|To: richardred who wrote (1083)||10/14/2010 9:41:52 AM|
|Merck/Ariad Pharmaceuticals: Results of Synergistic Collaboration Coming Soon|
Ariad Pharmaceuticals (NASDAQ: ARIA) captured Merck’s (NYSE: MRK) attention enough with its cancer drug, ridaforolimus, in July 2007 to forge a partnership to help Ariad through several clinical trials for multiple cancer indications. More recently, preliminary results of the phase III were impressive enough to give Ariad enough leverage to modify the agreement in May to a much more favorable position for Ariad.
The agreement gave Merck an exclusive license to develop, manufacture and commercialize ridaforolimus; and Merck assumed responsibility for ridaforolimus activities, including clinical trials and regulatory filings. In exchange, Ariad received $50 million upfront as well as an additional $19 million to retroactively fund the development of ridaforolimus to the date of the new agreement.
Previously, at the start of the collaboration, Merck had already made a $75 million upfront payment to ARIAD and since then has paid ARIAD $53.5 million in milestone payments for the initiation of Phase 2 and 3 clinical trials of ridaforolimus in addition to paying its 50 percent share of ridaforolimus development, manufacturing and commercialization costs.
In the future, ARIAD will be eligible to receive up to $514 million in regulatory and sales milestones based on the successful development and commercialization of ridaforolimus in multiple indications. This includes $65 million in milestones associated with the potential sarcoma indication, which currently is in Phase 3 clinical development ($25 million for acceptance of the new drug application by the FDA, $25 million for U.S. marketing approval, $10 million for European marketing approval, and $5 million for Japanese marketing approval) and $200 million in milestones based on achievement of significant sales thresholds.
Ridaforolimus is Ariad’s most advanced drug in clinicals. It is being studied in a trial termed SUCCEED. This trial is a randomized, double-blind, placebo-controlled Phase 3 study of oral ridaforolimus in patients with metastatic soft tissue and bone sarcomas who have achieved a favorable response to chemotherapy. This trial will be completed and data compiled in 4Q 2010. Sarcomas are a group of aggressive cancers of connective tissues for which there are limited treatment options.
In 2009, the American Cancer Society estimated that approximately 10,600 new cases of soft-tissue sarcomas were diagnosed in the United States, and more than 3,800 Americans would die of the disease. In addition, approximately 2,600 new cases of bone sarcomas would be diagnosed and nearly 1,500 deaths were estimated. See here for more information.
There has been no new approved therapy in the U.S. for patients with soft tissue or bone sarcomas in more than 20 years. Ridaforolimus has been designated both as a fast-track and orphan drug product by the U.S. Food and Drug Administration (FDA) and as an orphan drug by the European Medicines Agency (EMEA) for the treatment of soft tissue and bone sarcomas. Merck and ARIAD are pursuing this indication as the initial registration path for ridaforolimus. Ridaforolimus is a novel small-molecule inhibitor of the protein mTOR, a "master switch" in cancer cells. Blocking mTOR creates a starvation-like effect in cancer cells by interfering with cell growth, division, metabolism and angiogenesis. Merck’s interest in ridaforolimus is, not doubt, fueled by the fact that this mechanism could potentially be utilized to fight multiple indications of cancer, not only the soft tissue and bone sarcomas.
On May 25th of this year, shortly after the modification of the initial agreement between Ariad and Merck, Ariad announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial completed the second interim efficacy analysis as specified in the study protocol and recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to its final analysis, without modification to the study protocol. Additionally, they noted that no new safety signals were noted and that the final analysis of progression free survival, the primary endpoint, is expected in the second half of 2010. With the FDA’s apparently increased new focus on drug safety, ridaforolimus as an mTOR inhibitor could benefit as pertaining to its safety profile from Wyeth Pharmaceutical’s (NYSE: WYE) TORISEL and Novartis’ (NYSE: NVS) Afinitor. TORISEL and Afinitor are both mTOR inhibitors. Torisel, given by infusion, was approved by the FDA in May of 2007 for advanced kidney cancer. Afinitor, given orally, was approved in March of 2009 specifically as first treatment for patients with kidney cancer after failure of either of the drugs sunitinib or sorafenib. Although this could be a likely first-in-class approval for sarcomas, the kidney cancer indications for TORISEL and Afinitor both give a proven safety and concept track record for this class of drugs.
Merck has deep pockets with its varied pipeline and $45.4 billion dollar 2010 projected revenue. However, it must really see promise in ridaforolimus and its inhibition of mTOR as viable and a likely mechanism to fight cancer in order to invest in the drug’s past, present and future. Ariad has already benefited from the collaboration and may likely continue doing such as the phase II and III preliminary data for ridaforolimus in multiple applications indicate.
Oncology drugs take a tremendous amount of time and money to discover, develop in phase I, II and III trials as well as have the production facilities and marketing to manufacture and promote. This appears to be a win-win scenario for Merck and Ariad Pharmaceuticals. Merck benefits from the novel discovery of another, smaller and perhaps more flexible and creative company’s product. Meanwhile, Ariad Pharmaceuticals benefits from the financial aspects of development, and the experience with the FDA and production facilities of Merck.
With this partnership, the potential could always arise for something more than a partnership between the two companies. At market close on October 13, 2010 the market cap for Ariad Pharmaceuticals at $3.91 per share could be a tempting offer for Merck at $433 million.
As the final phase 3 data is evaluated and a NDA is filed likely during 4Q of this year, more details of the product’s efficacy and safety will become self-evident. Meanwhile, Merck could possibly be the party initiating a surprise change of its own in the relationship between them and Ariad Pharmaceuticals.
Disclosure: Author holds long positions in the above-mentioned stocks
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|To: richardred who wrote (2430)||10/14/2010 9:59:24 AM|
|EMC Takes a Big-Data Swipe at Oracle, H.P. and I.B.M.|
By ASHLEE VANCE
Big data is like the testosterone of business computing right now. It has put technology’s largest players on an aggression bender.
The latest tech giant to flex its big-data muscle is EMC. On Wednesday, the storage specialist introduced the EMC Greenplum Data Computing Appliance. EMC acquired Greenplum in July, giving it some of the top data warehousing software in the market. The company has taken that code and wrapped it in a metal bundle, adding servers, storage units and networking to make a so-called appliance, which is data-center speak for a system that’s meant to perform a single function well.
The product stands out as EMC’s first real foray into selling customers a complete system rather than just storage bits and bobs. (Look under the covers, though, and you’ll find that Dell actually makes the server part of the appliance.)
Data warehousing systems vacuum up information from huge databases and then let companies poke and prod at that information in the hopes of gleaning insights about their business. Typically, these computing products munch away on inventory, sales, shipping, employee and customer data.
EMC’s move follows I.B.M.’s acquisition last month of the data warehouse appliance maker Netezza for $1.7 billion. Oracle too spent most of its recent customer conference talking about its data warehousing appliances made out of hardware it acquired in the purchase of Sun Microsystems.
Hewlett-Packard and Microsoft have built out their data warehousing arsenals in recent years as well through a combination of in-house work and acquisitions. And Teradata remains the independent market leader.
These companies are all racing to make bigger, faster systems that can keep up with the flood of data being produced by people and all types of things with digital heartbeats.
“Before it was just humans entering data, but now the machines are generating their own information,” said Scott Yara, a co-founder of Greenplum and now a vice president at EMC. “There are wireless networks, switches, routers and sensors. The machines are generating 10 times more data than the humans.”
Greenplum specialized in making software capable of running across many computers linked together. This technique allows customers to analyze huge data sets in a reasonable amount of time.
The bigger the data sets, the better for the technology companies because they’re selling more gear and getting closer to their customers by handling prized information.
“I think data will become so synonymous to computing,” Mr. Yhttp://bits.blogs.nytimes.com/2010/10/13/emc-takes-a-big-data-swipe-at-oracle-h-p-and-i-b-m/?partner=yahoofinanceara said.
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|From: richardred||10/15/2010 12:24:42 PM|
|It's for Real: Seagate Confirms Buyout Talks|
By Anders Bylund | More Articles
October 15, 2010 | Comments (0)
Here we go: Hard drive maker Seagate Technology (Nasdaq: STX) has confirmed that it's in buyout talks with an unnamed "interested party."
Both Seagate and chief rival Western Digital (NYSE: WDC) have been looking like buyout bait for a long time, thanks to a combination of solid business and rock-bottom valuations. I have identified both companies as tremendous values, and fellow Fool Brian Pacampara agrees. It's about time somebody takes advantage of Seagate's mispriced, high-quality business.
Private equity firms are masters of sniffing out undervalued assets and flipping them over a couple of years for a sweet profit. With acquisition talk building, you could see public companies get interested as well. Other potential buyers include serial buyout bingers Hewlett-Packard (NYSE: HPQ), Oracle (Nasdaq: ORCL), and IBM (NYSE: IBM), all of whom have a strong interest in data storage and could integrate a cheap and guaranteed supply of disk drives into their industrywide operations. And there's always the outside chance that Cisco Systems (Nasdaq: CSCO) has decided to take an even deeper interest in hardware systems by building a storage presence from the ground up.
However, there are parts of a Seagate acquisition that wouldn't make sense for this list of serial acquirers. IBM exited the hard drive market years ago by selling that operation to Hitachi. Cisco would be better served by a builder of storage systems such as NetApp (Nasdaq: NTAP) rather than Seagate's nuts-and-bolts products. Finally, Bloomberg reports that Seagate (which has been taken private once before) had recent talks with buyout firms, but those fell apart after the company wouldn't meet financial projections the private equity firm expected.
With official word from Seagate's management, this newest deal-making process sits a cut above rumors, but is still less than signing on the dotted line. You can still buy Seagate and benefit from the final buyout premium, if it happens. Conversely, current shareholders skeptical of a complete deal can sell and enjoy the preliminary pop.
How are you playing Seagate's announcement? Share your thoughts in the comments box below.
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|To: richardred who wrote (2315)||10/18/2010 9:36:17 AM|
|Another medical device maker bites the dust. |
St Jude to buy AGA Medical for over $1 bln
Mon Oct 18, 2010 7:28am EDT
* At $20.80, deal is 41 pct premium
* AGA Medical went public in October
NEW YORK Oct 18 (Reuters) - St Jude Medical Inc (STJ.N) will buy AGA Medical Holdings Inc (AGAM.O), a maker of devices to treat heart defects and vascular problems, for more than $1 billion in cash and stock, the companies said on Monday.
At $20.80 per share, the deal values AGA Medical shares at a 41 percent premium to Friday's closing price. The companies valued the deal at about $1.3 billion, including the assumption of about $225 million in debt.
AGA Medical went public in October at $14.50 per share. Its major shareholders include those affiliated with private equity firm Welsh, Carson, Anderson & Stowe, and AGA Medical's co-founder Franck Gougeon.
The deal involves an even split between cash and stock. The exchange ratio for the stock component will be determined by the average closing price of St. Jude stock over 10 trading days, ending two days before the close of the exchange offer.
St Jude said it expects the transaction to close by year's end and it does not affect its earnings outlook for 2010. (Reporting by Lewis Krauskopf, editing by Maureen Bavdek)
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|To: richardred who wrote (2458)||10/18/2010 10:47:09 AM|
|Medical device theme. Considering what St. Jude payed for AGA Medical Holdings. I'm encouraged that will up the speculative appeal in ANGO,IART,OFIX, and ICIU. All in my portfolio currently. All are much more profitable and have much better balance sheets than AGA did. IART, OFIX, and ICIU are currently growing much faster quarterly, YOY.|
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|To: richardred who wrote (2274)||10/18/2010 11:03:48 AM|
|I found it curious that as far as I can tell. MRX was not seeking FDA approval for it's BOTOX copy cat drug DYSPORT for the indication of migraine headaches. AGN just got FDA approval for that indication. Analysts say that could add about 600 mllion dollars to sales.|
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|To: richardred who wrote (2335)||10/19/2010 12:11:42 AM|
|UPDATE 1-ICU Medical Q3 beats Street, raises FY outlook|
Mon Oct 18, 2010 4:42pm EDT
* Q3 EPS $0.65 vs est $0.48
* Revenue up 40 pct at $75.7 mln vs est $66.6 mln
* Sees FY10 EPS $2.00-$2.07
* Sees FY10 revenue $277-$282 mln
Oct 18 (Reuters) - ICU Medical Inc (ICUI.O) posted a better-than-expected quarterly profit, helped by strong sales across all its product lines, and raised its full-year outlook for a second time this year.
The maker of disposable medical connection systems reported July-September net income of $9 million, or 65 cents a share, compared with $6.3 million, or 42 cents a share, a year ago.
Revenue at the company, which makes custom I.V. systems, catheters and cardiac monitoring systems, rose 40 percent to $75.7 million.
Analysts on average expected earnings of 48 cents a share, before items, on revenue of $66.6 million, according to Thomson Reuters I/B/E/S.
The company raised its fiscal 2010 earnings-per-share forecast to $2.00-$2.07 from its prior outlook of $1.85-$1.92.
For the full year, it expects revenue of $277-$282 million, up from its earlier forecast of $270-$275 million.
ICU Medical's shares closed at $38.15 Monday on Nasdaq. The stock has risen 11 percent in value since the company reported strong second-quarter results and raised its full-year view in July. (Reporting by Shravya Jain in Bangalore; Editing by Anne Pallivathuckal)
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|To: richardred who wrote (2459)||10/19/2010 7:59:11 AM|
|Deal-Making in Medical Technology Sector Surpasses 2009 Level, Report Says|
By David Olmos - Oct 19, 2010 12:01 AM ET
The value of mergers and acquisitions of medical technology companies in the first half of 2010 surpassed the total for all of 2009, driven by buyers’ taste for bigger deals of established companies, a report found.
Eighty-nine deals with a value of $16.9 billion were struck in the first half of this year in the U.S. and Europe, compared with 172 transactions worth $15.7 billion in 2009, according to an Ernst & Young LLP report released today. The 2010 totals exclude Swiss drugmaker Novartis AG’s proposed $28.3 billion offer to purchase Nestle SA’s majority stake in Alcon Inc., the eye-care company, Ernst & Young said.
Deals should remain brisk in 2010’s second half, as shown by St. Jude Medical Inc.’s proposed $1.08 billion acquisition of AGA Medical Holdings Inc., announced yesterday, said John Babbitt, head of Ernst & Young’s medical technology practice in the Americas, in a telephone interview. Activity in 2010 may approach $30 billion, about double the value of 2009 deals, which was the lowest since 2002, the report said.
“We’ll probably see more deals of $1.5 billion and below,” said Les Funtleyder, a health-care portfolio manager at Miller Tabak & Co. in New York. Mergers and acquisitions will likely increase in the fourth quarter of this year, as companies try to get transactions completed by year’s end, he said.
There have been 240 deals in the last five years in the medical-device sector, with an average deal value of $369.5 million and an average premium of 41.8 percent, according to Bloomberg data. The biggest deal was Boston Scientific’s 2005 acquisition of Guidant Corp. for $25.2 billion.
Merck KGaA Deal
Much of the gain in 2010’s deal volume came from one transaction, Darmstadt, Germany-based Merck KGaA’s $6.8-billion acquisition in July of Millipore Corp., the supplier of biotechnology equipment based in Billerica, Massachusetts.
“We’re seeing fewer but larger deals,” said Babbitt, of the accounting firm, noting that investment has shifted away from early-stage companies.
“The real interest has been in buying mid-tier medical technology companies that have attractive valuations,” Babbitt said. “They are folding them into leaner and more efficient structures that the larger medical technology companies now have.”
Besides Merck, some of the bigger deals in 2010 have been Dublin-based Covidien Plc’s $2.5 billion acquisition of heart- device maker ev3 Inc. in July, and Minneapolis-based Medtronic Inc.’s $350-million acquisition of Invatec, an Italian maker of heart devices, in April.
“I don’t think we’re going to see a Guidant-size deal,” Funtleyder said, referring to the rest of this year.
The report defines the medical technology sector as companies including those that make medical devices, imaging technology such as magnetic-resonance imaging scanners, non- imaging diagnostic gear and equipment used in scientific research.
To contact the reporter on this story: David Olmos in San Francisco at firstname.lastname@example.org
To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net
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|To: richardred who wrote (2458)||10/19/2010 8:15:07 AM|
|Opto Circuits to Acquire Cardiac Science|
Press Release Source: Cardiac Science Corporation On Tuesday October 19, 2010, 6:15 am EDT
BOTHELL, Wash. and BANGALORE, KARNATAKA, India, Oct. 19 /PRNewswire-FirstCall/ -- Cardiac Science Corporation (Nasdaq:CSCX - News) and Opto Circuits (India) Limited [BSE Code: 532391; NSE: OPTOCIRCUI] today announced they have entered into a definitive merger agreement under which Opto Circuits has agreed to acquire all of the outstanding shares of Cardiac Science common stock for $2.30 USD per share. The $2.30 price represents a 10% premium to the closing price of Cardiac Science common stock of $2.10 on October 18, 2010, a 28% premium to the average closing price for the 30 day period ended October 18, 2010 and a 30% premium to the average closing price for the 100 day period ended October 18, 2010.
"We believe this transaction provides excellent value to our shareholders and expanded opportunity for our customers, employees, and partners," said Dave Marver, Cardiac Science president and chief executive officer. "Our business will benefit greatly from Opto Circuits' financial resources, operational capabilities, and global scale."
"We are delighted to expand our presence in noninvasive diagnostic monitoring through this acquisition and are excited to enter the high-growth automated external defibrillation market," said Vinod Ramnani, Opto Circuits chairman and managing director. "Cardiac Science has a strong reputation for innovative, high-quality products and services. This transaction is expected to open many new global markets for Cardiac Science's products and will greatly enhance Opto Circuits' product offering and presence in the United States."
Piper Jaffray acted as financial advisor to Cardiac Science and delivered a fairness opinion to Cardiac Science's board of directors. Perkins Coie LLP served as outside legal counsel to Cardiac Science, while Quarles & Brady LLP served as outside legal counsel to Opto Circuits.
About the Transaction
The boards of directors of both companies have unanimously approved the transaction, which will take the form of an all-cash tender offer by a wholly-owned subsidiary of Opto Circuits, followed by a second-step merger. The closing of the tender offer by Opto Circuits, which is expected to be commenced within 10 business days, is subject to customary conditions, including that shares representing at least sixty percent (60%) of Cardiac Science's outstanding shares of common stock are validly tendered into the offer. As a result of the second-step merger, any shares that have not been validly tendered into the offer will be converted into the right to receive cash equal to the offer price of $2.30 per share. The subsequent closing of the merger may be subject to obtaining stockholder approval of the merger agreement if Opto Circuits does not acquire a sufficient number of shares to effect a short-form merger. If such approval is needed, Cardiac Science will call a special meeting of its stockholders. If a stockholder meeting is required to approve the merger, Opto Circuits has agreed to vote (or cause its acquisition subsidiary to vote) all shares of Cardiac Science it owns in favor of the merger. The companies are targeting a late fourth quarter 2010 closing, assuming satisfaction of closing conditions and successful execution of the tender offer process.
Upon completion of the merger, Cardiac Science will become a wholly-owned subsidiary of Opto Circuits. Opto Circuits will fund the purchase with its cash and credit lines.
About Cardiac Science
Cardiac Science develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators (AED), electrocardiograph devices (ECG/EKG), cardiac stress treadmills and systems, diagnostic workstations, Holter monitoring systems, hospital defibrillators, vital signs monitors, cardiac rehabilitation telemetry systems, and cardiology data management systems (informatics) that connect with hospital information (HIS), electronic medical record (EMR), and other information systems. The company sells a variety of related products and consumables and provides a portfolio of training, maintenance, and support services. Cardiac Science, the successor to the cardiac businesses that established the trusted Burdick®, HeartCentrix®, Powerheart®, and Quinton® brands, is headquartered in Bothell, Washington. With customers in more than 100 countries worldwide, the company has operations in North America, Europe, and Asia. For information, call 425.402.2000 or visit cardiacscience.com.
About Opto Circuits
Opto Circuits (India) Ltd. (OCI) (BSE Code: 532391; NSE Symbol: OPTOCIRCUI) is an Indian MNC in the business of design, development, manufacture and marketing of healthcare equipment and interventional products. The product profile includes pulse oximeters, patient monitoring systems, sensors, digital thermometers, anesthesia and respiratory care equipment, stents, catheters and other innovative products. Some of the well-known brands marketed by Opto Circuits are Criticare, Mediaid, Unetixs and Eurocor. It is presently a Group of 14 companies with a consolidated total sales of USD $243 million/Rs.1077 crores (FY10) and it is headquartered in Bengaluru, Karnataka, India. Its key markets are the US, Europe and South East Asia. It was ranked as one amongst 200 Best Under a Billion companies in AsiaPac by Forbes Asia in 2009, 2008. Visit us at www.optoindia.com
Important Additional Information
The tender offer for the outstanding common stock of Cardiac Science referred to in this press release has not yet commenced. This press release is neither an offer to purchase nor a solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Cardiac Science's common stock will be made pursuant to an offer to purchase and related materials that Opto Circuits and a wholly-owned subsidiary of Opto Circuits intend to file with the Securities and Exchange Commission. At the time the offer is commenced Opto Circuits and its wholly-owned subsidiary will file a tender offer statement on Schedule TO with the Securities and Exchange Commission, and thereafter the Company will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the offer. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement will contain important information that should be read carefully and considered before any decision is made with respect to the tender offer. These materials will be sent free of charge to all stockholders of the Company when available. In addition, all of these materials (and all other materials filed by the Company with the Securities and Exchange Commission) will be available at no charge from the Securities and Exchange Commission through its website at www.sec.gov. Investors and security holders may also obtain free copies of the tender offer documents, once available, from the information agent for the tender offer or by mailing a request to Cardiac Science Corporation, Attention: Investor Relations, 3303 Monte Villa Parkway, Bothell, Washington 98021.
This release contains forward-looking statements regarding the proposed acquisition of Cardiac Science, the expected timetable for completing the transaction, future business prospects and market conditions and benefits and synergies of the transaction. Such statements are based on the current assumptions and expectations of Cardiac Science' and Opto Circuits' management and are neither promises nor guarantees. The words "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. There can be no assurance that management's estimates of future results will be achieved. Actual results and performance may vary significantly from those expressed or implied in such statements. The actual results of the acquisition could vary materially as a result of a number of factors, including: uncertainties as to how many of Cardiac Science Corporation's stockholders will tender their stock in the tender offer; the possibility that competing offers will be made; and the possibility that various closing conditions for the transaction may not be satisfied or waived. Other factors that may cause actual results to differ materially include those set forth in the reports that Cardiac Science files from time to time with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2009 and quarterly and current reports on Form 10-Q and 8-K. These forward-looking statements reflect Cardiac Science Corporation's expectations as of the date of this document. Cardiac Science Corporation undertakes no obligation to update the information provided herein.
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|From: richardred||10/19/2010 11:08:22 AM|
|MASSY ENGY : Massey Comments on Strategic Opportunities|
10/19/2010 | 10:35 am
JULIAN, W.Va., Oct. 19 /PRNewswire/ -- Massey Energy Company (NYSE: MEE) today released the following statement in response to reports that the company is exploring strategic opportunities:
(Logo: newscom.com )
(Logo: photos.prnewswire.com )
Our Board of Directors and management team are always focused on opportunities to create shareholder value. However, we do not comment on specific opportunities.
We are very proud of our company, our members, and our support of the communities in which we operate.
Massey Energy Company, headquartered in Richmond, Virginia, with operations in West Virginia, Kentucky and Virginia, is the largest coal producer in Central Appalachia and is included in the S&P 500 Index.
SOURCE Massey Energy Company
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