Brand Research

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FDA strengthens warning on antidepressant Paxil; GSK completes ID Biomedical acquisition The Food and Drug Administration asked GlaxoSmithKline Plc to reclassify the antidepressant Paxil (paroxetine hydrochloride) as a Category D drug for pregnant women, which indicates the drug poses a risk to fetuses.

A previous warning about the risk of possible birth defects resulting from the use of Paxil was issued in September, when GSK posted a letter on the FDA's Web site alerting physicians and caregivers to the potential risk.

The FDA said early results of two studies showed that taking Paxil during the first three months of pregnancy appears to increase the risk of giving birth to a baby with a heart defect by approximately 1.5 to two times as compared with women who are taking other antidepressants or women in the general population.

Health care professionals should not prescribe Paxil for women who are in their first trimester of pregnancy or who are planning a pregnancy, the agency recommended, unless other treatment options are not appropriate. However, the FDA noted that in some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus.

In separate news, GSK completed its acquisition of Canadian influenza vaccine manufacturer ID Biomedical Corp., making the company a wholly owned subsidiary of GSK.

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Roche reaches agreements with generic drugmakers to manufacture Tamiflu F. Hoffmann-La Roche Ltd. reached agreements with Teva Pharmaceutical Industries Ltd. and Mylan Laboratories Inc. to manufacture the influenza drug Tamiflu (oseltamivir phosphate), Sen. Charles Schumer, D-N.Y., said in a statement. Similar agreements were made with 13 other manufacturers.

Details of the arrangements were not available.

The increased production is intended to address the possibility of an epidemic of avian flu, which has affected poultry in Asia and parts of Europe and has the potential for widespread human infection. Schumer has been working with Roche to secure licenses with generic pharmaceutical manufacturers to increase the supply of the drug, according to a release on his Web site.

Schumer said in a statement, "The purpose here is not to break the patent on Tamiflu, but rather to meet an emergency need for quantities of this drug that Roche itself simply cannot do alone."

Last month, Roche said that by the end of 2006, it would increase its annual Tamiflu production capacity to 300 million treatments.

Members of Congress are seeking funding to stockpile more of the drug, a Bloomberg report indicated.

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Treatment begins in Dyax, Genzyme's Phase III trial for hereditary angioedema drug Dyax Corp. and Genzyme Corp. said patient treatment has begun in a Phase III clinical trial of Dyax's recombinant plasma kallikrein inhibitor, DX-88.

DX-88 is a recombinant small protein being investigated as a subcutaneous treatment for hereditary angioedema (HAE), a rare genetic disorder that causes acute episodes of localized swelling and inflammation.

The two-phase study will further assess the efficacy of DX-88. Dyax plans to enroll 62 patients in the trial, which is being conducted in the United States, Canada, Europe and Israel.

The first phase of the study will consist of a double-blind comparison between a single dose of DX-88 30 mg and placebo. Patients who complete this phase will be eligible to enter the second phase, in which they will receive repeat dosing with DX-88 for subsequent acute episodes.

"Currently, there is no treatment for HAE in the United States and, with the start of this trial, Dyax and Genzyme are one step closer to a potential drug being approved and on the market for the HAE patient community," stated Dr. Henry Li, one of the researchers involved in the study.

Now that the trial has begun, Dyax will receive a $3 million milestone payment from Genzyme through a collaborative agreement between the two companies. Dyax will receive an additional $10 million milestone payment upon the drug's approval by the Food and Drug Administration.

In addition to the current Phase III trial, Dyax has completed two Phase II trials of DX-88 for the treatment of HAE, with a third Phase II trial nearing completion. The company has also completed a Phase I/II study of the drug as a treatment for preventing blood loss during heart surgery.

Dyax shares closed at $4.92, up $0.61, or 14.2 percent, in heavy trading on the Nasdaq.

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Sonus presents encouraging safety, efficacy data regarding its Tocosol paclitaxel formulation Sonus Pharmaceuticals Inc. presented "encouraging" safety and efficacy data from a Phase II clinical program for the company's Tocosol paclitaxel, a novel, ready-to-use, injectable formulation of the widely prescribed chemotherapy drug paclitaxel, at the San Antonio Breast Cancer Symposium.

Data from an ongoing Phase II trial, which includes 47 women with first-line metastatic breast cancer, revealed that the drug showed promising anti-tumor activity as a first-line treatment for metastatic breast cancer, with preliminary objective response rates of 49 percent to 53 percent. These rates are "at the upper end of published objective response rates for weekly taxane therapy in metastatic breast cancer," according to Dr. Michael Stewart, Sonus' chief medical officer.

The drug's Phase II program has included studies in metastatic breast, non-small cell lung, bladder and ovarian cancers, and a multinational Phase III study involving patients with metastatic breast cancer was initiated in September. The Phase III study is being conducted under a special protocol assessment from the Food and Drug Administration.

Sonus licensed exclusive worldwide development and commercialization rights for Tocosol paclitaxel to Schering AG, and the drug will be marketed in the United States by Berlex Oncology, a unit of Berlex Inc., if approved by the FDA.

"The continuing strength of the efficacy and safety data being observed in the Phase II studies reinforces our belief that Tocosol paclitaxel may one day offer a promising new treatment option for cancer patients that is efficacious, well tolerated, more convenient to administer and does not require advance preparation," Stewart added.

Berlex is a division of Schering.

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Febuxostat more effective than allopurinol in treatment of gout, study demonstrates TAP Pharmaceutical Products Inc.'s febuxostat, an investigational treatment for hyperuricemia and gout, was shown to be more effective than allopurinol in lowering serum urate in a clinical study published in the Dec. 8 issue of The New England Journal of Medicine.

A total of 762 patients with gout and serum urate concentrations of at least 8 mg/dL were randomized to receive febuxostat at a dosage of 80 mg/day or 120 mg/d or allopurinol 300 mg/d for one year. Patients received naproxen or colchicine as prophylaxis against gout flares during the first eight weeks of the study.

Fifty-three percent of patients who received febuxostat 80 mg and 62 percent of patients who received febuxostat 120 mg achieved the primary endpoint (serum urate concentration of less than 6 mg/dL at the last three monthly assessments). In comparison, 21 percent of patients who were treated with allopurinol reached this endpoint.

Furthermore, patients who received febuxostat 80 mg experienced a median 83 percent reduction in tophus area compared with 66 percent for patients who received febuxostat 120 mg and 50 percent for patients who received allopurinol.

The incidence of adverse events was similar in all three treatment groups, with most events being of mild to moderate intensity. Although four of the 507 patients who received febuxostat died compared with no deaths in the allopurinol group, all deaths were deemed unrelated to the study drugs.

The researchers noted that a lower-than-predicted percentage of patients in the allopurinol arm achieved the primary endpoint. They attributed this finding to a mean baseline serum urate concentration of approximately 10 mg/dL and treatment with allopurinol not being titrated as the package insert recommends, a decision made to safeguard the blinding of the study.

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QLT reduces 2005 Visudyne guidance QLT Inc. announced a lower 2005 sales forecast for its lead product, Visudyne (verteporfin), which is approved for the treatment of the wet form of age-related macular degeneration.

The company's 2005 guidance on Visudyne annual sales is being reduced to a range of $480 million to $485 million from the previous range of $500 million to $530 million. QLT cited as a "near-term hurdle" the impact of competition on Visudyne, even though it still expects the agent to remain a key treatment option for patients.

As part of a new strategic plan, QLT plans to concentrate on its core eye-care unit and one other therapy it will select in 2006 based on trial data. The company will also cut its work force by as much as 46 percent, with approximately half of those reductions being implemented in January. The remainder will occur in conjunction with divestitures of noncore operations, QLT added.

During the fourth quarter of 2005, the company will incur a restructuring charge of approximately $5 million to $6 million. QLT said the restructuring initiative is expected to result in estimated annualized savings of approximately $10 million.

Visudyne is marketed by Novartis Ophthalmics.

QLT shares closed at $6.20, down $0.80, or 11.4 percent, in heavy trading on the Nasdaq.

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Shares of Protherics soar on news of licensing agreement with AstraZeneca Protherics Plc entered into a late-stage licensing agreement with AstraZeneca Plc valued at approximately $341.9 million. The news sent the company's shares soaring to close up 61.8 percent.

AstraZeneca licensed Protherics' sepsis drug, CytoFab, and will be responsible for global development and commercialization of the drug in all human applications. Protherics, in turn, is responsible for the bulk manufacturing of the drug.

Under the agreement, AstraZeneca will make an initial payment of approximately $28.6 million, an equity investment of approximately $13.1 million and payments that could total nearly $300 million, depending on milestones. Protherics also will receive royalties amounting to 20 percent of net sales.

According to Protherics, CytoFab is currently being prepared for a single Phase III registration study in severe sepsis in line with guidance received following a Phase II meeting with the FDA. AstraZeneca plans to start the pivotal Phase III study for CytoFab in 2007.

Protherics shares closed at $15.45, up $5.90, in heavy trading on the Nasdaq. Shares of AstraZeneca closed at $47.40, up $0.75, or 1.6 percent, in moderate trading on the New York Stock Exchange.

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F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. entered into an agreement with Ambrx Inc. to use Ambrx's technology to develop next-generation proteins and peptides, which the companies said could offer efficacy or safety advantages over products that are currently available. The technology will be used initially to generate novel pegylated interferon alpha molecules. The agreement calls for Roche to fund product research and development; it will also pay Ambrx license fees, milestone payments and royalties on product sales. Roche will retain exclusive worldwide commercialization rights.

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Boston Scientific Corp. Boston Scientific Corp. is voluntarily recalling approximately 40,000 of its Flextome cutting balloons, which are used to help clear blocked arteries, due to a potential product failure. The company said it received eight complaints that the distal shaft of the catheter separated during withdrawal of the device, with three of the cases requiring a separate surgery to correct the problem. The flaw affects the Flextome Cutting Balloon Device Monorail Delivery System and the Peripheral Cutting Balloon Microsurgical Dilatation Device Small Monorail Delivery System. Boston Scientific noted that the recall does not affect patients who have already been treated, since the failure occurs during the actual surgical procedure; however, the company has asked hospitals to discontinue using the products and return unused devices to the company.

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Vertex Pharmaceuticals Inc. Vertex Pharmaceuticals Inc.'s investigational oral hepatitis C virus protease inhibitor, VX-950, received fast track designation from the Food and Drug Administration for the treatment of HCV infection. A Phase II study of the agent designed to evaluate its safety, tolerability and pharmacodynamics when dosed with pegylated interferon and ribavirin was initiated this month. Vertex said results of this and a European Phase Ib study of VX-950 should be available early next year.

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Romark Laboratories LC Romark Laboratories LC said a newly completed clinical study demonstrated that Alinia (nitazoxanide), a treatment for Clostridium difficile-associated disease (CDAD), does not interact with warfarin, which is commonly used by patients with CDAD. Clostridium difficile is associated with the use of antibiotics and is a leading cause of hospital- or nursing home-contracted colitis and diarrhea, Romark said. Drug interactions with warfarin are "not uncommon" and can be dangerous and costly, making the study's findings important to Romark's CDAD development program, according to Dr. Jean-Francois Rossignol, the company's chairman.