Lisa Dreyer - Page 33 - Pappas Capital

CoLucid Pharmaceuticals Details Phase 3 Development Strategy for Lasmiditan to Address Major Unmet Needs in Acute Migraine Therapy

Durham, NC, September 18, 2012 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administration’s Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies: 1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans. The development program will be confirmed via the Special Protocol Assessment process.

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a member of a novel chemical class called “ditans” and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans.

CoLucid has further evaluated lasmiditan’s cardiovascular profile by recently completing a Thorough QT/QTc study (TQT) titled COL MIG-105: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Re-polarization Duration as well as other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) with those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects. The statistical evaluation of the primary variable revealed that lasmiditan caused no significant QT prolongation either at 100 mg (the putative therapeutic dose) or at 400 mg (supratherapeutic dose), whereas moxifloxacin caused a QT prolonging effect similar to that seen in published studies and thus assay sensitivity for this study was demonstrated. No pro-arrhythmic effect of lasmiditan was observed in the assessments of ECGs made by a cardiologist, and safety and tolerability were similar to observations in previous studies.

”We believe that lasmiditan’s unique central mechanism of action provides acute migraine relief without the associated chest symptoms and vasoconstrictor effects seen with triptans. Lasmiditan could be a very important treatment for those patients who are warned not to take triptans, such as patients with high blood pressure or high cholesterol, obese patients or those with diabetes, smokers and patients with a strong family history of coronary artery disease, post-menopausal women or men over 40 years of age,” commented Thomas P. Mathers, Chief Executive Officer. “There are a large number of acute migraine patients who do not respond to triptan therapy. Lasmiditan could provide an excellent therapeutic alternative for these patients who now frequently turn to opioids.”

About Lasmiditan

Six clinical studies have been successfully completed, including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved secondary endpoints, including relief of nausea, photophobia and phonophobia. Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous six clinical studies, CoLucid expects that the pivotal Phase 3 studies will confirm that lasmiditan's side effect profile is highly differentiated from triptans and ergotamines.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine headache. For more information, please visit CoLucid at www.colucid.com.

CoLucid Pharmaceuticals - 09/18/2012

TYRX(R) Receives New Product Innovation Award

AIGISRx Antibacterial Envelope for Pacemakers and Defibrillators Recognized by Frost & Sullivan

MONMOUTH JUNCTION, N.J., Sep 14, 2012 (BUSINESS WIRE) -- TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with cardiovascular implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, announced today that Frost & Sullivan has named the AIGISRx(R) Antibacterial Envelope as the recipient of its prestigious New Product Innovation Award for 2012.

"To date TYRX's AIGISRx is very unique in the fact that it is the first and only antibacterial product of its kind to receive U.S. Food and Drug Administration (FDA) clearance. The product not only helps in stabilizing the pacemaker or ICD, but it also helps reduce infection by delivering antibiotics directly to the surgical site in the first 7 to 10 days following implantation," said Darshana De, IP and Best Practices Analyst from Frost & Sullivan.

The AIGISRx Antibacterial Envelope is designed to address surgical-site infections which are expensive to treat and have a significant impact on patients and hospitals.

Patients suffering from surgical-site infections following CIED procedures:

spend an average of two extra weeks in the hospital
undergo repeat surgical procedures to treat the infection
cost the facility an average of $72,485
experience significant increases in morbidity & mortality, with 1-year mortality rates of 26.5% to 35.1%, depending on device type

The recipient of the Frost & Sullivan New Product Innovation Award is selected after rigorous analysis of industry's leading companies who demonstrate outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

"Since TYRX was founded, we have been working diligently to research, develop, and commercialize technologies which help reduce surgical-site infections and improve patient outcomes," remarked Robert White, President and CEO of TYRX. "Our team appreciates Frost & Sullivan's acknowledgement of our product leadership and innovation."

TYRX - 09/14/2012

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