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Nemifitide
Today’s Risks in Investing and
Tomorrow’s Possible Financial Gains
Depression is Sweeping the
Globe
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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.
Innapharma, Inc.
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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.
Innapharma Wants Some of the
Pie
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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 drug’s lack of
side effects and high level efficacy.
Market Analysis
Prozac
Paxil
Other
Zoloft
Celexa
Estimated Earnings by 2007
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By the 2006, the market is
estimated to be at about $18 billion
and Nemifitide’s projected earnings
are $500 million.
By 2007, Nemifitide’s projected
earnings are $1.8 billion.
Thereafter, the market is expected
to increase to $20 billion with
Nemifitide drawing in $3 billion.
Market Estimate Post 2007
Generics
25%
40%
Celexa
Nemifitide
20%
15%
Other New Compounds &
Non-Generic New SSRIs
So what is Nemifitide?
Nemifitide: Hard to pronounce but it makes
rats AND humans happy.
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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.
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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.
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.
Comparison of Nemifitide With Other
Major Anti-Depressants
Nemifitide
SSRIs (Prozac,
Zoloft, Paxil)
TCAs
(Elavil)
MAOIs
(Nardil)
3-5 Days
2-6 Weeks
2-6 Weeks
2-6 Weeks
Dosing
Once every 4
months
Daily
Daily
Daily
Side Effects Leading to
Discontinuation of Drug
1 out of 427
Yes
Yes
Yes
Major Drug Interactions
No
Yes
Yes
Yes
Sexual Dysfunction
No
Yes
Yes
Yes
Sleep Disturbance
No
Yes
Yes
Yes
Altered Appetite and Weight
No
Yes
Yes
Yes
Interference With Cognitive
Skills
No
Yes
Yes
Yes
Onset of Action
Standards for Food And Drug Administration
Approval
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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 Prozac’s
results for these trials with
Nemifitide’s to see if Innapharma’s
estimates are well-founded.
Phase I
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Start out on animals and then on
humans.
Purpose is to evaluate safety, safe
dosage ranges, and any immediate side
effects.
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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.
Phase II
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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.
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.
Calculation of Innapharma’s Risk in Phase II
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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 Nemifitide’s percentage and P2 is Prozac’s percentage during the same
stage of testing.
Percentage of Respondents
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P1=.8
P2=.45
Z- Score: -8.6613
.5-.4990=.001
Percentage of Patients with Side
Effects
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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.
Common Side-Effects Experienced with Most
Anti-Depressants
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Injection Site Reaction
Headache
Dizziness
Nausea
Constipation
Metallic Taste
Abdominal Pains
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 P1>P2 and the null
hypothesis for the calculation of side effects is
P1<P2.
• Innapharma has a slim chance of being wrong.
Margin of Error
• Formula: 100*1/square root N
• N=427
• Margin of Error = 4.839%
Prozac
• N=300
• 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.
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 Innapharma’s new
anti-depressant, Nemifitide.