4/25/2012
Alitair Announces Patent Allowance for Platform Delivery Technology
Alitair Pharmaceuticals, Inc., a mid-stage pharmaceutical company with multiple respiratory product candidates in development, recently announced it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its ion-exchange resin platform drug delivery technology, REA. Alitair has out-licensed two product candidates utilizing its REA platform technology, and additional product candidates are available for out-licensing.
“Our propriety ion exchange resin delivery platform can be utilized across a range of therapeutic classes and with many different molecules,” said Alitair President and CEO, William W. Howard, PhD. “The REA platform technology allows us to improve upon currently available therapies and create new oral-solid formulations with less-frequent dosing schedules, both of which have been shown to improve patient adherence.”
“Receiving this Notice of Allowance is an important milestone in our product development strategy and the growth of Alitair,” continued Mr. Howard. “We will continue to pursue additional patent protection in the
Alitair Pharmaceuticals, Inc. discovers, invents, and develops medicines for the treatment of respiratory illnesses. Alitair has out-licensed two prescription cough candidates that use its proprietary ion-exchange resin technology, REA, and other product candidates are available for out-licensing. Additional information about Alitair is available at www.alitair.com or by calling Faith Pomeroy-Ward, Vice President, Corporate Development, at 817-490-5152 or emailing at faith@alitair.com.
EMD Millipore Launches Model for In Vitro Transdermal Diffusion Studies
EMD Millipore recently introduced Strat-M membrane for screening compounds and formulations via in vitro diffusion studies. The synthetic membrane can be successfully used in place of human or animal skin to provide meaningful and reproducible information about permeation characteristics of the compound through human skin.
Strat-M membrane is a synthetic membrane constructed of multiple layers of polyethersulfone polymer creating morphology similar to human skin; membrane layers are increasingly more porous and thick through the depth of the membrane. After casting, the membrane undergoes a post treatment to impart lipophilic characteristics similar to human skin.
During development of transdermal drugs and personal care products, assessment of percutaneous adsorption and diffusion of the active ingredients is typically conducted using human cadaver skin or animal skin models (rat, mouse, pig). Unfortunately, a number of drawbacks to these biological models exist – the most significant being high variability. The diffusion rate through human cadaver skin is dependent on the site from which the skin is removed and affected by the age, race, and sex of the donor. Plus, biological models have special storage requirements, may be difficult to procure, and are considered biohazard and need special disposal.
“Results from our internal studies indicate that diffusion through the Strat-M membrane is predictive of diffusion through human skin for a wide range of compounds and formulations,” said John Sweeney, Head of Life Science Business Field, EMD Millipore. “In most cases, the correlation between Strat-M membrane and human skin is much better than the commonly used animal skin models for in vitro testing of transdermal formulations. Furthermore, the benefits of a synthetic test model with low variability simplify experimental design and data analysis.”
EMD Millipore is the Life Science division of Merck KGaA of
Idenix Provides Update on Clinical Development Programs
Idenix Pharmaceuticals, Inc. recently announced data from a Phase I clinical trial of IDX719, an NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection, demonstrating potent pan-genotypic antiviral activity with single doses. In January 2012, Idenix initiated a Phase I clinical study of IDX719.
The first part of the study evaluated the safety, pharmacokinetics, and food effect of IDX719 in 40 healthy volunteers at single doses ranging from 5 to 100 mg. Eight healthy volunteers received 100 mg of IDX719 daily for 7 days. All doses were well tolerated, and pharmacokinetic data supports once-daily dosing in future studies. In the second part of the Phase I study, single-ascending doses of IDX719 achieved substantial viral load reductions in the following cohorts of HCV-infected patients:
-A cohort of 12 HCV genotype 1-infected patients received single IDX719 doses of 1, 5, 10, 25, 50 or 100 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log10, 2.6 log10, 3.3 log10, 3.7 log10, 2.8 log10, and 3.5 log10, respectively;
-A cohort of three HCV genotype 2-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 0.4 log10, 3.2 log10 and 3.5 log10, respectively; and
-A cohort of three HCV genotype 3-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 2.2 log10, 3.7 log10 and 3.3 log10, respectively.
The single-dose data were presented at the Cambridge Healthtech Institute’s 5th Annual HCV Drug Discovery meeting this week in
“These single-dose IDX719 data show potent viral load reductions, with some patients maintaining viral suppression out to three days,” said Douglas Mayers, Chief Medical Officer of Idenix Pharmaceuticals. “We are pleased with the promising antiviral activity in genotypes 1, 2 and 3, and we look forward to seeing multiple-dose data in a larger number of patients from the ongoing 3-day proof-of-concept study.”
Additionally, Idenix has completed enrollment of the second cohort of 30 patients in the ongoing 12-week Phase IIb study of IDX184, an HCV nucleotide inhibitor, in combination with pegylated interferon and ribavirin (PegIFN/RBV). IDX184 continues to be safe and well tolerated with no treatment-emergent serious adverse events reported and a side effect profile similar to that of PegIFN/RBV. As the study currently remains blinded, further data from the ongoing clinical trial will be available in the second half of 2012.
“Idenix’s clinical programs have made significant progress in the past few months. For IDX184, we are looking forward to initiating a combination study with a protease inhibitor and ribavirin in the near-term to establish the safety and potency of an all-oral IDX184-containing regimen, and, if successful, potentially support a Phase III clinical program,” said Ron Renaud, Idenix’s President and Chief Executive Officer. “We are also very pleased with the early viral load reduction data for IDX719. Our ultimate goal is to advance a proprietary, pan-genotypic HCV treatment regimen. We intend to evaluate the combination of IDX184 and IDX719 in a clinical trial that is planned to begin by the end of this year.”
Idenix Pharmaceuticals, Inc., headquartered in
NuSil Technology Announces Major Expansion
NuSil Technology LLC, the global leader in silicone materials for the healthcare, aerospace, pharmaceutical, aircraft, and drug delivery industries, recently announced plans for a major facility and capacity expansion in Bakersfield, CA. Construction of a third building is complete, and the site is on track to reach a total of seven buildings on the 15-acre campus.
“This facility expansion will result in increased employment opportunities across many functional areas at NuSil Technology’s
The newly completed third building significantly increases the polymer processing capacity while adding additional warehousing space. The fourth building, at approximately 35,000 sq ft, is now under construction and is scheduled for completion in September 2012. This new structure will become the center for Quality Assurance, Human Resources, and Engineering, and will feature an enlarged QA testing laboratory and expanded office facilities. Two additional manufacturing buildings have been designed and are quickly entering the permit stage.
“The goal of this campus expansion is to increase plant capacity by three to four times over the next few years,” said Jim Yabsley, Vice President of Engineering.
NuSil is a leading formulator of silicone compounds for healthcare, aerospace, electronics and other applications requiring precise, predictable materials performance. ISO 9001-certified since 1994 and AS 9100-certified since 2008, NuSil operates state-of-the-art laboratories and processing facilities in
Baxter International’s New Plant to Bring 1,500 High-Paying Jobs
Baxter International Inc. recently announced it will build a new state-of-the-art manufacturing facility in
Baxter expects capital investments at the
”This investment demonstrates our long-term commitment to patients around the world who rely on our plasma-based therapies,” said Robert L. Parkinson, Jr., Baxter’s Chairman and CEO.
Construction will begin this year at the new
”We would like to thank Governor Nathan Deal and the many other officials involved in the site selection process, and we look forward to becoming part of the
In connection with this investment, the company also expects to create more than 200 new positions in
Baxter is a scientific leader and innovator in plasma-derived therapies, with a focus on providing solutions to unmet patient needs. Its products include GAMMAGARD LIQUID (marketed as KIOVIG outside the US and Canada), an immunoglobulin therapy (IG) for people living with primary immunodeficiency (PI), albumin therapies used to treat burns and maintain adequate fluid volume in critically ill patients, as well as blood protein therapies for people suffering from alpha-1 antitrypsin deficiency. The company continues to investigate its treatments in additional areas of significant patient need, including multifocal motor neuropathy and Alzheimer’s disease. These products are produced from plasma that is collected from human donors.
Spinnovation Biologics Predicts Biomanufacturing Success
With expertise and know-how in high-end analysis for biologics, Spinnovation Biologics recently announced the launch of a breakthrough solution -Spedia-Predict- for Bioprocess performance troubleshooting and performance prediction of bioproduction, at the annual Bioprocess International European meeting.
Spedia-Predict monitors and validates process-critical parameters as a company looks to manage the culture media consistency used in their production environment. Good Manufacturing Practice (GMP) and FDA Quality by Design (QbD) approaches demand close control, but traditional analytical methodology can be costly, time-consuming, and require sample preparation ahead of measurement. They also lack the ability to characterize chemically complex media. As a result, many companies monitor only a handful of components, failing to get the complete picture and missing information on how it will perform in scale-up.
Spedia-Predict rapidly profiles most constituents in a medium; it delivers quantitative data and can be applied equally to chemically fully defined or complex media. Spedia-Predict allows identification of markers that can correlate with performance of a specific bioprocess, and monitor batch-to-batch consistency, for example. As a result, it helps to prevent failure and performance variability in large-scale commercial production, by enabling efficient and cost-effective processes.
“Using Spedia-Predict, we help our clients to understand and monitor the factors that are most influential to their cell culture performance,” said Dr. Frederic Girard, CEO. “This is a huge advantage. Importantly, we provide information early in production planning – effectively establishing a QC standard – which can then be used in routine manufacturing to reduce the risk of process failure, and increase the consistency in production performance. Risk factors are reduced and replaced with consistent, reproducible results.”
Spinnovation’s core expertise in Nuclear Magnetic Resonance Spectroscopy (NMR) and Mass Spectrometry (MS) to study molecules and materials is increasingly being applied in the biopharma production environment. The introduction of Spedia-Predict demonstrates the company’s continuous efforts to develop and implement new analytical methods to meet most demanding industry requirements. For more information, visit http://www.spinnovation-biologics.com/services/spedia-predict.html.
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