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WARNER CHILCOTT AGREES TO $3 BILLION TAKEOVER ___________________________________________________________________________ Warner Chilcott Plc entered into an agreement to be acquired by private buyout group Waren Acquisition Ltd. for approximately $2.96 billion in cash.

Warner Chilcott is a United Kingdom-based pharmaceutical firm focused on women's health and dermatology; it was formerly known as Galen Holdings Plc. Waren Acquisition is controlled by funds managed or advised by J.P. Morgan Partners LLC and DLJ Merchant Banking III Inc., a division of Credit Suisse First Boston.

Under the agreement, Waren Acquisition will pay 862 U.K. pence, or $15.79, for each share of Warner Chilcott, representing a 33 percent premium over the stock's closing price on Sept. 17, the last business day before Warner Chilcott announced it had been approached regarding a takeover. Holders of American depositary shares will receive approximately $63.33 for each share.

Waren Acquisition outbid consortiums led by Goldman Sachs Group and Bain Capital LLC for the right to purchase Warner Chilcott, according to a Bloomberg report.

During the 12 months ended Sept. 30, Warner Chilcott accumulated $522.9 million in revenue and $272.1 million, or $1.12 per share, in total operating profit, the company reported Wednesday. In the most recent quarter, revenue totaled $125.1 million, down 10 percent from the same period of last year, while total operating profit climbed 1 percent to $66.2 million. Earnings per share dropped 9 percent to $0.27 in the quarter.

Warner Chilcott shares closed at $63.84, up $2.01, or 3.3 percent, in heavy trading on the Nasdaq.



ALLEGRA-D 24-HOUR TABLETS APPROVED BY FDA; AAIPHARMA SHARES SOAR ___________________________________________________________________________ Shares of aaiPharma Inc. surged 59 percent Wednesday after the sanofi-aventis Group received Food and Drug Administration approval to market Allegra-D 24-Hour tablets (fexofenadine hydrochloride/pseudoephedrine hydrochloride) for the treatment of seasonal allergy symptoms with nasal congestion in patients aged 12 years or older.

AaiPharma said Allegra-D 24-Hour is the only approved once-daily prescription antihistamine with a decongestant. Allegra-D 24-Hour was developed using aaiPharma's extended-release drug technology, according to Reuters.

The company will receive a one-time payment from sanofi-aventis as well as royalty payments on sales of the product, which will provide aaiPharma with much-needed cash, according to a Thomas Weisel research note cited by CBS MarketWatch. AaiPharma has laid off workers, changed senior management and attempted to sell certain assets this year in an effort to alleviate its financial difficulties. The amount of the upfront and royalty payments was not disclosed.

"Most importantly, we believe this approval further underscores aaiPharma's considerable expertise. ...said Thomas Weisel analyst Donald Ellis. "As [aaiPharma] has recently disclosed its intention to potentially divest its pharmaceuticals division, we continue to believe the company is transitioning back to its roots as a clinical research organization."

Ellis said transitioning back to a clinical research organization could help restore aaiPharma to profitability.

Allegra generated approximately $1.6 billion in sales in 2003, according to CBS MarketWatch, while Allegra-D had $461 million in sales.

Shares of aaiPharma closed at $2.64, up $0.98, in heavy trading on the Nasdaq. Shares of sanofi-aventis closed at $36.71, up $1.16, or 3.3 percent, in heavy trading on the New York Stock Exchange.

FOSRENOL APPROVED FOR REDUCING HIGH PHOSPHORUS LEVELS ASSOCIATED WITH RENAL DISEASE ___________________________________________________________________________ The Food and Drug Administration approved Shire Pharmaceuticals Group Plc's Fosrenol (lanthanum carbonate), a non-aluminum, non-calcium phosphate binder, which reduces high phosphorus levels in patients with end-stage renal disease.

The product, approved in 250 mg and 500 mg strengths, is expected to be available in U.S. pharmacies by the end of the year. Paul Diggle, a Code Securities industry analyst, said approval of the 500 mg dose means that patients will need fewer doses than with Genzyme Corp.'s Renagel (sevelamer hydrochloride), according to a Reuters report. Diggle estimated that peak annual sales of Fosrenol could total $350 million.

The drug is formulated as a chewable tablet that does not require water to be swallowed, which is beneficial for patients with ESRD who must restrict fluid intake, Shire said.

During clinical trials, ESRD patients who were treated with Fosrenol demonstrated serum phosphorus reduction one week after the treatment was initiated, and a majority of the patients reached target levels within eight weeks. In long-term, open-label extensions, Fosrenol-treated patients have maintained this reduction in phosphorus levels for up to three years.

Shire explained that when kidneys fail, they can no longer effectively remove phosphorus that is absorbed from food by the gastrointestinal tract. Fosrenol is designed to bind to dietary phosphorus so the Fosrenol/phosphorus complex cannot be absorbed into the bloodstream and is instead eliminated from the body.



SHARES RISE AFTER CARDINAL HEALTH POSTS LONG-AWAITED FINANCIAL RESULTS ___________________________________________________________________________ Shares of Cardinal Health Inc. jumped 20.4 percent Wednesday after the health products and services provider posted a rise in revenue and earnings from continuing operations for both the fourth quarter and fiscal year of 2004.

According to CBS MarketWatch, market analysts speculated this stock surge reflected investor relief that the financial results were not alarming considering recent events. Along with investigations by the Securities and Exchange Commission and New York federal attorneys, Cardinal Health delayed the release of these financial results after its chief financial officer resigned in July.

In accordance with Generally Accepted Accounting Principles, revenue rose 11 percent to $16.9 billion for the quarter ended June 30 and 15 percent to $65.1 billion for the fiscal year. During the quarter, earnings from continuing operations rose 11 percent to $397.4 million, or by 15 percent to $0.91 per diluted share. On a fiscal-year basis, earnings from continuing operations totaled $1.5 billion, or $3.47 per share, representing increases of 10 and 14 percent, respectively.

Robert Walter, chief executive officer, said some businesses performed lower than historic standards, but there were strong contributions from other divisions, especially the Medical Products and Services segment.

"In Pharmaceutical Distribution and Provider Services, the business model transition underway put pressure on our earnings; however, over the long-term, we believe the future of pharmaceutical distribution is secure," Walter added.

Operating earnings growth for this segment was flat for the quarter and dropped 1 percent for the year, which Cardinal Health attributed to the ongoing transition in how pharmaceutical manufacturers pay for the firm's distribution services. Cardinal Health expects that a change to fee-based agreements with pharmaceutical manufacturers, a transition planned for completion by April 1, 2005, will "improve returns and provide greater visibility to future earnings."

However, one analyst said the transition is one of the company's biggest risks, CBS MarketWatch reported. Eric Coldwell, a Robert W. Baird analyst, does not expect the change will be completed by the end of March and said the fee-based model "doesn't have precedent so we don't know what it will look like when it is complete."

Coldwell also said the firm faces negative margin trends, sluggish growth and operating issues in all divisions, as well as rapid staff turnover.

Indeed, Cardinal Health cited its ongoing business model transition, margin pressure on medical products, delays in manufacturing, associated costs of new sterile manufacturing projects and pressure on the sale of automation systems as contributing to the estimated decline in earnings early next year. The company expects earnings per share to drop by between 10 and 15 percent during the first half of fiscal 2005, with an approximate 25 percent decline during the first quarter.

Shares of Cardinal Health closed at $47.35, up $8.02, in heavy trading on the New York Stock Exchange.

ANTHEM PROFIT UP 23 PERCENT IN THIRD QUARTER; COMPANY RAISES FY 2004 GUIDANCE ___________________________________________________________________________ Anthem Inc. reported third-quarter earnings that exceeded Wall Street expectations Wednesday and raised its forecast for the full year.

In the quarter, Anthem's net income reached $242.1 million, or $1.70 per share, up 23 percent from $196.5 million, or $1.38 per share, in the same period of 2003. Results in each quarter included net realized gains of $0.03 per share. Excluding the $0.03-per-share gain, analysts polled by Thomson First Call had predicted earnings of $1.65 per share, according to a CBS MarketWatch report.

Operating revenue in the quarter totaled $4.73 billion, up 13 percent from $4.19 billion in the third quarter of 2003. The revenue growth was attributed to disciplined pricing and solid membership gains, with Anthem's small and local large group businesses contributing most significantly to the increase. Overall medical enrollment increased by 890,000 members, or 8 percent, to 12.7 million members as of Sept. 30.

Anthem said its net income in the fourth quarter of this year is expected to be "relatively consistent" with results for the third quarter. For the full year, Anthem increased its expectation from a range of $6.95 to $7.05 per share to a range of $7.05 to $7.10 per share. In 2005, net income is expected to reach at least $7.60 per share, representing a 15 percent increase over 2004.

Shares of Anthem closed at $81.12, up $4.28, or 5.6 percent, in heavy trading on the New York Stock Exchange.



VIAGRA EFFECTIVE IN PHASE III PULMONARY ARTERIAL HYPERTENSION TRIAL ___________________________________________________________________________ Pfizer Inc.'s sildenafil citrate, marketed as Viagra for erectile dysfunction, successfully treated patients with pulmonary arterial hypertension (PAH) in a Phase III study, according to a Reuters report.

The study included 278 patients who were treated with placebo or sildenafil three times daily in 20 mg, 40 mg or 80 mg doses.

Twelve-week data showed sildenafil-treated patients in each dosing group had better results than placebo-treated patients on a six-minute walk test. According to TheStreet.com, sildenafil-treated patients had a 46-meter improvement in six-minute walk distance compared to placebo-treated patients. Actelion Ltd.'s Tracleer (bosentan), the only oral drug approved in the United States for PAH, elicited a 40-meter improvement during its registration study, TheStreet.com said.

"With Viagra's comparable efficacy to that of Tracleer, its safer toxicity profile and roughly half the cost of Tracleer, we expect Viagra will assume Tracleer's spot as front-line monotherapy in treating Class II and many Class III PAH patients and also serve to significantly expand the addressable patient base," wrote Wachovia analyst Martin Auster in a flash note, according to TheStreet.com.

Though Viagra may take some of the PAH market from competitors such as Tracleer, Pfizer's marketing strength is likely to expand the overall PAH market, TheStreet.com speculated, which could also increase the number of patients treated with combinations of drugs. TheStreet.com said "a small percentage of PAH patients" are currently treated with the combination of Tracleer and off-label Viagra.

Tracleer generated $99.75 million in worldwide sales last year. United Therapeutics Corp. markets the only other Food and Drug Administration-approved PAH drug--the injectable drug Remodulin (treprostinil), which generated $45.1 million in sales last year.

Myogen Inc. and Encysive Pharmaceuticals Inc. also have prospective PAH treatments involved in Phase III testing.

Pfizer's data were presented in Seattle at the annual meeting of the American College of Chest Physicians.

Shares of Pfizer closed at $29.04, up $0.71, or 2.5 percent, in moderate trading on Wall Street. Meanwhile, Encysive shares gained $1.07, or 14.3 percent, to close at $8.56; Myogen gained $0.56, or 6.8 percent, to close at $8.76; and United Therapeutics gained $1.86, or 6.3 percent, to close at $31.35, all in heavy trading on the Nasdaq. Actelion shares are not traded in the United States.



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ELI LILLY AND CO. ___________________________________________________________________________ Eli Lilly and Co. acquired from Merck KGaA exclusive worldwide rights to EMD 281014, a 5-HT2a antagonist being evaluated for the treatment of insomnia. The product is currently in Phase I trials. Merck will receive an upfront payment of approximately $29 million as well as potential milestone and royalty payments.

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ISIS PHARMACEUTICALS INC. ___________________________________________________________________________ Isis Pharmaceuticals Inc. reported a Phase III trial of Isis and Eli Lilly and Co.'s Affinitak failed to show a benefit of Affinitak therapy when added to cisplatin and Lilly's Gemzar (gemcitabine hydrochloride) for patients with non-small-cell lung cancer. Patients in both treatment groups had median survival of approximately 10 months. These results are similar to Phase III findings reported by the companies in March of last year.

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ONYX PHARMACEUTICALS INC. ___________________________________________________________________________ Onyx Pharmaceuticals Inc. and Bayer Pharmaceuticals Corp. received an orphan drug designation from the Food and Drug Administration for sorafenib, also known as BAY 43-9006, in the treatment of renal cell carcinoma. The product is currently in Phase III testing. Earlier this week, Onyx said it anticipates a 2006 launch of the drug; some investors had been hoping the firm would attain FDA approval in 2005 based on Phase II data alone.

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PENINSULA PHARMACEUTICALS INC. ___________________________________________________________________________ Peninsula Pharmaceuticals Inc. received a fast track designation from the Food and Drug Administration for the use of Doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Peninsula is currently conducting six Phase III trials of the compound, including two trials comparing intravenous Doripenem with standard antimicrobial regimens in patients with nosocomial pneumonia, including VAP. Peninsula licenses Doripenem, a member of the carbapenem class of beta-lactam antibiotics, from Shionogi & Co. Ltd.  

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