exploring biosimilars & bio manufacturing 2010
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. , . ., .Jupiter Biotechnologies, LLC.
Biosimilars & Biomanufacturing Program
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What are Biogenerics? Large protein molecules derived from living cells,
Growing at twice the rate of normal drugs
Already on the market in Europe Over $10 BB available for generic competition
Patients using them pay more then $10,000 per year forthese drugs
60% of prescriptions in the US are now filled
with generic drugs.
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Top 10 Blockbuster Drugs05 Top 7 arechiral!!!
1. LIPITOR Pfizer high cholesterol: $8.4 billion
2. ZOCOR Merck high cholesterol: $4.4 billion
3. NEXIUM AstraZeneca heartburn: $4.4 billion
4. PREVACID Abbott & Takeda heartburn: $3.8 billion
Next 3 areprotein-
based!
5. ADVAIR DISKUS GlaxoSmithKline asthma: $3.6 billion
6. PLAVIX Bristol-Meyers Squibb & Sanofi-Aventis heart disease $3.5 billion
7. ZOLOFT Pfizer depression: $3.1 billion
8. EPOGEN Amgen anemia: $3.0 billion
9. PROCRIT Johnson & Johnson anemia: $3.0 billion
10. ARANESP Amgen anemia: $2.8 billion
Source: Forbes. Com; 2/27/06
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Proteins & DiseaseTARGETS THERAPEUTICS
Most drugs on the market are directedtowards correcting protein malfunction
About 10,000 disease related proteinscould be targeted About 500 proteins have beentargeted to date
Blood factors, growth factors,interferons, interleukin, monoclonal
antibodies Fastest-growing new therapeuticarea; $50B market
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Economic Impact Biogenerics will save over $100 BB for patients and
insurers over the next 10 years
Over 150 medicines are available to become
Eleven countries have adopted laws that allowbiogenerics
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Evolution of protein expression systems
E. coli
S. cerevisiae
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Todays market place
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Politics of Biogenerics President Obamas FY10 budget proposal calls for a
pathway
Recommends a similar path for these as was for
Several bills are moving through congress that willallow biogeneric competition
Momentum is skyrocketing for biogeneric legislation
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What is needed Two generic companies dominate the industry and
have the money to build their own biogenericcapabilities (Teva and Novartis)
Most of the other eneric com anies must rel on rd
parties to provide development services
Experimental capacity (incubator) is not available inthe US.
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A Biogeneric, Biosimilars Cluster Generic firms have historically combined economic
efforts to build technology
Once an incubator establishes a process, productionfollows nearb
A Biogeneric Cluster will form around the incubatorand remain for decades
The cluster will leverage existing technology (Scripps,
Leinco, Ocean Ridge)
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What is the FDA approval process?
Step #1 Discovery Thousands and perhaps millionsof new substances are screened and provide targets
for further study. Generic products do not require.example of an organization that provides this service.However, the experts at Scripps will be critical for thedesign of the next phase.
Cutting Edge Upstream
Negligible Downstream
Articulate the gap between Biomanufacturing productneeds and community capabilities in manufacturing
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What is the FDA approval process? Step #2 Development of a way to make the active
material - Making a macro-molecule is difficult andrequires complex laboratory and productionca abilities. These are costl and hard to o erate.
(In the case of a biogenerics, biosimilars this is themissing piece of the puzzle that the cluster wouldenable.)
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What is the FDA approval process?
Step #3 Clinical Testing First animals, then humansare treated with the material produced. For a
discovery this may take several years; however, for a,mini phase III study (as adopted by Europeanauthorities). Clinical CROs are common and availableworldwide.
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What is the FDA approval process? Step #3a Manufacturing of the clinical trial
materials Normally, these dosage forms require a lotof work and development support. Few companiesexist that are capable of providing such services andanalytical support. The cluster would build andlease this capability as one of several services to beshared.
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What is the FDA approval process?
Step #4 Continued Clinical Trials and productionscale up At this point, the material has been proven
to be appropriate and large scale production of both,creating a permanent biogeneric presence locally.
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What is the FDA approval process? Step #5 Submission and Approval The factory that
will make each product will be supported by theclusters shared capabilities, staff and overheads. Eachgeneric will build unique capabilities only whereneeded, and share the expense of laboratories, andother common needs. Production will yield hundredsof high-paying jobs with little or no environmentalimpact on our community.
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Proposed Exploratory Option Fund corporate development resources to
approach generic firms desiring to enter the
biogeneric market, but who lack the financiala y o o a one. us, we propose o eg nwith a single individual who would prepare adraft business plan, seek the opinion and
direction of generic business leaders, and modifythe plan accordingly. Ultimately, the clusterwould be self-funded led by JupiterBiotechnologies, LLC and partners in cordination
with the the TOJ.
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Thank YouMarco A. Baez, Ph.D., MBA.
Jupiter Biotechnologies, LLC.Biosimilars & Biomanufacturing Program