Financing News, G1 Therapeutics raises $12.5M Series A

G1 Therapeutics raises $12.5M Series A financing led by MedImmune Ventures.        ·      Co-investors include Hatteras Venture Partners and Mountain Group Capital.      ·      Financing will accelerate lead clinical candidate to IND and initial clinic­al testing.      ·      The lead clinical candidate is a proprietary, potent and selective cyclin-dependent kinase (CDK) 4/6 inhibitor that has been evaluated in a number of pre-clinical studies for the potential treatment of chemotherapy-induced myelosuppression.      ·      Based on a recent pre-IND meeting with the U.S. Food & Drug Administration, the company expects to file its IND by summer 2014 and initiate clinical testing before the end of 2014 Full Press Release Follows. SOURCE: G1 Therapeutics, Inc. CHAPEL HILL, N.C., Oct. 16, 2013 /PRNewswire/ -- G1 Therapeutics, Inc. today announced that it has raised a Series A financing of $12.5M that will enable the advancement of its lead clinical candidate through the filing of an Investigational New Drug application (IND) and initial clinical testing. The financing was led by MedImmune Ventures. Co-investors include Hatteras Venture Partners and Mountain Group Capital.  Michael Gutch, Ph.D., Managing Director, MedImmune Ventures, and Ron Laufer, M.D., M.P.H., Senior Managing Director, MedImmune Ventures, have joined G1's board of directors. G1's lead clinical candidate is a proprietary, potent and selective cyclin-dependent kinase (CDK) 4/6 inhibitor that has been evaluated in a number of pre-clinical studies for the potential treatment of chemotherapy-induced myelosuppression. Based on a recent pre-IND meeting with the U.S. Food & Drug Administration, the company expects to file its IND by summer 2014 and initiate clinical testing before the end of 2014.  "G1 Therapeutics has made significant progress since Hatteras provided seed financing in September 2012 that enabled the company to select a lead molecule and complete the majority of pre-IND-required studies," said Christy Shaffer, Ph.D., Executive Chair of G1 Therapeutics' Board of Directors. "We are excited to have MedImmune Ventures partner with Hatteras and G1 in order to accelerate the lead candidate toward clinical testing." In addition to venture funding, G1 received several government grants to fund its drug discovery pipeline, including a National Cancer Institute Fast Track Grant in 2012 for its lead potential indication. In addition, the company received early funding from the North Carolina Biotechnology Center and the University of North Carolina's Kickstart Program. The company was founded on intellectual property from the Sharpless lab, which was in part funded by the University Cancer Research Fund. "Ron and I are delighted to be joining the board," said Michael Gutch, Ph.D., Managing Director at MedImmune Ventures. "We look forward to working alongside Hatteras and Mountain Group to support the innovative and elegant science from G1's founders, Dr. Ned Sharpless of the University of North Carolina Lineberger Comprehensive Cancer Center and Dr. Kwok Wong of the Belfer Institute of Applied Cancer Science at the Dana-Farber Cancer Institute, to address the serious complications of myelosuppression in patients undergoing chemotherapy treatment."   About G1 Therapeutics, Inc. G1 Therapeutics, Inc. is a privately held pharmaceutical company based in Chapel Hill, NC that focuses on the discovery and development of novel small molecules for use in cancer therapy and biodefense applications. These molecules are being developed for targeting specific proteins associated with cell proliferation and growth. Such therapies may be useful to protect the bone marrow and other organs, including the kidney and lung, from toxic insult. In October 2013, the company raised $12.5 million in a Series A financing led by MedImmune Ventures that will enable it to advance its lead clinical candidate into clinical trials for the potential treatment of chemotherapy-induced myelosuppression. Visit www.g1therapeutics.com for more information. About Hatteras Venture Partners Hatteras Venture Partners (HVP) is a venture capital firm based in Durham, NC with a focus on seed and early stage opportunities in biopharmaceuticals, medical devices, diagnostics, and related opportunities in human medicine. The firm consists of an experienced team with a broad and complementary skill set that is particularly relevant to building successful new biomedical companies. Hatteras Discovery provides seed funding to facilitate company launches, particularly out of academia. Visit www.hatterasvp.com for more information. About MedImmune Ventures MedImmune Ventures, a wholly-owned global venture capital fund within the AstraZeneca Group, invests in private companies developing small and large molecule therapeutics, pharmaceutical technologies and platforms, medical devices and diagnostics, and imaging and healthcare information technology. MedImmune Ventures invests across all therapeutic areas, in companies with early to late-stage technologies, from seed through mezzanine rounds of financing. MedImmune Ventures manages $400 million in an evergreen fund and has invested in more than 30 companies since 2002. For more information, visit www.medimmuneventures.com. SOURCE G1 Therapeutics, Inc. CONTACT: Christy Shaffer, G1 Therapeutics, 919-484-0730, ext. 204, christy@hatterasvp.com; Media: Tony Plohoros, 6 Degrees Communications, 908-940-0125, tplohoros@6degreespr.com Web Site: http://www.g1therapeutics.com

What’s on your Tray? National School Lunch Week Oct 14-Oct 18 2013

More than 32 million children eat school lunch everyday across the USA, and to celebrate healthy lunch choices, schools across the country will celebrate National School Lunch Week: October 14-18, 2013. The theme, "School Lunch Across the USA" will include events and activities that promote the benefits of healthy school lunches. It will also celebrate the flavors, ingredients, and culture of various regions. The campaign will put a spotlight on the healthy foods and positive changes that schools have incorporated into their menus.

The federally-funded National School Lunch Program (NSLP) provides nutritionally balanced, healthy meals to students everyday. The program, which has been serving the nation's children for over 60 years, requires school meals to meet federal nutrition standards by:

·      Ensuring students are offered both fruits and vegetables every day of the week;

·      Substantially increasing offerings of whole grain-rich foods;

·      Offering only fat-free or low-fat milk varieties; and

            ·    Reducing amounts of saturated fat, trans fats and sodium.

For more information about healthy school meals, visit www.TrayTalk.org.

Press Release Follows.

SOURCE: School Nutrition Association, http://www.schoolnutrition.org

About NSLW

The School Nutrition Association’s National School Lunch Week (NSLW) 2013 theme is “School Lunch Across the USA,” and It’s about celebrating the regional flavors, ingredients, and traditions from across the country. Whether you live in Boston or Biloxi, you’ll be sure to find fun and exciting ways to celebrate NSLW in your cafeteria.

Every part of the country is known for different food—whether it’s New England chowder, southern black-eyed peas, Florida oranges, or southwestern salsa. “School Lunch Across the USA” allows you to celebrate the popular flavors in your own region, and across the country too!

Recognizing NSLW can help you:

·      ·   Increase student participation for your program

·     ·   Spread the message to parents that you’re serving healthy and tasty meals

·      ·   Earn media coverage from local papers, blogs, and TV stations

·      ·   Connect with teachers and administrators at your school or in your district to spread the word that school meals are healthy

The campaign runs from July 2013 to October 2013, culminating in National School Lunch Week, October 14-18, 2013.

SNA members determine the success of NSLW – so what are you waiting for? Mark your calendar, download the resources, and start brainstorming your celebration ideas!

WEBSITE: http://www.schoolnutrition.org

CONTACT: Diane Pratt-Heavner at 301-686-3124, media@schoolnutrition.org.  

SNA members wishing to view the report, click here.

The School Nutrition Association is a national, non-profit professional organization representing 55,000 school nutrition professionals across the country. Founded in 1946, SNA and its members are dedicated to making healthy school meals and nutrition education available to all students.  SNA’s website for parents, www.TrayTalk.org, features school nutrition success stories from across the country.

FDA Clears New Continuous Blood Pressure Technology

FDA Clears New Continuous Blood Pressure Technology From Sotera Wireless. The ViSi Mobile System is the first wrist-worn monitor to measure all core patient vital signs: continuous non-invasive blood pressure (cNIBP), heart rate or pulse rate, electrocardiogram (ECG), blood oxygenation level, respiration rate and skin temperature, with the accuracy of systems used in hospital intensive care units. Wireless technology transmits vital sign data, enabling clinicians to monitor measurements on remote viewing or notification devices. The system incorporates safety features, such as an advanced alarm management system that notifies clinicians of unfavorable changes in a patient's condition, enabling early intervention if needed Full Press Release Below.  SOURCE: Sotera Wireless  FDA Clears New Continuous Blood Pressure Technology From Sotera Wireless. First FDA Clearance of Passive, Non-Invasive Technique Could Transform Cardiovascular Medicine SAN DIEGO, Oct. 10, 2013 /PRNewswire/ -- Sotera® Wireless, Inc. today announced the U.S. Food and Drug Administration has cleared the Company's patented continuous non-invasive blood pressure (cNIBP) technology, a new feature of the ViSi Mobile® wireless patient monitoring system. For the first time clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the use of a catheter or blood pressure cuff. Physicians can use cNIBP measurements to better manage patients with hypertension, commonly known as high blood pressure. Hypertension affects 67 million, or one in three, American adults resulting in a direct healthcare cost of approximately $50 billion. In the United States, hypertension is present in 69 percent of people who have a first heart attack, 77 percent of people who have a first stroke, and 74 percent of people with chronic heart failure, placing it among the most dangerous risk factors for cardiovascular disease. Numerous studies point to the benefits of beat-to-beat blood pressure monitoring, but obtaining accurate continuous data currently requires catheter insertion, exposing patients to discomfort and risk of infection. Sotera's cNIBP technology maximizes comfort and safety by obtaining measurements without invasive procedures or the frequent use of a blood pressure cuff. In studies comparing the clinically validated cNIBP technology with invasive arterial line procedures cNIBP technology demonstrated a bias of less than 5 mmHg. "Blood pressure is one of the most important vital signs and yet it is considerably undervalued, largely because most clinicians are limited to periodic cuff-based measurements," said Tom Watlington, Sotera chief executive officer. "By providing data collected around the clock without disrupting a patient's sleep, we believe the ViSi Mobile System with cNIBP will help improve diagnosis and management of hypertension, saving lives and dollars." The ViSi Mobile System is the first wrist-worn monitor to measure all core patient vital signs: cNIBP, heart rate or pulse rate, electrocardiogram (ECG), blood oxygenation level, respiration rate and skin temperature, with the accuracy of systems used in hospital intensive care units. Wireless technology transmits vital sign data, enabling clinicians to monitor measurements on remote viewing or notification devices. The system incorporates safety features, such as an advanced alarm management system that notifies clinicians of unfavorable changes in a patient's condition, enabling early intervention if needed. About Sotera Wireless . Sotera Wireless, Inc. is a San Diego based medical device company dedicated to the development, marketing and sale of a new generation of comprehensive vital signs monitoring. Sotera's mission is to improve patient safety by empowering clinicians to detect early signs of deterioration in virtually any care setting and enable early intervention and rapid response, all without limiting the patient's freedom of movement. More information on the company or its ViSi Mobile System can be obtained at www.soterawireless.com or by sending an email to info@soterawireless.com. Sotera® and ViSi Mobile® are registered trademarks of Sotera Wireless, Inc.  SOURCE Sotera Wireless, Inc. CONTACT: Sotera Wireless, Inc., Tom Watlington, Chief Executive Officer, +1-619-427-4629 Web Site: http://www.soterawireless.com

Cardiome Publishes Study Data, AF Patients

­­Cardiome announces publication of positive data from an observational, retrospective study of BRINAVESS. During the observation period, 70% of the AF patients treated with BRINAVESS converted with a median time of 11 minutes. Conversion efficacy was 76% in patients with AF duration <10 hours. The median time spent in the ER for patients who converted on BRINAVESS was 6.5 hours.  Full Press Release Below. SOURCE: Cardiome NASDAQ: CRME TSX: COM VANCOUVER, October 7, 2013 /PRNewswire/ --Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced publication of positive data from an observational, retrospective study performed at the Skåne University Hospital in Malmö, Sweden. The study included 251 recent-onset atrial fibrillation (AF) patients who received 355 BRINAVESS™ treatments during the period between January 15, 2011 and April 15, 2013. During the observation period, 70% of the AF patients treated with BRINAVESS converted with a median time of 11 minutes. Conversion efficacy was 76% in patients with AF duration <10 hours. The median time spent in the ER for patients who converted on BRINAVESS was 6.5 hours. These results are published in the October 2013 issue of The European Journal of Cardiovascular Medicine. "It is exciting to see that patients treated in the clinically critical first 48 hours after AF onset appear to continue to derive better-than-expected benefit from BRINAVESS and that they also prefer this therapy over DC cardioversion," stated William Hunter, M.D., Chief Executive Officer of Cardiome Pharma Corp. "The high conversion efficacy coupled with short hospital stay we believe makes BRINAVESS a practical option for physicians and patients who value rapid relief from AF." "Skåne University Hospital developed a "fast-track" AF program in the emergency room where patients with short duration AF were promptly treated with BRINAVESS, which likely contributed to the higher efficacy seen in this setting compared to the ACT and AVRO clinical trials," stated Dr. Steen Juul-Möller, the study's Principal Investigator and Cardiome's Medical Director. "The finding that 75% of successfully treated BRINAVESS patients remained in normal sinus rhythm after a one year follow-up period - was an extremely interesting and important finding that requires further investigation," added Dr. Juul-Möller. Patients with recent-onset AF and whom cardioversion was considered were evaluated for BRINAVESS treatment. Over the period of the study, 251 patients received 355 treatments. In all patients, 70% of BRINAVESS treatments were successful and 70% of the patients responded at least once with conversion to sinus rhythm. The conversion rate was higher at 76% among patients with AF duration <10 hours compared to 66% in those with AF >10 hours (P<0.05). Transient bradycardia and hypotension were seen in 5 patients (1.4%) occurring within minutes after conversion and were judged as a response to the change in heart rhythm. No ventricular tachyarrhythmias, including Torsade-des-Pointes were seen.[ 1 ] Those patients who did not respond to BRINAVESS treatment were subsequently treated with DC cardioversion. All patients who had experienced both BRINAVESS and DC cardioversion were given a questionnaire to assess cardioversion preference and were followed up for a maximum period of 27 months (BRINAVESS [n = 156]; DC cardioversion [n=91]). Among those who converted with BRINAVESS, 72% would prefer this treatment, in patients who did not convert with BRINAVESS, 61% said they would prefer DC cardioversion if they experienced a relapse (P<0.001). Furthermore, among BRINAVESS responders, 78% were satisfied or very satisfied with the treatment.  In the follow up portion of the study, after 12 months, 75% of BRINAVESS responders were still in sinus rhythm, compared to 45% of patients that required DC cardioversion (P<0.001). References: 1. Juul-Möller, S. Vernakalant in recently developed Atrial Fibrillation: How to translate pharmacological trials into clinical practice.  European Journal of Cardiovascular Medicine . Vol. 2, Issue 4. Published online October 4, 2013. About Cardiome Pharma Corp. Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESS[ TM ] (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at http://www.cardiome.com. Forward-Looking Statement Disclaimer Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions.  Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2013 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at http://www.sec.gov and the Canadian securities regulatory authorities at http://www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law. For further information: Cardiome Investor Relations +1-604-676-6993 or Toll Free: 1-800-330-9928 Email: ir@cardiome.com