Exploring Biosimilars & Bio Manufacturing 2010

8/2/2019 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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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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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

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Exploring Biosimilars & Bio Manufacturing 2010