Cisco Systems (CSCO) to Hold 10% Stake in VCE; Will Have Controlling Interest in EMC Oct 22, 2014 08:07AM

EMC (NYSE: EMC), Cisco (Nasdaq: CSCO) and VCE announced the next phase of evolution for VCE. Expected to be finalized this quarter, VCE will become an EMC business. Cisco and VMware will continue as strategic partners and investors, with Cisco having an approximately 10% equity interest in VCE. VCE's charter will focus on simplifying the deployment of hybrid clouds, including a full range of converged infrastructure offerings, applying its unique innovations and expertise to a broad range of hybrid cloud solutions. Under this next phase, VCE will continue to advance new solutions based on its industry-leading Vblock® Systems, which feature best-of-breed technologies exclusively from Cisco, EMC and VMware.

VCE embarks upon this new structure with full support from its original founders Cisco, EMC and VMware (NYSE: VMW). As part of the EMC family, VCE will remain intact under the leadership of CEO Praveen Akkiraju and his senior team with its own mission, operating charter and organizational structure. Underscoring their commitment to VCE customer success are existing and renewed multi-year engineering, resell and support agreements among Cisco, EMC and VCE. As part of EMC, VCE will be an integration point for technologies from across the company.

As one of the industry's most successful joint ventures, the speed and scale of VCE's success in pioneering and validating converged infrastructure has been unprecedented, with VCE as the clear leader. EMC, Cisco and VCE jointly determined that this new structure would serve as the optimal model for VCE's next phase of expansion, innovation, and long-term growth.

VCE surpassed a $2 billion annualized demand run-rate1 for Vblock and Vblock-related products and services exiting Q3 2014, its sixth consecutive quarter of greater than 50% year-over-year demand growth. According to IDC2, total worldwide spending on converged infrastructure is growing at 32.8% annually and will reach approximately $14.37 billion in 2017 (up from $5.4 billion in 2013). VCE is the clear leader in integrated infrastructure systems according to Gartner3 and IDC4. Earlier in 2014, VCE was positioned as a leader in the Gartner, Inc. Magic Quadrant for Integrated Systems5, based on an evaluation of VCE's completeness of vision and ability to execute.

VCE Vblock Systems are engineered, manufactured, managed, supported, and sustained as a single solution, providing an exceptional customer experience. More than 1,000 enterprises and service providers have deployed over 2,000 Vblock Systems worldwide, realizing significant benefits in speeding application deployments, simplifying operations, increasing availability, and reducing costs. A recent study conducted by IDC revealed that, on average, VCE customers were able to deploy new services five times faster, reduce downtime by 96%, and lower their annual datacenter costs by 50% with Vblock Systems.

VCE's reorganization and recapitalization, which will result in the acquisition of a controlling interest by EMC, are expected to be completed in the fourth quarter of 2014, subject to customary regulatory approvals, and are expected to have no material impact to EMC GAAP and non-GAAP EPS for the full 2014 fiscal year. Once finalized, EMC will begin reporting VCE financials as part of its consolidated financial statements.

Executive Quotes:

Joe Tucci, Chairman and CEO of EMC

"VCE was created to be a disruptive force by radically transforming and simplifying IT data center architectures, accelerating a shift to cloud computing. It has been a huge success and has changed the conversation with CIOs. VCE's size, scale and market reach now requires a more traditional business structure. Our commitment to increased investment will enable VCE to significantly expand the scale and scope of its solutions, helping customers take better advantage of hybrid cloud and next-generation IT opportunities." Tucci continued, "We would like to welcome Praveen, VCE President Frank Hauck and the VCE team to EMC and congratulate them on the tremendous success of VCE."

John Chambers, Chairman and CEO of Cisco

"VCE represents another example of Cisco's strategy of aggressively investing to drive key market transitions. VCE was created to positively disrupt data center architectures utilizing Cisco's UCS and Nexus platforms, and we have been thrilled with the execution, results and customer demand the VCE team has delivered. I look forward to the next chapter of VCE's evolution and Cisco's continued commitment in VCE as a crucial route to market for Cisco's next-generation technologies for the data center and cloud."

Praveen Akkiraju, CEO of VCE

"VCE has proven to be a game-changer for customers, dramatically accelerating the deployment of next-generation data center and cloud environments. As the company that pioneered converged infrastructure, I could not be more proud of what the VCE team has accomplished through our customer-centric DNA and deep solution expertise. I am energized by this next phase as we apply the unique VCE Experience to enable customers' journey to the cloud."

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Atossa Genetics (ATOS) Receives CE Mark for ForeCYTE Breast Aspirator Oct 22, 2014 08:03AM

Atossa Genetics (NASDAQ: ATOS) announced it has received certification to Annex II of the European Medical Device Directive (MDD) from its European Notified Body, DQS Medizinprodukte GmbH, which allows Atossa to place the "CE" Mark on the ForeCYTE Breast Aspirator for distribution in the European Union and its member states. DQS Medizinprodukte GmbH, a Notified Body/Registrar, is also a participant in the FDA's third-party inspection program.

MDD certification verifies that the ForeCYTE Breast Aspirator device meets all applicable directives and standards applicable for its device classification per the directive and has been evaluated and meets the requirements outlined in Annex I, Essential Requirements of the directive. The ForeCYTE Breast Aspirator device is a reusable, hand-held pump device intended for the collection of a small amount of nipple aspirate fluid (NAF) from a woman's breast for cytological testing (not available in the U.S.). The granting of this "CE" mark involved a comprehensive audit of the company's quality system as well as a thorough evaluation of the ForeCYTE Breast Aspirator overall design to assure it performs safely. The "CE" mark affirms Atossa's commitment to product quality and development, and augments its registration to the International Organization for Standardization's (ISO)13485:2003 "Medical devices - Quality management systems - Requirements for regulatory purposes," EN ISO 13485:2012 and AC:2012 (Canadian) and ISO 9001:2008 "Quality managements systems - Requirements" standards, which the company received in June 2014.

"This approval marks an essential pivot point for Atossa as we pursue commercialization of the ForeCYTE Breast Aspirator into various European markets," said Steven C. Quay, Chairman, CEO & President of Atossa. "We are very pleased to attain this important certification as the "CE" mark validates our capability to manufacture and develop a device that meets the applicable regulatory requirements for the European Union," he continued.

DragonWave (DRWI) Reports Follow on Orders in India Oct 22, 2014 08:02AM

DragonWave Inc. (NASDAQ: DRWI) today announced it has received follow on purchase orders for Horizon Compact+ from a major Indian Telecom and Broadband Service Provider.

"We are pleased to have received additional orders from this key Indian customer to further build out their 4G Network," said DragonWave President and CEO Peter Allen. "India is a very important market and our solutions are ideally placed to deliver cost effective capacity for operators who are modernizing their networks to deliver 4G services."

DragonWave Horizon Compact+ uniquely offers a combination of 2048 QAM modulation, together with the industry's only bandwidth accelerator bulk compression capability, to deliver unsurpassed spectral efficiency. After extensive customer testing DragonWave's Horizon Compact+ it was determined that it was an excellent fit to build a high capacity backbone to support a leading 4G network.

Regulus Therapeutics (RGLS) Reports Interim RG-101 Results Oct 22, 2014 07:50AM

Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV"). Interim results from the ongoing clinical study demonstrate that treatment with a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy resulted in significant and sustained reductions in HCV RNA in a varied group of patients, including difficult to treat genotypes and patients who experienced viral relapse after a prior IFN-containing regimen. Additionally, RG-101 was safe and well tolerated and has demonstrated a very favorable pharmacokinetic profile to date, which may allow for combination with oral direct-acting antiviral ("DAA") agents to treat HCV.

Interim results from the ongoing clinical study are summarized below:

  • In the first dose cohort of part IV of the ongoing study, 16 HCV patients were enrolled with multiple genotypes, 10 GT1s, 5 GT3s, and 1 GT4. 14 patients, 8 naïve and 6 patients who experienced viral relapse after a prior IFN-containing regimen, received a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy while 2 patients received placebo.
  • In the 14 HCV treated patients, there was a mean viral load reduction of 4.1 log10 at day 29 (range -5.8 log10 to -2.3 log10).
  • 6 out of 14 patients had HCV RNA levels below the limit of quantification at day 29 and the 3 patients from this group who have reached day 57 still have HCV RNA levels below the limit of quantification.
  • Viral load reduction occurs within the first 96 hours and virologic response is not influenced by IL-28 genotype.
  • Due to the long-lasting and sustained virologic effect seen, the ongoing study protocol has been amended to follow patients for up to six months after dosing to evaluate the possibility for certain patients to achieve viral cure after a single dose of RG-101.
  • There were no drug-drug interactions from part III of the ongoing study in which RG-101 was combined with simeprevir (OLYSIO™), an approved oral DAA (protease inhibitor), and the combination had no effect on the pharmacokinetic profile of RG-101 or simeprevir (OLYSIO™).
  • RG-101 is safe and well tolerated with no serious adverse events reported to date.

"We are very excited to have demonstrated our first human proof-of-concept results with a microRNA therapeutic from the ongoing study of RG-101, which is a significant milestone in Regulus' history, and represents a key achievement under our 'Clinical Map Initiative'," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus. "We believe these interim data are exceptional and provide strong evidence to support the rapid advancement of RG-101 into future clinical studies, while presenting a clear opportunity for a potentially disruptive therapy to the current HCV treatment paradigm."

"RG-101 is the first microRNA therapeutic in clinical development to combine the most advanced RNA technologies from three leading RNA therapeutics companies; chemistry 2.5 from Isis, GalNAc conjugate from Alnylam, and Regulus' unique and proprietary chemistry including the novel linker that facilitates the release of the parent oligonucleotide after hepatocyte uptake," said Neil W. Gibson, Ph.D., Chief Scientific Officer. "We believe the innovative design of RG-101 has led to achievement of our first human proof-of-concept results, and hope these findings will advance the growth of our microRNA therapeutics pipeline."

"We are very pleased and encouraged with the interim results and believe these findings strongly support the rapid advancement of RG-101 into Phase II development," said Paul Grint, M.D., Regulus' Chief Medical Officer. "Currently, we plan to file an Investigational New Drug Application with the U.S. Food and Drug Administration in the first quarter of 2015 and plan to initiate a Phase II DAA combination study of RG-101 in HCV patients in the second quarter of 2015. In addition, we look forward to reporting additional data from the ongoing study in the first half of next year."

"The efficacy and sustained viral response seen with a single dose of RG-101 is very promising and it was encouraging to see response across a diversity of genotypes and treatment experience in this clinical trial. Additionally, all patients in the first cohort on active therapy demonstrated a viral response to RG-101, which is also very encouraging," said Dr. Eric Lawitz, M.D., Vice President, Scientific and Research Development, The Texas Liver Institute, and Clinical Professor of Medicine, University of Texas Health Science Center in San Antonio. "These findings suggest the clinical benefit of utilizing a unique mechanism of action to potentially treat difficult patient populations. There may be an opportunity to improve upon the current real world compliance issues with therapies such as RG-101 that may be administered subcutaneously by a clinician. I look forward to seeing RG-101 advance into future clinical trials."

Federal-Mogull (FDML) Misses Q3 EPS by 13c Oct 22, 2014 07:48AM

Federal-Mogull (NASDAQ: FDML) reported Q3 EPS of $0.13, $0.13 worse than the analyst estimate of $0.26. Revenue for the quarter came in at $1.87 billion versus the consensus estimate of $1.82 billion.

Federal-Mogul on September 3, 2014 announced its plan to separate its Powertrain and Motorparts divisions into two independent, publicly traded companies by spinning off the Motorparts division to current shareholders. The spin-off will provide additional operating and financial flexibility for each division to aggressively grow and improve its distinct business while preserving commercial benefits of continued collaboration in certain areas.

Completion of the transaction is subject to various approvals and conditions. While no assurances can be given regarding the ultimate timing of the separation or that it will be consummated, the company's objective is to complete the spin-off of Federal-Mogul Motorparts in the first half of 2015.

For earnings history and earnings-related data on Federal-Mogull (FDML) click here.

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