LipoScience Press Release - LipoScience Announces Closing of Initial Public Offering

LipoScience Press Release - LipoScience Announces Closing of Initial Public Offering

RALEIGH, N.C.  – January  30, 2013  – LipoScience, Inc. (NASDAQ:  LPDX) today announced it has closed its previously announced initial public offering of 5,000,000 shares of common stock at a price to the public of $9.00 per share.  In connection with the initial public offering, the underwriters exercised in full their option to purchase an additional 750,000 shares from the company.  As a result, the total initial public offering size was  5,750,000 shares. LipoScience expects to receive, after deducting underwriting discounts and commissions and estimated offering expenses payable by  the company, net proceeds of approximately $44.9 million from the offering.

LipoScience Receives 2012 Diagnostic Marketing Association Creative Communications First Place Award

NMR LipoProfile® test campaign communicates importance of LDL-particles in cardiovascular disease risk and management

RALEIGH, N.C.--(BUSINESS WIRE)--LipoScience, Inc., an in vitro diagnostic company advancing patient care by developing high value proprietary clinical diagnostic tests using nuclear magnetic resonance (NMR) technology, today announced that it has received first place recognition at the 2012 Diagnostic Marketing Association (DxMA) Creative Communications Awards for the integrated print and online category for LipoScience’s NMR LipoProfile® test campaign.

The award was presented at the 2012 DxMA awards reception on April 25 in Chicago. The DxMA recognizes excellence in diagnostics marketing, advertising and promotional programming. LipoScience partnered with Motivation Mechanics, a Philadelphia-based marketing research and communications strategy firm, on the campaign.

“It is an honor to be recognized by the DxMA for our clinical communication initiatives,” said Mark Kirtland, Vice President, Marketing and Business Development at LipoScience. “The goal of our educational campaign continues to focus on increasing awareness of the NMR LipoProfile test and communicating the clinical value it can provide physicians and their patients in managing cardiovascular disease risk.”

“We are extremely proud of this industry award, which acknowledges the efforts of our marketing team to educate the broader physician community,” said Richard O. Brajer, President and Chief Executive Officer of LipoScience.

Selventa Granted Patent for Discovery of Biomarker Profiles

CAMBRIDGE, Mass. – January 23, 2012 – Selventa™, a biomarker discovery company that enables personalized healthcare through stratification of patients based on disease-driving mechanisms, today announced that the U. S. Patent & Trademark Office has issued the Company U.S. Patent No 8,802,109, titled "Computer-aided Discovery of Biomarker Profiles in Complex Biological Systems." This patent, which was issued on December 20, 2011, relates to methods and techniques that facilitate discovery of biomarkers and thus aid in the development of predictive and prognostic diagnostic tests for therapeutics targeting complex multi-factorial diseases.

In particular, the patent describes a method of biomarker discovery using a model representative of one or more causative biophysical or biochemical relationships underlying a biological state in a biological system of interest.  A candidate set of biological data is then compared against the model to discern a candidate biomarker for the biological state.  A sample received from a patient can then be assayed for the presence of the candidate biomarkers to discern a biological state of the patient.

"Using the technique, biomarkers may be developed to predict efficacy or toxic effects of a drug. This may permit a researcher or physician to know, in advance, whether the presenting patient will benefit from or be harmed by administration of the drug," said David de Graaf, Ph.D., President and CEO of Selventa. "In addition, the patented technique facilitates the development of biomarkers as diagnostics for a disease, as a means of making treatment decisions or as a means of stratifying patients in a clinical trial. This will likely improve the success of clinical trials by screening for subjects that are more likely to benefit from the drug and avoiding those who are unlikely to respond."

About Selventa
Founded in 2002 and privately-held, Selventa collaborates with partners to match the optimal treatments for the right patients. The company analyzes molecular patient data to identify key disease-driving mechanisms and accelerates the development process to clarify therapeutic and diagnostic decisions through identification and development of biomarkers for patient stratification. Selventa engages in strategic relationships with leading pharmaceutical and life science companies including clinical research organizations, diagnostic companies and reference laboratories to enable personalized healthcare primarily in autoimmune diseases and oncology.  For more information, visit www.selventa.com.

Finding satisfaction in stratification

CAMBRIDGE, Mass.—Selventa, a personalized healthcare company focused on stratification of patients and development of predictive biomarker panels based on disease-driving mechanisms, recently formed a strategic scientific alliance with Linguamatics, a software solutions company that provides knowledge extraction through its I2E natural language processing (NLP) text-mining platform.

The idea is to combine the analytical capabilities of both companies to efficiently extract complex life science knowledge in a computable, structured, biological expression language format that can be used to interpret large-scale experimental data in the context of published literature.

That format is BEL, a structured language designed to represent scientific findings in a computable form with supporting contextual information, such as tissue, disease, species and publication. BEL is use-neutral, notes Dr. David Milward, chief technology officer at Linguamatics, and it articulates an idea in a manner that is “unambiguous, terse and conveys the facts and associated contexts without loss or ambiguity.” BEL, along with the BEL Framework, is available through a portal to the scientific community to promote the collection, sharing and interchange of structured scientific knowledge. Selventa's discovery platform operates on top of a scientific knowledge base made up of a set of BEL statements.

“The Selventa and Linguamatics collaboration shows how precise, detailed information can be automatically extracted from the literature and provided in a format suitable for further analysis and reasoning,” says Milward. “This will allow reuse of knowledge from the literature, at greater scale and speed.”   Much of the business and the future of Selventa are tied into biomarker discovery and personalized healthcare, David de Graaf, CEO of Selventa, tells ddn.

“The way we get there is having qualified knowledge available to us and to other users and comparing it to patient data sets. It’s a matter of pulling together prior knowledge in a usable manner with the analytics on top,” he says.

He notes that well-structured knowledge is already being customized within the scientific realm by organizations that are able to generate knowledge bases in specific areas, but in many cases they are using resources in China and India, “and we can’t directly compete with that,” he adds. “But well-quantified and organized knowledge is something our clients need and that drew us to Linguamatics so that this general knowledge out there could be put in a more terse and usable form.”

By using NLP-based capabilities to efficiently identify and extract relationships hidden in unstructured text and generate structured data for comprehensive biological investigation and analysis, the I2E platform is said to offer dramatically increased speed, scale and reproducibility, and the possibility to efficiently go back into a textual data source to pull out additional information that has become relevant.

“This partnership is a great strategic fit to facilitate the representation of complex biological knowledge that can be recycled and maximized through our analytical platform,” said de Graaf in the news release about the deal. “Collaborating with Linguamatics will enable rapid yet comprehensive investigation of new areas of biology by extracting computable knowledge from unstructured text. This will lead to innovation on many fronts, such as next-generation sequencing, where well-structured information for reasoning has been limited.”

One of primary goals for Selventa in this partnership is to be able to stratify patients using biomarkers.   “We’re doing a lot of this kind of work through the BEL initiative with Pfizer and along with Linguamatics as well, de Graaf says. He tells ddn that his company has also talked to other people in the knowledge space, whether publishers or other makers of knowledge bases, to get the best data possible.

“When customers acquire their data sets they often acquire broad assets that are shallow. They cover a lot of territory, like everything about clinical trials or a particular kind of chemistry, but what they don’t do is get what they often really need, which might be everything relevant in a particular area, like multiple sclerosis or breast cancer,” de Graaf says. “So you want to go relatively narrow but much deeper by integrating resources, and this is where Linguamatics helps us meet customers’ needs. We have a set of analytic tools that analyze prior experimental data and compare to your current set of experiments, and Linguamatics provides us with a platform for generating well-quantified knowledge from that.”

Having worked at companies like AstraZeneca and Boehringer Ingelheim, de Graaf had previously been involved in the evaluation and acquisition of NLP tools, and says that he came into Selventa already knowing folks at Linguamatics, “and far as I’m concerned, they are a premier provider of NLP solutions,” he says. “Unlike with other NLP platforms, where they are not expandable, Linguamatics meets our needs because its flexible—we knew our platform would require lots of tweaking, and knocking on their door to get technology that could handle that was just logical.”

Looking toward the future, de Graaf says he plans to work with the “best of the best” to implement not only a set of tools to feed into BEL but also to discover and analyze biomarkers, better stratify patients and more.

N.C. diagnostics firm LipoScience files for $86M IPO

Diagnostics company LipoScience aims to become North Carolina’s next public company.

Raleigh, North Carolina-based LipoScience has filed with securities regulators plans to raise up to $86.2 million in an initial public stock offering. It’s the second time LipoScience has flirted with a public stock offering. The company filed IPO plans in 2001, only to withdraw them in 2002 due to market conditions. But recent market conditions have improved; LipoScience’s IPO would follow the Durham company Tranzyme Pharma‘s (NASDAQ:TZYM) $48 million public offering in April.

LipoScience plans to use proceeds from its stock offering to expand its sales and marketing and fund continued R&D for new tests to supplement an already commercialized blood test to gauge the risk of cardiovascular disease. LipoScience is targeting the cholesterol testing market, which represents an estimated 75 million tests each year in the United States.

Last year, LipoScience recorded more than 6 million orders for its lipoprotein test and the company reports that from 2006 to 2010, test orders have increased at a compound annual growth rate of approximately 30 percent. That growth has been helped by insurance industry acceptance of the test. The NMR LipoProfile test is covered by a number of payors including Medicare, TRICARE, WellPoint, United HealthCare and several Blue Cross Blue Shield affiliates.

“We plan to significantly increase our geographic presence across the United States to expand market awareness and penetration of the NMR LipoProfile test, with the goal of ultimately becoming a clinical standard of care,” the company said in the filing.

LipoScience’s proprietary blood test counts the number of lipoprotein particles in a blood sample in order to gauge cardiovascular risks. LipoScience’s patented technology uses nuclear magnetic resonance to test for lipoproteins, which the company says are a better measure of cardiovascular risk than cholesterol levels.

The testing technology was developed at North Carolina State University by biochemistry professor James Otvos, who is now the company’s chief scientific officer.Otvos founded LipoScience in 1994 and by 1999, the company had developed tests to sell to clinicians and diagnostic laboratories. Investors in the company include Durham, North Carolina-based Pappas Ventures and Three Arch Partners, a Bay Area venture firm.

When LipoScience pulled its IPO plans nine years ago, the company’s revenue was $18.5 million. According to LipoScience’s most recent filing, the company generated $39.3 million in 2010 revenue. The company turned a profit of $4.3 million last year. But the filing notes that although LipoScience recorded profits in 2009 and 2010, it incurred a $500,000 loss in the first quarter of 2011. The company does not expect to be profitable this year or in coming years as it expands its growth strategy for its NMR LipoProfile test and develops new diagnostics. The company is also developing tests for diabetes and other diseases.

LipoScience expects that its latest diagnostic device should raise the market potential for its blood tests even more. Right now, blood samples using LipoScience’s tests must be sent to the company’s Raleigh headquarters to complete the testing because it’s the only facility with the proper equipment. But the company has developed a machine, called Vantera, that will allow institutions or laboratory testing facilities to complete that testing at their own sites. Vantera has already been site tested at a number of facilities across the country, including the Mayo Clinic and the Cleveland Clinic. LipoScience plans to file with the U.S. Food and Drug Administration for 510(k) clearance on Vantera by the end of this year.

Dynogen presents results of its positive Phase 2 IBS-d study with DDP225

Dynogen Pharmaceuticals, Inc. announced today the presentation of positive results from its Phase 2a trial of DDP225 in patients with irritable bowel syndrome with diarrhea (IBS-d) at the Digestive Disease Week 2008 (DDW) scientific meeting. The randomized, double-blind, placebo controlled trial established clinical proof-of-concept with statistically significant results for the endpoint of relief of abdominal pain or discomfort associated with IBS-d. Dynogen previously reported top-line results from this Phase 2a trial in December 2007. The DDW abstract was co-authored by Dynogen and a team of investigators from leading clinical centers in Canada. The DDP225 results were presented yesterday in a Distinguished Abstract Plenary session on Neurogastroenterology and Motility by Steven B. Landau, M.D., a member of Dynogen’s Scientific Advisory Board.

Panacos Announces Study Elucidating PA-457's Mechanism of Action Published in Journal of Virology;Findings Corroborate Novel Target and Support Further Maturation Inhibitor Development

Panacos Pharmaceuticals, Inc. (Nasdaq: PANC), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced the publication of an article authored by Panacos scientists and Dr. Michael Sakalian and colleagues at the University of Oklahoma Health Sciences Center in the June 2006 issue of the Journal of Virology. The article describes the results of a study elucidating the mechanism of action of PA-457, Panacos' lead drug candidate. PA-457 is the first in a new class of HIV drug candidates called Maturation Inhibitors that are designed to prevent the release of a key viral protein called Capsid from its precursor protein, Gag.

FDA Grants Cerexa Fast Track Designation for PPI-0903

Cerexa, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PPI-0903, a next-generation, broad-spectrum, cephalosporin antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA). Cerexa initiated a Phase 2 trial of PPI-0903 for the treatment of cSSSI in October 2005. Under the FDA Modernization Act of 1997, the Fast Track program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential to address unmet medical needs for such a condition.