Collegium Pharmaceutical Inc. Announces U.S. Patent Issued Covering its DETERx(TM) Abuse Deterrent Sustained Release Technology

until 2025

CUMBERLAND, R.I.–(EMWNews)–Collegium Pharmaceutical, Inc., a specialty pharmaceutical company,

today announced that a new patent has been issued by the U.S. Patent and

Trademark Office (USPTO) relating to its tamper resistant,

abuse-deterrent formulation platform. US Patent Number 7,399,488

contains claims that cover orally administrable compositions comprising

Collegium’s proprietary micro-particle

formulations. The formulations are designed to be more resistant to

physical methods of tampering than currently available sustained release

dosage forms. US Patent No. 7,399,488 will provide protection for DETERx™

and products incorporating the DETERx™

technology into the year 2025.

The patent will provide broad coverage for Collegium’s

abuse-deterrent, sustained-release, orally administered DETERx™

formulation platform. The DETERx™ platform

consists of a multi-particulate matrix formulation in a capsule. While

developed primarily to provide tamper resistant properties, the

multi-particulate design potentially allows patients with difficulty

swallowing to open the capsule and administer the contents on food or

with water, while maintaining the sustained release properties of the

product.

Collegium’s lead DETERx™

product candidate, COL-003, a formulation of sustained release

oxycodone, will be covered by the patent. As previously reported,

COL-003 is currently under clinical development pursuant to an active

investigational new drug application on file with the United States Food

and Drug Administration (“FDA”). Based on in vitro

testing and previously reported pharmacokinetic results, COL-003 is

expected to provide adequate plasma concentrations to effectively treat

pain over a 12 hour period. The abuse-deterrent properties of DETERx™

are the result of the formulation itself, which protects the drug from

dose dumping, as demonstrated in a variety of laboratory tampering

simulations, without relying on aversive agents or pharmacological

approaches that could have harmful effects in legitimate patients. The

product received Fast Track Designation from the FDA.

“We are pleased to announce the issuance of

the first patent that broadly covers our DETERx™

technology. Since the claims cover the DETERx™

technology, we are not limited to one specific drug candidate. This

patent will protect a variety of active ingredients incorporated into

DETERx™, in addition to our lead product

COL-003. We intend to continue to prosecute additional patents that will

strengthen our intellectual property for this technology.” said Michael

Heffernan, President and CEO, Collegium Pharmaceutical.

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company

focused on the development of proprietary, late stage pharmaceutical

products. These products target market opportunities through formulation

based product improvements protected by intellectual property (IP).

Collegium is focused on building a portfolio of pain products that

incorporate its patent protected DETERx™

formulation platform that provides for sustained release and tamper

resistance. The Company through its subsidiary, Onset Therapeutics (www.onsettx.com)

develops and commercializes products for skin and skin related disorders

using its novel DELEVO™ Foam Technology. For

more information, visit the Company’s website

at www.collegiumpharma.com.

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