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FDA panel says Serevent, Advair, Foradil should remain on market; Foradil should add warning

The Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee said that GlaxoSmithKline Plc's Serevent (salmeterol xinafoate), Advair Diskus (fluticasone propionate/salmeterol xinafoate) and Novartis AG's Foradil Aerolizer (formoterol fumarate) should remain on the market, according to a report by Dow Jones Newswires. Schering-Plough Corp. markets Foradil in the United States.

Last month, Dr. Badrul Chowdhury, director of the FDA's division of pulmonary and allergy drug products, asked the committee if the asthma drugs should continue to be marketed in the United States and if Foradil should carry a black box warning concerning severe and potentially fatal asthma attacks in a small number of patients, as Serevent and Advair currently do.

The panel voted 12-0, with one abstention, for the latter because Foradil is a member of the same drug class, FDAAdvisoryCommittee.com reported.

However, Chowdhury said earlier that study data for Foradil "to date do not confirm or refute" the conclusion that the drug may have a similar effect to Serevent and Advair.

According to Dow Jones, the panel said the warning could state that the small increase in mortality risk due to severe asthma attack was not specifically seen in patients taking Foradil.

All three drugs are indicated for the long-term, twice-daily maintenance treatment of asthma in certain age groups.

Certain panel members said a great number of patients improperly use the drugs for short-term asthma management. It is unclear if this misuse could account for some of the serious asthma attacks patients have experienced, Dow Jones added.

In January 2003, GSK halted a study after a significantly greater number of respiratory and asthma-related events, including deaths, were found among black patients receiving Serevent versus those treated with placebo.

Later that year, the FDA added warnings to Serevent and Advair after a small, but significant risk of life-threatening asthma episodes or asthma-related deaths was observed in patients taking the drugs. Another warning was added to their labels in September 2004 relating to the 1.71 relative risk of asthma death or life-threatening experience observed in the SMART study among patients who used the drugs, FDAAdvisoryCommittee.com added.

Although not obliged to do so, the FDA typically follows the advice of its panels.

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Phase IIIb/IV trial of TNKase halted early due to 30-day mortality difference

Boehringer Ingelheim GmbH and Genentech Inc. said that their randomized, open-label Phase IIIb/IV clinical study of the single-bolus thrombolytic TNKase (tenecteplase) in combination with a planned percutaneous coronary intervention (PCI) in the treatment of patients with large acute myocardial infarctions (AMI) has been stopped early due to mortality concerns.

Tenecteplase is marketed by Boehringer as Metalyse in several countries worldwide, while Genentech markets the product as TNKase in the United States.

The ASSENT 4 PCI study, which was designed to compare morality with TNKase plus unfractionated heparin and PCI versus PCI alone, was stopped when a difference in 30-day mortality was observed between the two treatment arms.

While the mortality rate in the TNKase plus PCI arm was consistent with that of previous large-scale thrombolytic trials, the mortality rates in the PCI alone arm were lower than expected. Furthermore, the difference was not attributable to major bleeding, a known complication associated with TNKase, and intracranial hemorrhage appeared comparable to that seen in previous fibrinolytic trials.

"While we are somewhat surprised at these preliminary 30-day findings, we will further evaluate the complete 90-day follow-up data to better understand this outcome among patients with severe heart attacks," said Dr. Frans Van de Werf, chair of the trial's executive steering committee. "The findings of this trial have no impact on current guidelines and leave open the possibility to further investigate options to enhance the care of AMI patients using [TNKase] both with and without PCI. This is especially true in the pre-hospital and community hospital settings, where the large majority of patients with [AMI] present."

TNKase, the first "clot-buster" that can be administered over five seconds in a single dose in the treatment of AMI, was approved by the Food and Drug Administration in June 2000.

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Abbott's Q2 net earnings, sales rise

Abbott reported strong net earnings and sales growth during the second quarter ended June 30 as its pharmaceutical sales climbed 18 percent.

Net earnings rose 38.3 percent to $877.1 million, or $0.56 per diluted share, compared with $634.3 million, or $0.40 per diluted share, in the second quarter of 2004. Earnings per diluted share from continuing operations, excluding one-time charges, were $0.58, slightly better than an average estimate of $0.57 from analysts polled by Thomson First Call, according to Dow Jones Newswires.

For the second quarter of 2005, net sales totaled $5.52 billion, an increase of 17.5 percent from $4.7 billion in the previous-year period.

Miles White, Abbott's chief executive officer, attributed the company's success to "another strong quarter of double-digit growth in both medical products and pharmaceuticals."

The firm's pharmaceutical products group was led by strong sales of rheumatoid arthritis drugs Humira (adalimumab), which increased 58.4 percent to $321 million, and Mobic (meloxicam), which increased 204.4 percent to $322 million. Abbott currently co-promotes Mobic in the United States with Boehringer Ingelheim GmbH, although Michael Weinstein, a J.P. Morgan analyst, told Reuters that Abbott no longer uses its own sales force to sell the product.

According to Reuters, Abbott plans to immediately cut 700 positions, or approximately 1 percent of its work force.

"More reductions will come next year, although they will represent only a small percentage of our work force," an Abbott spokesman told Reuters when discussing the 700 job cuts.

In the second half of 2005, Abbott expects to take a one-time after-tax charge of approximately $215 million related to consolidation within its global manufacturing operations, Reuters reported. Once completed, the company expects the realignment will result in annual savings of more than $200 million. The firm also expects approximately $60 million in one-time after-tax charges in 2006, Reuters added.

For the third quarter of 2005, Abbott expects earnings of $0.56 to $0.58 per share, excluding one-time charges, below the average Wall Street estimate of $0.60, Dow Jones reported. Abbott also confirmed its full-year earnings-per-share guidance of $2.47 to $2.53, excluding one-time charges expected to be approximately $0.23 per share in 2005.

Abbott shares closed at $47.65, down $2.06, or 4.1 percent, in heavy trading on the New York Stock Exchange.

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Risk of secondary leukemia higher with increased doses of Ellence, cyclophosphamide, study shows

In patients with early breast cancer, treatment with higher-than-standard doses of Pfizer Inc.'s Ellence (epirubicin hydrochloride) plus cyclophosphamide leads to a higher risk of developing secondary leukemia, according to a meta-analysis.

A group of researchers reviewed follow-up data from 9,796 patients with early breast cancer treated in 19 randomized trials of Ellence. From the start of treatment, these patients were observed for 53,080 patient-years.

Up to Dec. 31, 2001, 30 patients presented with acute myeloid leukemia and/or myelodysplastic syndrome (AML/MDS), including 28 of the 7,110 patients who had received Ellence-containing regimens. The cumulative probability of developing AML/MDS in these Ellence-treated patients was 0.27 percent at three years, 0.46 percent at five years and 0.55 percent at eight years.

The cumulative probability of AML/MDS was significantly higher in the patients who received planned Ellence doses of more than 100 mg/m2 of body weight per cycle, more than 33.3 mg/m2 per week or a total dose of more than 720 mg/m2 than in the patients who were treated with lower Ellence doses.

Furthermore, the eight-year cumulative probability of developing secondary leukemia was 0.37 percent in the patients administered 720 mg/m2 or less of Ellence and 6,300 mg/m2 or less of cyclophosphamide, compared with 4.97 percent in the patients who received higher cumulative doses of the drugs.

"In clinical practice, the described regimens have a strong benefit to risk ratio, and patients and clinicians can be reassured that the risk of leukemia is likely to be low if the cumulative doses of these regimens are not exceeded," the reviewers concluded in the study published in the June 20 issue of the Journal of Clinical Oncology.

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Researchers assess relationship between adherence, resistance among antiretroviral-naive, HIV-1 patients receiving Abbott's Kaletra, Pfizer's Viracept

Low levels of drug adherence appear to be related to low rates of drug resistance among antiretroviral-naove, HIV-1 patients receiving Abbott's Kaletra (lopinavir/ritonavir) or Pfizer Inc.'s Viracept (nelfinavir mesylate), trial findings reveal.

Furthermore, the trial showed that regardless of adherence level, Viracept-treated patients had a significantly higher risk of detectable HIV-1 RNA loads or of resistance to protease inhibitors (PI) or GlaxoSmithKline Plc's Epivir (lamivudine) than Kaletra-treated patients. Epivir is manufactured under an agreement with Shire Pharmaceuticals Group Plc.

In the double-blind study, 590 antiretroviral-naove, HIV-1 patients were randomized to receive Kaletra (400/100 mg twice daily; n=292) plus placebo or to receive Viracept (1,250 mg twice daily; n=298) plus placebo. In addition, all subjects received standard doses of Epivir and Bristol-Myers Squibb Co.'s Zerit (stavudine) two times per day.

The investigators used local linear regression or logistic regression to assess the relationships between adherence and the risk of developing drug resistance.

According to the results, an average of 92 percent of the Kaletra-treated group and 93 percent of the Viracept-treated group adhered to their treatment regimen, as measured by pill count. The researchers found that an increased risk of detectable HIV-1 RNA loads after week 24 was associated with lower adherence. An increased risk of detectable HIV-1 RNA loads was also associated with Viracept use as compared with Kaletra use.

A bell-shaped relationship was detected between adherence and the risk of Viracept resistance among Viracept-treated patients. For these patients, the maximum probability of primary PI mutations was approximately 20 percent with an adherence of 85 to 90 percent. In addition, among the participants receiving Viracept, the maximum probability of Epivir resistance was more than 50 percent at an adherence level of 75 to 85 percent.

For those treated with Kaletra, the maximum probability of Epivir resistance was approximately 15 percent at an adherence level of 80 to 85 percent.

"[A]lthough adherence remains a crucial factor in maximizing viral suppression, it is important to recognize that different PI-based regimens may offer different levels of 'forgiveness' to nonadherence," the authors wrote.

This study was published in the June 15 edition of The Journal of Infectious Diseases.

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More than one-half of women see symptoms return after stopping menopausal hormone therapy, study finds

More than one-half of women who use a combination of estrogen and progestin to control symptoms of menopause may see their symptoms return when they stop the treatment, even after long-term use, according to data from the Women's Health Initiative trial.

The study, which was published in the July 13 issue of JAMA, examined symptoms and management strategies for menopausal symptoms in 8,405 women eight to 12 months after stopping treatment with Wyeth's Prempro (conjugated equine estrogens/medroxyprogesterone) or placebo.

Of women who reported severe vasomotor symptoms or pain and stiffness at baseline, 55.5 percent also reported these symptoms after discontinuing use of Prempro. However, these women did not include those where were unwilling to receive treatment or who had stopped taking the pills earlier, the authors noted.

"For women who do not have vasomotor symptoms before they start [menopausal hormonal therapy], it appears that discontinuing use does not induce these symptoms," the authors added.

The authors concluded by noting that "[s]hort-term use of [Prempro] may only alleviate symptoms temporarily for many women, including older women, who may experience a return of menopausal symptoms after stopping [menopausal hormonal therapy]."

"Before this study, we knew little about the effects a woman experiences when she suddenly stops menopausal hormone therapy use," said Sherry Sherman, Ph.D., of the Geriatrics and Clinical Gerontology Program at the National Institute on Aging, in a National Institutes of Health press release. The NIH supported the study.

"Now women are learning that their symptoms might return, even after using these hormones for more than five years," she concluded.

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PacifiCare Health Systems Inc.

PacifiCare Health Systems Inc. could be required to pay UnitedHealth Group Inc. a termination fee of $243.6 million if the companies' planned merger falls through. Termination rights for both UnitedHealth and PacifiCare are outlined in the merger agreement filed with the Securities and Exchange Commission. According to the agreement, if the deal is not completed by May 5, 2006, subject to a potential three-month extension, either company can choose not to go through with the merger. UnitedHealth signed a definitive agreement last week to acquire PacifiCare for approximately $8.1 billion in cash and stock.

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AaiPharma Inc.

AaiPharma Inc.'s pharmaceutical division will be purchased by privately held Xanodyne Pharmaceuticals Inc. for approximately $209.3 million in cash. Xanodyne won the bid for the sale of all the assets of aaiPharma's pharmaceutical department at an auction approved by the bankruptcy court. Xanodyne's winning bid, which is subject to bankruptcy court approval, is approximately $40 million higher than Xanodyne's original "stalking horse" offer that aaiPharma previously announced when filing for chapter 11 bankruptcy. Xanodyne also purchased up to $30 million of services that are to be provided by aaiPharma's development services division over the next three years.

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Able Laboratories Inc.

Able Laboratories Inc. gave the Food and Drug Administration erroneous or incomplete data that could have affected the agency's decisions about the company's drugs, according to an FDA report. Since 2001, 41 instances were cited when drugs contained more than or not enough of the active ingredient. According to the FDA's report, Able's Quality Unit and Senior Management did not ensure the safety and quality of the drug products, thus "releasing batches of drug products which failed to meet in-process, finished product and stability specifications." Also, there were nine instances when the company neglected to issue alerts about impure drugs. The FDA based its report on a two-month inspection of the company's records and facilities, The Associated Press reported.

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U.S. District Court

U.S. District Court Judge Joseph Hood turned down a lawsuit filed by eight Parkinson's disease patients who were attempting to regain access to Amgen Inc.'s experimental glial cell line-derived neurotrophic factor drug they said slowed or halted disease progression, according to The Associated Press. The drug was used in a University of Kentucky study and was pulled last year after Amgen said that brain damage occurred in some monkeys who received high doses of the drug. Judge Hood agreed with Amgen's decision, saying other studies showed the drug was not effective and produced safety concerns.

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Labeling Design