NPS Pharmaceuticals to Present at Upcoming Health Care Conferences
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) will present at the Citi 2011 Global Health Care Conference in New York on Tuesday, March 1, 2011 at 10:30 a.m. ET and the Cowen and Company 31st Annual Health Care Conference in Boston on Monday, March 7, 2011 at 2:30 PM ET. Presentations will be available as live webcasts with replays available approximately three hours after the presentation has concluded.
About NPS Pharmaceuticals
NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, GATTEX® (teduglutide) in short bowel syndrome (SBS) and NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) in hypoparathyroidism. NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, Kyowa Hakko Kirin, Nycomed, and Ortho-McNeil Pharmaceutical.
Salix takes center stage in drug-stock trading
BOSTON (MarketWatch) — Shares of Salix Pharmaceuticals Ltd. plunged in afternoon trading Thursday on news that the U.S. Food and Drug Administration does not plan to approve its drug Xifaxan at this time.
Salix (SLXP 31.55, -0.06, -0.19%) shares tumbled 22% to $32.20 at last check. \
The company said that after speaking with FDA officials, it now expects to receive a Complete Response Letter from the agency on or before March 7. The FDA issues a Complete Response Letter when it determines that a drug’s market application is insufficient for approval.
Salix is seeking to have Xifaxan approved to treat certain types of irritable bowel syndrome.
Shares of Protalix BioTherapeutics Inc. (PLX 9.30, -0.06, -0.64%) slipped 2%. The
Israel-based drug maker is expected to hear by late Friday whether the FDA will approve its new treatment for Gaucher’s disease.
If approved, the product, called taliglucerase alfa, would compete against Genzyme Corp.’s (GENZ 75.35, -0.01, -0.01%) flagship drug Cerezyme. Protalix has been
developing the product with Pfizer Inc. (PFE 18.90, +0.14, +0.75%)
Par Pharmaceutical Co. (PRX 34.39, +3.12, +9.98%) shares slid 9%.
Early Thursday, Par said its fourth-quarter profit rose to 48 cents a share from 31 cents a share in the 2009 quarter. Revenue, however, fell to $227 million from $290 million, due in part to increased competition for its drugs metoprolol, meclizine and clonidine.
The drug sector’s two key indexes were mixed. The NYSE Arca Pharmaceutical Index (DRG 301.67, -1.49, -0.49%) eased 0.9% to 300.84, while the NYSE Arca Biotechnology
Index (BTK 1,267, +6.05, +0.48%) rose 0.3% to 1,264.87.
Vertex’s New Cystic Fibrosis Drug Treats the Cause, Not Just the Symptoms
Vertex Pharmaceutical (VRTX) shares soared 15% Wednesday as Wall Street cheered the results of a late-stage study of its new cystic fibrosis drug, an experimental treatment that targets the underlying cause of the disease rather than just its symptoms.
In patients with cystic fibrosis, a defective gene and the protein it creates cause the body to produce unusually thick, sticky mucus that builds up in the lungs and the pancreas, leading to life-threatening lung infections and an impairment of the body’s ability to properly break down and absorb food.
The drug, VX-770, is a pill that targets the defective protein. It showed sustained improvements in lung function of over 10% in patients with a specific gene mutation. The caveat, though, is that the specific mutation being targeted by the drug, G551D, affects just 4% of the CF population. But it’s possible that the results of this trial will provide a basis for the use of VX-770 to treat other mutations. VX-770 is currently being tested in combination with another drug, VX-809, in people with two copies of the more common Delta F508 mutation.
In the trial, patients also showed improvement across all key secondary goals of the study, Vertex said, including decreased pulmonary and respiratory symptoms and weight gain (seven pounds on average). In addition, average sweat chloride (salt) levels, a key clinical indicator of CF, dropped toward normal levels, indicating that the drug is having an effect on the underlying defect.
VX-770 helps “open the gate” at the cell surface — enabling the protein to pass through, as it would in healthy cells. This restores a proper flow of salt and fluids on the surface of the lung, the company explained.
“Treating the underlying cause of cystic fibrosis with VX-770 led to clinical improvements that were far beyond our expectations, providing support for an entirely new approach to the treatment of this disease,” said Peter Mueller, executive VP of global research and development, and chief scientific officer for Vertex.
A Long Time Between Genetic Discovery and New Medicine
“These results are highly encouraging,” said Robert Beall, president and CEO of the Cystic Fibrosis Foundation, which collaborated with Vertex on the drug development, including an approximately $75 million investment. “They provide scientific evidence that support our long-standing belief that targeting the underlying defect of CF may have a profound effect on the disease.”
Cystic fibrosis is an inherited genetic disease that affects about 30,000 people in the U.S. and 70,000 worldwide, according to the Cystic Fibrosis Foundation. In the 1950s, few children with cystic fibrosis lived to attend elementary school. Today, patients can expect to live into their 30s, 40s and beyond. Still, very few treatments are available to CF patients, and those that are generally target the disease’s symptoms.
But while this drug trial is being hailed a victory, it also highlights the problems of targeted therapy, as Mathew Herper of Forbes writes. “Cystic fibrosis is a symbol of how difficult it is to move from genetic discoveries to new medicines. The gene for the disorder, which causes patients’ lungs to fill with thick mucus, was discovered in 1989 by Francis Collins, now the director of the National Institutes of Health. Yet treatments have been slow in coming.”
Vertex said it will file for U.S. approval of the drug in the second half of this year. Analysts estimate VX-770 could, if approved, generate peak annual sales of some $600 million.
Par Pharmaceutical Q4 Profit Rises – Quick Facts
Par Pharmaceutical Companies, Inc. (PRX: News ) Thursday said net income for the fourth quarter was $17.50 million compared to $10.70 million last year. On a per share basis, profit was $0.48 versus $0.31 in the prior year.
Adjusted cash basis from continuing operations was $22.29 million compared to $25.80 million in the previous year. Cash earnings per share from continuing operations was $0.61 versus $0.74 in the previous year.
On average, eight analysts polled by Thomson Reuters expected the company to report earnings of $0.67 per share. Analysts’ estimates typically exclude special items.
Total revenues for the three months were $227.03 million compared to $290.32 million a year ago. Market expectation was for revenues of $210.69 million for the period.
The company attributed the rise in revenues principally to additional competition in metoprolol, meclizine, and clonidine.
Corona new pres. at Masters Pharmaceutical
Masters Pharmaceutical Inc., a Forest Park-based national wholesale distributor of pharmaceutical and medical products, on Tuesday announced the promotion of Wayne A. Corona to president and COO.
Corona, who was formerly senior vice president of purchasing, joined Masters in 2002. Since then the privately held company has grown to more than 15,000 customers nationwide.
“Wayne has contributed greatly to our growth, utilizing his vast experience and skill set. His 35 years in our industry has made him a truly great asset to Masters Pharmaceutical,” said Denny Smith, Masters chairman and CEO.