Collegium Announces Authorized Generic Agreement with Hikma Pharmaceuticals USA Inc. for Nucynta® and Nucynta® ER

Rhea-AI Summary

Collegium Pharmaceutical, Inc. (Nasdaq: COLL) has announced an authorized generic agreement with Hikma Pharmaceuticals USA Inc. for Nucynta® and Nucynta® ER, bolstering the value of the Nucynta Franchise through 2025 and beyond. Collegium will manufacture and supply Hikma with authorized generic products, with Hikma having exclusive rights to sell them in the U.S. Collegium will receive a share of net profits based on the number of generic entrants.

Pharmaceutical Industry Analyst

The agreement between Collegium Pharmaceutical and Hikma Pharmaceuticals for the authorized generic versions of Nucynta® involves a strategic move designed to maintain revenue streams from a pharmaceutical product nearing the end of its exclusivity period. This type of partnership is common in the industry, as it allows the original manufacturer to continue capitalizing on their investment past the patent expiration, creating a scenario that can stave off immediate revenue loss due to generic competition.

Financial Analyst

In terms of financial outcomes for Collegium, the agreement's structure, where Collegium will receive a portion of the net profits that decline with increased generic competition, is a tactic to mitigate the impact of revenue erosion. The financial health of the company could be supported by this deal, as the earnings from the authorized generic versions will provide a buffer as they navigate the competitive landscape post-patent expiry. However, for investors, the critical detail lies in the actual percentage share of profits and the projected market penetration, as these numbers will directly influence the impact on Collegium's bottom line.

Market Access Strategist

From a market access perspective, Collegium's choice to partner with Hikma, a player known for its manufacturing and distribution capabilities, could ensure continued product availability with potentially minimal disruption for patients. Ensuring consistent accessibility to these medications aligns with Collegium's commitment to patient care, but also helps maintain the brand's presence in the market, which is beneficial from a commercial standpoint. Nevertheless, the longer-term sustainability of this strategy will largely depend on how the authorized generic competes with other generic entrants in terms of pricing and payer acceptance.

STOUGHTON, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced it has entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc. (“Hikma”), pursuant to which Hikma will have the exclusive right to sell the authorized generic versions of Nucynta^® and Nucynta^® ER (“the Nucynta Franchise”) in the United States.

“Our agreement with Hikma bolsters the value of the Nucynta Franchise through 2025 and beyond,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Collegium is pleased to work with Hikma, an industry leader, to ensure that these important products continue to be manufactured to the highest quality standards and remain broadly and consistently accessible to appropriate patients.”

Under the terms of the agreement:

• Collegium will manufacture and supply Hikma with all authorized generic product for sale on an exclusive basis during the term of the agreement.
• Hikma will sell the authorized generic forms of the Nucynta Franchise in the United States, commencing 30 days prior to the anticipated loss of exclusivity for each product, or earlier under certain circumstances.
• Collegium will receive a meaningful share of net profits of the authorized generic products, that declines based on the number of generic entrants, if any.
  

About Collegium Pharmaceutical, Inc.

Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contact:
Christopher James, M.D.                                                                                       
Vice President, Investor Relations
ir@collegiumpharma.com

Media Contact:
Marissa Samuels
Vice President, Corporate Communications
communications@collegiumpharma.com

FAQ

What is the authorized generic agreement announced by Collegium Pharmaceutical, Inc. (Nasdaq: COLL)?

Collegium announced an authorized generic agreement with Hikma Pharmaceuticals USA Inc. for Nucynta® and Nucynta® ER, boosting the value of the Nucynta Franchise through 2025 and beyond.

Who will have the exclusive right to sell the authorized generic versions of Nucynta® and Nucynta® ER in the United States?

Hikma Pharmaceuticals USA Inc. will have the exclusive right to sell the authorized generic versions of Nucynta® and Nucynta® ER in the United States.

What will Collegium Pharmaceutical, Inc. manufacture and supply to Hikma under the agreement?

Collegium will manufacture and supply Hikma with all authorized generic product for sale on an exclusive basis during the term of the agreement.

How will Collegium receive profits from the authorized generic products under the agreement with Hikma?

Collegium will receive a share of net profits of the authorized generic products, which declines based on the number of generic entrants, if any.