3/27/2012
Marinomed’s Nasal Spray Achieves Positive Clinical Results
Marinomed Biotechnologie GmbH, recently announced that data from a clinical trial for the company’s iota-carrageenan nasal spray was presented at the 14th International Symposium on Respiratory Viral Infections (ISRVI) in
The study’s aim was to investigate the effects of a nasal spray containing iota-carrageenan, a polymer derived from red seaweed that helps create a protective antiviral barrier in the nasal cavity. A total of 203 subjects who had experienced the onset of cold symptoms within 48 hours of the study were administered either a placebo saline nasal spray or iota-carrageenan nasal spray, 3 times a day for a period of 7 days. By keeping track of the symptoms associated with common cold and frequently analyzing nasal lavages for viruses or biomarkers, researchers were able to show that iota-carrageenan nasal spray successfully reduced the viral load in nasal secretions and mediated a reduction of disease duration by about 2 days in virus-infected patients.
“These results show that the statement, a cold comes 3 days, stays 3 days, and leaves 3 days, is finally outdated. By reducing the duration of the disease, iota-carrageenan-containing nasal spray is able to increase the quality of life for numerous people concerned and affected by the high incidence of this illness every year,” said Dr. Andreas Grassauer, CEO of Marinomed.
MUV’s Dr. Martin Ludwig presented detailed data from the study in a talk titled Carrageenan Nasal Spray Against Common Cold, a Double Blind Placebo Controlled Prospective Trial.
Marinomed Biotechnologie GmbH was founded in 2006 and develops therapies against respiratory diseases based on an innovative antiviral respiratory technology platform. The usability of this safe and effective technology has been proven by its first marketed product, an antiviral nasal spray. The huge potential of the technology is reflected by Marinomed´s additional products concentrating on influenza, combination products for asthmatics, and other high-risk patients. In addition, the company develops a novel treatment against type I allergy and autoimmune diseases. Marinomed Biotechnologie GmbH is a spin-off from the Veterinary University Vienna and is located in
Bend Research Launches New Biotherapeutics Development Initiative
Bend Research Inc. recently announced an initiative to expand its scientific and engineering expertise into biotherapeutics, including offering new technologies and equipment proven to improve biotherapeutic and vaccine production.
In the new initiative, Bend Research will partner with clients to develop and optimize pharmaceutical engineering processes and technologies by coupling fundamental cellular processes with the optimal cell environment for each phase of production.
“The campaign is grounded in science and engineering fundamentals, with a focus on applying macro-engineering approaches to leverage an understanding of complex cell-biology,” said Dr. Lisa Graham, Senior Vice President at Bend Research. “We’ve validated this approach in our small-molecules business, and we’re now uniquely positioned to bring this valuable experience to the broader biotherapeutics market.”
Bend Research has made a wide range of bioprocessing services and capabilities available to help clients advance biotherapeutic products and processes, capitalizing on the company’s extensive experience in process development, analytical sciences, and formulation science. This includes comprehensive development methodologies, individual tools and models, upstream and downstream bioprocessing solutions, computational modeling at multiple scales, and prototype engineering.
The initiative is the outgrowth of Bend Research’s more than 35 years of experience in the development of small-molecule pharmaceutical delivery systems, formulations, and processes. It builds upon an exclusive relationship of nearly 7 years, in which Bend Research worked with Pfizer to develop new tools and models to advance candidates in the Pfizer biotherapeutics pipeline. Through those projects, innovative tools were developed that streamline production within existing plants and provide other cost-savings opportunities during the design of new plants.
As part of Bend Research’s long-term collaboration with Pfizer, both companies worked on a joint campaign to design the Plant of the Future. The effort was aimed at reducing the capital investment required for new biotherapeutics production facilities by half and reducing conventional plant operating costs by two-thirds. Significant progress and innovations were jointly made toward those goals.
“Pfizer’s partnership with Bend Research has focused on developing innovative new technologies in bioprocessing and integrated process analytics,” explained John Ludwig, Vice President in BioTherapeutics Pharmaceutical Sciences for Pfizer Worldwide Research and Development. “We are pleased these technologies are supporting advancement of our biotherapeutics and vaccines portfolio.”
For more information about the biotherapeutics initiative or Bend Research, please contact Phoenix Ivers via email at Phoenix.Ivers@bendresearch.com, by phone at (541) 382-4100 or 800-706-8655, or visit the Bend Research website at http://www.bendresearch.com/.
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve 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. Bend Research provides formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in biotherapeutics technologies; novel formulations, including solubilization technologies such as spray-dried dispersions and hot-melt extrusion formulations; and controlled-release, inhalation, and nanoparticle technologies.
Particle Sciences & Pernix Therapeutics Enter Development Agreement
Particle Sciences, Inc. recently announced it is developing with Pernix Therapeutics a new topical dermatology product for the pediatric market.
“There are multiple treatments for many pediatric skin conditions,” said Mark Mitchnick, CEO of Particle Sciences. “The unmet need is in the delivery of these agents via a more convenient, and improved vehicle. Particle Sciences is applying advanced drug delivery and formulation technologies to an established pediatric product category. For parents, this product is designed to be a potentially better and easier-to-use product.”
“We are enthusiastic about working with Particle Sciences for this product candidate, which may be another opportunity to further expand our pediatric product line,” added Cooper Collins, Pernix Therapeutics’ President and CEO.
Particle Sciences is an integrated provider of drug development services focusing on emulsions, gels, micro and nano-particulates, drug/device combination products and highly potent compounds across all dosage forms. Through a full range of formulation, analytic, and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic. Visit http://www.particlesciences.com/, email info@particlesciences.com, or contact us at (610) 861–4701 for more information.
FDA Clears Expanded Compatibility for
Ikaria, Inc., recently announced that the Center for Devices and Radiological Health (CDRH) branch of the US FDA has granted 510(k) clearance for compatibility of its INOMAX drug delivery systems with three additional respiratory care devices. The INOMAX DS and the INOMAX DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems, and other respiratory care devices.
The INOMAX DS and INOMAX DSIR are proprietary drug delivery systems that deliver INOMAX (nitric oxide) for inhalation, the only drug approved by the FDA to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX selectively relaxes pulmonary blood vessels, improves oxygenation, and treats HRF in this fragile newborn population.
The FDA’s clearance of these additional respiratory care devices for use with the INOMAX DS and INOMAX DSIR makes Ikaria’s INOMAX drug delivery systems fully compatible with the most commonly used invasive mechanical ventilation methods and non-invasive respiratory strategies in neonatal intensive care units (NICUs), including continuous positive airway pressure (CPAP) and nasal cannulae. This represents
The INOMAX drug delivery systems are now compatible with the Fisher & Paykel Healthcare Bubble CPAP System and the Hamilton-C2 and Hamilton-G5 ventilators. For a complete list of ventilators, anesthesia systems, and other respiratory care devices with which INOMAX drug delivery systems have been validated, please visit www.inomax.com.
The INOMAX DS and INOMAX DSIR drug delivery systems are part of a comprehensive offering known as the INOMAX therapy package. In addition to use of Ikaria’s proprietary, FDA-cleared drug delivery systems, the INOMAX therapy package includes INOMAX (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, 24/7/365 customer service, and all related disposable items.
Ikaria, Inc. is a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients. For more information, please visit www.ikaria.com.
Nektar Therapeutics Moving 30 Research Jobs
Nektar Therapeutics recently announced it is consolidating its US-based research scientists at the company’s existing
“Bringing our highly productive
Nektar will continue to operate its 105,000-square-foot manufacturing and process development facility in
Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain, and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase III clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic in development to treat chronic pain, has completed Phase I development and is being prepared for Phase II development. In oncology, NKTR-102 is being evaluated in a Phase III clinical study for the treatment of metastatic breast cancer and in Phase II studies for the treatment of ovarian and colorectal cancers. Further information about the company and its drug development programs and capabilities may be found online at www.nektar.com.
Bioniche Life Sciences Secures $20 Million
Bioniche Life Sciences Inc. recently announced it has accepted an offer of a $20 million financing from investment funds managed by US-based Capital Royalty L.P. Capital Royalty has agreed to provide a 5-year term loan to Bioniche Life Sciences Inc. to facilitate the company’s corporate growth and support its capital requirements. The terms include a 15% interest rate, with a portion deferred and capitalized for the first 3 years of the term of the loan. An additional royalty interest of 2% will be paid to Capital Royalty on all product sales revenues for the term of the loan. Principal repayments of eight equal installments begin in June, 2015. The transaction is expected to close April 2012.
“We are very pleased that Capital Royalty has expressed its confidence in the company through this strategic investment,” said Mr. Graeme McRae, Chairman, President, and CEO of Bioniche Life Sciences Inc. “Through the due diligence process, Capital Royalty has demonstrated an excellent understanding of our business and commercialization program. It is particularly gratifying to be able to receive such an investment with no dilution of our equity shareholders.”
“We welcome the opportunity to develop and fund customized financing structures for innovative life science companies like Bioniche,” said Charles Tate, Chairman & Founder of Capital Royalty L.P. “The company has a diverse base of existing revenue in addition to exciting opportunities for future growth.”
Further information about this transaction will be made available via the company’s filings on www.SEDAR.com and www.asx.com.au.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The company’s primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value. For more information, please visit www.Bioniche.com.
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