Recently, Endo Pharmaceuticals (ENDP) received a notification from Mylan Inc. (MYL) regarding a patent challenge for Endo’s pain drug, Lidoderm. Endo Pharmaceuticals has received a paragraph IV certification notice informing it that generic player Mylan is lookingto market a generic version of the Lidoderm topical patch.
Endo Pharma, which is currently reviewing the notice, intends to defend the patents on the drug. Mylan has challenged the patents 5,741,510 and 5,827,529, which deal with the formulation of Lidoderm. They are listed on the US Food and Drug Administration’s (FDA) approved drug products list (Orange Book). The two patents on Lidoderm, launched in 1999, are set to expire in March 2014and October 2015, respectively.
Endo Pharma Inks Deal
In a bid to develop its oncology portfolio, Endo Pharma recently inked a deal with Orion Corporation, a European research & development based pharmaceutical and diagnostic company. Per the terms of the deal, the companies will co-develop 8 cancer candidates which include 4 from each company’s pipeline. While the responsibility for marketing the candidates (on approval) in Europe, including Russia, lies with Orion, Endo Pharma is responsible for marketing in North America.
Subsequent to the partnership, Endo Pharma has exercised its option to license the lead candidate in this collaboration discovered at Orion, which will be co-developed by the companies across the globe. The candidate, a novel androgen-receptor antagonist for treating patients suffering from advanced prostate cancer, will be moving into human studies shortly.
Our Recommendation
Currently, we have a ‘Neutral’ stance on Endo Pharma in the long-run, which is supported by the Zacks #3 Rank (short-term ‘Hold’ recommendation) carried by the company. We have a similar stance on Mylan.
