GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Here’s Merrimack’s PR on the new U.S. patent for
MM-093. The 2025 patent expiration includes five
years of statutory extension under the Hatch-Waxman
act. Of interest is what this PR does not say: there is
no longer any mention of the MM-093 program in
psoriasis. If indeed the psoriasis program has been
terminated, the remaining MM-093 programs are the
ones in RA and uveitis.

http://biz.yahoo.com/prnews/070612/netu041.html?.v=9

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Merrimack Pharmaceuticals Receives U.S. Patent Covering Composition of Matter for Recombinant, Non-Glycosylated Human Alpha-fetoprotein; Extends Patent Protection of MM-093 to 2025

CAMBRIDGE, Mass., June 12 /PRNewswire/ -- Merrimack Pharmaceuticals announced today the issuance of a patent from the United States Patent and Trademark Office covering the composition of matter for recombinant, non-glycosylated human alpha-fetoprotein, referred to as MM-093. U.S. Patent No. 7,208,576 entitled, "Non-glycosylated Human Alpha-fetoprotein, Methods of Production, and Uses Thereof" was filed in 2003 and provides patent protection in the U.S. into 2025 including already accrued patent term extension time.

"This patent significantly strengthens our intellectual property portfolio surrounding MM-093 and the commercial life of this important product," said Robert Mulroy, President & CEO of Merrimack Pharmaceuticals. "We continue to view MM-093 as a novel and highly differentiated therapeutic that could have a significant impact in the treatment of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, uveitis, inflammatory bowel disease and psoriasis, among others."

MM-093, Merrimack's lead product, has completed several clinical trials including a Phase 1 study in healthy volunteers, a pilot study in RA patients and an exploratory, dose-ranging Phase 2 study. These studies have demonstrated that MM-093 is well tolerated and bioactive in addressing the signs and symptoms of RA. The Company is currently conducting an additional Phase 2 study in RA patients as well as a Phase 2 pilot study of MM-093 in patients with autoimmune uveitis. [Note that the psoriasis program is not mentioned in this paragraph.]

Merrimack controls a strong intellectual property estate around MM-093 comprised of 15 patents and a number of pending applications, both in the U.S. and internationally, covering composition of matter, production methods, and therapeutic uses.

Merrimack Pharmaceuticals, Inc. is a biotechnology company focused on the discovery and development of novel treatments for diseases in the areas of autoimmune disease and cancer. Its lead compound, MM-093, is currently in clinical development to treat patients with rheumatoid arthritis, psoriasis or with autoimmune uveitis. MM-093 is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency. The company's proprietary Network Biology discovery platform, developed with the help of leading scientists from MIT and Harvard, enables the high throughput profiling of protein networks as a basis for improved validation, lead identification and speed in the development of innovative, effective and safe therapeutics. Merrimack is a privately-held company based in Cambridge, Massachusetts. For additional information, please visit http://www.merrimackpharma.com.
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