|January 21, 2014|
|07:12 EDT||AZN, FRX, IRWD||Ironwood reports Q4 LINZESS net product sales $51M, as reported by Forest|
Ironwood (IRWD) says LINZESS net product sales, as reported by Forest Laboratories (FRX) were $51M in Q4, an increase of approximately 48% quarter over quarter, and $118.8M for the year ended December 31, 2013. More than 220,000 LINZESS prescriptions were filled in Q4, resulting in more than 24% growth in total prescriptions quarter over quarter, and over 580,000 LINZESS prescriptions were filled in 2013, according to IMS Health. In 2013, more than 50,000 healthcare practitioners prescribed LINZESS, including approximately 90% of high prescribing gastroenterologists and approximately 70% of other high prescribing healthcare practitioners, primarily primary care physicians. Physician prescribing continues to increase month over month. Almirall, S.A., Ironwood’s European partner, continues to launch CONSTELLA in Europe. CONSTELLA is currently available to adult IBS-C patients in nine countries in Europe, including the United Kingdom and Germany. Ironwood and AstraZeneca (AZN) continue to enroll patients in a Phase III clinical trial of linaclotide in adult patients with IBS-C in China. The trial is expected to be completed in the first half of 2015. Astellas Pharma Inc. has completed enrollment in a Phase II double-blind, placebo-controlled, dose-ranging clinical trial of linaclotide in adult patients with IBS-C in Japan.
News For IRWD;FRX;AZN From The Last 14 Days
|July 28, 2015|
|07:20 EDT||AZN||Brookings Institute to hold a public meeting|
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|July 27, 2015|
|05:25 EDT||AZN||Genzyme acquires Caprelsa from AstraZeneca for $300M|
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
|July 22, 2015|
|13:58 EDT||AZN||Piper cuts Array target by only 50c after failed trial|
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
|09:07 EDT||AZN||On The Fly: Pre-market Movers |
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|07:38 EDT||IRWD||Ironwood announces data from Phase I IW-1973 study|
Ironwood Pharmaceuticals announced top-line data from a Phase I study of IW-1973, its lead investigational soluble guanylate cyclase stimulator. In the study, IW-1973 demonstrated cardiovascular pharmacodynamic effects, extensive tissue distribution, proof of mechanism for sGC stimulation, and a dose range that was well tolerated in healthy volunteers. The totality of clinical and preclinical data generated to date strongly support continued development of IW-1973 as a potential once-daily oral therapy. Ironwood intends to initiate a Phase Ib multiple ascending dose study of IW-1973 in the fourth quarter of 2015. This study will inform the selection of doses and priority indications for the Phase II program, which will focus on areas with the highest unmet need and optimal path to market. Ironwood intends to initiate at least two Phase II proof of concept studies for IW-1973 in 2016. The randomized, double-blind, placebo-controlled, single ascending dose Phase I study enrolled 46 healthy volunteers. Participants were randomized 3:1 to receive a single dose of IW-1973 or placebo administered via an oral capsule. Top-line clinical data were consistent with preclinical findings and included cardiovascular pharmacodynamic effects, dose-proportional pharmacokinetics, biomarker-based confirmation of target engagement, and evidence of extensive distribution to tissues. No serious adverse events were reported. Reported adverse events were consistent with the mechanism of action. Data from clinical and preclinical studies of IW-1973 are expected to be presented at a future medical conference.
|05:12 EDT||AZN||AstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint |
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
|July 15, 2015|
|17:00 EDT||AZN||InnerWorkings to provide AstraZeneca exclusive marketing execution|
InnerWorkings (INWK), the leading marketing execution firm, has become the exclusive North American marketing execution partner of AstraZeneca (AZN). Under the seven-year agreement, InnerWorkings will manage AstraZeneca’s marketing print operations across North America, which will improve AstraZeneca’s transparency and reporting as well as strengthen its brand impact. Strategically placed across the U.S., InnerWorkings’ three onsite teams based in Delaware, Maryland, and Pennsylvania will help AstraZeneca sharpen its financial visibility, unify its brands, and enhance its marketing effectiveness. By tapping InnerWorkings’ $1B-dollar buying power, AstraZeneca will gain vital insights, promote sustainability, and refine its marketing spend.
|08:21 EDT||IRWD||Synergy upside largely dependent on buyout, says Citi|
Citi doubled its price target for Synergy Pharmaceuticals (SGYP) to $12 from $6 but cautions that upside from current levels is likely dependent on a potential takeout. The firm sees raised expectations into the new the data readout for plecanatide. The drug's effectiveness in chronic idiopathic constipation looks fairly similar to Ironwood's (IRWD) Linzess, Citi tells investors in a research note. It keeps a Buy rating on Synergy.