Replies to post #1484 on Fresenius Kabi Pharmaceuticals (APCVZ)

[The Rainmaker]

That's the total market for Bicalutamide also known as Casodex. Astra Zeneca sells it, several others have approval to sell generic versions. What percentage of the total market will Fresenius Kabi Pharmaceuticals garner and how long will it take?

FDA Approves Generic Casodex (Bicalutamide) for Prostate Cancer

India-based drug maker Sun Pharmaceuticals Industries Ltd said today it has been given U.S. Food and Drug Administration approval to market generic versions of the prostate cancer drug Casodex.

Casodex, known generically as bicalutamide, is made by AstraZeneca PLC and is administered in tablet form. Casodex earned annual sales of about $314 million in the United States, officials said.

http://www.attorneyatlaw.com/2009/07/fda-approves-generic-casodex-bicalutamide-for-prostate-cancer/

[The Rainmaker]

You were right about this post you made regarding Letrozole tentative FDA approval.

Letrozole has patent protection until June 2011 and can't be sold by APCVZ until the Novartis patent expires June 2011 so you won't get any sales from this drug to help APCVZ hit their 1.26 Billion dollar target by 12/31/2010. That's why APCVZ only got tentative FDA approval that is only good after June 2011 when Novartis patent expires.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva’s Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

The brand product had annual sales of approximately $556 million in the United States, based on IMS sales data.

Posted by: chmcnfunds Member Level Date: Friday, May 14, 2010 3:09:47 PM
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Tentative approval of Letrozole on 5/13/10.

Posted by: toucan Member Level Date: Friday, May 14, 2010 5:47:24 PM
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"Tentative approval" generally means that the FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.

[Aragorn1]

What are the chances APCVZ meets the required EBIDTA level?