Pharma Insight

Tuesday, October 17, 2006

Forest Laboratories (FRX.N: Quote, Profile, Research) on Tuesday said fiscal second-quarter earnings rose on higher revenue from drugs to treat depression and Alzheimer's disease, and its raised its 2007 forecast.

The New York-based company said it earned $241 million, or 75 cents per share, compared with $205 million, or 59 cents per share, in the year-ago period.

Quarterly results include a $9.1 million charge.

The company boosted its forecast for the year ending March 31, 2007 to $2.60 to $2.65 per share, from a previous view of $2.45 to $2.50 per share.

Quarterly revenue rose to $847 million from $736 million a year earlier.

posted by pharma-insight @ 8:09 AM 0 comments

Diversified health care product maker Abbott Laboratories Inc. reports earnings for the fiscal third quarter on Wednesday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: In July, the company gained its third approved use for its best-selling drug Humira. Already approved for rheumatoid arthritis and psoriatic arthritis, Humira was approved to treat ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.

In late September, Abbott and Boston Scientific were targeted by a lawsuit filed by Johnson & Johnson. The suit alleged the Abbott and Boston Scientific benefited from a leak within medical device maker Guidant that helped them bid to buy the company. Boston Scientific's bid was successful, and the company divested Guidant's stent business to Abbott. Guidant had already agreed to be purchased by Johnson & Johnson.

EXPECTATIONS: Abbott forecast third-quarter earnings of 57 cents to 59 cents. Analysts surveyed by Thomson Financial estimate earnings of 58 cents per share on revenue of $5.48 billion.

ANALYST TAKE: Citigroup's Matthew Dodds, who rates the company a "Sell," on Friday raised his earning-per-share estimate by a penny to 57 cents on sales of $5.44 billion and predicted results "should remain uninspiring."

Banc of America's Glenn Novarro, who rates Abbott "Buy," was forecast below-consensus earnings of 57 cents per share on sales of $5.49 billion.

WHATS AHEAD: At the beginning of the fourth quarter, Abbott said it would no longer pursue its Zomaxx drug-coated stent in favor of the acquired Xience V stent, causing some analysts to lower Abbott's projected market share.

Prudential Equity analyst Larry Biegelsen, who rates Abbott "Overweight" and forecasts earnings per share of 58 cents for the third quarter, said he expects Humira to keep driving drug revenue until 2009 and the acquisition of Guidant to boost earnings in 2007, but forecast that shares should stay put in the near-term with profit taking and uncertainty over the November elections.

STOCK PERFORMANCE: Shares of Abbott rose nearly 14 percent to close the third quarter at $48.56 on the New York Stock Exchange. Since the beginning of the year, the stock has increased by 23 percent.

posted by pharma-insight @ 1:51 AM 0 comments

Monday, October 16, 2006

Diversified health care products maker Johnson & Johnson reports earnings for the fiscal third quarter on Tuesday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: In the third quarter, analysts started curtailing sales estimates for drug-coated stents as studies began circulating showing the devices raised the risk of blood clots. Also, in late September, J&J sued Boston Scientific and Abbott Labs for $5.5 billion in damages, alleging that acquisition target Guidant leaked confidential information during a bidding war that J&J eventually lost.

EXPECTATIONS: J&J forecast that third-quarter earnings should not exceed 93 cents per share, and analysts surveyed by Thomson Financial estimate earnings per share of 93 cents on revenue of $13.08 billion.

ANALYST TAKE: Banc of America analyst Glenn Novarro expects earnings per share of 95 cents on sales of $13 billion with slightly stronger drug sales of $5.7 billion watered down by weaker-than-expected stent sales. Prudential Equity's Larry Biegelsen figures the company will reach the consensus of 93 cents per share with sales of $12.94 billion.

WHAT'S AHEAD: Wall Street will continue to look for updates as J&J integrates the $16.6 billion acquisition of Pfizer's consumer products business. Also, upcoming medical conferences and an FDA panel on drug-coated stents are expected to keep pressure on sales of the devices because of raised safety concerns.

STOCK PERFORMANCE: Shares of J&J rose 8 percent over the third quarter to close at $64.94. Shares are also up about 8 percent for the year.

posted by pharma-insight @ 8:51 PM 0 comments

Sunday, October 15, 2006

UnitedHealth (UNH) said Chairman and Chief Executive William McGuire is stepping down as part of a shake-up of its senior ranks following an investigation into the backdating of past stock option awards. McGuire quit Sunday as chairman, and he will resign from the CEO post by Dec. 1. Until then, he will remain CEO to assist in the transition, UnitedHealth said. Replacing McGuire as chief executive will be Stephen Hemsley, the current president and chief operating officer who joined the company in 1997. At the same time, the company created the position of nonexecutive chairman of the board and said Richard Burke, the founding CEO of UnitedHealth and a director since 1977, will take the post immediately. McGuire though, wasn't the only executive on his way out of the health insurer. The board also accepted the resignation of director William Spears, and said David Lubben will proceed with his plans to retire and is stepping down as general counsel and secretary. Hemsley has voluntarily agreed to reprice all options awarded through 2002 to the annual high share price for each year, and "to take any other appropriate action to eliminate any possible financial benefit from options-related issues" found during the options probe. Additionally, McGuire will reprice all the options he received from 1994 through 2002 to the annual high share price for each year. UnitedHealth's board will have five seats filled by new independent directors during the next three years, and a new senior executive position of chief legal officer will be established. The company will also have a chief ethics officer among its senior executives. Going forward, the company will eliminate the authority of management to make equity awards. From now on, broad-based equity awards to executives and employees will occur annually and will be approved at the board meeting that generally coincides with UnitedHealth's annual meeting. UnitedHealth reaffirmed its previously issued guidance for the remainder of 2006 and for 2007, and it plans to hold its quarterly earnings conference call on Oct. 19, as scheduled. However, the company will likely delay filing its third-quarter Form 10-Q with the Securities and Exchange Commission. UnitedHealth hasn't determined whether any restatements of will be required.

posted by pharma-insight @ 7:00 PM 0 comments

Thursday, October 12, 2006

FDA Warns BioMarin Pharmaceutical Over Claims on a Web Site Promoting Orapred Drug

- Federal health officials sent a warning letter to BioMarin Pharmaceutical Inc. Wednesday, saying a company Web site makes unsubstantiated claims for the liquid form of the drug Orapred, a steroid used to reduce inflammation in asthma and other conditions.

In the letter from the Food and Drug Administration dated Oct. 11, the agency says BioMarin's Web site "suggests Orapred is safer and more effective than has been demonstrated." According to the agency, the company fails to highlight risks of taking the drug, which is known to cause mood swings and is contraindicated in patients with systemic fungal infections. The Web site also does not mention adverse reactions associated with the drug, which include fluid retention, hypertension, increased appetite and weight gain.

Orapred is primarily used to treat asthma in children because it contains flavor additives to mask the taste of its active ingredient, prednisolone. The drug is also prescribed to control inflammation from other conditions, including types of dermatitis and drug hypersensitivity.

In the warning letter, FDA takes issue with claims that the drug's flavor makes it easier to take. According to the agency, "these claims misleadingly suggests that because of its formulation, patients gag less often when taking Orapred." FDA says there is no documented evidence to support the claim.

BioMarin said Thursday it will comply with FDA by taking the site down immediately. Company spokesman Joshua Grass said BioMarin was surprised by the warning letter because FDA reviewed the content of the site last year and found no problems.

The company entered a North American licensing agreement for Orapred with privately held Alliant Pharmaceuticals in March 2006. In August Biomarin reported receiving a $7.5 million payment from Alliant under the agreement.

Shares of BioMarin Pharmaceutical rose 8 cents Thursday to $16.54 in midday trading on the Nasdaq.

posted by pharma-insight @ 11:48 AM 0 comments

Wednesday, October 11, 2006

Biovest International Gets Orphan Drug Designation for BiovaxID in Europe

Biovest International Inc., which is majority-owned by drug developer Accentia Biopharmaceuticals Inc., said Wednesday that a European commission registered its BiovaxID therapy as a rare disease treatment, conferring market exclusivity to treat a rare cancer.

The company said the Commission of the European Union entered BiovaxID into the Drug Register for Rare Diseases for Follicular Lymphoma, an immune system cancer where the disease is grouped in clusters in the lymph node. The designation follows a recommendation by a European Medicines Agency committee to make BiovaxID an orphan drug for the disease.

Orphan drug status in Europe gives the company 10 years of marketing exclusivity for the specific drug use upon approval, along with reduced filing fees and regulatory assistance.

Accentia shares rose 22 cents, or 8.9 percent, to $2.66 in afternoon trading on the Nasdaq. Since going public on Oct. 28, the stock has changed hands between $1.96 and $8.86, and is off nearly 52 percent year-to-date.

posted by pharma-insight @ 12:59 PM 0 comments

Saturday, October 07, 2006

Analysts expect biotechnology companies to report mixed third-quarter earnings with several pointing out that revenue increased but the sector still lagged in growth compared with the rest of the market.

Without any sweeping industrywide factors hampering or boosting stocks, companies faced a divergent mix of issues during the quarter, but sales of key drugs will help most companies to meet or beat expectations, several analysts said in forecasts for the quarter.

The sector itself held steady. The American Stock Exchange's biotechnology index posted a 6 point gain between June 30 and Sept. 30, marking a leveling out after a losing 46 points in the previous quarter.

Analysts cited industry sales data in giving a mixed assessment on company returns. But overall they thought sales from several key drugs would mark profitable quarters for companies like Genentech Inc. and Gilead, and many are expected to match Wall Street expectations. Also, higher enrollment figures in the Medicare Part D prescription drug program could be a sales-boosting factor for several companies.

Drug developer Genentech Inc. kicks off earnings season Oct. 10. Based on sales data for its cancer drugs analysts expect the company to post another strong quarter. Also, the company received approval for its age-related blindness drug Lucentis just before the start of the quarter and is tracking ahead of sales expectations.

Morgan Stanley analyst Dr. Steven Harr expects Genetech's Avastin sales to meet Wall Street expectations in the mid-to-high $440 million range, but said sales could be higher, reaching his estimate of $460 million. Other drugs, including Rituxan and Lucentis, are also poised to meet estimates.

Analysts polled by Thomson Financial expect the company to earn 50 cents per share on revenue of $2.31 billion.

Genzyme Corp. is expected to post revenue and earnings in line with Wall Street. Analysts expect earnings of 71 cents per share on revenue of $819.6 million.

Sales of its kidney disease treatment Renagel likely received a boost from more patient enrollment under the Medicare D prescription drug plan, said Merrill Lynch analyst Eric Ende. He's expecting worldwide sales of Renagel to total $130 million for the quarter, making it the company's best-selling drug.

Genzyme will report results Oct. 12.

Gilead Sciences Inc. plans to post third-quarter results Oct. 18, with high expectations for its once-a-day HIV pill Atripla. The drug is a combination pill that includes two Gilead drugs. Sales were moving above estimates as of August, according to Rodman & Renshaw analyst Michael King Jr.

Jefferies & Company analyst Eun Yang expects the company to post results in line with or slightly above Wall Street expectations. Analysts on average forecast profit of 56 cents per share on revenue of $705.2 million.

"We expect Gilead to deliver a solid quarter driven by continuing strong sales in its HIV franchise," Yang wrote in a note to investors.

Cubist Pharmaceuticals Inc. will also report its third-quarter results Oct. 18, and analysts expect profit of 4 cents per share on revenue of $54.3 million. The stock will likely see a boost from on-target sales of its staph infection drug Cubicin, Yang said.

posted by pharma-insight @ 1:37 PM 0 comments

Wednesday, October 04, 2006

Canadian regulators approved the drug Tysabri for the treatment of relapsing-remitting forms of multiple sclerosis. The drug is sold by U.S. company Biogen Idec (BIIB) and Ireland's Elan (ELN) . Biogen Idec was up $1.02, or 2.3%, at $45.90, and Elan was adding 14 cents, or 0.9%, to $15.70.

posted by pharma-insight @ 1:53 PM 0 comments

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