Collegium Announces Authorized Generic Agreement with Hikma Pharmaceuticals USA Inc. for Nucynta® and Nucynta® ER
April 29 2024 - 8:00AM
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 Relationsir@collegiumpharma.com
Media Contact:Marissa SamuelsVice President,
Corporate Communicationscommunications@collegiumpharma.com
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