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news.Insmed has signed a licensing agreement with AstraZeneca for global exclusive rights to AZD7986, a novel oral inhibitor of dipeptidyl peptidase I (DPP1, also known as cathepsin C).
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DPP1 is an enzyme that catalyzes the activation of neutrophil serine proteases (NSPs), which play a key role in pulmonary diseases such as non-cystic fibrosis bronchiectasis (non-CF bronchiectasis).
Insmed has renamed the compound INS1007 and will pursue an initial indication of non-CF bronchiectasis, a rare, progressive, neutrophil-driven pulmonary disorder in which the bronchi become permanently dilated due to chronic inflammation and infection.
Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition.
The estimated global prevalence of non-CF bronchiectasis exceeds 2 million, of which at least 110,000 cases are in the United States. There is currently no cure for non-CF bronchiectasis.
Bronchiectasis increases susceptibility to nontuberculous mycobacterial (NTM) lung disease, and up to 50 percent of patients with bronchiectasis may also have an active NTM infection. NTM lung disease is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal.
Insmed is currently advancing a global phase 3 clinical study of ARIKAYCE (liposomal amikacin for inhalation) in NTM lung disease.
Insmed has also completed a phase 2 study of ARIKAYCE for the treatment of chronic Pseudomonas aeruginosa infection in non-CF bronchiectasis.
Insmed president and CEO Will Lewis said: "With this transaction we have added a highly complementary therapy that aligns perfectly with our established expertise in rare pulmonary diseases.
"Because NTM lung disease and bronchiectasis often co-exist, we can readily leverage our existing relationships with physician experts around the world who are eagerly awaiting new treatment options. We continue to expect patient enrollment in our phase 3 study of ARIKAYCE to conclude later this year and to report top line data in 2017.
"We expect that when approved, ARIKAYCE and INS1007 will allow us to provide great value to the patients who are living with NTM lung disease and bronchiectasis, as well as the physicians who treat them."
Maarten Kraan, head of the Respiratory and Inflammation Innovative Medicines Unit at AstraZeneca, said: "We are pleased to be working with Insmed on this program from our early stage respiratory portfolio, which represents a novel approach to treating bronchiectasis.
"Insmed has the expertise and experience required to take AZD7986 forward in this important indication and bring about results that we hope will benefit patients in the future."
In a phase 1 study of healthy volunteers AZD7986 was well tolerated and demonstrated inhibition of the activity of the NSP neutrophil elastase in a dose and concentration dependent manner.
In preclinical studies, AZD7986 was shown to effectively and reversibly inhibit DPP1 and the activation of NSPs within maturing neutrophils. Insmed is completing its plans for a phase 2 study in non-CF bronchiectasis. The study is expected to begin in 2017.
Under the terms of the agreement, Insmed will pay AstraZeneca an upfront payment of $30 million. AstraZeneca will be eligible to receive future payments totaling $120 million in future clinical, regulatory, and sales-related milestones.
AstraZeneca would also be entitled to receive tiered royalties ranging from a high single-digit to mid-teen. In addition, the agreement provides AstraZeneca with the option to negotiate a future agreement with Insmed for commercialization of AZD7986/INS1007 in chronic obstructive pulmonary disease or asthma.
Insmed recently closed a $55 million debt agreement with Hercules Capital, Inc., which refinanced the company's existing debt and will add $30 million of new debt to fund the upfront payment. The company confirms its cash operating expense guidance for the second half of 2016 of $62 to $72 million.
Going forward the company remains committed to maintaining a disciplined use of capital that ensures key corporate activities pertaining to its priority ARIKAYCE and INS1007 programs are fully resourced.
About INS1007
INS1007 is a small molecule, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow.
Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. Neutrophils contain three NSPs (neutrophil elastase, proteinase 3, and cathepsin G) that have been implicated in a variety of inflammatory diseases.
In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. INS1007 may decrease the damaging effects of inflammatory diseases, such as non-cystic fibrosis bronchiectasis, by inhibiting DPP1 and its activation of NSPs.