Magazin
2007-10-03
Wellesley Hills, Massachusetts (ots/PRNewswire) -
- Broadens late-stage product development portfolio building onlead product candidate EcoNail in Phase 2 trial for onychomycosis
MacroChem Corporation (OTC Bulletin Board: MACM) today announcedthat it has exercised the option it acquired in July, 2007 to acquireexclusive worldwide license rights for drug uses of pexiganan, anovel, small peptide anti-infective for treatment of patients withmild diabetic foot infection (DFI), from Genaera Corporation.
"We believe this is a unique opportunity for MacroChem to broadenits product portfolio with a product that has already completed twoPhase 3 clinical trials and that fits our strategic focus andcomplements our lead product candidate, EcoNail(R) for treatment ofnail fungus," stated Robert J. DeLuccia, President and CEO ofMacroChem. "Both drugs would treat diseases of the foot predominantlytreated by the same prescribing specialists, namely podiatrists. BothEcoNail and pexiganan are potentially of interest to a larger numberof physician specialists and primary care physicians. MacroChem wouldultimately be seeking a partner for marketing to those groups whileretaining rights to market to selected physician specialists."
In clinical trials previously conducted by Genaera, over 1000human subjects were exposed to pexiganan without safety concerns,including 418 patients who received pexiganan in two Phase 3 clinicaltrials submitted in a New Drug Application to the U.S. Food and DrugAdministration (FDA) in 1998. The primary clinical endpoint of one ofthe two Phase 3 trials was judged by the FDA to have been achieved.The other Phase 3 clinical trial, which did not meet its specifiedendpoint, provided strong supportive data indicative of the clinicalbenefit of pexiganan. At that time, difficulties with ChemistryManufacturing & Controls (CMC) and an FDA request for one additionalcontrolled trial precluded approval. MacroChem believes that sincethat time, significant improvements have been made in peptidemanufacturing processes as well as in clinical trial design andexecution. MacroChem plans to implement a program to address thepreviously identified CMC issues and resume formal dialogue with theFDA to determine the appropriate clinical development path.
"We are pleased to enter into an agreement with MacroChemCorporation for the therapeutic rights to pexiganan. This agreementreflects a first step in the execution of Genaera's strategy todivest its non-core-assets, including Squalamine and LOMUCIN(TM). Webelieve pexiganan has significant potential to treat infecteddiabetic foot ulcers and that MacroChem is dedicated to thecommercialization of this asset," stated Dr. Henry Wolfe, ExecutiveVice President and Chief Scientific Officer of Genaera.
Mr. DeLuccia further noted, "We are pleased to have pexiganan inour hands since we believe that, if approved, it would be welcomed byphysicians and patients for the treatment of diabetic foot infection.In recent years, there have been many advances in peptidemanufacturing, a better understanding of the treatment of diabeticfoot infection, improvements in clinical trial design and execution,and more clarity concerning regulatory requirements for topicalanti-infectives, with the potential market being even more attractivethan before."
He added, "There continues to be a very large and growingincidence of diabetes and, as a result, a growing number of diabeticfoot infections in the U.S. Diabetic foot ulcers in the approximately20 million diabetics in the US alone are a major concern and burdento both patients and healthcare system. There is also a lack ofeffective topical anti-infectives to treat diabetic foot infection.Accordingly, we believe that pexiganan could fill an important unmetmedical need for a topical anti-infective treatment and provide asignificant commercial opportunity in an addressable market ofmillions of diabetic foot infections annually with a potentialestimated half billion dollar market."
Benjamin Lipsky, M.D., Professor of Medicine, University ofWashington School of Medicine and Chairman of the Infectious DiseaseSociety of America (IDSA) Guidelines Committee on Diabetic FootInfection, commented, "I think there is a clear need for a topicalantimicrobial compound for treatment of mild diabetic footinfections. Why expose the entire body to the potential toxic andmicrobial-altering effects of systemic therapy when the infection islimited to a superficial wound? With the growing problem ofresistance of microorganisms to antibiotics, new types ofantimicrobial agents and novel routes of treatment that allow lowerdoses of these agents would be welcomed. There are currently very fewtopical antimicrobial compounds available, none of which has beenspecifically proved to be effective for diabetic foot infections."
Under the terms of the license agreement, MacroChem will payGenaera an initial fee of US$1 million through February 1, 2008. Thedeal terms also include payments of US$7 million to Genaera upon theachievement of certain clinical and regulatory milestones throughapproval, sales-based milestones of up to US$35 million, and 10%royalty payments on net sales. In addition, MacroChem will assume allclinical development, manufacturing and regulatory activities forpexiganan. MacroChem will require additional funding to fully developthe product.
About Pexiganan
Pexiganan is a 22-amino acid linear peptide. It is formulated as acream and has a novel mechanism of action based on its ability todisrupt the integrity of bacterial cell membranes. It hasantimicrobial activity against Gram positive (methycillin resistantstaphylococcus aureus (MRSA)) and Gram negative organisms thatcommonly infect skin and soft tissue. It has a low potential forinduction of resistance and no cross-resistance with existingtherapeutic antibiotics as a consequence of its mechanism of action.
About Diabetes and Diabetic Foot Infection
According to the U.S. Centers for Disease Control and Prevention(CDC), there are about 20.8 million people with diabetes in the U.S.(in 2005). Current estimates are that about 7% of all Americans havediabetes, and that prevalence is expected to increase each year.Among the complications caused by diabetes are foot disorders. It isestimated that up to about 25% of persons with diabetes will developa foot ulcer in their lifetime of which about 60% get infected.Diabetic foot ulcers generally result from the consequences ofperipheral neuropathy, with loss of protective sensations and footdeformities. The presence of peripheral vascular disease, increasedbiomechanical stress and acute trauma further increase the risk offoot ulcers. It usually takes several months for an ulcer to heal,and during this period there is a continual risk of foot infection.Infected foot ulcers can result in bone infection (osteomyelitis) orprogressive gangrene, and are the major immediate cause of lower limbamputation. Diabetes is now the top cause of non-traumatic legamputations in the developed world. Furthermore, foot ulcers are nowthe most frequent cause of diabetes-related hospitalizations. Thus,diabetic foot ulcers and infection are a major burden to both thepatient and the healthcare system resulting in long-term disabilitiesand high demands on the healthcare system.
About MacroChem
MacroChem Corporation is a specialty pharmaceutical company thatdevelops and seeks to commercialize pharmaceutical products.Currently, our portfolio of proprietary product candidates is basedon our drug delivery technologies: SEPA(R), MacroDerm(TM) andDermaPass(TM). Our lead product candidate is EcoNail(TM), a topicallyapplied SEPA-based econazole lacquer for the treatment ofonychomycosis, a condition commonly known as nail fungus. Our otherclinical stage product candidate, Opterone(R), is a topically appliedSEPA-based testosterone cream designed to treat male hypogonadism. Inaddition to EcoNail and Opterone, our pipeline of early-stage productcandidates is based on our SEPA, MacroDerm and DermaPass drugdelivery technologies. For more information visit our website,http://www.macrochem.com.
About Genaera
Genaera Corporation is focused on advancing the science andtreatment of metabolic diseases. The Company has significant marketopportunities with a first-in-class molecule, trodusquemine(MSI-1436), that has the potential to redefine the treatment paradigmfor obesity and type 2 diabetes and is presently in a Phase 1 trialin obesity. In addition, Genaera has a value-driven, fullyout-licensed partnership with MedImmune, Inc. for a second coreprogram that is presently undergoing Phase 2 clinical testing inasthma. http://www.genaera.com.
Forward-Looking Statements
With the exception of historical information contained in thispress release, the matters described herein are forward-lookingstatements that involve risks and uncertainties. MacroChem's actualresults may differ significantly from the results discussed in theforward-looking statements. Factors that might cause such adifference include, but are not limited to, those discussed orreferred to in the section entitled "Risk Factors" in MacroChem'sAnnual Report on Form 10-K, as well as those discussed elsewheretherein, and include, without limitation, risks regarding productdevelopment, the timing and results of clinical trials, theregulatory approval process, capital requirements, financialcondition, patent protection and dependence on third parties fordevelopment and licensing arrangements. Readers are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of the date hereof. MacroChem undertakes no obligation toupdate publicly any forward-looking statements, whether as a resultof new information, future events or otherwise. For more informationvisit our website, http://www.macrochem.com.
Contact: MacroChem Corp.: Bernard Patriacca - VP/CFO bpatriacca@macrochem.com +1-781-489-7310 Investor Relations: The Investor Relations Group, Inc. Christine Berni/ Joseph Triunfo, +1-212-825-3210 cberni@investorrelationsgroup.com jtriunfo@investorrelationsgroup.com Media: Bill Douglass/ Michaela Heller, +1-212-825-3210 bdouglass@investorrelationsgroup.com mheller@investorrelationsgroup.com Web site: http://www.macrochem.com http://www.genaera.com
ots Originaltext: MacroChem CorporationIm Internet recherchierbar: http://www.presseportal.de
Contact:Bernard Patriacca - VP, CFO of MacroChem Corp., +1-781-489-7310, bpatriacca@macrochem.com; or Investor Relations, Christine Berni, cberni@investorrelationsgroup.com, or Joseph Triunfo, jtriunfo@investorrelationsgroup.com, or Media, Bill Douglass, bdouglass@investorrelationsgroup.com, or Michaela Heller, mheller@investorrelationsgroup.com, all of The Investor Relations Group, Inc., +1-212-825-3210
MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
- Broadens late-stage product development portfolio building onlead product candidate EcoNail in Phase 2 trial for onychomycosis
MacroChem Corporation (OTC Bulletin Board: MACM) today announcedthat it has exercised the option it acquired in July, 2007 to acquireexclusive worldwide license rights for drug uses of pexiganan, anovel, small peptide anti-infective for treatment of patients withmild diabetic foot infection (DFI), from Genaera Corporation.
"We believe this is a unique opportunity for MacroChem to broadenits product portfolio with a product that has already completed twoPhase 3 clinical trials and that fits our strategic focus andcomplements our lead product candidate, EcoNail(R) for treatment ofnail fungus," stated Robert J. DeLuccia, President and CEO ofMacroChem. "Both drugs would treat diseases of the foot predominantlytreated by the same prescribing specialists, namely podiatrists. BothEcoNail and pexiganan are potentially of interest to a larger numberof physician specialists and primary care physicians. MacroChem wouldultimately be seeking a partner for marketing to those groups whileretaining rights to market to selected physician specialists."
In clinical trials previously conducted by Genaera, over 1000human subjects were exposed to pexiganan without safety concerns,including 418 patients who received pexiganan in two Phase 3 clinicaltrials submitted in a New Drug Application to the U.S. Food and DrugAdministration (FDA) in 1998. The primary clinical endpoint of one ofthe two Phase 3 trials was judged by the FDA to have been achieved.The other Phase 3 clinical trial, which did not meet its specifiedendpoint, provided strong supportive data indicative of the clinicalbenefit of pexiganan. At that time, difficulties with ChemistryManufacturing & Controls (CMC) and an FDA request for one additionalcontrolled trial precluded approval. MacroChem believes that sincethat time, significant improvements have been made in peptidemanufacturing processes as well as in clinical trial design andexecution. MacroChem plans to implement a program to address thepreviously identified CMC issues and resume formal dialogue with theFDA to determine the appropriate clinical development path.
"We are pleased to enter into an agreement with MacroChemCorporation for the therapeutic rights to pexiganan. This agreementreflects a first step in the execution of Genaera's strategy todivest its non-core-assets, including Squalamine and LOMUCIN(TM). Webelieve pexiganan has significant potential to treat infecteddiabetic foot ulcers and that MacroChem is dedicated to thecommercialization of this asset," stated Dr. Henry Wolfe, ExecutiveVice President and Chief Scientific Officer of Genaera.
Mr. DeLuccia further noted, "We are pleased to have pexiganan inour hands since we believe that, if approved, it would be welcomed byphysicians and patients for the treatment of diabetic foot infection.In recent years, there have been many advances in peptidemanufacturing, a better understanding of the treatment of diabeticfoot infection, improvements in clinical trial design and execution,and more clarity concerning regulatory requirements for topicalanti-infectives, with the potential market being even more attractivethan before."
He added, "There continues to be a very large and growingincidence of diabetes and, as a result, a growing number of diabeticfoot infections in the U.S. Diabetic foot ulcers in the approximately20 million diabetics in the US alone are a major concern and burdento both patients and healthcare system. There is also a lack ofeffective topical anti-infectives to treat diabetic foot infection.Accordingly, we believe that pexiganan could fill an important unmetmedical need for a topical anti-infective treatment and provide asignificant commercial opportunity in an addressable market ofmillions of diabetic foot infections annually with a potentialestimated half billion dollar market."
Benjamin Lipsky, M.D., Professor of Medicine, University ofWashington School of Medicine and Chairman of the Infectious DiseaseSociety of America (IDSA) Guidelines Committee on Diabetic FootInfection, commented, "I think there is a clear need for a topicalantimicrobial compound for treatment of mild diabetic footinfections. Why expose the entire body to the potential toxic andmicrobial-altering effects of systemic therapy when the infection islimited to a superficial wound? With the growing problem ofresistance of microorganisms to antibiotics, new types ofantimicrobial agents and novel routes of treatment that allow lowerdoses of these agents would be welcomed. There are currently very fewtopical antimicrobial compounds available, none of which has beenspecifically proved to be effective for diabetic foot infections."
Under the terms of the license agreement, MacroChem will payGenaera an initial fee of US$1 million through February 1, 2008. Thedeal terms also include payments of US$7 million to Genaera upon theachievement of certain clinical and regulatory milestones throughapproval, sales-based milestones of up to US$35 million, and 10%royalty payments on net sales. In addition, MacroChem will assume allclinical development, manufacturing and regulatory activities forpexiganan. MacroChem will require additional funding to fully developthe product.
About Pexiganan
Pexiganan is a 22-amino acid linear peptide. It is formulated as acream and has a novel mechanism of action based on its ability todisrupt the integrity of bacterial cell membranes. It hasantimicrobial activity against Gram positive (methycillin resistantstaphylococcus aureus (MRSA)) and Gram negative organisms thatcommonly infect skin and soft tissue. It has a low potential forinduction of resistance and no cross-resistance with existingtherapeutic antibiotics as a consequence of its mechanism of action.
About Diabetes and Diabetic Foot Infection
According to the U.S. Centers for Disease Control and Prevention(CDC), there are about 20.8 million people with diabetes in the U.S.(in 2005). Current estimates are that about 7% of all Americans havediabetes, and that prevalence is expected to increase each year.Among the complications caused by diabetes are foot disorders. It isestimated that up to about 25% of persons with diabetes will developa foot ulcer in their lifetime of which about 60% get infected.Diabetic foot ulcers generally result from the consequences ofperipheral neuropathy, with loss of protective sensations and footdeformities. The presence of peripheral vascular disease, increasedbiomechanical stress and acute trauma further increase the risk offoot ulcers. It usually takes several months for an ulcer to heal,and during this period there is a continual risk of foot infection.Infected foot ulcers can result in bone infection (osteomyelitis) orprogressive gangrene, and are the major immediate cause of lower limbamputation. Diabetes is now the top cause of non-traumatic legamputations in the developed world. Furthermore, foot ulcers are nowthe most frequent cause of diabetes-related hospitalizations. Thus,diabetic foot ulcers and infection are a major burden to both thepatient and the healthcare system resulting in long-term disabilitiesand high demands on the healthcare system.
About MacroChem
MacroChem Corporation is a specialty pharmaceutical company thatdevelops and seeks to commercialize pharmaceutical products.Currently, our portfolio of proprietary product candidates is basedon our drug delivery technologies: SEPA(R), MacroDerm(TM) andDermaPass(TM). Our lead product candidate is EcoNail(TM), a topicallyapplied SEPA-based econazole lacquer for the treatment ofonychomycosis, a condition commonly known as nail fungus. Our otherclinical stage product candidate, Opterone(R), is a topically appliedSEPA-based testosterone cream designed to treat male hypogonadism. Inaddition to EcoNail and Opterone, our pipeline of early-stage productcandidates is based on our SEPA, MacroDerm and DermaPass drugdelivery technologies. For more information visit our website,http://www.macrochem.com.
About Genaera
Genaera Corporation is focused on advancing the science andtreatment of metabolic diseases. The Company has significant marketopportunities with a first-in-class molecule, trodusquemine(MSI-1436), that has the potential to redefine the treatment paradigmfor obesity and type 2 diabetes and is presently in a Phase 1 trialin obesity. In addition, Genaera has a value-driven, fullyout-licensed partnership with MedImmune, Inc. for a second coreprogram that is presently undergoing Phase 2 clinical testing inasthma. http://www.genaera.com.
Forward-Looking Statements
With the exception of historical information contained in thispress release, the matters described herein are forward-lookingstatements that involve risks and uncertainties. MacroChem's actualresults may differ significantly from the results discussed in theforward-looking statements. Factors that might cause such adifference include, but are not limited to, those discussed orreferred to in the section entitled "Risk Factors" in MacroChem'sAnnual Report on Form 10-K, as well as those discussed elsewheretherein, and include, without limitation, risks regarding productdevelopment, the timing and results of clinical trials, theregulatory approval process, capital requirements, financialcondition, patent protection and dependence on third parties fordevelopment and licensing arrangements. Readers are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of the date hereof. MacroChem undertakes no obligation toupdate publicly any forward-looking statements, whether as a resultof new information, future events or otherwise. For more informationvisit our website, http://www.macrochem.com.
Contact: MacroChem Corp.: Bernard Patriacca - VP/CFO bpatriacca@macrochem.com +1-781-489-7310 Investor Relations: The Investor Relations Group, Inc. Christine Berni/ Joseph Triunfo, +1-212-825-3210 cberni@investorrelationsgroup.com jtriunfo@investorrelationsgroup.com Media: Bill Douglass/ Michaela Heller, +1-212-825-3210 bdouglass@investorrelationsgroup.com mheller@investorrelationsgroup.com Web site: http://www.macrochem.com http://www.genaera.com
ots Originaltext: MacroChem CorporationIm Internet recherchierbar: http://www.presseportal.de
Contact:Bernard Patriacca - VP, CFO of MacroChem Corp., +1-781-489-7310, bpatriacca@macrochem.com; or Investor Relations, Christine Berni, cberni@investorrelationsgroup.com, or Joseph Triunfo, jtriunfo@investorrelationsgroup.com, or Media, Bill Douglass, bdouglass@investorrelationsgroup.com, or Michaela Heller, mheller@investorrelationsgroup.com, all of The Investor Relations Group, Inc., +1-212-825-3210
MacroChem Corporation
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