Collegium Pharmaceutical Inc. (NASDAQ: COLL) has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding a secondary offering. The company has not released how many shares it plans to price in the offering, but the most recent closing price was $25.58 per share. However, the company values the offering up to $86.25 million.

The underwriters for the offering are Jefferies, Piper Jaffray, William Blair, Needham and Janney Montgomery Scott.

This is a specialty pharmaceutical company developing and planning to commercialize next-generation abuse-deterrent products that incorporate its patented DETERx platform technology for the treatment of chronic pain and other diseases. Collegium’s lead product candidate, Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication.

On November 6, 2015, the U.S. Food and Drug Administration (FDA) granted tentative approval to the new drug application (NDA) for Xtampza for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA granted tentative approval because Xtampza met the required quality, safety and efficacy standards for approval but remains subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma.

The FDA may grant final regulatory approval on the earliest to occur of expiration of the automatic stay, the court invalidating Purdue’s patents or issuing an opinion of non-infringement, and expiration of Purdue’s listed patents.
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In the filing the company said:

In 2014, there were approximately 29 million prescriptions for extended-release and long-acting opioids in the United States. OxyContin OP accounted for approximately $2.5 billion in total U.S. sales from approximately 6 million prescriptions. Despite the introduction of OxyContin OP in 2010 as the first FDA-approved, abuse-deterrent, extended-release opioid formulation, abuse of extended-release opioids, including OxyContin OP, continues to be a major public health issue. OxyContin OP, even with its abuse-deterrent formulation, remains vulnerable to abuse using common household objects, like pill crushers. Third party studies found that abusers of OxyContin OP use various routes of abuse — including snorting, injection and oral abuse.

The company intends to use the net proceeds from the offering to develop its commercial infrastructure and pipeline, as well as for working capital and general corporate purposes.

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