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ABILIFY APPROVED FOR TREATING ACUTE BIPOLAR MANIA ___________________________________________________________________________ The Food and Drug Administration approved Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd.'s Abilify (aripiprazole) for treating acute bipolar mania, including the manic and mixed episodes associated with bipolar disorder. The drug is already approved for treating schizophrenia.

The regulatory agency based its approval on results from two placebo-controlled trials that lasted three weeks and enrolled 516 hospitalized patients with bipolar I disorder who were experiencing an acute manic or mixed episode. Patients treated with Abilify demonstrated significant improvement in episode symptoms.

There was also no significant difference between treatment groups with respect to weight gain, blood sugar levels or lipids. Results indicated that 3 percent of Abilify-treated and 2 percent of placebo-treated patients met a weight gain criterion of 7 percent or more of body weight.

Additionally, those who received Abilify in short-term, placebo-controlled trials in bipolar mania showed a low incidence of somnolence versus the placebo arm; somnolence was reported in 14 percent of patient receiving Abilify and 7 percent of patients receiving placebo.

Discovered by Otsuka, Abilify is being developed and commercialized in the United States and Europe through a collaboration between Otsuka and BMS.



FDA APPROVES REMICADE REGIMEN AS FIRST-LINE THERAPY FOR RA ___________________________________________________________________________ The Food and Drug Administration approved Centocor Inc.'s Remicade (infliximab) regimen--a combination of Remicade and methotrexate--as a first-line treatment for patients with rheumatoid arthritis.

The expanded label eliminates the requirement that patients must fail on methotrexate treatment before they can start receiving the Remicade regimen, Centocor said.

The Johnson & Johnson subsidiary noted that the approval was based on a trial that showed the Remicade regimen was superior to methotrexate alone in changing disease course when administered early in patients with moderately to severely active rheumatoid arthritis. The majority of patients treated with the Remicade regimen in that study experienced no progression of structural damage while the majority of patients given methotrexate alone progressed significantly, despite titrations to high doses.

"Intervention early is critical to change the course of joint destruction in this debilitating disease," Centocor said in a press release.

Remicade is an antibody that breaks down and prevents overproduction of tumor necrosis factor-alpha, which is believed to play a role in the development of rheumatoid and other types of arthritis.



MERCK, NITROMED HALT PHASE II TRIAL OF EXPERIMENTAL PAIN DRUG ___________________________________________________________________________ NitroMed Inc. reported that Merck & Co. Inc. halted a mid-stage clinical trial of its investigational pain drug, which contains a derivative of Merck's recently recalled arthritis drug Vioxx (rofecoxib).

The drug is being studied under a three-year licensing and research collaboration between NitroMed and Merck. NitroMed, a Lexington, Mass.-based biotechnology firm, licensed the drug to Merck as a potential treatment for pain and inflammation.

Their agreement, which was launched in January 2003 to develop nitric oxide COX-2 inhibitors, remains in effect, NitroMed noted.

As reported, Merck voluntarily withdrew Vioxx from the market Thursday after a study revealed that some patients had an increased risk of heart attack and stroke 18 months after they started taking the drug.

NOVARTIS ISSUES LETTER WARNING OF JAW OSTEONECROSIS IN PATIENTS RECEIVING ZOMETA, AREDIA ___________________________________________________________________________ Last week, the Food and Drug Administration posted on its Web site a letter that Novartis AG sent to physicians regarding labeling changes for Zometa (zoledronic acid) and Aredia (pamidronate disodium) injection due to reports of jaw osteonecrosis.

Osteonecrosis is a condition in which poor blood supply causes bone death. Both Zometa and Areda are indicated for treating hypercalcemia and bone metastases associated with malignancy or solid tumors, sometimes as adjuvant therapies.

In the letter, Novartis said it had received spontaneous reports of osteonecrosis of the jaw, mostly in patients with cancer who were receiving these biphosphonates as part of their treatment. Many were also receiving chemotherapy and corticosteroids. Most of the cases were associated with dental procedures like tooth extraction, Novartis said, and many of the patients had signs of local infection including osteomyelitis.

"Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged," Novartis recommended in the letter, adding that dental surgery could exacerbate jaw osteonecrosis.

"For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw," the letter reads.

Geoff Cook, a Novartis spokesman, said approximately 2.5 million patients have been treated with one of the drugs, according to Dow Jones. Novartis has received 300 reports of osteonecrosis, Dow Jones added.



ADVANCED NEUROMODULATION SYSTEMS WITHDRAWS PROPOSAL TO BUY CYBERONICS ___________________________________________________________________________ Medical device maker Advanced Neuromodulation Systems Inc. withdrew its bid to acquire Cyberonics Inc.

In August, ANS acquired 3.5 million shares, or approximately 14.7 percent, of Cyberonics' stock. Weeks later, ANS said it wanted to discuss merging with Cyberonics. However, Cyberonics stated it was not interested in such a transaction.

ANS acquired its stake soon after Cyberonics' shares had fallen on news that the Food and Drug Administration issued a "not approvable letter" for its implantable vagus nerve stimulation (VNS) therapy system to treat depression.

The FDA made its decision despite an approval recommendation from the Neurological Devices Panel of the agency's Medical Devices Advisory Committee.

Cyberonics said it would fight the ruling, and has since received approval from the FDA to market the device, on a limited basis, as a treatment for chronic or recurrent treatment-resistant depression. The Houston-based firm noted that it intends to "gain clarity and certainty on the revised depression regulatory plan and timetable."

"Given the amount of time that could transpire before Cyberonics attains the clarity and certainty it seeks, its Board's decision not to discuss a combination and our judgment that it does not make good business sense to try to force the issue, we have decided to withdraw our proposal at this time," said Chris Chavez, president and chief executive officer of ANS.

Shares of Cyberonics closed at $18.85, down $1.61, or 7.9 percent, in moderate trading on the Nasdaq.



WARNER CHILCOTT APPROACHED BY SECOND PARTY INTERESTED IN BUYING THE FIRM ___________________________________________________________________________ Warner Chilcott Plc's Board of Directors confirmed on Friday that the firm has been approached by a second party interested in purchasing the company's entire issued share capital.

On September 20 and 30, the board confirmed that a consortium of private equity institutions had approached the company with an indicative offer of approximately $2.7 billion.

In the company press release, the board reiterated that each approach "remains preliminary in nature. There can be no certainty either that an offer will actually be made or to the level of an offer, if made." The Northern Irish company has entered into a confidentiality agreement with the bidders, who are now undertaking due diligence enquiries.

Warner Chilcott, formally known as Galen Holdings, has not identified either of the prospective bidders, but people familiar with the situation said the first approach was from a consortium comprising Texas Pacific and The Goldman Sachs Group Inc.'s private equity arm, The Blackstone Group, Reuters reported.

Last year, a takeover offer worth up to the same amount fell through, Reuters added. Industry sources said Barr Laboratories was the bidder, but pulled out of the deal after the news leaked.

Reuters said Warner Chilcott posted $432 million in sales last year and an operating profit before amortization and exceptional items of $187 million.



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ORTHO BIOTECH PRODUCTS L.P. ___________________________________________________________________________ Ortho Biotech Products L.P., a Johnson & Johnson company, said it received a subpoena from the the Inspector General of the U.S. Department of Health & Human Services requesting documents about the sales and marketing of its anemia treatment Procrit (epoetin alfa). The company said it is cooperating in responding to the subpoena.

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TAP PHARMACEUTICAL PRODUCTS INC. ___________________________________________________________________________ TAP Pharmaceutical Products Inc. named Glenn Warner executive vice president, effective immediately. Warner most recently served as the divisional vice president and executive director of the Clara Abbott Foundation.

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UCB SA ___________________________________________________________________________ UCB SA, a biopharmaceutical and specialty chemical company based in Brussels, Belgium, sold its Surface Specialties unit to Cytec Industries Inc. for approximately $1.87 billion in cash and stock. UCB said the transaction is intended to transform it "from a hybrid to a pure biopharmaceutical company." Surface Specialties, which makes resins and adhesives, had sales of $1.36 billion in 2003, while UCB's pharmaceutical divisions had sales of $1.86 billion, The Wall Street Journal reported.

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RANBAXY PHARMACEUTICALS INC. ___________________________________________________________________________ Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd., recevied approval from the Food and Drug Administration to manufacture and market clorazepate dipotassium tablets in 3.75 mg, 7.5 mg and 15 mg doses. Total market sales for clorazepate dipotassium tablets, which are bioequivalent to Ovation Pharmaceuticals Inc.'s Tranxene, are $21.8 million, according to IMS Health Inc. data. Tranxene is indicated for the management of anxiety disorders or for the short-term relief of anxiety symptoms.

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OMNICARE ___________________________________________________________________________ Omnicare Inc., a distributor of medicine to nursing homes, extended by one month its tender offer to buy NeighborCare Inc. for $1.3 billion. The offer is now set to expire Oct. 29. Omnicare said 52.5 percent of NeighborCare's outstanding shares had been tendered to it as of Sept. 30.  

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