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Keryx Biopharma Shares Rally On Orphan-Drug Designation

DOW JONES NEWSWIRES Keryx Biopharmaceuticals Inc. (KERX) said the U.S. Food and Drug Administration has given orphan-drug designation to perifosine, a treatment for cancer including neuroblastoma, or cancer of the nervous system in infants. Shares of the biopharmaceutical company jumped 13% to $4.04 in recent trading, while U.S.-traded shares of Keryx's Canadian partner Aeterna Zentaris Inc. (AEZ.T, AEZS) were recently up 10% to $1.20. The designation was announced three months after the drug received fast-track status, which authorizes an expedited review for drugs that treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. "The Orphan Drug designation is an important component of our development plan for perifosine in neuroblastoma, an indication where no FDA-approved therapies currently exist," said Chief Executive Ron Bentsur. The Orphan Drug Act provides incentives to create therapies for so-called orphan diseases--those that affect fewer than 200,000 Americans. There are about 7,000 such maladies, most of them serious, that have few or no drugs to treat them. Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including seven years' marketing exclusivity and tax breaks. Bentsur said the company is exploring the next steps for the development, which "we hope, ultimately, could provide a new treatment option for children and infants" suffering with the illnesses. Perifosine also is in Phase 3 clinical trial for treating refractory advanced colon cancer and multiple myeloma, as well as in Phase 1 and Phase 2 trials for several other tumor types. -By Jodi Xu, Dow Jones Newswires; 212-416-3037; jodi.xu@dowjones.com

Stock News for Aeterna Zentaris (AEZS)
DateTimeHeadline
05/23/201620:15:00Aeterna Zentaris Elects Ms. Carolyn Egbert as Independent Chair...
05/12/201612:15:44Amended Appointment of Agent for Service of Process and Undertaking...
05/10/201616:00:00Aeterna Zentaris Announces Election of Directors at 2016 Shareholders...
05/10/201611:40:06Report of Foreign Issuer (6-k)
05/09/201618:06:00Report of Foreign Issuer (6-k)
05/09/201618:04:21Report of Foreign Issuer (6-k)
05/09/201617:00:00Aeterna Zentaris Reports First Quarter 2016 Financial and Operating...
04/27/201616:05:00Aeterna Zentaris Acquires Exclusive U.S. Promotional Rights for...
04/26/201608:30:00Aeterna Zentaris to Announce First Quarter 2016 Financial and...
04/08/201615:00:00Aeterna Zentaris Mails Information Circular in Connection with...
04/01/201617:19:49Prospectus Filed Pursuant to Rule 424(b)(5) (424b5)
04/01/201617:17:53Report of Foreign Issuer (6-k)
04/01/201617:05:00Aeterna Zentaris Announces At the Market Issuance Program
04/01/201616:39:23Securities Registration: Employee Benefit Plan (s-8)
04/01/201616:31:11Report of Foreign Issuer (6-k)
03/30/201606:07:07Report of Foreign Issuer (6-k)
03/30/201606:07:07Annual and Transition Report (foreign Private Issuer) (20-f)
03/30/201606:07:06Report of Foreign Issuer (6-k)
03/29/201617:00:00Aeterna Zentaris Reports Fourth Quarter and Full-Year 2015 Financial...
03/15/201608:00:00Aeterna Zentaris to Announce Fourth Quarter and Full-Year 2015...

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