MacroChem Acquires Rights To Pexiganan, A Novel Topical Anti Infective For Treatment Of Diabetic Foot Infections, From Genaera
MacroChem Corporation (OTC Bulletin Board: MACM) announced that it hold exercise the picking it acquire surrounded by July, 2007 to acquire superintendent customary license rights all for remedy use of pexiganan, a innovative, short peptide anti-infective for use of patients near placid diabetic foot infectivity (DFI), from Genaera Corporation.
“We recognize this be a advanced opportunity for MacroChem to amplify its goods portfolio with a product that has already completed two Phase 3 clinical trial and that fits our strategic focus and complement our front product contestant, EcoNail(R) for treatment of staple fungus,” stated Robert J. DeLuccia, President and CEO of MacroChem. “Both drugs would luxury bug of the foot predominantly treat with equal to prescribe professional, namely podiatrists. Both EcoNail and pexiganan be potentially of tang to a larger numeral of physician specialists and earliest perfectionism physician. MacroChem would ultimately be seeking a partner for marketing to those assortment while retain rights to flea market to elected physician specialists.” In clinical trials in earlier times conduct by Genaera, done 1000 human subject be open to pexiganan minus safekeeping attentiveness, with 418 patients who received pexiganan in two Phase 3 clinical trials submit in a New Drug Application to the U.S. Food and Drug Administration (FDA) in 1998. The primary clinical endpoint of one of the two Phase 3 trials be referee by the FDA to have be achieve. The other Phase 3 clinical research, which do not draw together its specified endpoint, afford sturdy supportive movement indicative of the clinical bonus of pexiganan. At that instance, difficulties with Chemistry Manufacturing & Controls (CMC) and an FDA behest for one new controlled trial precluded high opinion. MacroChem believe that since that time, of great vastness improvements have been made in peptide firm system in plop of muscularly as in clinical trial ornamentation and lynching. MacroChem policy to implement a program to address the previously identified CMC issues and initiate again name on top of ceremony dialogue with the FDA to discern the arrogate clinical initiation side of the road.
“We are thrilled to enter into an agreement with MacroChem Corporation for the beneficial rights to pexiganan. This agreement echo a untimely pace in the execution of Genaera’s strategy to repudiate its non-core-assets, including Squalamine and LOMUCIN(TM). We believe pexiganan has significant forthcoming to treat diseased diabetic foot ulcer and that MacroChem is dyed-in-the-wool to the commercialization of this venture,” stated Dr. Henry Wolfe, Executive Vice President and Chief Scientific Officer of Genaera.
Mr. DeLuccia further noted, “We are pleased to have pexiganan in our hand since we believe that, if qualified, it would be philanthropy by physicians and patients for the treatment of diabetic foot infection. In recent years, in that have been several credit in peptide manufacturing, a enhanced liberally of the treatment of diabetic foot infection, improvements in clinical trial design and execution, and more logic in scythe to regulatory requirements for topical anti-infectives, with the potential market someone even more advantageous than former.” He added, “There continue to be a vastly cosmic and budding equilibrium of diabetes and, as a corollary, a growing figure of diabetic foot infection in the U.S. Diabetic foot ulcers in the almost 20 million diabetics in the US alone are a supreme concern and load to both patients and healthcare correspondence. There is also a defect of insistent topical anti-infectives to treat diabetic foot infection. Accordingly, we believe that pexiganan could imbue an huge unmet medical stipulation for a topical anti-infective treatment and provide a significant commercial opportunity in an addressable market of millions of diabetic foot infections annually with a potential inexact pretty billion dollar market.” Benjamin Lipsky, M.D., Professor of Medicine, University of Washington School of Medicine and Chairman of the Infectious Disease Society of America (IDSA) Guidelines Committee on Diabetic Foot Infection, mention, “I quality there is a at verdict need for a topical antimicrobial intricate for treatment of mild diabetic foot infections. Why come across the complete thing to the potential poisonous and microbial-altering effects of systemic psychiatric endow with a hand when the infection is controlled to a temporary cut? With the growing woe of hostilities of germs to antibiotics, latest manner of antimicrobial agents and novel journey of treatment that allow subjugate dose of these agents would be welcomed. There are immediately very few topical antimicrobial compound reachable, none of which has been expressly prove to be effective for diabetic foot infections.” Under the language of the license agreement, MacroChem will wage Genaera an first allowance of $1 million through February 1, 2008. The operate terms also account payments of $7 million to Genaera upon the win through of unquestionable clinical and regulatory milestone through approval, sales-based milestones of adept of $35 million, and 10% sovereigns payments on web sale. In introduction, MacroChem will put forward all clinical development, manufacturing and regulatory goings-on for pexiganan. MacroChem will want additional bequest to fully walk propagate the product.
About Pexiganan Pexiganan is a 22-amino sombre linear peptide. It is formulate as a cream and has a novel gears of action base on its handiness to ruin the integrity of bacterial cell membranes. It has antimicrobial entertainment. resistant Gram favourable (methycillin impermeable staphylococcus aureus (MRSA)) and Gram cynical organisms that universally infect buffalo hide and pulpy tissue. It has a minimal potential for induction of resistance and no cross-resistance with extant therapeutic antibiotics as a consequence of its mechanism of action.
Singer, a professor of pediatrics, psychology and nonspecific medical sciences at Case Western Reserve University who also study prenatal cocaine exposing in children.
Current ballpark figure are that about 7% of all Americans have diabetes, and that high proportion is scheduled to proliferate all year. Among the complications effect by diabetes are foot disorder. It is estimated that watchful to about 25% of people with diabetes will develop a foot spot in their lifetime of which about 60% obtain infected. Diabetic foot ulcers primarily result from the effect of divergent neuropathy, with disadvantage of protecting sensations and foot difference. The enterprise of peripheral vascular disease, increased biomechanical elocution and acute trauma further increase the venture of foot ulcers. It conventionally take several months for an ulcer to restore to health, and during this tenure there is a continual risk of foot infection. Infected foot ulcers can result in clean infection (osteomyelitis) or accommodating gangrene, and are the major split second cause of lower accomplice amputation. Diabetes is now the uttermost cause of non-traumatic leg amputations in the automated world. Furthermore, foot ulcers are now the prevailing repetitive cause of diabetes-related hospitalizations. Thus, diabetic foot ulcers and infection are a major burden to both the forgiving and the healthcare system consequential in long-term disabilities and soaring demands on the healthcare system.
About MacroChem MacroChem Corporation is a specialty pharmaceutical company that develop and hope to commercialize pharmaceutical products. Currently, our portfolio of proprietary product candidate is based on our drug confinement technology: SEPA(R), MacroDerm(TM) and DermaPass(TM). Our lead product candidate is EcoNail(TM), a topically applied SEPA-based econazole lacquer for the treatment of onychomycosis, a disease commonly dedicated as nail fungus. Our other clinical dais product candidate, Opterone(R), is a topically applied SEPA-based testosterone cream designed to treat mannish hypogonadism. In addition to EcoNail and Opterone, our pipeline of early-stage product candidates is based on our SEPA, MacroDerm and DermaPass drug delivery technologies. For more news drop by our website, About Genaera Genaera Corporation is obdurate on advance the science and treatment of metabolic diseases. The Company has significant market opportunity with a first-in-class molecule, trodusquemine (MSI-1436), that has the potential to redefine the treatment paradigm for largeness and type 2 diabetes and is presently in a Phase 1 trial in obesity. In addition, Genaera has a value- driven, fully out-licensed partnership with MedImmune, Inc. for a second essence program to be precise presently go through Phase 2 clinical trialling in asthma.
Forward Looking Statements With the indemnity of historical information contained here grip deliverance, the thing describe herein are forward-looking publication that need risk and uncertainties. MacroChem’s actual grades may be at variance categorically from the results question in the forward-looking statements. Factors that influentially will cause such a variance include, but are not limited to, those discussed or referred to in the piece qualified “Risk Factors” in MacroChem’s Annual Report on Form 10-K, above and beyond as those discussed elsewhere therein, and include, without decrease, risks on the subject of product development, the time and results of clinical trials, the regulatory approval process, funds requirements, fiscal condition, the system allow asylum and reliance on third gathering for development and license measures. Readers are presage not to place undue trust on these forward-looking statements, which utter solely beginning the date hereof.
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