Catalent Licenses Innovative Technology
Following a successful research collaboration, Catalent Pharma Solutions recently announced it has taken an exclusive license to innovative taste-masking technology developed by the New Jersey Institute of Technology (NJIT). The technology has been developed to mask the most challenging, unpleasant, and bitter-tasting pharmaceutical active ingredients.
Under the terms of the license, Catalent will complete transfer of the technology into its world class, cGMP facilities to support manufacture of novel dosage forms, such as its Zydis fast-dissolve platform. It is expected the taste-masking technology will be effective for developing a wide variety of formulations, including granules/sachets, sprinkles, chewables, effervescent, and oral dispersible tablets.
“Taste-masking of fine drug particles has remained a technical challenge for formulators,” said Dr. Rajesh Davé, Distinguished Professor and Principal Investigator at NJIT. “Through funding from Catalent, we have been able to leverage our expertise to innovate technology and processes that allow for these materials to be cost effectively coated and taste-masked.”
Kurt Nielsen, PhD, Catalent’s Senior Vice President of Research and Development, added, “Dr. Davé and his group at NJIT are leaders in pharmaceutical particle engineering. The unique approach to API coating is a perfect complement to Catalent’s extensive dose form capabilities and will facilitate formulation of the most difficult-to-taste-mask actives. Catalent has already produced the first feasibility samples, which have exceeded our expectations. This efficient and versatile taste-masking technology will allow development of new dosage forms, delivering significant advantages to our customers and benefits to patients and consumers in global markets.”
Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. For more information, visit www.catalent.com.
NJIT, New Jersey’s science and technology university, enrolls more than 9,558 students pursuing bachelors, masters, and doctoral degrees in 120 programs. The university consists of six colleges: Newark College of Engineering, College of Architecture and Design, College of Science and Liberal Arts, School of Management, College of Computing Sciences and Albert Dorman Honors College. For more information, visit www.njit.edu.
Frost & Sullivan Predicts Growth for Therapeutic Monoclonal Antibodies
Efficient resource to therapy of complex disorders with lesser side-effects has accelerated growth of monoclonal antibodies-based therapeutics against conventional chemical drugs. However, high developmental costs constitute a major barrier for mid-segment market entrants. Growing market opportunities generated by innovative treatment methods and existing product success rate will boost market growth.
New analysis from Frost & Sullivan, Analysis of the Therapeutic Monoclonal Antibodies Market in Europe (www.pharma.frost.com), finds that the market earned revenues of $19.01 billion in 2011 and estimates this to reach $42.37 billion in 2018, at a compound annual growth rate (CAGR) of 12.1% from 2011-2018.
Monoclonal antibodies (mAbs) are mono-specific high molecular weight complex proteins that are capable of post translational modifications, such as glycosylation. They are commonly used biologics for therapeutics and therefore are the fastest growing segment within the biotechnology market. mAbs are predominantly used in the treatment of cancer and autoimmune and inflammatory disorders. Other therapy areas using mAbs include cardiovascular and infectious diseases, as well as organ transplants.
“Technological development within the biotech and genomic markets triggered the use of mAbs for therapeutics,” notes Frost & Sullivan Research Analyst Deepika Pramod Chopda. “With the rise in disease incidence rate and deterioration in human health conditions, the need for innovative and effective cure has been in great demand.”
High developmental costs act however as a major barrier for market entrants due to the complex production process, expensive biological and chemical materials, and clinical trials, as well as required safety, efficacy, and quality tests. The average production cost of developing monoclonal antibodies ranges from $650-$750 million and takes about 8 to 9 years. This factor particularly hinders the entrance of small biotech companies and favors big pharma participants, because of their financial strength and capabilities. On the other hand, the rise in other specialty pharmaceuticals with biotech invasion is expected to expand therapeutics at niche levels, thereby creating opportunities for bigger and better biologics business.
“Alliances between big pharma and small biotech firms for developing biologics are a key trend observed in this market,” added Mr. Deepika. “High developmental costs due to expensive research and testing activities trigger the overall expenditure of mAbs. Alliances with financially adept companies will help small biotech firms to develop new technologies, thus encouraging product development within this market.“
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Analysis of the Therapeutic Monoclonal Antibodies Market in Europe is part of the Pharmaceutical and Biotechnology Growth Partnership Service program, which also includes research in the following markets: European Biosimilars Market, Global Generics Market and European Autoimmune Diseases Therapeutics Market. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.
Pharmacyclics Inks Agreement With Novo Nordisk
Pharmacyclics Inc. recently announced it has signed an agreement with Novo Nordisk A/S giving the Danish insulin producer rights to certain uses of its Factor VIIa molecule inhibitor, according to a regulatory filing. Pharmacyclics shares rose 3.75% to $67.20 in after-hours trading. Through the close, the stock had more than doubled in the past 6 months.
Under the terms of the agreement, Novo Nordisk will acquire the world-wide rights to PCI-27483 for specific non-cancer-related uses. The Danish company plans to use it as an excipient in an unnamed product within its biopharmaceutical unit.
Pharmacyclics has been developing PCI-27483 to inhibit the intracellular signaling involved in tumor growth and to thwart the blood clots that afflict some cancer patients. The biopharmaceutical company expects to receive an up-front payment of $5 million, as well as up to $55 million based on the achievement of certain development, regulatory, and sales milestones. It also will receive royalties on sales of Novo Nordisk products that use PCI-27483. Novo Nordisk’s American depositary shares closed Tuesday at $161.38 and were unchanged after hours. The ADS are up 40% so far this year.
Pharmacyclics is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases. Its corporate mission statement is to build a viable biopharmaceutical company that designs, develops, and commercializes novel therapies intended to improve quality of life, increase duration of life, and resolve serious medical healthcare needs; to identify promising product candidates based on exceptional scientific development expertise; develop its products in a rapid, cost-efficient manner; and to pursue commercialization and/or development partners when and where appropriate.
Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs toward potential commercialization. The company is headquartered in Sunnyvale, CA. For more information, visit www.pharmacyclics.com.
Future of Pharmaceutical R&D Requires Innovative Dosage Formulations
A survey of 500 pharmaceutical industry influencers reveals that four out of five surveyed (82%) believe innovative dosage form technologies are required to meet the needs of today’s pharmaceutical research and development challenges. Three-quarters (76%) are actively investigating strategies to improve pharmaceutical products by adding drug delivery functionality, such as patient-centric dosing, combination therapy, and controlled-release options. And when asked to rank the top three key drivers of innovative dosage forms, patient safety was the top priority followed by combination therapies and controlled release.
This survey provided critical insights into R&D needs in terms of dosage innovation and outsourcing decisions today and in the future. This type of understanding is fundamental to interpreting the innovation likely to be required to meet evolving patient-centric dosage needs driven by healthcare trends.
Commissioned by Capsugel and conducted by an independent market research company, the survey of influential decision-makers in the pharmaceutical industry captures current opinions on dosage form innovation.
The development of suitable drug formulations and delivery systems remains a major challenge, and there is an increasing need for outsourcing to fill the knowledge gap. More than half (58%) of the companies indicated that they outsource dosage form development. Poorly soluble compounds represent a very high proportion of the industry’s development pipeline. Yet survey respondents cited only moderate expertise on specific technologies related to poorly soluble compounds, specifically lipid drug delivery technologies. Half (50%) reported plans to specifically outsource lipid drug delivery technologies for poorly soluble compounds.
“The survey findings reinforce Capsugel’s focus on lipid-based technologies to address many of the challenges presented by poorly soluble compounds. We work with customers to develop specialized approaches to address unique lipid-based formulations needs at our world-class centers based in Europe and the US,” said Hassan Benameur, PhD, Senior Director of Pharmaceutical Sciences at Capsugel and elected Chairman of the Lipid Formulation Classification System Consortium.
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 innovative R&D product development services, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production. For more information, visit www.capsugel.com.
Bend Research Receives US Patents for Technology to Enhance Bioavailability
Bend Research Inc. recently announced it has received two new US patents related to its pioneering efforts to improve the oral bioavailability of low-solubility drugs. The patents protect compositions and processes for making spray-dried dispersions (SDDs) that enhance the absorption of low-solubility drugs. The patents cover SDDs made with an API and hydroxypropyl methylcellulose acetate succinate (HPMCAS), a polymer that is also known as hypromellose acetate succinate.
Demand is high for this technology, as more than 40% of drugs in development are estimated to have low-aqueous solubility. The HPMCAS SDDs enable the use of lower drug doses to achieve effective therapies for low-solubility drugs. The technology works by sustaining high concentrations of drug in patients’ gastrointestinal tracts.
“These patents offer important protection for this vital technology,” said Bend Research CEO Rod Ray. “Our goal is to provide a growing patent portfolio for our customers’ use in protecting their investments in advancing low-solubility compounds to the market.”
The patents are among a growing number of formulation- and process-related patents associated with Bend Research’s solubility-enhancing drug formulation technologies. These solubilization technologies enhance the concentration of drug in patients’ bloodstreams and enable faster drug dissolution than is possible with crystalline drug forms.
The patents, which are both titled Solid Pharmaceutical Dispersions with Enhanced Bioavailability, were assigned US Patent Nos. 8,257,741 and 8,263,128 by the US Patent and Trademark Office. The inventors are William Curatolo, Scott Herbig, and Jim Nightingale. Both patents are the result of work funded by Pfizer Inc. and are assigned to Bend Research Inc.
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and by solving their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding. For more information, visit www.benbdresearch.com.
Aptalis Sponsors Research Achievement Awards at AAPS
Aptalis Pharmaceutical Technologies, formerly Eurand, focused on developing differentiated oral products utilizing its pharmaceutical technologies, recently announced its sponsorship of the American Association of Pharmaceutical Scientists (AAPS) Research Achievement Awards in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (PPDM) and its participation in the 2012 AAPS Annual Meeting and Exposition October 14-18, 2012, in Chicago, IL.
The 2012 annual meeting and exposition is an international forum for the exchange of knowledge among an expected 9,000 attendees, including scientists working in drug design, discovery, development, delivery, packaging, scale-up, clinical trials, and regulatory sciences.
The AAPS Research Achievement Awards are intended to recognize outstanding scientists who have conducted fundamental research that has had significant impact in the fields of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism. PPDM is the section of the AAPS that provides an opportunity for the presentation of new data and an exchange of ideas by individuals actively engaged in the various facets of pharmacokinetics, pharmacodynamics, drug metabolism, transport, biopharmaceutics, and related sciences. Meeting participants are invited to visit the Aptalis Pharmaceutical Technologies’ poster presentation: T2132, Development of Orally Disintegrating Tablets Comprising Controlled-Release Multiparticulate Beads, by P.J. Stevens, G. Venkatesh, J. Lai, October 16, 2012, Hall F, McCormick Place 9:30 AM to 12:30 PM and to visit the Aptalis Career Center Booth No. CC1.
Aptalis Pharmaceutical Technologies, formerly known as Eurand Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODTs (orally disintegrating tablets) and other dosage forms. Together, these technology platforms combined with licensing, manufacturing, and R&D capabilities enable Aptalis Pharmaceutical Technologies to produce customized drug formulation solutions for partners across a range of dosage forms and therapies with high patient acceptability. Aptalis Pharmaceutical Technologies develops and manufactures products for its partners, as well as supports the drug development process for the Aptalis Pharma pipeline and portfolio of products. For more information about Aptalis Pharmaceutical Technologies, visit www.AptalisPharmaTech.com.
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