Collegium Pharmaceutical Stock

Collegium Pharmaceutical, Inc. operates as a diversified specialty pharmaceutical company.

The company has leveraged its research and development efforts as well as acquisitions and licensing relationships with third parties, to develop a portfolio of meaningfully differentiated products for use in the treatment of moderate to severe pain. The company commercializes its pain portfolio, consisting of Xtampza ER, Nucynta ER and Nucynta IR (collectively the Nucynta Products), Belbuca, and Symproic, in the United States.

Xtampza ER

Xtampza ER is a pain treatment option designed with abuse deterrent properties. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone. Xtampza ER is formulated using the company's novel abuse-deterrent technology platform, DETERx, which provides extended-release delivery, while also providing barriers to common methods of abuse and misuse (e.g., crushing, chewing, heating, and injecting). This technology combines an active opioid ingredient with a fatty acid and waxes to form microspheres that are filled into a capsule. These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation.

In April 2016, the United States Food and Drug Administration (FDA) approved the company's New Drug Application (NDA) for Xtampza ER. Xtampza ER is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. The approved labeling for Xtampza ER includes human abuse potential studies, as well as data supporting the administration of the product as a sprinkle or through feeding tubes. Xtampza ER's label indicates a dosing regimen of one capsule every 12 hours, and it must be taken with food. In 2016, the company commercially launched Xtampza ER in the United States.

Xtampza ER, OxyContin, and the authorized generic versions of OxyContin (which are identical to the branded versions) are the only extended-release oxycodone products marketed in the United States as of January 2024. Xtampza ER and OxyContin (along with its authorized generics) feature the same active pharmaceutical ingredient (oxycodone) and feature abuse-deterrent technologies - though the abuse deterrent technologies are designed differently. In 2017, the company announced FDA approval of a Supplemental New Drug Application (sNDA) for Xtampza ER to include comparative oral pharmacokinetic data from a clinical study evaluating the effect of physical manipulation by crushing Xtampza ER compared with OxyContin and a control (oxycodone hydrochloride immediate-release). In the study, Xtampza ER maintained its extended-release pharmacokinetic profile when crushed, while OxyContin showed a rapid release of oxycodone when crushed with common household tools; crushed OxyContin was bioequivalent to crushed oxycodone IR. The sNDA also added results from an oral human abuse potential study and an oral abuse deterrent claim to the label, making Xtampza ER the only single-agent extended-release oxycodone with oral, intranasal, and intravenous abuse-deterrent labeling.

The company is committed to ongoing monitoring and public dissemination of its real-world abuse and diversion data, regardless of the results. The two main sources of real-world abuse, misuse, and diversion data are RADARS and Inflexxion, an IBH Company. The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs through its multiple data sources. Abuse, misuse, and diversion of Xtampza ER has remained low compared to commonly abused schedule II opioid analgesics for three years after introduction into the U.S. market. Methods to defeat the tamper resistant properties of Xtampza ER are reported but there is no indication of widespread or expanding abuse or misuse in the data streams evaluated. The company plans to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza.

Nucynta Products

The Nucynta Products are extended-release (ER) and immediate-release (IR) oral formulations of tapentadol. In November 2008, the FDA approved Nucynta ER and Nucynta IR. Nucynta ER is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. Nucynta IR is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg. In August 2023, the FDA granted New Patient Population exclusivity for Nucynta IR in pediatric patients. This grant extended the period of U.S. exclusivity for Nucynta IR from June 27, 2025, to July 3, 2026.

The company began commercializing the Nucynta Products in 2018 pursuant to a commercialization agreement (the Nucynta Commercialization Agreement) with Assertio Therapeutics, Inc. (Assertio), pursuant to which Assertio granted it a sublicense of certain of its intellectual property related to the Nucynta Products for commercialization of such products in the United States. In February 2020, the company acquired additional assets related to the Nucynta Products from Assertio and assumed all commercialization responsibilities, including sales and marketing, for the Nucynta Products through the acquisition of a license from Grünenthal Gmbh (the Grünenthal License and such acquisition, the Nucynta Acquisition).

Belbuca and Symproic

On March 22, 2022, the company acquired BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions (the BDSI Acquisition). Upon closing the BDSI Acquisition, the company acquired Belbuca and Symproic.

Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in 2015 for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative options are inadequate. Symproic was approved by the FDA in March 2017 for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. The company began shipping and recognizing product sales related to Belbuca and Symproic in March 2022.

Products

Xtampza ER is manufactured using a proprietary process. As of December 31, 2023, the company had produced Xtampza ER through a contract manufacturing organization, Patheon, a subsidiary of Thermo Fisher Scientific, pursuant to a third-party supply agreement. The company's microsphere production is conducted in a dedicated manufacturing suite as it transitioned the microsphere production to the new suite in 2021. Patheon has an established record of manufacturing FDA-approved products in the United States, including products containing controlled substances. The company owns all of the intellectual property, including know-how and specialized manufacturing equipment, necessary to be able to qualify the manufacturing equipment located at Patheon's facility at an alternative location (and with an alternative vendor) if necessary.

The Nucynta Products are manufactured pursuant to supply agreements with third-party manufacturers. Nucynta ER was historically produced by Janssen at a facility in Puerto Rico pursuant to a supply agreement that the company assumed from Assertio in connection with the Nucynta Acquisition. In 2022, the company completed the transfer of the Nucynta ER manufacturing process through a technology transfer program to enable manufacturing of Nucynta ER at Patheon in Cincinnati, Ohio. Nucynta ER is manufactured by Patheon. Nucynta IR is manufactured by Halo Pharmaceutical, Inc. in Whippany, New Jersey.

Belbuca and Symproic are manufactured pursuant to supply agreements with third-party manufacturers. Belbuca laminate (i.e., bulk product) is produced by Adhesives Research in Glen Rock, Pennsylvania. Belbuca laminate is then sent to either LTS Therapy Systems in St. Paul, Minnesota or Sharp Packaging Solutions in Allentown, Pennsylvania where it is converted into individual dosage units and, ultimately, into finished goods. For the Belbuca product portfolio, the company is qualifying alternate bulk and secondary packaging operations at its existing manufacturer's sites. Symproic is manufactured by UPM Pharmaceuticals in Bristol, Tennessee and packaged by Sharp Packaging Solutions in Allentown, Pennsylvania.

Marketing and Commercialization

The company commercializes its products in the United States with a dedicated field sales force, consisting of approximately 110 sales representatives and managers, to call on the approximately 10,000 health care professionals who write approximately 66% of the branded extended-release opioid prescriptions in the United States, with a primary focus on pain specialists. The company also employs a market-access team to support its formulary approval and payor contracting.

The company's marketing strategy focuses on increasing awareness of the differentiated features of its products. As an integral part of educating clinicians regarding the properties and differentiated profiles of its products, the company's sales force is trained to share information relating to significant risks associated with prescription opioids, including risks relating to addiction, abuse, and misuse.

The company primarily sells its products to wholesalers that, in turn, distribute its products to retail outlets (such as drug store and supermarket chains and independent pharmacies), managed health care organizations and government agencies.

Intellectual Property

The protection of patents, designs, trademarks and other proprietary rights that the company owns or licenses is critical to its success and competitive position. Xtampza ER is protected by twelve issued patents in the United States (which cover both the abuse-deterrent technology and methods of using it to treat patients), one granted and two pending applications in the European Patent Office, two issued patents in Canada, and one issued patent in each of Japan and Australia. Finally, the company has six patent applications pending in the United States, one pending patent application in each of Canada and Japan, and one pending Patent Cooperation Treaty (PCT) application. The company's issued U.S. patents are projected to expire in 2025, 2030, and 2036 and its pending patent applications in the United States, if issued, would be projected to expire in 2030 and 2036. In addition, the company uses a unique and proprietary process to manufacture its products that requires significant know how, which it protects as trade secrets.

Nucynta IR is protected by one issued patent in the United States (which covers both the drug substance and drug product) that is projected to expire in 2025. Nucynta IR is also covered by New Patient Population exclusivity in pediatric patients that is projected to expire in 2026. Nucynta ER is protected by four issued patents in the United States (which cover the drug substance, drug product, certain characteristics of the dosage form, and methods of treating patients) that are projected to expire in 2024, 2025, and 2028. Belbuca is protected by three issued patents in the United States (which cover a method of treating patients) that are projected to expire in 2027 and 2032.

The company has concluded that some of its technology is best protected as proprietary know-how, rather than through obtaining patents. Except for licenses from Grünenthal GmbH to commercialize the Nucynta Products in the United States and its territories, and a license from Shionogi to commercialize Symproic in the United States and its territories, its technology and products are not in-licensed from any third party, and the company owns all of the rights to Xtampza ER.

The company has received trademark registration for Collegium Pharmaceutical, Inc., DETERx, and Xtampza ER in the United States, and acquired trademarks associated with the Nucynta Products in connection with the Nucynta Acquisition and Belbuca and Symproic in connection with the BDSI Acquisition.

Competition

The company's suppliers for Xtampza ER and the Nucynta Products active pharmaceutical ingredients also supply the company's primary competitor in the extended-release oxycodone space, Purdue Pharma, L.P.

Government Regulation

Several of the company's products are regulated as 'controlled substances' as defined in the Controlled Substances Act (CSA), which establishes registration, security, recordkeeping, reporting, storage, distribution, importation, exportation, and other requirements administered by the DEA.

Xtampza ER and the Nucynta Products are listed by the DEA as Schedule II controlled substances under the CSA, while Belbuca is listed as a Schedule III controlled substance.

History

The company was founded in 2002. It was incorporated in Delaware in 2002 and then reincorporated in Virginia in 2014. The company was formerly known as Collegium Pharmaceuticals, Inc. and changed its name to Collegium Pharmaceutical, Inc. in 2003.