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Pfizer set to acquire biotechnology company Rinat Pfizer Inc. entered into an agreement to acquire Rinat Neuroscience Corp., a privately held biotechnology company that is developing products designed to treat diseases and disorders of the central nervous system.

Rinat was formed in 2001 when Genentech Inc. granted Rinat a broad license to its key neuroscience assets.

Rinat's most advanced new drug candidate is RN624, which is entering Phase II clinical trials to be studied as a treatment for acute and chronic pain. Additionally, Rinat is developing RN1219 as a treatment for Alzheimer's disease. Rinat has other compounds in late pre-clinical development for migraine prophylaxis and cachexia, as well as discovery programs in obesity, pain, neuropathy and Parkinson's disease.

"Rinat is a pioneer in developing protein-based therapeutics and we see tremendous potential in its research to develop new medicines ...," said John LaMattina, president of global research and development at Pfizer. "Combining Rinat's potential product portfolio with Pfizer's capabilities is a further step in our strategy to enhance Pfizer's internal research and development efforts with high-potential, externally sourced product candidates and technologies."

The companies expect the acquisition to close by mid-2006. Financial terms of the transaction were not disclosed.

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FDA approves skin patch to treat ADHD in children Shire Pharmaceuticals Group Plc's once-daily transdermal patch Daytrana (methylphenidate) received approval from the Food and Drug Administration to treat attention-deficit/hyperactivity disorder in children.

Approved in 10 mg, 15 mg, 20 mg and 30 mg doses, Daytrana is the only non-oral treatment choice for these patients, Shire said. The efficacy of the patch was shown by results from two controlled trials in children aged 6 to 12 years with ADHD, Shire noted. In both studies, the patch was generally well tolerated with mild to moderate adverse events, including decreased appetite, insomnia and mood swings.

Daytrana is licensed globally to Shire by Noven Pharmaceuticals Inc. It uses Noven's DOT Matrix transdermal technology and can remain attached to a child's skin for up to nine hours daily, even through daily activities, including bathing.

As previously reported, the FDA initially sent an approvable letter to Shire for its New Drug Application for Daytrana. The agency had questions on the product's labeling as well as made requests for data clarification and post-marketing studies and surveillance.

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Pfizer, OSI update Macugen's label to include reports of rare allergic reactions Pfizer Inc. and OSI Pharmaceuticals added information to Macugen's (pegaptanib sodium injection) label about reported rare cases of serious allergic reactions when patients use the drug in conjunction with other medications.

Macugen is indicated to treat wet age-related macular degeneration and is administered to patients by injection once every six weeks.

The companies submitted a letter to the Food and Drug Administration that included information concerning reports of anaphylaxis/anaphylactoid reactions following administration of Macugen along with various treatments administered as part of the injection preparation procedure. The cases occurred after the drug was approved in 2004, Reuters reported.

"A direct relationship to [Macugen] or any of the various medications administered as part of the injection preparation procedure or other factors has not been established in these cases," the companies stated in the letter.

The letter also stated that a patient's medical history for hypersensitivity reactions should be evaluated prior to injection.

OSI shares closed at $30.02, down $1.10, or 3.5 percent, in moderate trading on the Nasdaq, while Pfizer shares closed at $24.69, down $0.40, or 1.6 percent, in light trading on the New York Stock Exchange.

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Tysabri linked with improved quality of life, lower risk of disease progression, according to new data Biogen Idec Inc. and Elan Corp. Plc's Tysabri (natalizumab) demonstrated significant effects on health-related quality of life and disability rates for patients with multiple sclerosis, new Phase III study results demonstrate.

The companies previously suspended clinical trials of Tysabri following concerns that the drug was linked to progressive multifocal leukoencephalopathy (PML), a potentially fatal disease of the central nervous system. On March 8, the Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to reintroduce Tysabri to the market as a treatment for relapsing forms of MS.

Researchers presented positive results of two Phase III trials (AFFIRM AND SENTINEL) in San Diego at the American Academy of Neurology's 58th Annual Meeting. In the AFFIRM study, researchers analyzed Tysabri as a monotherapy and in the SENTINEL study, Tysabri was added to Biogen Idec's Avonex (interferon beta-1a).

The primary efficacy endpoint at two years for both trials was the rate of disability progression sustained for three months. Using the Expanded Disability Status Scale (EDSS) to measure the rate, the researchers noted a 42 percent reduction in the risk of disability progression achieved by Tysabri-treated patients compared with the placebo group in the AFFIRM study. The Tysabri treatment group also demonstrated a significant delay in progressing to an EDSS score of 4 (ambulatory with moderate disability) and 6 (requiring a cane, crutch or brace). Additional tests on disability progression, including the Multiple Sclerosis Functional Composite, showed a significant impact from Tysabri use.

In the AFFIRM study, patients treated with Tysabri had a significant improvement in the physical measure and mental component of the Short Form-36 Health Survey as compared with declines experienced by the placebo group. Quality of life assessed by a Visual Analogue Scale (VAS) indicated significant benefits for the Tysabri group as well.

Based on the SENTINEL data, Tysabri plus Avonex also demonstrated significant benefits using the VAS.

The trials additionally measured visual function and found that, compared with control groups, Tysabri-treated patients had a reduction in the risk of visual loss, which is one of the most common causes of disability and reduced quality of life among MS patients, the firms noted.

Phase III safety data revealed cases of PML in two MS patients who received Tysabri and Avonex and in one patient with Crohn's disease who had recently received an immunosuppressant. The incidence and rate of other serious infections, such as pneumonia, urinary tract infection and appendicitis, were balanced between the Tysabri groups and the placebo-treated patients, the firms said.

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Trial shows Schering-Plough's Avelox as effective as levofloxacin plus ceftriaxone in treating patients with severe pneumonia Results of a clinical study of Schering-Plough Corp.'s Avelox (moxifloxacin hydrochloride) showed that the drug is as effective as the high-dose combination of levofloxacin plus ceftriaxone in treating patients with severe community-acquired pneumonia (CAP) who require hospitalization.

The double-blind, double-dummy comparative study, known as MOTIV, included 738 patients who were randomized to receive Avelox intravenous/oral 400 mg once daily for seven to 14 days or the combination of ceftriaxone intravenous 2 g once daily plus levofloxacin intravenous 500 mg twice daily, followed by levofloxacin oral 500 mg twice daily, for seven to 14 days.

Based on the patients' renal function, the dose of levofloxacin could be adjusted. Of the 569 patients in the per-protocol group, 59.1 percent were classified as having severe pneumonia based on the Pneumonia Severity Index. The primary efficacy endpoint for the two per-protocol treatment groups was clinical cure rates four to 14 days after the last dose of treatment. Results showed no significant difference between the groups for the primary efficacy endpoint; Avelox-treated patients experienced an 86.9 percent clinical cure rate compared with 89.9 percent of patients in the combination group.

Avelox is a broad-spectrum fluoroquinolone antibiotic that is approved as monotherapy to treat patients with CAP. Levofloxacin is the active ingredient in Ortho-McNeil Inc.'s Levaquin; the high-dose of levofloxacin used in the study is not approved in the United States.

These results were presented at the European Congress of Clinical Microbiology and Infectious Diseases in Nice, France.

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Long-term efficacy of Cervarix to protect against cancer-causing genotypes demonstrated in new study GlaxoSmithKline Plc's cervical cancer vaccine candidate Cervarix may be safe and efficacious up to 4.5 years against precancerous lesions associated with human papillomavirus (HPV) genotypes 16 and 18, new follow-up data suggest.

The study was a follow-up to a 2004 trial conducted among 1,113 women aged 15 to 25 years. The patients were randomized to three doses of Cervarix or placebo on a zero-, one- and six-month schedule. The extension study included 776 women who originally received all three doses of the vaccine; no vaccines were administered during the follow-up phase.

Based on a mean follow-up of 47.7 months, HPV antibodies 16 and 18 were detected in more than 98 percent of women who received the vaccine. Additionally, the results showed that Cervarix demonstrated substantial protection against infection with the third and fourth most prevalent cancer-causing types of HPV, 45 and 31. Overall, 80 percent of cervical cancers globally can be attributed to HPV types 16, 18, 45 and 31, the researchers noted.

The incidence of serious adverse events was comparable in the vaccine and placebo groups. More placebo-treated women reported adverse events and new-onset chronic disease.

"These findings set the stage for the widescale adoption of HPV vaccination for prevention of cervical cancer," the study authors wrote.

The findings were published April 6 as an early online article by the journal The Lancet.

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Wyeth Wyeth purchased an additional 10 percent stake in Wyeth K.K., its joint venture with Takeda Pharmaceutical Co. Ltd. Wyeth now owns 80 percent of the stake. Financial details of the equity transfer were not disclosed. Through the partnership, Wyeth and Takeda co-promote biological products, including Amgen Inc. and Wyeth's Enbrel (etanercept). Wyeth and Takeda are hoping to make Japan one of the strongest markets for Enbrel, Wyeth said.

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Food and Drug Administration The Food and Drug Administration said it plans to add outside medical experts to an existing advisory panel to help evaluate the safety of already marketed heart devices, according to The New York Times. The new advisors would help the FDA interpret data from device makers and form responses to immediate problems, such as recalls. According to The Times, the FDA has been criticized for gaps in its supervision of some products, such as in the recent situation when heart rhythm management devices made by Guidant Corp. were recalled. In the past, Reuters said the safety of medical devices has been assessed through reports to the FDA from manufacturers.

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Sanofi Pasteur Sanofi Pasteur's Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) continues to be recommended for people who require the vaccine for treatment of Neisseria meningitidis, despite three additionally reported cases of Guillain-Barre Syndrome (GBS), according to PharmaLive. In October 2005, the Food and Drug Administration and Centers for Disease Control and Prevention issued an alert concerning Menactra after five cases of GBS developed in patients two to four weeks after being vaccinated. Further studies and monitoring are ongoing, but the additional cases have not changed the FDA's recommendation of the vaccine. GBS is a serious neurological disorder that involves temporary paralysis.

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Galenea Corp. Galenea Corp. aligned its strategy to focus exclusively on discovering and developing treatments for diseases of the central nervous system. Galenea also recently agreed to sell its siRNA program for the treatment of influenza and other respiratory viruses to Nastech Pharmaceuticals Co. Inc. Revenue brought in by the siRNA program will enable the company to in-license additional CNS programs to expand its pipeline. The company will continue its research collaboration with Otsuka America Pharmaceuticals Inc.; the agreement focuses on the development of new treatments for schizophrenia and other CNS disorders.


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