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BrightSpring Health Services Announces Onco360® Was Selected as National Pharmacy Partner for OJEMDA™

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BrightSpring Health Services (NASDAQ: BTSG) announced that its subsidiary, Onco360®, has been selected as the national pharmacy partner for OJEMDA™, a newly FDA-approved treatment for pediatric low-grade glioma (LGG) with BRAF mutations. This partnership with Day One Biopharmaceuticals aims to provide this cutting-edge, once-weekly oral medication to children aged six months and older who have relapsed or refractory LGG. The approval is based on the FIREFLY-1 clinical trial, and ongoing confirmatory trials are required for continued approval. Onco360® offers specialized oncology medications and support services, including financial assistance, clinical counseling, and insurance verification.

Positive
  • Onco360® selected as national pharmacy partner for OJEMDA™.
  • OJEMDA™ approved by FDA for treating pediatric LGG with BRAF mutations.
  • Once-weekly oral medication offers new hope for children with relapsed or refractory LGG.
  • Partnership with Day One Biopharmaceuticals underscores Onco360®'s role in pharmaceutical innovation.
  • Onco360® provides robust access to distribution oncology medications.
  • Specialized oncology support services include financial assistance, clinical counseling, and insurance verification.
Negative
  • Continued FDA approval for OJEMDA™ is contingent on ongoing confirmatory trials.
  • Potential risks associated with reliance on results from the FIREFLY-1 trial pending further verification.
  • Uncertainties related to the commercial success and adoption rate of OJEMDA™ in the market.

Insights

As an expert in oncology, I find this partnership noteworthy for several reasons. First, OJEMDA™ targets pediatric low-grade glioma (LGG), a condition affecting a significant percentage of children with brain tumors. With 75% of these patients having BRAF gene alterations, this medication addresses a substantial unmet need. The drug's approval based on the FIREFLY-1 clinical trial suggests promising initial results, although final approval depends on ongoing trials. This indicates a cautious optimism but also a potential for significant improvements in patient outcomes if long-term efficacy is demonstrated.

In the short term, this partnership could enhance BrightSpring's reputation in the oncology community, potentially driving increased business and investor interest. Long-term, it's a strategic move that positions the company as a leader in pediatric oncology.

From a financial perspective, this partnership could be quite beneficial for BrightSpring Health Services (NASDAQ: BTSG). The inclusion of an FDA-approved treatment that targets a specific genetic mutation in pediatric patients can open new revenue streams. Investors should note the company's potential to capitalize on a market with high demand and limited competition. Financial assistance services and insurance benefit verification offered by Onco360® may also increase patient access, aiding in revenue stability.

However, it is important to watch the ongoing confirmatory trials closely. Failure to secure continued approval could impact future earnings. This move appears promising in expanding BrightSpring's market reach and boosting its financial performance in the oncology sector.

LOUISVILLE, Ky., May 20, 2024 (GLOBE NEWSWIRE) -- BrightSpring Health Services (“BrightSpring” or “BrightSpring Health Services”) (NASDAQ: BTSG) is proud that its company, Onco360®, one of the nation’s largest independent oncology pharmacies, is being selected as a pharmacy partner by Day One Biopharmaceuticals for OJEMDA™, a cutting-edge treatment for children diagnosed with certain central nervous system tumors.

The FDA-approved treatment is specifically used for patients six months and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. LGG is the most common central nervous system tumor in children, representing 30% of pediatric brain tumors. BRAF is the most commonly altered gene in pediatric LGG, as 75% of patients have BRAF alterations.

“We’re proud of the work that Onco360® is doing to improve the lives of adults and children battling cancer,” said BrightSpring’s President and CEO, Jon Rousseau. “They are partnering at the forefront of pharmaceutical innovation and their pharmacy collaboration with Day One Biopharmaceuticals for OJEMDA™ is evidence of their commitment to administering best-in-class oncology medications. This is yet another therapeutic that will have far-reaching health and clinical benefits for children living with central nervous system tumors.”

“At Onco360®, we’re always looking for partnerships to advance groundbreaking treatment options for rare cancers. We’re proud to partner with Day One Biopharmaceuticals to become a specialty provider for OJEMDA™,” said Benito Fernandez, Chief Commercial Officer at Onco360®. “This innovative once-weekly, oral medication will give children with pediatric LGG and their families hope for remission.”

The FDA approval for OJEMDA is based on the ongoing multicenter, open-label, single-arm FIREFLY-1 clinical trial. Eligible patients were required to have a relapsed or refractory pediatric LGG harboring an activating BRAF alteration based on local laboratory testing. Continued approval for this drug will be based upon verification and clinical benefit in the ongoing confirmatory trials.

Onco360® operates with the mission of improving the lives of patients battling cancer. The pharmacy has robust access to limited distribution oncology medications and offers personalized services such as financial assistance sourcing, expert clinical counseling, insurance benefit verification, and digital support.

To learn more about Onco360® and BrightSpring, please visit https://www.brightspringhealth.com/.

About BrightSpring Health Services 
BrightSpring Health Services is the parent company of leading service lines that provide complementary and integrated home- and community-based pharmacy and health solutions for complex populations in need of specialized and/or chronic care. Through the company’s service lines, including pharmacy, primary care and home health care, and rehabilitation and behavioral health, we provide comprehensive care and clinical solutions in all 50 states to over 400,000 customers, clients and patients daily. 

About Onco360 Oncology Pharmacy
Onco360 is one of the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit onco360.com.

Media Contact:  
Leigh White
Leigh.white@brightspringhealth.com
502.630.7412


FAQ

What is BrightSpring's relationship with Onco360®?

BrightSpring Health Services owns Onco360®, one of the largest independent oncology pharmacies in the U.S.

What type of cancer does OJEMDA™ treat?

OJEMDA™ treats pediatric low-grade glioma (LGG) with BRAF mutations.

Who can receive OJEMDA™ treatment?

OJEMDA™ is approved for children aged six months and older with relapsed or refractory pediatric LGG harboring specific BRAF mutations.

What clinical trial supported the FDA approval of OJEMDA™?

The FDA approval of OJEMDA™ is based on the ongoing FIREFLY-1 clinical trial.

What services does Onco360® offer?

Onco360® offers services including financial assistance, expert clinical counseling, insurance benefit verification, and digital support.

What is the significance of Onco360® being selected as the national pharmacy partner for OJEMDA™?

The selection highlights Onco360®'s role in advancing access to cutting-edge oncology medications for pediatric cancer patients.

What is the stock symbol for BrightSpring Health Services?

The stock symbol for BrightSpring Health Services is BTSG.

BrightSpring Health Services, Inc.

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