Patent Challenge for Auxilium Pharma - Analyst Blog
January 04 2013 - 1:17PM
Zacks
Auxilium Pharmaceuticals, Inc. (AUXL) and
Xstelos Holdings, Inc. (XTLS) recently received a
notice from Upsher-Smith Laboratories, Inc. regarding the filing
of a 505(b)(2) new drug application (NDA) for Auxilium
Pharma’s 1% testosterone gel, Testim.
The 505(b)(2) NDA contains a paragraph IV certification under 21
U.S.C. Section 314.52(c). The company is challenging ten US patents
which are slated to expire in the 2023-2025 timeframe.
We note in April 2012, Watson Pharmaceuticals
(WPI) also challenged Testim’s patents. Auxilium Pharma has filed a
patent infringement lawsuit against Watson.
Testim is the lead product at Auxilium Pharma, approved for the
treatment of hypogonadism or low testosterone level. Testim sales
came in at $55.4 million in the third quarter of 2012, accounting
for 78% of the company’s revenues.
Testim’s share of total prescriptions for the gel segment of the
testosterone replacement therapy (TRT) market was 20% in 2011, down
from 22% in the year-ago period. The TRT gel market is growing at a
slower rate and this will affect sales going forward.
Apart from this, the TRT market is highly competitive with the
presence of Abbott Labs’ (ABT) AndroGel,
Endo Pharmaceutical’s (ENDP) Fortesta and
Eli Lilly’s (LLY) Axiron.
The testosterone gel market will become even more competitive
from 2015 when generic versions of AndroGel 1% are scheduled to
enter the market. The availability of a cheaper generic
testosterone gel product could impact Testim’s market share as well
as its formulary status.
In this scenario, the sooner-than-expected entry of a generic
version would be a major blow for the company.
Auxilium Pharma currently carries a Zacks #3 Rank (Hold).
Currently, pharma stocks which look more attractive are
Valeant Pharmaceuticals International, Inc. (VRX)
and Ironwood Pharmaceuticals, Inc. (IRWD). Both
carry a Zacks #1 Rank (Strong Buy).
ABBOTT LABS (ABT): Free Stock Analysis Report
AUXILIUM PHARMA (AUXL): Free Stock Analysis Report
ENDO PHARMACEUT (ENDP): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
VALEANT PHARMA (VRX): Free Stock Analysis Report
WATSON PHARMA (WPI): Free Stock Analysis Report
(XTLS): ETF Research Reports
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