Dr. Yvette Bordelon mentioned this experimental medication, Nypta, in her webinar on Thursday. There will be a phase II trial on the safety and tolerability of Nypta in the US and Europe, starting “before the end of the year” (according to the press release) and in early 2010 (according to Dr. Bordelon).
This financial news article is about the Spanish biotech company’s share price rising given its acquisition of orphan drug status from the FDA and the European Commission. Sorry, that’s all I could find on this drug so far.
http://www.reuters.com/article/rbssIndu … 1320091103
Zeltia’s Nypta gets orphan drug status, shares gain
Tue Nov 3, 2009 3:30am EST
* Being developed to treat progressive supranuclear palsy
* Shares up 2.2 pct
MADRID, Nov 3 (Reuters) – Spanish biotechnology firm Zeltia’s (ZEL.MC) Nypta drug to treat a degenerative brain disease has received orphan drug status from the European Commission and the U.S. Food and Drug Administration.
Nypta is being developed by Zeltia’s Noscira unit to treat progressive supranuclear palsy (PSP), a rare disease that gradually destroys nerve cells in the brain that control eye movements, breathing and muscle coordination.
Phase II clinical trials on the drug are due to begin before the end of the year, Zeltia said in a statement on Tuesday.
Orphan drug designation is reserved for new therapies that are being developed to treat rare medical conditions, and in the United States the label grants the drug developers seven years of market exclusivity.
Shares in Zeltia rose 2.2 percent to 4.44 euros by 0820 GMT, bucking the negative market trend in Spain to extend an 8 percent gain on Monday after its Yondelis drug received European approval to treat ovarian cancer.