CMC
Lahore, Pakistan
CMC
Lahore, Pakistan

Time filter

Source Type

News Article | March 2, 2017
Site: www.prweb.com

NDA Partners Chairman Carl Peck, MD, announced today that Greg Coulter, PhD, a pharmaceutical development executive with more than twenty years of experience in GLP, GMP, and GCP regulated drug development and manufacturing has joined the company as an Expert Consultant. He has extensive experience in drug substance characterization, drug product formulation, manufacturing scale-up, regulatory compliance, quality assurance, and CMC regulatory writing, and is a specialist in development of liquid and solid oral formulations, liquid and lyophilized injectable formulations, and clinical supplies manufacturing. During his professional career, Dr. Coulter has provided operational and regulatory CMC guidance for virtual, start-up, development stage, and commercial organizations. Dr. Coulter was formerly the Director of Formulations and Analytical Services at SNBL USA, Ltd.; Manager, cGMP Manufacturing at Cell Therapeutics, Inc.; Senior Process Chemist at Synthetech Inc.; and President of CTM Solutions, LLC. He is an experienced program manager and has planned and led the construction, equipping, hiring, and expansion of two GLP-compliant laboratories for a global CRO. “Dr. Coulter’s extensive experience in drug product formulation, process development, scale-up, and manufacturing, along with his expertise in clinical packaging, labeling, and distribution logistics for global clinical trials, make him an excellent addition to our Expert Consultant team,” said Dr. David Savello, Partner and Manager, Product Quality & CMC Practice. “We are pleased to welcome him to NDA Partners and introduce him to our clients.” Dr. Coulter earned his PhD in Biological Chemistry and MSc in Organic Chemistry from University of Guelph, Canada, and his BSc, Hon. in Biochemistry from Bishop’s University, Canada. About NDA Partners NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.


Chinese private equity firm China Media Capital (CMC), led by Chinese media mogul Li Ruigang, announced on Tuesday that it has partnered with its portfolio company SECA, a sports marketing company in China to invest tens of millions of Euros into Formula E Holdings, the official promoter of the FIA Formula E Championship auto racing. Financial details of the transaction were not disclosed but CMC and SECA plan to help introduce and expand Formula E’s influence in China. Established in 2014, the Formula E Championship is the world’s first electric powered single-seater racing series featuring electric-powered cars manufactured by makers including Renault, Jaguar, and Mahindra racing in major cities around the world. Its third season, which started in October and runs until July, comprised of races in cities such as Mexico City, Hong Kong, Paris, Berlin, Brussels, New York, and Montreal. According to Formula E, its Hong Kong race in 2016 was watched by 488,000 Chinese viewers via the internet. “The opening round of each season has been hosted in this region – Beijing and Hong Kong – and we have teams and drivers such as TECHEETAH and Ma Qing Hua already competing in the series. We look forward to working closely with CMC Capital Partners, and continuing to grow the profile of Formula E in key territories across the globe,” Alejandro Agag, the Founder & CEO of Formula E, said. Formula E has also established partnerships with Chinese TV stations and online video sites including Chinese national television operator CCTV and online video platform iQiyi.com to broadcast races in China. “Since its inauguration three years ago, Formula E has quickly evolved into a premium global sports IP under a first-class leadership, with remarkable progress in promoting sustainability, innovation, and market penetration of electric vehicles, as well as in media partnership, sponsorship, and tourism,” Li Ruigang said. “CMC has been focusing on investing in premium global and local sports IPs, and we look forward to working together with Formula E both in China and globally,” he further adds. The investment in Formula E follows a series of investments made by CMC and its affiliates in sports companies, including SoccerWorld China, Lanxiong Sports, and Beijing Wesai Era Sports Technology Co. This also includes leading an angel round in a sports content startup founded by Chinese football celebrity Sun Jihai in December, In 2015, CMC and CITIC Capital agreed to invest US$400 million for the acquisition of a 13% of City Football Group, the owner of football related clubs and businesses including Manchester City, New York City, Melbourne City, and a minority shareholder in Japanese football association Yokohama F. Marinos. Founded in 2009, CMC was the mainland’s first media sector focused fund dedicated to media and entertainment investments in China and around the world. It has separate movie-making ventures with IMAX Corp and Warner Brothers Entertainment, as well as a partnership with Jeffrey Katzenberg’s Dreamworks Animation Skg, which produced Kung Fu Panda 3. The company signed a deal in October 2015 for the exclusive global broadcast rights over the next five years of Chinese Super League, Commenting on the fundraising, Agag said, “We are excited to welcome CMC Capital Partners, led by Mr. Ruigang Li, to the increasing list of investors joining Formula E and the electric revolution. China is an important player in the potential of electric vehicle manufacturing and production, and this partnership reinforces our intentions to promote sustainable mobility across Asia and Mainland China.”


News Article | February 23, 2017
Site: globenewswire.com

TEL-AVIV, Israel, Feb. 23, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported its financial results for the fourth quarter and full-year ended December 31, 2016. Revenues for the fourth quarter of 2016 were $0.1 million, compared to immaterial revenues for the fourth quarter of 2015. Research and Development Expenses for the fourth quarter of 2016 were $7.5 million, up 51% compared to the fourth quarter of 2015. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA® for gastroenteritis and IBS-D, respectively, the ongoing Phase III study with RHB-104 for Crohn’s disease and ongoing studies with YELIVA® for multiple indications. General, Administrative and Business Development Expenses for the fourth quarter of 2016 were $1.6 million, down 6.9% compared to the fourth quarter of 2015. The decrease was mainly due to a decrease in professional services. Operating Loss for the fourth quarter of 2016 was $9 million, up 33% compared to the fourth quarter of 2015. The increase was mainly due to an increase in research and development expenses, as detailed above. Financial Income, net for the fourth quarter of 2016 was $0.6 million, up 214%, compared to the fourth quarter of 2015. The increase was mainly due to a fair value gain on derivative financial instruments. Net Cash Used in Operating Activities for the fourth quarter of 2016 was $10.1 million, up 69% compared to the fourth quarter of 2015. The increase was mainly due to the increase in operating loss, as detailed above. Net Cash Provided by Investment Activities for the fourth quarter of 2016 was $21.3 million, up 206% compared to the fourth quarter of 2015. The increase was mainly due to maturity of bank deposits. Net Cash Provided by Financing Activities for the fourth quarter of 2016 was $35.9 million compared to an immaterial amount for the fourth quarter of 2015. The increase was mainly due to the December 2016 public offering. Revenues for 2016 were $0.1 million, compared to immaterial revenues in 2015. Research and Development Expenses for 2016 were $25.2 million, up 42% compared to 2015. The increase was mainly due to the ongoing Phase III MAP US study with RHB-104 for Crohn's disease, the ongoing Phase III and Phase II studies with BEKINDA® for gastroenteritis and IBS-D, respectively, and the ongoing studies with YELIVA® for multiple indications. General, Administrative and Business Development Expenses for 2016 were $5.4 million, up 31% compared to 2015. The increase was mainly due to an increase in professional services, compensation and other operating expenses. Operating Loss for 2016 was $30.5 million, up 39% compared to 2015. The increase was mainly due to an increase in research and development expenses, as detailed above. Financial Income, net for 2016 was $1.2 million, up 29% compared to 2015. The increase was mainly due to a fair value gain on derivative financial instruments. Net Cash Used in Operating Activities for 2016 was $28.2 million, up 59% compared to 2015. The increase was mainly due to an increase in operating loss, as detailed above. Net Cash Provided by Investment Activities for 2016 was $24.5 million, up 215% compared to 2015. The difference was mainly due to maturity of bank deposits. Net Cash Provided by Financing Activities for 2016 was $36 million, down 34% compared to 2015. The decrease resulted primarily from the two public offerings in February and July 2015 of the comparable period. Cash Balance3 as of December 31, 2016 was $66.3 million, an increase of $8.2 million compared to $58.1 million as of December 31, 2015 and an increase of $25.8 million compared to $40.5 million as of September 30, 2016. Micha Ben Chorin, RedHill’s CFO, said: “Our strong cash position of approximately $66 million at the end of 2016 should allow us to continue to execute our strategic plans for 2017. We are looking forward to an important year ahead, including the planned initiation of a confirmatory Phase III study with RHB-105 for H. pylori infection, a second independent DSMB meeting for the ongoing MAP US Phase III study with RHB-104 for Crohn’s disease, top-line results from the ongoing Phase III and Phase II studies with BEKINDA® for gastroenteritis and IBS-D, respectively, and commencement of our promotional activities in the U.S. with Donnatal®." The Company will host a conference call on Thursday, February 23, 2017, at 9:00 am EST to review the financial results and business highlights. To participate in the conference call, please dial the following numbers 5-10 minutes prior to the start of the call: United States: +1-877-280-1254; International: +1-646-254-3366; and Israel: +972-3-763-0145. The access code for the call is 4402478. The conference call will be broadcasted live and available for replay on the Company's website, http://ir.redhillbio.com/events.cfm, for 30 days. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. RHB-105 - H. pylori bacterial infection (confirmatory Phase III) (QIDP status)         Following the announcement of the successful final results from a first Phase III clinical study with RHB-105 for the eradication of H. pylori infection (the ERADICATE Hp study) in March 2016, RedHill concluded two positive Type B meetings with the U.S. Food and Drug Administration (FDA) regarding RHB-105. The first meeting, announced in April 2016, confirmed the path to marketing approval of RHB-105 and the planned confirmatory Phase III study. A second Type B meeting, announced in November 2016, discussed the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program towards filing the CMC package as part of the potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a dual therapy amoxicillin and omeprazole regimen at equivalent doses, is planned to be initiated in the second quarter of 2017, subject to the successful completion of the ongoing supportive pharmacokinetic (PK) program and submission of the Clinical Study Report to the FDA. The confirmatory Phase III study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S. In October 2016, RedHill provided an update on the RHB-104 Phase III Crohn’s disease development program, planned enhancements to the ongoing MAP US Phase III study and expected milestones, including an increase in the total number of patients planned to be enrolled in the MAP US study from 270 to 410, and the addition of an open-label extension study offering patients who complete 26 weeks of study participation and remain out of remission (Crohn’s disease active index (CDAI) >150) the opportunity to receive treatment with RHB-104 for a 52-week period. The open-label extension study is expected to be initiated in the coming weeks. Following a pre-planned review of safety data from its ongoing MAP US study by an independent Data and Safety Monitoring Board (DSMB), RedHill announced in December 2016 that it had received a unanimous recommendation to continue the MAP US study as planned. A second independent DSMB meeting of the MAP US study, expected in the second quarter of 2017, will include an interim efficacy analysis and will evaluate the option for an early stop for success for overwhelming efficacy, according to a pre-specified statistical significance threshold. Taking into account the increase in the total number of patients planned in the MAP US study, and assuming the MAP US study is not stopped for success or inefficacy following the independent DSMB meeting in the second quarter of 2017, completion of recruitment is expected by the end of 2017. In December 2016, RedHill announced encouraging top-line final results of a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (the CEASE MS study). The top-line final results (48 weeks) were consistent with previously announced interim results, suggesting meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development. In January 2017, RedHill announced that RHB-104 had been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of nontuberculous mycobacteria (NTM) infections. RedHill plans to consult with the FDA regarding the RHB-104 development program for NTM infections. In February 2017, RedHill announced that the last patient enrolled in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA® 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study) had completed the treatment course and observation period for the primary endpoint evaluation. Top-line results are expected in the second quarter of 2017. A randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA® 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) is ongoing in the U.S. with top-line results expected in mid-2017. In June 2016, RedHill announced positive final results from a Phase I study with YELIVA® in patients with advanced solid tumors. The Phase I study, conducted at the Medical University of South Carolina Hollings Cancer Center, successfully met its primary and secondary endpoints, demonstrating that the drug is well-tolerated and can be safely administered to cancer patients at doses predicted to have therapeutic activity. In September 2016, RedHill announced a research collaboration with Stanford University School of Medicine for the evaluation of YELIVA®. The research collaboration is intended to complement RedHill’s planned Phase Ib clinical study to evaluate YELIVA® as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy. The Phase Ib study is planned to be initiated in mid-2017. In October 2016, RedHill announced the initiation of a Phase II clinical study with YELIVA® for advanced hepatocellular carcinoma at the Medical University of South Carolina. In December 2016, RedHill announced that the first patient was dosed in a Phase Ib/II study with YELIVA® for refractory or relapsed multiple myeloma, conducted at Duke University Medical Center. A Phase I/II clinical study evaluating YELIVA® in patients with refractory/relapsed diffuse large B-cell lymphoma is ongoing at the Louisiana State University Health Sciences Center and was recently amended to address overall recruitment prospects and to include Kaposi sarcoma patients in the study. A Phase II study to evaluate the efficacy of YELIVA® in patients with moderate to severe ulcerative colitis is planned to be initiated in the second half of 2017.    In 2016, RedHill and its co-development partner, IntelGenx Corp., entered into exclusive license agreements for the commercialization of RIZAPORT® oral thin-film for acute migraines with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and with Pharmatronic Co. for South Korea. Re-submission of the RIZAPORT® NDA to the FDA is expected in the third quarter of 2017. In January 2017, RedHill announced the signing of a new collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University for the evaluation of RedHill’s Phase II-stage oncology drug candidate, MESUPRON. The new research collaboration follows previous non-clinical studies conducted with Denmark’s Aarhus University and is designed to identify additional high affinity molecular targets of MESUPRON. Further evaluation of MESUPRON, together with Aarhus University, may allow for selection of appropriate sub-populations of patients toward demonstrating the activity of MESUPRON in planned clinical trials. RedHill is currently preparing a protocol for a Phase I/II study of the safety, efficacy and dose evaluation of MESUPRON in combination with chemotherapy in patients receiving adjuvant chemotherapy for resected pancreatic cancer. The Phase I/II study is expected to be initiated in the second half of 2017 in up to six sites in Germany. As part of RedHill’s strategic initiative to become a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered in January 2017 into an exclusive co-promotion agreement with a subsidiary4 of Concordia International Corp., granting RedHill certain U.S. promotional rights for Donnatal®, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel)5. RedHill expects to initiate promotion of Donnatal® in the coming months. In December 2016, RedHill closed an underwritten public offering and a registered direct offering of American Depositary Shares (ADSs) and warrants to purchase ADSs for aggregate net proceeds, after deducting underwriting discounts and commissions, placement agent fees and other offering expenses, of $35.9 million. Investors in the public offering included, among others, Sabby Management, LLC, DAFNA Capital Management, Rosalind Advisors, Inc., Koramic Holding, Lincoln Park Capital, and Nexthera Capital LP. About Donnatal®: Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast acting liquid. Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe. Further information, including prescribing information, can be found on www.donnatal.com. Please see the following website for important safety information about Donnatal®:           http://www.donnatal.com/professionals/important-safety-information/ About RedHill Biopharma Ltd.: RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis. RedHill’s clinical-stage pipeline includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered uPA inhibitor, targeting gastrointestinal and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015. More information about the Company is available at: www.redhillbio.com. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law. 1 All financial highlights are approximate and are rounded to the nearest hundreds of thousands. 2 All financial highlights are approximate and are rounded to the nearest hundreds of thousands. 5 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.


News Article | February 15, 2017
Site: co.newswire.com

CMC Networks (CMC), Africa’s largest managed connectivity provider, today announced that The Carlyle Group (NASDAQ: CG), a Global Alternative Asset Manager, has acquired a majority shareholding of CMC. The transaction value exceeds $100 million (R1.4 billion) and Carlyle’s investment gives them a majority shareholding. Further financial details of the transaction were not disclosed. Founded in 1989, CMC has the largest managed connectivity network in Africa, with a comprehensive office footprint spanning some 70 countries in Africa and the Middle East, and plans to further extend into Asia and South America. Through its unique ability to provide services in operationally challenging regions of Africa and the Middle East, while providing world class reliability and latency standards, CMC serves over 50 global telecommunications carriers, including 12 out of 14 of the largest ones. These carriers use CMC to provide fast, reliable data and internet connections to global enterprises operating in Africa and the Middle East. Grant Walker, founder and CEO of CMC, said, “Over the last 28 years, CMC has grown its network organically, and has responded to this region’s increasing appetite for reliable and secure data and internet connectivity. CMC’s research has shown that Africa’s demand for high quality bandwidth is growing by some 30% p.a. CMC has cultivated a blue-chip customer base driving international traffic into Africa but is also presently experiencing a growing amount of traffic leaving Africa from African customers. This investment by Carlyle will accelerate CMC’s growth through greater investments into new partnerships and acquisitions.” Martin Springer MD of CMC said, "CMC has quadrupled its revenue in the last five years and at present we have in excess of 100 POPs, 2000 circuits, and, through our carrier customers, we currently manage high quality data and internet connections to over 400 enterprises, including over half the Fortune 500. We have an extensive geographic footprint, which enables us to serve multi-geography and multi-site customers. We believe this investment from Carlyle is opportune as it allows us to rapidly pursue new markets, products and avenues for growth.” Braam Verster, a Director of Carlyle’s Sub-Saharan Africa Fund said, “We are excited about our partnership with CMC and its talented management team. We believe the fast growing data demand in Africa and the Middle East offers tremendous growth opportunities for CMC, and we look forward to using our sector expertise and global network to help them achieve their goals.” Equity for the transaction came from the Carlyle Sub-Saharan Africa Fund. This is the seventh investment by Carlyle’s dedicated Sub-Saharan Africa fund. Financing was provided by Standard Bank of South Africa and Rand Marchant Bank. CMC is a global telecommunications carrier, serving the data communications needs of wholesale carriers across the globe. CMC owns in excess of 100 global pops that are integrated into other wholesale carrier partner networks in order to deliver a global wholesale footprint to the carrier community. CMC has the largest Pan African network spanning across 70 countries. In addition, CMC has an extensive Middle Eastern (MENA and Western ASIA) network, which is extended via our wholesale partner program into other regions. The CMC Carrier Interconnect Model enables delivery into the USA, Europe, UAE, India, Asia, Australia and various African aggregation points. CMC provides its clients with a broad portfolio of carrier grade network solutions including: Ethernet, MPLS, DIA and private line services. The Carlyle Group (NASDAQ: CG) is a global alternative asset manager with $169 billion of assets undermanagement across 125 funds and 177 fund of funds vehicles as of September 30, 2016. Carlyle’s purpose is to invest wisely and create value on behalf of its investors, many of whom are public pensions. Carlyle invests across four segments – Corporate Private Equity, Real Assets, Global Market Strategies and Investment Solutions – in Africa, Asia, Australia, Europe, the Middle East, North America and South America. Carlyle has expertise in various industries, including: aerospace, defense & government services, consumer & retail, energy, financial services, healthcare, industrial, real estate, technology & business services, telecommunications & media and transportation. The Carlyle Group employ more than 1,625 people in 35 offices across six continents. Established in 2012 the Carlyle Sub-Saharan Africa Fund, with $698 million of committed capital, has invested almost $300 million to date across a variety of industries, including logistics, agribusiness, mining services, retail and financial services, and across a variety of geographies, including Nigeria, Mozambique, Zambia, Tanzania and South Africa. The fund makes buyout and growth capital investments in private and public companies from offices in Johannesburg, South Africa and Lagos, Nigeria. For more information, please contact:


News Article | February 22, 2017
Site: www.prweb.com

NDA Partners Chairman Carl Peck, MD, announced today that Dr. Daniel Spyker, PhD, MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff has joined the company as an Expert Consultant. In Dr. Spyker’s accomplished career, he held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma. Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications. “Dr. Daniel Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners. He will bring great value to our medical device clients and we are very pleased to welcome him,” said Dr. Feigal, who heads NDA Partners’ Medical Device Practice. Dr. Spyker earned his PhD from the University of Minnesota in Electrical Engineering and Mathematics, his MD from the University of Virginia, and MS from Purdue University. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, and diplomate of the American Board of Clinical Pharmacology. About NDA Partners NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.


News Article | February 22, 2017
Site: www.businesswire.com

WASHINGTON--(BUSINESS WIRE)--Millions of seniors who depend on Medicare Advantage (MA) plans could see cuts to their coverage and benefits if new payment changes take effect next year. That’s according to a new analysis by Oliver Wyman prepared for America’s Health Insurance Plans (AHIP). Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to MA rates that will impact the 18.5 million seniors enrolled in the program. According to Oliver Wyman, these changes, if finalized, would result in an estimated 2 percent reduction to MA net revenues in 2018. These reductions come at a time when Medicare costs are rising at nearly 3 percent, according to CMS. “We estimate that the payment policies proposed in the 2018 Advance Notice could disrupt beneficiaries in the MA market,” the report states. The most significant factors affecting the MA program include: Oliver Wyman also notes that CMS would maintain the use of encounter data to calculate risk scores. However, the system used to capture these data has numerous unresolved operational and technical issues and fails to capture a reliable, comprehensive picture of beneficiaries’ diagnoses. This could put payments at risk, which could also increase premiums and decrease benefits. “Seniors should not face any further cuts to their coverage,” AHIP President and CEO Marilyn Tavenner said. “Medicare Advantage works. We urge CMS to protect millions of seniors across the country by taking steps needed to avoid further cuts to the Medicare Advantage program.” The new report comes at a time when a growing number of voices are urging CMS to prevent further cuts to MA, including large bipartisan support from members of Congress. AHIP’s Coalition for Medicare Choices (CMC), the largest advocacy group of more than 2 million MA seniors, recently launched a nationwide grassroots and ad campaign to protect MA. Final payment rates are expected on April 3, 2017. Below is a brief analysis of the proposed changes: To view the full report, click here. America’s Health Insurance Plans (AHIP) is the national association whose members provide coverage for health care and related services to millions of Americans every day. Through these offerings, we improve and protect the health and financial security of consumers, families, businesses, communities and the nation. We are committed to market-based solutions and public-private partnerships that improve affordability, value, access and well-being for consumers. Visit www.ahip.org Learn more about health insurance and how it works at myhealthplan.guide.


News Article | February 23, 2017
Site: www.prweb.com

The National Academy of Certified Care Managers (NACCM) has revised its certification exam and eligibility requirements effective with the April 2017 testing period. NACCM, a nonprofit organization, has provided the premier certification for Care Managers since 1995. “The Care Manager Certified (CMC) exam is periodically re-calibrated to ensure that newly certified professionals are prepared to work effectively on behalf of clients in today’s world,” says NACCM Board President Jullie Gray, MSW, LICSW, CMC. “The updated exam tests the knowledge, skills, and abilities deemed essential for the practice of care management in a wide variety of settings.” All Care Manager Certified (CMC) Candidates must meet rigorous education, experience, and supervision requirements to qualify for the exam. This validated, standardized examination assures that Care Managers are qualified to perform the full range of care management tasks. Consumers, employers and other professionals can be confident that working with a Certified Care Manager ensures working with a professional that demonstrates competency in: “Care management is not a licensed field,” says Gray, “so you can be assured that professionals who hold the CMC designation have demonstrated competence and commitment to the highest practice and ethical standards.” The CMC exam test is administered by an independent testing company. To maintain certification, CMCs are required to participate in continuing education and professional development. Certification is renewed every three years. The online application process for the April exam is open now through February 28, 2017. For complete details visit NACCM’s website at http://www.naccm.net. An exam prep course and study guide are available. About NACCM: The National Academy of Certified Care Managers (NACCM) is a non-profit organization that provides the Care Manager Certified (CMC) designation. NACCM’s mission is to support a high level of competence in the practice of care management through the administration of a formal certification and re-certification program. NACCM is governed by an independent board of directors and is managed by the Aging Life Care Association®. For more information, visit http://www.naccm.net.


News Article | February 15, 2017
Site: www.prweb.com

Ziegler, a specialty investment bank, is pleased to announce the successful closing of the $48,405,000 tax-exempt, Series 2016 new money bond issue through South Carolina Jobs-Economic Development Authority for Conway Medical Center (CMC), a long-standing Ziegler client. CMC is a not-for-profit health system that is licensed for 210 general acute care beds that generates nearly $200 million in annual operating revenue with operations in the Myrtle Beach area of Horry County.   Despite the new leverage associated with the Series 2016 Bond issue, Ziegler assisted CMC, previously rated ‘A3’ by Moody’s, with a new ‘A’ rating from Fitch to support the lowest possible cost of capital in a volatile interest rate environment. The issue was structured with three term bonds due in 2026, 2037 and 2047 with principal amortization wrapped around existing debt to support the lowest possible maximum annual debt service. The Series 2016 bond issue accomplished all of our financing objectives and facilitates Conway Medical Center carrying out its important mission to the high growth communities that we serve. “I was very pleased with our issue’s efficient execution in a more volatile capital markets environment led by Ziegler,” stated Bret Barr, Executive Vice President and Chief Financial Officer for CMC. Proceeds from the Series 2016 Bonds will be utilized to fund various infrastructure improvements at the main campus and a free standing ED in a very high growth section of Horry County, which is one of the fastest growing counties in the United States. “Ziegler was delighted to assist CMC with this important financing. CMC was able to leverage its strong and consistent track record of operating profitably driven by a seasoned and exceptional management team and an enviable liquidity position to minimize its cost of capital on the Series 2016 Bonds. Low cost proceeds from the issue will help CMC meet the expanding healthcare needs of Horry County,” stated, Mike Quinn, Managing Director in Ziegler's Healthcare Finance practice. Ziegler is a premier investment bank to community and regional healthcare providers, and is the fourth-largest lead managing underwriter of healthcare issues, according to Thomson Financial Securities Data. For over 80 years, we have been assisting these organizations with creative, tailored financial solutions for their capital needs. Specializing in transactions that cover the broad spectrum of healthcare management – from hospitals, physician groups, managed care companies and senior living facilities to post-acute service organizations – Ziegler offers an array of services including investment banking, financial risk management, merger and acquisition services, as well as capital and strategic planning. For further information on the structure and use of this issue, please see the Official Statement located on the Electronic Municipal Market Access system's Document Archive. For more information about Ziegler, please visit us at http://www.Ziegler.com. About Ziegler: The Ziegler Companies, Inc., together with its affiliates (Ziegler), is a privately held, specialty investment bank with unique expertise in complex credit structures and advisory services. Nationally, Ziegler is ranked as one of the leading investment banking firms in its specialty sectors of healthcare, senior living, religion, and education, as well as general municipal and structured finance. Headquartered in Chicago, IL with regional and branch offices throughout the U.S., Ziegler provides its clients with capital raising, corporate finance, FHA/HUD, strategic advisory services and research. Ziegler serves institutional and individual investors through its wealth management and capital markets distribution channels. Certain comments in this news release represent forward-looking statements made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995. This client’s experience may not be representative of the experience of other clients, nor is it indicative of future performance or success. The forward-looking statements are subject to a number of risks and uncertainties, in particular, the overall financial health of the securities industry, the strength of the healthcare sector of the U.S. economy and the municipal securities marketplace, the ability of the Company to underwrite and distribute securities, the market value of mutual fund portfolios and separate account portfolios advised by the Company, the volume of sales by its retail brokers, the outcome of pending litigation, and the ability to attract and retain qualified employees. # # #


IRVING, Texas, Feb. 23, 2017 /PRNewswire/ -- Commercial Metals Company (NYSE: CMC), in conjunction with its second quarter earnings release, invites you to listen to its conference call that will be broadcast live over the Internet on Thursday, March 23, 2017, at 11:00 a.m. Eastern Time (1...


News Article | March 2, 2017
Site: www.businesswire.com

TORONTO--(BUSINESS WIRE)--Kew Media Group Inc. (TSX: KEW.A, KEW.WT) (“Kew”) today announced that shareholder advisory firm Institutional Shareholder Services Inc. (“ISS”) has recommended approval of Kew’s qualifying acquisition (the “Qualifying Acquisition”). The Qualifying Acquisition comprises the acquisition by Kew of 100% of six leading content companies to create a global media platform: Content Media Corporation plc (“CMC”); Architect Films Inc.; Bristow Global Media Inc.; Frantic Films Corporation; Media Headquarters Film & Television Inc.; and Our House Media Inc. In a report issued on February 27, 2017, ISS recommends that shareholders of Kew vote FOR the approval of the Qualifying Acquisition. ISS states that: “…support for the qualifying transaction is warranted as there is an adequate strategic rationale for the transaction that creates combined high-growth portfolio of content production and distribution businesses with CMC’s extensive diversified distribution operations being complemented by ten content producing companies.” ISS adds that: “Moreover, the estimated pro-rated resulting equity value appears to propose a significant up-side potential to the existing public shareholders.” With regard to Kew’s business prospects following closing of the Qualifying Acquisition, ISS comments that: “…the company is expected to transform into a significant independent content business with dynamic media platform, and with main offices in key entertainment industry centres. […] Overall, such unique business combination is expected to provide the resulting issuer with proliferation of distribution and production opportunities.” Kew also announced ISS’ recommendation that shareholders of Kew vote FOR the approval of each of its shareholder rights plan (the “Rights Plan”) and advance notice by-law (the “Advance Notice By-Law”), the adoption of which are being sought at Kew’s special meeting of shareholders to approve the Qualifying Acquisition, which is scheduled for March 13, 2017. Following discussions with ISS, Kew has made minor amendments to the Rights Plan and the Advance Notice By-Law. The amended versions of the Rights Plan and the Advance Notice By-Law are available under Kew’s profile on SEDAR at www.sedar.com. Kew expects the Qualifying Acquisition to be completed on or around March 20, 2017, subject to the satisfaction of certain conditions as set out in the purchase agreements for the six businesses. This news release may contain forward‐looking statements (within the meaning of applicable securities laws) which reflect Kew’s current expectations regarding future events. Forward-looking statements are identified by words such as “believe”, “anticipate”, “project”, “expect”, “intend”, “plan”, “will”, “may”, “estimate” and other similar expressions. These statements are based on Kew’s expectations, estimates, forecasts and projections and include, without limitation, statements regarding the completion of the Qualifying Acquisition. The forward-looking statements in this news release are based on certain assumptions, including without limitation the receipt of any required regulatory and shareholder approvals, and the expected timing related thereto, that Kew’s future objectives and strategies to achieve those objectives will not change and the expectation that no event, change or other circumstance will occur that could give rise to the termination of any of the purchase agreements. The forward-looking statements are not guarantees of future performance and involve risks and uncertainties that are difficult to control or predict. A number of factors could cause actual results to differ materially from the results discussed in the forward-looking statements, including, but not limited to, the risk that the Qualifying Acquisition may not be completed as planned. Readers, therefore, should not place undue reliance on any such forward-looking statements. Further, these forward-looking statements are made as of the date of this news release and, except as expressly required by applicable law, Kew assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Loading CMC collaborators
Loading CMC collaborators