New Dosages of Solodyn Approved – Analyst Blog

Medicis Pharmaceutical Corp. (MRX) recently announced that the US Food and Drug Administration (FDA) has approved the marketing of new dosage strengths of its acne treatment drug, Solodyn. Solodyn will now be available in 55 mg, 80 mg and 105 mg dosage strengths in addition to the previously available dosage strengths of 45 mg, 90 mg, 135 mg, 65 mg and 115 mg. The drug is approved for use in patients aged 12 years and older.

 

Solodyn, the flagship product of Medicis Pharma, is facing patent challenges (for the ‘838 patent scheduled to expire in 2018) from a number of generic manufacturers including Mylan Inc. (MYL), Teva Pharmaceutical Industries Ltd. (TEVA), Impax Laboratories Inc. (IPXL), Novartis AG (NVS) and Ranbaxy Laboratories (a part of Daiichi Sankyo) to name a few. These companies have filed Abbreviated New Drug Applications (ANDA) with the FDA to market their generic versions of Solodyn.

 

Medicis Pharma entered into settlement agreements with a few of these generic manufacturers. As per the terms of the agreements, these companies can bring their respective generics of 45 mg, 90 mg and 135 mg dosage strengths to the market in November 2011 or earlier under certain circumstances.

 

We currently have a Neutral recommendation on Medicis Pharma, which is supported by a Zacks #3 Rank (short-term Hold rating). We are pleased with the approval of additional dosage strengths of Solodyn as we believe that the company will look to shift patients to the new dosage strengths so as to reduce the impact of the entry of generic versions of older dosages post November 2011. On the second quarter call, Medicis Pharma stated that the 65 mg and 115 mg strengths, which were approved in July 2009, accounted for 61.5% of new prescriptions and 58.5% of total prescriptions. We note that the timeline of the launch of the generic versions of these newer dosage strengths, 65 mg and 115 mg, is not yet known.

 

On the flip side, we are concerned about the competitive threats for Dysport from Allergan Inc.’s (AGN) Botox and the lack of pipeline visibility.