PHARMACY

Abbott posts double-digit sales and earnings growth in Q1

BY Adam Kraemer

ABBOTT PARK, Ill. Abbott this week announced financial results for the first quarter ended March 31, 2008, seeing worldwide sales growth of 13.8 percent, to $6.8 billion, on pharmaceutical sales up 14.3 percent.

Diluted earnings per share, excluding specified items, were $0.63, reflecting 14.5 percent growth, at the upper end of Abbott’s previously announced guidance range of $0.61 to $0.63. Diluted earnings per share under GAAP were $0.60, up 33.3 percent.

The increase in worldwide pharmaceutical sales was driven by double-digit growth in Humira, Niaspan and Kaletra and 9.8 percent growth in TriCor. Abbott forecasts global sales of Humira, a rheumatoid arthritis medication, of more than $4 billion in 2008.

Worldwide medical products sales increased 13.7 percent, driven by 14.3 percent growth in worldwide diabetes care sales, 22.0 percent growth in international diagnostics sales, and 34.7 percent growth in international vascular sales. International nutritionals saw a 20.8 percent growth.

“Abbott started 2008 with a strong first quarter, following double-digit sales and earnings growth last year,” said Miles White, chairman and chief executive officer. “In addition, we received five key new product approvals during the quarter. The continued productivity of our late-stage pipeline, combined with the underlying strength of our broad mix of businesses, gives us a high level of confidence in our future growth outlook.”

In March, as reported in Drug Store News, Abbott and Takeda announced an agreement to conclude the TAP joint venture, evenly splitting the assets. Abbott will receive full U.S. ownership of Lupron, a complementary product to its oncology pipeline, as well as future cash payments over the next five years. Abbott also received five regulatory approvals in the quarter: Humira for psoriasis and for juvenile rheumatoid arthritis, Simcor for cholesterol, and two FreeStyle glucose monitoring systems.

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Major drug companies fight stronger restrictions on off-label marketing on drugs

BY Diana Alickaj

WASHINGTON Ten major drug companies have formed a coalition and will submit their arguments to the Food and Drug Administration to push for looser proposed restrictions on off-label marketing, according to published reports.

The 10 companies include Pfizer Inc., Bayer Corp., the U.S. unit of Bayer AG; AstraZenecaPLC; and Johnson & Johnson who will be represented by Daniel Troy a former FDA Chief Counsel and is currently working with APCO Worldwide Inc.

Merck & Co., according to two reports from the Journal of the American Medical Association, was reported to have not effectively marketed the risks of its painkiller, Vioxx, which reportedly served as a risk for heart attack to Alzheimer’s patients. Congressional investigators also have accused Merck and Schering PloughCorp, the makers of Vytorin, a cholesterol drug, of trying to withhold information that questioned the drug’s effectiveness. These two instances are one of many in which Congress is trying to place stronger restrictions on the companies marketing strategies for these drugs.

According to published reports, a poll conducted during an annual conference sponsored by the drug-marketing magazine DTC Perspectives stated that 60 percent of participants felt that Congress might place limits on TV advertising for pharmaceutical companies. Another idea that the drug companies are not in favor of is to place a telephone number in ads, so consumers can call the FDA  to express their problems with a specific drug.

According to published reports, the chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell already is taking this issue seriously by calling a hearing on direct-to-consumer advertising. In a statement regarding this issue,  Dingell said, “Drug companies should know that they would be held accountable for inappropriate behavior and inaccurate representations made in their ads.” The hearing is expected to take place in a few weeks.

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Roche acquires Piramed for $160 million

BY Adam Kraemer

ZURICH , Switzerland Roche Holdings said it will buy U.K.-based biotech firm Piramed for $160 million in an attempt to strengthen its oncology and arthritis pipelines.

An additional payment of $15 million is due upon the commencement of Phase II clinical trials for the company’s oncology program, the Swiss company said.

The final transaction value will be adjusted by the net cash balance remaining upon closing. Regulators are expected to approve the deal in the second quarter of 2008.

Piramed focuses on the development of PI3-K inhibitors, which are known to play an important role in halting disease progression and in preventing resistance to chemotherapeutics in cancer cells. Pre-clinical studies have demonstrated their potential importance in treating inflammatory diseases such as rheumatoid arthritis, Roche said.

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