Prexige

SPOTLIGHT: Prexige gets the boot in UK, Germany

Mon, 19 Nov 2007 06:59:52 -0500

Drug regulators in the UK, Germany, and Austria have suspended Novartis' license to sell Prexige, an arthritis drug linked to possible liver damage. Report | Report

Wyeth CEO: FDA creating monopoly meds

Mon, 05 Nov 2007 06:59:55 -0500

U.S. drug regulators aren't playing fair, says outgoing Wyeth CEO Bob Essner. New meds that should be allowed on the market--because they're safe and effective--are blocked if they're not demonstrably better than existing products. That effectively hands monopoly status to the first company to market with a given type of drug, Essner says.

Essner is echoing concerns raised by Novartis CEO Daniel Vasella (photo), who questioned the FDA's right to ask whether new drugs are better than those already being sold. Both companies suffered painful denials recently, Wyeth for bifeprunox, a schizophrenia treatment, and Novartis for Prexige, a painkiller.

- check out the report from the Financial Times
- read this interview for more

Related Articles:
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report

Novartis gains Aclasta, loses Prexige

Fri, 05 Oct 2007 06:59:57 -0400

From the good news, bad news file: Novartis got the EU's approval to sell its new osteoporosis drug Aclasta, known in the U.S. as Reclast. Reclast got the FDA's nod six weeks ago, and analysts are saying the drug is likely to generate $1.2 billion in sales by 2011--which unfortunately happens to be the year when its active ingredient goes off patent.

Practically simultaneously to the E.U.'s blessing on Aclasta, Canadian regulators pulled the pain pill Prexige because of the same liver-damage fears that brought it down in Australia in August. Some experts called Health Canada's ban a "knee-jerk" reaction; others questioned the fact that Prexige was approved at all, considering that it's a Cox-2 inhibitor, a class of drugs known to cause serious side effects.

You'll recall that Novartis and its stock analysts had big hopes for Prexige, once predicting yearly sales of $1 billion or more. So far this year, it's only generated $52 million.

- here's the press release on Aclasta
- see the MarketWatch article about Aclasta
- read this report on Prexige

Related Articles:
FDA says Aclasta "approvable" for Paget's. Report
Novartis' Reclast gets FDA blessing. Report
Australia bans Novartis' Prexige. Report
Vasella doubtful of Prexige approval. Report

Diabetes drugs linked to fracture risk

Thu, 04 Oct 2007 06:59:56 -0400

One more strike against diabetes drugs. Australia's regulators are warning that the class of drugs including Avandia and Actos may boost the risk of bone fractures in older women.

A four-year study of 4,360 patients showed that post-menopausal women taking one of the thiazolidinediones were more likely to break a bone. The Therapeutic Goods Administration won't withdraw the drugs, but manufacturers are warning doctors about the newly identified risks.

- read the report from the Sydney Morning Herald

Related Articles:
Avandia, Actos don't boost death risk. Report
Actos on a good-news roll. Report
Avandia risks back in the headlines. Report
Australia bans Novartis' Prexige. Report

FDA rejects embattled Novartis drug

Thu, 27 Sep 2007 06:59:55 -0400

Is expected bad news better than unexpected bad? Ask Novartis. Today the company announced the FDA's rejection of the Cox-2 painkiller Prexige--a thumbs-down that CEO Daniel Vasella predicted last week. But it might not be the agency's final word.

Prexige, of course, was banned in Australia last month, after reports of severe liver-related side effects--including two deaths. Now, the company says it won't give up on the drug; the FDA is open to exploring the use of Prexige in people who might benefit most, such as ulcer patients who can't take other pain remedies.

Meanwhile, apparently looking for ways to wipe Prexige's slate clean, Novartis has asked the FDA for another approval--to change the drug's brand name.

- see this press release from Novartis
- read more from Swiss Info

Related Articles:
Australia bans Novartis' Prexige. Report
Novartis CEO Vasella doubtful of Prexige approval. Report
UK doctors warned over Novartis' Prexige. Report

SPOTLIGHT: Vasella doubtful of Prexige approval

Thu, 13 Sep 2007 06:59:52 -0400

The FDA probably won't approve the Novartis painkiller Prexige now that it's faced regulatory action in other countries, according to CEO Daniel Vasella. Report

ALSO NOTED: New Zealand bans high dose of Prexige; Merck, Newron continue safinamide development;

Wed, 22 Aug 2007 06:59:50 -0400

> Add New Zealand to the list of countries banning high doses of Prexige, Novartis' Cox-2 inhibitor that's been linked to liver damage. Both 200 mg and 400 mg strengths will be pulled from the market; the 100 mg tablets will still be sold, but their use will be "closely monitored." Report

> Merck and partner Newron are pledging to press ahead with their Parkinson's remedy safinamide, despite a failed Phase III trial that tested the drug on patients in the disease's early stages. Newron says it's planning new trials of safinamide in patients with mid- to late-stage Parkinson's. Report

> Another drug maker/government scandal in Minnesota: The state's Department of Human Services has been using a contractor funded by Eli Lilly to police prescriptions for psychotropic drugs--at no charge. FierceHealthcare

> India's drug-price regulators are seeking to control the cost of an anti-parasite medication sold by more than 80 companies to the tune of some $660 million annually, including GlaxoSmithKline, which has 45 percent of that market. The government thinks the tablet form of the drug is 8.5 times more costly than it should be, and the suspension form is 2.5 times too expensive. Report

And Finally... McKinsey & Co. apparently thinks India's appeal will surpass any Section 3(d)-related, intellectual property drawbacks. The management consulting firm predicts that the country's pharmaceuticals industry will grow by 12 percent per year to reach $20 billion by 2015, partly on the strength of India's growing domestic healthcare industry. Report