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

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

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.

Merck snags Chimerix antiviral HIV program in $168.5M deal

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.   

Both of Chimerix's programs are "orally delivered, absorbed through the gut, and remain intact in the blood stream," says the CEO. "It's only inside the cell membrane that the molecules are broken apart by the enzymes inside the cells, and converted into active, potent antivirals." Merck's main goal here is to be on the cutting edge of the next generation of antivirals. "We think this drug has the chance to be a much longer delivery cycle," he adds, which can change the dosing parameters while maintaining a positive safety and efficacy profile.

The deal with Merck leaves Chimerix focused squarely on its lead program. Company officials have wrapped up their end of Phase II meeting with regulators and are preparing for Phase III. Under an ideal timeline, says the CEO, they can be on the market in 2016, with plans to retain U.S. marketing rights while partnering outside the states. 

Those partnering talks, he adds, are already well under way. And with a pharma giant like Merck signing up for a licensing deal, he says, the tech endorsement should improve the company's prospects. Chimerix's staff has swelled to about 50 and the company has raised $101 million in venture cash.

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.

Pappas Ventures Names Pat Gage to Scientific Advisory Board

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.

Art Pappas makes TBJ "Triangle's Most Influential Business Leaders" List

Welcome to Triangle Business Journal’s inaugural “The Triangle’s Most Influential Business Leaders” list.

The 100 names for this list were chosen by the TBJ editors after going through hundreds of names across various sectors that fall under the general coverage guidelines of this newspaper.

A special feature relating to these 100 individuals will be published in our July 27 issue. At that time, you will read about the influence and impact these individuals have had on our communities.

The 2012 list contains many familiar names in business, education, philanthropy and government. It also contains some names you may not recognize right away because they have just started their careers but hold tremendous promise for our communities.

Also, you will see some names missing from this list, including North Carolina Gov. Beverly Perdue, former Progress Energy (NYSE: PGN) CEO Bill Johnson and former Raleigh Mayor Charles Meeker. These individuals have made unparalleled contributions in forwarding our collective goal of being one of the best places in the country to live, work and play. But with this list, we also wanted to look ahead and take inventory of what individuals we believe will continue to make a substantial contribution in the coming years.

Also on this list you will find some former corporate executives such as Red Hat’s (NYSE: RHT) Matthew Szulik, Mulkey’s Barbara Mulkey and Martin Marietta Materials’    (NYSE: MLM) Steve Zelnak who have managed to remain active in this community by participating in ventures that make our communities richer in talent, culture and education.

As I mentioned, the process itself being subjective, might result in some disagreements over who has been included since we only chose 100 individuals. And that’s where you come in. We would love to hear from you any names you feel deserve mention as part of the Top 100.

Click Here for the Full List

Tesaro raises $81M in a rare IPO success story

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. 

MethylGene announces encouraging data from Phase I tumor study

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.

Click here to read the full story.

Liquidia Announces Product Development Collaboration with GSK

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.

CED Selects Officers and Board of Directors Members

CED, the Southeast’s largest entrepreneurial support organization, today announced the officers and members elected to its Board of Directors for terms beginning July 1, 2012. Nominations to the Board of Directors were approved by the full CED Board of Directors at the May 2012 meeting.

Eric Linsley, managing partner at Pappas Ventures, remains Chair of the Board, and David Spitz, president and COO at Channel Advisor, remains Chair-elect. Helga Leftwich, partner at Hutchison Law Group, was elected Secretary, and David Hood, audit partner at Ernst & Young, was elected Treasurer. All officers serve one-year terms. 

Members of CED’s Board of Directors serve two-year terms. The seven newly elected members are: Larry Bettino, general partner, StarVest Partners; Glen Caplan, shareholder, Robinson Bradshaw; Bob Geolas, president and CEO, RTP Foundation; Gary Hayes, managing director, Scale Finance; Nick Jordan, founder and managing director, Smashing Boxes; Giles Shih, CEO, BioResource International; and Craig Stone, CEO, HireNetworks.

Returning to CED’s Board of Directors for a second consecutive two-year term are: Kyle Breischaft, Emergency Technologies; Lee Buck, BlueBright Ventures; Kent Christison, K & L Gates; Joe Colopy, Bronto Software; John Crumpler, Hatteras Venture Partners; Mike Elliott, Noro-Moseley Partners; Vipin Garg, Tranzyme Pharma; Jonathan Gindes, Affinergy; Collin Hill, Cherry Bekaert & Holland; John Kerr, York Commercial Properties; R. Brooks Malone, III, Hughes, Pittman & Gupton; Chris Matton, Bandwidth.com; David Rizzo, NCIDEA; Laura Robinette, PwC; David Routh, Bank of America; Chip Royce, Lenovo; Lori Spivey, Financial Directions Group; Teresa Spangler, PlazaBridge Group; Alan Spurgin, Square 1 Bank; Wright Steenrod, Chrysalis Ventures; Rob Tyler, Poyner Spruill; and Rik Vandevenne, River Cities Capital Funds.