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Clarinex-D 12 Hour extended-release tablets receive FDA approval Schering-Plough Corp. received approval from the Food and Drug Administration for Clarinex-D 12 Hour (desloratadine 2.5 mg/pseudoephedrine sulfate 120 mg) extended-release tablets as a treatment for nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients aged 12 years or older.

The two-layer tablet formulation controls the release of pseudoephedrine, thereby ensuring consistent delivery of the drug. The new formulation, which will be available in March, gives physicians and patients an alternative to Clarinex and Clarinex-D 24 Hour extended-release tablets, the company said.

The approval was based on results from two trials that included 1,248 patients with seasonal allergic rhinitis. In both trials, the antihistaminic efficacy of Clarinex-D 12 Hour was significantly greater than that of pseudoephedrine alone. Additionally, the decongestant efficacy of Clarinex-D 12 Hour was significantly greater than that of desloratadine alone.

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Imitrex 4 mg injection approved with use of STATdose System GlaxoSmithKline Plc's new formulation of Imitrex (sumatriptan succinate) injection received Food and Drug Administration approval.

The new formulation allows patients to use the Imitrex STATdose System to take a 4 mg dose of the drug, which is indicated for the acute treatment of migraines with and without aura in adults.

Before this approval, there was no convenient way for patients to administer Imitrex doses of less than 6 mg by injection, GSK said, noting that certain types of migraine are better treated by injection than by oral dosing.

"Migraine patients who experience nausea or vomiting with their headaches often require an injection, since oral treatments are typically not well tolerated by these patients," said Dr. Robert Kaniecki, director of The Headache Center at the University of Pittsburgh. "Additionally, injections bypass the digestive system and enter the bloodstream quickly, which is especially important for treating certain migraine attacks, such as morning and rapidly escalating migraines."

The efficacy of Imitrex 4 mg injection was studied in three double-blind trials of adults with acute migraine. The largest of the trials, which included 577 patients with moderate to severe migraine pain, found that 67 percent of Imitrex-treated patients received headache relief within an hour compared with 25 percent of placebo-treated patients. Some patients said they experienced relief in as little as 10 minutes.

The Imitrex STATdose System includes an autoinjector pen and two disposable cartridges with a single 4 mg dose of Imitrex in each.

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AstraZeneca's thyroid cancer treatment granted fast track status; firm reports higher Q4, full-year earnings AstraZeneca Plc received a fast track designation from the Food and Drug Administration for its investigational drug Zactima, formerly known as ZD6474, which was developed to treat medullary thyroid carcinoma.

The treatment is being studied in a Phase II trial in medullary thyroid cancer, and patients are being enrolled in a separate Phase II trial in locally advanced or metastatic hereditary medullary thyroid cancer. AstraZeneca noted that no curative modalities or approved chemotherapies exist for advanced thyroid cancer.

In separate news, the company announced its fourth-quarter and full-year results for 2005, which were up on strong growth from the company's leading products.

The firm posted net profit of $1.23 billion, or $0.77 per diluted share, in the fourth quarter of 2005, up from $929 million, or $0.55 per diluted share, in the fourth quarter of 2004.

Fourth-quarter sales were up as well, from $5.8 billion in 2004 to $6.29 billion in 2005.

For the full year, AstraZeneca recorded net profit of $4.72 billion, or $2.91 per diluted share, compared with $3.68 billion, or $2.18 per diluted share, in 2004. These results were in line with analysts' expectations, according to Reuters.

These quarterly and full-year results were based on international financial reporting standards.

On a generally accepted accounting principles basis, net income was $3.88 billion, or $2.40 per diluted share, in the full year of 2005 compared with $2.95 billion, or $1.76 per diluted share, in 2004.

Full-year sales increased from $21.43 billion in 2004 to $23.95 billion in 2005.

For 2006, AstraZeneca expects to earn $3.40 to $3.60 per share. Reuters noted, however, that approximately $0.45 of this amount is tied to beta blocker Toprol-XL (metoprolol succinate) extended-release tablets and that generic versions of the drug could be approved soon.

AstraZeneca shares closed at $46.80, down $2.21, or 4.5 percent, in heavy trading on the New York Stock Exchange.

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FDA grants Nabis Civacir fast track status The Food and Drug Administration granted Nabi Biopharmaceuticals' investigational hepatitis C drug, Civacir (hepatitis C immune globulin), fast track status.

Civacir is an antibody compound designed to prevent hepatitis C virus reinfection in patients who have received a liver transplant.

Based on recent discussions with U.S. and European Union regulators, Nabi believes that a proof-of-concept Phase II trial, followed by a pivotal Phase III study, will be sufficient evidence for the drug to be licensed in the United States and Europe, assuming the studies meet predetermined endpoints.

Nabi said it is putting together an independent scientific and clinical advisory panel to assist with the regulatory, clinical and commercial stages of Civacir's development program and to help design an optimal Phase III pivotal trial.

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ISTAs combination therapy yields positive results in Phase III trial A Phase III bioequivalence study showed that Ista Pharmaceuticals Inc.'s investigational ophthalmic product can successfully treat steroid-responsive inflammatory ocular conditions in which a risk of bacterial infection exists.

Ista's formulation contains two commonly used eye treatments--prednisolone acetate, which is a steroid, and tobramycin, an antibiotic.

The randomized, double-blind trial achieved its primary endpoint, which was to demonstrate the bioequivalence (of prednisolone) between the combination product and prednisolone acetate.

The study also met its secondary endpoints by showing that the combination therapy and prednisolone acetate had similar maximum concentrations and that the time to reach maximum concentration was the same for both products.

Ista plans to submit a New Drug Application for its combination therapy by midyear.

Ista shares closed at $7.97, up $0.79, or 11 percent, in heavy trading on the Nasdaq.

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Genta releases positive data on Genasense in metastatic melanoma Genta Inc.'s shares rose 15.2 percent after the firm reported positive results from a Phase III trial of injectable Genasense (oblimersen sodium) plus chemotherapy in patients with advanced metastatic melanoma.

The trial included 771 patients who were randomized to treatment with standard chemotherapy using dacarbazine with or without Genasense. Before they were randomized, patients were stratified according to performance status, baseline levels of serum lactate dehydrogenase (LDH) and sites of metastatic disease.

Each of the stratification factors was significantly correlated with survival, a multivariate analysis confirmed. The correlation existed whether the factors were examined alone or in a Cox multivariate model, Genta noted. LDH was the only factor that statistically significantly interacted with treatment.

After accounting for prognostic factors, the researchers found that Genasense was significantly superior to chemotherapy alone in major efficacy variables. The patients who appeared to benefit the most from treatment with Genasense were those without elevated LDH at baseline. These patients accounted for approximately two-thirds of the trial population.

The results were based on a minimum of 24 months of follow-up. Data from an analysis conducted at six months of follow-up were included in a New Drug Application for Genasense that Genta withdrew in 2004.

Last month, Genta filed an NDA for the drug to treat relapsed or refractory chronic lymphocytic leukemia.

Data from the advanced metastatic melanoma trial were presented in Paris at the 17th International Congress on Anticancer Treatment.

Genta shares closed at $3.18, up $0.42, in heavy trading on the Nasdaq.

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Bristol-Myers Squibb Co. Bristol-Myers Squibb Co., which owns approximately 17.1 percent of ImClone Systems Inc.'s outstanding shares, said it has no plans at this time to buy more ImClone shares or sell those it owns. BMS made the statement in a regulatory document filed with the Securities and Exchange Commission after ImClone announced that a sale, a merger or an alliance may be in the company's future. BMS and ImClone have a commercialization agreement for Erbitux (cetuximab), a colorectal cancer treatment. "Under its terms, the commercialization agreement would survive any change of control or similar strategic transaction involving ImClone," BMS noted.

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SkyePharma Plc SkyePharma Plc's board of directors has determined that the company should sell its injectable business interests and focus instead on its oral and pulmonary products. The decision follows a strategic review initiated in November when the company received an unsolicited merger proposal. Although SkyePharma has been considering a sale, merger or divestiture, the board said it has not received an offer for the company as a whole that it can recommend to shareholders. In addition, the company appointed Dr. Argeris Karabelas to the position of nonexecutive chairman.

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Cephalon Inc. Cephalon Inc. said the Food and Drug Administration extended the action date for its review of the New Drug Application for Nuvigil (armodafinil) tablets from Jan. 31 to April 30. According to the company, the FDA extended the action date because Cephalon's response to a request for more information has been categorized as a major amendment to the NDA. Nuvigil is said to improve wakefulness among patients who have excessive sleepiness associated with narcolepsy, shift work sleep disorder and obstructive sleep apnea/hypopnea syndrome.

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AtheroGenics Inc. AtheroGenics Inc. extended its research and development collaboration with Astellas Pharma Inc. for AGI-1096, AtheroGenics' oral treatment for the prevention of chronic organ transplant rejection. The companies will continue to assess the therapeutic potential of AGI-1096 through additional studies. Astellas retains the option to negotiate late-stage development and commercial rights to the compound and will fund costs associated with the drug's development program during the extended term.

 

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