Cougar Biotechnology

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Cougar Biotechnology

• Stalking prostate cancer

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Hormone Therapy
Pre-Hormone Therapy
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HRPC treatments

• 1. Lupron or Zoladex. Chances are youve been on
  Lupron or Zoladex(or on one of the LHRH agonists
  provided outside the U.S.), perhaps for some
  years. Or you may have had an orchiectomy
  instead. In the case of Lupron or Zoladex, for
  example, you should plan to stay on this drug for
  the foreseeable future, preferably on a 28-84 day
  injection schedule. The Lupron or Zoladex will
  continue to suppress the testosterone that would
  otherwise stimulate the cancer cells to
  proliferate. HRPCa is a mixture of cancer cells,
  some of them still sensitive to hormone
  blockade.  The Lupron or Zoladex you continue
  taking keeps those cells under control. 2.
  Bisphosphonate. For bone integrity.3. An
  estrogenic drug, such as DES (diethyl
  stilbestrol). This drug has been used more
  frequently since the herbal remedy PC SPES was
  taken off the market. That remedy contained
  rather strong phytoestrogens. Although there is a
  general search underway for a replacement for PC
  SPES, we know of no equivalent at this time. With
  an estrogen, one must be aware of the risk of
  blood clots. Interestingly, these estrogenic
  drugs have been shown to work for some period of
  time with HRPCa, even in addition to the Lupron.
• 4. An Anti-Androgen.5. HDK HC or LDK
  (high-dose ketoconazole plus hydrocortisone).
  Ketoconazole is an anti-androgen. It works by
  blocking the hormone receptors on the cancer
  cells, thus preventing access by
  cancer-stimulating testosterone. In the advanced
  stage, prostate cancer cells often acquire an
  overabundance of additional hormone receptors,
  with the result that even a minuscule amount of
  testosterone is sufficient to stimulate
  proliferation. The hydrocortisone is needed to
  replace the steroid lost when the ketoconazole
  shuts down that production by the adrenal glands.
  Some men have great success with taking HDK, and
  others have great difficulty with the side
  effects. Life most of these treatments, we only
  know if they are effective for a given individual
  when that person actually takes the drug.6.
  Taxotere is the first of a number of
  chemotherapies that work with HRPCa. It is the
  most effective one against HRPCa. There are mixed
  feelings about using chemotherapy to fight
  cancer. The reactions include (1) a fear of the
  side effects and (2) a concern that the use of
  chemotherapy will disqualify them from
  consideration for clinical trials. The decision
  is up to the individual. However, it is unwise to
  let the PSA increase to the point at which there
  are widespread metastases. It is true that
  chemotherapy is not an easy treatment the side
  effects include fatigue, some nausea, and
  peripheral neuropathy (numbness in feet and
  hands) to mention the most bothersome. However,
  it does bring down the PSA, and it does extend
  survival (despite some medical claims) when used
  in a series of treatments. Insofar as the concern
  about clinical trials goes, one should not let
  the PSA run out of control purely for the hope
  that something experimental might work. Most of
  the members of our support list have had
  chemotherapy treatments and can answer any
  questions about the experience.

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Flutamide Schering-Plough
Nilutamide
Sanfois Aventis
AstraZeneca 1.2 billion in sales 2006
Abiraterone
Ketoconazole
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Abiraterone

• P450 inhibitor specific for 17-alpha hydroxylase
  and C17,20-lyase
• Does not inhibit mineralocorticoid synthesis
• Fewer side effects than ketoconazole
• Androgen depletion within malignant cells as well
  as in adrenal glands
• Comparable PSA decreases (60 of patients) and
  radiologically significant changes in tumour
  progression
• Phase I/II trials completed
• Median time to progression 9 mo
• Responses seen even after ketoconazole,
  chemotherapy

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Financials

• Last years burn rate 18 milliom
• Estimates 85 million to make it to FDA approval
• They have 96 million in the bank

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How much is a drug worth

• If my market size for my preclinical drug is 1
  million people and my drugs price will be 50,000
  dollars a year, my drug should be worth 50
  billion dollars a year! Why wont Pfizer offer me
  something close to that amount?

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• Probabilities
• Based on historical numbers, drugs in clinical
  trials have been approved by the FDA at the
  following ratesPhase I 20Phase II 30Phase
  III 67New Drug Application 85
• The percentage of drugs moving from one stage to
  another is the following
• Phase I to Phase II 67Phase II to Phase III
  45Phase III to NDA 79NDA to FDA Approval
  85These percentages are the probabilities that
  we use when a drug moves to a different stage.
• Cash FlowsDetermining a drug's cash flows can
  be very difficult. First, we must determine the
  costs. Secondly, we want to determine the
  potential revenues.--CostsCosts tend to be
  determinate on the stage that a drug is in.
• Phase I (1 year) 500,000 for animal testing
  12,000 per human subject (20-80 subjects)Phase
  II (1.5 yrs) 1 mil for animals 12,000 per
  human (100-300)Phase III (3 yrs) 1.5 mil for
  animals 6,000 per humna (1000-3000)New Drug
  Application (1 yr) 1.8 million
• RevenuesA peak sales estimate (which can
  usually be obtained about 3 years after FDA
  approval) can be determined by taking the market
  size and multiplying it by an estimated market
  share. Also, drugs tend to have a life of around
  10 years. Revenues are usually assumed to ramp
  up, and ramp down with about 5-7 years of peak
  sales.