Wed, Aug. 5, 4:19 PM
Wed, Aug. 5, 10:11 AM
- Ironwood Pharmaceuticals (IRWD +1.9%) will co-promote VIBERZI (eluxadoline) in the U.S. with Allergan (AGN +1.5%) as soon as the product receives its final scheduling designation by the U.S. Drug Enforcement Administration. The FDA recommended that it be classified as a controlled substance.
- Under the terms of the agreement, Ironwood's sales force will detail VIBERZI to the same 25,000 healthcare providers that it currently details LINZESS and Cologuard. Ironwood will be compensated based on the number of calls made by the sales group as well as unspecified performance metrics. Allergan will be responsible for all other commercialization costs related to VIBERZI.
- VIBERZI is a mu-opioid receptor agonist indicated for the treatment of adult patients with irritable bowel syndrome with diarrhea (IBS-D). In a drug discrimination study, intravenous administration of eluxadoline hydrochloride produced full generalization to the morphine cue. In a self-administration study in monkeys, eluxadoline hydrochloride was self-administered to a degree less than half for heroin but greater than saline. Two human abuse studies of oral and intranasal doses of showed a rate of euphoria of 14 - 28% compared to 44 - 76% for oxycodone.
Wed, Jul. 8, 8:56 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) reports that commercialization partner AstraZeneca (NYSE:AZN) is set to file a marketing application in early 2016 with the Chinese Food and Drug Administration (CFDA) seeking approval for linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). If cleared, it will be the first prescription drug available in China for both male and female patients with IBS-C.
- A Phase 3 study conducted mainly in China met all of its primary and secondary endpoints. 60% of linaclotide-treated patients were Abdominal Pain/Discomfort Responders compared to 48.8% for placebo (p=0.001) while 31.7% of the linaclotide group were IBS Degree of Relief Responders versus 15.4% for placebo (p<0.0001). Full results from the trial will be presented at a future medical meeting.
- Ironwood and AstraZeneca are jointly responsible for the development and commercialization of linaclotide in China. AstraZeneca has the bulk of the responsibility for local operations. Per their collaboration, AstraZeneca paid Ironwood an upfront fee of $25M. P&L will be shared on a 55/45 basis (favoring AstraZeneca) that will adjust to 50/50 after a certain milestone is achieved. Ironwood is also eligible for additional commercial milestones of $125M.
- Linaclotide is marketed in the U.S. as Linzess by Actavis and Ironwood and in Europe as Constella by Almirall.
Wed, Jun. 17, 9:22 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) slumps 5% in premarket trading on robust volume. Investors apparently perceive less rosy prospects for Ironwood's CIC candidate linaclotide after Synergy Pharmaceuticals (NASDAQ:SGYP) reported successful Phase 3 results for plecanatide this morning.
- Previously: Synergy Pharma's plecanatide successful in late-stage trial; shares up 50% premarket (June 17)
Wed, Jun. 10, 8:17 AM
- Ironwood Pharmaceuticals' (NASDAQ:IRWD) $300M of convertible senior unsecured notes due June 15, 2022 will bear an interest rate of 2.25% payable semi-annually. The conversion rate is 60.3209 shares of IRWD Class A common stock per $1,000 principal amount of the notes, equivalent to $16.58 per share.
- Initial purchasers have the option to buy up to an additional $45M of the notes.
- Net proceeds of ~$292M (~$336M if the over-allotment is fully exercised) will be used for general corporate purposes.
Mon, Jun. 8, 5:31 PM| Mon, Jun. 8, 5:31 PM | 3 Comments
Tue, May 5, 4:19 PM
Mon, May 4, 5:35 PM
- ACLS, AGU, AIZ, ALL, AMRS, AMSG, ANAD, ANDE, ARC, ATSG, AWR, AXLL, BIO, BRDR, CENT, CERS, CLUB, COUP, CRAY, CSU, CTL, CVG, CYH, DK, DKL, DLR, DTLK, DVN, EA, ENPH, EXAM, FISV, FOSL, FTR, GCA, GHDX, GMED, GNMK, GPOR, GRPN, HK, HLF, HRZN, IAG, ICUI, IGTE, IRWD, JIVE, KAR, KGC, KONA, LC, MHLD, MM, MYGN, MYL, NDLS, NFX, NVGS, NYMT, OCLR, OKE, OKS, OUT, PAA, PACB, PAGP, PBPB, PKD, PXD, PZZA, QGEN, QNST, QUAD, REGI, REXX, RLOC, RNR, RP, RUBI, SBRA, SCTY, SKUL, SLF, SM, SPA, SUPN, TEG, TMH, TNET, TRNX, TSRA, TTGT, USNA, VVUS, WAGE, WES, WGP, WR, WSR, WSTC, WTR, WTW, XXIA, Y, ZAGG, ZEN, ZLTQ, ZU
Fri, Mar. 13, 5:40 PM
Mon, Mar. 9, 1:44 PM
- In a effort to reach more physicians, Exact Sciences (EXAC +1.1%) enters into a one-year agreement with Ironwood Pharmaceuticals (IRWD -0.9%) to co-promote Exact's colorectal cancer screening test, Cologuard.
- Under the terms of the agreement, Ironwood will be compensated for net sales of Cologuard from the physicians it calls on, although promoting Linzess (linaclotide) capsules for the treatment of chronic ideopathic constipation and irritable bowel syndrome with constipation remains its top priority. Exact maintains responsibility of all other aspects of commercializing Cologuard. The firms will also collaborate on medical education approaches to support a greater understanding of Cologuard and the importance of colorectal cancer screening.
Fri, Feb. 13, 5:36 PM
Fri, Feb. 13, 10:38 AM
- Ironwood Pharmaceuticals (IRWD -3.8%) Q4 results: Revenues: $38.1M (+662.0%); COGS: $13.1M (+999%); R&D Expense: $27.5M (+22.2%); SG&A: $30.6M (+6.6%); Operating Loss: ($33.1M) (+29.1%); Net Loss: ($37.6M) (+27.7%); Loss Per Share: ($0.27) (+37.2%).
- FY2014 results: Revenues: $76.4M (+233.6%); COGS: $25.6M (+255.6%); R&D Expense: $101.9M (-0.5%); SG&A: $118.3M (-4.0%); Operating Loss: ($169.4M) (+32.8%); Net Loss: ($189.6M) (+30.5%); Loss Per Share: ($1.39) (+40.9%); Quick Assets: $248.3M (+25.7%).
- 2015 Guidance: Operating expenses: $220M - 250M; R&D expenses: $105M - 120M; SG&A expenses: $115M - 130M; Linzess marketing and sales expenses: $230M - 260M.
Thu, Feb. 12, 4:08 PM
Wed, Feb. 11, 5:35 PM
Wed, Feb. 4, 11:42 AM
- On the basis of positive top line data from an exploratory Phase 2a study in patients with refractory gastroesophageal reflux disease (GERD), Ironwood Pharmaceuticals (IRWD +3.1%) plans to advance its bile acid sequestrant, IW-3718, into a Phase 2b dose-ranging trial.
- In the 93-subject Phase 2a study, the percentage of heartburn-free days for patients treated with IW-3718 increased 30.3% in the overall group and 34.6% in the bile reflux-positive group compared to 24.7% and 23.6%, respectively, in the placebo cohort.
- The baseline was 13.7% so this means that patients in the overall group treated with IW-3718 experienced 17.9% heartburn-free days. The comparable figure for the bile reflux-positive group was 18.4 days. This is only slightly better than placebo's 17.1 days and 16.9 days, respectively.
- Refractory GERD is characterized by the chronic presence of symptoms like heartburn despite treatment with a proton pump inhibitor (PPI) to suppress stomach acid. It affects ~8M Americans.
- The company intends to present the Phase 2a data at a future medical meeting.
Thu, Jan. 29, 4:52 PM| Thu, Jan. 29, 4:52 PM | Comment!
IRWD vs. ETF Alternatives
Other News & PR