Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. and Almirall, a privately held pharmaceutical company headquartered in Barcelona, Spain, announced that the two companies have entered an agreement to develop, market and distribute Almirall's novel inhaled, long-acting muscarinic antagonist, LAS34273, in the United States.
The innovative LAS34273 is now entering phase III studies in the United States and Europe for chronic obstructive pulmonary disease (COPD).
LAS34273 has been evaluated in phase II studies that demonstrate that it has a fast onset of action and provides 24 hours of bronchodilation. LAS 34273 is designed to have a very specific action in the lungs resulting in a low level of systemic exposure. Studies to date including cardiovascular safety studies support a favourable side effects profile. The product is being developed in a Multi Dose-Dry Powder Inhaler (MDPI) which represents an improvement in drug delivery over currently available devices.
This new treatment promises to provide relief for the many sufferers of COPD. According to the World Health Organisation, COPD is the 5th leading cause of death worldwide and the fourth in the US. Affecting over 12 million adults in the US, it is also estimated that a further 24 million show some evidence of impaired lung function highlighting a clear under diagnoses of COPD. The condition, which is mainly caused by smoking, results in damage to the airways which triggers symptoms such as cough, breathlessness, excess sputum and chest infections.
Under terms of the agreement, Forest will make an upfront payment of $60 million to Almirall and will pay future undisclosed milestone payments. In addition, Almirall will receive royalty payments based on LAS34273 sales. Forest and Almirall will jointly oversee the development and regulatory approval of LAS34273 and share all expenses for current and future development programs. Almirall has granted Forest the rights of first negotiation for other Almirall respiratory products that could be combined with LAS34273.
Forest will be responsible for sales and marketing of LAS34273 in the US and Almirall has retained an option to co-promote the product in the future while retaining commercialization rights for the rest of the world. In addition to five years of Hatch-Waxman exclusivity granted upon approval, LAS34273 is protected by an issued US composition of matter patent expiring in 2020. Extension of exclusivity under Hatch-Waxman legislation is expected.
Howard Solomon, chairman and chief executive officer of Forest commented: "We are very pleased to be entering into this partnership with Almirall, which is the largest and a highly successful independent pharmaceutical company in Spain. We expect LAS34273 to become an important product in the treatment of COPD, a major respiratory disease that affects over 12 million people in the United States and is the nation's fourth leading cause of death. We have been very impressed by the clinical profile of the drug based on the Phase II study results as well as its convenient inhalation delivery system. LAS34273 is another later stage product that augments our growing pipeline and validates again our unique position and our business strategies."
"We are very pleased to be working with Forest to launch LAS34273 into the fast growing COPD market", said Dr. Jorge Gallardo, Chairman and Chief Executive Officer of Almirall. "Through this agreement we will collaborate with a strong and experienced partner who has a successful track record in building successful brands in the United States. We are confident that this will be a successful partnership leveraging Forest's proven skills in clinical development and marketing in the competitive US market. Both companies believe LAS34273 is a compelling product that has promising potential to become a leading treatment for patients suffering from COPD."