies at Kosmos Pharma and MonoSol Rx, as well as independently developing extruded sheet technology, and have extensive experience working with big and specialty pharma. For more information, visit www.fuisz.com.
DSM Announces Biologics Development & Manufacturing Agreement
DSM Pharmaceutical Products recently announced it has signed a biologics contract manufacturing agreement with Paranta Biosciences Ltd of Melbourne, Australia. The contract covers the process development and cGMP manufacture by DSM of Paranta’s lead recombinant human protein. This project represents an agreement for DSM with an Australian customer at their Brisbane facility.
“Working with Paranta is an important milestone for DSM to support the local client base directly from our facility in Australia, expanding our presence in global regions,” said Alexander Wessels, CEO of DSM Pharmaceutical Products. “Our collaboration with Biopharmaceuticals Australia (BPA), the Queensland Government, and the Australian Commonwealth Government is already bringing benefits to Australia by providing biopharmaceutical firms local support and manufacturing expertise.”
Ross Barrow, CEO of Paranta Biosciences, added, “Follistatin has been shown to have great potential in treating a wide range of inflammatory and fibrotic respiratory diseases, which affect over 300 million people worldwide. Our selection of DSM as Paranta’s biologics manufacturing partner is the culmination of an extensive global search process spanning more than 9 months. We are looking forward to working with the Groningen and Brisbane groups of DSM Biologics as we continue the development and manufacturing scale-up of what we believe will be a truly exciting biotherapeutic.”
In addition to an R&D and manufacturing site in Groningen, The Netherlands, DSM is building operations in Brisbane, Australia, with the support of the governments of Queensland and the Commonwealth. The Brisbane facility is DSM’s blueprint for its “biologics plant of the future” for the production of biopharmaceuticals.
“For Biopharmaceuticals Australia, DSM’s signing-up Paranta for the new facility represents a key endorsement of the wisdom of the public sector investment in the project.” said CEO, David Hughes. “The Paranta contract is an important step in ensuring that more of the drug development value chain is retained locally. BPA, an industry-development company owned by the Queensland State Government, put together the partnering deal with DSM, and is currently project managing the final stages of the construction of the new state-of-the-art facility in cooperation with DSM Biologics.”
Paranta Biosciences is an early stage drug development company committed to the research, development, and commercialization of recombinant human follistatin for the treatment of respiratory diseases and conditions. For more information, visit www.parantabio.com.
Novozymes & Malvern Publish Collaborative Study
In a recently published article, researchers from Novozymes Biopharma and Malvern Instruments describe collaborative work using light scattering techniques to demonstrate the short- and long-term stability of the novel recombinant human albumins Albucult and Recombumin. These rAlbumins have been developed and optimized to deliver a safe, stable, and regulatory-compliant product for therapeutic formulations. The teams applied the resolving and detection capabilities of size exclusion chromatography light scattering (SEC-LS) and dynamic light scattering (DLS) offered by Malvern systems to monitor the stability of these Novozymes products. The article Tools for Evaluating the Stability of Human Recombinant Albumins Used in Human Therapeutics can be accessed at www.malvern.com/formulation-development.
Novozymes Biopharma develops and manufactures high-quality, animal-free, and regulatory-compliant recombinant ingredients and technologies to support the development of innovative pharmaceutical products. For more information, visit www.biopharma.novozymes.com.
Malvern offers a growing range of systems for protein characterization.The Zetasizer Nano is one of the most widely applied systems for measuring particle size and molecular size using dynamic light scattering, and protein mobility (zeta potential) by electrophoretic light scattering, while the Zetasizer APS offers robust, simple-to-operate, dynamic and static light scattering and automates the measurement of samples in industry standard 96- or 384-well plates. For more information, visit www.malvern.com.
Shire Invests $22 Million Into R&D Partnership
Shire plc recently announced a long-term, broad-based, multi-indication research collaboration in rare diseases with Fondazione Telethon, a major Italian biomedical charitable foundation, for research carried out at the Telethon Institute of Genetics and Medicine (TIGEM). This alliance will facilitate research on 13 undisclosed rare disease indications and has the potential to add multiple, novel therapeutic candidates into Shire’s early stage pipeline. The partnership underscores Shire’s long-term commitment to bring innovative therapies to patients with rare diseases worldwide.
The collaboration brings together Shire’s established capabilities in developing and distributing effective, life-altering therapies for patients with rare diseases and TIGEM’s world renowned research expertise in gene therapy and other novel therapeutics. Under the terms of the agreement, Shire will provide $22 million funding over 5 years for several research projects that collectively address a number of different lysosomal storage disorders and neurodegenerative diseases. The majority of the research will be conducted in TIGEM’s facility in Naples, Italy, under the direction of Andrea Ballabio. Successful projects that arise from this research will be incorporated into Shire’s development pipeline and benefit from additional Shire investment and resources.
“As a leader in rare diseases, Shire’s partnership with Fondazione Telethon is another way for us to ensure that we expand into new disease areas and enhance our collaborative relationships with academic institutions,” said Philip J. Vickers, Senior Vice President, Research and Development, Shire HGT. “Shire’s developmental expertise combined with TIGEM’s early stage research capabilities will enable us to accelerate our discovery and development efforts. This research collaboration is evidence of Shire’s commitment to patients with rare diseases and our intent to work with the best institutions to achieve this.”
“The collaboration with Shire proves yet again the value of Telethon-funded research, which is able to attract interest in the pharmaceutical market, even in a critical phase like the current one. We are particularly pleased because alliances like this one represent, for a not for profit organization like ours, an actual opportunity to fulfill the promise made to patients and donors who have been supporting us; translating the excellent results of scientific research into therapies that are accessible to people suffering from genetic diseases still lacking a cure. Those are the people for whom Telethon was born and still exists and keeps working,” added Francesca Pasinelli, General Manager of Fondazione Telethon.
Fondazione Telethon is a major Italian charity. Born in 1990 from a promise to a community of patients, its ultimate goal is to cure rare genetic diseases through investments in excellent biomedical research. For more information, visit www.telethon.it/en.
Bayer & QIAGEN Partner on Cancer Companion Dx
QIAGEN and Bayer HealthCare recently announced a collaboration agreement for the development and commercialization of companion diagnostics paired with novel Bayer HealthCare drugs, initially to enhance the treatment of various solid tumors. Companion diagnostics are tests that unlock molecular information from each patient’s tumor genome to guide treatment decisions with medications for cancers or other diseases. The parties will also collaborate on the development of novel technologies for patient profiling that may result in innovative research-use-only products for exploratory and translational medicine. Financial details were not disclosed.
The targeted companion diagnostics will be designed to run on the QIAsymphony family of automated instruments, which is transforming laboratory workflows and helping disseminate standardized, regulator-approved diagnostics.
“We are very pleased to partner with Bayer HealthCare in developing companion diagnostics to improve life for cancer patients. As healthcare providers increasingly select the right drugs based on each individual’s genomic information, the treatment of cancer is undergoing a revolution,” said Dr. Helge Lubenow, Senior Vice President Molecular Diagnostics Business Area and Member of the Executive Committee of QIAGEN. “The first collaborations for Bayer HealthCare and QIAGEN include companion diagnostics based on the identification of patients who may respond to therapies in clinically unmet disease classifications. Our agreement also lays the groundwork for a strong partnership in creating future companion diagnostics both inside and outside of oncology.”
“Partnering with QIAGEN on companion diagnostics will help Bayer HealthCare to develop innovative therapies, enabling physicians to analyze DNA and proteins from each patient. This helps to design more efficient clinical trials and to increase the overall probability of therapeutic success for patients suffering from cancer,” said Prof. Dr. Andreas Busch, Head of Global Drug Discovery and Member of the Executive Committee of Bayer HealthCare.
QIAGEN is a leading partner globally in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases. In July 2012, QIAGEN received FDA approval for the therascreen KRAS RGQ PCR Kit as a companion diagnostic in patients with metastatic colorectal cancer. For more information, visit www.qiagen.com.
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