Overcoming the obstacles in the pharma/biotech industry: 2008 Update

Graul, A.; Revel, Laura; Rosa, Esmeralda; Cruces, Elisabet

doi:10.1358/dnp.2009.22.1.1303817

Cited by 13 publications

(10 citation statements)

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“…Against this updated backdrop, we now present our analysis of the role of natural products in the drug discovery and development process, dating from 01/1981 through 09/2019. As in our earlier analyses, − we have consulted the following published sources: Annual Reports of Medicinal Chemistry from 1984 to 2014 − and its successor, Medicinal Chemistry Reviews , now published as a PDF file. − Then, in order to obtain more comprehensive coverage of the 1990–2018 time frame, we have added data from the publication Drug News and Perspective − and continued with the successor listings in Drugs of Today . − These, together with searches of the Clarivate Integrity database, and inclusion of information from individual investigators form the basis of our data sets. We have continued our attempts to capture vaccine data for the years covered, but this area of the database is still not as complete as we would hope.…”

Section: Resultsmentioning

confidence: 99%

Natural Products as Sources of New Drugs over the Nearly Four Decades from 01/1981 to 09/2019

Newman¹,

Cragg²

2020

J. Nat. Prod.

4,000

2,843

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For all approved therapeutic agents, the time frame has been extended to cover the almost 39 years from the first of January 1981 to the 30th of September 2019 for all diseases worldwide and from ∼1946 (earliest so far identified) to the 30th of September 2019 for all approved antitumor drugs worldwide. As in earlier reviews, only the first approval of any drug is counted, irrespective of how many "biosimilars" or added approvals were subsequently identified. As in the 2012 and 2016 reviews, we have continued to utilize our secondary subdivision of a "natural product mimic", or "NM", to join the original primary divisions, and the designation "natural product botanical", or "NB", to cover those botanical "defined mixtures" now recognized as drug entities by the FDA (and similar organizations). From the data presented in this review, the utilization of natural products and/ or synthetic variations using their novel structures, in order to discover and develop the final drug entity, is still alive and well. For example, in the area of cancer, over the time frame from 1946 to 1980, of the 75 small molecules, 40, or 53.3%, are N or ND. In the 1981 to date time frame the equivalent figures for the N* compounds of the 185 small molecules are 62, or 33.5%, though to these can be added the 58 S* and S*/NMs, bringing the figure to 64.9%. In other areas, the influence of natural product structures is quite marked with, as expected from prior information, the anti-infective area being dependent on natural products and their structures, though as can be seen in the review there are still disease areas (shown in Table 2) for which there are no drugs derived from natural products. Although combinatorial chemistry techniques have succeeded as methods of optimizing structures and have been used very successfully in the optimization of many recently approved agents, we are still able to identify only two de novo combinatorial compounds (one of which is a little speculative) approved as drugs in this 39-year time frame, though there is also one drug that was developed using the "fragment-binding methodology" and approved in 2012. We have also added a discussion of candidate drug entities currently in clinical trials as "warheads" and some very interesting preliminary reports on sources of novel antibiotics from Nature due to the absolute requirement for new agents to combat plasmid-borne resistance genes now in the general populace. We continue to draw the attention of readers to the recognition that a significant number of natural product drugs/leads are actually produced by microbes and/or microbial interactions with the "host from whence it was isolated"; thus we consider that this area of natural product research should be expanded significantly.

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Section: Resultsmentioning

confidence: 99%

Natural Products as Sources of New Drugs over the Nearly Four Decades from 01/1981 to 09/2019

Newman¹,

Cragg²

2020

J. Nat. Prod.

4,000

2,843

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“…It is disappointing to observe that the success rate in Phase II from these companies fell down to 18% during 2008 and 2009, even lower than 28% recorded in 2006 and 2007. Thomas Reuters Life Science Consulting analyzed the drugs for major indications that were dropped in Phase II during 2008-2010 and for which the reasons for failure were disclosed (87 out of 108) [10][11][12]. The analysis (Fig.…”

Section: Clinical Failures -Shifting Paradigmmentioning

confidence: 99%

Drug discovery in pharmaceutical industry: productivity challenges and trends

Khanna¹

2012

Drug Discovery Today

378

223

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“…Against this backdrop, we now present an updated analysis of the role of natural products in the drug discovery and development process, dating from January 1981 through December 2014. As in our earlier analyses, − we have consulted the Annual Reports of Medicinal Chemistry , in this case from 1984 to 2014, − and to obtain more comprehensive coverage of the 1981–2014 time frame we have added data from the publication Drug News and Perspective, − the successor listings in Drugs of Today , − and searches of the Prous (now Thomson-Reuter’s Integrity ) database, as well as by including information from individual investigators. As in the last review, the biologics data prior to 2005 were updated using information culled from disparate sources that culminated in a 2005 review on biopharmaceutical drugs .…”

Section: Introductionmentioning

confidence: 99%

Natural Products as Sources of New Drugs from 1981 to 2014

Newman¹,

Cragg²

2016

J. Nat. Prod.

4,930

3,456

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This contribution is a completely updated and expanded version of the four prior analogous reviews that were published in this journal in 1997, 2003, 2007, and 2012. In the case of all approved therapeutic agents, the time frame has been extended to cover the 34 years from January 1, 1981, to December 31, 2014, for all diseases worldwide, and from 1950 (earliest so far identified) to December 2014 for all approved antitumor drugs worldwide. As mentioned in the 2012 review, we have continued to utilize our secondary subdivision of a "natural product mimic", or "NM", to join the original primary divisions and the designation "natural product botanical", or "NB", to cover those botanical "defined mixtures" now recognized as drug entities by the U.S. FDA (and similar organizations). From the data presented in this review, the utilization of natural products and/or their novel structures, in order to discover and develop the final drug entity, is still alive and well. For example, in the area of cancer, over the time frame from around the 1940s to the end of 2014, of the 175 small molecules approved, 131, or 75%, are other than "S" (synthetic), with 85, or 49%, actually being either natural products or directly derived therefrom. In other areas, the influence of natural product structures is quite marked, with, as expected from prior information, the anti-infective area being dependent on natural products and their structures. We wish to draw the attention of readers to the rapidly evolving recognition that a significant number of natural product drugs/leads are actually produced by microbes and/or microbial interactions with the "host from whence it was isolated", and therefore it is considered that this area of natural product research should be expanded significantly.

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Overcoming the obstacles in the pharma/biotech industry: 2008 Update

Cited by 13 publications

References 0 publications

Natural Products as Sources of New Drugs over the Nearly Four Decades from 01/1981 to 09/2019

Natural Products as Sources of New Drugs over the Nearly Four Decades from 01/1981 to 09/2019

Drug discovery in pharmaceutical industry: productivity challenges and trends

Natural Products as Sources of New Drugs from 1981 to 2014

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