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Thrombosis is a general name for blood vessel occlusion diseases, which are the leading
causes of mortality in developed countries, outnumbering all other causes combined.
Thrombosis causes damage to vulnerable circulatory beds and leads to heart conditions
such as stroke, and other high mortality vaso-occlusive diseases. Current treatment
includes antithrombotic drugs, mostly blood thinners that can prevent, interrupt, or
reverse the progressive growth of blood clots.
Agrile® offers people at risk of a coronary event due to thrombosis a drug that substantially reduces
the probability of a debilitating and potentially deadly heart attack or stroke. Patients will also benefit
from having a drug that retains normal platelet function avoiding risky side effects such as prolonged
or spontaneous bleeding caused by other anti-platelet drugs.
Physicians can directly measure platelet count to determine the maximum effective dosage for each
patient because it directly affects the number of circulating platelets, rather than platelet function.
People being treated with Agrile® will lessen the possibility of hospitalization and long term care that
is necessary following a heart attack or stroke, avoiding the high cost associated with the aftercare of
coronary episodes. Because of the reduction in serious side effects, patients using Agrile® will enjoy
a higher quality of life with a minimum of restriction experienced by many people being treated with
other drugs
SIDE EFFECTS
Bleeding is the primary problem with all drugs in this class. All marketed antithrombotic
drugs have this significant side effect, as they impair homeostasis, and encounter a risk
of bleeding as indicated by the doctors we interviewed. “The obvious problem is the
increased bleeding” or “There is a high risk for internal bleeding which creates problems
for endoscopies
EFFICACY
Another problem is that current drugs are not always administered only once a day
(depends on the patient’s condition). We found in our research that” My patients usually
forget to take the second or third pill” and that “If a new drug comes along that is just
as effective, but easier to deliver, that is a big decision factor” and even “Taking a pill
once a day vs. multiple times a day will influence my decision to prescribe a drug”.
BUSINESS OPPORTUNITY
Because of the danger of side effects and the limited effectiveness of current
treatments for Thrombosis and frequency of taking a dosage, we see a business
opportunity to develop a new drug that will effectively treat Thrombosis, while reducing
dramatically the risk of side effects.
BENEFITS
The benefit to the patients will be better health and life style, as one of our interviewees
indicated: “Side effect profile is extremely important to patients; they want it to be
minimized”. The benefits to the doctor include easier monitoring of their patients with
more accurate information. It is also less likely that patients will forget to take a pill. The
benefits to the insurance companies are a cost saving since Agrile® will lessen the
possibility of hospitalization and long term care that are associated with heart attacks or
strokes.
The bottom line is Agrile® will provide benefits for all parties, patients, doctors, and
insurance companies.
PRODUCT DESCRIPTION
It has been known since 1991 that platelet count within the normal range is an
independent risk factor, similar to cholesterol and several other risk factors, for
thrombotic vascular events. The relationship between platelet count and the frequency
of coronary events may be approximately linear. Platelet counts in the low normal range
(e.g., 80% of average) are safe, and even a greatly reduced platelet count does not
typically cause spontaneous bleeding in humans. Meanwhile, platelet count reduction is
antithrombotic in animal models. Studies have shown direct correlation between platelet
count and thrombus growth in primates. Agrile® efficacy and safety profiles should be
quite favorable since the drug is already effective in humans.
TYPICAL CUSTOMER
Agrile® is a prescription only drug intended to be used and indicated for the reduction
of atherosclerotic (thrombotic) events (myocardial infarction, stroke, and vascular
death) in patients suffering from arteriosclerosis, “hardened” arteries, documented by
recent stroke, recent myocardial infarction, or established peripheral arterial disease.
Additional and broader target indications include reduction of vaso-occlusive events in
patients without a history of such events, prevention of synthetic and natural vascular
graft and dialysis access graft occlusions, reduction of cerebrovascular and peripheral
vascular events in patients with atrial fibrillation, and reduction of atherosclerotic events
and organ damage in patients with diabetes mellitus.
VALUE PROPOSITION
Physicians can directly measure platelet count to determine the maximum effective
dosage for each patient because it directly affects the number of circulating platelets,
rather than platelet function. People being treated with Agrile® will lessen the
possibility of hospitalization and long term care that is necessary following a heart
attack or stroke, avoiding the high cost associated with the aftercare of coronary
episodes. Because of the reduction in serious side effects, patients using Agrile®will
enjoy a higher quality of life with a minimum of restriction experienced by many people
being treated with other drugs.
Insurance providers of people who use Agrile® will see the health benefits of a more
effective heart attack and stroke prevention drug that provides an overall cost reduction
compared to other treatments.
MARKET ANALYSIS
Total Pakistan Pharma Market is US$ 1.572 billion while the total World Market is US$
751 Bn on with a growth of 3.4
If we look at the market of systemic antiplatelet in Pakistan, the data revealed that it is the largest
therapeutic segment (Rs. 22,626 million) accounting for approximately 33.7% of the total
pharmaceutical market
Flowpla
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(Prasugrel)
MARKET SEGMENTATION
In the complex pharmaceutical world, market segmentation means dividing the market
to distinct groups of buyers or decision makers. We adopted this definition with an
emphasis on distinct groups of decision makers. In our case we identified three groups
of decision makers with somewhat different desired outcome, and different reasons to
buy. The three main market segments are doctors, insurers, and patients. All three are
closely related. A patient is unlikely to receive a medication if it is not prescribed by
his/her doctor, and doctors may not prescribe a medication that is not covered by the
insurer in order to be considerate with their patients’ pocket.
Since Agrile®is treating a vascular disease with major implications to risks of heart
attacks and strokes; we anticipate that the most influential physicians that will
eventually determine the shape of the market are cardiologists. One of the cardiologists
we interviewed can be a typical example of our typical target consumer/influencer.
Insurers typically use a pharmacy benefit manager (PBM) to manage their drugs. PBMs
are external organizations that purchase drugs directly from the pharmaceutical
companies. Because they purchase in large quantities they can achieve tremendous
savings per unit. This savings translates into lower costs per medication for the health
insurance company that uses the PBM.
A “formulary” is a list of medications that will be covered under the insured patient’s
insurance benefit. The PBM, as part of their process, performs an analysis on all the
available drugs in each drug category, and ranks them according to cost and
effectiveness. Those drugs that are the cheapest and have at least the same safety and
effectiveness profile are ranked highest. Those drugs that cost the most and have equal
or poorer safety and effectiveness profiles are ranked lowest.
Based on this analysis, the formulary contains “preferred drugs” which are sometimes
referred to as “tier – 1” that have the highest ranking. The health insurer typically gives
a discount to the patient for these drugs in order to channel them to use these drugs.
“Tier – 2” drugs typically are more expensive but equally effectiveness. The patient will
pay more for these drugs because they are more expensive and there is a tier-1
alternative.
“Tier – 3” drugs are the most expensive and are typically only offered by the insurer if
(a) there is no cheaper substitute, or (b) the doctor insists (and can document) that the
patient does not respond to other medications. Insurers typically only pay for ½ the
price (or less) of these drugs, and the patient pays the rest.
Therefore, health insurers rely on the comparative analysis of drugs in each drug class.
Drugs are compared on price, safety and clinical effectiveness. In most cases, the
cheapest drug alternative with a similar safety and effectiveness profile will be chosen
as the preferred drug in that drug class.
Insurers consider different information to select which drug to cover. For example, drugs
for multiple indications are preferred over drugs for single indications. Similarly, drugs
with fewer contra-indications or side-effects are preferred over those with those with
either more contra-indications or side-effects, or major contra-indications or side-effects.
This is a critical criteria for Agrile®, which strives on lowering side effects and contra-
indications (i.e., bleeding) to become a drug of choice for insurers.
The CVD’s have been derived from several interviews we had with physicians and
insurance company consultants. These led us to summarize the decision-related
attributes that are perceived by the prospected customers to be highly important in
their decision making to buy. Since Thrombosis is the most significant unmet medical
challenge to human well-being it justifies intensive efforts to find and develop improved
treatment modalities. The problem is grave. Accordingly, the potential market for safe
and efficacious products is substantial for these three market segments. These are the
CVD’s for the respective segments. We included physicians and patients in the same
table because most value drivers are the same for these groups.
MARKET SIZE
Agrile® will target and penetrate the defined and well-established market of the leading
antithrombotic (antiplatelet) product in the Pakistan. Plavix® (Bristol-Myers Squibb),
Lowplate (Pharmevo) that has surpassed $3.3 billion in annual sales in 2009. The
market for continues to grow
GROWTH POTENTIAL
Thrombosis is not only a common disease, but also growing in numbers in the world.
This opens the opportunity for potential growth. Agrile® targets specifically patients
with arterial thrombosis. Each year in the Pakistan alone there are new cases of
peripheral arterial disease. These are potential target consumers per year! Therefore,
we anticipate that growth will come directly from an increased number of patients per
year.
MARKET SHARE
Accurate data on market share is extremely difficult to come by, or is very expensive to obtain.
According to Agrile® estimates the key players in the proprietary antithrombotic drugs market are
Plavix® and Ticlid. Of the two, Plavix® outsells Ticlid by a 7:1 ratio, translating into approximately
87.5% market share, compared to only 12.5% by Ticlid of patients per year.
This figure also shows approximately 0.5M new cases of stroke per year. However, more
rigorous counting of stroke cases in all racial and ethnic groups increased the yearly
estimate to 731,000 cases.
Deep venous thrombosis 2MMyocardial infarction 1.1MStroke 0.5MRenal dialysis access
grafts 0.5M Peripheral arterial disease 2.6
COMPETITOR ANALYSIS
Plavix®, the primary competitor for Agrile® inhibits platelet aggregation by blocking the
platelet receptor for adenosine diphosphate, a known platelet agonist. Generic aspirin,
another widely used platelet inhibitor, acts by reducing the production of a substance
called “prostaglandins”. Prostaglandins in the blood trigger a series of events that cause
blood platelets to clump together and form blood clots. Thus, when aspirin inhibits
prostaglandins, it inhibits the formation of blood clots as well.
Since Plavix® is marginally more effective than aspirin alone, and aspirin is sold by
numerous companies, the Competitor Analysis will focus on Plavix®.
Advantages
• Efficacy: Taken once daily by high risk patients over a prolonged period of time,
Plavix® has been shown to marginally reduce the overall risk of adverse
cardiovascular events from 10.64% to 9.78% (CAPRIE trial) without an apparent
significant increase in bleeding events (3.7% aspirin vs. 5.3% Plavix®, p>0.05),
although Plavix® is generally considered to produce more bleeding than aspirin after
surgery or trauma.
• Long-term Plavix® therapy does not require frequent and routine laboratory
monitoring.
• Its combination with aspirin is well tolerated and improves patient outcomes
Disadvantages
• Safety: The bleeding event rate is higher in both Plavix®-treated and aspirin-treated
patients than in the general population. Severe bleeding occurs at similar rates with
the two drugs. Gastrointestinal and intracranial bleeding are severe and potentially
life threatening adverse events. Deaths due to bleeding partially offset the
advantages of the treatment.
• Plavix® may interfere with the clearance of several drugs that are metabolized by the
liver. Severe neutropenia (bone marrow depression) is a rare but recognized life-
threatening adverse effect of both Plavix® and its parent molecule, ticlopidine.
In conclusion, Plavix® has displaced the use of aspirin for many cardiovascular
indications despite the facts that:
Thus, Agrile® which is expected to be both safer and more effective than Plavix®,
should have an enormous competitive advantage in this market, which has quickly
reached a substantial 3+ billion in sales.
Platelet inhibitors, which act by mechanisms other than through inhibition of the platelet ADP
receptor and platelet GPIIb/IIIa complex, could be superior to Plavix®. Such agents, e.g., PAR
receptor blockers, might already be under development, but none has yet reached the market
and might not be safe and efficacious. Some specific inhibitors of GPIIb/IIIa (e.g., Dupont's
compound) under development for chronic indications have exhibited unacceptable toxicity in
clinical trials, and thus were discontinued. Regardless of their mechanism of action, most new
agents, which produce global inhibition of platelet function, are expected to impair both
thrombosis and hemostasis because these approaches will hamper the natural defense functions
of all circulating platelets. Since Agrile ® does not impair platelet function; it is expected to have
exceptional hemostatic safety.
Selective targeting of the platelet count as a means to prevent thrombosis is a novel strategy
that the competition is not currently matching. Since the platelet count is regulated by the
activation of the megakaryocytic "mpl-pathway" (an intracellular protein kinase - signaling
pathway), Agrile® will also have patent protection on targeting the mpl-pathway in order to raise
barriers against potential competition in this area, and to protect the use of anagrelide.
SWOC ANALYSIS
Strengths Weaknesses
Opportunities Challenge
This table is presenting a scan of internal and external traits that are important part of
our strategic planning process. The environmental factors that are internal to Agrile are
classified here as the strengths and weaknesses, and those external to the firm are
classified as the opportunities and threats. The SWOC analysis is providing us the
information that is helpful to match our product resources and capabilities to the
competitive environment in which our product Agrile® will operate.
Based on the information above we noticed new opportunities in the marketplace, such
as an unfulfilled customer need for a safer drug. This is discussed in our market strategy
part. With our marketing strategy we will try to convince the reader that we can develop
a competitive advantage by linking our strengths and the upcoming opportunities.
Specifically, we will demonstrate how our product is different and how it addresses
consumers’ needs for safer and better product
MARKETING STRATEGY
ENTRY STRATEGY
PLACE:
Sales team is operating in all major cities and towns of Pakistan. The most
important strength of the company is its own distribution network, which is
necessary indeed to give a push in sales not only in the launch phase but also
in all product life.
• Karachi
• Hyderabad
• Thatta
• Mirpurkhas
• Sukkar
• Quetta
• Multan
• Faisalabad
• Lahore
• Rawalpindi
• Peshawar
Regional Managers are headed by Sales Managers (South, Central &
North), who report to Business Unit Head.
PROMOTIONAL ACTIVITIES:
Sales team is equipped with product & sales knowledge with a successful
track record of new product launches , marketing team is legendary for
establishing new product’s launch campaign & promotional plan. Product
Managers are responsible for product strategy designing under the
supervision of Business Unit Head. Each Product Manager reports to his /
her respective Business Unit Head.
INCENTIVE PLANS:
Introducing very attractive incentive plan for its sales team, which is as
follows :
ADVERTISING:
FREQUENCY OF CALLS
POSITIONING STRATEGY
We’ve found out that all the physicians we interviewed familiarize and
educate themselves with Plavix®, our main competitor. Statements like:
“Plavix® is pretty well tolerated”, “I usually prescribe Plavix® 75mg once a
day”, “Plavix® is really the only drug in its class that is used” helped as to
understand that in our customers mindset Plavix® is the leader. But at the
same time statements like: “occasionally someone is allergic to it or can not
tolerate it” and “There is someone allergic to everything somewhere, it would
be nice to have an alternative”, and most importantly “I’ll choose one med
over another if they have better cost, ease of administration, frequency of
dosing, safety” indicate that there is a place for a better replacement. This
had led us to decide that in order to position Agrile® in people’s mind we
should introduce ourselves as, better in performance, and the drug of choice
of cardiologists. The idea is to send a clear message that we responded to a
real market need and that we have a better product.
Since “People only know what they’re told” we will use all our efforts to
communicate our product Agrile® and to promote our product through
different channels to gain advantage over our competitors. Conferences
would be one of our main target efforts since this is one place cardiologists
decide to change to a new drug. Although “people do not easily or willingly
change their minds concerning a company or a product’s positioning” our
product solution will be addressed in an educating way using all marketing
communication strategies to gain market share. Ultimately we will align our
entry strategy of publication in scientific journals with our main target sector
(cardiologists), and establish a strong presence in this sector. We believe that
these steps will enable us to develop out credibility and leadership position in
the antithrombotic drugs market.
Safety Agrile®
Efficacy
Note that current drugs play in the same zone of efficacy-safety, while our
product will address a zone of functionality that is currently not challenged.
This is the basis of our competitive advantage
PRICING STRATEGY
Plavix® is the clear and current market leader for anti thrombotic drugs.
Since Agrile® promises increased efficacy with reduced side effects, this
would suggest a premium over Plavix®, which currently sells for 15 per tab.
With this in mind, we will initially price Agrile® at 20rps. per tab.
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Agrile will eventually use a small but focused Direct Sales force comprised of
representatives that will target key hospitals and Cardiology specialty
centers. Secondary in focus will be Hematologists, and family practice
physicians. However, initially we will look to contract with companies that
specialize in providing outsourced sales and marketing services to the
biopharmaceutical and medical devices and diagnostics industries.
Determining where to focus our sales efforts will be a collaborative effort with
our contracted sales representatives.