NEW PRODUCT DEVELOPMENT.

1. Humira

Abbot
world best selling drug.(mega blockbuster
drug)
Arthritis is a disease of the joints. Osteoarthritis, which is generally the result
of "wear and tear", is a condition in which inflammation of the joints results
in pain and degeneration. Rheumatoid arthritis is an autoimmune disease in
which the immune system attacks the joints. According to the CDC, over 46
million Americans suffer from arthritic symptoms, and 19 million are
physically limited by their condition. The pharmaceutical market for arthritis
generated $15.9 billion in revenues in 2008.

COMPETITIOR ANALYSIS
The major players in the arthritis drug market include Abbott Laboratories, Johnson
& Johnson, Amgen, Roche, and Pfizer. As of 2008, Abbott Laboratories' Humira,
which was approved by the FDA in 2003, is the highest selling drug in the arthritis
market, with sales growing 50% from 2007 to 2008 to $4.5 billion.[4] Bristol-Myers
Squibb's Orencia, which was approved by the FDA in 2005, is the fastest growing
arthritis drug, with sales increase of 91% from 2007 to $441 million in 2008.[5]
Arthritis Drugs Market Share by Revenue, 2008
Rank Market Share Company

Product

Revenue ($ billion)

28%

Humira

4.50

50%

23% Johnson & Johnson

Remicade

3.70

18%

23%

Amgen

Enbrel

3.60

12.5%

16%

Pfizer

Celebrex

2.49

9%

5%

Roche

Rituxan

0.75

NA

3%

BMS

Orencia

0.44

91%

Abbott

Growth

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2%

Merck

Arcoxia

0.38

14.6%

NEED FOR NEW PRODUCT DEVELOPMENT

On a dollar basis, the arthritis drug market is dominated by biologic drugs,
specifically proteins which block tumor necrosis factor (TNF). Biologic drugs
are much harder to replicate than small molecule drugs, and current
legislation makes it very difficult for competitors to produce generic versions
of the drug. However, proposed new legislation may pave a pathway for
generic biologics, which if approved will affect the arthritis market by
enabling the entry of generic competition which will lower prices and
decrease the overall market size.Branded arthritis treatments are also
threatened by over-the-counter treatments that offer lower prices and higher
accessibility. In addition, there have been concerns that anti-TNF antibodies
can lead to cancer in children and adolescents.New drugs under
development with novel mechanisms of action have the opportunity to
achieve blockbuster sales in this market.Humira is not only the best-selling
arthritis drug; it is also the best-selling drug in the world right now. And it is
the backbone of Abbot ($ABBV), the newest member of Big Pharma, which
was spun off from Abbott Laboratories ($ABT) January 1

PRODUCT LIFE CYCLE OF HUMIRA.

The drug is approved for a long list of indications in the U.S. and Europe and had
2012 global sales of $9.6 billion, with about half of that in rheumatoid arthritis. In
the second quarter of the year, Humira sales were up 12% to $2.6 billion, indicating
the company continues to gain ground with the treatment. AbbVie has other drugs
in its pipeline, but Humira makes up about half its revenues. And the drugmaker
needs to milk that as much as it can, while it can, because Humira's patent expires
in 2016 and it has a target on its back. Because it is the world's best-selling drug,
there are plenty of companies focusing on it as part of their biosimilar plans.
Currently the drug is in its maturity stage.

Comercialization of humira
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Humira is sold in the market as the prescription drug.Extensive strategies are

being adopted to promote the drug to the medical practitioners in order to
arrive to achieve the break even point rapidly and increase the economies of
scale.

New product (humira) pricing.

It is most costly product that has been sold in the market at the exhorbitant price in
order to recover the research and development expenses it has the patent
expiration in 2016 and it had proven the best revenue generating drug for abbot
.one tablet of the humira cost around 50,000INR($ 1000) half of the revenue for the
abbot comes from the humira.

PRICING STRATEGIES
Innovative pricing by novartis for antimalarials.
Price is just one of many factors affecting access to healthcare. We know that novel pricing
models and generic medicines can help expand access, and both are part of our access
programs.

Differential pricing for sustainable access

Differential pricing can help make medicines accessible a treatment that is sold at full
price in developed markets can be provided at a subsidized price in the poorest countries.
As part of our Malaria Initiative, Novartis provides its antimalarial medicine at not-for-profit
prices for public sector use. Since 2004, thanks to economies of scale in sourcing and
manufacturing, significant cost reductions were achieved, which allowed the price to be
reduced by half for public-sector buyers over the years.
Novartis is a company of firsts: the first company to distribute its antimalarials without profit to
endemic countries and the first vaccine manufacturer to create a not-for-profit vaccines research
institute the Novartis Vaccines Institute for Global Health.

Patents and licensing in least developed countries

Novartis does not enforce patents in least developed countries (LDCs). The United Nations
designates these countries as highly disadvantaged in their development process, for
structural, historical and geographical reasons. LDCs are also characterized by their
vulnerability to external economic shocks, natural and man-made disasters and
communicable diseases.
Novartis will grant non-exclusive licenses to qualified third parties to supply our patented
products exclusively to LDCs.

High-quality generic medicines

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Generic medicines can expand access by offering affordable treatments with the same
safety and efficacy after a patent expires.
Novartis is the only major healthcare company with leadership positions in both patented
and generic pharmaceuticals. Our Sandoz Division is the second-largest producer of
generics, and the price points of numerous Sandoz medicines are accessible to 90% of the
worlds population.
Sandoz and its affiliate 1A Pharma often compete in tenders, where the lowest price product
with the best delivery conditions usually wins the contract. Sandoz and 1A Pharma have
successfully tendered bids in numerous African countries.
Sandoz is the leader in biosimilars, which helps improve access to biopharmaceuticals after
patent expiry.

DISTRIBUTION OF PHARMACEUTICALS.
Exclusive distribution of swine flu drug by Hetero
healthcare
Swine flu: Hetero Healthcare increases Fluvir production by 400%
HYDERABAD: City-based Hetero Healthcare Limited, the first pharma company in India to launch antiH1N1 drug Oseltamivir in retail market, today said it has increased its Fluvir production by 400 per cent to
address the presentswine flu outbreak across the country.
Considering the gravity of the present swine flu situation where more than 930 deaths have already been
recorded, Hetero is taking all necessary steps to meet the demand of Fluvir across the country on a
priority basis, Hetero said in a press release.
Hetero is the only Indian pharmaceutical company to have the licensing rights from Hoffmann-La Roche
Ltd to manufacture and supply Oseltamivir in India as well as in other 100 underdeveloped and
developing countries.
Fluvir is the first Oseltamivir drug launched in Indian retail market and available to only exclusive
medical by the government of india for swine flu drugs due to its shortage.
Hetero has dedicated manufacturing facilities at Visakhapatnam in Andhra Pradesh and Baddi
in Himachal Pradesh exclusively to produce the drug. It is fully prepared with adequate raw materials and
manufacturing capacities to meet the demand of Fluvir to treat millions of swine flu patients, the company
said.
Hetero's Marketing Director Srinivas Reddy said the production of Fluvir has been increased significantly
to meet the challenge of the availability of swine flu drugs across India.
"We are also very happy to launch the swine flu helpline number to help the people across India. The
helpline along with our other measures would definitely play a very important role in addressing the
present swine flu situation in India. With our manufacturing facilities for Fluvir, we will be able to deliver
sufficient number of doses to treat more than 20 million people in an emergency situation

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