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zoom RSS ジェンザイム社に1億7500万ドルの罰金/FDA

<<   作成日時 : 2010/04/23 23:58   >>

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 バイオ企業ジェンザイムは、ベストセラー薬剤2種の深刻な不足をきたした問題で、FDAにより少なくとも1億7500万ドルの罰金を科される予定である。
 会社はまた、ファブリ病・ゴーシェ病の薬Fabrazyme・Cerezymeの完全供給の復活が更に遅れると発表したが、遅れの原因は地域の停電によるという。ジェンザイムは第一四半期の赤字が、予想される罰金のための処理により、1億1490億ドルとなるとも発表した。罰金額は先月アナリストが予想した範囲であるという。
 オールストン工場の外観は荘厳な大聖堂ににているが、内部は混乱している。6月にウイルス汚染が発覚し、当初6〜8週間の遅れとしていたが、不足は現時点では少なくとも1年は続きそうである。不足を補うために連邦当局はライバル会社の早期市場参入を許可した。薬剤費は年間約20万ドルにもなる高価なもので、世界の数千人の使用者の怒りをかっている。
 設定された締め切り日までに出荷されない場合は、売上の18.5%の罰金が科される予定であり、他の違反として1日15,000ドルの罰金が科される可能性もある。四半期の収入は56%低下して9930万ドルとなった。
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ジェンザイム製の稀な遺伝病の治療薬の不足/米国医療事情
http://kurie.at.webry.info/201004/article_13.html
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Genzyme Expects a Fine of $175 Million
By ANDREW POLLACK
Published: April 21, 2010
http://www.nytimes.com/2010/04/22/business/22genzyme.html

画像Genzyme, the beleaguered biotechnology company, said on Wednesday that it expected to be fined at least $175 million by the Food and Drug Administration because of manufacturing problems that have caused severe shortages of two of its best-selling drugs.

The company also announced another delay in restoring full supplies of the two drugs, Cerezyme, for Gaucher disease, and Fabrazyme, for Fabry disease. This time, it said, the culprit was a municipal power failure.

Genzyme made the announcements in reporting that it had lost $114.9 million in the first quarter because it had set aside the money to pay the anticipated fine. At $175 million, the fine would be within the broad range that analysts had expected since last month, when Genzyme announced that the F.D.A. wanted to enter into a consent decree and to take a greater role in overseeing its main factory, which is in the Boston neighborhood of Allston.

“In our opinion, the news on the consent decree was better than feared, while a new delay to production at Allston was unanticipated,” analysts at Cowen & Company wrote in a note to clients on Wednesday. “Over all, probably more positive than negative, but the news was certainly not uniformly good.”

Genzyme’s shares rose 87 cents on Wednesday, to close at $54.45.

The Allston factory, a picturesque building on the banks of the Charles River, resembles a serene and stately cathedral from the outside. But on the inside, things are apparently chaotic.

The factory was temporarily shut in June because of contamination from a virus, leading to a shortage of the two drugs that Genzyme initially estimated would last six to eight weeks.

But one setback has followed another, so the shortage now looks likely to last at least a year.

Activist investors, including Carl C. Icahn, are calling for changes in strategy and possibly leadership at Genzyme, one of the oldest and most successful biotechnology players. And to help ease the shortages, federal regulators have granted early market access to companies selling drugs competing with Genzyme’s.

The several thousand patients throughout the world who depend on Cerezyme and Fabrazyme have become increasingly exasperated, especially given that the drugs are priced at around $200,000 a year.

“It just becomes more and more outrageous,” said Dr. Charles D. Goodman, a Los Angeles pediatrician who has Gaucher disease.

Despite pain and fatigue because of the shortage, Dr. Goodman said he stuck with Cerezyme out of loyalty to Genzyme. But the newest delay exhausted his patience. He is switching to a recently approved drug from Shire. “I don’t believe them anymore,” he said of Genzyme.

Genzyme, based in Cambridge, Mass., said Wednesday that patients using Cerezyme would continue getting half a dose for two or three more months. It previously said full supplies would be restored May 1.

It said patients getting Fabrazyme would continue to be allocated a third of their usual dose at least through the third quarter. The company had previously hoped to resolve the Fabrazyme shortage in the third quarter.

The company said that a municipal power failure on March 29 had worsened problems with unusually high microbe levels in the system that provides pure water for the manufacturing. Production had to be halted while the water system was fixed.

Genzyme said the $175 million figure was in a draft of the proposed consent decree that it was negotiating with the F.D.A. The figure represents the disgorgements of some profit from the sales of the drugs made at the Allston factory.

Under the proposed terms, Genzyme would be subject to future fines of 18.5 percent of the sales of product from Allston if the packaging of drugs into vials was not moved out of that factory by a deadline not yet set. It could also face fines of $15,000 a day for other violations.

Not counting the fine and some other adjustments, Genzyme said its net income for the quarter fell 56 percent to $99.3 million, or 37 cents a diluted share, from the year-earlier level of $227.5 million, or 70 cents. Revenue fell to $1.07 billion from $1.15 billion.

Mr. Icahn has mounted a proxy challenge to get himself and three associates elected to the board in June. Last week Genzyme appointed another activist investor, Ralph Whitworth of Relational Investors, to its board.

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