The FDA accepts for review Ironwood Pharmaceuticals' (IRWD +1.7%) New Drug Application (NDA) seeking approval for DUZALLO (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout. The agency's action should be in H2.
Lesinurad inhibits the function of transporter proteins involved in uric acid resorption in the kidneys, thereby helping them excrete uric acid. Allopurinol inhibits an enzyme called xanthine oxidase which plays a key role in the oxidation of the alkaloid xanthine to uric acid.
Gout is a type of arthritis caused by too much uric acid in the blood.
Ironwood obtained the U.S. rights from AstraZeneca (AZN +0.4%) in April 2016.
Ironwood Pharmaceuticals (NASDAQ:IRWD) and commercialization partner Allergan (NYSE:AGN) announce positive results from a Phase 2b clinical trial assessing two targeted delivery formulations of LINZESS (linaclotide), currently approved in the U.S to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation.
The study randomized 532 adult subjects into eight possible treatment arms. Top-line data showed patients receiving 300 mg of CR1 experienced numerically greater abdominal pain relief compared to placebo and to 290 mcg of immediate-release linaclotide. Patients receiving CR2 also experienced numerical improvement in abdominal pain and other abdominal symptoms compared to placebo, with no apparent effect on bowel movement function.
The companies plan to discuss the next development steps with the FDA, specifically a Phase 3 study, expected to commence in H2 2017. They are also pursuing patent protection for CR1 and CR2.
Ironwood Pharmaceuticals (IRWD +2.9%) announces that the Japanese Ministry of Health, Labor and Welfare has approved LINZESS (linaclotide) for the treatment of adults with irritable bowel syndrome. The approval triggers a $15M milestone payment from commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY).
Investors are selling the news as they mull what's next after Synergy's (SGYP -6.8%) successful Phase 3 trial for plecanatide. There's another Phase 3 trial, but those results aren't to be released for several weeks.
Also an issue is who might step up for a buyout given the costs associated with bringing the drug to market.
Citi's Liav Abraham sees Takeda Pharmaceutical (OTCPK:TKPYY +1.5%) as the most likely buyer in her coverage universe, and the FT today reported the company as willing to spend up to $15B in acquisitions to boost its U.S. presence. Abraham retains her Neutral rating and $4 price target (current price is $5.15).
Ironwood Pharmaceuticals (NASDAQ:IRWD) announces that ZURAMPIC(lesinurad) is now available in pharmacies throughout the U.S. ZURAMPIC is approved as a once-daily oral tablet to be taken in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia – high serum uric acid (sUA) levels in the blood – associated with gout in patients who have not achieved target sUA levels with an XOI alone.
In clinical trials, when added to allopurinol in patients with gout who failed to achieve target sUA levels with allopurinol alone, ZURAMPIC nearly doubled the number of patients who achieved sUA target of <6 mg/dL at month 6, reduced the mean sUA to <6 mg/dL by month 1 and maintained that level through month 12.
When added to febuxostat 80 mg in clinical trials, ZURAMPIC helped a greater, but not statistically significant, proportion of patients with tophaceous gout achieve sUA <5 mg/dL at month 6, and maintained that level through month 12. Acute renal failure has occurred with ZURAMPIC and was more common when ZURAMPIC was given alone. ZURAMPIC should be used in combination with an XOI.
ZURAMPIC (lesinurad) is a URAT1 inhibitor approved by the FDA for use in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels (sUA) with an XOI alone.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Allergan's (AGN -0.9%) TRUBERZI (eluxadoline) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).
In two pivotal studies, patients treated with TRUBERZI experienced significant reductions in the two most bothersome IBS-D-related symptoms: abdominal pain and diarrhea, with sustained relief over six months.
A final decision from the European Commission (EC) usually takes ~60 days.
If approved, TRUBERZI will join Ironwood Pharmaceuticals' (IRWD -2.1%) CONSTELLA (linaclotide), approved by the EC in June 2013, as the only medications in the EU licensed to treat IBS-D symptoms.
Ironwood Pharmaceuticals (IRWD +0.3%) and U.S. commercialization partner Allergan (AGN -0.6%) announce that the FDA has accepted for review their supplemental New Drug Application (sNDA) seeking approval of a 72 mcg dose of LINZESS (linaclotide) for the treatment of chronic idiopathic constipation. The decision date should be early next year.
LINZESS is currently approved at a dose of 145 mcg.
Net Loss: (13.3) (+60.0%); Non-GAAP Net Loss: (11.7) (+64.9%); Loss Per Share: (0.08) (+66.7%); Non-GAAP Loss Per Share: (0.08) (+66.7%). Consensus: Loss of 0.14 per share on revenues of $53.6M.
LINZESS net U.S. Sales by Allergan: $137.1M (+43.6%); IRWD's portion: $46.6 (+85.6%).
2016 Guidance: Use of less than $70M in cash for operations, up from less than $60M before lesinurad deal with AstraZeneca. Combined (with Allergan) sales & marketing expenses to support LINZESS: $220M - 260M.
Q2 Consensus: Loss per share of $0.16 on revenues of $53.1M.
Ironwood Pharmaceuticals (NASDAQ:IRWD) secures exclusive U.S. rights to AstraZeneca's (NYSE:AZN) Zurampic (lesinurad), approved by the FDA in December 2015, in combination with a xanthine oxidase inhibitor, for the treatment of hyperuricemia (excess uric acid in the blood) associated with uncontrolled gout. Lesinurad inhibits the function of transporter proteins involved in uric acid resorption in the kidneys, thereby helping them excrete uric acid.
Under the terms of the agreement, AstraZeneca will receive an upfront payment of $100M, milestones up to $165M and tiered single-digit royalties. It will be responsible for manufacturing and supply, certain product support services, the FDA's post-approval commitment and an regulatory submission in H2 for a fixed-dose combination product.
Ironwood expects to pay the upfront fee with cash on hand. The deal should be cash flow accretive in 2019 and beyond. Peak sales of Zurampic are expected to be ~$300M in 2022.
Management will host a conference call this morning at 8:00 am ET to discuss the deal.
Update: On June 3, Ironwood announced the deal closed. The transaction includes exclusive rights to the fixed dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination program to the FDA for review in H2 2016 on Ironwood's behalf. The agreement also includes certain rights to potentially access RDEA3170 in gout indications in the U.S.
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Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
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