Talon Therapeutics’ NDA Accepted for Filing by US FDA Under Subpart H
Talon Therapeutics, Inc. recently announced its NDA seeking accelerated approval of Marqibo (vincristine sulfate liposomes injection) has been accepted for filing by the FDA. Marqibo will be reviewed by the FDA under Subpart H – Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses, for the treatment of adult
“Two important hurdles have been crossed with the acceptance for filing of the Marqibo NDA and affirmation of the accelerated approval review path. We remain 100% focused on our goal of an FDA approval of Marqibo,” said Steven R. Deitcher, President, Chief Executive Officer, and Board Member of Talon Therapeutics. “The patients we are seeking to treat represent a rare hematologic malignancy and have a grave prognosis. The accelerated approval path has the potential to provide access to a new, well-tolerated, and effective treatment more quickly for these patients. We aim to initiate and commence enrollment in the Phase III confirmatory trial, that recently received an SPA, prior to the May PDUFA date.”
In August 2011, Talon received Special Protocol Assessment (SPA) agreement from the FDA for its proposed Phase III confirmatory study, named HALLMARQ, for the treatment of adults greater than or equal to 60 years old with newly diagnosed ALL. In addition to the Phase III adult, front-line ALL study, Talon is developing Marqibo for pediatric cancers (solid tumors and hematologic malignancies) in a Phase I-II clinical study conducted by the National Cancer Institute and for newly diagnosed aggressive Non-Hodgkin’s Lymphoma to be conducted by the German High Grade Non-Hodgkin’s Lymphoma Study Group.
Marqibo is a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon has been primarily developing Marqibo for the treatment of adult, Ph- ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies, such as lymphomas and leukemias. Talon’s encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees. In addition to Marqibo, the company has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well-characterized, proven chemotherapies and enable high-potency dosing without increased toxicity.
Novozymes to Supply Recombumin for Type 2 Diabetes Drug
Novozymes Biopharma, part of Novozymes A/S, recently announced it has concluded an exclusive supply agreement with ConjuChem LLC of Los Angeles, CA. Novozymes will supply its recombinant human albumin, Recombumin, for use in the development of a new GLP-1 analog in Phase II testing for type 2 diabetes. The use of Recombumin in the development of the product potentially significantly reduces dosing frequency, allowing patients to self-inject once per week instead of once or twice daily.
“This supply agreement is a great example of using Novozymes’ Recombumin as a vehicle for extending the half-life of peptides in drug delivery applications,” said Thomas VidebÃ¦k, Executive Vice President of Novozymes’ BioBusiness. “Also the agreement for this new drug will potentially pave the way for the use of Recombumin in other peptide-based therapies.”
Recombumin is the only commercially available, animal-free recombinant human albumin approved for use in human therapeutics. Manufactured to cGMP quality standards in large-scale facilities, the product is compliant with US Pharmacopeia (USP) National Formulary (NF) standards and is supported by a strongly documented safety package and drug master file. These features greatly improve regulatory approval processes for therapeutics, thus accelerating the time to market. In addition, Recombumin offers a secure supply and batch-to-batch consistency, which reduces processing and testing times to drive product efficiencies for manufacturers.
“This exclusive agreement is an excellent partnership for Conjuchem,” added Patrick Soon-Shiong, MD, CEO at ConjuChem. “The Recombumin technology and the strong commitment from Novozymes will be key as we develop next-generation treatment for a disease affecting more than 360 million people worldwide.”
Novozymes is a world leader in bioinnovation, and together with customers across a broad array of industries, it creates tomorrow’s industrial biosolutions, improving customers’ business and the use of the planet’s resources. With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace.
ConjuChem creates novel, next-generation medicines using unique, long-acting therapeutic peptides. Underlying all ConjuChem compounds are bioconjugation platforms called Drug Affinity Complex (DAC) and Preformed Conjugate-Drug Affinity Complex (PC-DAC). When applied to a given peptide, DAC and PC-DAC can create new drugs with similar therapeutic activities but with significantly longer durations of activity and improved safety profiles.
Boehringer Ingelheim Expands its Business With Biosimilars
As part of its corporate strategy, Boehringer Ingelheim recently announced it will establish a new separate business for the development and commercialization of its own biosimilars. Boehringer Ingelheim started more than 30 years ago as a pioneer in biopharmaceuticals with the development and manufacturing of biopharmaceutical therapeutics. Today, Boehringer Ingelheim Biopharmaceuticals is one of the leading companies in this field straight following its strategy to serve best-in-class development and manufacturing for its clients and Boehringer Ingelheim itself.
“We believe that biosimilars will become a major part of the biopharmaceutical market and will enable many more patients access to important medicines,” said Prof. Dr. Wolfram Carius, member of the Board of Managing Directors and responsible for Operations. “We feel confident that we are able to leverage our capabilities in product development, supply, and clinical expertise at Boehringer Ingelheim to offer high-quality Biosimilars understanding patients’ needs.”
Silence Therapeutics Signs siRNA Delivery Collaboration
Silence Therapeutics plc, a leading RNA interference (RNAi) therapeutics company, recently announced it has entered into an agreement with one of the world’s leading global pharmaceutical companies to investigate the application of Silence’s proprietary DACC delivery technology for intravenous delivery of short interfering RNA sequences (siRNAs) to the pulmonary vascular endothelium.
Under the terms of the agreement, Silence’s partner will provide Silence with specific siRNAs, which Silence will formulate with its DACC delivery system. Silence and its partner will undertake in vitro and in vivo studies of the DACC-formulated siRNAs developed under the agreement and select lead candidates for further evaluation. Financial terms were not disclosed.
DACC is a novel lipid delivery system that includes Silence’s proprietary lipid AtuFect and is used to embed siRNAs into a multiple lipid bi-layer structure. Whilst closely related to the AtuPLEX delivery system used in Atu027, Silence’s lead oncology candidate in Phase I trials, DACC has significantly different properties on a physiochemical and pharmacological level. The DACC delivery system is incorporated in Atu111, Silence’s preclinical development candidate for the treatment of acute lung injury, and enables functional, highly specific, and efficient delivery of RNAi therapeutics to the pulmonary vascular endothelium. In preclinical models, the DACC delivery system has demonstrated highly focused delivery to lung tissue and sustained knockdown of the desired target gene expression in this particular cell type. Of note, the DACC delivery system has shown sustained protein knock-down of over 3 weeks.
“We are delighted to be collaborating with another of the world’s largest pharmaceutical companies for the use of our delivery systems to deliver their selected siRNAs,” said Thomas Christély, Chief Executive Officer of Silence Therapeutics. “As we have stated, Silence is now significantly increasing its resource in business development, and we are delighted to be announcing another partnership. We believe that Silence’s proprietary DACC delivery system offers the potential to selectively deliver siRNAs and other oligonucleotides to pulmonary vascular endothelium, and we look forward to working closely with our partner on this project. Functional delivery into target cells is one of the greatest challenges facing most nucleic acid therapies and Silence remains committed to the development of its DACC and its other proprietary delivery systems, including AtuPLEX and DBTC, as it seeks to overcome these challenges.”
UPM Pharmaceuticals to Add Low Humidity, OEB 4 & Specialized Xcelodose Manufacturing Capability
UPM Pharmaceuticals recently announced it will expand its existing manufacturing capacity, including an OEB 4 processing room, a low humidity processing suite, and a unique dedicated Xcelodose production facility. The overall expansion will add almost 50% more manufacturing space for current production.
“To meet our client’s growing needs, UPM is making a major capital commitment to enhance client services,” said UPM’s President, James Gregory. “In response to an increasing number of requests for production of compounds with more stringent environmental safety requirements, UPM is building a unique suite for handling of manufacturing processes associated with OEB 4 compounds. We are also building a dedicated suite for handling and production of low humidity compounds. Finally, as a leader in providing neat API direct-fill-in-a-capsule services using the latest Xcelodose technology, UPM will be developing a unique segregated four-room suite to handle Xcelodose processing and encapsulation activities associated with the 600 and 600S equipment systems. We intend to provide these services under the most strict handling conditions up to and including OEB 4 compounds. With the outstanding service being provided by our skilled R&D, manufacturing, laboratory, and Quality Assurance teams, UPM’s business is significantly growing. This expansion will allow us to keep pace with our clients’ needs and continue our commitment to speed and quality in the services we provide.”
UPM Pharmaceuticals, Inc. is a Baltimore-based, independent drug development and contract manufacturer serving the pharmaceutical and biotechnology industries. They provide high-quality pharmaceutical drug development services, including formulation development, cGMP manufacturing, analytical methods development, and stability testing. They are characterized by the quality, speed, and thoroughness with which they complete all their projects. UPM’s clients enjoy service that is customized and fast with total quality management characteristic of a customer-focused business. Their history includes successful collaborative interactions with virtual to multi-million dollar companies providing them with customized product development services and solutions. UPM focuses on drug development for dosages with oral routes of administration, in solid dosage forms, such as capsules and tablets.
CoreRx Adds Additional Capabilities With New Tablet Press
CoreRx, a leader in early drug contract development, has expanded manufacturing capabilities to include the OYSTAR Manesty FLEXITAB, a fully automated, single station tablet press with a multi-layer tablet function, giving it the unique capacity to produce three-layer tablets using a minimal amount of material. Its variable punch displacement and dwell time can be set to simulate compression on any rotary press using compression forces up to100 kN
CoreRx is a contract research organization providing formulation development, preformulation, analytical, and clinical trial manufacturing to American and European companies since 2006. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. CoreRx’s unique corporate structure creates project teams that work intensively with each client, bringing an extension of their own organization into the CoreRx lab.
As a fully cGMP contract facility, CoreRx provides formulation development, analytical, and clinical material resources, utilizing a variety of multi-layer tablet equipment for combination products. CoreRx also offers development and manufacture of multi-particulate combination drug products. Whether your need is for multiple tablets in a capsule, pellets, granules, nano-particles, co-processed spray dried powders, or multiple powders in capsules, CoreRx has its clients covered.
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