Almirall obtains rights for Linaclotide in Mexico
- Almirall has solid experience in the gastrointestinal field and has been operating directly in Mexico over the last decade
- This agreement with Forest complements Almirall's rights for the product in Europe and expands its global outreach
- Linaclotide, a first-in class therapeutic option for Irritable Bowel Syndrome with constipation (IBS-C), has just been approved in the US while regulatory response in Europe is expected soon
Barcelona, 7 September 2012.-Almirall (ALM.MC) announces an agreement by which Forest grants Almirall commercialization rights for Linaclotide in Mexico, formerly obtained from Ironwood, for the treatment of IBS-C and other gastrointestinal conditions. Financial details of the agreement have not been disclosed.
"Almirall provides its knowledge on gastrointestinal disorders, a key therapeutic area for us, with its own drugs in Mexico for dyspepsia, gastroesophageal reflux and acidity" says Luciano Conde, ChiefOperating Officer at Almirall. "We are confident that we will make the most of this new opportunity in a territory where we have been directly operating for over a decade now" he also comments.
Almirall has exclusive Linaclotide rights from Ironwood in Europe where it has been in charge of its regulatory process and will manage its future commercialisation. This agreement in Mexico expands the company's product outreach in order to reinforce Almirall's global presence.
Linaclotide is a first-in class therapeutic option that has just been approved in the US. Regulatory feedback in Europe is expected in the coming months.
About Linaclotide Linaclotide is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine. In preclinical models, linaclotide reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. The effects on secretion and transit are mediated through cyclic guanosine monophosphate (cGMP), which is also believed to modulate the activity of local nerves to reduce pain. Linaclotide is an orally delivered peptide that acts locally in the gut with no measurable systemic exposure at therapeutic doses and is intended for once-daily administration.
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. co-developed linaclotide in the United States and will co-promote it there. Ironwood has out-licensed linaclotide to Almirall in Europe, and to Astellas Pharma Inc. in Japan, Indonesia, Korea, the Philippines, Taiwan and Thailand.
About Irritable Bowel Syndrome with constipation (IBS-C) IBS-C is defined as ‘a functional bowel disorder in which abdominal pain or discomfort is associated with defecation or a change in bowel habit and with features of disordered defecation'1.
The Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders includes criterion for the diagnosis of IBS-C2, as:
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Recurrent abdominal pain or discomfort at least three days/month, in the last three months, associated with two or more of the following:
- improvement with defecation
- onset associated with a change of frequency of stool
- onset associated with a change in form (or appearance) of stool
The estimated prevalence of IBS in Mexico is around 20%3. It leads to a substantial reduction in quality of life, accompanied by considerable socio-economic and psychological consequencesand represents a major proportion of gastrointestinal workload in both primary and secondary care.
About Almirall Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people's health and wellbeing. Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, psoriasis and other dermatological conditions. Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 13 affiliates.
For further information please visit the website at: www.almirall.com.
1 Longstreth GF, Thompson WG, Chey WD et al. - Functional Bowel Disorders. Gastroenterology 2006; 130: 1480-1491 2 Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders 3 Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán www.iinnsz.mx
Almirall media contact: Carolina Rodríguez +34 91 788 32 00 carolina.rodriguez@ketchumpleon.com
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