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ECYT > SEC Filings for ECYT > Form 8-K on 30-Oct-2012All Recent SEC Filings

Show all filings for ENDOCYTE INC

Form 8-K for ENDOCYTE INC


30-Oct-2012

Other Events


Item 8.01 Other Events.

Janssen Cilag International NV notified EU health care providers today that EU Regulators (CHMP) have approved the supply of CAELYX® (doxorubicin HCl liposome injection) following limitations on availability due to production difficulties at the product manufacturing site. Endocyte notes that:

• Endocyte's phase 3 PROCEED trial in platinum resistant ovarian cancer is currently enrolling patients in select EU investigative sites.

• Sustainable commercial supply will not be immediately available, so Endocyte plans to activate additional sites in the EU as CAELYX® supply becomes sufficient to support them.

• CAELYX® is marketed as DOXIL® in the U.S. As previously reported, the PROCEED trial sites in the U.S. have full access to supply of DOXIL®.


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