Key Developments: Furiex Pharmaceuticals Inc (FURX.O)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
Furiex Pharmaceuticals Inc Confirms Takeda Pharmaceutical Company Limited's Receives FDA Approval For New Type 2 Diabetes Therapies
Furiex Pharmaceuticals Inc announced that Takeda Pharmaceutical Company Limited has received approval from the U.S. Food and Drug Administration of three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. Under its agreement with Takeda, Furiex is entitled to receive a $25 million payment as a result of this approval, as well as royalties on sales in the United States and potential sales-based milestones. Furiex has already been receiving royalty payments from Takeda for the sale of NESINA and LIOVEL in Japan. NESINA is a DPP-4 inhibitor for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). OSENI is a fixed dose combination therapy that combines alogliptin and pioglitazone in a single tablet for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. KAZANO is a fixed dose combination therapy for the treatment of type 2 diabetes that combines alogliptin and metformin in a single tablet. Metformin is a widely-used diabetes medication that acts primarily by reducing the amount of glucose produced by the liver. Full Article
Furiex Pharmaceuticals Inc Shares Fall On Cholesterol Drug Development Halt-Reuters
Reuters reported that shares of Furiex Pharmaceuticals Inc fell more than 11% on Friday, a day after the company said it would stop development of its cholesterol drug. The company said patients taking the drug did not experience less muscle pain than when given Pfizer's Lipitor or a dummy drug, in a mid-stage trial. Full Article
Furiex Pharmaceuticals Inc Announces Results for Phase II Trial of PPD-10558
Furiex Pharmaceuticals Inc announced top-line results from the Phase II trial of the investigational drug PPD-10558 in patients with statin-associated myalgia, or SAM. PPD-10558 did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study. The study enrolled patients with high cholesterol and a prior history of SAM, and evaluated recurrence rates for SAM over a twelve-week treatment period across the following three different treatment regimens: placebo; PPD-10558; and atorvastatin. Patients did not report any significant differences in muscle symptoms, nor did they drop out due to SAM in significantly different percentages, among the three regimens. As expected, however, PPD-10558, a novel statin, did significantly lower LDL-cholesterol compared with placebo, and the compound also had a favorable safety profile. Full Article
Furiex Pharmaceuticals Inc Acquires Full Exclusive License To MuDelta For Treatment Of Diarrhea-Predominant IBS
Furiex Pharmaceuticals Inc announced that it has acquired full exclusive license rights to develop and commercialize the compound MuDelta under its existing development and license agreement with Janssen Pharmaceutica N.V. Furiex acquired these rights as a result of Janssen’s decision, after an evaluation of strategic fit within its late stage portfolio, not to exercise its option under the agreement to continue development of MuDelta. Furiex will owe payments to Janssen based on Phase III trial initiation, future regulatory milestones and, if the product is approved, sales milestones and royalties. Terms of acquisition were not disclosed. Full Article
Furiex Pharmaceuticals Inc Reports Positive Phase II Results for MuDelta In Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Furiex Pharmaceuticals Inc announced that successful results from its Phase II proof-of-concept clinical trial evaluating the safety and efficacy of MuDelta, an investigational oral agent for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). IBS-D is a common functional bowel disorder that causes chronic diarrhea and abdominal pain. Full Article
Furiex Pharmaceuticals Inc Enters Into Loan Agreement For Up To $15 Million
Furiex Pharmaceuticals, Inc. announced that it has entered into a loan agreement with MidCap Financial and Silicon Valley Bank to provide up to $15.0 million in capital through a secured term loan. Furiex intends to use the proceeds to support research and development for its clinical stage compounds JNJ-Q2, MuDelta and PPD10558. The loan agreement is structured in two tranches. The first tranche in the amount of $10.0 million was drawn upon closing of the transaction. The second tranche of $5.0 million only becomes available to the Company if a pre-defined Furiex financing event occurs. Both tranches will have interest-only payments for the first 12 months. The first tranche will have principal and interest payments for a subsequent 36 month period. The second tranche will have principal and interest payments for a subsequent 33 or 36 month period, depending upon the date of execution. Full Article
BRIEF-Furiex Pharma jumps in premarket after FDA ok's new drug treatments for type 2 diabetes
NEW YORK, Jan 28 - Furiex Pharmaceuticals Inc : * Furiex Pharma jumps 34.2 percent to $28.50 in premarket after FDA OK's new Takeda Pharmaceutical's drug treatments for type 2 diabetes, resulting in milestone payments for Furiex
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