ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Sept 23,2016 - The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Amjevita is approved for the following indications in adult patients:

- moderately to severely active rheumatoid arthritis;
- active psoriatic arthritis;
- active ankylosing spondylitis (an arthritis that affects the spine);
- moderately to severely active Crohn’s disease;
- moderately to severely active ulcerative colitis; and
- moderate to severe plaque psoriasis.

Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.

Sept 27 & 28, 2016 - ANI Pharmaceuticals management to meet with Roth Capital Meetings to be held in Boston on September 27 and in New York on September 28 hosted by Roth Capital.

Roth Meetings

Sept 28, 2016 Dr. Michael appear to have changed jobs within Abbvie he is now listed as Medical Director PD-MD3.

Snabes

Oct 6, 2016 J&J's drug outperformed Humira in treating psoriasis.

J&J


Seeing that the Roth Capital Partners analyst, Scott Henry, did not increase their price target on Anip following the Q2 earnings release, along with Dentons seeking patent application extensions without submitting a response to the Office Action, leads me to believe that Libigel is in play and Abbvie is the partner.

If Ani is going to co-promote Libigel, then they will need to make another offering. This could explain the meetings with Roth in both cities.

Remember Abbvie still has not used the Priority Review Voucher they acquired for $350 million the day after Addyi was approved. Amgen must also give 180 days notice to Abbvie prior to launching the biosimilar. If Amgen submitted the 180 day notice already. It could explain what we are seeing.

Should be a very interesting 3 to 6 months.

JMHO