RALEIGH, N.C.--(BUSINESS WIRE)--September 5, 2012--LipoScience, Inc., an in vitro diagnostic company committed to advancing patient care in cardiovascular, metabolic and other diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera® Clinical Analyzer.

The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology. Ease-of-use and walk-away automation provide efficient workflow to maximize laboratory resources while producing high quality results.

“LipoScience is pioneering a new field of personalized diagnostics based on NMR technology,” said Rick Brajer, Chief Executive Officer of LipoScience. “The FDA clearance of our Vantera Clinical Analyzer is a pivotal event that advances our vision of decentralizing our technology and becoming a clinical standard of care.”

The first assay cleared on this new in vitro diagnostic platform is low density lipoprotein particle number (LDL-P). LDL-P is a key component of LipoScience’s NMR LipoProfile® test, which provides physicians and their patients with actionable information to personalize management of risk for heart disease from a single blood sample. To date, over 8 million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart health.

“Historically, all NMR LipoProfile tests have been performed at LipoScience’s CLIA-certified laboratory in North Carolina,” said Tom Clement, Vice President of Regulatory and Quality Affairs. “The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S., as well as at leading medical centers and hospital outreach laboratories, in order to drive both geographic expansion and the technology adoption necessary for successful execution of our market conversion strategy.”

About LipoScience, Inc. 

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary diagnostic test, the NMR LipoProfile® test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 8 million NMR LipoProfile tests have been ordered. LipoScience’s automated clinical analyzer, Vantera has recently been cleared by the FDA and will be placed with national and regional clinical laboratories. LipoScience is driving toward a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of metabolic and other diseases. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

RESEARCH TRIANGLE PARK, NC– June 20, 2012 -­‐ Liquidia Technologies today announced the initiation of a broad, multi-­‐year collaboration with GlaxoSmithKline (GSK), which has acquired exclusive rights to research and develop certain vaccine and inhaled product candidates using the company’s proprietary PRINT® (Particle Replication In Non-­‐Wetting Templates) technology. Liquidia’s PRINT technology is a powerful and versatile nanoparticle technology product development and manufacturing platform that is changing the way companies engineer healthcare products.

RESEARCH TRIANGLE PARK, NC– June 20, 2012 -­‐ Liquidia Technologies today announced the initiation of a broad, multi-­‐year collaboration with GlaxoSmithKline (GSK), which has acquired exclusive rights to research and develop certain vaccine and inhaled product candidates using the company’s proprietary PRINT® (Particle Replication In Non-­‐Wetting Templates) technology. Liquidia’s PRINT technology is a powerful and versatile nanoparticle technology product development and manufacturing platform that is changing the way companies engineer healthcare products.

Full Release Attached

Liquidia Technologies, a small Research Triangle Park drug-development company, has signed a transformational licensing deal with pharmaceutical giant GlaxoSmithKline that could be worth up to several hundred million dollars.

Liquidia said Wednesday that GSK has licensed the rights to develop certain experimental vaccines and inhaled drugs using Liquidia’s proprietary nanotechnology, but the announcement didn’t include specifics. Liquidia said that a combination of payments from GSK -- including up-front money, research-and-development funding and milestone payments -- could amount to “up to several hundred million dollars” if all goes well.

Liquidia and GSK, which are collaborating on the drug-development efforts, are neighbors. London-based GSK has 3,800 workers at its U.S. headquarters in RTP and another 600 employees in Zebulon.

Liquidia was founded in 2004 based on the nanotechnology research of Joseph DeSimone, a chemist at N.C. State University and UNC-Chapel Hill. DeSimone founded the company with colleagues from UNC.

The privately held company has been nurtured by venture capital investments up to now, including funding provided by Triangle firms Pappas Ventures and the Wakefield Group.

“We are very pleased to have the opportunity to work with GSK, a company known for its commitment to scientific excellence, medicinal chemistry expertise and expansive knowledge of proprietary compounds that could potentially benefit from Liquidia’s...technology,” Liquidia CEO Neal Fowler said in a statement.

Liquidia has retained the rights to develop certain respiratory and vaccine medicines, as well as the right to use its technology to develop drugs in other therapeutic areas.

The company says that its PRINT technology -- Particle Replication In Non-Wetting Templates -- has the potential to develop next-generation drugs. For example, its technology is geared to deliver inhaled drugs to specific regions of the lung, which holds great promise for treating diseases such tuberculosis and cystic fibrosis.

Read more here: http://www.newsobserver.com/2012/06/20/2148891/liquidia-technologies-signs-lucrative.html#storylink=cpy

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Liquidia Technologies today announced the results of two newly-released studies that illustrate the unique benefits of the company’s proprietary PRINT® (Particle Replication In Non-Wetting Templates) platform in the development of advanced respiratory therapeutics. Despite the high prevalence of lung disease, optimizing critical parameters of respiratory therapeutics to improve their pulmonary distribution and effectiveness has remained a challenge for the biopharmaceutical industry. These studies demonstrate how the PRINT platform can be used for respiratory drugs by precisely engineering particles with controlled shape, size, and chemistry, all characteristics that could lead to better lung delivery and therapeutic performance. Aspects of these findings were published in the Journal of Drug Delivery and presented at the Respiratory Drug Delivery Conference being held May 13-17, 2012 in Phoenix, Arizona.

Read the full article at BioSpace.

DURHAM – Durham-based Liquidia Technologies’ is working on developing vaccines using tiny particles manufactured as carriers of substances meant to trigger or boost the body’s immune response. The goal is to “finely tune” that response, and increase vaccine efficiency and safety, the company’s chief executive said.

But the start-up company could also branch into other applications with its technology, Liquidia’s CEO Neal Fowler said Wednesday. Speaking as part of a panel at the Nanotech Commercialization Conference in Durham, Fowler said the company has established a deal with Procter & Gamble for the technology’s use in consumer products, and could look into other areas outside of life science as well.

The two-day conference, hosted by the NanoBusiness Commercialization Association and other groups, was focused on businesses in that use nanotechnology, which is technology conducted at a very small scale – the nano scale.

Charles Hamner, chair of The Hamner Institutes for Health Sciences, a nonprofit research organization that’s based in the Research Triangle Park, said the business development using nanotechnology is still in the innovation stage of development, but he believes it’s about to enter the growth stage, which is the stage before maturity.

Hamner, who was also on the panel alongside Fowler, said he believes resources need to be allocated to help grow nanotechnology’s use. John Hardin, executive director of the N.C. Department of Commerce’s Office of Science & Technology, advocated for the government’s role in allocating public resources to help stimulate early stage business sectors like business using nanotechnology.

Hardin said has office has been pushing nanotechnology, but added that his office also been selected for review by state legislators that he believes will lead to reduced funding.

“(We’re) now at a prime time to support nanotechnology and its growth,” Hamner said.

As for Liquidia’s development, Fowler said the company is now focused on working on its “second generation” vaccine candidates – vaccines for malaria and pneumonia.

The first generation involved work on an influenza vaccine candidate. The company announced the launch of a Phase 1 clinical trial for a seasonal influenza vaccine in 2010, which was a trial that helped the company show the safety of its technology, Fowler said.

In February of last year, the company announced a collaboration with the international nonprofit PATH Malaria Vaccine Initiative to explore using the company’s technology in the development of “next generation” malaria vaccines.

In March, Liquidia announced a $10 million equity investment from the Bill & Melinda Gates Foundation for development and commercialization of vaccines and therapeutics with a focus on malaria and flu vaccines.

Then in December, Liquidia announced a collaborative agreement with PATH to do preclinical proof-of-concept studies for a next-generation pneumonia vaccine.

“We’re in preclinical animal models now, we hope to get to human in the not-too-distant future,” Fowler said.

The company’s board has also had discussions about other applications for the company’s technology, Fowler said, including spinning out one application, or licensing it for another, as a way to generate revenue.

“We’ve had a lot of discussions about the right time to do that,” he said. “A lot of other applications outside vaccines are at a very early stage,” he added.

The company now has a partnership “looking at a couple consumer products,” with Procter & Gamble, a company that manufactures personal care, cleaning, laundry detergents, prescription drugs and other products.

“Our challenge going forward is, our opportunity will be, how to pace those events to get the technology (going) faster and faster,” Fowler said. “(We) had to go through three or four years of understanding what we have on our hands, (we’re) now figuring out how to unleash it.”

The company could use its particle technology across an array of products, he said, speaking generally.

“The world is full of particles, (we could) produce things for diagnostics, consumer products, solar panels to green building materials,” he said. “We can use our technology for any of that.”

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Liquidia Technologies today announced the Company’s CEO, Neal Fowler, will participate in a panel discussion titled “How to Create 54 Liquidias” at the upcoming Nanotech Commercialization Conference (NCC) on April 4th, 2012. The concept of the panel is to explore how North Carolina can further create opportunities and provide resources that will lay the foundation for innovators to build successful companies like Liquidia in the region. The NCC is the preeminent nanotechnology conference in the region and is being held this year in Research Triangle Park, North Carolina April 4-5, 2012.

“Through this panel we want to explore the opportunities that exist for our next generation of innovators and how they too can find success in North Carolina”

Over the next decade, nanotechnology has the potential to influence every aspect of our lives, including our energy, food, medicines, water, buildings, and much, much more. According to a published report by BCC Research, the market value of the worldwide nanomedicine industry is estimated to grow at a CAGR of 12.5% to reach $130.9 billion by the fiscal year 2016. The acceptance and application of nanotechnology to everyday products is a foreshadowing of the growth expected across a multitude of fields including medicine, devices, and diagnostics.

“Liquidia’s success continues to be a shining example of what is possible for startup companies that make roots in North Carolina”, said Jim Roberts, Director of Business Development at COIN, “Through this panel we want to explore the opportunities that exist for our next generation of innovators and how they too can find success in North Carolina”.

Chris William, Managing Director of the Private Client Group at Wells Fargo and Executive Producer of the PBS television series, Carolina Business Review, will host the NCC panel that will also include the Chairman of The Hamner Institutes for Health Sciences, Charles E. Hamner, D.V.M., Ph.D., and Executive Director of the Office of Science & Technology for the North Carolina Department of Commerce, John Hardin. Conference details can be found at http://www.nanoevent.org.

ABOUT LIQUIDIA

Liquidia Technologies, founded in 2004, is a privately held biotechnology company located in Research Triangle Park, North Carolina. By leveraging precise fabrication techniques of the semiconductor industry, Liquidia has become the only company in the world with the ability to rapidly design and manufacture precisely engineered particles of virtually any size, shape, or composition using a unique particle engineering and manufacturing platform know as PRINT®. This unique ability to precisely engineer particles enables scientists to explore new product frontiers that, until now, have otherwise been out of reach for the life sciences industry. In addition to the development of its own products, Liquidia licenses its PRINT particle technology and its GMP manufacturing capabilities to support proprietary programs advanced by collaborators. For more information, please go to www.liquidia.com.