CAMBRIDGE, Mass. -- (BUSINESS WIRE) -- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its fourth quarter 2012 and recent business activities.
“The past several months have been a remarkable period of time for us at Ironwood – particularly with the commercial launch of LINZESS in the U.S. and the approval of Constella in the E.U.,” said Peter Hecht, Chief Executive Officer of Ironwood. “In December, the joint Ironwood and Forest team stocked LINZESS in over 44,000 pharmacies across the U.S. and began educating over 85,000 physicians. Looking ahead, we will continue to focus on the LINZESS launch, while also exploring development opportunities to strengthen the clinical profile of linaclotide and broaden the product label in other indications and geographies. We will also continue to progress our other pipeline programs, including potential linaclotide-based combination products, IW-9179 for functional dyspepsia and IW-2143 for anxiety, among others. Through these activities, we continue to work towards our overarching goals of delivering differentiated medicines to patients and value to our shareholders.”
Fourth Quarter 2012 and Recent Highlights
Linaclotide (Rest of World)
Research & Development
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time, on Tuesday, January 15, to discuss its fourth quarter 2012 and recent business activities. Individuals interested in participating in the call should dial (877) 643-7155 (U.S. and Canada) or (914) 495-8552 (international) using conference ID number 83300312. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting today at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on January 22, 2013. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 83300312. The archived webcast will be available on Ironwood’s website for 14 days.
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist approved by the FDA for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is thought to work in two ways based on nonclinical studies. LINZESS binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and transit and a reduction in visceral pain, which is thought to be mediated by decreased activity of pain-sensing nerves. The clinical relevance of the effect on pain fibers in nonclinical studies has not been established.
In placebo-controlled Phase III clinical trials of more than 2,800 adults, LINZESS was shown to reduce abdominal pain in IBS-C patients and increase bowel movement frequency in both IBS-C patients and CIC patients. Improvement in abdominal pain and constipation occurred in the first week of treatment and was maintained throughout the 12-week treatment period. Maximum effect on abdominal pain was seen at weeks 6-9 and maximum effect on constipation occurred during the first week. When a subset of LINZESS-treated patients in the trials were switched to placebo, they reported their symptoms returned toward pretreatment levels within one week, while placebo-treated patients switched to LINZESS reported symptom improvements. LINZESS is contraindicated in pediatric patients up to 6 years of age. The use of LINZESS in pediatric patients 6 through 17 years of age should be avoided. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice. LINZESS has not been studied in pediatric patients. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
Ironwood and Forest Laboratories, Inc. are co-promoting LINZESS in the United States. Linaclotide was also approved by the European Commission for the treatment of adults in the European Union with IBS-C and will be marketed under the brand name Constella® through a license agreement between Ironwood and Almirall, S.A. Ironwood also has partnered linaclotide with Astellas Pharma Inc. for development and commercialization in Japan and certain other Asian countries and with AstraZeneca for development and commercialization in China.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial pharmaceutical company dedicated to the art and science of great drugmaking. Ironwood is located in Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.
Important Safety Information
WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients up to 6 years of age. Use should be avoided in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.
Warnings and Precautions
No drug-drug interaction studies have been conducted with LINZESS. Linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses; hence, no systemic drug-drug interactions or drug interactions mediated by plasma protein binding of linaclotide or its metabolite are anticipated.
Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies. In addition, linaclotide is neither a substrate nor an inhibitor of the efflux transporter P-glycoprotein (P-gp). Ironwood Pharmaceuticals, Inc.
This press release contains forward looking statements. Investors are cautioned not to place undue reliance on these forward‐looking statements, including, but not limited to, the potential for LINZESS as a treatment option for adults in the United States suffering from IBS-C and CIC, the availability of LINZESS in pharmacies in the U.S., Ironwood’s and Forest’s intended non-clinical and clinical development activities for linaclotide and Ironwood’s intended activities and associated timelines for the other product candidates and early development programs in its pipeline, the anticipated launch timeline for Constella in the European Union, the development and potential commercialization of linaclotide in China, and the potential for IW-9179 as a treatment option for adults suffering from functional dyspepsia. Each forward‐looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the commercial launch of LINZESS in the U.S. is not executed as anticipated, Ironwood or its partners are unable to manufacture or distribute a sufficient commercial supply of LINZESS, adoption of LINZESS by physicians or patients is faster or slower than anticipated, Almirall is unable to obtain sufficient pricing or reimbursement for Constella in countries in the European Union, serious adverse events arise in patients that are deemed to be definitely or probably related to linaclotide treatment, the incidence or severity of diarrhea in patients treated with linaclotide is higher than expected, or advancements in the further development of linaclotide in additional patient populations or indications, or in the development of other products or early development programs in Ironwood’s pipeline, do not proceed as expected, as well as risks related to the difficulty of predicting regulatory approvals and the acceptance of and demand for new pharmaceutical products. Applicable risks also include those that are listed in Ironwood’s Quarterly Report on Form 10‐Q for the quarter ended September 30, 2012, in addition to the risk factors that are listed from time to time in Ironwood’s Annual Reports on Form 10‐K, Quarterly Reports on Form 10‐Q and any subsequent SEC filings. Ironwood undertakes no obligation to update these forward‐looking statements to reflect events or circumstances occurring after this press release. These forward‐looking statements speak only as of the date of this press release. All forward‐looking statements are qualified in their entirety by this cautionary statement.
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and available-for-sale securities||$||168,228||$||164,016|
|Accounts receivable, net||1,487||652|
|Prepaid expenses and other current assets||8,026||2,899|
|Total current assets||184,440||167,567|
|Property and equipment, net||37,537||33,625|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||48,561||$||24,568|
|Current portion of capital lease obligations||261||233|
|Current portion of deferred rent||2,735||4,042|
|Current portion of deferred revenue||3,381||36,291|
|Total current liabilities||54,938||65,134|
|Capital lease obligations||308||422|
|Total stockholders’ equity||144,052||109,856|
|Total liabilities and stockholders’ equity||$||229,907||$||208,977|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
|Cost and expenses:|
|Cost of revenue||965||—||965||—|
|Research and development||28,273||24,224||113,474||86,093|
|Selling, general and administrative||33,274||13,925||92,538||45,546|
|Total cost and expenses||70,880||39,186||223,007||132,013|
|Loss from operations||(43,900)||(7,032)||(72,762)||(66,142)|
|Other income (expense), net||45||58||138||1,293|
|Net loss before income tax expense||(43,855)||(6,974)||(72,624)||(64,849)|
|Income tax expense||—||—||—||3|
Net loss per share —basic and diluted
Weighted average number of common shares
used in net loss per share —basic and diluted