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.
Alkermes, Inc.
Headquarters
Cambridge, Mass.
Location(s)
Cambridge, Mass. (headquarters and R&D) and Wilmington, Ohio (manufacturing)
Years in Drug Research
21 years
Spokesperson
Richard F. Pops, Chairman
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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Other |
About The company/organization
Alkermes is a biotechnology company committed to developing innovative medicines to improve patients' lives. We have developed our products based on our industry leading drug delivery and formulation technologies, in collaboration with some of the world’s leading pharmaceutical companies as well as on our own. Today, we manufacture Risperdal Consta for our partner Johnson & Johnson who markets it around the world for the treatment of schizophrenia, and we manufacture and share in the marketing of Vivitrol, which is indicated for the treatment of alcohol dependence. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has facilities in Massachusetts and Ohio.
A 10-year perspective: Advances and roadblocks
10 years ago, Alkermes was in the process of completing acquisitions to obtain key technologies that would create the technology platforms for the future. In 1996, the company acquired Medisorb, which has become Alkermes’ flagship technology for long-acting injectable drugs. In 1999, the company acquired Advanced Inhalation Research (AIR), which has become Alkermes’ technology for inhaled drug products.
In essence, these strategic acquisitions served to transform Alkermes from its original concept as a biotech discovering new ways for drugs to cross the blood-brain barrier to a company using advanced technologies to develop CNS and other innovative medications. The primary limitation of Alkermes’ original focus was that it did not have sufficient breadth to be the basis for building a large, multi-product biotech company. Alkermes leveraged its strong business position and acquired valuable technology platforms that enabled us to build what we are today--a profitable, substantial biotech company with multiple major products and a deep pipeline.
R&D Challenges in the next 10 years
At Alkermes, our biggest challenge and opportunity over the next 10 years is to bring forward the second wave of products from our R&D pipeline. Our first wave of products is at or near the commercial stage, with three drug compounds addressing major opportunities: Risperdal Consta, for the treatment of schizophrenia and other mental illnesses, Vivitrol, for the treatment of addiction, and once weekly exenatide, for the treatment of type 2 diabetes. With the successful completion of this first wave of product development, we have validated our technology platforms and distinguished ourselves as a significant player in the development of innovative new products. So now we are advancing a pipeline of earlier-stage product candidates that have been incubating for some time and leverage our technologies and expertise in important disease areas. We are focused on identifying product candidates that we have determined to have high probabilities of technical and clinical success along with valuable benefits for patients.
Business/regulatory challenges for the next 10 years
From a business standpoint, the next 10 years will be entirely different because Alkermes is now a profitable, financially strong company. In an industry characterized by an ongoing need for capital to fuel innovation, Alkermes is in an elite group of companies able to fund its own future. This is a major competitive advantage.
From a regulatory standpoint, the challenges for the next 10 years are no different – just intensified. The development of new drugs is complex, time consuming, expensive and inherently risky. This is why long-term success depends on the ability to advance a portfolio of product candidates, not simply a single good idea. It will continue to be a challenge to meet ever-higher regulatory standards of FDA and other regulatory authorities to demonstrate the safety and efficacy of new drugs.
Finally, the ongoing challenge for our industry will be to develop new drug products that have real, compelling value to patients, physicians and payors.
Bold Prediction: Where will the company/organization be in 10 years?
In 10 years, Alkermes will be distinguished among biotech companies because of its broad range of product successes, its business strength, and its continued foundation of world-class scientific excellence. We hope to be recognized for bringing innovative, new therapeutic approaches to patients in existing diseases, like schizophrenia and diabetes, as well as in new pioneering areas, like alcoholism and addiction.
Bold Prediction: Where will the industry will be in 10 years?
In 10 years, it will become clear that the majority of truly innovative drugs in development will have originated within biotech companies. As we progress in the next decade, the biotech industry will be viewed by the public as a wellspring of new ideas and treatments for the most important diseases and medical challenges we face.
