Alpha Natura (ANR) to 'Right Size' Mining Ops in Virginia Jul 31, 2014 05:01PM

Eight operating affiliates of Alpha Natural Resources, Inc. (NYSE: ANR) have notified their employees late this afternoon that the coal mines and other facilities where they work are subject to being idled due to sustained weak market conditions and government regulations that have challenged the entire Central Appalachian mining industry.

In accordance with requirements of the Worker Adjustment and Retraining Notification (WARN) Act, notice has been given today to approximately 1,100 employees at 11 Alpha affiliated surface mines in West Virginia, as well as preparation plants and other support operations, advising them of the expected idling of those facilities based on Alpha's current assessment of market conditions. The operations affected are:

  • Highland Mining's Superior, Reylas, Freeze Fork and Trace Fork surface mines in Logan County and the North surface mine in Mingo and Logan Counties
  • Black Castle Mining's surface mine in Boone County
  • Independence Coal's Twilight surface mine in Boone County
  • Alex Energy's Edwight surface mine in Raleigh County
  • Republic Energy's Republic and Workman Creek surface mines in Raleigh County
  • Pioneer Fuel's Ewing Fork #1 surface mine in Kanawha and Fayette Counties
  • Additional technical and other support services for these mine operations.

While no reductions in force are occurring immediately at these sites, they are currently planned to take place by mid-October.

These actions are being triggered by persistent weakness in U.S. and overseas coal demand and depressed price levels, along with government regulations that are causing electric utilities to close coal-fired power plants and forego new construction. Excess supply of coal worldwide also has contributed to falling coal prices. The international price of coal shipped to power plants in Europe has been hovering at a four-year low, while prices for metallurgical coal used to make steel have declined more than 20 percent in less than a year, reflective of oversupplied markets.

Industry forecasts for 2015 indicate that coal production from Central Appalachia will be less than half the region's output in 2009. A major contributor to the demand erosion has been competition from natural gas as an alternate fuel for electricity generation in the U.S., along with competition from other coal producing basins. Additionally, EPA regulations are at least partly responsible for more than 360 coal-fired electric generating units in the U.S. closing or switching to natural gas. Nearly one of every five existing coal-fired power plants is closing or converting to other fuel sources, and Central Appalachian coal has been the biggest loser from EPA's actions. EPA's new MATS air emissions rule alone is expected to take more coal-fired power generation offline next year than in the previous three years combined. Much of that is in markets historically supplied by Central Appalachian mines.

Alpha's President Paul Vining said: "Many mines in the region have done a great job finding ways to reduce costs and remain economically viable in this unprecedented business climate, but some Central Appalachia mines haven't been able to keep up with the fast pace at which coal demand has eroded and prices have fallen. So, our operations managers have to take a hard and serious examination whether they can sustain a number of mines and related operations by finding additional cost reductions and whether the business will be there to support them in the year ahead.

"Over the next two months they will continue to run forecasts for expected customer commitments for next year, along with anticipated pricing, and a determination will be made whether the overall economics make sense given the cost structures at these operations and the business we expect to secure," Vining added.

The mines receiving today's WARN notifications produced 4.2 million tons of thermal and metallurgical coal through the first half of this year. Vining said that both domestic shipments and shipments to Europe from Central Appalachia are expected to be cut back significantly, though it was too early to project exactly how much annualized production might be taken offline due to today's announcement.

"These actions are consistent with steps that we've taken in the past to build a smaller but more sustainable portfolio of mining assets across our three coal-producing basins," Vining said. "Altogether we've idled about 35 million tons of coal production in just three years, primarily operations with the highest cash costs. The result has been an improved cost structure, which bolsters our competitiveness in the face of challenging market conditions.

"Our company has faced challenges in the last several years, but this is the most difficult part of the job. Coal miners are some of the hardest working, most dedicated people in America. This country would not be where it is today without them. As difficult as these decisions have been, they're essential for our organization in a business environment that's undergone an enormous and fundamental transformation."

Omnicom Group (OMC) Amends, Extends $2.5B Revolver Jul 31, 2014 04:43PM

Omnicom Group (NYSE: OMC) announced the amendment and extension of its multiyear revolving credit facility to July 2019. Amounts available for borrowings under the facility are unchanged at $2.5 billion. The facility includes a provision to increase the commitment by up to $500 million without further amendment at the option of Omnicom. The agreement also now includes an option to extend the facility for an additional year at both the first and second anniversary of the effective date with each bank's approval.

There were no borrowings outstanding under the prior revolving credit facility at June 30, 2014.

Kaman (KAMN) Receives $5.4M Award Modification from JPF Jul 31, 2014 04:38PM

Kaman (NYSE: KAMN) announced that its Aerospace segment has been awarded a contract modification in the amount of $5.4 million for the procurement of Joint Programmable Fuzes (JPF). The award is a follow-on order raising the cumulative quantity under Option 11 of Kaman’s JPF contract with the U.S. Air Force (USAF) to more than 15,000 fuzes. Delivery of fuzes under Option 11 is anticipated to occur in 2015 and 2016.

"We are pleased with this additional order from our customer, the U.S. Air Force for our largest single program. We believe the JPF's reliability, operational flexibility, and cost effectiveness make it superior to all other bomb fuzes. The order demonstrates the USAF's continued demand for the product and commitment to the program," stated Kaman Aerospace Group President, Greg Steiner.

Kaman has been the sole provider of the JPF to the USAF since 2002. In addition to the USAF, Kaman provides the JPF to twenty-six other nations. The JPF allows the settings of a weapon to be programmed on wing in flight and is the current bomb fuze of choice of the USAF. The JPF is used with a number of weapons including general purpose bombs, and guided bombs that use JDAM or Paveway kits, on U.S. aircraft such as F-15, F-16, F-22, A-10, B-1, B-2, B-52 and the MQ-9 UAV as well as on international aircraft such as Mirage 3 and Gripen. Kaman produces the JPF at facilities in Orlando, Florida and Middletown, Connecticut.

Vertex Pharma (VRTX) Receives EC Approval of KALYDECO in Certain Patients with CF Jul 31, 2014 04:19PM

Vertex Pharma (Nasdaq: VRTX) announced that the European Commission has approved KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Today’s approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2014. KALYDECO was first approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which is the most common gating mutation. The eight additional gating mutations included in today’s approval are: G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250 people ages 6 and older have one of these non-G551D gating mutations.

“Today’s approval in people with additional gating mutations marks another step toward our goal of helping more people with this disease,” said Simon Bedson, Senior Vice President and International General Manager at Vertex. “We are committed to working closely with the appropriate national authorities to make KALYDECO available for these patients as soon as possible.”

Today’s approval is based on previously announced data from the first part of a Phase 3, two-part, randomised, double-blind, placebo-controlled, cross-over study of 39 people with CF ages 6 and older who have a non-G551D gating mutation. The first part of the study showed statistically significant improvements in lung function (FEV1), sweat chloride, body mass index and CFQ-R scores. Data from the second part of the study were presented at the European Cystic Fibrosis Society Conference in June 2014 and showed that these improvements were maintained through 24 weeks of treatment. The safety profile was similar to prior Phase 3 studies of KALYDECO in people with the G551D mutation.

“By treating the underlying cause of cystic fibrosis, KALYDECO has changed the way we treat patients with the most common gating mutation, G551D. In general, people with other gating mutations have similarly severe disease to people with the G551D mutation and have an urgent need for new medicines that address the underlying cause of the disease,” said Kris De Boeck, M.D., Ph.D., Professor of Pediatric Pulmonology, University Hospital Gasthuisberg, Leuven, Belgium, and President-Elect of the European Cystic Fibrosis Society. “In the Phase 3 study in people with non-G551D gating mutations, KALYDECO led to rapid, significant and sustained improvements in lung function and other measures of disease.”

In addition, the CHMP approved the inclusion of data from the long-term follow-up PERSIST study in the KALYDECO label. PERSIST is a Phase 3, open-label, 96-week, rollover extension trial that evaluated the long-term safety and durability of treatment with KALYDECO by enrolling people ages 6 and older with at least one copy of the G551D mutation who completed 48 weeks of treatment in the Phase 3 ENVISION and STRIVE studies (placebo and KALYDECO treatment groups) and met other eligibility criteria. Results from PERSIST demonstrated that the safety and efficacy of KALYDECO seen in the Phase 3 STRIVE and ENVISION trials was maintained through nearly three years (144 weeks) in G551D patients.

Cystic fibrosis is caused by a defective or missing CFTR protein that results from mutations in the CFTR gene. CFTR proteins act as channels at the cell surface that control the flow of salt and water into and out of the cell. In people with gating mutations, the CFTR protein at the cell surface is defective and does not work properly, causing abnormally thick, sticky mucus to build up in the lungs. The digestive tract and a number of other organs are also affected.

KALYDECO, an oral medicine known as a CFTR potentiator, helps the CFTR protein function more normally once it reaches the cell surface. It targets the abnormal CFTR protein channels and opens them to allow chloride ions to move into and out of the cell, which helps thin the mucus so it can hydrate and protect the airways.

pSivida (PSDV) ILUVIEN Receives Marketing Apprval from Danish HMA Jul 31, 2014 04:13PM

pSivida (Nasdaq: PSDV) announced that the Danish Health and Medicines Authority granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. ILUVIEN has now been approved in nine EU countries (Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and the United Kingdom), and is commercially available in the United Kingdom and Germany. ILUVIEN is in the national phase, pending approval, in eight more EU countries (Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden) following the successful completion of the Mutual Recognition Procedure (MRP) for subsequent marketing authorizations.

ILUVIEN is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014.

“We are pleased to see the continued expansion of marketing authorizations for ILUVIEN across Europe,” said Paul Ashton, PhD, president and chief executive officer of pSivida. “We look forward to the FDA’s action on ILUVIEN. We are entitled to a $25 million milestone payment from our licensee Alimera Sciences upon FDA approval of ILUVIEN. We are also entitled to share in the net profits from Alimera’s sales of ILUVIEN on a country-by-country basis including in the EU and the U.S.”

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