Keryx Biopharma (KERX) Reports Zerenex Met Primary Endpoint in Phase 3 Jul 24, 2014 05:01PM

Keryx Biopharma (NASDAQ: KERX) announced the publication of results from the long-term, randomized, active control Phase 3 study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis. The PERFECTED study (PhosphatE binding and iRon delivery with FErric CiTrate in EsrD) was published online today in the Journal of the American Society of Nephrology (JASN).

This Phase 3 study was a multicenter, randomized, open-label trial in 441 ESRD patients on hemodialysis or peritoneal dialysis designed to determine the safety and efficacy of Zerenex as a treatment to reduce serum phosphorus as well as raise iron stores and reduce intravenous (IV) iron and erythropoietin-stimulating agents (ESA) usage.

Zerenex met the study's primary end-point demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Placebo Control Period. Using a sequential gatekeeping strategy for the key pre-defined secondary end-points, Zerenex also demonstrated statistically significant increases in serum ferritin and transferrin saturation (TSAT), and significant reductions in the use of IV iron and ESAs, versus an active control of Renvela® (sevelamer carbonate) and/or Phoslo® (calcium acetate) over the 52-week Active Control Period of the study. In addition, mean hemoglobin levels were higher in subjects treated with Zerenex as compared to subjects treated with active control.

"Zerenex effectively reduces serum phosphorus levels within the KDOQI range (3.5 mg/dL to 5.5 mg/dL) while having the additional patient benefits of increasing iron stores and decreasing the need for IV iron and ESAs, while maintaining hemoglobin levels," said Julia Lewis, MD, lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. "If approved, the combined benefits of Zerenex would be of value for patients, health care professionals and the healthcare system."

The Company's New Drug Application (NDA) for Zerenex is currently under review by the U.S. Food and Drug Administration (FDA).

Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very pleased with the publication of the Phase 3 PERFECTED study results in a premier peer-reviewed nephrology journal and are encouraged by Zerenex's potential differentiated product profile." Mr. Bentsur added, "We thank the investigators and patients who participated in this study and look forward to potentially bringing Zerenex to market in the U.S."


Weyerhaeuser (WY), DuPont Pioneer Enter Seed Tech Licensing Agreement Jul 24, 2014 02:08PM

Weyerhaeuser (NYSE: WY) announced a technology license agreement with DuPont Pioneer that will advance seed technologies to help meet growing global demands for food, feed and fiber.

The agreement brings together agricultural and forestry know-how to sustainably improve crop productivity for corn growers around the world. Based on scientific research behind years of Weyerhaeuser NR sustainable forestry, the manufactured seed technology allows for the storage, nourishment, planting and germination of cells capable of growing into a plant. This technology provides a means to cost-effectively regenerate valuable, limited or fragile plant material.


Verso (VRS) Amends Terms of Subordinated Debt Exchange Offer Jul 24, 2014 01:37PM

Verso Paper Corp. (NYSE: VRS) announced today that two of its wholly owned subsidiaries, Verso Paper Holdings LLC and Verso Paper Inc. (collectively, the "Issuers"), have amended the terms of their previously announced exchange offer and consent solicitation with respect to their outstanding 11 3/8% Senior Subordinated Notes due 2016 (the "Old Subordinated Notes" and, the related exchange offer, the "Subordinated Notes Exchange Offer").

The Subordinated Notes Exchange Offer, together with the Issuers' previously announced exchange offer and consent solicitation with respect to their outstanding 8.75% Second Priority Senior Secured Notes due 2019 (the "Old Second Lien Notes" and, the related exchange offer, the "Second Lien Notes Exchange Offer") are being conducted pursuant to the Agreement and Plan of Merger dated as of January 3, 2014 (the "Merger Agreement"), among Verso, Verso Merger Sub Inc. ("Merger Sub"), and NewPage Holdings Inc. ("NewPage"), pursuant to which Verso will acquire NewPage by means of the merger of Merger Sub with and into NewPage on the terms and subject to the conditions set forth in the Merger Agreement (the "Merger"), with NewPage surviving the Merger as an indirect, wholly owned subsidiary of Verso. The closing of the Merger is conditioned upon consummation of the exchange offers.

Verso also announced that the Second Lien Notes Exchange Offer has been amended to give holders of Old Second Lien Notes who tender before the Second Lien Notes Expiration Time (as defined below) on July 30, 2014 the same consideration as those who tendered prior to the Second Lien Notes Early Tender Time (as defined below) on July 16, 2014.

As of July 23, 2014, holders of approximately $99.7 million in aggregate principal amount of Old Subordinated Notes have tendered their Old Subordinated Notes or agreed with Verso and the Issuers to tender their Old Subordinated Notes in the amended Subordinated Notes Exchange Offer, and holders of approximately $286.9 million in aggregate principal amount of Old Second Lien Notes have tendered their Old Second Lien Notes in the Second Lien Notes Exchange Offer.

"We thank the holders of our Old Second Lien Notes and Old Subordinated Notes who have committed to the exchange offers for their support," said Verso President and CEO Dave Paterson, "Successful completion of the exchange offers is an important step toward the closing of our acquisition of NewPage."

Amendment to Subordinated Notes Exchange Offer

The Subordinated Notes Exchange Offer and the Subordinated Notes consent solicitation have been amended as set forth below.

                               Consideration per $1,000
Principal Amount of Merger
Old Subordinated Notes Tendered Adjustment
-------------------------------- ----------------
Principal Amount
Subordinated of New
Notes Total Subordinated Subordinated
Consideration Notes Exchange Notes Following
Outstanding if Tendered Consideration if the Merger per
Principal prior to Tendered after $1,000 Principal
Amount of or on the the Amount of New
Old Subordinated Subordinated Subordinated
Subordinated Notes Early Notes Early Notes Prior to
CUSIP/ISIN Notes Tender Time (1) Tender Time the Merger
------------ ------------- --------------- ---------------- ----------------
92531XAF9/ $142,500,000 $1,000 $850 principal $710 principal
US92531XAF96 principal amount of amount of New
amount of New Subordinated Subordinated
New Notes and Notes subject to
Subordinated Warrants (2) adjustment based
Notes and on participation
Warrants (2) in the
Subordinated
Notes Exchange
Offer (3)

(1) Includes the Subordinated Notes consent and early tender payment of $150
principal amount of New Subordinated Notes.

(2) Holders will receive for each $1,000 principal amount of Old
Subordinated Notes tendered a number of Warrants equal to (a) $1,000
divided by (b) the aggregate principal amount of New Subordinated Notes
as of the date of consummation of the Subordinated Notes Exchange Offer
multiplied by (c) 6.670% of the total number of outstanding shares of
Common Stock, determined on a fully diluted basis after giving effect to
the Merger and the issuance of Common Stock upon the mandatory
conversion of Warrants issued in the Exchange Offers (the "Subordinated
Notes Warrant Consideration"). Verso will not issue fractional Warrants
and Warrants issued to Eligible Holders in the Subordinated Notes
Exchange Offer will be rounded up to the nearest whole Warrant.

(3) The principal amount of New Subordinated Notes following the Merger per
$1,000 principal amount of New Subordinated Notes prior to the Merger
will be adjusted based on participation in the Subordinated Notes
Exchange Offer as follows:

Percentage of Aggregate Principal Principal Amount of New Subordinated
Amount of Old Subordinated Notes Notes Following the Merger per $1,000
Participating in the Subordinated Principal Amount of New Subordinated
Notes Exchange Offer Notes Prior to the Merger
------------------------------------- --------------------------------------
70% $620
75% $635
80% $650
85% $665
90% $680
95% $695
100% $710

If holders in the aggregate tender a percentage of Old Subordinated Notes that is not set forth in the table above, holders will receive the principal amount corresponding to the closest lower percentage (e.g., if 87.5% of the Old Subordinated Notes are tendered, holders will receive the principal amount corresponding to 85%).

The Issuers have also amended the terms of the New Subordinated Notes as follows: upon the consummation of the Merger, (i) the principal amount of the outstanding New Subordinated Notes will be adjusted such that a holder of $1,000 principal amount of New Subordinated Notes immediately prior to the Merger will hold $710 principal amount of New Subordinated Notes immediately following the Merger (assuming 100% participation in the Subordinated Notes Exchange Offer), (ii) the maturity date of the New Subordinated Notes will be extended to August 1, 2020 and (iii) the interest rate will be adjusted such that the New Subordinated Notes will bear interest from and after the date of the consummation of the Merger at a rate of 11% per annum payable in cash plus 5% per annum payable by increasing the principal amount of the outstanding New Subordinated Notes or by issuing additional New Subordinated Notes.

Following the consummation of the Merger, the Issuers may redeem the New Subordinated Notes, in whole or in part, at any time prior to August 1, 2017 at a redemption price equal to 100% of the principal amount thereof, plus accrued and unpaid interest, if any, plus a make-whole premium. At any time following the consummation of the Merger and on or after August 1, 2017, August 1, 2018 or August 1, 2019, the Issuers may redeem the New Subordinated Notes at their option at 105.500%, 102.750% and 100.000%, respectively.

The consummation of the Subordinated Notes Exchange Offer is conditioned upon, among other things, the valid tender, and not withdrawal, of at least 70% in aggregate principal amount of outstanding Old Subordinated Notes. The Issuers will make alternative arrangements on similar economic terms to the Subordinated Notes Exchange Offer for holders who are not Eligible Holders; the 70% minimum condition will include in it any Old Subordinated Notes held by such holders that tender pursuant to such alternative arrangements.

Eligible Holders who validly tender Old Subordinated Notes prior to 12:00 midnight, New York City time, at the end of July 30, 2014 (such date and time, as it may be extended by us, the "Subordinated Notes Early Tender Time") and do not validly withdraw their tender prior to 12:00 midnight, New York City time, at the end of July 30, 2014 will receive the Subordinated Notes Total Consideration for Old Subordinated Notes accepted in the Subordinated Notes Exchange Offer. "Subordinated Notes Total Consideration" means, for each $1,000 principal amount of Old Subordinated Notes tendered and accepted by us, $1,000 principal amount of New Subordinated Notes (which includes the Subordinated Notes consent and early tender payment of $150 principal amount of New Subordinated Notes), without giving effect to the adjustment in principal amount upon the consummation of the Merger, and the Subordinated Notes Warrant Consideration. The expiration time of the Subordinated Notes Exchange Offer is being extended from 12:00 midnight, New York City time, at the end of July 30, 2014, to 12:00 midnight, New York City time, at the end of August 6, 2014 (such date and time, as it may be extended by us, the "Subordinated Notes Expiration Time") so that Eligible Holders who validly tender Old Subordinated Notes after the Subordinated Notes Early Tender Time will receive the Subordinated Notes Exchange Consideration for Old Subordinated Notes accepted in the Subordinated Notes Exchange Offer. "Subordinated Notes Exchange Consideration" means, for each $1,000 principal amount of Old Subordinated Notes tendered and accepted by us, $850 principal amount of New Subordinated Notes, without giving effect to the adjustment in principal amount upon the consummation of the Merger, and the Subordinated Notes Warrant Consideration.

Subject to the terms and conditions described in the Offering Documents (as defined below), payment of the Subordinated Notes Total Consideration or Subordinated Notes Exchange Consideration will occur promptly after the Subordinated Notes Early Tender Time or the Subordinated Notes Expiration Time, as applicable.

The Issuers will not pay accrued and unpaid interest on the Old Subordinated Notes exchanged on the early settlement date or the final settlement date of the Subordinated Notes Exchange Offer; interest on the New Subordinated Notes will accrue from August 1, 2014.


FDA Approves GlaxoSmithKline's (GSK) Flonase For Sale Over-The-Counter Jul 24, 2014 01:35PM

GlaxoSmithKline plc (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50 mcg spray), containing the No. 1 prescribed allergy treatment ingredient1, as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.2

Flonase® Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms3,4 including runny nose, sneezing, itchy nose5-7, nasal congestion8-11 and itchy and watery eyes.12-15 Flonase® Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief.

Roughly 50 million people in the United States suffer from nasal allergies16, and allergies take a toll on sufferers:

  • Nasal allergies can lead to fatigue, sleep disturbances, learning and attention problems and impaired function at work and/or school.17
  • In 2010, Americans with allergic rhinitis (AR) spent approximately $17.5 billion on health- related costs, lost more than 6 million work and school days and made more than 16 million visits to the doctor.18
  • 70 percent of sufferers treat their symptoms with prescription or OTC treatments19; however, 50 percent of them report they are not completely satisfied with their current method of treatment.20

No other intra-nasal hay fever and allergy treatment has been proven more effective than Flonase® Allergy Relief,1,8 a once-a-day nasal spray which helps relieve inflammation to provide 24-hour non-drowsy symptom relief.21,22 Fluticasone propionate, the active ingredient in Flonase® Allergy Relief, has helped more allergy sufferers than any other nasal spray and has a well-established safety profile with 30 million accumulated patient years since it was first approved as a prescription medicine in 1994.23

Colin Mackenzie, President, Consumer Healthcare North America, GSK, said, "With the significant number of allergy sufferers in the United States and a considerable number of those unsatisfied with their current treatments, we believe the wide availability of Flonase® Allergy Relief over-the-counter is great news for these individuals. GSK has a strong heritage – 40 years – in discovering and developing respiratory products used by patients worldwide. We are proud of our track record of successful Rx-to-OTC switches which over the years have significantly improved access to important medicines for our consumers."

"This approval will bring Flonase® Allergy Relief to consumers in a convenient way at the same dosage strength as found in prescription Flonase. For those with allergies, being able to find simple, effective relief over the counter may mean the difference between a day lost to allergies and a day enjoying their favorite activities," said Dr. Vidhu Bansal-Dev, Vice President, Research and Development, GSK.

Flonase® Allergy Relief will be available over-the-counter in early 2015.

To learn more, visit www.Flonase.com for information and to sign up for allergy updates, allergy tips and special savings.


BGC Partners (BGCP) Makes Statement on Recent Stock Transactions Jul 24, 2014 01:32PM

BGC Partners, Inc. (NASDAQ: BGCP)
BGC Partners, Inc. (NASDAQ: BGCP) today released the following statement.

On July 21, 2014, BGC and/or its affiliates completed certain transactions involving Cantor Fitzgerald, L.P. ("CFLP" or "Cantor.") A Form 4 was filed yesterday with the SEC that describes these purchases in detail. These transactions also triggered related filings on Form 4 by BGC's Chairman and Chief Executive Officer, Howard W. Lutnick and an affiliate to report beneficial ownership, although the transactions were not conducted by Mr. Lutnick personally.

The net result of the transactions described in the Forms 4 is effectively as follows:

  • Certain individuals who were formerly partners of Cantor effectively sold approximately 3.1 million BGC shares and/or units.
  • BGC immediately purchased approximately 3.1 million BGC shares and/or units from Cantor.
  • BGC additionally purchased another approximately 1.9 million BGC shares from CFLP, the proceeds of which went to certain current partners of Cantor, excluding Mr. Lutnick.
  • BGC purchased these shares and/or units at an average price of $7.74, which was the closing price on the day these transactions were completed.
  • The transactions described in the Forms 4 reduced BGC's fully diluted share count by approximately 5 million shares.
  • None of these sales included shares and/or units held personally by BGC's Chairman and Chief Executive Officer Howard W. Lutnick or his family.
  • Mr. Lutnick did not and will not receive any proceeds from these transactions.
  • Mr. Lutnick currently does not intend to sell any BGC shares and/or units held personally or in family trusts, other than dispositions related to charitable donations.


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