8/15/2012
Quintiles Acquires Company to Advance Personalized Medicine
Quintiles recently announced the acquisition of Expression Analysis, Inc. (EA), a premier provider of genomics testing and analysis to biopharma, academic, government, and non-profit customers, to help biopharmaceutical companies significantly improve drug development productivity and deliver greater value.
Terms of the transaction were not disclosed. This is the latest in a series of acquisitions and alliances designed to help Quintiles’ customers leverage the power of genomics to better understand diseases; develop diagnostic tools; and deliver safer, more effective therapies based on the genetic makeup of the disease and the patient.
“The addition of EA’s Genomic Know-How to Quintiles is another step forward in our efforts to bring personalized medicine into mainstream drug development,” said Thomas Wollman, Senior Vice President, Quintiles Global Laboratories. “Its expertise in genetic sequencing and advanced bioinformatics is essential to understanding diseases and drugs at the molecular level. That’s a huge step in creating more value across the healthcare spectrum.”
EA has about 77 employees, most based in its offices near
“The combination of Quintiles Global Laboratories and EA genomic technology excellence will facilitate worldwide access to resources and expertise to drive improvements in the diagnosis, treatment, and management of complex disease,” added Steve McPhail, EA President and Chief Executive Officer. “EA can now play a global role in helping biopharma succeed in the New Health. This is the right move for our company and our employees. Our mission perfectly fits Quintiles’ strategy to use genomic data and advanced informatics to yield actionable insights and more effective personalized treatments.”
EA provides whole genome to focused-set gene expression and genotyping assays, along with next-generation sequencing services, sequence enrichment technologies, and bioinformatics support. It offers a broad range of services across multiple platforms. Its quality system follows CLSI guidelines and its CLIA-registered laboratory supports GLP compliance.
Quintiles Global Laboratories supports trials worldwide with wholly owned facilities in the
Oculus Innovative Sciences Announces Licensing Agreement
Oculus Innovative Sciences, Inc. recently announced the exclusive licensing of the company’s Microcyn-based human healthcare products in
“Since our founding in 2007, More Pharma has established a track record of strong growth because of our ability to identify and partner with cutting-edge pharmaceutical technologies,” said Guillermo Ibarra, More Pharma’s CEO. “We believe the Microcyn Technology – already proven and with a dominant share of the Mexican market – is a compelling addition to our product portfolio, allowing us to build upon Oculus’ established success in the Mexican market and affording us the opportunity to achieve similar commercial success throughout the South and Central American and Caribbean countries.”
Under the terms of the agreement, More Pharma will pay Oculus an up-front $5.1-million licensing fee. The transition of the marketing and sales effort in
“We are excited about partnering with More Pharma and their rapidly growing sales and marketing teams in Mexico, the Caribbean, Central, and South America,” added Hoji Alimi, CEO of Oculus. “We believe this positions us for accelerated long-term unit sales growth in
Founded in 2007, More Pharma is a pharmaceutical company with strong growth performance and a team of more than 300 people. The company has a talented sales and marketing team with significant prior experience with large international pharmaceutical companies. For more information, visit www.morepharmacorp.com.
Oculus Innovative Sciences is a commercial healthcare company that designs, produces, and markets innovative, safe, and effective healthcare products. Oculus is pioneering innovative solutions in multiple markets, including dermatology, oral care, surgical, wound care, animal healthcare, and others and has commercialized products in the US, Europe, India, China, and Mexico and select Middle East countries. For more information, visit www.oculusis.com.
GeNO LLC Receives Two Additional Patents for Inhaled Drug Delivery
GeNO LLC recently announced it has been awarded two new
“These two new patents are important additions to our company’s strong intellectual property portfolio, and extend the company’s patent protection into year 2030,” said GeNO LLC Founder and President Dr. David Fine. “It is unusual for a drug company already in Phase II clinical trials to have 18 years of patent protection on its key chemistry.”
GeNO is developing three unique nitric oxide delivery platforms: a stand-alone gas cylinder system for hospital and outpatient use, a ventilator-based platform for Intensive Care Unit use, and a pocket-sized ambulatory system for chronic outpatient use. All of the platforms are designed to deliver extremely low levels of the toxic by-product nitrogen dioxide that are undetectable by conventional means, while also addressing the cost, complexity, and lack of portability of approved inhaled nitric oxide treatment systems. GeNOnitric oxide gas has the potential for treatment of a multitude of serious pulmonary and cardiac diseases, and potentially could reach a much larger group of patients.
GeNO recently completed a Phase II pilot study of its nitric oxide for use as a diagnostic in Pulmonary Arterial Hypertension (PAH). The company is currently performing a dose-escalation trial for the Treatment of Pulmonary Hypertension in patients with PAH and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF).
Additional study details can be found on http://clinicaltrials.gov/ – ClinicalTrials.gov Identifier NCT01265888. At present, GeNO’s delivery technologies are investigational and are not approved by regulatory authorities.
GeNO LLC, founded in 2006, is a privately held biotechnology company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the true potential of inhaled nitric oxide to be realized for the treatment of a multitude of diseases. The company is focused on applying its technology to delivering inhaled NO to patients in a variety of settings, including ambulatory and in-home use for potential chronic treatment. GeNO will provide stand-alone medical devices and combination products that include the base delivery system and GeNO’s nitric oxide gas. GeNO’s systems have been designated as Combination Products by the FDA Office of Combination Products, with the Division of Cardiovascular and Renal Products designated as the lead reviewer for GeNO’s initial INDs. The combination products will be regulated by the FDA as new drugs with their own NDAs. For more information, visit www.genollc.com.
NanoViricides Reports Oral Administration of Drug is Effective
NanoViricides, Inc. recently announced that an anti-influenza drug candidate under its FluCide program is effective when given orally. The company has received information that a FluCide drug candidate designed for oral administration has shown very strong efficacy in corresponding animal studies. This information was received from the contract laboratory that performed the studies, namely, KARD Scientific, Inc. The studies involved the same highly lethal animal model the company has continued to use for its influenza drug development program. The company is awaiting data from the studies and intends to release additional information as the data are analyzed and studied.
“An orally administered drug is highly desirable for treating out-patient influenza,” said Anil R. Diwan, PhD, President of NanoViricides. “We are pleasantly surprised that the modifications that we have been studying for the development of a nanoviricide that can be orally effective have indeed succeeded. Molecules that nanomedicines are composed of are notoriously difficult to develop into orally available drugs. This is indeed a coup for our nanomedicine technologies.”
“We are very excited by the success of this oral administration study and look forward to the data,” added Randall W. Barton, Chief Scientific Officer of NanoViricides. “An orally available FluCide will have a significant impact on our anti-influenza program.”
“An orally administered drug is highly desirable for treating out-patient influenza,” elaborated Eugene Seymour, MD, MPH, CEO of NanoViricides. “This will complement our proposed IV piggy-back therapy for the critically ill hospitalized patients. This administration route enables quick and strong response.”
Nanoviricides, Inc. has been working on the development of an orally available nanoviricide for several years now. The essential chemistries were finally worked out during the CMC studies for its current FluCide drug candidate. An initial feasibility study to determine whether a nanoviricide anti-influenza drug candidate would work when administered orally was undertaken perviously and had shown positive indications. The company continued further development and has now completed a definitive animal model study to determine whether one of the FluCide anti-influenza drug candidates was effective when administered orally.
The study was conducted by KARD Scientific, Inc. Dr.
This was a double-blind study. Until the data are received and the code is broken by the company scientists, the identity of the FluCide drug candidates that were orally active will not be known. The company expects to receive information from the various analyses in this study over the next several weeks, as the data are compiled and returned by analytical laboratories. The company intends to provide additional information as the data become available and are analyzed by its scientific staff.
NanoViricides, Inc. is a development stage company that is creating special purpose nanomaterials for viral therapy. The company’s novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. For more information, visit www.nanoviricides.com.
Protalix BioTherapeutics Receives Clearance to Initiate Study
Protalix BioTherapeutics, Inc. recently announced it has received clearance of its
PRX-102 is a proprietary plant cell-expressed, chemically modified, recombinant alpha-galactosidase-A in development as a long-term enzyme replacement therapy (ERT) for the treatment of Fabry disease. The Phase I/II clinical trial is designed as a multi-center, open label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of PRX-102 in adult Fabry patients.
“We are very excited to begin the clinical development of PRX-102, which we believe may prove to present an important improvement to the well being of patients with Fabry disease, a rare, genetic lysosomal storage disorder affecting approximately 8,000 people globally,” said Dr. David Aviezer, Protalix’s President and Chief Executive Officer. “We have designed PRX-102 as a potentially improved version of the currently marketed enzyme replacement therapies for Fabry disease given its potential to be a more stable, potent, and specific enzyme. This enzyme is expressed through ProCellEx, our proprietary, plant cell-based protein expression system. We are also excited that another biotherapeutic protein evolving from our ProcellEx platform technology is anticipated to enter clinical development shortly.”
Eighteen adult Fabry patients will be enrolled in one of three dosing groups. Each patient will receive intravenous infusions of PRX-102 every 2 weeks for 12 weeks, and will be infused sequentially and stepwise in order to evaluate safety. Exploratory efficacy parameters will be evaluated as a preliminary assessment. Following the end of the trial, the company intends to offer patients the option to continue to receive PRX-102 in an open-label extension study.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, ELELYSO (taliglucerase alfa), was approved for marketing by the US FDA on May 1, 2012, and is partnered with Pfizer Inc. for worldwide development and commercialization, excluding
Theorem Clinical Research & Gallus BioPharmaceuticals Announce Exclusive Partnership
Theorem Clinical Research has entered an exclusive partnership with Gallus BioPharmaceuticals in which Gallus will provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to Theorem’s customers. In return, Theorem will offer contract research services to Gallus’ customers to increase both companies’ global reach and accelerate their customers’ products through the clinic to market.
Gallus and Theorem have indicated their collaboration is aimed at addressing various time and cost issues in the current working relationship between sponsor companies and service providers by supporting the needs of their customers to outsource the research, development, and ultimate commercial production of products more cost effectively and to accelerate the path to market.
“Our intent is to make the process as seamless as possible,” said Gallus President and CEO Mark Bamforth.
Theorem is one of the industry’s leading full-service, global CROs providing core clinical research and development services. The company provides core CRO services for Phases I to IV, but with niche business units in the areas of clinical analytics, medical device, and pharmaceutics. Theorem Chief Executive Officer John Potthoff says that many of Theorem’s customers, especially those in Asia, need manufacturing assistance in the
Gallus is a world-class CMO, operating a commercially licensed manufacturing site in
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