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Novartis bids to purchase rest of Chiron for $4.5 billion Novartis AG made an offer to acquire all of the remaining 112 million outstanding, fully diluted shares of Chiron Corp. for $40.00 per share in cash, or a total of approximately $4.5 billion.

Novartis already owns a 42.2 percent stake in Chiron.

The Swiss drug company hopes to gain a strategic platform in the vaccine market through the acquisition and possibly establish a foothold in the still-open market of avian flu vaccination, according to The Wall Street Journal. The Journal noted that the acquisition of Chiron's biopharmaceutical products in the areas of infectious disease and cancer are also likely to complement Novartis' own business in those areas.

As reported, Chiron has experienced falling profits and rising expenses during the last year as a result of alleged contamination problems at the company's Liverpool plant. The company was unable to deliver any of its Fluvirin flu vaccine to the United States because of these problems.

Chiron has since reopened the plant, although it will have to go through further inspection and approval from U.S. and U.K. regulators before it can resume selling the vaccine.

Chiron shares closed at $42.93, up $6.49, or 17.8 percent, in heavy trading on the Nasdaq, while Novartis shares closed at $49.19, up $0.44, or 0.9 percent, in moderate trading on the New York Stock Exchange.

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Eisai submits sNDA for Aricept to treat severe AD Eisai Medical Research Inc. submitted a supplemental New Drug Application for Aricept (donepezil hydrochloride) tablets as a treatment for severe Alzheimer's disease.

Aricept is already approved to treat mild to moderate AD.

The sNDA is based on data from a six-month, double-blind trial of approximately 250 nursing home patients with severe AD (defined as having scores of 1 to 10 on the Mini-Mental State Examination).

Patients who received Aricept had statistically significant improvements compared with patients who received placebo on both of the trial's primary efficacy measures: the Severe Impairment Battery scale, which measures cognition, and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease scale, which measures patient function and ability associated with activities of daily living.

Aricept-treated patients reported adverse events of diarrhea and hallucinations at more than twice the rate of those who took placebo. Also, more patients in the Aricept group discontinued the study as a result of adverse events than did patients in the placebo group (15.6 percent vs. 6.7 percent).

Aricept, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc., is thought to work by preventing the breakdown of acetylcholine, according to Eisai. Acetylcholine is a chemical in the brain that affects memory and thinking.

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MGI Pharma, SuperGen's Dacogen deemed approvable for treating MDS MGI Pharma Inc. and SuperGen Inc. received an approvable letter from the Food and Drug Administration for Dacogen (decitabine), a potential injectable treatment for myelodysplastic syndromes (MDS), a group of diseases that affect the bone marrow and can progress to acute leukemia.

The companies submitted the New Drug Application for Dacogen last November.

The letter said the FDA could approve the injection pending review of "a requested analysis of the transfusion requirements of patients enrolled in the completed Phase III trial, submission of certain other information and completion of labeling discussions."

Lonnie Moulder, chief executive officer of MGI Pharma, said the company will be ready to launch the drug as soon as it is approved.

"We are working diligently to complete the requested analysis of data and provide this information to the FDA as early as possible during the fourth quarter," Moulder said.

MDS is most often seen in patients aged 60 years or older, and the life expectancy for those diagnosed with the condition typically ranges from six months to five years, according to MGI Pharma. Symptoms and complications associated with MDS include anemia, bleeding, infection, fatigue and weakness.

Patients with high-risk MDS may experience bone marrow failure, which ultimately can lead to death as a result of bleeding and infection.

Dacogen is also being assessed as a treatment for acute myeloid leukemia; alternative dosing regimens are being studied, as well.

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MDS to cut 500 jobs, shift focus to global life sciences MDS Inc. intends to reduce the number of its core businesses from six to three as part of a strategic plan to concentrate on opportunities in the global life sciences markets, a move that will result in the elimination of approximately 500 jobs worldwide.

The plan is the first big announcement from the Canadian health services company since Stephen DeFalco took the helm as chief executive officer on July 1.

"The fast-growing life sciences markets hold tremendous potential for MDS--an area where we already hold strong customer franchises," DeFalco said. "MDS will drive down its cost structure and improve execution to serve these markets effectively and drive shareholder value. A review of alternatives for company assets which are not part of MDS' core focus is under way and focused on maximization of shareholder value."

The company is also evaluating alternatives for its interests in two businesses--medical, surgical and lab supply distributor Source Medical Corp. and life sciences venture capital provider MDS Capital Corp.--and is in discussions with its partners in these businesses.

In addition, MDS will eliminate its enterprise services unit, rescale its information technology group and review its information technology outsourcing agreements to further cut costs.

The company said that currently 65 percent of its revenue comes from international markets; it expects this figure to increase to 95 percent after the restructuring.

While the move is projected to reduce revenue by approximately $21 million this year, MDS expects the job cuts to save the company more than $33 million next year.

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Nexium improves sleep, work productivity as it reduces nighttime heartburn, study suggests AstraZeneca Plc's Nexium (esomeprazole magnesium) reduced nighttime heartburn and led to fewer sleep disturbances, thereby improving sleep quality and work productivity, according to trial results published in the September issue of the American Journal of Gastroenterology.

Researchers first enrolled patients who had any history of erosive esophagitis or a history of heartburn or acid regurgitation for at least three months. Subjects then had to meet additional criteria to be eligible for a screening period of seven to 15 days, during which they recorded the severity of their heartburn symptoms and the occurrence of sleep disturbances related to gastroesophageal reflux disease.

Those who reported sleep disturbances and moderate or severe nighttime heartburn on three or more of the previous seven days were randomized to receive 40 mg of Nexium (n=220), 20 mg of Nexium (n=226) or placebo (n=229) each day for four weeks. The use of antacid tablets as rescue medication was limited to six per day or 21 throughout any seven-day period.

A total of 650 participants were included in the efficacy analyses, and 642 completed the study. The primary outcome measure was relief of nighttime heartburn symptoms during the last seven days of the study; relief was defined as a diary card response of "none" on at least six of the seven days.

A significantly higher percentage of Nexium-treated patients reached the primary outcome than did subjects who received placebo (53.1 percent with high-dose Nexium, 50.5 percent with low-dose Nexium and 12.7 percent with placebo).

The average difference between the 40 mg Nexium and placebo arms was 40.4 percent; the average difference between the 20 mg Nexium and placebo arms was 37.8 percent.

The rate of complete resolution and relief of GERD-associated sleep disturbances and heartburn symptoms was also significantly higher with active therapy than with placebo.

Additionally, of the 83 percent of patients who had poor sleep quality at baseline (global Pittsburgh Sleep Quality Index score greater than 5), only 54 percent in the Nexium 40 mg group and 43 percent in the Nexium 20 mg group had poor sleep quality at four weeks versus 64 percent of those who received placebo.

Moreover, Nexium appeared to improve work productivity. At baseline, approximately 16 work hours per week were lost as a result of GERD-related sleep disturbances for each of 350 study participants who were employed. After therapy, significantly more work hours were saved with Nexium (per patient: 11.6 hours/week with 40 mg and 12.3 h/wk with 20 mg) than with placebo (per patient: 6.2 h/wk).

"[T]reatment strategies for GERD should include improved sleep as an important goal if clinicians are to define 'optimal therapy' as that which achieves the best clinical outcomes," the study authors recommended.

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Aclasta superior to risedronate in head-to-head comparison among patients with Paget's disease, study reveals A single infusion of Novartis AG's Aclasta (zoledronic acid) 5 mg solution produced a more rapid, complete and sustained response than did risedronate in patients with Paget's disease, researchers reported.

The data came from two identical randomized, double-blind trials, results of which were published in the Sept. 1 issue of The New England Journal of Medicine. The trials, which included a total of 347 patients with Paget's disease, compared one 15-minute intravenous infusion of Aclasta and a 60-day oral regimen of risedronate at a dosage of 30 mg/day.

The studies were designed to assess the rate of therapeutic response, defined as a normalization of alkaline phosphatase levels or a reduction of at least 75 percent in the total alkaline phosphatase excess, at six months.

A total of 96 percent of patients who received Aclasta demonstrated a therapeutic response compared with 74.3 percent of patients who received risedronate, and Aclasta was associated with a shorter median time to a first therapeutic response.

Furthermore, in post-trial follow-up, 21 of 82 patients who received risedronate reported a loss of therapeutic response, while only one of 113 patients who received Aclasta did so.

The two drugs were similarly tolerated and, overall, led to a similar number of adverse events. Mild to moderate flu-like symptoms were the most commonly reported adverse event among patients who received the Aclasta infusion.

The study authors noted that the intensity and duration of effect with Aclasta "are likely to result from its single-dose administration, the drug's high affinity for bone mineral and [the] potent inhibition" of its molecular target. They also suggested that the "persistence of [Aclasta's] effect makes it a particularly suitable agent for the management of Paget's disease, in which the need for frequent re-treatment is a major clinical problem."

Paget's disease is a chronic, potentially debilitating bone disorder that includes symptoms of bone pain, skeletal deformity, neurologic complications and deafness.

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GlaxoSmithKline Plc GlaxoSmithKline Plc, in an effort to expand its supplies of vaccines for the U.S. market, acquired a production and research facility in Marietta, Pa. The 90-acre facility was formerly owned by Wyeth, who received an undisclosed cash payment in the sale. GSK Chief Executive Officer J.P. Garnier said the company plans to develop new influenza technology at the site and will make additional investments in the plant after it has developed a new vaccine based on tissue culture. GSK estimates that approximately 270 people will be employed at the new location.

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Barr Pharmaceuticals Inc. Barr Pharmaceuticals Inc. received final approval from the Food and Drug Administration to market its generic version of sanofi-aventis Group's Allegra (fexofenadine hydrochloride) 30 mg, 60 mg and 180 mg allergy tablets. Barr claims to be the first company to seek regulatory approval for a generic version of the drug; if so, the company would have 180 days of market exclusivity. However, Teva Pharmaceutical Industries Ltd. received tentative approval of its own version in July, and sanofi-aventis is defending its five Allegra-related patents in court to block the generic versions until the patents expire, the latest of which would be in 2017, Reuters reported.

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Cephalon Inc. Cephalon Inc. and McNeil Consumer & Specialty Pharmaceuticals entered into a co-promotion agreement for Attenace (modafinil) tablets, Cephalon's proprietary dosage form of modafinil. Cephalon currently markets modafinil as Provigil, a treatment for sleep disorders, and is awaiting approval of a supplemental New Drug Application it submitted in December 2004 for Attenace to treat attention-deficit/hyperactivity disorder in adolescents and children. Under the agreement, more than 300 McNeil sales representatives who currently promote McNeil's ADHD product, Concerta (methylphenidate hydrochloride) CII extended-release tablets, will promote Attenace for up to three years after it is launched in the United States. Cephalon will pay commission fees to McNeil and will be responsible for the development, manufacturing, distribution and sales of Attenace.

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Perlegen Sciences Inc. Perlegen Sciences Inc., a company that specializes in rapid genome analysis, expanded its relationship with GlaxoSmithKline Plc to allow for multiple studies related to genetics "to be conducted over a period of time." This agreement builds on Perlegen's two previous whole genome association studies, one in October 2004, and Perlegen's first pharmaceutical collaboration in September 2002. Terms of the agreement, financial or otherwise, were not disclosed.

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