AMSTERDAM, October 29 Amsterdam MolecularTherapeutics (AMT) and Progenika Biopharma announced today that the companieshave entered into a development and commercialization agreement forLPLchip(TM), a diagnostic tool to rapidly diagnose patients with complete andpartial lipoprotein lipase deficiency (LPLD). AMT has developed Glybera(R) asa gene therapy for patients with this disease.
In June of this year AMT announced new clinical data showing that aone-time administration of its lead product Glybera(R) results in significantlong-term health benefits for LPLD patients. Long-term follow-up data fromtwo clinical trials with complete LPLD patients show that Glybera(R) therapyresults in a significant and clinically important reduction in acutepancreatitis, the most debilitating complication of the disease. The dataalso confirm that the therapy is well-tolerated and safe. AMT intends to fileGlybera(R) for marketing approval with EMEA by the end of this year.
LPLchip(TM) based on the Progenika's DNA-chip technology, will be used torapidly diagnose patients with complete and partial LPLD and will beimportant to effectively identify patients that could benefit from Glybera(R).
AMT has selected Progenika as a partner for the development ofLPLchip(TM) because of the company's long-standing expertise in thedevelopment of diagnostic chips and its access to both European and NorthAmerican markets. Jorn Aldag, CEO of AMT commented: "We are delighted to workwith Progenika on the development of the LPLchip(TM), as the company brings aunique expertise that fits the diagnostic needs for LPLD. LPLchip(TM) will bean important tool in early patient diagnosis, enabling us to make Glybera(R)available to the right patients as quickly as possible." Antonio Martinez,CEO of Progenika Biopharma said: "This collaborative project demonstrates howDNA-based diagnostics and highly targeted gene therapy can be combined tobring personalized medicine to patient groups whose medical needs werepreviously unmet."
PROGENIKA, a pioneering company in the emerging field of personalisedmedicine, is dedicated to the design, development and manufacture of novelDNA genotyping microarrays for the diagnosis, prognosis and drug-responseprediction of complex human diseases. The company's comprehensive facilitiesfor microarray design and manufacture are supported by an expert team ofbioinformaticians who develop multivariate algorithms and software packagesthat allow user-friendly interpretation of clinical results. PROGENIKA hasdeveloped and clinically validated LIPOchip, a microarray for the diagnosisof Familial Hypercholesterolemia that was marketed in 2004, as the firstCE-marked DNA microarray for routine clinical diagnosis. PHARMAchip, a DrugMetabolism genotyping microarray and BLOODchip, a Blood Group genotypingmicroarray were launched in 2007. A series of new diagnostic microarrays areunder development or in late-stage clinical validation: fibromyalgia,inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis,osteoarthritis, etc.
About Amsterdam Molecular Therapeutics
AMT has a unique gene therapy platform that to date appears to circumventmany if not all of the obstacles that have prevented gene therapy frombecoming a mainstay of clinical medicine. Using adeno-associated viral (AAV)vectors as the delivery vehicle of choice for therapeutic genes, the companyhas been able to design and validate what is probably the first stable andscalable AAV production platform. As such, AMT's proprietary platform holdstremendous promise for thousands of rare (orphan) diseases, especially thosethat are caused by one faulty gene. Currently, AMT has a product pipelinewith nine products at different stages of development.
Certain statements in this press release are "forward-looking statements"including those that refer to management's plans and expectations for futureoperations, prospects and financial condition. Words such as "strategy,""expects," "plans," "anticipates," "believes," "will," "continues,""estimates," "intends," "projects," "goals," "targets" and other words ofsimilar meaning are intended to identify such forward-looking statements.Such statements are based on the current expectations of the management ofAmsterdam Molecular Therapeutics only. Undue reliance should not be placed onthese statements because, by their nature, they are subject to known andunknown risks and can be affected by factors that are beyond the control ofAMT. Actual results could differ materially from current expectations due toa number of factors and uncertainties affecting AMT's business, including,but not limited to, the timely commencement and success of AMT's clinicaltrials and research endeavors, delays in receiving U.S. Food and DrugAdministration or other regulatory approvals (i.e. EMEA, Health Canada),market acceptance of AMT's products, effectiveness of AMT's marketing andsales efforts, development of competing therapies and/or technologies, theterms of any future strategic alliances, the need for additional capital, theinability to obtain, or meet, conditions imposed for required governmentaland regulatory approvals and consents. AMT expressly disclaims any intent orobligation to update these forward-looking statements except as required bylaw. For a more detailed description of the risk factors and uncertaintiesaffecting AMT, refer to the prospectus of AMT's initial public offering onJune 20, 2007, and AMT's public announcements made from time to time.
SOURCE Amsterdam Molecular Therapeutics B.V