Not at all. I never have cared who owns and who does not. The comparison with Closure only confirms what Arch has accomplished. Closure's pre-tax profitability was huge even with a bloated employee load.
“ARCH Business Model
Our present business model is to operate with a relatively small internal team of key personnel and engage third party service providers to conduct larger scale research, development and manufacturing activities. Our internal team collectively has a broad range of expertise and experience working with and managing third party vendors. This general approach enables us to use the services of third party entities, which are expert in various aspects of our operations, while preserving capital and efficiencies by avoiding certain internal scale-up costs and resource duplication.” END
Closure 2004--- 123 full-time employees, 107 were dedicated to research, development, manufacturing, quality control and regulatory affairs, and 16 were dedicated to administrative activities. Fifteen members of our research, development and regulatory affairs staff have doctoral or advanced degrees (Arch last 6 years 8 employees only—3 with doctoral degrees)
In 1996 Closure completed an 818-patient controlled, randomized clinical trial of DERMABOND at ten sites throughout the United States. (Arch’s human clinical trials have all been small with less than 50 patients at ONE location)
Closure Research & Development Costs 12/31 1996 $ 3.167 million 1997 $ 3.594 million 1998 $ 6.297 million 1999 $6.296 million 2000 $ 5.852 million 2001 $ 5.622 million 2002 $ 6.436 million 2003 $ 8.134 million 2004 $ 10.01 million (Arch highest R&D in last six years is only $2.9 million)
Arch’s AC5 received FDA approval December 17, 2118 allowing for the product to be marketed for external applications.
Arch is adopting multiple selling partner marketing strategy in 2019.
Arch External Applications 1) Diabetic foot ulcers..1 to 1.5 million patients year Annual US Healthcare system cost $11 billion 2) Pressure Ulcers (bedsores) 2.5 million patients year Annual spent on wound care products exceeds $ 15 billion 3) Adhesions 2.5 million patients/year US Form after 70-90% of major absominal surgery & 50-100% of women after pelvic surgery Market growing 15% year Need: Cover, protect, promote moist environment, enable healing Opportunity $ 1 to $2 Billion 4) GI Sealant 2-15% leak rate in anastomoses Significant morbidity and mortality. Significant reoperation rate with added expenses. Opportunity $.5 million to $ 1 Billion and potentially greater 5) Burns 500K patients/year in US Plus many many more
War chest of over 50 patents. Intellectual property is where value is stored. IMHO most of the big R&D is behind us.
This is the person who made it all happen for Arch since 2007--few understand this:
Steven Kates, PhD has worked with Arch Therapeutics since 2007. He is a highly experienced pharmaceutical executive with over twenty years in R&D for both life science products and human therapeutics, Dr. Kates is regarded as a world leading chemist and industry expert in peptide design and manufacture in the biopharmaceutical industry. He has advanced several compounds through drug development from early pre-clinical to early clinical development. He was responsible for the successful development of clinical candidates for both 505(b)2 and NCE applications.
He has held senior positions at Ischemix, Citius Pharmaceuticals, Surface Logix, Consensus and Millipore Corporation.Dr. Kates has authored or co-authored over 100 articles, reviews, and patents, and is a member of the American Chemical Society, the American Peptide Society, and the Association of BioMolecular Research Facilities. Dr. Kates has served as editor of Solid-Phase Synthesis: A Practical Guide and ADMET for Medicinal Chemists: A Practical Guide; guest editor of Biopolymers; co-editor of ADMET for Medicinal Chemists, A Practical Guide; a member of the Editorial Board of International Journal of Peptide Research and Therapeutics (formerly Letters in Peptide Science); and is an ad hoc reviewer for the NIH bio-organic and natural products study section.An Adjunct Professor in the Bouvé College of Health and Sciences, Center for Drug Discovery and College of Professional Studies at Northeastern University, and Visiting Professor of Chemistry at Brandeis University,
Dr. Kates earned his B.S. in chemistry from Bates College and his PhD in Synthetic Organic Chemistry from Brandeis University, and conducted post-doctoral studies at The Massachusetts Institute of Technology. His research interests include solid-phase peptide and organic synthesis as well as synthesis of peptides and small molecules with therapeutic activities for stroke, coronary artery bypass graft (CABG), myocardial infarction (MI) and inhibitors and substrates for kinases, proteases and G-protein coupled receptors.
