To mark its 10th anniversary, Drug Discovery & Development magazine invited pharmaceutical and biotechnology companies to reflect on the history and made predictions about future of the industry. Featured here are verbatim comments from this company.
PolyMedix, Inc.
Headquarters
Radnor, Pa.
Years in Drug Research
6 years
Spokesperson
Nicholas Landekic, President & CEO
Web site
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Small Molecule |
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Biological |
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Disease Research |
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Pre-clinical Studies |
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Target Identification |
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IND Submission |
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Target Validation |
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Drug Sample Manufacturing |
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Lead Identification |
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Clinical Trials |
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Early Safety Tests |
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NDA Submission |
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Lead Optimization |
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Post-marketing Studies |
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Drug Delivery |
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About the company/organization
PolyMedix is focused on developing novel, first-in-class therapeutic drugs for serious, life-threatening acute disorders. Our therapeutic focus is infectious diseases and cardiovascular thrombosis disorders. To treat these diseases we develop biomimetics - novel small molecule drugs which mimic the activity of proteins. We have created our entire product pipeline ourselves using a proprietary computational technology platform. The first two products are a novel antibiotic drug and a unique heparin antagonist, both in Phase I clinical development. PMX-30063 antibiotic is the first and only small molecule defensin mimetic, a unique mechanism of action which makes bacterial resistance unlikely to develop. PMX-60056 heptagonist is the first and only heparin and LMWH antagonist in development. Both of these drugs are first in class and only in class.
A 10-year perspective: Advances and roadblocks
PolyMedix was started 6 years ago. In that short time, and with only 14 employees at present, we have discovered two new drugs starting from scratch. Both of these drugs have novel mechanisms of action, are the first and only ones of their kind, and have blockbuster commercial potential. We have succeeded more quickly and on far less money than big pharma efforts in these areas because of our proprietary computational drug design technology, originally developed at and exclusively licensed form the University of Pennsylvania. In both programs we have been able to go from program initiation to drug in the clinic for less than $17 million per drug.
R&D Challenges in the next 10 years
Continued access to capital to advance the product pipeline. Most investors for the past several years have been very short term focused, and very conservative and risk-adverse. There is little interest in the capital markets for investing in true drug discovery of novel products.
Business/regulatory challenges for the next 10 years
The continued evolution of both regulatory standards for approval, and third party payer requirements for reimbursement and formulary listing. Medicine continues to evolve drug standards from “approvable”, to “clinically meaningful” and “cost effective”. It will no longer be enough to show that a drug is ‘safe and effective’. Regulatory standards are increasingly moving to demonstrate ‘clinically meaningful’ in terms of drug effect, which often means showing superiority over standard of care. Likewise, third party payers are increasing their requirements for demonstrating ‘cost effectiveness’ for new drugs, generally hard-dollar cost savings or cost avoidance, not simply soft-dollar quality of life. The standards for proving ‘clinically meaningful’ or ‘cost effective’ and unclear, and thus difficult to quantify.
Bold Prediction: Where will the company/organization be in 10 years?
Ideally, we will be selling our own acute care drugs for infectious diseases and cardiovascular disorders in the North American hospital market. However, it is probably more likely that, given the dry pipelines across the big pharma companies, PolyMedix will be acquired and its products absorbed into a larger organization.
Bold Prediction: Where will the industry will be in 10 years?
In a word, smaller. The combination of looming patent expirations over the next few years on half of the pharmaceutical products sold, with dry pipelines across the major pharma companies, with investor reluctance to finance drug discovery, with weak general economic conditions which result in reluctance to pay for expensive new therapies, will all likely result in a contraction of the pharmaceutical industry.