IMMUNEX – recombinant human IgGFc for the treatment of autoimmune disease
Background: Intravenous immune globulin (IVIG) obtained from human sources is a mainstay of treatment for autoimmune diseases. IVIG is thought to work by blocking Fc receptors thereby decreasing the likelihood that auto – or self recognizing – immunoglobulins (predominantly IgG) will not be able to bind to cells and cause havoc on the body. However difficulties with this product include (a) that it is derived from human source (pooled sera) and therefore carries a risk of infectious disease transmission, (b) is not well quantified with respect to the components they contain (c) can precipitate anaphylaxis in patients with IgA deficiency if there is trace IgA in the product (d) can cause immune complex deposits, and (e) can interfere with other immune treatments of cause interpretation difficulties with lab tests.
Autoimmune disease market:
Ø Affects >50 million Americans
Ø Aggregate autoimmune disease costs are estimated at $100 billion
Ø Annual treatment in autoimmune disease can range from ~$6,000-$45,000, per patient, or greater, depending on the prevalence/incidence of disease and individual patient responses.
Ø IVIG costs $42-$104 per gram (average wholesale cost)
Ø IVIG market revenue estimated at ~$33 million per month.
Immunex is a recombinant component of the IgG Fc molecule which obviates the issues above with respect to autoimmunte treatment.
IP: Recombinant IgGFc for treatment of autoimmune diseases – Dr Bluth (Downstate Medical Center). Patent claims were initially rejected and subsequently abandoned. Market opportunity consists of first to treat will establish branding of novel product and considerable lead time over any competitors. Further, new composition of matter or modification of prior art will provide new patent applications.
Background: Intravenous immune globulin (IVIG) obtained from human sources is a mainstay of treatment for autoimmune diseases. IVIG is thought to work by blocking Fc receptors thereby decreasing the likelihood that auto – or self recognizing – immunoglobulins (predominantly IgG) will not be able to bind to cells and cause havoc on the body. However difficulties with this product include (a) that it is derived from human source (pooled sera) and therefore carries a risk of infectious disease transmission, (b) is not well quantified with respect to the components they contain (c) can precipitate anaphylaxis in patients with IgA deficiency if there is trace IgA in the product (d) can cause immune complex deposits, and (e) can interfere with other immune treatments of cause interpretation difficulties with lab tests.
Autoimmune disease market:
Ø Affects >50 million Americans
Ø Aggregate autoimmune disease costs are estimated at $100 billion
Ø Annual treatment in autoimmune disease can range from ~$6,000-$45,000, per patient, or greater, depending on the prevalence/incidence of disease and individual patient responses.
Ø IVIG costs $42-$104 per gram (average wholesale cost)
Ø IVIG market revenue estimated at ~$33 million per month.
Immunex is a recombinant component of the IgG Fc molecule which obviates the issues above with respect to autoimmunte treatment.
IP: Recombinant IgGFc for treatment of autoimmune diseases – Dr Bluth (Downstate Medical Center). Patent claims were initially rejected and subsequently abandoned. Market opportunity consists of first to treat will establish branding of novel product and considerable lead time over any competitors. Further, new composition of matter or modification of prior art will provide new patent applications.