Shire Plc

WASHINGTON - The Food and Drug Administration said Thursday it approved a drug from Shire PLC to treat a rare inherited disease that can cause dangerous swelling in the limbs, face and intestines. The drug Firazyr was approved to treat flare-ups of hereditary angioedema, a condition that affects less than 30,000 people in the United States. The disease can cause rapid swelling of the hands, feet, windpipe and other internal organs, which can cause disfigurement and even death.

Shire P.L.C., maker of the attention-deficit-hyperactivity-disorder medication Adderall XR, has held off a second rival company from marketing a cheaper generic version of its top-selling drug, the companies said yesterday. In doing so, Shire has agreed to sell to Barr Laboratories Inc. an earlier form of its drug for $63 million. It also has entered into a partnership with Barr to co-market Barr's new contraceptives, including one designed essentially to eliminate a woman's period.

Powered by higher-than-expected sales of its new ADHD drugs, Shire P.L.C. yesterday reported a tripling of fourth-quarter net income to $212.1 million from $68.6 million a year earlier. The maker of top-selling Adderall XR for attention-deficit/hyperactivity disorder also said fourth-quarter revenue rose 46 percent to $724.5 million from $497 million in 2006's last quarter. Shire is based in Britain with U.S. headquarters in Wayne. The company projects 2008 revenue growth in the mid- to high-teens range and says sales will keep growing at least through 2010.

Shire P.L.C., the Britain-based pharmaceutical company with major operations in Wayne, said yesterday that profit fell 44 percent in the second quarter due to the high cost of marketing new products and absorbing another company last year. The maker of Adderall XR, the world's best-selling drug for attention deficit hyperactivity disorder, already had been expecting a big decline because of its $1.6 billion acquisition last year of Transkaryotic Therapeutics, renamed Shire Human Genetic Therapies.

What does this say about a drug company? The lobby walls at Shire P.L.C. bear no paeans to good health, no maxims of venerable founders, no gilded corporate logos - all standard foyer fare. Instead Shire, Britain's third-largest drug company, greets all comers to its North American headquarters in Wayne with this: A stock ticker. Call it honest. Half of Shire's revenue hinges on sales for one controversial condition, attention deficit hyperactivity disorder, or ADHD.

Shire P.L.C. yesterday reported a 19 percent rise in third-quarter revenue as it continues to expand its share of the U.S. market for attention deficit hyperactivity disorder medicines. The British drugmaker, which has major operations in Wayne, makes the world's best-selling ADHD drug, Adderall XR. Shire said its total share of the U.S. ADHD market rose to 29 percent from 26 percent at the end of June. For its third quarter that ended Sept. 30, Shire posted net income of $87.2 million, or 17 cents a share, compared with a loss of $630.

Shire P.L.C., a specialty pharmaceutical company with its U.S. headquarters in Wayne, reported a 35 percent jump in revenues for the second quarter, to $849 million. The firm, which is based in Dublin, Ireland, and has headquarters in Basingstoke, England, reported $224 million in earnings, a 547 percent increase from last year. Earnings per share for the quarter ended June 30 were 86 cents, up from 24 cents last year. Shire benefitted from robust sales of its top-selling drugs, including Vyvanse, an treatment for ADHD, and Replagal, a treatment for Fabry disease, a rare genetic condition where cells fail to properly process waste material.

Shire P.L.C. chief executive officer Matthew Emmens will become nonexecutive chairman of Britain's third-largest drugmaker in June, after five years at the helm. Angus Russell, 51, Shire's chief financial officer since 1999, will succeed Emmens as chief executive. Emmens, 56, will become chairman, after the retirement of James Cavanaugh, 70, who told the board in the spring that he would retire next June. "The board ultimately asked me if I'd like to be chairman," said Emmens, who lives in Malvern and opened Shire's U.S. headquarters in Tredyffrin Township, Chester County, in 2004.

Shire P.L.C. announced today that it had agreed to purchase Belgium's Movetis NV for euros 428 million (about $566 million). Drugmaker Movetis specializes in gastrointestinal medications and currently holds a patent for Resolor, a treatment for chronic constipation. Shire, which is based in Dublin, Ireland, and has headquarters in Basingstoke, England, and U.S. headquarters in Wayne, expects that the drug, which is approved for sale in 30 European countries, will eventually bring in euros 300 million a year.

In the Region DRPA to borrow $320 million The Delaware River Port Authority plans to borrow $320 million, the agency said. The DRPA, jointly set up by Pennsylvania and New Jersey, may benefit from a sparse market for debt, said John Flahive, Boston-based director of fixed income for BNY Mellon Wealth Management , which manages about $20 billion in municipal bonds. "You won't have a lot of competition, so it's not a bad time to come to the market," Flahive said in an interview.

WASHINGTON - The Food and Drug Administration said Thursday it approved a drug from Shire PLC to treat a rare inherited disease that can cause dangerous swelling in the limbs, face and intestines. The drug Firazyr was approved to treat flare-ups of hereditary angioedema, a condition that affects less than 30,000 people in the United States. The disease can cause rapid swelling of the hands, feet, windpipe and other internal organs, which can cause disfigurement and even death.

Shire P.L.C., a specialty biopharmaceutical company with North American headquarters in Wayne, said Tuesday that it agreed to pay $750 million for Advanced BioHealing Inc. Advanced BioHealing's key product is Dermagraft, which is designed to be used to treat diabetic foot ulcers. The company's U.S. facilities include a headquarters in Westport, Conn., a manufacturing facility in La Jolla, Calif., and a research center in Brentwood, Tenn. "This acquisition is a strong and complementary strategic fit for Shire," Mike Cola, president of Shire's specialty pharmaceuticals business, said in a statement.

In the Region Hired in May, president departs Destination Maternity Corp. president Emilia Fabricant resigned after less than three months on the job, the Philadelphia clothing retailer said Wednesday. Fabricant cited her desire to return to Southern California to be with her family. Fabricant had been president and chief merchandising officer of Charlotte Russe. Destination Maternity chief executive officer Ed Krell will also serve as president, the company said. - Paul Schweizer Shire earnings sharply higher Shire P.L.C.

Shire P.L.C., a specialty pharmaceutical company with its U.S. headquarters in Wayne, reported a 35 percent jump in revenues for the second quarter, to $849 million. The firm, which is based in Dublin, Ireland, and has headquarters in Basingstoke, England, reported $224 million in earnings, a 547 percent increase from last year. Earnings per share for the quarter ended June 30 were 86 cents, up from 24 cents last year. Shire benefitted from robust sales of its top-selling drugs, including Vyvanse, an treatment for ADHD, and Replagal, a treatment for Fabry disease, a rare genetic condition where cells fail to properly process waste material.

Shire P.L.C. announced today that it had agreed to purchase Belgium's Movetis NV for euros 428 million (about $566 million). Drugmaker Movetis specializes in gastrointestinal medications and currently holds a patent for Resolor, a treatment for chronic constipation. Shire, which is based in Dublin, Ireland, and has headquarters in Basingstoke, England, and U.S. headquarters in Wayne, expects that the drug, which is approved for sale in 30 European countries, will eventually bring in euros 300 million a year.

Shire P.L.C. has received FDA approval for its ADHD treatment Daytrana to be used for teens age 13 to 17. The medication, which is administered by transdermal patch, had been approved previously by the U.S. Food and Drug Administration for patients age 6 to 12. It is a treatment designed to be used in conjunction with psychological, educational and other measures. Shire, which is based in Dublin, Ireland, has headquarters in Basingstoke, England, and operations in Chester County.

Shire P.L.C. overstates the benefits of Intuniv, its drug for attention deficit hyperactivity disorder in children, in promotional materials, U.S. regulators said. The company has operations in Chester County. Brochures in a patient starter kit for the drug make "unsubstantiated effectiveness claims" and "omit and minimize important risk information," the Food and Drug Administration said in a June 22 letter to the company posted today on the agency's website.    - Bloomberg News A spokeswoman for Shire didn't immediately return telephone calls seeking comment.

Shire P.L.C. is hoping that one day soon investors will pay less attention to its attention-deficit drug franchise. The company's drugs in this category, which include Adderall XR and Vyvanse, accounted for about one-third of Shire's second-quarter sales. That figure at one time was as high as 50 percent. But even though the company has diversified its revenues, attention-deficit hyperactivity disorder treatments remain so dominant that after Adderall XR faced its first generic competition in April, Shire's second-quarter sales shrank 19 percent from a year ago. Chief executive Angus Russell, who is based at the Wayne U.S. headquarters of the British company, thinks that performance signals success.

Shire P.L.C. is hoping that one day soon investors will pay less attention to its attention-deficit drug franchise. The company's drugs in this category, which include Adderall XR and Vyvanse, accounted for about one-third of Shire's second-quarter sales. That figure at one time was as high as 50 percent. But even though the company has diversified its revenues, attention-deficit hyperactivity disorder treatments remain so dominant that after Adderall XR faced its first generic competition in April, Shire's second-quarter sales shrank 19 percent from a year ago. Chief executive Angus Russell, who is based at the Wayne U.S. headquarters of the British company, thinks that performance signals success.