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Pharming announces positive results from Prodarsan(R) Phase I Study
LEIDEN, NETHERLANDS -- (Marketwire) -- 11/26/08 --
Key step in clinical program for ageing diseases
Leiden, The Netherlands, November 26, 2008. Biotech company PharmingGroup NV ("Pharming") (NYSE Euronext: PHARM) announced today that itswholly owned subsidiary DNage has successfully completed a Phase Itrial, in healthy human volunteers, to evaluate the pharmacokineticsand tolerability of Prodarsan®.
In this Phase I study, single and multiple escalating doses wereadministered to healthy volunteers. The data obtained show thatProdarsan® is safe and well tolerated when used in dosages that haveearlier shown to yield positive effects in preclinical studies. SinceProdarsan® will be used as an oral, liquid formulation the effects offood intake on absorption and elimination of the product were alsoinvestigated. Based on these data, combined with data generated inthe preclinical program, an oral dosing scheme has been establishedthat will be used in clinical studies with patients suffering fromCockayne Syndrome.
Cockayne Syndrome, the initial target of Prodarsan®, is a raregenetic disease in which children suffer from accelerated (orpremature) ageing, while developing severe ageing diseases. Prematureageing is a group of genetic diseases which manifests in severalforms that are genetically and clinically similar although notidentical. Dependent on the specific form of the disease, patientshave a significantly reduced life expectancy and exhibit manyageing-related diseases early on in their lives. Quality of life forthese patients is seriously impaired. Cockayne Syndrome is one of themore common forms of premature ageing and is characterized, amongstothers, by growth failure, mental retardation, eye abnormalities anda reduced life expectancy. Currently, no effective therapy forCockayne Syndrome is available. Pharming has demonstrated thatProdarsan® has significant beneficial effects in animal models forCockayne Syndrome.
Dr. Rein Strijker, General Manager of DNage and member of the Boardof Management of Pharming, commented: "Prodarsan®, as the firstproduct being developed with DNage technology, is testimony to thegreat potential of this approach in treating diseases related toageing in humans. The data announced today, combined with thepositive effects of Prodarsan® in preclinical testing, are promisingfor further development of this program. In consultation with theregulatory authorities, we are determining the next steps to be takenfor clinical development program for Prodarsan®. We look forward tobegin testing the product in patients suffering from premature ageingin the near future. We will also apply the same principles to starttests with various other product candidates for the treatment ofageing diseases in the elderly population. The medical need for newproducts in the field of premature ageing, but also in more commonageing diseases such as neurodegeneration (for instance dementia), ishuge. We believe that the DNage technology can contribute toinnovative new approaches in this area."
Prodarsan® is a defined combination of small molecules which is beingdeveloped to delay the progression of age-related diseases.Prodarsan® is thought to act by reducing DNA-damage accumulationwhich has been established as an important element in ageing and thedevelopment of ageing related pathology. For instance, patients thatsuffer from premature ageing usually have a genetic defect thatresults in insufficient DNA-repair. DNage has previously also shownthat defective DNA-repair in animals leads to the development ofageing related diseases such as osteoporosis and neurodegeneration.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatmentof genetic disorders, ageing diseases, specialty products forsurgical indications, intermediates for various applications andnutritional products. Pharming has two products in late stagedevelopment - Rhucin® for Hereditary Angioedema and human lactoferrinfor use in food products. The advanced technologies of the Companyinclude innovative platforms for the production of proteintherapeutics, technology and processes for the purification andformulation of these products, as well as technology in the field ofDNA repair (via DNage). Additional information is available on thePharming website, http://www.pharming.com.
This press release contains forward looking statements that involveknown and unknown risks, uncertainties and other factors, which maycause the actual results, performance or achievements of the Companyto be materially different from the results, performance orachievements expressed or implied by these forward lookingstatements.
Contact:Carina Hamaker, Investor Voice, T: +31 (0)6 537 499 59 orT: +31 (0)71 52 47 400Julia Phillips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 orT: +44 (0)7770 827 263Samir Singh (US), Pharming Group NV, T: +1 908 720 6224Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
This announcement was originally distributed by Hugin. The issuer issolely responsible for the content of this announcement.
Copyright © Hugin AS 2008. All rights reserved.
Leiden, The Netherlands, November 26, 2008. Biotech company PharmingGroup NV ("Pharming") (NYSE Euronext: PHARM) announced today that itswholly owned subsidiary DNage has successfully completed a Phase Itrial, in healthy human volunteers, to evaluate the pharmacokineticsand tolerability of Prodarsan®.
In this Phase I study, single and multiple escalating doses wereadministered to healthy volunteers. The data obtained show thatProdarsan® is safe and well tolerated when used in dosages that haveearlier shown to yield positive effects in preclinical studies. SinceProdarsan® will be used as an oral, liquid formulation the effects offood intake on absorption and elimination of the product were alsoinvestigated. Based on these data, combined with data generated inthe preclinical program, an oral dosing scheme has been establishedthat will be used in clinical studies with patients suffering fromCockayne Syndrome.
Cockayne Syndrome, the initial target of Prodarsan®, is a raregenetic disease in which children suffer from accelerated (orpremature) ageing, while developing severe ageing diseases. Prematureageing is a group of genetic diseases which manifests in severalforms that are genetically and clinically similar although notidentical. Dependent on the specific form of the disease, patientshave a significantly reduced life expectancy and exhibit manyageing-related diseases early on in their lives. Quality of life forthese patients is seriously impaired. Cockayne Syndrome is one of themore common forms of premature ageing and is characterized, amongstothers, by growth failure, mental retardation, eye abnormalities anda reduced life expectancy. Currently, no effective therapy forCockayne Syndrome is available. Pharming has demonstrated thatProdarsan® has significant beneficial effects in animal models forCockayne Syndrome.
Dr. Rein Strijker, General Manager of DNage and member of the Boardof Management of Pharming, commented: "Prodarsan®, as the firstproduct being developed with DNage technology, is testimony to thegreat potential of this approach in treating diseases related toageing in humans. The data announced today, combined with thepositive effects of Prodarsan® in preclinical testing, are promisingfor further development of this program. In consultation with theregulatory authorities, we are determining the next steps to be takenfor clinical development program for Prodarsan®. We look forward tobegin testing the product in patients suffering from premature ageingin the near future. We will also apply the same principles to starttests with various other product candidates for the treatment ofageing diseases in the elderly population. The medical need for newproducts in the field of premature ageing, but also in more commonageing diseases such as neurodegeneration (for instance dementia), ishuge. We believe that the DNage technology can contribute toinnovative new approaches in this area."
Prodarsan® is a defined combination of small molecules which is beingdeveloped to delay the progression of age-related diseases.Prodarsan® is thought to act by reducing DNA-damage accumulationwhich has been established as an important element in ageing and thedevelopment of ageing related pathology. For instance, patients thatsuffer from premature ageing usually have a genetic defect thatresults in insufficient DNA-repair. DNage has previously also shownthat defective DNA-repair in animals leads to the development ofageing related diseases such as osteoporosis and neurodegeneration.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatmentof genetic disorders, ageing diseases, specialty products forsurgical indications, intermediates for various applications andnutritional products. Pharming has two products in late stagedevelopment - Rhucin® for Hereditary Angioedema and human lactoferrinfor use in food products. The advanced technologies of the Companyinclude innovative platforms for the production of proteintherapeutics, technology and processes for the purification andformulation of these products, as well as technology in the field ofDNA repair (via DNage). Additional information is available on thePharming website, http://www.pharming.com.
This press release contains forward looking statements that involveknown and unknown risks, uncertainties and other factors, which maycause the actual results, performance or achievements of the Companyto be materially different from the results, performance orachievements expressed or implied by these forward lookingstatements.
Contact:Carina Hamaker, Investor Voice, T: +31 (0)6 537 499 59 orT: +31 (0)71 52 47 400Julia Phillips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 orT: +44 (0)7770 827 263Samir Singh (US), Pharming Group NV, T: +1 908 720 6224Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
This announcement was originally distributed by Hugin. The issuer issolely responsible for the content of this announcement.
Copyright © Hugin AS 2008. All rights reserved.
For more information, go to www.marketwire.com
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