Here are a few numbers:
The recombinant interferon business in the US for 2015 = 10B
Around 20-25% of recombinant patients develop anti-bodies to the interferon, making it useless.
About 80% of those patients will respond to natural interferon (alferon), eg they can continue treatment.
The PR lists S American countries and compares to Argentina, where we (hemispherx) already has approval to use alferon for ANY indication where anti-bodies develop as a result of recombinant interferon. Most of the interferon business is driven by HEP-C. Hep-C is big in S America.
Alferon is an approved drug and can be prescribed for ANY indication the clinician sees fit to or insurance will pay for. Thus the mention of MS.
In the US, alferon has been prescribed off-label or approved by insurance for these indications:
Cigna covers interferon alfa-n3 (Alferon® N) as medically necessary for ANY of the following
indications:
• acquired immune deficiency syndrome (AIDS)-associated Kaposi's sarcoma
• basal cell carcinoma
• carcinoid tumors
• chronic hepatitis B in patients with compensated liver disease who have failure, contraindication, or
intolerance to peginterferon alfa therapy
• chronic myelocytic leukemia
• condylomata acuminata, intralesional only
• cutaneous T-cell lymphomas (e.g. mycosis fungoides, Sezary syndrome)
• epithelial ovarian carcinoma
• essential thrombocytosis
• hairy cell leukemia
• laryngeal papillomatosis
• malignant melanoma
• multiple myeloma
• non-Hodgkin's lymphoma
• polycythemia vera
• renal carcinoma (kidney cancer)
• superficial bladder carcinoma
Hemispherx plans on charging a 'premium' for alferon for these reasons. I believe, about 2k per vial. Once they have their state of the art, continuous process, 600 liter bioreactor going, for two shifts a day.....
....they will still be hopelessly behind in demand. In my opinion. :) They need two more bioreactors, possibly larger capacity, which they are already thinking about. But first things first.
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