Marco A. Baez, Ph.D., MBA.

Jupiter Biotechnologies, LLC.

Biosimilars & Biomanufacturing Program

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 for

these drugs 60% of prescriptions in the US are now filled with generic drugs.

Top 10 Blockbuster Drugs05

Top 7 are
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 5. ADVAIR DISKUS GlaxoSmithKline asthma: $3.6 billion

chiral!!!

Next 3 are

proteinbased!

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

Proteins & Disease

TARGETS THERAPEUTICS

Most drugs on the market are directed towards correcting protein malfunction About 10,000 disease related proteins could be targeted About 500 proteins have been targeted to date

Blood factors, growth factors, interferons, interleukin, monoclonal antibodies Fastest-growing new therapeutic area; $50B market

Economic Impact
insurers over the next 10 years Over 150 medicines are available to become biogenerics Eleven countries have adopted laws that allow biogenerics
Biogenerics will save over $100 BB for patients and

Evolution of protein expression systems

S. cerevisiae E. coli

Todays market place

Politics of Biogenerics
pathway Recommends a similar path for these as was for normal generic products Several bills are moving through congress that will allow biogeneric competition Momentum is skyrocketing for biogeneric legislation
President Obamas FY10 budget proposal calls for a

What is needed
have the money to build their own biogeneric capabilities (Teva and Novartis) Most of the other generic companies must rely on 3rd parties to provide development services Experimental capacity (incubator) is not available in the US.
Two generic companies dominate the industry and

A Biogeneric, Biosimilars Cluster

efforts to build technology Once an incubator establishes a process, production follows nearby A Biogeneric Cluster will form around the incubator and remain for decades The cluster will leverage existing technology (Scripps, Leinco, Ocean Ridge)
Generic firms have historically combined economic

What is the FDA approval process?

of new substances are screened and provide targets for further study. Generic products do not require this phase of the process. The Scripps Institute is an example of an organization that provides this service. However, the experts at Scripps will be critical for the design of the next phase. Cutting Edge Upstream Negligible Downstream

Articulate the gap between Biomanufacturing product needs and community capabilities in manufacturing

Step #1 Discovery Thousands and perhaps millions

What is the FDA approval process?

material - Making a macro-molecule is difficult and requires complex laboratory and production capabilities. These are costly and hard to operate. (In the case of a biogenerics, biosimilars this is the missing piece of the puzzle that the cluster would enable.)
Step #2 Development of a way to make the active

What is the FDA approval process?

Step #3 Clinical Testing First animals, then humans

are treated with the material produced. For a discovery this may take several years; however, for a biogeneric, biosimilars this stage is likely a short mini phase III study (as adopted by European authorities). Clinical CROs are common and available worldwide.

What is the FDA approval process?

Step #3a Manufacturing of the clinical trial

materials Normally, these dosage forms require a lot of work and development support. Few companies exist that are capable of providing such services and analytical support. The cluster would build and lease this capability as one of several services to be shared.

What is the FDA approval process?

Step #4 Continued Clinical Trials and production

scale up At this point, the material has been proven to be appropriate and large scale production of both active and dosage is dedicated for each product, thus creating a permanent biogeneric presence locally.

What is the FDA approval process?

Step #5 Submission and Approval The factory that

will make each product will be supported by the clusters shared capabilities, staff and overheads. Each generic will build unique capabilities only where needed, and share the expense of laboratories, and other common needs. Production will yield hundreds of high-paying jobs with little or no environmental impact on our community.

Proposed Exploratory Option

Fund corporate development resources to approach generic firms desiring to enter the biogeneric market, but who lack the financial ability to do it alone. Thus, we propose to begin with a single individual who would prepare a draft business plan, seek the opinion and direction of generic business leaders, and modify the plan accordingly. Ultimately, the cluster would be self-funded led by Jupiter Biotechnologies, LLC and partners in cordination with the the TOJ.

Thank You
Marco A. Baez, Ph.D., MBA.
Jupiter Biotechnologies, LLC.
Biosimilars & Biomanufacturing Program