Thursday, February 24, 2005

IN BRIEF: SHIRE PHARMACEUTICALS GROUP PLC

Shire Pharmaceuticals Group Plc is reviewing a Paragraph IV Notice letter from Teva Pharmaceuticals USA Inc. informing Shire of Teva's filing of an Abbreviated New Drug Application for its amphetamine combination drug, which is a generic pharmaceutical drug version of Shire's Adderall XR (mixed amphetamine salts). Adderall XR is pharmaceutical drug intended to treat attention deficit/hyperactivity disorder and is protected by two patents that expire in 2018. Shire previously filed lawsuits in response to ANDAs from Barr Laboratories Inc. and Impax Laboratories Inc. for their generic versions of Adderall XR.

Friday, February 11, 2005

FDA ADVISES HEALTH CARE PROFESSIONALS OF ADDERALL XR SUSPENSION IN CANADIAN MARKET

The Food and Drug Administration issued a Public Health Advisory notifying U.S. health care professionals that Health Canada asked Shire Pharmaceuticals Group Plc to suspend sales of its pharmaceutical drug for attention deficit hyperactivity disorder (ADHD) treatment, Adderall XR (mixed amphetamine salts), in the Canadian market.

The Canadian drug regulatory agency made its decision following "a thorough review of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death in patients taking either Adderall (sold in the United States, not in Canada) or Adderall XR (sold in Canada)."

The FDA said it will continue to carefully evaluate reports of serious adverse events in patients being treated with Adderall and related products, but at this time the agency cannot conclude that recommended doses of Adderall can cause sudden death.

According to Shire, the FDA's evaluation of the same data used by Health Canada led to a revised label for Adderall XR in the United States in September 2004. The new label states that, in general, the drug should not be used in children or adults with structural cardiac abnormalities.

In the United States, Adderall XR is approved for adults and children aged 6 to 12 years with ADHD. Adderall, which is the immediate-release formula, is approved for pediatric patients with ADHD.

Health Canada approved the pharmaceutical brand name drug, Adderall XR, in January 2004, and approximately 11,000 patients in Canada are currently prescribed the pharmaceutical drug. In its first year on the Canadian market, Adderall XR accounted for approximately $10 million of Shire's annual revenue, according to Shire.

While Shire is complying with Health Canada's request to suspend sales in Canada, the pharmaceutical company said it "strongly disagrees" with the request and is considering "appropriate" responsive action.

"We are surprised by this action from Health Canada," said Matthew Emmens, chief executive officer of Shire. "Shire remains confident in the safety and efficacy of Adderall XR."

Shire shares closed at $31.80, down $3.84, or 10.8 percent, in heavy trading on the Nasdaq.

Friday, August 13, 2004

FDA APPROVES ADDERALL XR ADHD THERAPY FOR ADULTS

The Food and Drug Administration approved Shire Pharmaceuticals Group Plc's Adderall XR (amphetamine aspartate/amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine sulfate) as a once-daily treatment for attention-deficit/hyperactivity disorder in adults.

The FDA also informed Shire that approval of the new proprietary brand name drug for Adderall XR with 40 mg, 50 mg and 60 mg strengths will require submission of additional clinical data, according to a company press release.

The company said that studies have shown up to 65 percent of children diagnosed with ADHD continue to display symptoms of the condition through adulthood, with an estimated 4.4 percent of the adult U.S. population affected by the condition.

"Although we have not been able to promote adult usage, many physicians have been prescribing Adderall XR for adults off label for some time," noted Matthew Emmens, Shire's chief executive.

"Adults represent 15 to 20 percent of the current Adderall XR total prescriptions. We can now support the expansion of this adult market segment," he added.

For the six months ended in June, Adderall XR generated approximately $283 million in sales in the United States, up 30 percent from the comparable period of 2003. The therapy was approved in November 2001 for treating ADHD in children.

Friday, July 30, 2004

SHIRE RAISES GUIDANCE; REPORTS HIGHER INCOME FROM CONTINUING OPERATIONS DURING SECOND QUARTER

Shire Pharmaceuticals Group Plc posted increases in income and revenue from continuing operations during the second quarter, spurred by sales of its attention-deficit/hyperactivity disorder drug Adderall XR (mixed amphetamine salts).

Before taxes, income from continuing operations totaled $126.6 million, representing a 27 percent rise from $99.4 million in the comparable period last year.

Net income dropped 48 percent from $65.5 million to $34 million this past quarter, but this included $18.2 million in reorganization costs, a $14.8 million gain on the sale of a listed investment and $55.5 million in expected loss from a discontinued operation.

Excluding these items, earnings per share rose from $0.14 in the prior-year period to $0.18 in the second quarter of 2004.

Revenue from continuing operations rose 8 percent to $321 million this past quarter, as sales of proprietary brand name drug, Adderall XR, jumped 40 percent to $143.5 million. One year ago, Shire reported revenue of $299 million.

"With our growing confidence in Shire's underlying business, we are upgrading our current year earnings guidance, and we now anticipate earnings growth for continuing operations to be in excess of 20 percent for 2004, after excluding the impact of the discontinued vaccines business, the $55 million cost associated with the reorganization and the $14.8 million gain on the sale of a portfolio investment," Shire said.

The firm added that its revenue growth is estimated to be in the high-single-digit range, and after 2004, it remains "committed to achieving our target of earnings growth, on average, in the mid teens range with consistent operating margins."

Separately, Shire BioChem Inc. out-licensed worldwide rights to Structural GenomiX Inc. (SGX) for Troxatyl (troxacitabine). The potential cancer agent is currently being studied in Phase I/II trials for the treatment of acute myelogenous leukemia. SGX plans to complete the studies and advance Troxatyl into Phase II trials early next year.

Shares of Shire closed at $26.25, up $2.44, or 10.3 percent, in heavy trading on the Nasdaq.

Monday, May 10, 2004

ADDERALL XR IMPROVES BEHAVIOR, ATTENTION IN CHILDREN WITH ADHD BETTER THAN STRATTERA IN HEAD-TO-HEAD CLASSROOM STUDY

Findings from a head-to-head classroom study indicate Shire Pharmaceuticals Group Plc's Adderall XR (mixed amphetamine salts, extended-release) improves behavior and attention in children with attention-deficit/hyperactivity disorder significantly better than Eli Lilly and Co.'s Strattera (atomoxetine).

After receiving placebo for three days, 200 children with ADHD (age, 6 to 12 years) were randomized to receive once-daily treatment with Adderall XR or Strattera. Each therapy was dosed according to its approved product label.

Researchers observed participants during four simulated, 12-hour classroom sessions held at the beginning of the study and at weeks one, two and three.

Results showed that patients treated with Adderall XR had consistently improved behavior scores at each weekly interval, while those treated with Strattera had varied behavior scores from one week to the next. Analysis of behavior improvement at various time points throughout the day suggested continuous behavior improvement with Adderall XR but not with Strattera.

Furthermore, Adderall XR was found to significantly improve children's attention and academic productivity as compared with Strattera.

Both therapies had similar tolerability profiles.

Strattera is a selective norepinephrine reuptake inhibitor, in contrast to Adderall XR, a stimulant.

These data were presented in New York City at the annual meeting of the American Psychiatric Association.

Friday, March 12, 2004

SHIRE REPORTS GAINS IN REVENUE, EARNINGS IN 2003 AIDED BY INCREASE IN ADDERALL XR SALES

Shire Pharmaceuticals Group Plc recognized gains in revenue and earnings in 2003, driven by a 49 percent increase in sales of its proprietary pharmaceutical drug, Adderall XR, (dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate) for attention deficit/hyperactivity disorder treatment.

For the period ended Dec. 31, the company achieved total revenue of nearly $1.24 billion, a 19 percent increase from $1.04 billion in 2002. Net income in 2003 reached $276.1 million compared with $250.6 million in 2002, representing a 10 percent gain, while diluted earnings per share increased 11 percent to $0.54.

During the year, Adderall XR generated $474.5 million in sales, up from $317.9 million in the previous year, and retained 23 percent of the total U.S. market for ADHD therapies, the company noted.

Shire added that the 49 percent increase in Adderall XR sales was due primarily to a 19 percent increase in the total U.S. ADHD market as well as Shire's successful marketing efforts.

Chief Executive Officer Matthew Emmens said the company expects earnings growth in the mid-teens this year and will seek "to maintain consistent margins beyond 2004."

Shire shares closed at $29.22, down $0.98, or 3.3 percent, in heavy trading on the Nasdaq.

Friday, May 2, 2003

SHIRE REPORTS Q1 RESULTS, RAISES 2003 REVENUE OUTLOOK

Shares of Shire Pharmaceuticals Group Plc climbed 9.8 percent as the pharmaceutical company reported an 11 percent rise in first-quarter profit during 2003 and improved its forecast for annual revenue.

Net income for the first quarter totaled $63.1 million, or $0.12 per share, which was in line with analysts' expectations, according to Reuters. In the same period of 2002, net income reached $56.8 million, or $0.11 per share.

First-quarter revenue totaled $304.5 million, a 28 percent rise from the $237 million posted in the comparable quarter of 2002.

Shire noted that sales of its pharmaceutical brand name drug for attention deficit/hyperactivity disorder, Adderall XR (dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate), have continued to perform strongly, totaling $115.2 million in the quarter. Shire said competition from "recent entrants to the [ADHD] market has not had a significant impact on Adderall XR market share."

"We're holding [market] share with strong resilience," Chief Executive Matthew Emmens told Reuters. "Meanwhile, the market [for hyperactivity drugs] is growing at around 15 percent."

For the full year 2003, Shire raised its guidance for revenue growth to mid-to-high teens from low-to-mid teens. However, its forecast for earnings per share remains unchanged at "high single-digit to low double-digit growth."

Shire shares closed at $21.90, up $1.95, in heavy trading on the Nasdaq.