Par Formulations Private Limited, the operating subsidiary of
Par Pharmaceuticals Companies Inc.
) received its first approval from the US Food and Drug
Administration (FDA). The FDA approved the company's abbreviated
new drug application (ANDA) for its generic version of hypertension
drug Trandate (labetalol).
Trandate was originally a part of
) portfolio. Glaxo subsequently divested Trandate to Aspen
Pharmacare Holdings Ltd. Par Formulations expects to start shipping
its generic version of Trandate in August 2012.
Par Pharma's generic version will be available in 100 mg, 200 mg
and 300 mg dosages. The tablets can be taken either solely or
together with antihypertensive agents like thiazide and
Par Formulations was formed following Par Pharma's February 2012
acquisition of India-based Edict Pharmaceuticals. Par Pharma had
acquired Edict Pharma for $20.5 million along with a debt repayment
of $4.4 million. The acquisition has expanded Par Pharma's R&D
efforts and manufacturing capabilities.
As of March 31, 2012, Par Pharma had 71 ANDAs filed with the FDA
representing more than $20 billion of combined branded product
sales. These ANDA filings include 21 first-to-file
We currently have a Neutral recommendation on Par Pharma. The
stock carries a Zacks #3 Rank (Hold rating) in the short run. Par
Pharma was in the news recently with the company announcing that it
has entered into an agreement with an affiliate of leading global
private equity firm TPG Capitals, whereby TPG will acquire Par
Pharma for $1.9 billion.
However, the agreement also permits Par Pharma's Board of
Directors to search for alternative superior proposals until August
24, 2012, from other bidders. Prospective suitors could include
other generic players or ex-US companies looking to strengthen
their presence in the US. If no alternative offer turns up, the TPG
deal is expected to go through in 2012.
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