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重大事件 即時報告 8-K 2026-07-01

Cumberland Pharmaceuticals 完成1億美元出售品牌藥品線,專注ifetroban管線開發

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Cumberland Pharmaceuticals(納斯達克:CPIX)於7月1日完成與加拿大最大製藥公司Apotex的戰略交易,以1億美元現金出售其品牌藥品線,該交易已獲股東批准(支持率超過99%)。本次8-K申報文件披露交易細節。 Cumberland保留創新候選藥物管線及Cumberland Emerging Technologies的多數股權,未來將集中資源開發核心藥物ifetroban(一種強效血栓素拮抗劑),針對四項罕見及進行性疾病: - 杜興氏肌肉營養不良症心肌病:II期臨床取得突破性結果,已與FDA展開討論,獲孤兒藥、罕見兒科疾病及快速通道資格。 - 系統性硬化症:II期安全性數據正在評估,預計公佈頂線結果為下一個里程碑。 - 特發性肺纖維化:II期試驗在美國多個中心招募中,中期安全性良好,下一步將公佈療效數據。 - 癌症轉移:與Vanderbilt Health合作的II期先導研究顯示,ifetroban組因轉移性疾病的死亡人數較少,且安全性良好,支持進一步開發。 管理層表示,交易顯著強化財務狀況,可專注於管線的巨大市場機會,目標是為患者提供創新療法並持續為股東創造價值。對投資者而言,Cumberland現金充裕,未來催化劑包括FDA對DMD心肌病的審批進展、系統性硬化症及IPF的數據公佈,以及癌症轉移領域的後續開發,但需留意臨床試驗及監管風險。
展開英文正文
EX-99.1
3
tm2619330d1_ex99-1.htm
EXHIBIT 99.1

 

 

Exhibit 99.1

 

 

Cumberland Pharmaceuticals
Closes

Strategic Transaction
with Apotex

 

$100 million Transaction
Follows Cumberland Shareholder Approval

Strengthens Cumberland’s
Focus on Rare Disease Pipeline

 

NASHVILLE, Tenn. (July 1, 2026) - Cumberland
Pharmaceuticals Inc. (Nasdaq: CPIX), a U.S. biopharmaceutical company, today announced the closing
on an agreement with subsidiary of Apotex Health Corp. (“Apotex”), the largest Canadian-based pharmaceutical company, to
integrate their branded U.S. businesses. Under the terms of the agreement, Apotex has acquired Cumberland’s line of branded pharmaceuticals
for cash consideration of $100 million funded at closing, which followed approval by Cumberland’s shareholders. 

 

“We are pleased to complete this value-creating
transaction, which was strongly supported by our shareholders with over 99% of the votes cast in favor of the transaction,” said
A.J. Kazimi, CEO of Cumberland. “This milestone significantly strengthens our financial position, enabling us to focus on the large
market opportunities associated with our pipeline programs. Our goals are to deliver innovative new products to improve patient care,
while continuing to build value for our shareholders.”

 

Cumberland has retained its robust portfolio
of innovative product candidates and its majority ownership position in Cumberland Emerging Technologies Inc. Following the closing,
Cumberland will focus its resources on developing ifetroban, a potent thromboxane antagonist currently being studied across clinical
programs targeting serious rare and progressive diseases:

 

·Duchenne Muscular Dystrophy
 Cardiomyopathy: 

Cumberland
announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with this rare, fatal
genetic neuromuscular disease. Interactions with the FDA have been underway regarding study results and requirements for approval. The
program has received FDA Orphan Drug, Rare Pediatric Disease and Fast Track designations.

 

·Systemic Sclerosis:
 

Cumberland
has conducted a Phase II clinical study evaluating the safety of ifetroban in patients with this debilitating autoimmune disorder. Evaluation
of the study data is underway with top-line results anticipated as the next milestone.

 

·Idiopathic Pulmonary
 Fibrosis: 

A
Phase II study evaluating ifetroban in patients with the most common form of progressive fibrosing interstitial lung disease is actively
enrolling at medical centers across the U.S.. Favorable interim safety findings have been announced and the next milestone is the announcement
of the efficacy results.

 

·Cancer Metastasis:
 

Cumberland, in collaboration with Vanderbilt
Health, recently announced the results of a Pilot Study of ifetroban in patients with high-risk solid tumors. The findings suggests the
potential to block cancer metastasis, as a favorable trend was identified with fewer deaths due to metastatic disease in those receiving
ifetroban rather than a placebo. The Phase 2 clinical trial also found ifetroban to be safe and well tolerated in the oncology patients,
supporting further development of the drug to prevent cancer metastasis.

 

  

  

 

 

About Apotex

 

Apotex (APTX.TO), is a Canadian-based global
health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the
world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered
in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical
company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

 

Learn more at www.apotex.com

 

About Cumberland Pharmaceuticals

 

Cumberland Pharmaceuticals Inc. is a Nashville-based
biopharmaceutical company focused on developing new therapies for rare diseases. The company is advancing a late-stage pipeline of product
candidates through a series of late stage clinical studies. The treatments are being developed across multiple therapeutic areas to address
serious patient conditions that represent unmet medical needs.

 

Cumberland's Phase 2 clinical programs are evaluating
ifetroban in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis, Idiopathic Pulmonary Fibrosis and Cancer Metastasis.

 

For more information, please visit www.cumberlandpharma.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements,
which are subject to certain risks and reflect Cumberland’s current views on future events based on what it believes are reasonable
assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland’s operations
are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland’s
results of operations. These factors include market conditions, competition, an inability of manufacturers to meet FDA standards or supply
Cumberland’s products on a timely basis, natural disasters, public health epidemics, and other events beyond our control, as more
fully discussed in the Company’s most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that
results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly
revise these statements to reflect events after the date hereof.

 

SOURCE: Cumberland Pharmaceuticals Inc.

 

 
 Investor Contact:
 Medica Contact:

 
 Shayla Simpson
 Emily Kent

 
 Cumberland Pharmaceuticals Inc.
 Dalton Agency

 
 (615) 255-0068
 (540) 621-5448