Drug Packaging

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BMS may terminate development of Pargluva Bristol-Myers Squibb Co. is considering terminating development of Pargluva (muraglitazar), the investigational oral diabetes treatment it has been collaborating on with Merck & Co. Inc.

The Food and Drug Administration issued an approvable letter for Pargluva on Oct. 18 in which it requested more information on the drug's cardiovascular safety profile.

"We and our partner, Merck, have determined that to receive regulatory approval and to achieve commercial success, additional studies may be required because the ongoing trials were not designed to answer questions raised by the FDA. The additional studies could take approximately five years to complete," BMS said, adding that it will discuss ending its collaboration with Merck.

BMS also plans to continue discussions with the FDA to decide whether to conduct more studies or to end development of the drug.

In September, an FDA advisory committee voted 8-1 in favor of approving Pargluva. Last week, however, a study published by JAMA showed that the drug is associated with an excess incidence of death, major adverse cardiovascular events and congestive heart failure. The study authors said Pargluva should not be approved until further testing has been carried out.

Drug Packaging

FDA deems Alza's dapoxetine not approvable as treatment for premature ejaculation Alza Corp. received a not approvable letter from the Food and Drug Administration regarding the company's New Drug Application for dapoxetine hydrochloride, an investigational compound for the treatment of premature ejaculation (PE).

The company "continues to believe that dapoxetine provides important benefits for men who suffer from PE" and plans to continue its global development program while addressing questions raised in the FDA letter.

No drugs are approved to treat this condition, which Alza said can have a significant impact on a man's life, including not only sexual satisfaction, but also the ability to build and maintain relationships and sustain a general sense of confidence. The company added that traditional methods of treating PE "rely heavily on behavioral therapy and/or off-label use of older drugs that are approved for other conditions, all of which yield limited success."

Alza is a subsidiary of Johnson and Johnson, which licensed the drug from PPD Inc.

PPD shares closed at $55.60, down $6.85, or 11 percent, on the Nasdaq, while J&J shares closed at $61.44, down $1.37, or 2.2 percent, on the New York Stock Exchange, both in heavy trading.

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UCB Pharma files sNDA for use of Keppra to treat myoclonic seizures in adults, adolescents UCB Pharma Inc. filed a supplemental New Drug Application with the Food and Drug Administration for the use of Keppra (levetiracetam) as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy (JME).

The application is based on a double-blind, randomized study that assessed the drug's efficacy in 120 patients who had idiopathic generalized epilepsy with myoclonic seizures.

Compared with 23.3 percent of patients who received placebo, 58 percent of the patients who received Keppra 3,000 mg/day for 12 weeks experienced at least a 50 percent reduction in myoclonic seizure days, defined as any day in which a patient experienced one or more myoclonic seizures.

Keppra was generally well tolerated, although use of the drug was associated with somnolence, behavioral abnormalities, neck pain and pharyngitis.

"A surprising number of patients (up to 45 percent) do not respond to current first-line or new therapies," said Gregory Krauss, one of the authors of the study. "This pivotal study shows that Keppra may be an effective treatment option for these patients that are difficult to treat."

Keppra is currently approved as adjunctive therapy in treating partial onset seizures for adults and children aged 4 years or older who have epilepsy.

Drug Packaging

GSK's net profit rises 20 percent in third quarter; company raises earnings guidance GlaxoSmithKline Plc reported a 20 percent higher net profit in the third quarter on strong sales of key pharmaceutical products such as asthma drug Advair (fluticasone proprionate/salmeterol xinafoate) and diabetes drug Avandia (rosiglitazone maleate), as well as a strong performance from the company's vaccines franchise.

Net profit for GSK increased to $2.22 billion or approximately $0.37 per share, up from approximately $1.9 billion, or approximately $0.32 per share, in the same period in 2004. Revenue rose 11 percent to approximately $9.68 billion, up from an estimated $8.91 billion in the same period in 2004; pharmaceutical sales for the quarter rose 10 percent to approximately $8.32 billion. GSK's third-quarter sales were only expected to increase 8 percent, Dow Jones Newswires reported.

The company expects this year's strong performance to continue into the fourth quarter and has therefore raised its full-year 2005 earnings guidance to a mid-teens earnings per share percentage growth in terms of constant exchange rates, up from the low double digits.

In separate news, Reuters reported that GSK is offering free licenses to partners that can manufacture the company's flu drug Relenza (zanamivir), one of two drugs recommended for use should a bird flu pandemic occur. GSK originally licensed the drug from Biota Holdings Ltd.

GSK shares closed at $51.34, up $1.98, or 4 percent, in heavy trading on the New York Stock Exchange.

Drug Packaging

AstraZeneca raises guidance on strong Q3 earnings AstraZeneca Plc raised its full-year guidance after posting strong earnings in the third quarter.

Net profit for the quarter increased to $1.23 billion, or $0.76 per share, up from $1.14 billion, or $0.68 per share, in 2004.

Analysts polled by Reuters expected the firm to earn $0.71 per share.

Sales were up 10 percent for the quarter, rising from $5.27 billion in the third quarter of 2004 to $5.79 billion in the third quarter of 2005, led by cholesterol-lowering therapy Crestor (rosuvastatin calcium) and proton pump inhibitor Nexium (esomeprazole magnesium).

Quarterly sales of Crestor increased 23 percent over last year's third quarter, from $260 million to $325 million. Third-quarter sales of Nexium went from $951 million in 2004 to $1.13 billion in 2005.

Analysts expected the firm to record total sales of $5.91 billion, Reuters said, noting that some analysts said the firm is relying on lower spending, and not sales, to fuel growth.

For the full year, the firm continues to expect sales growth close to the double-digit range and now expects full-year earnings per share of between $2.85 and $2.95. Previously, it had forecast earnings of at least $2.75 per share.

Shares of AstraZeneca closed at $44.95, down $1.08, or 2.4 percent, in heavy trading on the New York Stock Exchange.

Drug Packaging

Express Scripts posts strong Q3 earnings, raises guidance Express Scripts Inc.'s 2005 third-quarter net income rose 64 percent from the same quarter last year, prompting the pharmacy benefits manager to increase its full-year guidance.

The firm earned $101.7 million, or $0.68 per diluted share, this last quarter compared with $61.9 million, or $0.40 per diluted share, in the third quarter of 2004.

Express Scripts attributed the earnings growth to lower drug purchasing costs and increases in home delivery and generic drug utilization. Generic drug use increased from 51 percent of total prescriptions in the third quarter of last year to 55 percent in the third quarter of this year, the company noted.

Excluding nonrecurring items, the company earned $0.67 per diluted share, which still beat the $0.61 forecasted by analysts at Reuters Estimates.

Third-quarter revenue increased 2 percent, going from $3.77 billion in 2004 to $3.85 billion in 2005.

For the full year, Express Scripts now expects to report diluted earnings per share of $2.62 to $2.69, which is up from its previous estimate of $2.44 to $2.49. Excluding $0.08 in net, nonrecurring benefits, the company forecasts 2005 earnings to range from $2.54 to $2.61.

Express Scripts shares closed at $72.42, up $10.35, or 16.7 percent, in heavy trading on the Nasdaq.

Drug Packaging

Drug Packaging
F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. temporarily suspended shipments of its antiviral drug Tamiflu (oseltamivir phosphate) to U.S. wholesalers and other private-sector recipients to ensure that sufficient treatments will be available for the regular flu season, according to The Associated Press. There has been an increase in demand for Tamiflu recently, as some health experts perceive the drug to be the best option for treating bird flu, should it mutate into a form that can be easily passed among humans. A Roche spokesman said the halting of shipments will not affect U.S. government orders for the drug but declined to comment on what impact it will have on U.S. pharmacies and wholesalers, the AP reported.

Drug Packaging

Drug Packaging
The Psychopharmacologic Drugs Advisory Committee The Psychopharmacologic Drugs Advisory Committee of the Food and Drug Administration voted 7-4 that Somerset Pharmaceuticals Inc.'s 20 mg Emsam (selegiline) transdermal system does not need to carry a warning against ingesting foods containing tyramine while using the patch, Reuters reported. The panelists voted 6-4 that it would be acceptable to have such a warning on the 30 mg and 40 mg versions of the drug without requiring it on the lower-dose version. Emsam has already been deemed approvable by the FDA, and the agency is expected to make a final decision by the end of November. If approved, Emsam will be the first transdermal patch indicated for major depressive disorder.

Drug Packaging

Drug Packaging
Elan Corp. Plc Elan Corp. Plc reported a third-quarter net loss of $67.1 million, or $0.16 per share, compared with a net loss of $107.8 million, or $0.28 per share, in the third quarter of 2004. Analysts polled by Reuters expected the firm to report a net loss of $0.22 per share. The firm attributed the difference to litigation costs and product disposals that occurred in 2004, as well as strong recent growth in core business product revenue. Elan's total revenue rose from $101.1 million in last year's third quarter to $128.6 million in the most recent year.

Drug Packaging

Drug Packaging
MGI Pharma Inc. MGI Pharma Inc. and SuperGen Inc. provided regulatory updates for their Dacogen (decitabine) injection for the treatment of myelodysplastic syndromes. The companies said the New Drug Application for Dacogen is currently under review by the Food and Drug Administration, and a Marketing Authorization Application for the drug is being reviewed by the European Medicines Agency. The companies have finished collecting and analyzing the transfusion data required according to an FDA approvable letter and will finalize and submit their response after discussions with the agency have been concluded. MGI said it "anticipates that a final decision regarding the European regulatory strategy may be finalized in collaboration with a partner," as the company continues to conduct licensing negotiations with potential partners for rights to Dacogen outside of North America.

Drug Packaging