Lisa Dreyer - Page 34 - Pappas Capital

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

MethylGene Announces Encouraging Data from Phase 1 Tumor Study

June 25, 2012

MethylGene Inc., a biopharmaceutical company, has announced the encouraging clinical data from the company's Phase I Met/VEGFR multi- kinase inhibitor MGCD265 study.

The MGCD265, a multitargeted oral tyrosine kinase receptor inhibitor of Met and VEGFR: Dose-escalation Phase I study provided an interim update on the monotherapy trial 265-101.

Trial 265-101 is an ongoing Phase I, multicenter, open-label trial. In this trial patients are treated with MGCD265 alone, dosed orally every day over a 21 day cycle. Data was presented on 57 patients with advanced metastatic or unresectable solid malignancies that were refractory to standard therapy and/or unlikely to derive clinical benefit from existing therapies.

In an ex vivo system designed to assess the biological activity of MGCD265 using plasma samples from study patients, increased plasma concentration of MGCD265 was associated with inhibition of Met phosphorylation in a dose-dependent manner, suggesting coverage of the biological target, Met, in the clinical setting.

Mirati Therapeutics - 06/25/2012

Liquidia Announces Product Development Collaboration with GlaxoSmithKline

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.

Liquidia Technologies - 06/20/2012

Biotech All Stars Buy Castoff Experimental Merck Cancer Drug

June 6,2012

Tesaro of Waltham, Mass., a tiny biotech now preparing for its initial public offering, just licensed a promising anti-cancer drug from Merck. The startup is attempting to repeat the success its top executives had turning Big Pharma’s castoffs into hits at MGI Pharma, which was bought by Eisai for $3.9 billion in 2008.

The drug, known as niraparib or MK-4827, is a medicine that targets a mutation that can cause certain hard-to-treat breast and ovarian cancers. AstraZeneca, Abbott Laboratories and Pfizer are also developing similar medicines. The deal was disclosed in a filing with the Securities and Exchange Commission.

At the same time that big drug companies are increasingly buying new medicines developed outside their own walls, they are also selling more of the medicines that they invent but don’t plan on developing to smaller biotechs. This has always happened – Cubist Pharmaceuticals’ antibiotic Cubicin was licensed from Eli Lilly more than a decade ago. But now it is becoming more commonplace, with Pfizer, for instance, talking about the option of selling experimental drugs to outside companies as a central part of its strategy.

TESARO - 06/06/2012