Genentech, Ipsen/Tercica, and Insmed have been contacted by people living with amyotrophic lateral sclerosis (ALS) and their loved ones seeking access to an IGF-I/IGFBP3 product called Iplex, which is solely manufactured by Insmed.
Although Iplex has not been rigorously tested in people with ALS, nor received regulatory approval for use in ALS, all the companies involved appreciate the urgency and desperation for new treatments in the ALS community. The company is working diligently to determine how best to respond to that need.
The availability of Iplex is subject to a Court-Ordered Settlement Agreement. On November 8, 2008, Genentech and Ipsen/Tercica signed a letter of intent whereby they have consented to amend the Court-Ordered Settlement Agreement to permit Insmed to supply Iplex in connection with named-patient ALS programmes worldwide on a royalty-free basis. Insmed's ability to do so will be dependent on satisfying any regulatory requirements in any country where a request for treatment is made.
Ipsen/Tercica and Insmed also plan to enter into negotiations concerning the development of Iplex for the treatment of ALS, subject to analyzing the data from the ALS patients in Italy who have received Iplex, and satisfying any applicable regulatory requirements.
These actions represent each company's commitment to find a solution to the requests coming from the community of patients and their families. Insmed will update the community as further progress is made.
Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's disease, is a progressive neurodegenerative disease that attacks nerve cells in the brain and spinal cord resulting in muscle weakness and atrophy.
Iplex is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3).
Insmed is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs.