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Genzyme's (Nasdaq: GENZ) manufacturing issues just won't go away. Four months after the company announced that it had shut down a manufacturing plant because of viral contamination, it's still dealing with the aftermath.

The plant is sanitized and back up and running, but the damage is done. Sales of Cerezyme and Fabrazyme, which both treat rare genetic disorders, have both been affected, since inventories couldn't keep up with demand. Even the fourth quarter will take a hit, since Genzyme doesn't expect to resume shipping Cerezyme until late next month, and Fabrazyme in late December.

Not surprisingly, the company slashed full-year adjusted guidance from $2.35-$2.90 per share to around $2.26. By comparison, adjusted earnings per share for 2008 were $4.00.

The question now is whether Genzyme is a bad-news buy or not. Shares are down 22.5% this year, substantially worse than Pfizer (NYSE: PFE), which announced an acquisition that many weren't thrilled about, and Amgen (Nasdaq: AMGN), which has seen declining sales and pipeline delays. In contrast, Genzyme's manufacturing delays are more of a one-time issue.

Maybe.

Both Shire (Nasdaq: SHPGY) and Protalix BioTherapeutics (NYSE: PLX) are developing treatments that will compete against Cerezyme. In the wake of the shortages, the Food and Drug Administration gave them the green light to give the drugs to patients before they were given full approval. Genzyme essentially gave its competition a big head start on a lot of free publicity among patients, which could affect Cerezyme sales once the drugs are approved.

I think investors have probably overreacted slightly, but management will still have to deliver -- for instance, by getting approval for the long-awaited larger manufacturing scale of its Myozyme drug -- before investors come back in droves.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is an Inside Value recommendation. The Fool has a disclosure policy.

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On October 22, 2009, at 4:36 PM, needster wrote:

    I do not believe that the FDA gave any drug company the right to sell its drugs before approval. What they probably did was allow them to give it away under a treatment protocol. They will still need to go through the process of approval before making any money.

  • Report this Comment On October 23, 2009, at 7:09 AM, marcelitoS wrote:

    the protalix product will cost less. Is proced with carrots cels that are DNA transformed and the pacient body belive that is reciving human cells.Is posible to read in PLX place all tthe comenntaries. Also there is commentaries in F.D.A. place In Israel all the people (450) suffering of Gaucher is treated by only one Hospital . Doctiors from all over the country call him by telephon and Porf. Zimran answer / The pacients ,that are suffering a lot now without medicines are ready to takie any step in order to evade suffering. From PLX place to any point of the State a bus will take 2 and half hs. to arrive. Then the carrot miracle will help very quickly. In deed FDA authorized already a protocol to Shire but the information is not up to date .

  • Report this Comment On October 23, 2009, at 4:42 PM, TMFBiologyFool wrote:

    needster,

    You're right, I got ahead of myself. We updated the article.

    -Brian

  • Report this Comment On October 25, 2009, at 9:34 AM, marcelitoS wrote:

    there are very intresting developments between TEVA

    and PLX there are seriuos whispers about the intrest of teva in buying PLX at about 20$ the share,Please see bIzportal.co.il

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