Dendreon Gets FDA Nod for New LA Cancer Drug Factory

6/29/11Follow @xconomy

Seattle-based Dendreon (NASDAQ: DNDN) said today that it has won clearance from the FDA to start manufacturing its immune-boosting drug for prostate cancer at a new factory in the Los Angeles area. The manufacturing plant OK, which was widely expected by analysts, means that Dendreon now has its first new location to produce its treatment outside its original commercial factory in New Jersey.

The company is also seeking FDA clearance for a third facility in the Atlanta, GA area, which the company is hoping will get the green light by a regulatory deadline of August 28. The new capacity is important to Dendreon because it has been unable to meet all the demand from patients for its drug, sipuleucel-T (Provenge), in its first year on the market.

Getting FDA sign-off on the factories isn’t trivial. Dendreon’s first-of-its-kind manufacturing process is complicated, in that it requires running a patient’s own cells through a proprietary system to “teach” the cells to recognize hallmarks of prostate cancer cells, so that when they are re-infused into the patient, they should be able to start fighting the cancer cells like a virus. Getting all three factories running on schedule is critical for Dendreon if it is going to hit its sales forecast of $350 million to $400 million in sales of the treatment this year.

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  • http://na John

    Luke,

    Where ya been already regarding Dendreon news? Xconomy has been quiet lately.

    Right on!
    So I’m presuming you’ll write another something on her after we here the final ruling from CMS later this week?
    2 Xconomy articles on DNDN in 1 week..Yes!

    J

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    John—I ordinarily don’t like to tip my hand to let my competitors know what I’m working on, but yes, I’m thinking a story on the CMS decision makes sense this week. I have another bigger feature in mind for later this summer, which I have partially reported already, and just need some time to write it up. That’s all I’ll say for now!—Luke

  • http://na John

    Super Luke; LoL; Can’t wait to read them.

    If you ever talk/text/email Dr. Gold, please tell him congratulations from 1 fan among 1000′s across the country.

    The immunotherapy era continues to grow ever-stronger after decades of complete domination by toxic chemos/big pharma!
    John

  • goscinski

    Why the downdraft on DNDN after good news?

  • http://na John

    Luke,
    Found the following from Deutsche Bank research today:
    We wanted to address weakness in DNDN shares today. Two main issues putting pressure on shares and our response:

    1. Final NCD out tonight:
    **ASP file for 3Q give us confidence about no change in drug category in NCD tonight. We highlight that the recent ASP file for 3Q 2011 titled “payment allowance limits for Medicare Part B Drugs” shows a Provenge injection with a Q code (Q2043) and reimbursable payment limit of $32,860. We interpret this as CMS will continue to reimburse at expected levels.

    2. Concern around 3Q:
    **We believe street is underestimating how fast LA will ramp and we see upside in 3Q. We project $129m for 3Q vs consensus $102m. Here is how we derive our projections: 30m run rate for NJ at 36 workstations = $90M for 3Q. We assume a slightly faster ramp in LA (6 work stations every 2-3 weeks) which gets you to around $40M. We believe about 6 workstations came on every 4 weeks in NJ, and we project that 6 more come online at beginning of 3Q.
    We believe there is a good chance that the company raises the lower end of their guidance ($350M) or at least street raises their numbers.

    Luke, as you can see DB is already raising guidance for Q3 and this IS NOT GOOD because DNDN has said nothing about changing their overall 2011 guidance ($350M-$400M) and increasing quarterly rev estimates only makes it MORE DIFFICULT for a company to meet or beat them.

    I guess so many different agendas out there including mine (which is long).
    Thanks for listening.
    J