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FDA issues warning regarding increased risk of serious blood disorder from treatment with Campath The Food and Drug Administration issued an alert regarding the use of Berlex Inc. and Genzyme Corp.'s cancer drug, Campath (alemtuzumab), in treating patients with multiple sclerosis.

The notification warned patients and physicians that treatment with Campath can lead to an increased risk of developing idiopathic thrombocytopenic purpura (ITP), a serious blood disorder in which the body attacks and kills its own blood platelets.

Although Campath is not approved as a treatment for MS, the companies were conducting clinical studies to determine the drug's viability in these patients. It was during one such study that three patients developed ITP; one of the patients died.

A total of 334 patients with MS were enrolled in the study, which was halted in September when the increased risk of ITP was first recognized. Other participants in the trial are being monitored. The trial was designed to compare different doses of Campath, administered annually, to Pfizer Inc. and Serono SA's Rebif (interferon beta-1a).

The patient who died received a five-day course of Campath, followed a year later by a three-day course of the drug. The patient experienced a fatal intracranial hemorrhage approximately seven months after receiving the second course of therapy, according to a Dow Jones Newswires report.

Of the other two patients who developed ITP, one developed the condition 11 months after completing the second round of Campath and the other after the third round of Campath, the Dow Jones report noted.

Campath is approved only for treating B-cell chronic lymphocytic leukemia, a form of blood cancer. Concerns have been raised that physicians may be prescribing the drug off-label to patients with MS.

Berlex is a division of Schering AG.

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The Medicines Co.'s Angiomax approved for new indication in patients undergoing PCI The Medicines Co.'s anticoagulant, Angiomax (bivalirudin), was approved for a new indication by the Food and Drug Administration.

The drug is now approved to treat patients with or at risk of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia thrombosis syndrome (HITTS) who are undergoing percutaneous coronary intervention (PCI).

"The updated Angiomax label will allow for broader dissemination of information to interventional cardiologists and, now, hematologists regarding the role of Angiomax in this high-risk patient population," said John Kelley, the firm's chief operating officer. "HIT/HITTS is not well understood in clinical practice, and we are planning a future registry study in hospitals to further evaluate Angiomax in this setting."

HIT/HITTS, a complication of heparin administration, can lead to limb amputation, renal failure and death, The Medicines Co. said.

Angiomax is also being studied in patients with or at risk of HIT/HITTS who are undergoing cardiac surgery, and the company plans to submit an application to the FDA for this indication.

Angiomax, which is intended for use with aspirin, is also indicated for use in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty. It is also indicated for treating provisional GPIIb/IIIa inhibition in patients undergoing PCI.

"We hope to continue demonstrating that replacing heparin with Angiomax leads to better outcomes, particularly in high-risk patients, such as those with HIT/HITTS," said Kelley.

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Novo Nordisk, FDA update warnings for hemophilia drug Novo Nordisk Inc. and the Food and Drug Administration revised the warnings and adverse reactions sections of the prescribing information for NovoSeven Coagulation Factor VIIa (recombinant activated factor VII).

The prescribing information for the drug, which is indicated to treat bleeding episodes in patients who have hemophilia A or B with inhibitors to Factor VIII or Factor IX, now warns of thrombotic and thromboembolic adverse events. Novo Nordisk said the updated information is based on post-marketing safety surveillance and studies in patients without hemophilia.

According to Novo Nordisk, the extent of the risk of these adverse events is unknown, but patients with advanced atherosclerotic disease, crush injury, disseminated intravascular coagulation or septicemia, as well as those receiving concomitant treatment with activated or nonactivated prothrombin complex concentrates, may be at increased risk for thrombotic adverse events.

The firm added that a clinical study of elderly patients without hemophilia who had experienced an intracerebral hemorrhage showed a possible increased risk of arterial thromboembolic adverse events with the use of NovoSeven. Adverse events included myocardial ischemia, myocardial infarction, cerebral ischemia and cerebral infarction.

Post-marketing data showed similar adverse events, but Novo Nordisk pointed out that it was not possible to establish a casual relationship based on this information.

"Evaluation and interpretation of these post-marketing events is confounded by underlying diagnoses, concomitant medications, pre-existing conditions and inherent limitations of passive surveillance," the company noted.

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Clinical review board says Shire, Noven's transdermal patch for treatment of ADHD should not be approved Shire Pharmaceuticals Group Plc and Noven Pharmaceuticals Inc.'s proposed transdermal patch for the treatment of attention-deficit/hyperactivity disorder should not be deemed approvable, according to documents released before the meeting of the Psychopharmacologic Drugs Advisory Committee of the Food and Drug Administration Friday.

The once-daily patch, known as the methylphenidate transdermal system (MTS), is intended for use in children aged 6 to 12 years. It contains the same active ingredient as Novartis AG's Ritalin (methylphenidate hydrochloride) and a number of other ADHD drugs.

Although the review board found that the patch has certain advantages over oral formulations, such as ease of administration and lack of interaction with food intake, the disadvantages associated with the transdermal formulation, including insomnia, weight loss and potential for abuse, outweigh the patch's benefits. Furthermore, when compared with patients who received an active comparator, patients who received MTS experienced significantly more adverse events, including headache, vomiting, nausea and upper abdominal pain, along with an increased risk of developing tic disorder.

The FDA is not required to follow the advice of the review board but is likely to do so, as the agency previously rejected the patch in April 2003. The current New Drug Application reduced the number of hours the patch was to be worn from 12 to nine hours, but the review board said that even this modification did not overcome the potential dangers associated with the drug.

"In my opinion, the safety and tolerability profile of MTS treatment in these two new studies does not appear to be significantly more acceptable than that in the previous MTS submission," wrote Dr. Robert Levin, a reviewer for the FDA. "Generally, it appears that the identical safety concerns remain."

Shire shares closed at $36.95, up $0.41, or 1.1 percent, in moderate trading on the Nasdaq, while Noven shares closed at $11.17, down $2.34, or 17.3 percent, in heavy trading on the Nasdaq.

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MediGene's NDA for genital wart cream to be reviewed by FDA MediGene AG's New Drug Application for Polyphenon E ointment, an investigational treatment for genital warts, was accepted for review by the Food and Drug Administration.

The NDA, which was submitted in September, is based on data from two Phase III trials that included more than 1,000 patients. MediGene most recently presented the results from these trials in October at the 14th Congress of the European Academy of Dermatology and Venereology in London.

The firm said both trials achieved their objectives, with approximately 55 percent of all patients showing complete clearance of all warts. Of those treated with Polyphenon E, approximately 78 percent showed complete or almost complete clearance of the warts. During the 12 weeks of follow-up, approximately 6 percent of patients had recurring warts.

In addition to this indication, the company is developing the drug to treat certain skin tumors. The active substance in Polyphenon E is a green tea extract with a defined catechin composition, according to MediGene.

"Pending approval, we plan to begin marketing Polyphenon E ointment in the United States, which currently represents the largest market for the target indication," said Peter Heinrich, chief executive officer of MediGene. "Negotiations with a potential marketing partner are well-advanced. The acceptance of the NDA will promote closing the marketing partnership."

The company noted that Polyphenon E is a temporary name for the product while it is still in the developmental stages. For the genital wart indication, MediGene expects the drug's sales potential to exceed $117 million annually.

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Rigel's hay fever treatment flops in clinical trial Rigel Pharmaceuticals Inc. said R112, its investigational intranasal therapy for the treatment of allergic rhinitis, failed to show a statistically significant difference from placebo in a double-blind, Phase II clinical study.

The study included a total of 396 patients who experienced seasonal allergic rhinitis during the summer/fall pollen season of the previous two years. The participants were required to stop taking any allergy medications during a screening period, which was followed by a placebo run-in period. They were then randomized to a seven-day treatment cycle of R112, GlaxoSmithKline Plc's Beconase AQ (beclomethasone dipropionate monohydrate) or placebo, taken twice daily.

In addition to failing to meet one of the primary endpoints, superiority to placebo, the study also showed R112 to be inferior to Beconase. However, R112 was safe and well tolerated, thereby meeting the other primary endpoint.

"We are disappointed in today's results," said James Gower, Rigel's chief executive officer. Gower expressed surprise at the study's findings, as a previous Phase II study of R112 demonstrated "a statistically significant reduction in the symptoms associated with allergies." Shares of Rigel closed at $8.01, down $13.91, or 63.5 percent, in heavy trading on the Nasdaq.

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St. Jude Medical Inc. St. Jude Medical Inc. agreed to acquire Savacor Inc., a private company that is developing "heart failure diagnostic and therapy guidance products and technologies," for $50 million. Savacor is currently conducting clinical trials to evaluate an implantable sensor device that can assist physicians in detecting and managing symptoms related to progressive heart failure. "The Savacor technology has exciting potential and will complement the development efforts already under way at St. Jude Medical in managing the co-morbidities of heart failure patients," said Michael Coyle, president of St. Jude's cardiac rhythm management business. St. Jude will incur a $50 million research and development charge in connection with the transaction, which is expected to close by the end of the year. Further financial details were not disclosed.

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Par Pharmaceutical Cos. Inc. Par Pharmaceutical Cos. Inc. said the Food and Drug Administration granted tentative approval of the company's Abbreviated New Drug Application for cabergoline tablets, a generic version of Pfizer Inc.'s Dostinex tablets, for the treatment of hyperprolactinemic disorders. Par is the first to receive tentative approval for a generic version of the drug, the firm said. Final approval cannot be granted until all patent and exclusivity issues have expired for the branded version; Par expects to launch its product soon thereafter.

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Alza Corp. Alza Corp. is modifying its clinical development strategy for OROS Hydromorphone, also known as AP-77, a treatment for chronic pain. "The company is considering different options for moving forward following recent discussions with the Food and Drug Administration in which it became clear that an additional clinical trial would be required to meet the agency's standards for approval," the firm said, adding that the modifications are not the result of any safety concerns associated with the drug. Outside of the United States, the clinical development program will continue as previously planned, Alza said. The firm plans to launch the drug next year in the European Union.

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Lexicon Genetics Inc. Lexicon Genetics Inc. expanded its drug discovery alliance with Genentech Inc. to include the advanced research, development and commercialization of new biologic drugs. Under the expanded agreement, Lexicon will conduct advanced research on a broad subset of targets included in Genentech's Secreted Protein Discovery Initiative program; Lexicon can also develop and commercialize drugs modulating up to six of these targets. During the three-year span of the advanced research period, Genentech will pay Lexicon $25 million in up-front and milestone payments and research funding. Depending on which company is responsible for a specific product's commercialization, the other company may be entitled to receive milestone payments associated with the approval of drugs that result from the collaboration.