Shire

Shire recalls ADHD drug patches

Tracy Staton — Mon, 25 Aug 2008 10:46:13 -0400

Drug patches have had a tough time lately, with recalls coming on everything from too-tight adhesive to slits in active-ingredient reservoirs. Today, the recalled patch in the news is Shire's Daytrana, an attention deficit hyperactivity disorder med. Two lots were withdrawn on concerns about the patch's liner, which could be difficult for patients to remove before applying the patch. Shire recalled a limited number of patches for the same reason just a year ago.

Shire sells the patches on license from Noven Pharmaceuticals, which sent out a statement saying that it has identified the "definitive root cause" of the defect and is now "aggressively testing potential solutions."

- read the Associated Press article

Is Shire worth a 25% premium?

Tracy Staton — Mon, 16 Jun 2008 09:38:46 -0400

Can Shire weather the upcoming loss of Adderall XR to the off-patent wildnerness? Company execs say it can: They point out that 60 percent of the company's revenues derive from other products. And they say Vyvase, their new ADHD med, will pick up the Adderall slack--despite the fact that its uptake so far hasn't met expectations. But as Barron's points out, Shire is trading now at 15 times earnings, a 25 percent premium to the current industry multiple of 12 times. If the FDA doesn't listen to Shire's petition--which calls for XR copycats to undergo clinical trials--then generics will hit the market next year. And if Vyvanse doesn't step up to the plate, "Shire wouldn't merit its 25 percent premium," Barron's bluntly states. That's a lot of "ifs"--on either side.

- see the Barron's analysis

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

Rumor Mill: AZ a possible Shire suitor

Tue, 18 Mar 2008 07:59:58 -0400

Shire is suddenly the talk of the town as investors and investment banks publicly mull a match-up with AstraZeneca. The U.K. drugmaker's stock gained 7 percent today after UBS said AstraZeneca could bid for Shire at a 40 percent premium and still create value. And this comes after big gains last Friday on rumors that Pfizer might put in a bid.

What's UBS's thinking? The Swiss bank said its analysis showed that even at a 40 percent premium, Shire would boost AstraZeneca earnings by 2 percent to 9 percent from 2009 to 2011. But here's the caveat: In raising money to help buy Shire, AstraZeneca might run into issues "with certain loss scenarios on Seroquel and Nexium," big sellers that go off patent soon. Moreover, UBS stated, "A bid would to us confirm that many of AstraZeneca's problems are in fact related to long-term maintenance of margins." Really.

Other analysts said that though an AstraZeneca buyout of Shire would be more plausible than a Pfizer deal, AstraZeneca and Shire aren't a natural fit. The merger talk may say more about investors' desire for a big-news deal than about what's really going on. Plus, deal speculation is more fun than worrying about which economic shoe will drop next.

- see the story in The Times
- get more details on UBS' analysis in The Guardian
- more analysts handicap a deal at Trading Markets

ALSO: AstraZeneca could face its first Seroquel challenger next week as a patent expiration puts Teva Pharmaceutical Industries in position to launch its version of the drug at risk. The med delivered $4 billion to AZ's top line last year. Report

Related Articles:
Shire stock jumps on Pfizer rumors. Report
Analyst: AZ "worst performer" in pharma. Report
AstraZeneca lays out road map for recovery. Report

SPOTLIGHT: Investors expected to boost GSK, AZ

Wed, 09 Jan 2008 06:59:52 -0500

Credit Suisse lifted its share-price targets for GlaxoSmithKline, AstraZeneca, and Shire, saying it expects the pharma sector to be something of a port in a storm for investors worried about the economy. Report

Shire investor objects to CEO shift

Mon, 17 Dec 2007 06:59:57 -0500

One of Shire's shareholders is crying foul at the drug maker's big management reshuffling announced last week. You'll recall that Shire tapped its current CEO as non-executive chairman and promoted its CFO to CEO, effective in June. The Association of British Insurers, however, says the moves may amount to a breach of the UK's best governance practices. Worse, it may herald a downturn in Shire's fortunes.

ABI director of investment affairs, Peter Montagnon, said that the organization did talk to Shire ahead of the announcement, but it didn't approve the moves. A non-executive chair is supposed to be a check on company officials' strategies, so if the chairman was the CEO who developed the strategy, "he is supervising himself," Montagnon said. "There are risks in that." Other companies that have elevated their CEOs to chairman "did not perform terribly well," Montagnon added.

ABI members own about one-fifth of Shire's equity. Next step? Polling those members to see whether they object to the moves.

- read the report from the Financial Times

Related Articles:
Shire surprises by tapping new CEO. Report
New guard takes over Big Pharma. Report
Shire on lookout for acquisitions. Report
Shire to Massachusetts: Pass incentive bill now. Report

Shire on lookout for acquisitions

Fri, 02 Nov 2007 07:59:55 -0400

Fresh off its best quarterly results ever, Shire says it's still in the market for smaller companies to buy. "That is how we get new products," CEO Matthew Emmens said.

Shire's 41 percent third-quarter sales growth led the company to boost its year-end forecast--it's now expecting revenues to increase 30 percent or more. What's driving it? Newer products such as Fosrenol for dialysis patients and Elaprase for the genetic condition Hunter Syndrome. Vyvanse, the company's next generation attention deficit hyperactivity drug also is growing in the U.S., where it launched over the summer and captured 4 percent of the market since. A lot hinges on Vyvanse; Shire hopes it will replace ADHD blockbuster Adderall XR, which goes off patent in 2009.

- read the report from the London Telegraph

Related Articles:
Who's next on the biotech buyout hit list? Report
More takeover targets for Big Pharma. Report
Should Pharma take the M&A cure? Report
Shire to Massachusetts: Pass incentive bill now. Report
FDA approves Shire's new ulcerative colitis drug. Report

ALSO NOTED: Korea fines pharma firms for kickbacks; Medco boosts profits 16 percent;

Thu, 01 Nov 2007 07:59:50 -0400

> Ten Korean drug makers were fined $22 million for illegal rebates to hospitals and wholesalers. Report

> Pharmacy-benefits giant Medco Health Solutions posted a 16 percent hike in third-quarter profits and boosted its year-end earnings outlook again. Report

> Shire boasted a 41 percent increase in sales for the quarter, to $543 million, and raised its prediction for 2007 revenue growth to 30 percent from 25 percent. Release

> Shire also appointed MedImmune CEO David Mott as non-executive director; Mott also is executive vice president of AstraZeneca, which owns MedImmune. Report

> Drugs distributor Amerisource Bergen saw fourth-quarter profits fall 28 percent because of a big writedown on vaccine inventories. Report

> Smith & Nephew reported a 16 percent increase in adjusted earnings per share on a 24 percent increase in revenue to $845 million. Report

> A revolution in genomics and molecular biology has spurred a burst of new development activity in the vaccines business. Report

And Finally... Nematode worms treated with lithium live 46 percent longer. Would humans? Report

Shire casts off non-core drugs for $213M

Mon, 08 Oct 2007 06:59:57 -0400

UK-based Shire Pharmaceuticals is selling a block of medicines to Almirall of Spain for $213 million. The remedies--deemed "non-core products"--include two skin treatments, Solaraze and Vaniqa. Company officials say the move will let Shire focus on its core therapeutic areas: attention deficit disorder, gastrointestinal and renal disease, and genetic therapies.

The company also wants to expand its international reach and develop a new specialty in regenerative medicine. Recently Shire licensed the anti-scarring remedy Juvista from Renovo, in its first foray into the regenerative arena.

- see the release from Shire
- check out this article for more

Related Articles:
Shire to Massachusetts: Pass incentive bill now. Report
FDA signals a quick approval for Shire's ADHD drug. Report
Shire snares New River Pharma in $2.6B buyout. Report
Shire gambit aimed at delaying generic Adderall XR. Report