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.

Scott Weiner will join a panel discussion around perspectives on biotechnology transfer and investments at GTC’s Biotechnology Transfer & Commercialization Conference, October 24-26, 2012 in Philadelphia, PA. 

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.

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 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.

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

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.

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.

Mike Grey will join a discussion panel entitled "Are we Heading into a Pharmaceutical and Biotechnology Market of Orphan and Narrow Indications" at the 2012 BIO International Convention on June 19th in Boston, MA.

WALTHAM, Mass., May 16, 2012 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., an oncology company moving into phase 3 having completed randomized, placebo controlled phase 2 studies, announced Luke Evnin, Ph.D. will join the board of directors replacing Steven St. Peter, M.D. 

"We are thankful to Steven for his commitment over the past few years and we are excited to have Luke join the board given his experience and track record of building cutting-edge biotechnology companies since 1990," said Dennis Podlesak, chairman of the Syndax board of directors.  "Syndax is well positioned to bring its lead product entinostat into phase 3 testing and to continue building out the company to support this growth phase."

Dr. Evnin has served as a managing director at MPM Capital since he co-founded MPM's asset management business in 1997.   Dr. Evnin focuses on global healthcare investing for MPM. Prior to joining MPM, Dr. Evnin was at Accel Partners for over seven years including four as a general partner. He was involved in biopharmaceutical, medical device and healthcare service companies for several of Accel's funds.  Dr. Evnin currently serves as a director of Enteromedics, Inc. (ETRM) and Pacira (PCRX),  publicly-traded companies, as well as private companies, NeuroTherapeutics Pharma, Inc. and Oxagen Limited.  Dr. Evnin earned his Ph.D. in the department of biochemistry at the University of California-San Francisco, and received his A.B. in molecular biology magna cum laude from Princeton University.

"With entinostat, a promising late-stage oncology product candidate, and a talented management team in place, our vision at MPM that we invested in several years ago is now being realized," said Dr. Evnin.  "If the randomized phase 2 data is confirmed in a phase 3 trial, entinostat, an oral HDAC, will be a new and compelling option to allow women to remain successfully treated with  hormone therapy, the standard of care for metastatic breast cancer.   Entinostat has shown in preclinical trials the ability to reverse or delay the emergence of epigentically driven resistance to targeted therapies in solid tumors.  I am looking forward to contributing to moving this promising oncology product candidate forward and building a company that can maximize its impact for patients."

About Syndax Syndax is a late-stage oncology company initiating pivotal programs in solid tumors based on employing epigenetic strategies to overcome the problem of resistance in oncology care. Syndax holds worldwide rights to entinostat, an oral, highly selective histone deacetylase (HDAC) inhibitor, which inhibits the cancer-relevant class 1 HDAC enzymes that contribute to epigenetic alterations driving cancer growth and drug tolerance. Entinostat's unique pharmacokinetic properties, convenient oral dosing and HDAC selectivity, maximize the opportunity to safely combine with and potentially extend the benefit of proven cancer therapies. Entinostat has been studied in more than 600 cancer patients with clinical activity in solid tumors and hematologic malignancies. Randomized, placebo-controlled phase 2 studies with entinostat have demonstrated promising results in combination with aromatase inhibitors in breast cancer (ENCORE 301) and with the EGFR-TKI erlotinib (ENCORE 401) in non-small cell lung cancer. Results from the ENCORE clinical program have provided the basis for moving entinostat into pivotal, phase 3 testing across a platform of solid tumor indications. NCI and Syndax are collaborating on the development of entinostat under a Cooperative Research and Development Agreement.

The company is supported by top venture capitalists and led by industry experts developing treatments for large markets including metastatic breast and lung cancer. Formed in 2005, Syndax's intellectual property is based on work from scientific founder Ronald Evans, Ph.D., recipient of the 2004 Albert Lasker Prize for Basic Medical Research, a Member of the National Academy of Sciences, a professor at the Salk Institute for Biological Studies and a Howard Hughes Medical Institute Investigator. For more information please visit www.syndax.com.