PHARMACY

Novartis enters agreement for U.S., Canadian rights for schizophrenia treatment

BY Allison Cerra

EAST HANOVER, N.J. A drug maker has entered an exclusive agreement to launch an oral therapy for the acute treatment of schizophrenia in adults.

Novartis said it has entered into an agreement for exclusive U.S. and Canadian rights to Fanapt (iloperidone) from Vanda Pharmaceuticals, and plans to launch the drug in the United States in early 2010. As part of the agreement with Vanda Pharmaceuticals, Novartis will have exclusive commercialization rights to the oral formulation of this medicine in the U.S. and Canada, as well as exclusive rights to develop and commercialize a long-acting injectable formulation of this medicine for these markets.

Vanda completed phase 3 clinical trials in 2006 and gained U.S. regulatory approval for this medicine in May 2009.

“Schizophrenia remains one of the most chronic and debilitating of the major psychiatric illnesses, underscoring the need for new treatment options,” said Ludwig Hantson, PhD, head of Pharma North America, CEO, Novartis Pharmaceuticals Corp. “With the launch of Fanapt in early 2010, we will broaden our presence in psychiatry and build on the heritage of Novartis in offering innovative treatments for devastating psychiatric diseases.”

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IMS Health forecasts growth in U.S., global pharmaceutical markets

BY Alaric DeArment

NORWALK, Conn. Strong near-term growth in the U.S. pharmaceutical market will drive growth in the global pharmaceutical market, according to a forecast by market research firm IMS Health.

In its IMS Market Prognosis report, the firm forecasted market growth of 4% to 6% on a constant dollar basis next year, exceeding $825 billion, with an expansion of up to 7% through 2013, when the total market value will expand to at least $975 billion. Growth in the United States, likely to be 3% to 5% in 2010, is expected to drive global growth.

“Overall, market growth is expected to remain at historically low levels, but stronger-than-expected demand in the U.S. is living both our short- and longer-term forecasts,” IMS SVP healthcare insight Murray Aitken said in a statement. “The economic climate will continue to be a dampening influence in most mature markets, particularly in those countries with rising budget deficits and publicly funded healthcare systems.”

Blockbuster drugs that generate $137 billion in sales a year – particularly Pfizer’s Lipitor (atorvastatin calcium), GlaxoSmithKline’s Seretide (fluticosone propionate and salmeterol xinafoate) and Plavix (clopidogrel bisulfate), by Sanofi-Aventis and Bristol-Myers Squibb – will lose patent protection over the next five years and face generic competition. At the same time, new drugs that treat diseases such as cancer, osteoporosis and multiple sclerosis are unlikely to generate the same sales as the blockbuster drugs. These two factors will combine to dampen growth prospects, according to IMS.

Still, growth prospects in the United States have improved, the report said. Pharmacy chains have more tightly managed their inventory levels based on expectations of patient demand, which has increased purchasing volatility but also created higher-than-expected sales growth in first quarter 2009. Meanwhile, papers have sought to limit price increases and boost the use of generic drugs.

“In the U.S., pricing flexibility and inventory management actions are contributing to much higher growth than anticipated earlier this year and are the main reasons for the upward adjustment to our five-year forecast,” Aitken said.

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Sanofi Pasteur: H1N1 shot boosts immune response

BY Michael Johnsen

LYON, France Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Thursday announced that a single dose of influenza A (H1N1) 2009 monovalent vaccines, Panenza (15 mcg dose, non-adjuvanted) or Humenza (3.8 mcg dose, adjuvanted), administered to children (3 years of age and older) and adults just one time induces a robust immune response that is considered protective in 93% or more of adults 18 to 59 years old and in 83% or more of adults 60 years of age and older, according to results from clinical trials conducted in Europe.

In children 3 years of age through 17 years of age, 94% or more of study participants achieved seroprotective antibody response.

“These significant clinical data concerning Sanofi Pasteur’s pandemic influenza vaccines will help build public confidence in the vaccine and will support efforts by health authorities to face the challenge posed by pandemic influenza,” stated Wayne Pisano, president and CEO of Sanofi Pasteur.

The results are based on interim analysis following the first vaccination dose from clinical trials conducted in France and Finland. No serious adverse events have been observed to date in these clinical trials. Local injection site (redness, swelling and pain) and systemic complaints of mild fever, headache and fatigue were reported.

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