Brand Identity

Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management

SHIRE TO ACQUIRE TRANSKARYOTIC FOR $1.6 BILLION ------------------------------------------------------------------------------- Shire Pharmaceuticals Group Plc signed an agreement to acquire Transkaryotic Therapies Inc., a biopharmaceutical company that specializes in products to treat rare genetic disorders caused by protein deficiencies, for $37 per share in a cash transaction valued at approximately $1.6 billion.

Shire said the acquisition would "dilute earnings initially but be neutral in the second year and boost profits thereafter," according to a Reuters report. Reuters also noted that Shire faces the possibility of generic competition for its attention-deficit/hyperactivity disorder drug, Adderall XR (mixed amphetamine salts), in 2006.

Analysts said the proposed acquisition "looked expensive," warning that it could take "several years to boost earnings for Britain's third-biggest drugmaker," according to Reuters.

"We expect that Transkaryotic's protein-based drugs and clinical development pipeline . . . will enable us to diversify and broaden our revenue base while continuing to grow our profits and further build our pipeline and platform for growth," said Matthew Emmens, Shire's chief executive officer.

The transaction is expected to close in the third quarter. Warburg Pincus & Co. and certain of its affiliates, which together own approximately 14 percent of Transkaryotic's outstanding common stock, have agreed to vote all of their shares in favor of the transaction.

Michael Astrue, Transkaryotic's chief executive officer, resigned from the company and its board of directors. David Pendergast, the company's former chief operating officer, will assume Astrue's responsibilities.

"We are extremely gratified that Shire has recognized the value of our business and the dramatic progress we have made, particularly in the last two years," Pendergast said. "We believe the substantial resources and capabilities of Shire can accelerate the commercial opportunities of our products and future product candidates."

The companies also signed a license agreement, which will take effect only if the acquisition does not occur for specific reasons. Under the agreement, Shire would gain the right to manufacture and distribute Dynepo (epoetin delta), a new erythropoietin product Transkaryotic developed to treat anemia associated with kidney disease, in countries outside of North America.

Transkaryotic also recently completed a Phase III trial evaluating an enzyme replacement therapy, iduronate-2-sulfatase (I2S), for the treatment of Hunter syndrome.

Transkaryotic shares closed at $35.21, up $4.71, or 15.7 percent, while Shire shares closed at $31.02, down $3.50, or 10.1 percent, both in heavy trading on the Nasdaq. -=-

POZEN'S MIGRAINE DRUG, TREXIMA, MEETS PRIMARY, REGULATORY ENDPOINTS IN SECOND PHASE III TRIAL ------------------------------------------------------------------------------- Pozen Inc. said its next-generation treatment for migraine, Trexima, achieved statistical significance for all primary and regulatory endpoints in the second of two Phase III pivotal trials.

Trexima combines the triptan sumatriptan and naproxen sodium, a nonsteroidal anti-inflammatory drug, in a single tablet. GlaxoSmithKline Plc's RT Technology was used in developing the formulation, enabling the drug to dissolve quickly after it has been swallowed and then release rapidly into the bloodstream.

As a new combination drug, Trexima had to demonstrate superiority over the individual components to meet regulatory requirements. According to Pozen, Trexima achieved this endpoint in both trials. The drug also showed efficacy as a treatment for relief of pain and other symptoms associated with migraine as compared with placebo.

Pozen said it has met with the Food and Drug Administration to discuss results of both Phase III trials and other information needed to submit a New Drug Application for Trexima. Based on these discussions, the company believes no further preclinical or clinical trials are necessary for the submission, which is scheduled for the third quarter.

GSK is co-developing the drug with Pozen and has proposed the brand name Trexima, which is subject to FDA approval.

Pozen shares closed at $5.96, up $2.41, or 67.9 percent, in heavy trading on the Nasdaq. GSK shares closed at $47.12, down $0.01, or 0.02 percent, in light trading on the New York Stock Exchange. -=-

MERCK'S Q1 EARNINGS SURPASS EXPECTATIONS BUT FALL SHORT OF 2004 FIGURES ------------------------------------------------------------------------------- Merck & Co. Inc. recognized higher-than-expected earnings in the first quarter of 2005, but the results were lower than those achieved in the comparable period of 2004.

For the first quarter of this year, net income totaled $1.37 billion, or $0.62 per diluted share, compared with nearly $1.62 billion, or $0.73 per diluted share, in the prior-year period. Analysts surveyed by Thomson First Call expected the company to report earnings of $0.59 per share.

The company generated $5.36 billion in global sales, down 5 percent from $5.63 billion in the first quarter of 2004.

However, excluding 2004 first-quarter sales of its COX-2 inhibitor Vioxx (rofecoxib), sales jumped 8 percent during the period, "reflecting growth in Merck's newer franchises and higher alliance revenues," according to the company.

Specifically, global sales of Singulair (montelukast sodium), indicated for treating chronic asthma and relieving symptoms associated with seasonal allergic rhinitis, totaled $735 million in the first quarter, an 18 percent increase from the comparable period last year. Additionally, sales of hypertension therapies Cozaar (losartan potassium) and Hyzaar (losartan potassium/hydrochlorothiazide) rose 14 percent during the period to $719 million.

Worldwide sales of cholesterol-lowering drug, Zocor (simvastatin), fell 15 percent to $1.1 billion in the first quarter of 2005 as a result of increased competition in the U.S. statin market.

Merck expects earnings per share of $0.60 to $0.64 for the second quarter of this year, with anticipated full-year earnings per share in the range of $2.44 to $2.52.

Shares of Merck closed at $34.28, up $0.21, or 0.6 percent, in moderate trading on the New York Stock Exchange. -=-

NOVARTIS REPORTS Q1 NET PROFIT UP 16 PERCENT ON DRUG, ASSET SALES ------------------------------------------------------------------------------- Novartis AG reported first-quarter net income of $1.48 billion, a 16 percent increase compared with the same period from last year, and repeated forecasts for a record year in 2005 based on rising sales of its blood pressure and leukemia drugs.

The company's first-quarter profits, assisted by an 11 percent increase in sales of prescription drugs, the sale of an asset and a weaker U.S. dollar, were in line with expectations. Net sales increased from $6.64 billion in last year's first quarter to $7.34 billion, including $4.79 billion from prescription drug sales.

When calculated in terms of local currencies, prescription drug sales rose 8 percent, which is only slightly higher than the industry average of approximately 7 percent and substantially lower than the 22 percent growth reported by rival Roche Holding AG, in which Novartis owns a one-third stake, according to Dow Jones.

Sandoz, Novartis' subsidiary that manufactures generic drugs, reported a stronger-than-expected performance, contributing $803 million in net sales to the parent company's first-quarter figures. The acquisition of Germany-based private generic company Hexal AG, which is set to conclude in the second half of the year, will place Novartis ahead of Israel's Teva Pharmaceutical Industries Ltd. as the world's largest generic drug maker and make Novartis the only major pharmaceutical company to own a significant generic business.

Diovan (valsartan), a treatment for high blood-pressure, was once again Novartis' best-selling product, posting total sales of $845 million, a 17 percent increase compared with last year. Gleevec (imatinib mesylate), a leukemia drug, had total sales of $496 million, an increase of 41 percent. Cancer drugs Femara (letrozole) and Zometa (zoledronic acid) also showed significant increases in total sales of 51 percent and 17 percent, respectively.

"We anticipate delivering a competitive performance in 2005, with record sales and, on a comparable basis, record earnings," said Daniel Vasell, Novartis' chief executive officer.

Shares of Novartis closed at $48.75, up $0.76, or 1.6 percent, in moderate trading on the New York Stock Exchange. -=-

AMGEN RECORDS STRONG PERFORMANCE IN FIRST QUARTER, INCREASES FULL-YEAR GUIDANCE ------------------------------------------------------------------------------- Amgen Inc. reported gains in first-quarter 2005 net income and revenue, benefiting, in part, from an increase in demand for Aranesp (darbepoetin alfa), its anemia therapy.

For the period ended March 31, net income was $854 million, or $0.67 per diluted share, compared with $690 million, or $0.52 per diluted share, in the same quarter last year.

Adjusted net income for the quarter totaled $924 million, up 23 percent from $752 million generated in the first quarter of 2004. Adjusted earnings per share jumped to $0.72, up 23 percent from $0.57 in the comparable period last year. The company noted that adjusted net income and earnings per share figures from the first quarter of 2005 and 2004 exclude certain expenses associated with the acquisitions of Immunex Corp. and Tularik Inc.

Total product sales increased 24 percent to $2.7 billion, including $2.2 billion in sales in the United States and $504 million in international sales. Overall, total revenue during the first quarter rose 21 percent from the prior-year period to $2.8 billion.

The firm's performance was aided by higher demand for Aranesp, resulting in a 33 percent increase in sales of the drug. In the first quarter of 2005, Aranesp sales totaled $723 million compared with $543 million in the prior-year period. Specifically in the United States, quarterly sales of the therapy jumped from $330 million last year to $447 million this year.

Additionally, quarterly sales of Enbrel (etanercept), an anti-inflammatory treatment, rose 49 percent to $592 million, up from $397 million in the first quarter of 2004.

As a result of its strong performance in the first quarter of the year, the firm increased its full-year guidance for total revenue growth to a range of low double-digits to the mid-teens. Previously, Amgen expected revenue growth to range from the high single-digits to the low teens. The company also raised its earnings per share expectations for fiscal 2005 to a range of $2.80 to $2.90, up from its previously disclosed range of $2.70 to $2.85 per share.

"Our business continues to perform well despite uncertainties related to the Medicare reimbursement changes," noted Kevin Sharer, Amgen's chief executive officer. "Given this performance, we are comfortable increasing our revenue and adjusted earnings guidance for the full year."

Amgen shares closed at $59.25, up $1.12, or 1.9 percent, in moderate trading on the Nasdaq. -=-

FDA ASKS DRUG MANUFACTURERS TO RE-EVALUATE CLINICAL DATA REGARDING RISK OF SUICIDE AMONG PATIENTS TAKING ANTIEPILEPTIC DRUGS ------------------------------------------------------------------------------- The Food and Drug Administration has asked 14 manufacturers of antiepileptic drugs (AEDs) to re-evaluate clinical data to determine whether patients taking AEDs may have an increased risk of suicide. Manufacturers that have received the request include Pfizer Inc., Ortho-McNeill Pharmaceuticals Inc. and GlaxoSmithKline Plc, makers of Neurontin (gabapentin), Topamax (topiramate) and Lamictal (lamotrigine), respectively.

Drug makers have six months to respond to the request, which was issued last month.

Dr. Robert Temple, associate director of medical policy with the FDA's Center for Drug Evaluation and Research, told The Boston Globe that this is only the second time this type of review has been undertaken. The first evaluated the risk of suicide associated with antidepressant use in children and adolescents; based on findings from this first analysis, the FDA required antidepressant drug manufacturers to include black box warnings on product labels highlighting this risk.

Temple added that the current review is complex because this class of drugs is prescribed for several conditions aside from epilepsy, including pain, migraines, bipolar disorder and insomnia. Many of these conditions are associated with a risk of suicide, regardless of the treatment used.

"These are the sorts of people who are complicated to think about because they tend to be at risk already," Temple said, adding that adverse event reports "can't really tell you whether the suicidal event is because of the drug or despite the drug."

However, Temple asserted that reviewing the data was worthwhile because the risk of a particular adverse event may not be apparent if it is not clearly labeled. As an example, he noted that some antidepressant drug manufacturers had classified suicidal thinking as "emotional lability." As such, the prevalence of suicidal behavior in patients taking antidepressants may have been understated.

According to The Boston Globe, much of the impetus for the current review has come from New York attorney Andrew Finkelstein. In May of last year, Finkelstein filed a citizen's petition with the FDA asking that Pfizer be required to include a black box warning on Neurontin's product label similar to that carried by antidepressants. Neurontin's current prescribing information mentions "suicide gesture" as a rare adverse event (occurring in less than 1 percent of 1,000 patients) that has been observed in clinical trials.

Finkelstein claims to have submitted 271 adverse event reports to the FDA that describe patients who have committed suicide while taking Neurontin. He has filed more than 70 personal injury lawsuits against Pfizer, none of which has been tried or settled.

Finkelstein has asked the FDA to issue a Public Health Advisory while the review is under way, warning doctors and patients of the potential link between Neurontin and suicide.

Pfizer spokesman Paul Fitzhenry stated that the adverse event reports associated with Neurontin use during the past decade "show no link between Neurontin and suicidal thoughts or behavior."

According to IMS Health, AEDs are the fifth best-selling drug class. As the market leader, Neurontin's revenue exceeded $2.6 billion last year with 17 million prescriptions. Neurontin sales have fallen sharply since last August, however, when Alpharma Inc. launched the first generic formulations of gabapentin. -=-

Brand Identity
THE EUROPEAN MEDICINES AGENCY ------------------------------------------------------------------------------- The European Medicines Agency said that, pending the outcome of its review of the COX-2 inhibitor class, Pfizer Inc.'s Bextra (valdecoxib) should not be reintroduced in the European Union. The review is expected to be completed in June. Also, the European Commission formally asked the agency's Committee for Medicinal Products for Human Use (CHMP) to assess the occurrence of serious skin reactions during the review, in addition to cardiovascular safety issues. Additional hearings will be held with makers of COX-2 inhibitors at a CHMP meeting May 23-26. -=-

Brand Identity
GUILFORD PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Guilford Pharmaceuticals Inc. and the Food and Drug Administration's Division of Anesthetic, Critical Care and Addiction Drug Products agreed on a revised clinical development strategy for Guilford's Aquavan, a water soluble prodrug of propofol. It is also referred to as GPI 15715. Aquavan is an injectable sedative/hypnotic intended for use in procedural sedation. The revised strategy reduces the number of clinical trials from 13 to five and includes a dose-ranging study in colonoscopy. Based on the results of this study, the company expects to start two pivotal trials of the drug, one in colonoscopy and one in minor surgical procedures. Guilford said it will immediately reinitiate previously planned studies for intensive care unit sedation and potential drug interactions. The company anticipates filing the New Drug Application for Aquavan before the end of the year. Guilford's shares closed at $2.47, up $0.18, or 7.9 percent, in heavy trading on the Nasdaq. -=-

Brand Identity
GUIDANT CORP. ------------------------------------------------------------------------------- Guidant Corp.'s first-quarter net income grew 16 percent, reflecting nearly $1 billion in sales. Net income was $162.3 million, or $0.49 per diluted share, up from $139.4 million, or $0.44 per diluted share, in the first quarter of 2004. Income from continuing operations was $214.5 million, or $0.65 per diluted share. Analysts polled by Reuters Estimates expected earnings of $0.62 per share. Net sales for the quarter rose 2 percent to $953.3 million. Globally, implantable defibrillator sales rose 18 percent to $478 million, while coronary stent sales fell 33 percent to $115 million. Guidant said the company is making "timely progress" in its pending merger with Johnson & Johnson. Shares of Guidant closed at $74.20, down $0.06, or 0.1 percent, in moderate trading on the New York Stock Exchange. -=-

Brand Identity
GENZYME CORP. ------------------------------------------------------------------------------- Genzyme Corp. reported that the company's first-quarter net income rose 41 percent to $95.6 million, or $0.36 per diluted share, compared with $67.9 million, or $0.29 per diluted share, for the first quarter of 2004. Revenue for the quarter increased 28 percent, from $491.3 million in last year's first quarter to $629.9 million this year. First-quarter sales of Cerezyme (imiglucerase), an injectable enzyme replacement therapy for type I Gaucher disease, increased 11 percent to $226 million, while sales of Renagel (sevelamer hydrochloride), a treatment for patients with end-stage renal disease, climbed 19 percent to $99.4 million. Genzyme expects second-quarter earnings per diluted share of between $0.41 and $0.43 and full-year earnings per diluted share of between $1.72 and $1.78, a revision of its earlier guidance of $1.67 to $1.75 per share for the year. Genzyme shares closed down $1.37, or 2.3 percent, at $59.45 in heavy trading on the Nasdaq. -=-