Nexium

PPIs increase fracture risk

Christe Bruderlin-Nelson — Wed, 13 Aug 2008 06:17:13 -0400

Patients with heartburn, GERD, peptic ulcers or other conditions who take proton pump inhibitors to relieve symptoms are at increased risk of fractures, according to a large new study of patients aged 50 an older.

The study says the risk is for osteoporosis-related fractures, specifically for hip fractures. The risk for hip fractures shows up after 5 years of continuous use, but after 7 years, the risk of all fracture types goes up. The study did not show any correlation between fracture risk and short-term exposure to the medication class.

The findings are significant because most patients use these medications for the long haul, often indefinitely. The study looked at patients who had hip, spine or wrist fractures and included a control group with no history of any fractures in these areas.

- read the story at PharmaLive
- review the Canadian Medical Association Journal study
- see a study commentary in CMAJ

AZ reaffirms whole-hog API outsourcing

Wed, 30 Apr 2008 06:59:54 -0400

Remember last fall when AstraZeneca EVP David Smith said the company was looking to outsource most of its manufacturing? And the ensuing outcry had AstraZeneca's PR operation backpedaling like crazy?

Well, after AstraZeneca settled its differences with Ranbaxy Laboratories, Smith's boss affirmed a big chunk of those outsourcing plans. In a conference call about the Ranbaxy deal, CEO David Brennan (photo) said that AstraZeneca wants to outsource all API manufacturing within 10 years. AstraZeneca, remember, agreed to hand over manufacturing of Nexium's active ingredient to Ranbaxy as part of the settlement. "This move is absolutely consistent with our supply chain strategy," Brennan said. "We have long-term plans to exit all API production over the next five to 10 years."

While that's not exactly "most" of AstraZeneca's manufacturing, it is a sizable shift. Stay tuned.

- see the article in Contract Pharma

ALSO: India's Dr. Reddy's laboratories agreed to buy BASF's contract manufacturing plant in Shreveport, LA, which focuses on turning out finished prescription and OTC liquids, tablets, and creams for the U.S. market. Terms weren't disclosed, but the business brought in $43 million for BASF last year. Report

AZ, Amgen earnings flat; Shire sales leap

Fri, 25 Apr 2008 06:59:54 -0400

It's a mixed bag of drugmaker earnings reports today, with two biggies posting flat results and two smaller firms chalking up respectable gains.

AstraZeneca's profits suffered under restructuring costs and falling Nexium sales, reporting a $2.1 billion gain, 5 percent less than the same quarter last year. Sales were 10 percent higher at $7.7 billion, but much of that increase came from the weak dollar. Analysts and shareholders were unimpressed; UBS wrote that the "ramifications of [the first quarter results] could be far reaching."
Amgen's earnings were mostly flat: Net income of $1.14 billion compared with $1.11 billion a year ago, with accounting charges eating into earnings. Revenues, however, slid by 2 percent, to $3.61 billion. No big surprise, considering that sales of its biggest drug, Aranesp, free-fell by 25 percent; it and its sister med Epogen have been hamstrung by safety concerns for months now.
U.K. specialty pharma Shire posted a 33 percent hike in sales to $702 million, slightly ahead of analyst expectations. EPS was up to 22.7 cents from 21.3 cents during last year's first quarter. One sour note: The company estimated that its Vyvanse ADHD drug--which the company hopes will replace its soon-to-go-off-patent Adderall--would generate sales on the "lower end" of its predicted range of $350 million to $400 million.
Ireland's Elan also posted a big increase in sales--22 percent, to $214.7 million--but still reported a loss of $85.5 million. At least the loss is smaller than last year's $93 million. The revenue increase came from surging sales of its lead drug, the MS treatment Tysabri it co-markets with U.S.-based Biogen Idec.

- see the AstraZeneca piece in the Financial Times
- check out MarketWatch's story on Amgen
- read the Shire article at Orange
- find Elan's numbers in Forbes

AstraZeneca, Ranbaxy settle Nexium fight

Tue, 15 Apr 2008 06:59:58 -0400

AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. The copycat company agreed to wait till 2014 to sell its version of the heartburn med Nexium, AstraZeneca's top selling drug with $5.22 billion in revenues.

That's a huge coup for AstraZeneca, which has been fighting off the generic challenge since 2005. But it's also a good deal for Ranbaxy: the Indian drugmaker gets U.S. distribution rights to two off-patent AstraZeneca meds, Prilosec and Plendil, and will start supplying the active ingredient in Nexium to AstraZeneca beginning in 2009.

AstraZeneca still faces patent challenges on Nexium from Teva Pharmaceutical Industries and India's Dr Reddy's, but analysts said that Ranbaxy's willingness to settle may signal the strength of AstraZeneca's case. Market watchers also upped AstraZeneca's target share price.

- check out the press release from AstraZeneca
- read the piece in the Financial Times
- see the Wall Street Journal story
- find out how the market reacted at CNN Money

Related Articles:
AstraZeneca rivals could launch any day. Nexium report
FDA to review Nexium, Prilosec. Nexium report
Canada questions safety of Nexium, Prilosec. Nexium report
Nexium formulation wins FDA approval. Nexium report

AstraZeneca rivals could launch any day

Mon, 07 Apr 2008 06:59:56 -0400

You can bet the execs at AstraZeneca are biting their nails this week. Next Monday, April 14, marks the end of a 30-month stay on Ranbaxy Laboratories' copycat form of the mega-blockbuster Nexium. And a similar stay against Teva's Seroquel generic ran out March 26. Neither company will say whether they plan to launch the cheaper rivals that are waiting, FDA-approved and ready to go, in the wings.

Lawsuits over the meds' patents still are pending. AstraZeneca says Seroquel is protected till 2011 and Nexium till 2014. But Teva and Ranbaxy could launch at risk if they think their patent challenges will eventually prevail.

- read the article from the Wall Street Journal

ALSO: As part of its global restructuring--prompted in part by generic competition and in part by pipeline troubles--AstraZeneca will cut 132 jobs from its Spanish operations, despite strong growth in the country last year. Report

PLUS: When it comes to drug development, is bigger really better? That is the question Borje Eckholm, president and CEO of Investor AB--and one of AstraZeneca's biggest shareholders--poses in the London Times. Report

Related Articles:
FDA to review Nexium, Prilosec. Report
Canada questions safety of Nexium, Prilosec. Report
Nexium formulation wins FDA approval. Report