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Guidant warns of potential problem with 28,000 pacemakers

Guidant Corp. voluntarily advised physicians and patients of a potential degradation of the hermetic sealing component that could affect approximately 28,000 of its pacemakers. The Food and Drug Administration may classify the action as a recall, Guidant said.

This degradation results "in a higher than normal moisture content within the pacemaker case late in the device's service life," the company said, adding that the advisory is "intended to limit adverse events."

Devices affected by the advisory are Pulsar, Pulsar Max, Pulsar Max II, Discovery, Discovery II, Meridian, Virtus Plus II, Intelis II and Contak TR pacemakers that were manufactured between Nov. 25, 1997, and Oct. 26, 2000. Guidant said these products have not been sold or implanted for the last four years.

An estimated 28,000 out of a total of approximately 78,000 devices distributed with this potentially defective component are still implanted in patients.

As of July 11, Guidant has identified 69 devices that may have exhibited a failure mode. The likelihood of failure increases the longer the device has been implanted, Guidant said, noting that many of the remaining implanted devices have exceeded or are nearing their estimated longevity.

Guidant received one report of a patient dying after the patient's device exhibited sustained maximum sensor rate pacing. Guidant said the patient was admitted to the hospital with "multiple health issues" and, because the device was not returned, the company could not establish whether the device had failed as a result of degradation of the hermetic sealing component.

Guidant is recommending that physicians consider replacing the devices in patients who are dependent on their pacemakers. The company also advised patients to seek immediate medical attention if they experience shortness of breath, dizziness, lightheadedness or a rapid heart rate for a prolonged amount of time.

Last month, Guidant recalled some of its implantable cardiac defibrillators (ICD) and advised physicians to stop implanting a number of its other defibrillators. Analysts have speculated whether these actions will affect Johnson & Johnson's plans to acquire Guidant.

"This additional recall is clearly going to test the confidence of investors that the [J&J] acquisition will be completed," Deutsche Bank analyst Tao Levy said in a research note quoted by Reuters. "We believe the pacemaker problem is of relatively smaller significance than the ICD recalls," he added.

Guidant shares closed at $67.31, down $2.10, or 3 percent, in heavy trading on the New York Stock Exchange.

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Sankyo resumes development of CS-917 for treatment of type 2 diabetes

Sankyo Co. Ltd. intends to resume full development of CS-917, a product it is developing jointly with Metabasis Therapeutics Inc. as a potential treatment for patients with type 2 diabetes.

Earlier this year, Sankyo terminated a trial assessing CS-917 in combination with metformin after two patients experienced adverse events involving apparent lactic acidosis. Another study of CS-917 being conducted at the same time was also halted.

Having reviewed the clinical development program and data pertaining to the adverse events, Sankyo and Metabasis expect to initiate a Phase IIb trial of CS-917 by the end of the year, pending discussions with the Food and Drug Administration.

If the drug is successfully developed, the companies believe it may be used alone as first-line therapy and in combination with other diabetes agents, such as insulin sensitizers and sulfonylureas. They said additional clinical evaluations will be required to determine whether CS-917 can be used in conjunction with metformin.

Discovered by Metabasis, CS-917 is the first of a new class of diabetes drugs designed to selectively inhibit the gluconeogenesis pathway. In patients with type 2 diabetes, this pathway is responsible for the overproduction of glucose in the liver.

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Geron, Merck enter into collaborative agreement for cancer vaccine

Shares of Geron Corp. rose 26.6 percent after the company said it entered into a collaboration and license agreement with Merck & Co. Inc. to develop a cancer vaccine targeting telomerase, an enzyme found in most cancer cells that enables the cancer to grow and metastasize over time.

According to the agreement, Geron will receive an undisclosed payment up front, as well as developmental and regulatory milestone payments and royalties. Merck also agreed to acquire equity in Geron in the future. Other financial terms were not disclosed.

In addition, Merck has the option of negotiating a separate agreement for Geron's dendritic cell-based telomerase vaccine that is currently undergoing Phase I/II clinical trials. Geron will receive an option payment from Merck; further terms of an agreement for this vaccine will be negotiated if Merck exercises its option.

Shares of Geron closed at $10.89, up $2.29, in heavy trading on the Nasdaq.

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Roche, Trimeris sNDA accepted for needle-free delivery of HIV treatment

F. Hoffman-La Roche Ltd. and Trimeris Inc. said the Food and Drug Administration accepted their supplemental New Drug Application to consider including information regarding the Biojector 2000 (B2000) needle-free injection device in the labeling for the companies' HIV treatment, Fuzeon (enfuvirtide).

The filing is based on a single-dose, comparative pharmacokinetic study of Fuzeon administered via the B2000 system versus needle-syringe administration.

According to Roche and Trimeris, Fuzeon is the only entry inhibitor available to treat HIV. The therapy is currently approved for use with a needle and syringe.

The companies expect the FDA to make a decision on the sNDA later this year.

The B2000 system, a needle-free injector powered by carbon dioxide, is manufactured by Bioject Medical Technologies Inc. It works by dispersing liquid medication through the skin and has been used to deliver subcutaneous and intramuscular injections since 1996.

Trimeris and Roche plan to start a month-long, 40-patient trial of Fuzeon delivered using the B2000 system in August to evaluate tolerability, injection site reactions and pharmacokinetics.

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Genentech's Lucentis meets primary endpoint of maintaining vision in patients with wet AMD, study shows

Genentech Inc.'s Lucentis (ranibizumab) met its primary endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD), according to one-year trial data presented at the annual meeting of the American Society of Retina Specialists (ASRS) in Montreal.

The Phase III MARINA study included 716 patients with minimally classic or occult wet AMD. Patients were randomized in a two-to-one ratio to intravitreal Lucentis injections or control treatment. Those who received Lucentis were then randomized to either 0.3 mg or 0.5 mg of Lucentis once monthly for two years.

Visual acuity was measured using the Early Treatment of Diabetic Retinopathy eye chart.

The results showed that 95 percent (452/478) of patients treated with Lucentis lost fewer than 15 letters compared with baseline testing. Only 62 percent (148/238) of patients receiving the sham treatment had similar results. Moreover, there was a 17-letter difference in mean visual acuity change from study entry between those treated with either dose of Lucentis and the control group.

At one year, Lucentis-treated patients gained an average of seven letters in visual acuity compared with study entry, while the control group lost an average of 10.5 letters, Genentech said. Also at the one-year mark, approximately 40 percent of those treated with Lucentis achieved a visual acuity score of 20/40 or better compared with 11 percent of the control group.

"These data are very compelling because, for the first time, we have a potential treatment which has been shown to improve vision in a significant number of patients with wet AMD as opposed to just slowing progression of vision loss," noted Dr. Joan Miller, who presented the study results at the ASRS conference.

Earlier this month, Genentech requested fast track designation for Lucentis as a treatment for wet AMD. If the request is granted, the company said it could initiate a rolling Biologics License Application filing by the end of the year.

Eyetech Pharmaceutical Inc. and Pfizer Inc. currently sell the leading treatment for wet AMD, Macugen (pegaptanib sodium). Eyetech's stock fell when Genentech reported the initial results of this trial in May.

"The favorable safety profile of Macugen has been maintained for two years in patients who participated in clinical trials and in tens of thousands of patients who are using the drug," Eyetech said in a statement issued Monday.

Lucentis is being jointly developed by Genentech and the Novartis Ophthalmics Business Unit.

Genentech shares closed at $88.06, down $1.52, or 1.7 percent, in moderate trading on the New York Stock Exchange. Eyetech shares closed at $11.73, down $1.72, or 12.8 percent, in heavy trading on the Nasdaq, while Pfizer shares closed at $27.25, down $0.32, or 1.2 percent, in moderate trading on the New York Stock Exchange.

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NSAIDs associated with increased risk of AUR, data reveal

A new study shows that the risk of acute urinary retention (AUR), which is the sudden inability to urinate, is approximately two-fold among men who use nonsteroidal anti-inflammatory drugs as compared with men who do not use NSAIDs.

Researchers in the Netherlands conducted a population-based, case-control study that included all men aged 45 years or older who were registered in the Integrated Primary Care Information database between 1995 and 2002 and who had at least six months of valid database history.

Of this source population comprising 72,114 men, 536 with a validated diagnosis of AUR were included in the case-control analyses. A total of 5,348 controls from the same source population were matched to the cases based on age and index date.

Among current users of NSAIDs, the overall risk of AUR was 2.02 times higher than that among nonusers. Researchers observed that patients who had recently started taking NSAIDs and those using a dose equal to or higher than the recommended daily dose were at the greatest risk for developing AUR. Past use of NSAIDs, on the other hand, was not associated with an increased risk.

"We believe that physicians should be informed about the possibility of provoking AUR in patients using NSAIDs, especially in high-risk patients," the researchers concluded.

The study was published in the July 11 issue of Archives of Internal Medicine.

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Centocor Inc.

Centocor Inc. entered into a collaborative agreement with biotherapeutics company Xencor Inc. for the creation of improved monoclonal antibodies. Centocor will evaluate antibody drug candidates created by Xencor's XmAb engineered antibody Fc domains against an oncology target. Centocor will give Xencor an undisclosed up-front payment and, should Centocor develop candidates from this agreement, Xencor will be eligible to receive additional license fees, milestone payments and royalties.

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Xoma Ltd.

Xoma Ltd. terminated an exclusive worldwide licensing agreement with Zephyr Sciences Inc. for the research, development and commercialization of products containing a recombinant form of bactericidal/permeability-increasing protein (BPI). BPI is a protein found in white blood cells that helps protect the body against bacterial infections, according to Xoma. John Castello, Xoma's chief executive officer, said the agreement was terminated because Zephyr failed to meet financing requirements.

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Genaissance Pharmaceuticals Inc.

Genaissance Pharmaceuticals Inc. and Organon entered into an agreement whereby the companies will use Genaissance's HAP technology to identify genetic markers that explain interindividual variation in drug response. The collaboration will initially focus on psychiatric disorders, with the ultimate goal being to develop a diagnostic test to help guide therapy. According to the agreement, Organon will provide Genaissance with license and research funding; both companies will be eligible for royalties on product revenues resulting from the collaboration.

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Danco Laboratories LLC

Danco Laboratories LLC is updating safety information for Mifeprex (mifepristone), which is indicated for the medical termination of intrauterine pregnancy. Since the drug's approval in 2000, five deaths from bacterial infections and sepsis have occurred in women taking Mifeprex and misoprostol. Although no causal relationship has been established between the infections and this drug combination, the updated safety information recommends that women taking Mifeprex and misoprostol seek medical attention immediately if they experience abdominal pain or discomfort or general malaise.

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