Ironwood Announces Linaclotide European Licensing Agreement with Almirall
Ironwood logo. (PRNewsFoto/Ironwood Pharmaceuticals)
ORLANDO, FL UNITED STATES
- Ironwood Will Receive Up To $55 Million in Near Term Payments -
CAMBRIDGE, Mass., May 4 /PRNewswire/ -- Ironwood Pharmaceuticals, Inc.
today announced that the company has entered into an out-licensing
agreement with Laboratorios Almirall, S.A. for European rights to develop
and commercialize the investigational compound linaclotide for the
treatment of irritable bowel syndrome with constipation (IBS-C) and other
gastrointestinal conditions. This agreement is a continuation of Ironwood's
strategy to develop and market its products in the United States while
forming partnerships to accelerate delivery to patients in other
territories.
(Logo: http://www.newscom.com/cgi-bin/prnh/20081006/NEM080ALOGO )
Under the terms of the agreement, Almirall will provide Ironwood with
up to $55 million in near-term payments, including a $40 million upfront
licensing fee. Pre-commercial licensing fees and milestone payments total
$95 million. In addition, Ironwood will receive escalating royalties on
linaclotide sales. Almirall will be responsible for activities relating to
regulatory approval and commercialization, as well as expenses for the
European market. Ironwood continues to retain all rights to linaclotide
outside of North America and Europe.
"We are very pleased to be joining forces with Almirall to develop and
commercialize linaclotide for the millions of patients in Europe who suffer
from IBS-C and currently lack adequate therapies. Almirall presented us
with the best strategy to rapidly and effectively deliver linaclotide to
the market, and terms that, should linaclotide meet our expectations, allow
us to share approximately half of the long term value of the product," said
Peter Hecht, Ironwood's chief executive officer.
About Linaclotide
Linaclotide is a first-in-class compound in Phase 3 clinical
development for the treatment of IBS-C and chronic constipation (CC).
Linaclotide demonstrated proof of concept in a comprehensive Phase 2b
program, comprised of two clinical studies in over 700 patients with either
IBS-C or CC. In patients with IBS-C, linaclotide significantly reduced
abdominal pain and bloating and improved bowel function throughout the
12-week treatment period. In patients with CC, linaclotide reduced
constipation throughout the 4-week treatment period. In both studies the
most common adverse event was diarrhea. Linaclotide is a once daily, orally
delivered peptide that acts locally in the gut with no detectable systemic
exposure at therapeutic doses. Linaclotide is an agonist of guanylate
cyclase type-C, a receptor found on the lining of the intestine. Issued
composition of matter patents for linaclotide in the United States and
Europe provide protection beyond 2024. In September 2007, Ironwood and
Forest Laboratories, Inc. entered into a 50/50 collaboration to co-develop
and co-promote linaclotide in United States.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a chronic functional gastrointestinal disorder characterized
by abdominal pain and discomfort associated with altered bowel habits.
There are currently few available therapies to treat this disorder. In the
five major European markets alone, an estimated nine million patients
suffer from IBS-C. Patients suffering from IBS-C can be affected
physically, psychologically, socially, and economically.
About Almirall
Almirall is an international pharmaceutical company based on innovation
and committed to health. Headquartered in Barcelona, Spain, Almirall
researches, develops, manufactures, and commercializes its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research resources
are related to the treatment of asthma, COPD (chronic obstructive pulmonary
disease), rheumatoid arthritis, multiple sclerosis, psoriasis, and
dermatology. The company is also aiming to expand its development pipeline
though licensing-in in the areas mentioned plus some others including
gastrointestinal and neurology.
Almirall is currently present in over 70 countries with direct presence
in Europe and Latin America through 11 affiliates (Austria, Belgium,
France, Germany, Italy, Mexico, Poland, Portugal, Spain, Switzerland, and
the UK-Ireland). For further information please visit the website at:
http://www.almirall.com.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (http://www.ironwoodpharma.com) is an entrepreneurial
pharmaceutical company dedicated to the science and art of great
drugmaking. Linaclotide, the company's first in class compound, is being
evaluated in a comprehensive Phase 3 program for the treatment of irritable
bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
Ironwood also has a growing pipeline of additional drug candidates in
earlier stages of development. Microbia, Inc. (formerly Microbia Precision
Engineering), a majority-owned subsidiary of Ironwood, is an industrial
biotechnology company developing and commercializing novel bioprocesses for
the production of specialty chemicals. Ironwood has raised $281 million in
private equity financing and is located in Cambridge, Massachusetts.
Contact:
Susan Brady
Corporate Communications
617.621.8304
[email protected]