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392 Durant Way
Mill Valley, CA 94941 USA
phone:415-515-7614
fax:415-383-1381
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Private |
| Founded |
2007 |
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Drug Reformulation Platform |
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| Management |
| Nigel Ten Fleming, Ph.D, Chairman and Chief Executive Officer; Bob Ferri, MPA, Director |
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| Keywords |
| reformulation, patent, drugdelivery, drug delivery, fixed ratio drug combinations |
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| Description |
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Minerva Healthcare is a privately-held developmental stage specialty pharmaceutical company specializing in the reformulation of old drugs and currently marketed therapeutics nearing the end of their patent lives. |
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| Products / Services |
Minerva has a portfolio of reformulation projects in a variety of therapeutic areas. The company will use Fixed Ratio Drug Combinations (often presenting additive or synergistic effects) of older drugs to achieve better patient compliance and efficacy. In some cases, the drugs will have extensive clinical experience abroad but no approval in the United States. Minerva selects products based on their demonstrated potential for meaningful clinical improvements, strong patent positions, and peak sales well over $200 million. (Six products in the company's pipeline have sales peaking at about $350 million.) Minerva is also evaluating a superoxide dismutase mimetic for dermal applications, such as laser burns in cosmetic procedures and radiation burns in cancer treatments. The company plans to develop in all prescription drug categories, except for drugs addressing central nervous system conditions.
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| Technology / Differentiation |
| Minerva's mission is to reformulate drugs recently stripped off their patents into novel or different dosage forms that may achieve clinically significant benefits. The reformulated drugs can have a different route of administration (i.e, an oral drug used for dermal applications), which may lower the required dosage, establish completely new applications, or significantly reduce toxicity. Additionally, decreased dosing frequency, decreased side effects and increased compliance can be achieved via means of controlled-release technology. Controlled-release formulations not only alter the frequency and dosage of administration, but can also be used to spread the effective dose to different intestinal absorption sites. |
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| Market / Customers |
According to Wiley Pharmafocus, products collectively worth over $100 billion in sales will be going off-patent and becoming subject to generic incursion between 2008 and 2012. Drug reformulation is a lifecycle management tool that can assist pharmaceutical companies in maximizing the returns on their considerable investments.
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| Status |
| Minerva intends to achieve its goals through an abbreviated New Drug Application (NDA), a so-called 505(b)(2) route through the FDA that is less expensive and shorter than the conventional process and leads to five to seven years of exclusivity awarded by the FDA. Once Minerva takes its selected drugs through FDA approval, it will then license them for healthy royalties, as well as upfront and milestone payments to the strongest pharmaceutical candidate able to generate significant sales. |
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Biotech & Specialty Pharma
Healthcare Services
Medical Devices & Tech
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