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Success with Biobetters: Young Biobetters Companies and Pipelines
Decision Resources, Inc, Sep 2011
The enormous commercial success of biologics therapies has spawned a new wave of biotech companies that aim to develop improved versions of therapeutic monoclonal antibodies (MAbs) and recombinant proteins known as biobetters (less often known as biosuperiors). Biobetters are created by building additional properties into the originator biologic through glycosylation, amino acid changes, or conjugation to other components that make the new protein better than the originator biologic. The biobetters strategy takes advantage of the fact that the amino acid sequence of the originator biologic has gone off patent. In today’s pharmaceutical markets, companies need to invest their precious R&D resources in developing value-added therapies that can compete well in competitive and complex drug markets. The risk of developing biobetters is potentially less than that with de novo biologics because the original biologic has already demonstrated clinical and commercial success. Numerous technologies are available to tweak the structure of a protein therapy to make it better. In this report, information is provided on many small companies with protein therapy improvement technologies and discuss the biobetters activities of several different types of companies.
Questions answered in this report:
- Flagship Ventures managing partner Noubar Afeyan has said there is a clear need for a new generation of protein engineering companies. What value do protein engineering companies offer the pharmaceutical industry? What recent deals have taken place and with which partners?
- Biogen Idec’s chief medical officer Glenn Pierce says plasma-derived blood factors revolutionized hemophilia treatment, followed next by the development of recombinant factors. What does he consider to be the next phase in the evolution of replacement blood factors? What technology is Biogen Idec using to create improved therapies for hemophilia?
- Biobetters are in development based on enhancements of the originator biologics in terms of manufacturing yield, dosing/delivery, efficacy, and safety. Can nonclinical product features such as different formulations and delivery devices create enough value to drive commercial success of biobetters? Will different expression systems used to produce biobetters provide a sufficient advantage to decrease manufacturing costs and create a commercial advantage?
- Novo Nordisk has increased its hematology sales largely through indication-expansion programs. What additional strategy is the company now using? What technologies are in play?
- Pfizer has signaled an intention to play a leadership role in follow-on biologics, including biobetters, enhanced biosimilars, and biosimilars. Which Pfizer business units will pursue biobetters? What is the status of Pfizer’s current biobetters pipeline?
- Physician attitudes toward biobetters will be critical for market uptake, especially if biobetters have higher prices than originator biologics and biosimilars. How do physician attitudes in France, Germany, and the United States differ on the expected use of biobetters? How do biobetters pricing and improvements in efficacy and safety versus the originator biologic impact physician attitudes? What level of improvement for a biobetter would persuade physicians to prescribe the biobetter for the majority of their patients rather than an originator biologic or biosimilar?
Scope:
Technologies: Site-specific pegylation, glycopegylation, Fc fusions, in silico prediction algorithms, protein optimization, protein engineering, antibody drug conjugates, bispecific antibodies, non-natural amino acids, continuous chromatography, biodegradable delivery system, extended-release technology, antibody-fusion proteins, transgenic animal production, green plant-based expression, PER.C6 mammalian cell production, anticalins, carboxyl terminal peptide (CTP) fusion, combinatorial protein expression, drug delivery formulations, albumin fusions, transferrin fusions, acylation, C-terminus lysines, a-aminoisobutyric substitutions, single-chain variable region fragments (scFv), small modular immunopharmaceutical (SMIP).
Types of companies: Big Pharma, innovative brand manufacturers, global generics manufacturers, monoclonal antibody start-ups, contract research organizations (CROs), young biobetters companies, contract manufacturing organizations (CMOs), discovery service companies, preclinical services companies, corporate venture capital entitites, venture capital firms, virtual enterprises, spinouts, wholly owned subsidiaries.
Geographies: South Korea, United Kingdom, Switzerland, Denmark, Canada, Germany, Poland, the United States, France, Israel, Russia, Japan.
Physician survey: A total of 463 endocrinologists, nephrologists, gastroenterologists, rheumatologists, solid-tumor oncologists, and hematologist-oncologists were surveyed in the United States, France, and Germany about their expected use of biobetters.
Exhibits: 13 data-rich tables and figures.
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