Aspen Insurance (AHL) Shareholders Reject Endurance (ENH) Proposals Jul 28, 2014 08:15AM

Aspen Insurance (NYSE: AHL) announced that, based on preliminary voting results as of the close of business on July 25, 2014 – the target date for receiving consents set by Endurance Specialty Holdings Ltd. (“Endurance”) (NYSE: ENH) – the overwhelming majority of Aspen shareholders participating in the consent solicitation have rejected both of Endurance’s proposals.

Based on these preliminary results, as provided by the Company’s proxy solicitor, Aspen believes that shareholders owning at least 76% of Aspen’s outstanding shares did not support Endurance’s proposal to call a special meeting at which shareholders would vote on a proposal to increase the size of Aspen’s Board to 19 directors, and shareholders holding at least 81% of Aspen’s outstanding shares did not support Endurance petitioning the Supreme Court of Bermuda as part of a legal maneuver called an involuntary scheme of arrangement. Of these amounts, shareholders holding more than 60% of Aspen’s outstanding shares took action to affirmatively reject both proposals on Aspen’s blue revocation card. Thus, Aspen estimates that the number of shares affirmatively rejecting both Endurance proposals was at least two-and-a-half times as many as the number that consented.

Information on Aspen’s response to Endurance’s unsolicited offer, including links to press releases, presentations, and other important documents and SEC filings are available on the Internet at http://aspen.shareholderresource.com, or on Aspen’s website at http://www.aspen.co.

Goldman, Sachs & Co. is acting as financial advisor and Wachtell, Lipton, Rosen & Katz and Willkie Farr & Gallagher LLP are acting as legal advisors to Aspen.


Qiagen NV (QGEN), AstraZeneca (AZN) Enter Liquid Biopsy-Based Companion Diagnostic Collaboration Jul 28, 2014 08:14AM

Qiagen NV (Nasdaq: QGEN) announced a collaboration agreement with AstraZeneca plc (NYSE: AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer (NSCLC). The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumour tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014.

The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study (IRESSA Follow-up Measure) presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: "By combining AstraZeneca's expertise in lung cancer with QIAGEN's diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."

"We are very pleased to collaborate with AstraZeneca in developing this new tool to improve life for lung cancer patients. This collaboration will further expand QIAGEN's rapidly growing portfolio of liquid biopsy solutions for personalized healthcare which paves a path for patient monitoring using blood tests for future QIAGEN therascreen companion diagnostics. We are changing the treatment landscape with highly reliable genomic tests based on blood samples or other body fluids, providing physicians and patients with additional options to determine treatments and monitor progress," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "This new project with AstraZeneca under our master collaboration agreement, one of several such Pharma partnerships, adds to our expanding portfolio of reliable companion diagnostics which are creating valuable test content for the QIAsymphony family of automated instruments. As tests are developed, commercialization is accelerated through the established network of laboratories already using assays in QIAGEN's industry-leading portfolio of companion diagnostics."

IRESSA is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival. Certain EGFR gene mutations occur in a significant number of lung cancers, and these mutation-positive tumours are particularly sensitive to IRESSA. QIAGEN and AstraZeneca plan to develop a test that detects 21 EGFR mutations to identify patients most likely to benefit from the therapy, adapting QIAGEN technologies from the FDA-approved therascreen® EGFR RGQ PCR Kit. The new test kit is planned to run on QIAGEN's Rotor-Gene Q system, a member of the QIAsymphony family of automated instruments.

QIAGEN is at the forefront in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases. In the United States, QIAGEN received FDA approvals in 2012 and 2014 for the therascreen® KRAS RGQ PCR Kit in colorectal cancer and in 2013 for the therascreen EGFR test in NSCLC. Last month, QIAGEN announced a collaboration with Lilly to develop companion diagnostics for simultaneous analysis of DNA and RNA biomarkers in common cancers. Earlier this year, QIAGEN entered into a collaboration with Exosome Diagnostics to develop first-in-class, non-invasive diagnostics for key genetic biomarkers in lung and other cancers. QIAGEN's leading portfolio of liquid biopsy technologies also includes the QIAamp Circulating Nucleic Acid Kit, which is considered to be the gold standard sample technology for the processing of free circulating DNA and RNA, as well as the REPLI-g product line, which enables genomic analysis from single cells.


Celsion (CLSN) Provides Update on ThermoDox in Liver Cancer; Data Shows 57% Improvement in Survival Jul 28, 2014 08:06AM

Celsion Corporation (NASDAQ: CLSN) today announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). As of June 30, 2014, the latest quarterly Overall Survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 57% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.639 (95% CI 0.419 – 0.974) with a p-value of 0.037.

"As the data from the HEAT Study matures, it increasingly underscores the significant potential of ThermoDox® plus optimized RFA to markedly improve Overall Survival in primary liver cancer patients," stated Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy. "There is a pressing need for new treatment options to address HCC, which is a highly prevalent and deadly cancer. The consistency and strength of the HEAT Study data over each of the last five quarterly data analyses provide a strong rationale and clear roadmap for further development of ThermoDox® in this indication."

As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve OS compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037.

"The post-hoc HEAT Study data is striking in that it has consistently shown a marked OS benefit for ThermoDox® plus optimized RFA versus RFA alone in each of the quarterly data sweeps, with this 5th, and final data set demonstrating that this survival benefit is statistically significant," stated Michael Tardugno, Celsion's President and Chief Executive Officer. "This impressive clinical data set, together with prospective supportive preclinical study results and multivariate Cox Regression Analyses, reinforces our confidence in the protocol for our Phase III OPTIMA Study in primary liver cancer, which is evaluating ThermoDox® in combination with a standardized RFA protocol in primary liver cancer."

The HEAT Study and prior post-hoc analyses were presented at multiple medical conferences over the past year, including: the 2014 American Society of Clinical Oncology 50th Annual Meeting in June 2014; the 5th European Conference on Interventional Oncology in April 2014; the International Liver Cancer Association Annual Conference in September 2013; the European Conference on Interventional Oncology in June 2013; and the World Conference on Interventional Oncology in May 2013. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators.

The Company notes that, while the data and supporting analysis from the HEAT Study warrant additional clinical development, the information should be viewed with caution since it is based upon a retrospective analysis and this subgroup of the HEAT Study has not reached its median point for OS analysis.


Yingli Green Energy (YGE) Comments on Prelim. Commerce Dept. Antidumping Tariff Decision Jul 28, 2014 08:03AM

Yingli Green Energy (NYSE: YGE) commented on the preliminary anti-dumping duty ("AD") tariff decision by the U.S. Department of Commerce regarding the import of certain solar PV products assembled in China using components from a third country. According to the decision, Yingli Green Energy and its affiliates will be considered part of the Separate Rates Group and will be subject to a preliminary anti-dumping tariff of 42.33% on certain PV solar module imports.

"Unfortunately, this determination will increase the price of solar energy in America, severely jeopardizing the U.S. solar industry's tremendous progress in cost competiveness and affordability when compared with traditional energy sources," commented Mr. Robert Petrina, Managing Director of Yingli Green Energy Americas, Inc. "While we have fully cooperated throughout this investigation and were prepared for this preliminary decision, we ask that our industry comes together to resolve this dispute and focus on the growth of the promising American market. We remain committed to the U.S. solar market and will continue to support our partners and projects."

When combined with the previously announced preliminary countervailing duty ("CVD") tariff, Yingli's combined tariff rate on imported PV modules assembled in China, but containing cells manufactured in a third country from certain Chinese components, is 47.27%. Both the AD and CVD tariff determinations for all solar products covered by these petitions are preliminary, and may be revised once the International Trade Commission ("ITC") completes its investigation. The final AD and CVD determination is expected before the end of 2014, and the final ITC determination is expected in early 2015.

"As a result of protectionist trade policies that raise prices and slow the deployment of solar power, we anticipate that significantly fewer people in the U.S. and globally will experience the long-term economic and environmental benefits of widespread solar adoption," commented Mr. Liansheng Miao, Chairman and Chief Executive Officer of Yingli Green Energy. "At Yingli, our mission is to bring affordable green energy to all, so we are hopeful that a solution based on the principles of free trade and fair competition will be reached."


RPM International (RPM) Enters Agreement to Resolve Bondex-Related Asbestos Claims Jul 28, 2014 07:46AM

RPM International (NYSE: RPM) announced an agreement in principle with the official representatives of current and future claimants that would resolve all present and future asbestos personal injury claims related to Bondex International, Inc. and other related entities. The agreement in principle contemplates the filing of a plan of reorganization with the United States Bankruptcy Court in Delaware. The plan will be subject to approval of the claimants, as well as the U.S. Bankruptcy Court and U.S. District Court.

Under the terms of the agreement in principle, a trust will be established under Section 524(g) of the United States Bankruptcy Code for the benefit of current and future asbestos personal injury claimants, funded as follows:

Upon the plan becoming effective, the trust will be funded with $450 million in cash;
On or before the second anniversary of the effective date of the plan, an additional $102.5 million in cash, RPM stock or a combination thereof (at the discretion of RPM in this and all subsequent cases) will be deposited into the trust;
On or before the third anniversary of the effective date of the plan, an additional $120 million in cash, RPM stock or a combination thereof will be deposited into the trust; and
On or before the fourth anniversary of the effective date of the plan, a final payment of $125 million in cash, RPM stock or a combination thereof will be deposited into the trust.

These contributions to the trust total $797.5 million and are expected to be tax deductible. RPM estimates the after-tax net present value of the contributions to be approximately $485 million. The company anticipates that the cash necessary to initially fund the trust will be provided from amounts available under its revolving credit facilities and available cash resources. However, depending upon market conditions, RPM may determine to finance all or a portion of the contributions through the debt capital markets.

Pursuant to the agreement, Bondex's parent company, Specialty Products Holding Corp. ("SPHC"), will remain a wholly owned subsidiary of RPM and its results of operations will be reconsolidated with those of RPM for financial reporting purposes effective upon consummation of the plan. SPHC had revenues of approximately $385 million during the 12 months ended May 31, 2014, compared with revenues of approximately $300 million for the fiscal year ended May 31, 2010, when the bankruptcy commenced. Virtually all of SPHC's growth over that period has been organic. The company anticipates that reconsolidating SPHC's results will be accretive to RPM's earning per share in the first year, in part because the accounting rules that required RPM to record SPHC's non-controlling interests in certain RPM subsidiaries as a non-cash reduction to net income will no longer apply upon consummation of the plan.

"We have been able to reach a settlement on acceptable terms that will resolve the Bondex-related asbestos liability, while enabling us to reconsolidate the financial results of SPHC's growing and profitable businesses," stated Frank Sullivan, chairman and chief executive officer of RPM. "Consummation of a plan of reorganization incorporating these terms will allow RPM to move forward and put this chapter in our history behind us."

RPM expects the Bankruptcy Court will schedule future proceedings regarding this matter. The company expects to provide additional details on the financial impact of the agreement upon consummation of the plan, which is currently expected by the end of fiscal 2015.


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