Lisa Dreyer - Page 34 - Pappas Capital

LipoScience Receives FDA Clearance for Vantera Clinical Analyzer

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.

LipoScience - 09/05/2012

CardioDx Completes $58 Million Equity Financing

CardioDx Completes $58 Million Equity FinancingProceeds to Support Commercial Expansion of Corus CAD and New Product Development

PALO ALTO, Calif. – August 27, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced the completion of a $58 million two-tranche equity financing. The financing included Temasek, an Asia investment company based in Singapore; and existing investors Longitude Capital; Artiman Ventures; Kleiner, Perkins, Caufield & Byers; J.P. Morgan; Mohr Davidow Ventures; TPG Biotech; Intel Capital; Acadia Woods Partners; Bright Capital; the venture arm of RU-COM; Pappas Ventures; DAG Ventures; Asset Management Group; and GE Capital. All previous investors participated in the round.

Proceeds from the financing will be used to support the commercial expansion of Corus® CAD, the only clinically validated gene expression test for obstructive coronary artery disease, and to develop additional genomic diagnostics in the field of cardiovascular disease.

“This funding positions CardioDx well to capitalize on the significant opportunity to improve the diagnosis of the millions of patients who visit their physicians with symptoms suggestive of obstructive coronary artery disease each year,” said David Levison, the company’s President and Chief Executive Officer. “The favorable Medicare coverage decision that we received earlier this month is a significant milestone that further validates the clinical benefit of and economic rationale for Corus CAD. This additional capital will help us expand our sales force in the U.S., further broaden reimbursement coverage, and support continued investments in research and development of new products.”

CardioDx recently announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the Corus CAD gene expression test for the evaluation of patients presenting with typical and atypical symptoms suggestive of coronary artery disease. With this decision, the Corus CAD gene expression test is now a covered benefit for more than 40 million Medicare enrollees in the U.S.

Studies have shown that typical and atypical presentations of stable chest pain account for up to two percent of outpatient office visits each year in the U.S., which equates to up to three million patients per year in the Corus CAD intended-use population. However, a study of nearly 400,000 patients published in The New England Journal of Medicine in 2010 reported that as many as 62 percent of stable patients who undergo elective invasive angiographic procedures are found to have no obstructive coronary artery blockage, despite broad usage of prior noninvasive imaging. The authors concluded that current modalities used to identify patients for elective invasive angiography to diagnose obstructive coronary artery disease have limitations, and that better methods are needed for patient risk stratification.

As much as $5 billion is spent on noninvasive testing, imaging and elective invasive angiography in the Corus CAD intended-use population annually in the U.S.

CardioDx - 08/27/2012

Over 50% of Hospital CFOs Plan to Adopt New Technology in Response to Medicare Cuts for Cardiac Device Infections

Monmouth Junction, NJ (August 20, 2012): Medicare’s decision to stop reimbursing hospitals for the treatment of potentially avoidable surgical site infections following cardiac implantable electronic device (CIED) procedures, including pacemaker and defibrillator implants, will significantly impact hospital practices according to a new national survey of hospital chief financial officers (CFOs).

The Centers for Medicare and Medicaid Services (CMS) recently released its Hospital Inpatient Prospective Payment System (IPPS) Final Rule for Fiscal Year 2013 which adds Surgical Site Infection following CIED implantation as a condition subject to the Hospital Acquired Condition (HAC) payment provision. CMS considers these infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in higher payment to the hospital. Under the new policy, CMS will pay for the original implantation surgery, but will not reimburse hospitals at a higher rate for treating the infection.

The survey polled 50 hospital CFOs at academic health centers and community hospitals across the United States to determine how hospital practices are likely to change as the result of the new CMS rule. Findings included:

• 62% of CFOs consider the financial impact of the HAC on their hospital’s operations to be “very important.”

• Nearly all CFOs had adopted or plan to adopt new technologies to help reduce the risk of CIED infections; half those surveyed specifically cited increased use of the AIGISRx®Antibacterial Envelope.

• 82% of CFOs plan to use internal reporting measures to reduce the incidence of the CIED infections.

• 74% of CFOs believe their facilities may reduce the use of CIEDs when alternative therapies are available.

• Only 6% of hospital CFOs said their organization had not taken any actions to reduce the incidence of existing HACs.

Patients with surgical site infections following CIED procedures spend an average of two extra weeks in the hospital, undergo repeat surgical procedures to treat the infection, and cost the facility an average of $72,485. Additionally, such patients experience significant increases in morbidity and mortality, with 1-year mortality rates of 26.5 – 35.1%, depending on device type.

“Surgical site infections are expensive to treat and have a significant financial impact on hospitals as well as on patients’ health and wellbeing,” stated Robert White, Chief Executive Officer of TYRX, Inc., the leader in the commercialization of implantable medical devices intended to help reduce surgical site infections (SSIs). “New technologies, such as the AIGISRx® Antibacterial Envelope, can play an important role in reducing the incidence of such infections and thus lowering hospital costs.”

The survey, conducted by Epocrates, was sponsored by TYRX, Inc.

TYRX - 08/21/2012

CardioDx Wins Medicare OK of Molecular Test for Heart Disease

August 8, 2012

CardioDx has spent three years marketing a new genetic test that can tell when a patient’s chest pain is a sign of serious heart disease, or no big cause for alarm. It still has a long way to go before becoming part of mainstream medicine, but now the company has taken a big step ahead by persuading Medicare, the agency that provides health insurance to Americans over age 65, that its test is worth the money.

Palo Alto, CA-based CardioDx is announcing today that Palmetto GBA, the national contractor for Medicare, has agreed to reimburse the company for its Corus CAD test. CardioDx isn’t saying how much Medicare agreed to pay for the test, but it sells for a list price of $1,195 per patient, CEO David Levison says. The decision effectively means that more than 40 million Medicare patients are eligible for the test, as long as their doctor prescribes it.

CardioDx - 08/08/2012

TYRX® Comments on Medicare Decision to Stop Paying for Infections Following Pacemaker or Defibrillator Implants Release

Monmouth Junction, NJ (August 2, 2012) - In a bid to help control health care costs, on October 1, 2012, the Centers for Medicare and Medicaid Services (CMS) will stop paying hospitals for treating potentially avoidable surgical site infections following Cardiac Implantable Electronic Device (CIED) procedures including pacemaker and defibrillator implants. CMS just released its Hospital Inpatient Prospective Payment System (IPPS) Final Rule for Fiscal Year 2013 which adds Surgical Site Infection following CIED implantation as a condition subject to the Hospital Acquired Condition payment provision. CMS considers these infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in higher payment to the hospital. Under the new policy, CMS will pay for the original surgery, but will not reimburse hospitals at a higher rate for treating the infection.

TYRX - 08/02/2012

Merck snags Chimerix antiviral HIV program in $168.5M deal

July 24, 2012

Research Triangle Park, NC-based Chimerix has inked its first big partnership, reaping a $17.5 million upfront payment and a promise of up to $151 million more from Merck ($MRK), which gains rights to a mid-stage antiviral--CMX157--which has prospects as a new addition to future HIV cocktails.

It's a key deal for Chimerix, which has a platform for a lipid-antiviral conjugate technology that promises to rev up existing meds, turning them into chemical antiviral assault weapons that can trump anything that's currently expected of them. In this case, CMX157 is a more potent version of Viread.

"It's a lipid technology that dramatically alters the ADME (absorption,distribution, metabolism, and excretion profile) of the drug, really intracellular drug delivery," CEO Ken Moch tells FierceBiotech.

For Merck, the Chimerix pact is the most prominent move in a flurry of actions on the HIV front. While it was readying the news Merck--an active player in the HIV field--also signed a deal to develop Yamasa's inhibitor EFdA, which has showed some potential against the HIV virus. And Merck is readying a mid-stage study of MK-1439 in treatment naive patients.

Chimerix - 07/24/2012

Clinical Data Finds Strong Association Between HDL Particles and Coronary Heart Disease

Study published in JACC suggests HDL particles may be a more accurate indicator of cardiovascular health than HDL cholesterol

RALEIGH, N.C. – July 12, 2012 – 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 publication of the findings of a clinical study in the current issue of the Journal of the American College of Cardiology indicating that high density lipoprotein (HDL) particle number has a stronger, more independent association with coronary heart disease and carotid atherosclerosis than HDL cholesterol (HDL-C).

LipoScience - 07/12/2012

Pappas Ventures Names Pat Gage to Scientific Advisory Board

RESEARCH TRIANGLE PARK, N.C., July 9, 2012 /PRNewswire/ -- Pappas Ventures today announced the appointment of L. Patrick (Pat) Gage, PhD to the company's Scientific Advisory Board (SAB). Dr. Gage has extensive experience in the biotech and pharmaceutical industry, including previously-held senior positions at Hoffmann-La Roche, Genetics Institute and Wyeth (now Pfizer). Throughout his career, he oversaw the development of more than a dozen marketed biologics and vaccines, as well as several small molecule drugs.

Read the full press release here.

Uncategorized - 07/09/2012

Ultragenyx Initiates Phase 2 Study of UX001 in Hereditary Inclusion Body Myopathy

NOVATO, Calif., July 5, 2012 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced the dosing of the first two patients in a Phase 2 study of UX001 for hereditary inclusion body myopathy (HIBM). HIBM is a rare, severe, neuromuscular disease caused by sialic acid deficiency. UX001 is an extended-release oral tablet formulation of sialic acid (SA-ER) intended as a substrate replacement therapy for HIBM.

Ultragenyx Pharmaceutical - 07/05/2012

Tesaro raises $81M in a rare IPO success story

June 29, 2012

Just two years after getting started, the experienced cancer pros at Tesaro ($TSRO) have pulled off a successful IPO--a rarity in an industry that has been starved of IPO cash since 2007. On Thursday Tesaro made the switch to a public company, started trading at the middle of its range and actually went up a bit by the end of the day.

Tesaro, though, is different from many of the biotechs making a risky leap into the public markets these days. Its executive team, led by Lonnie Moulder, orchestrated the $3.9 billion sale of MGI Pharma. At Tesaro, they quickly raised $101 million in their second round, executing on a series of in-licensing deals for experimental cancer drugs.

There was one strategy in its IPO game plan that Tesaro shares with other newly public biotechs. It gained commitments from its insiders to buy up to $25 million in shares, helping to give its stock a boost as it came out of the gate.

The biotech--a 2011 Fierce 15 company--ended up selling 6 million shares at $13.50 a share, within its $12 to $15 range, raking in $81 million. Then it bumped up 1.4% by the end of the day. VC backers include New Enterprise Associates, set to become the largest shareholder with 39% of the stock, as well as Kleiner Perkins, Caufield Byers and Venrock.

Tesaro nabbed niraparib, a cancer drug in Merck's ($MRK) pipeline, recently. It has also in-licensed rolapitant and pushed the cancer treatment into a Phase III study, with an eye to delivering top-line data in the second half of next year. An IND for TSR-011 as a new therapy for non-small cell lung cancer, in-licensed from Amgen ($AMGN) in the spring of last year, is being prepped for filing in the second half.

TESARO - 06/29/2012