Healthcare Brand

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Pfizer terminates agreement with Altana for Daxas respiratory treatment; discontinues development of capravirine HIV/AIDS therapy

Pfizer Inc. and Altana AG terminated their co-development agreement for Daxas (roflumilast), a phosphodiesterase-4 inhibitor being examined as a potential therapy for chronic obstructive pulmonary disease and asthma. Altana shares fell 16.3 percent Friday as a result of the news.

Pfizer's decision to terminate the collaboration was based on data that showed Daxas did not reduce the number of asthma attacks observed in a recent study as compared with placebo. The treatment did meet its secondary endpoint of improving patient lung functions, according to The Wall Street Journal.

"It's too early to call Daxas off because all we know is the top-line data," Karl Heinz Koch, an analyst at private bank Lombard Odier Darier Hentsch, told The Journal. "But the fact that Pfizer, which must know more about the data than we do, pulled out of it just when the data are released lets you expect the worst," he added.

Pfizer will return all rights to the candidate to Altana, which will now assume sole responsibility for further development of the respiratory treatment.

Pfizer also said it will discontinue clinical development of HIV/AIDS treatment capravirine after results from two Phase IIb trials of the investigational compound failed to show a statistically significant difference between standard triple-drug HIV therapies and the same combinations plus capravirine.

Rights to capravirine will be returned to the Japanese company Shionogi & Co. Ltd.

Shares of Altana closed at $48.05, down $9.32, while Pfizer shares closed at $27.10, down $0.48, or 1.7 percent. Both stocks were traded heavily on the New York Stock Exchange.

Healthcare Brand

FDA urges monitoring for suicidal thinking, behavior among patients receiving antidepressants

Due to the potential suicide risks among patients taking antidepressants, the Food and Drug Administration issued a public health advisory last Thursday reiterating that health care professionals need to monitor these patients.

Specifically, the FDA recommended that adults being treated with antidepressants, especially those being treated for depression, should be "watched closely for worsening of depression and for increased suicidal thinking or behavior."

Vigilance is particularly important when treatment with antidepressants is initiated or if the dosage is changed, the FDA said. In addition, adults whose symptoms worsen during treatment, including those who exhibit an increase in suicidal thinking or behavior, should be evaluated by their health care professional. The agency said these recommendations are consistent with existing warnings in the approved labeling of these drugs.

According to the advisory statement, the FDA is conducting a review of available data to "determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications."

The review is expected to take a year or longer to complete and the results will be made available to the public, the FDA said.

Healthcare Brand

Advisory committee says FDA should tell public about psychiatric risks of certain ADHD drugs; does not recommend labeling change yet

The Food and Drug Administration's Pediatric Advisory Committee said in a June 30 meeting that the psychiatric adverse events reported in patients with attention-deficit/hyperactivity disorder who are taking McNeil Consumer & Specialty Pharmaceuticals' Concerta (methylphenidate hydrochloride) and other methylphenidate products "are not new or significant safety signals," according to an FDAAdvisoryCommittee.com news alert.

The agency convened the meeting to discuss intended labeling changes to these products that would disclose such psychiatric events as "visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior."

However, committee members were hesitant to advocate a labeling change for methylphenidate products regarding psychiatric events until the FDA analyzes other ADHD treatments, including amphetamine products and Eli Lilly and Co.'s Strattera (atomoxetine hydrochloride), the news alert stated.

"None of what I have heard today about these medications has made me particularly concerned," said committee member Thomas Newman.

Acting committee chair Robert Nelson said the agency should "delay the labeling change until they have a good sense of class effect." Nelson noted that adding warnings could be "interpreted as causality" and motivate patients to switch to other ADHD drugs that could have similar or worse psychiatric effects.

Nonetheless, panel members said the agency needs to inform the public about possible psychiatric events tied to methylphenidate product usage. Nelson suggested that the FDA issue a "Drug Watch" report on its Web site but said there is no need for a public health advisory, the news alert added.

"Empower parents to have enough information to truly monitor their children," committee member Deborah Dokken told Reuters.

According to FDAAdvisoryCommittee.com, a one-year post-pediatric marketing exclusivity adverse event review revealed that Concerta had more psychiatric events than immediate- and extended-release methylphenidate products (36 vs. 16, respectively).

Despite the committee's reluctance, Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics, said the agency may still change labeling to "try to make it clearer what the situation is with regard to certain adverse events."

The FDA previously noted that it is looking into "additional means to better characterize the cardiovascular risks for all drug products approved for ADHD."

According to data from IMS Health Inc. quoted by The Wall Street Journal, approximately 7.8 million prescriptions were filled for Concerta in the United States in 2004, with approximately 6 million going to people 16 years old and younger, the FDA estimated.

Other drugs containing methylphenidate include Celltech Pharmaceuticals Inc.'s Metadate CD and Novartis AG's Ritalin LA.

Healthcare Brand

Pegasys validated in Phase III testing as first-line therapy in chronic hepatitis B

Patients with HBeAg-positive chronic hepatitis B who are treated with F. Hoffmann-La Roche Ltd.'s Pegasys (peginterferon alfa-2a) are more likely to achieve a sustained response than those treated with GlaxoSmithKline Plc's Epivir (lamivudine), the current standard of care, according to results from a Phase III study published in the June 30 issue of The New England Journal of Medicine.

The randomized trial, which enrolled 814 participants, showed significant improvement in response rates of patients treated with Pegasys compared with those treated with Epivir for both HBeAg, an antigen that correlates with early and active hepatitis B infection, and HBsAg, an antigen that elevates before the onset of clinical symptoms. Additionally, there was no significant difference in response between patients who received combination therapy with both Pegasys and Epivir compared with Pegasys alone.

Significantly fewer adverse events were reported with Epivir, but withdrawal from therapy was low in all treatment groups. The most common adverse events were those known to occur with interferon alfa therapy, including fever, fatigue, headache and muscle pain, the authors noted.

According to the authors, the results "indicate that [Pegasys] offers a therapeutic advantage over available treatments for chronic hepatitis B," adding that Pegasys' ability to achieve HBeAg and HBsAg seroconversion after a defined period of treatment supports its use as first-line therapy.

Pegasys was approved in May 2005 for the treatment of hepatitis B.

Healthcare Brand

Seven clinical studies show benefits of Xolair in patients with severe allergic asthma

Treatment with Novartis AG and Genentech Inc.'s Xolair (omalizumab) significantly reduces the rate of severe asthma attacks and emergency medical visits in patients with severe allergic asthma that requires treatment with oral corticosteroids, according to data from seven clinical studies presented at the World Allergy Congress in Munich.

Compared with placebo, Xolair treatment significantly reduced the asthma exacerbation rate by 37.2 percent in patients receiving oral steroids and 38.8 percent in patients not receiving oral steroids.

Additionally, further analysis of data from two of the studies showed treatment with Xolair improved asthma control and reduced reliance on bursts of oral corticosteroid to manage acute asthma exacerbations in patients with moderate to severe allergic asthma.

"In some cases it is impossible to control the symptoms of severe allergic asthma, even with recommended treatment regimens," said Ulrich Wahn, president of the European Academy of Allergology and Clinical Immunology. "These data demonstrate that Xolair offers the potential to achieve a significant improvement in control and to improve the lives of patients who continue to suffer from this debilitating disease."

Xolair, which was developed under an agreement between Novartis, Genentech and Tanox Inc., has been available as a treatment for moderate to severe allergic asthma in the United States since June 2003.

Xolair is being considered for approval in Europe by the Committee for Medicinal Products for Human Use, with a decision expected later this year.

Healthcare Brand

Seroquel monotherapy effective, well tolerated for treatment of bipolar depression, study finds

More than half of the patients treated with AstraZeneca Plc's Seroquel (quetiapine fumarate) achieved remission from depressive symptoms, according to results of a recent study.

Researchers conducted a double-blind, placebo-controlled study of 542 outpatients with bipolar I or II disorder. Patients were randomized to eight weeks of treatment with fixed doses of Seroquel (300 mg or 600 mg) or placebo administered once daily.

The results of the study showed there were statistically significant improvements in Montgomery-Asberg Depression Rating Scale (MADRS) total scores with either dose of Seroquel compared with placebo. Improvements were seen as early as week one.

The proportions of patients who met response criteria (defined as at least a 50 percent MADRS score improvement) at the final assessment were 58.2 percent, 57.6 percent and 36.1 percent for patients treated with 600 mg of Seroquel, 300 mg of Seroquel and placebo, respectively. The proportions of patients who met remission criteria (defined as a MADRS score of 12 or lower) were 52.9 percent in the groups taking 600 mg/day and 300 mg/d of Seroquel versus 28.4 percent for placebo.

The study appeared in the July issue of the American Journal of Psychiatry.

Healthcare Brand

Healthcare Brand
Abbott

Abbott sued Takeda Pharmaceutical Co. because the firm contends the price Takeda charges the companies' joint venture, TAP Pharmaceuticals Products Inc., for the bulk material used in TAP's acid reflux disease drug Prevacid (lansoprazole) is much higher than the market price, Dow Jones Newswires reported. "Takeda has no right to take advantage of its special role as TAP's supplier and thereby divert to itself profits that rightly belong to Abbott and Takeda as equal joint venturers in TAP," Abbott said in the lawsuit, the news service reported. TAP said the lawsuit will not affect its day-to-day operations.

Healthcare Brand

Healthcare Brand
NitroMed Inc.

NitroMed Inc. said its heart failure drug, BiDil (isosorbide dinitrate/hydralazine hydrochloride), will be priced at a wholesale acquisition cost of $1.80 per tablet and supplied to pharmacists in bottles of 180 tablets. Most patients will take the tablets three times a day, Reuters said, adding that the announced price is higher than the $4 per day expected by JP Morgan analyst Corey Davis. NitroMed is implementing a patient assistance program through which BiDil will be available for free to uninsured patients with household incomes up to three times the poverty level and for $25 per prescription for all other uninsured patients. BiDil was approved last month for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients. NitroMed shares closed at $22.15, up $2.70, or 13.9 percent, in heavy trading on the Nasdaq.

Healthcare Brand

Healthcare Brand
Ortho-McNeil Pharmaceutical Inc.

Ortho-McNeil Pharmaceutical Inc. will revise the label for its Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) contraceptive, indicating the product does not provide a significant effect on low mineral bone density at one year in patients with anorexia nervosa, according to an FDAAdvisoryCommittee.com news alert. The change is based on the results of a recent Phase II study, which were recently presented at a Food and Drug Administration Pediatric Advisory Committee meeting.

Healthcare Brand

Healthcare Brand
The Centers for Disease Control and Prevention

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended that young adults aged 11 to 18 years receive a pertussis (commonly known as whooping cough) vaccine booster shot as part of scheduled vaccinations for this age group, Reuters reported. A 63 percent increase in pertussis since 2003 and evidence that immunity from childhood pertussis vaccination wanes by adolescence were among the reasons cited for the committee's recommendation.

Healthcare Brand

Healthcare Brand