Nemifitide

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Nemifitide

• Todays Risks in Investing and Tomorrows
  Possible Financial Gains

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Depression is Sweeping the Globe

• Depression affects 18 million Americans every
  year and costs the U.S. 24 billion annually.
• About 10 of the nation suffers from major
  depression but many remain untreated and
  undiagnosed.
• More than 45 million worldwide suffer from
  depression, making it the largest market for
  drugs.
• Over half of the people undergoing treatment for
  depression discontinue their usage due to side
  effects.

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Innapharma, Inc.

• Biopharmaceutical company that discovers,
  develops, commercializes pharmaceutical products
  that treat serious illnesses including
  depression, anxiety, and other central nervous
  disorders.
• Since 1990, has synthesized and patented a novel
  platform of pharmaceutical small chain peptides
  for the treatment of these diseases.

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Innapharma Wants Some of the Pie

• The current anti-depressant market is 13.4
  billion dollars and climbing at a rate of 10
  every year.
• The company hopes to capture a significant
  portion of this market because of its new drugs
  lack of side effects and high level efficacy.

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Estimated Earnings by 2007

• By the 2006, the market is estimated to be at
  about 18 billion and Nemifitides projected
  earnings are 500 million.
• By 2007, Nemifitides projected earnings are 1.8
  billion.
• Thereafter, the market is expected to increase to
  20 billion with Nemifitide drawing in 3
  billion.

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So what is Nemifitide?
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Nemifitide Hard to pronounce but it makes rats
AND humans happy.

• Nemifitide, a pentapeptide administered through
  an injection, is believed to be a powerful
  therapeutic tool in the treatment of depression.
• Nemifitide has distinct advantages over other
  drugs currently offered, such as Prozac, Zoloft
  and Paxil.
• It works faster. Rapid onset of action can be
  observed within 3 to 5 days and reaches peak
  effects within a week as oppose to other drugs
  that can take as long as 4 to 8 weeks to kick in.
• It works better. About 80 of patients with
  depression respond to it as opposed to most drugs
  with a response rate of about 50. Most of these
  patients enter remission from depression.
• It treats more disorders. Nemifitide is also
  effective against mild depression, anxiety
  disorders, anorexia, bulimia, panic disorder, and
  post-traumatic stress disorder.
• It can be given in many forms including orally,
  through injections, and skin patches.

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More on Nemifitide

• Innapharma has conducted extensive testing of
  Nemifitide on both animals and humans over the
  last ten years.
• Currently, the compound is in late Phase II
  clinical trials and is anticipated to be
  commercialized by early 2006.

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Comparison of Nemifitide With Other Major
Anti-Depressants
 
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Standards for Food And Drug Administration
Approval

• Process of approving a drug is notoriously
  vigorous, consisting of three distinct levels of
  clinical trials.
• Only 30 of proposed drugs make it past Phase I
  and only about 50 of those make it past Phase
  II.
• Nemifitide is in late Phase II right now and is
  moving on to Phase III within the next few
  months.
• For this project, we tested Prozacs results for
  these trials with Nemifitides to see if
  Innapharmas estimates are well-founded.

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Phase I

• Start out on animals and then on humans.
• Purpose is to evaluate safety, safe dosage
  ranges, and any immediate side effects.
• Testing on animals continues into Phase III to
  identify long-term side effects.
• Test on rats is called Porsalt test. A rat is
  placed in a beaker filled with water so that it
  cannot reach the bottom. Then it is tested with
  and without the drug to see how long it can swim.
  If it swims significantly longer with the drug,
  then the drug is said to be effective.

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Phase II

• Requires a double-blind placebo test (Neither
  patient nor doctor knows if placebo is being
  given).
• Patients must have same level of depression
  (determined by 17 point Hamilton scale).
• Patients with other disorders are not used i.e.
  drug addicts, multiple mental disorders, AIDS and
  cancer patients.
• No elderly or adolescent people are used either.

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Phase III

• An extension of Phase II with a larger population
  size. Large margin of errors later on in the
  presentation would be significantly decreased at
  this point.

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Calculation of Innapharmas Risk in Phase II

• In order to assess risks in these trials, we used
  two calculations.
• The formula Risk .05- (p1-p2)/ square root(
  p1(1-p1)/N1 p2 (1-p2)/N2) was used to calculate
  the risks associated with the respondent rate and
  the side effect percentages.
• The .05 in the above formula represents the
  concept that if the differences between the Ps is
  greater than or equal to 5, then the results are
  mathematically significant.
• The Ns are derived from the number of patients
  undergoing trials during Phase II of testing.
  Nemifitide used 427 people while Prozac used 300.
• P1 is Nemifitides percentage and P2 is Prozacs
  percentage during the same stage of testing.

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Percentage of Respondents

• P1.8
• P2.45
• Z- Score -8.6613
• .5-.4990.001

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Percentage of Patients with Side Effects

• P1.01(only 1 out 0f 427 dropped out)
• P2.2
• Z- Score 10.17
• .5-.4990.001
• Note- A side effect is only taken into
  consideration if it causes the patient to
  discontinue usage of the drug.

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Common Side-Effects Experienced with Most
Anti-Depressants

• Injection Site Reaction
• Headache
• Dizziness
• Nausea
• Constipation
• Metallic Taste
• Abdominal Pains

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Risks

• The risks have been calculated at a little or no
  risks with Z scores equaling .4990.
• The concept of risks can be defined as the chance
  we are taking. (Type I error)The null hypothesis
  for calculation of response is P1gtP2 and the null
  hypothesis for the calculation of side effects is
  P1ltP2.
• Innapharma has a slim chance of being wrong.

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Margin of Error

• Formula 1001/square root N
• N427
• Margin of Error 4.839
• Prozac
• N300
• Margin of Error 5.774
• The Margin of Error seems high for both but this
  will be improved in Phase III when 1000 patients
  are used.

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Conclusions

• In comparison to other leading anti-depressants,
  Nemifitide is a more effective drug with fewer
  side effects. The results are not doctored
  because like Prozac, Nemifitide had to pass FDA
  regulations.
• The risk we have calculated is small and the
  margin of error should be very small by the end
  of Phase III. Therefore, it seems wise to invest
  in Innapharmas new anti-depressant, Nemifitide.

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