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The cross currents of the us markets
1. The cross currents of the US markets, the continued allure of the emerging markets and the
potential of a new era of healthcare administration create both uncertainty and a horizon of new
opportunities inthe pharmaceutical industry.
As we enter the second half of 2012, the pharmaceutical majors are proceeding at a cautious
pace. Facing patent expiries for certain key drugs, first-quarter 2012 sales either decreased or
increased modestly for many of the large companies. Manufacturing investment proceeded at a
measured pace, and companies made select bolt-on acquisitions to boost their pipelines.
Insurance issue??? 3rd part and Obama care
Pfizer, perhaps the most important development thus far in 2012 is the revenue loss as a result of
the US patent expiry for its top-selling product, the anticholesterol product, Lipitor
(atorvastatin),,. As a result For the first quarter of 2012, Pfizer’s US revenues declined 15% to $6
billion, and its global revenues declined 7% to $15.4 billion. Pfizer expects to have regulatory
action in 2012 for three key drugs: Eliquis (apixaban), a drug to prevent strokes, which is being
developed with Bristol-Myers Squibb; tofacitinib, a drug to treat arthritis; and the anticancer
drug bosutinib. The company also expects to have Phase III data for bapineuzumab, a drug to
treat Alzheimer’s diseases in mid 2012.
Sanofi’s sales to emerging markets increased 9.9% to EUR 2.6 billion ($3.3 billion). Sales to BRIC (Brazil,
Russia, India, and China) countries were EUR 917 million ($1.1 billion), up 16.5% year over year. Sanofi’s
sales to emerging markets in the first quarter were slightly higher than its sales in the United States,
which were EUR 2.6 million ($3.3 billion) and Western Europe, which were EUR 2.2 billion ($2.8 billion).
Sales to the US increased 15.2% and declined 1.5% in Western Europe in the first quarter of 2012.
Roche. Roche’s first-quarter 2012 pharmaceutical sales increased modestly by 2% to CHF 8.6 billion
($8.95 billion). The company received US regulatory approval for Erivedge (vismodegib), an oral, once-aday capsule for treating adults with basal cell carcinoma. It also received EU approval for Zelboraf
(vemurafeni) for treating metastatic melanoma; the drug had received US approval in 2011. The
company also received priority review from FDA for its biologics license application for pertuzumab, a
monoclonal antibody, to be used in combination with Herceptin (trastuzumab) and docetaxel
chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable breast cancer,
who have not received previous treatment or whose disease has relapsed after adjuvant therapy. FDA is
scheduled to take action later this month
Merck received FDA approval for Janumet XR, an extended-release combination therapy
consisting of sitagliptin and metformin hydrochloride. The company also plans to file a new drug
application in 2012 for suvorexant, a dual orexin receptor antagonist for treating insomnia. And
2. in April, Merck signed an agreement with the Endocyte to develop and commercialize the
anticancer drug vintafolide.
Bristol-Myers Squibb. In May 2012, FDA approved Bristol-Myers Squibb’s biologics
manufacturing facility in Devens, Massachusetts, for commercial production of the company’s
arthritis drug Orencia (abatacept). The $750-million multiproduct bulk biologics manufacturing
facility in Devens represents the largest capital project in the company's history. Also, BristolMyers Squibb acquired Inhibitex, a clinical-stage biopharmaceutical company in February 2012.
The company’s lead compound is INX-189, a nucleotide polymerase inhibitor and antivral drug
candidate in Phase II development.
Eli Lilly. In the first-quarter of 2012, Eli Lilly reported a 4% decline in revenue to $5.6 billion,
which was in part due to the loss of patent exclusivity for the antipsychotic drug Zyprexa
(olanzapine). In May, Eli Lilly announced the opening of a new diabetes R&D center in
Shanghai. The center employs 150 scientists and staff hired primarily from China. Eli Lilly also
is constructing a new insulin production, packaging, and warehouse facility in Suzhou, China,
which is expected to open later this year.
Merck received FDA approval for Janumet XR, an extended-release combination therapy
consisting of sitagliptin and metformin hydrochloride. The company also plans to file a new drug
application in 2012 for suvorexant, a dual orexin receptor antagonist for treating insomnia. And
in April, Merck signed an agreement with the Endocyte to develop and commercialize the
anticancer drug vintafolide.
Bristol-Myers Squibb. In May 2012, FDA approved Bristol-Myers Squibb’s biologics
manufacturing facility in Devens, Massachusetts, for commercial production of the company’s
arthritis drug Orencia (abatacept). The $750-million multiproduct bulk biologics manufacturing
facility in Devens represents the largest capital project in the company's history. Also, BristolMyers Squibb acquired Inhibitex, a clinical-stage biopharmaceutical company in February 2012.
The company’s lead compound is INX-189, a nucleotide polymerase inhibitor and antivral drug
candidate in Phase II development.