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Biotech / Medical : NPSP NPS Pharmaceutical -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (347)3/19/2013 1:55:39 PM
From: tuck  Read Replies (1) | Respond to of 363
 
>>NPS regains right to drugs from Takeda for $50 mln in NPS shares

Tue Mar 19, 2013 1:59am EDT

* Drugs are for short bowel syndrome, osteoporosis

* Takeda may also earn $30 mln milestone payment

(Reuters) - NPS Pharmaceuticals Inc has regained full worldwide rights to a pair of drugs from Japan's Takeda Pharmaceutical Co in exchange for $50 million in NPS common shares, the companies announced on Tuesday.

Under the deal, NPS will have worldwide rights to develop and sell teduglutide, a treatment for a rare condition called short bowel syndrome sold in Europe as Revestive and in the United States as Gattex, and for an osteoporosis drug sold in Europe under the brand name Preotact.

Takeda had picked up the sales rights outside North America for the two drugs with its 2011 acquisition of Nycomed, which had licensed the commercial rights from NPS.

Takeda agreed to hand over to NPS all assets related to the two products, including its active pharmaceutical ingredient inventory and information related to the continued development, manufacture, and commercialization of the drugs, the companies said.

In addition to the $50 million in NPS shares, Takeda is entitled to a milestone payment in the first calendar year that combined worldwide net sales of the two products exceed $750 million, the companies said. NPS will have the option of making the $30 million milestone payment in cash or in NPS common stock.

Preotact, a redesigned form of a human parathyroid hormone also known as PTH1-84, is also being developed as a treatment for hypoparathyroidism in which the glands do not produce enough of the hormone, the companies said.<<

Stock is up almost 10% on a tough day for markets. I like the move, as I think the launch will go pretty well.

Cheers, Tuck



To: tuck who wrote (347)10/2/2013 2:42:42 PM
From: tuck  Respond to of 363
 
Company is presenting extension study data, and submitting sNDA for expanded label to include it. Not sure what that means in scrips, but can't hurt:

>>NPS Pharmaceuticals, Inc. ( NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today reported that results from the company’s STEPS 2 study of GATTEX® (teduglutide) in patients with Short Bowel Syndrome (SBS) were accepted for presentation at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in San Diego, California, October 11-16, 2013. STEPS 2 was a two-year open-label extension study that involved 88 adult SBS patients with short bowel syndrome. The abstract entitled, “Long-term Safety and Efficacy of Teduglutide for the Treatment of Intestinal Failure Associated with Short Bowel Syndrome: Final Results of the Steps-2 Study, a 2-year, Multicenter, Open-label Clinical Trial” by Schwartz et al. is also being recognized as an ACG Presidential Poster Award recipient. The ACG Educational Affairs Committee identifies the most highly ranked abstracts selected for the poster sessions in each category and acknowledges their achievement with this award. The company also reported that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Gattex, revising the product label to include long-term data from STEPS 2.

“The data from STEPS 2 show the sustained effects of Gattex, as evidenced by parenteral support volume reduction, days off parenteral support or for some patients complete independence from parenteral support,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharmaceuticals. “We’re especially pleased that 13 of the 88 patients in the study fall into the latter category, having been completely weaned off parenteral support while on Gattex. We look forward to the FDA’s response to our sNDA.”<<

snip

Cheers, Tuck



To: tuck who wrote (347)1/7/2014 2:55:16 PM
From: tuck  Respond to of 363
 
NPS begins pediatric SBS trial for Gattex. Assuming good results, sNDA in 2015 and possible approval ~early 2016, I'd guess. Have to think the market is smaller than the adult segment, but every little bit helps. Shouldn't cost much to run it - 36 patients - so why not?

clinicaltrials.gov

Cheers, Tuck