Nektar Therapeutics (NKTR) Wins FDA Approval of Movanik Sep 16, 2014 10:18AM

(Updated - September 16, 2014 10:18 AM EDT)

Nektar Therapeutics (NASDAQ: NKTR) and AstraZeneca plc (NYSE: AZN) won FDA approval of Movanik, according to Bloomberg.

UPDATE - The FDA press release is below:

The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.

“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo (sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.

Results of the first trial showed that 44 percent of participants receiving 25 mg of Movantik and 41 percent of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29 percent of participants receiving placebo. The second trial showed similar results.

Common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence).

The FDA is requiring a postmarketing study to further evaluate the potential risk of cardiovascular adverse events in patients taking Movantik. In June, the FDA held a public meeting to discuss what studies might be required to assess the cardiac safety of peripherally acting opioid receptor antagonists, including Movantik, intended to treat opioid-induced constipation.

Movantik is distributed by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.


Nektar Therapeutics (NKTR) Wins FDA Approval of Movanik Sep 16, 2014 10:18AM

(Updated - September 16, 2014 10:18 AM EDT)

Nektar Therapeutics (NASDAQ: NKTR) and AstraZeneca plc (NYSE: AZN) won FDA approval of Movanik, according to Bloomberg.

UPDATE - The FDA press release is below:

The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.

“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo (sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.

Results of the first trial showed that 44 percent of participants receiving 25 mg of Movantik and 41 percent of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29 percent of participants receiving placebo. The second trial showed similar results.

Common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence).

The FDA is requiring a postmarketing study to further evaluate the potential risk of cardiovascular adverse events in patients taking Movantik. In June, the FDA held a public meeting to discuss what studies might be required to assess the cardiac safety of peripherally acting opioid receptor antagonists, including Movantik, intended to treat opioid-induced constipation.

Movantik is distributed by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.


UPS (UPS) Plans More Hires for 2014 Holiday Shopping Season Sep 16, 2014 09:44AM

UPS (NYSE: UPS) announced that it expects to hire between 90,000 - 95,000 seasonal employees to support the anticipated holiday surge in package deliveries that will begin in October and continue through January 2015. The company is gearing up for increased holiday delivery volume in 2014 as it prepares to play a pivotal role in helping retailers take advantage of the holiday gift-giving season. The seasonal positions as package sorters, loaders, delivery helpers and drivers have long been an entry point for permanent employment, training and career opportunity after the company re-assesses its needs following the holiday period.

*** The number compares with 85,000 seasonal hires made last year.

"We have initial volume forecasts from our customers and are starting the hiring process for our temporary peak season jobs," said John McDevitt, UPS senior vice president of human resources and labor relations. "We have needs throughout the United States and anticipate more applicants this year than in 2013. Individuals who begin employment at UPS during the holiday season have the opportunity to pursue a permanent position afterwards. Seasonal positions provide an excellent entry point for becoming a long-term UPS employee."

Interested job seekers can easily apply for peak season opportunities by visiting UPSjobs.com on their computer, smartphone or tablet. Applicants must apply online.

UPS is ready to provide customers a smooth 2014 holiday experience and has implemented the following actions since the 2013 peak shipping season:

  • Using industry-wide delivery volume forecasts and working closely with high impact leading customers, UPS has made improvements to network utilization and schedule planning.
  • Daily processing capacity will increase with the opening of new and expanded buildings, plus installation of temporary mobile sorting and delivery centers. UPS is adding thousands of new or leased delivery vehicles, trailers, aircraft and portable loading aids to flex capacity in the UPS network.
  • Added operating days and shifts - full ground delivery and pick-up operations the Friday after Thanksgiving and nearly 50 new package sorting shifts throughout the company's existing hub locations.
  • Shipment tracking timing and accuracy will be improved with additional web and mobile app upgrades for enhanced information on package location and shipment status.
  • Enhancements to the UPS My Choice® service will give consumers receiving home deliveries improved alerts on delivery time windows and options for re-scheduling and re-routing.


FreeSeas (FREE) Complets $12.25M Sale of M/V 'Free Jupiter' Sep 16, 2014 09:08AM

FreeSeas (Nasdaq: FREE) announced that it has sold to unrelated third parties the M/V 'Free Jupiter' for USD 12,250,000 and subsequently entered into a long term bareboat charter with the vessel's new Owners.

The vessel has been chartered by the Company for seven years at a rate of USD 5,325 per day on bareboat charter terms typical for this type of transaction which grant the Company the full commercial utilization of the vessel against payment of the charter rate to her Owners. In addition, the terms of the charter afford a number of purchase options during its course. An amount of USD 3,750,000 was deposited by the Company as security for the fulfillment of the terms of the charter.

Mr. Ion Varouxakis, the Company's Chairman, President and CEO made the following statement: "We are pleased to announce today's transaction which releases significant liquidity and evidences the Company's ability to leverage its balance sheet at an opportune time without diluting its shareholders. The additional liquidity will provide invaluable balance sheet flexibility as part of our growth strategy moving forward, which follows the recently announced debt extinguishment and forgiveness which significantly reduced the Company's bank debt to USD 23 million from USD 90 million within the space of a few months." Mr. Varouxakis added: "The bareboat charter rate allows for significant upside from future operating earnings, especially as the market improves, while the purchase options allow participation in potential future asset appreciation. The vessel will be deployed in the spot market, which has shown recent signs of improvement."


Uranerz Energy (URZ) Makes First Sale from Nichols Ranch ISR Uranium Project Sep 16, 2014 09:03AM

Uranerz Energy (AMEX: URZ) announced its first sale of uranium from the Nichols Ranch ISR Uranium Project located in the Powder River Basin of Wyoming, U.S.A. The Company has sold 75,000 pounds which is a portion of the deliveries Uranerz is expecting to make this year pursuant to long-term contracts it has with its nuclear utility customers.

"This has been a very exciting year thus far," stated Paul Goranson, Uranerz President and Chief Operating Officer. "Uranerz has completed construction and development of its Nichols Ranch production facility and initial wellfields, started production of uranium, and has now made its first sale of product. We are very pleased to be an active participant in providing domestically produced uranium to U.S. nuclear utilities to fuel their electrical generating stations."

Uranerz has three long-term uranium sales agreements with two major U.S. nuclear utilities. The Company is currently making deliveries to satisfy these contracts with shipments of uranium to the ConverDyn Metropolis Works Facility.


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