An Extensive Developmental Pipeline, but Limited First in Class Innovation
The antibiotics pipeline is very active, with 741 products in development. Of these, the majority (85%) are at the Discovery or Preclinical stages and have not yet entered human trials. Such a high proportion of drugs at the earliest stages of development would, in other indications, provide hope of a steady stream of drugs due to advance through the stages of development and be approved within the next decade. However, the development of antibiotics, particularly the progression of drug candidates from Discovery to human trials, is notoriously difficult, with only 12 new antibiotics approved since 2000. Of these pipeline drugs, the distribution of molecular targets is very limited, with the majority having targets observed among marketed products.
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Reflecting this trend is the fact that despite the large pipeline, first-in-class drug development is minimal, with only 10% of pipeline drugs acting on a first-in-class target. This distribution reflects the pipeline, in which 85% is at either Discovery or Preclinical. Three first-in-class drugs are at Phase I, eight are at Phase II, but none are at Phase III. These 75 drugs act on 38 first-in-class targets.
Diversity is low among these 38 targets, of which 21, acted upon by 39 products, have mechanisms of action that can be classified under the broad modes of action common to established classes of antibiotics. One of the most common is protein synthesis inhibitors, under which eight first-in-class targets can be grouped. Other categories include RNA and DNA synthesis inhibitors, as well as bacterial cell wall and membrane disruptors. Of the drugs targeting first-in-targets, clinical trial data regarding their safety and efficacy are limited, with the majority of drugs being at either the Discovery or Preclinical stages of development. As such, firm conclusions can only be drawn on a select number of targets. Those with the most promising results include inhibitors of UDP2 epimerase, Methionine tRNA synthase, the FtsZ proteins, and NDM-1 beta lactamase.
Many of the targets under these categories were highlighted by research into conserved genomes of bacteria, driven by a desire to generate antibiotics with as broad a spectrum of use as possible. These studies have uncovered a plethora of targets that act upon mechanisms not yet utilized in the treatment of bacterial infection. It was hoped that high-throughput screens against these targets would lead to the development of novel classes of antibiotics; however, since the 1990s, only four new classes of antibiotics have been approved. With the failure of the genomic approach and the fact that the natural sources of many bacteria are thought to be exhausted, many companies have left the field altogether. However, incentives to draw pharma back to the field, and methods of improving success with compound searches, as outlined in this report, provide hope for the future.
A Moderate Number of Deals and Strategic Consolidations, but Little Interest in First-in-Class Products
Deals involving antibiotics are common, with 266 conducted from 2006–2014. Of these, the majority were licensing deals (64%), with 46% conducted once the product was marketed. This reflects the fact that drug development in antibiotics is relatively simple and has easy-to-assess endpoints, reducing the requirement of co-development deals to develop an antibiotic successfully once a strong lead candidate has been identified.
Deal values varied widely from $4.3m to $480m, but most were below $100m. Only 19% of deals were completed before the drug entered human trials, again supporting the theory that drug development in antibiotics does not require significant investment.
Reflective of the lack of first-in-class targets in the developmental pipeline, only six deals involve drugs against first-in-class targets. Two deals were conducted at Phase I, two at Phase II and one at an undisclosed Phase. No robust trends can be drawn from such limited data. However, with all disclosed deals conducted after the drug has entered human trials, it can be speculated that the historic trend in the failure of identified chemicals to translate into lead compounds strongly deters potential investors from investing in first-in-class compounds. With few first-in-class compounds in the current developmental pipeline, 80% of which are at Discovery or Preclinical, few deals involving first-in-class drugs are expected to be announced within the next few years.
The report covers and provides –
– A brief introduction to antibiotics, including profiles of clinically relevant infectious strains, bacteria virulence, and an overview of pharmacotherapy
– Highlights of the changing molecular target landscape between market and pipeline, focusing on points of innovation
– An overview of how innovation products are contributing to the pipeline and market for antibiotics
– A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of Phase distribution, molecule type, molecular target, and route of administration
– Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews of novel molecular targets
– Assessment of the licensing and co-development deals for antibiotic therapies
Reasons to buy
The report provides the following –
– Understanding of the overall focal shifts in the molecular targets in the antibiotics pipeline
– Understand of the distribution of pipeline programs by Phase of development, molecule type and molecular target
– Scientific and clinical analysis of first-in-class developmental programs
– Assessment of the valuations of licensed and co-developed antibiotic treatments
– A list of first-in-class therapies potentially open to deal-making opportunities
– Analysis of financial valuations on licensed or co-developed first-in-class therapies and generics
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