Replies to post #187619 on Biotech Values

[DewDiligence]

EGRX reports results for 3-month “stub” period ending 12/31/14 (see #msg-110060860):

http://www.sec.gov/Archives/edgar/data/827871/000082787115000011/eaglestubperiodrelease02-1.htm

Cash on hand at 12/31/14 was $34.9M.

No quarterly CC insofar as EGRX held a CC for the Treanda deal with Teva this morning.

[DewDiligence]

EGRX keeps on rolling—now +90% in 3 days. All this from the Trenda settlement with Teva.

[DewDiligence]

EGRX gets FDA OD-exclusivity for Ryanodex in malignant hyperthermia:

http://finance.yahoo.com/news/fda-grants-seven-years-market-152400906.html

Ryanodex is not EGRX’s lead program; the lead program is a reformulation of Treanda now partnered with Teva (#msg-110943484).

[DewDiligence]

EGRX receives US patent on low-sodium formulation of generic Treanda:

http://finance.yahoo.com/news/eagle-pharmaceuticals-announces-patent-low-145100715.html

Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted Patent No. 9,000,021 for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. The patent issued today expires in March 2033.

[DewDiligence]

EGRX/TEVA submit NDA for rapid-infusion formulation of Trenda:

http://www.sec.gov/Archives/edgar/data/827871/000082787115000025/tevaeaglebendaacceptedforf.htm

Please see #msg-110943484 for the terms of the settlement with respect to this product.

[DewDiligence]

EGRX Needham webcast link (4/15/15):

http://wsw.com/webcast/needham71/egrx/

[DewDiligence]

How EGRX used the “Depomed threat” to obtain orphan-drug exclusivity (ODE) for Ryanodex:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/09/how-effective-is-a-depomed-threat-at-resolving-an-orphan-drug-clinical-superiority-dispute.html

The same reasoning ought to hold when the FDA rules on ODE status for EGRX’s rapid-infusion Treanda. Note that TEVA waived ODE for branded Trenda as part of its Feb 2015 settlement with EGRX (#msg-110943484).