Linguistics

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

Chiron required to conduct additional trial for Pulminiq, will reduce supply of Begrivac influenza vaccine

In separate announcements made Friday, Chiron Corp. said it received an approvable letter for Pulminiq (cyclosporine) inhalation solution, and it will reduce the supply and possibly delay shipments of Begrivac influenza virus vaccine for the 2005-2006 influenza season.

An action letter from the Food and Drug Administration deemed Pulminiq "approvable," but the regulatory agency requires an additional pre-approval study to confirm the product's efficacy. This follows the FDA's Pulmonary-Allergy Drugs Advisory Committee's action last month in which the panel voted 11-5 that Chiron had fully addressed safety issues related to Pulminiq, according to a Reuters report. The committee was evenly split, however, as to whether data from a small, somewhat flawed Phase II trial were sufficient to recommend the product's approval.

Chiron is seeking to have Pulminiq approved, in combination with standard immunosuppressive therapy, for increasing survival and preventing chronic rejection in patients who are receiving allogeneic lung transplants. The company acquired the product from Novartis AG.

"Chiron in-licensed Pulminiq knowing the significant regulatory challenges associated with a single-center trial with a small patient population. We took on these challenges because we believe strongly in the data for Pulminiq," said Craig Wheeler, president of Chiron BioPharmaceuticals. "We will carefully review our options before making any decisions regarding the product."

Regarding the Begrivac announcement, Chiron will reduce its supply of the vaccine by approximately 8 million doses, decreasing the anticipated supply for customers outside the United States from the 12 million previously expected to a new projection of 4 million doses.

During regular internal quality assurance tests at the product's Marburg, Germany, manufacturing facility, Chiron found a small number of Begrivac lots "that did not meet product sterility specifications."

Chiron is working with a German regulatory agency, the Paul Ehrlich Institute, to determine the full extent of the issue, assuring that it will not release the vaccine until the necessary tests have been completed. Depending on the timing and outcome of the tests, along with potential manufacturing or regulatory developments, the Begrivac vaccine may not reach non-U.S. markets this season. Most of the vaccine produced in the Marburg facility is intended for use in Germany and the United Kingdom.

Thus, the firm is reallocating non-U.S. vaccine doses among the affected markets and allocating shipments of Agrippal S1 and Fluad influenza virus vaccines from extra production in its Siena/Rosia, Italy, facility to mitigate the reduced Begrivac supply.

Even though Chiron does not expect to record any sales of Begrivac vaccine in the third quarter of 2005, it still anticipates earnings from continuing operations will be between $0.86 and $1.11 per share.

Chiron also disclosed Friday that the FDA is currently conducting a full current Good Manufacturing Practices inspection of Chiron's facility in Liverpool, where the Fluvirin influenza virus vaccine is produced. The company plans to respond to any observations cited by the FDA and then wait for the FDA's assessment. The final outcome of the inspection will be released once the regulatory agency issues formal results, which could be several weeks after the inspection has been completed.

Shares of Chiron closed at $36.03, down $1.24, or 3.3 percent, in heavy trading on the Nasdaq.

Linguistics

FDA approves orally disintegrating formulation of Clarinex

The Food and Drug Administration approved a new orally disintegrating formulation of Schering-Plough Corp.'s Clarinex (desloratadine).

The so-called Reditabs are approved for the treatment of allergy symptoms caused by both perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria--or hives of unknown cause--in adults as well as children aged 6 years or older.

The company noted that Clarinex is the only prescription nonsedating antihistamine approved for patients as young as 6 months of age, and that the different dosage formulations provide better accommodation of patient preferences and symptoms. The allergy treatment is available as a tablet, as the orally disintegrating Reditab, as a syrup and in combination with the decongestant pseudoephedrine.

"This new formulation . . . helps physicians tailor the treatment regimen to patients' specific needs and allows them to provide a variety of safe and effective allergy treatments for both children and adults," said Dr. Robert Spiegel, Schering's chief medical officer.

The new formulation, which allows patients to take the rapidly dissolving tablet without water, is administered once daily and will be available in September in 2.5 mg and 5 mg dosages, Schering said.

Linguistics

FDA issues advisory regarding use of Duragesic pain patch

Deaths in patients using Janssen Pharmaceutica Products LP's Duragesic (fentanyl) transdermal system to manage pain have prompted the Food and Drug Administration to issue a Public Health Advisory for the skin patches.

Other serious side effects have been reported in connection with fentanyl overdoses, according to the FDA.

"The agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product," an FDA press release stated.

The FDA released the advisory, along with safety precautions for patients and health care professionals, because it believes some patients and/or their health care providers may not be completely aware of the dangers associated with potent narcotic products, such as Duragesic, or how to safely use them.

"The agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose," the FDA noted in the release.

Just last week, Janssen added safety information to the Duragesic label explaining the potency of fentanyl, cautioning that hypoventilation or potentially fatal fentanyl overdoses can occur.

Alza Corp. manufactures the Duragesic patch.

Linguistics

FDA approves first-ever implantable device-based treatment for depression

Cyberonics Inc. received approval from the Food and Drug Administration for its Vagus Nerve Stimulation (VNS) Therapy System for the adjunctive long-term treatment of chronic or recurrent depression in patients aged 18 years or older who have experienced a major depressive episode and who have not adequately responded to a minimum of four antidepressant treatments.

VNS Therapy, which is the first FDA-approved implantable device-based treatment for depression, is delivered through a small, pacemaker-like generator implanted in the chest that sends mild, preprogrammed, intermittent, electrical pulses through the vagus nerve in the neck to the brain. It is also the first treatment developed, studied, approved and labeled specifically for patients with treatment-resistant depression (TRD).

"Today, for the first time, Americans with [TRD] have an FDA-approved, informatively labeled, long-term treatment option for their lifelong and life-threatening illness," said Robert Cummins, chief executive officer of Cyberonics. "The safety and effectiveness of VNS Therapy was demonstrated in up to two-year studies of patients with the most chronic and resistant depressions ever studied."

The device was approved in 1997 for the treatment of refractory epilepsy; as a treatment for depression, however, the device's path to approval has been rocky. Last year, the FDA turned down Cyberonics' application despite an earlier recommendation in favor of the device by an FDA panel of medical experts. When the FDA subsequently deemed the product approvable earlier this year, the Senate Finance Committee called for an inquiry, according to a report in The Wall Street Journal.

"Seven years ago, Cyberonics, psychiatric thought leaders and a group of courageous Americans with [TRD] embarked on a seemingly impossible mission to pioneer the first safe and effective treatment for TRD," Cummins stated.

As additional research findings become available, the company plans to update the device's TRD labeling to reflect "unprecedented post-market surveillance, including a 460-patient randomized dosing study and a 2,000-patient, five-year TRD patient registry to facilitate fully informed VNS treatment decisions by psychiatrists, patients and their families and payers for years to come."

Linguistics

Axert effective for acute migraine attacks unresponsive to Imitrex

A recent study shows that 12.5 mg of Ortho-McNeil Neurologics Inc.'s Axert (almotriptan malate) may be an effective and well-tolerated treatment for acute migraine attacks in patients who respond poorly to 50 mg of GlaxoSmithKline Plc's Imitrex (sumatriptan succinate).

A total of 302 subjects with an International Headache Society diagnosis of migraine were included in the trial. The participants initially treated their migraine with 50 mg of Imitrex. Those who did not experience pain relief after two hours were randomized to treat their next migraine attack with either 12.5 mg of Axert (n=99) or placebo (n=99).

The rates of pain relief were significantly higher among those assigned to Axert than those given placebo (47.5 percent vs. 23.2 percent) on an intent-to-treat basis. Furthermore, pain-free rates at two hours were significantly higher in the treatment group than in the placebo group (33.3 percent vs. 14.1 percent), and Axert provided better-sustained pain-free efficacy than did placebo (20.9 percent vs. 9 percent).

No significant differences between Axert and placebo were found in terms of adverse events (7.1 percent vs. 5.1 percent, respectively).

"The data reported here and in other studies suggest that when migraine patients respond poorly to [Imitrex] or other triptan treatment, another agent in this class should be attempted," the authors concluded.

These results appear in the July/August issue of Headache.

Ortho-McNeil licenses Axert from Almirall Prodesfarma SA.

Linguistics

Faslodex, Arimidex associated with similar overall survival in second-line treatment of advanced breast cancer, data show

Overall survival following second-line treatment of breast cancer with AstraZeneca Plc's Faslodex (fulvestrant) is similar to that following treatment with the company's aromatase inhibitor, Arimidex (anastrozole), according to a study of postmenopausal women.

Faslodex is administered as a once-monthly injection, whereas Arimidex is administered orally once a day.

The survival analysis included data from two Phase III trials that compared the efficacy and tolerability of Faslodex with those of Arimidex. The study included 851 postmenopausal women with advanced breast cancer who had experienced disease progression following previous endocrine treatment. The patients were randomized to receive an intramuscular injection of Faslodex 250 mg once each month or an oral dose of Arimidex 1 mg once a day.

After a median follow-up of 27 months, the mortality rates in the Faslodex and Arimidex groups were 74.5 percent and 76.1 percent, respectively. Both drugs were associated with prolonged survival. The median overall survival for Faslodex-treated subjects was 27.4 months, which did not differ significantly from the 27.7 months observed for the Arimidex-treated subjects.

Gastrointestinal symptoms were the most commonly reported side effects, occurring in 48.7 percent of patients receiving Faslodex and 45.4 percent of those receiving Arimidex. Similar rates were observed for hot flashes, which were reported in 21.7 percent and 22.2 percent of patients in the respective treatment groups. However, Faslodex treatment was associated with a significantly lower incidence of joint disorders as compared with Arimidex treatment (8.3 percent vs. 12.8 percent).

"The combined overall survival data from two pivotal Phase III trials suggest that, in the treatment of postmenopausal women with advanced breast carcinoma, [Faslodex] is not inferior to [Arimidex] with respect to overall survival," the researchers concluded.

The study was published in the July 15 issue of the journal Cancer.

Linguistics

Linguistics
Ranbaxy Laboratories Ltd.

Ranbaxy Laboratories Ltd.'s zidovudine tablets, a generic version of GlaxoSmithKline Plc's AIDS drug, Retrovir, also known as AZT, received tentative approval from the Food and Drug Administration. Although a patent prevents Ranbaxy from marketing its generic version in the United States, the tentative FDA approval will allow the company to make the generic formulation available for use outside the United States through the President's Emergency Plan for AIDS Relief.

Linguistics

Linguistics
Schwarz Pharma

Schwarz Pharma bought all remaining rights to Aderis Pharmaceuticals Inc.'s rotigotine, a compound being developed for the treatment of Parkinson's disease. As a result of the purchase, Schwarz said it will record a net loss this year of approximately $71 million. However, the company's adjusted net income still looks as though it will break even for the year. Schwarz has filed for U.S. and European approval of Neupro, a transdermal patch system containing rotigotine as the active ingredient. The approval is being requested for Neupro to be used in treating patients with Parkinson's disease, but the product is also being studied as a potential therapy for restless legs syndrome. Phase II trials are expected to begin later this year for a nasal spray version of rotigotine in the treatment of acute symptoms of Parkinson's disease.

Linguistics

Linguistics
Adherex Technologies Inc.

Adherex Technologies Inc. and GlaxoSmithKline Plc entered into a licensing and development agreement in which Adherex will in-license eniluracil, a GSK oncology product, and GSK will have the option of licensing Exherin, a cancer drug that is also referred to as ADH-1 and is Adherex's lead biotechnology compound. According to the agreement, Adherex received an exclusive license to eniluracil for all indications; GSK reserved the right to buy back the compound at certain points while it is being developed. Adherex could receive milestone payments totaling approximately $120 million, plus double-digit royalties, if GSK exercises any of its options on eniluracil. If GSK does not exercise the buy-back option, Adherex can develop eniluracil on its own or with other partners; in this case, Adherex would make milestone and royalty payments to GSK.

Linguistics

Linguistics
National Institutes of Health

A National Institutes of Health internal review revealed that 44 scientists employed by the U.S. government who also work as consultants for drug companies violated the agency's ethics regulations. The House Energy and Commerce Committee requested the review based on discrepancies it found between NIH records and consulting agreements kept by a score of pharmaceutical companies. In each of the 44 cases, the scientist was found to have violated one or more of the following three NIH rules: reporting the income on financial disclosure forms, taking personal leave to do private work and gaining proper approval to do outside work. The 36 scientists who are still employed at NIH face possible disciplinary action and/or investigation for possible criminal violations.

Linguistics

Linguistics