Pfizer Fails to Maintain Patent on Norvasc in Canada

From Bloomberg:
Pfizer Inc., the world’s biggest drugmaker, failed to maintain its patent on the hypertension drug Norvasc in Canada after a federal judge granted Ratiopharm GmbH permission to sell a generic version of the medicine.

More than 7.8 million prescriptions of amlodipine besylate, marketed by Pfizer as Norvasc, are sold annually in Canada, Ulm, Germany-based Ratiopharm said today. A generic version probably will save Canadian patients about C$180 million ($155 million) a year, the closely held company said. Pfizer said it will appeal.

“We are extremely pleased at the decision by the Federal Court,” Jean-Guy Goulet, chief executive officer of Ratiopharm Canada, said in a statement. “This decision opens the amlodipine patent to generic manufacturers in Canada, the last major jurisdiction where the patent was held.”

Ratiopharm challenged the Canadian patent in 2004 and won in 2006. Pfizer successfully reversed the ruling on appeal. Ratiopharm then sued to invalidate Pfizer’s patent, with Judge Roger Hughes ruling in favor of Ratiopharm yesterday. ...more

HIV deal shows need for new pharmaceutical models

From Reuters:
The pharmaceutical industry is going back to the lab for its business models as it faces historic challenges.

Large drugmakers are experimenting with various collaborations as their major products face revenue declines, research productivity stalls, and governments and health insurers crack down on drug prices and healthcare costs.

The new ventures -- from deals on products to mega mergers -- seek to meet these challenges by cutting costs and mitigating the risks of research into new treatments.

Look no further than Thursday's deal between GlaxoSmithKline Plc and Pfizer Inc. The world's two biggest drug companies announced plans to merge their HIV operations into a new company.

"Pharma is feeling its way," said Erik Gordon, a professor at the Ross School of Business at the University of Michigan. "They know that the present business model isn't going to work in the future ... What they're not sure of is what will work." ...more

Pfizer to set up 600 smoking cessation clinics in 2 years

It looks like Pfizer will opt for a more direct approach when they are selling Champix in India. With the relatively open pharmaceutical laws, it could work there. I wonder how objective these clinics will be. Nonetheless, it's an innovative concept.

From the Economic Times (India):
Pfizer India plans to launch 600 smoking cessation clinics across the country in the next two years in partnership with private sector hospitals and clinics. Pfizer India director (pharmaceutical marketing) Anjan Sen said: “We have already tied up with 150 clinics in 17 cities, including Max Healthcare, and are in talks with more hospitals for partnerships. We are also in talks with the government to use this as a treatment option in the 600 clinics that they plan to set up.”

The government had last year announced to launch same number of clinics. The government clinics will use nicotine replacement therapies (NRT) like chewing gum and patches, along with counselling, to help people quit smoking, a method that doctors say has far less success rate than medication which blocks the receptors in the brain absorbing nicotine.

According to Mr Sen, the government will shortly conduct a clinical trial of the Pfizer drug, Champix, to check its efficacy and if satisfied it will become a part of the government’s anti-smoking programme. ...more

Pfizer buys Wyeth for $68-billion

From the Globe and Mail:
Pfizer Inc. is buying rival drug maker Wyeth in a $68-billion (U.S.) deal that will increase its revenue by 50 per cent, solidify its No. 1 rank in the troubled industry and transform it from a pure pharmaceutical company into a diversified health care giant.

At the same time, Pfizer announced cost cuts that include slashing more than 8,000 jobs as it prepares for an expected revenue crash when its cholesterol drug Lipitor — the world's top-selling medicine and source of one-quarter of Pfizer's revenue — loses patent protection in November, 2011.

There was no immediate word on whether the cuts would impact the company's Canadian operations, which employ more than 1,400 staff at facilities in Alberta, Ontario and Quebec.

The cash-and-stock deal, expected to close at the end of the third quarter or in the fourth quarter, comes as Pfizer's profit takes a brutal hit from a $2.3-billion legal settlement over allegations it marketed certain products for indications that have not been approved. The New York-based company is also cutting 10 per cent of its work force of 81,900, slashing its dividend, and reducing the number of manufacturing sites from 46 to 41. Those closures, and reducing its facilities square footage by about 15 per cent, will cost about $6-billion before taxes, of which $1.5-billion has been incurred, Pfizer said.

After the deal closes Pfizer expects to cut more jobs. The company said it expects eventually to cut the companies' combined work force by 15 per cent, a figure that the Pfizer cuts announced Monday. ...more

Pfizer Wins Canadian Order Blocking Generic Version of Lipitor

From Bloomberg:
Pfizer Inc., the world's biggest drugmaker, won a Canadian appeals court ruling blocking regulatory approval of Ranbaxy Laboratories Ltd.'s generic version of the cholesterol pill Lipitor.

Canada's Federal Court of Appeal yesterday reversed a lower-court ruling that Ranbaxy could seek approval for its competing version of Lipitor before Pfizer's patent expires in 2010, Pfizer spokeswoman Vanessa Aristide said in a phone interview.

Ranbaxy, India's largest drugmaker, also challenged Lipitor patents in the Netherlands. Pfizer said in February it would appeal a Dutch ruling invalidating one of its patents covering Lipitor, the world's best-selling medicine with ales of $12.7 billion last year. Ranbaxy can appeal yesterday's ruling to Canada's Supreme Court. The order doesn't apply to litigation in other countries, including the U.S., Aristide said. ...more

Pfizer vows to fight Canadian firm's version of Lipitor

Could we be seeing a Canadian generic version of Lipitor available in 2008? I suspect that this is merely one skirmish in a long legal battle between Apotex and Pfizer.

From the Canadian Press:
US drug giant Pfizer said Thursday it will appeal a Canadian federal court decision paving the way for the pharmaceutical firm Apotex to launch a generic version of its anti-cholesterol drug Lipitor.

The court had previously denied Pfizer's request to prevent Apotex from launching a generic version of Lipitor prior to the expiration of a Pfizer patent in July 2010.

The drug (atorvastatin calcium) has generated 13 billion dollars in sales worldwide for Pfizer, making it the leading cholesterol-lowering medication. ...more

Pfizer says Canadian court blocks generic Celebrex

From the Financial Post:
Pfizer Inc. said yesterday the Federal Court of Appeal of Canada has blocked generic drugmaker Teva Pharmaceutical Industries Ltd. from launching a copycat form of its Celebrex arthritis drug in the country until 2014.

Pfizer said the court, in its ruling, reversed a lower court ruling that would have permitted Teva's Novopharm affiliate to launch its form of Celebrex in Canada.

The patent concerned the chemical composition of Celebrex, Pfizer spokesman Bryant Haskins said. ...more