6/20/2012
Astex Earns $5.4-Million Milestone
Astex Pharmaceuticals, Inc. recently announced that Janssen Pharmaceutica NV has received clearance to commence a Phase I clinical trial of a Fibroblast Growth Factor Receptor (FGFR) kinase inhibitor from its collaborative, cancer drug discovery program with Astex. The regulatory approval required to take the compound into Phase I triggers a milestone payment to Astex of $5.4 million. Astex is also eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration.
The FGFR inhibitor program between Janssen and Astex originated from an earlier collaboration between Astex, the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre (NCC), and the Northern Institute for Cancer Research,
“We are delighted that Janssen has received approval to commence a Phase I study on this FGFR kinase inhibitor, a drug that has the potential to address a significant area of unmet medical need,” said Harren Jhoti, PhD, President of Astex. “This milestone underscores how effective collaborations between leading research institutions, biotech companies, and pharmaceutical partners can be in delivering new drug candidates for patients.”
The FGFR family of receptors and their somatic activation is increasingly recognized as a common abnormality in many cancers. This occurs through multiple mechanisms, including somatic mutation (eg, bladder, endometrial, and gastric cancers), gene amplification (eg, lung and breast cancers), and chromosomal translocation and generation of gene fusions (eg, multiple myeloma and myeloproliferative disease).
Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. The company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. For more information, visit www.astx.com.
NTA Used to Characterize Microvesicles as Potential Biomarkers
NanoSight recently reported on the work of Professor Hang (Hubert) Yin’s group at the University of Colorado at Boulder in which they apply Nanoparticle Tracking Analysis (NTA) to characterize biological nanoparticles, such as microvesicles.The Yin Research Lab is interested in studying at the interface of chemistry, biology, and engineering with a particular focus on structure-based drug design, cell signaling, biochemistry, biotechnology development, and membrane protein simulations.
The main research goal of the group is to identify and design peptides that sense membrane curvature to better understand protein/peptide-lipid interactions and potentially create non-invasive probes to detect highly curved extracellular vesicles. Currently, the group is studying microvesicles as potential biomarkers of tumor progression and cancer metastasis. These nanoparticles are shed into bodily fluids targeting other cells in the body and are vital for inter-cellular communication.
Their experimental protocol involves lipid vesicle preparation by pressure-controlled extrusion through different membrane pore sizes. Different lipid vesicle sizes are prepared in order to mimic the size range of the microvesicles that are shed into the extracellular matrix. Following vesicle extrusion, it is important to validate the vesicle size. By using NTA technology, the results provide an accurate quantification of different populations of vesicle sizes present in the sample. Prior to NTA, the group mostly used dynamic light scattering (DLS) to determine the sizes of its synthetic lipid vesicles.
“NTA brought several benefits over existing methods,” said Professor Hang Yin. “The detection ranges from 10 to 2000 nm for vesicle sizes, dimensions that cover our liposome size of interest. Flow cytometry has a lower limit detection of ~200 nm to accurately measure particle sizes, so it did not reach our lower requirement, while DLS measures the average size of all the particles present in the sample rather than accurately distinguish different pools of vesicle sizes, often creating a bias toward larger particles.”
NanoSight delivers the world’s most versatile and proven multi-parameter nanoparticle analysis in a single instrument. Its NTA detects and visualizes populations of nanoparticles in liquids down to 10 nm, dependent on material, and measures the size of each particle from direct observations of diffusion. Additionally, NanoSight measures concentration, and a fluorescence mode differentiates suitably labelled particles within complex background suspensions. Zeta potential measurements assess the surface charge on particles.
NTA’s particle-by-particle methodology goes beyond traditional light scattering and other ensemble techniques in providing high-resolution particle size distributions and validates data with information-rich video files of the particles moving under Brownian motion. NanoSight’s simultaneous multiparameter characterization matches the demands of complex biological systems, hence its wide application in development of drug delivery systems, of viral vaccines, and in nanotoxicology. This real-time data gives insight into the kinetics of protein aggregation and other time-dependent phenomena in a qualitative and quantitative manner.
NanoSight has a growing role in biodiagnostics, being proven in detection and speciation of nanovesicles (exosomes) and microvesicles. It has installed more than 450 systems worldwide with users including BASF, GlaxoSmithKline, Merck, Novartis, Pfizer, Proctor and Gamble, Roche, and Unilever together with the most eminent universities and research institutes. For more information, visit www.nanosight.com.
Cook Pharmica Receives Milestone FDA Approval
Cook Pharmica LLC recently announced it has received its first approval from the US FDA to manufacture commercial product. The product approval for commercial manufacturing came from the FDA’s Center for Biologics Evaluation and Research following a rigorous pre-approval inspection of Cook Pharmica in February. The inspection covered the company’s new vial filling line, lyophilization capabilities, and facility-wide quality systems.
“This FDA decision marks a very important milestone for our company,” said Tedd Green, President of Cook Pharmica. “This first commercial manufacturing approval opens Cook Pharmica’s doors to the vibrant biopharmaceutical industry as it generates breakthroughs for patients in the United States and worldwide.”
Company executives noted that the FDA’s approval of its vial filling line and lyophilization (freeze-drying) capabilities has already generated widespread industry interest in its full manufacturing and packaging capabilities, with inquiries coming from many leading biopharmaceutical companies. The rigorous preapproval inspection is a prerequisite for commercial manufacturing of clients’ drug product.
“This approval demonstrates Cook Pharmica’s ability and commitment to manufacture high-quality drug products within the FDA’s stringent regulatory standards and practices. Everyone at Cook Pharmica is very pleased to have the opportunity and responsibility to ensure that we deliver a dependable commercial drug-product supply for our clients and ultimately to patients,” added Mr. Green.
The parenteral manufacturing business unit of Cook Pharmica contains both vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging to prepare products for distribution. Capable of filling 15 million vials and 70 million prefilled syringes annually, Cook Pharmica’s assets are available to fill the shortage of domestic drug product manufacturing in the
Cook Pharmica is an integrated contract development and manufacturing organization that provides the pharmaceutical and biopharmaceutical industries with drug substance manufacturing from mammalian cell culture; analytical and formulation development; parenteral manufacturing in vials and prefilled syringes; lyophilization; and secondary packaging. Operating with more than 400 employees in a 900,000-sq-ft, $200-million facility in
D3 Pharma & Encap Drug Delivery Continue Partnership
D3 Pharma Limited recently announced its continuing partnership with Encap Drug Delivery to expedite the commercial manufacturing and product licensing program for its proprietary high-dose oral vitamin D3 product, Plenachol, for the treatment of vitamin D deficiency and insufficiency. Plenachol is a patented liquid-filled capsule formulation of vitamin D3, which was developed in conjunction with Encap and is available at three dose-strengths: 20,000, 40,000, and 100,000 international units.
Plenachol has a unique formulation base, which is free from animal-derived excipients and peanut constituents. The utility of Encap’s world-class capsule liquid-filling technology secures Plenachol as a first and best-in-class high-dose oral vitamin D3 product. Plenachol will continue to be made available as a Specials product during the pre-license phase via Encap Drug Delivery. For more information regarding Plenachol Specials supply please contact: Dr. Janice McLachlan (JMcLachlan@encap
D3 Pharma is a privately owned specialty pharmaceutical company based in the
Encap Drug Delivery is the world’s largest contract development and manufacturing organization (CDMO) totally dedicated to liquid and semi-solid (hot melt) filled capsules. The company was established in 1989 and is a global provider of oral drug delivery and pharmaceutical development services. The company provides clients with fully integrated analytical and formulation development services, clinical trial manufacturing, and high-volume commercial manufacturing. Encap’s state-of-the-art facility in the
XTL Biopharmaceuticals to Acquire Kitov for Up to $48 Million
XTL Biopharmaceuticals Ltd. recently announced it will acquire Kitov Pharmaceuticals Ltd. in consideration for shares as well as cash milestone payments throughout Kitov’s development and business progress of up to $48 million, which may be payable in XTL shares.
Kitov Pharmaceuticals Ltd., a company that researches and develops combination drug products, has focused on the treatment of hypertension and pain induced by osteoarthritis with its lead drug product, which is now ready to begin a Phase III clinical trial under an FDA Special Protocol Assessment (SPA).
According to the agreement, XTL shall allocate shares and warrants to Kitov shareholders representing 19.9% of the company’s issued and outstanding share capital upon such allocations. In addition, XTL shall pay cash milestone payments throughout the development and business progress, which may add up to $48 million. XTL may pay such payment by issuing its shares representing up to 26.4% of XTL issued and outstanding share capital post the transaction.
Kitov shareholders undertook a voluntary lock-up period in relation to the shares received in the transaction (including shares received upon meeting milestones) for a period of 12 to 24 months from the date of closing, except for part of the milestone payment shares. XTL has undertaken to execute a Phase III development plan for Kitov’s lead drug.
According to this undertaking, the company will invest up to $1.5 million in financing the sole planned pivotal trial, which will be conducted over an 18-month period. If XTL fails to meet this undertaking (to perform the aforementioned development plan) excluding certain cases, the voluntary lock-up period will expire for 50% of the company’s restricted shares allocated to Kitov. Kitov estimates it will require an accumulative investment of approximately $9 million for the development of its lead drug and through its approval for marketing.
Upon the completion of the transaction, Dr. Paul Waymack will join the board of directors of XTL as Active Chairman of the board and President. He will be responsible for the clinical and regulatory development of all of XTL’s products. Dr. Waymack is the founder of Kitov and has many years of experience in drug development, including interacting with the US FDA. Kitov will have the right to appoint an additional director to XTL’s board.
The completion of the transaction is contingent upon meeting several conditions, among others: Due diligence; pre-ruling from the Israeli Tax Authority; valuation report for Kitov; approval of the general meeting of the XTL’s shareholders; approval of the Tel-Aviv Stock Exchange; completion of the transaction by September 15, 2012.
“We are happy to acquire Kitov with its late-stage drugs. Kitov and its experienced team bring a high level of development capabilities, especially Dr. Paul Waymack, who previously worked for the FDA and has been developing drugs for many years,” said David Grossman, CEO of XTL. “We are sure his contribution will benefit all of our products in development.”
Ronen Twito, XTL’s Deputy CEO and CFO noted that “the structure of the transaction, by which XTL makes a down payment in shares, plus additional shares or payments upon meeting milestones throughout the development, creates common business interest with Kitov shareholders, which enables putting the financial and business efforts for the benefit of the products development and success of XTL.”
XTL Biopharmaceuticals, Ltd., a biopharmaceutical company, focuses on the acquisition, development, and commercialization of pharmaceutical products for the treatment of clinical unmet needs. XTL is focused on late-stage clinical development of drugs for the treatment of multiple myeloma, schizophrenia, and hepatitis C. For more information, visit www.xtlbio.com.
KineMed Announces Biomarker Discovery Collaboration With Major Pharma Co.
KineMed, Inc. recently announced a multi-year R&D collaboration with GlaxoSmithKline plc (GSK) that will apply KineMed’s proprietary biomarker discovery platform in therapeutic areas of interest to GSK. The collaboration will seek to identify, optimize, and validate novel biomarkers that would enable more informed and timely decision-making in clinical trials of compounds for muscle wasting, fibrosis, and metabolic diseases.
“We are delighted to announce this collaboration,” said David Fineman, President & CEO of KineMed. “The marriage of KineMed’s insights into biology with GSK’s clinical portfolio marks the start of an exceptional initiative to advance innovative evidence-based medicines.”
“Our shared goal with GSK is to identify causal pathways and kinetic signatures that can better inform drug development decisions,” added Marc Hellerstein, MD, PhD, Chief of the Scientific Advisory Board of KineMed. “The missing links in developing drugs to treat muscle wasting, fibrosis, and metabolic diseases have been reliable biomarkers that measure the degree to which we are having therapeutic impact on their underlying disease processes. KineMed’s technology, which measures the dynamics of cellular biochemical networks, is focused on developing better metrics of the disease pathology of those disorders and therefore generates competitive advantage in developing effective drugs against them.”
KineMed, Inc. is a biomarker discovery and development company based in
KineMed’s established, proprietary platform assists pharmaceutical collaborators by revealing the mechanism of action of complex diseases and providing quantitative measures of the effects of drugs on these causal processes. The company’s biomarkers are fully translational from animal to man, seamlessly harmonizing data across preclinical and clinical phases of development, through to the diagnosis and management of disease.
KineMed is seeking further broad collaborations with biotechnology, pharmaceutical, CRO, histopathology, diagnostics, and medical instrument partners. For more information, visit www.kinemed.com.
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