Posts tagged Braeburn
Braeburn names Mike Derkacz as president, CEO

Closely held Braeburn Pharmaceuticals appointed Michael Derkacz as president and CEO, succeeding Behshad Sheldon, who is stepping down from both posts and as a director, effective immediately, but will continue to serve as a consultant to Braeburn.

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Braeburn gets CMS J-code for Titan's Probuphine

Closely held Braeburn Pharmaceuticals announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) code, or permanent J-code, for Probuphine, the first and only six-month buprenorphine implant for the maintenance treatment of opioid addiction.

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Braeburn files for $150-million IPO

Closely held Braeburn Pharmaceuticals filed with U.S. regulators to raise up to $150-million in an initial public offering, seven months after its Probuphine implant to treat opioid addiction was approved by the FDA.

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Titan’s Probuphine, Behshad Sheldon win Stevie awards

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant was named a gold award winner at the 13th annual Stevie Awards for Women in Business in the category of "Best New Product or Service of the Year."

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Titan’s Probuphine featured at ISAM meeting

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant and marketing partner, closely-held Braeburn Pharmaceuticals, were featured in three presentations at the International Society of Addiction Medicine (ISAM) annual meeting in Montreal last week.

Probuphine, a subdermal implant of buprenorphine, is the first commercially available six-month maintenance treatment for opioid dependence. The FDA approved Probuphine in May.

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Popular Science picks Titan’s Probuphine for “Best of What’s New” award

Titan Pharmaceuticals’ (NASDAQ: TTNP) Probuphine implant has been recognized as one of the "12 Most Important Innovations of the Year" in the health category in Popular Science's annual Best of What's New issue.

Probuphine, a subdermal implant developed using Titan's proprietary ProNeura technology, was approved by the FDA in May, becoming the first commercially available long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.

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Titan’s Probuphine gains more media attention

Titan Pharmaceutical’s (NASDAQ:TTNP) Probuphine six-month implant of sublingual buprenorphine continues to attract widespread media attention for its ability to treat addiction to opioids.

Independent TV station, WHDT, in Stuart, FL. has produced a segment on Probuphine with Dr. Stuart Segal and one of his patients, who was successfully weaned off her use of opioids.

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Buprenorphine patient limit raised to 275

The Obama Administration will raise to 275 from 100 the limit on the number of patients with opioid addiction that certain physicians can treat with buprenorphine.

The move was part of several announced by the administration as part of an effort to stem the opioid abuse epidemic that is killing nearly 80 people from overdoses every day.

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Braeburn presents Probuphine data at CPDD meeting

Closely-held Braeburn Pharmaceuticals has presented data from the poster of the Phase 3 study of Probuphine, a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence, at the annual scientific meeting of The College on Problems of Drug Dependence (CPDD).

The FDA recently approved Probuphine, which was developed by its partner, Titan Pharmaceuticals (NASDAQ:TTNP), on May 26.

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Titan Pharma receives milestone on Probuphine approval

Titan Pharmaceuticals (NASDAQ:TTNP) has received a $15-million milestone payment from development and commercialization partner, Braeburn Pharmaceuticals, following FDA approval of Probuphine, the first six-month maintenance treatment of opioid dependence.

Under terms of the licensing agreement, closely-held Braeburn will pay Titan tiered royalties on net sales in the U.S. and Canada at rates ranging from the mid-teens to low-twenties. In addition, Titan is eligible for up to $165-million in milestone payments based on achievement of certain annual sales targets.

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Roth ups Titan Pharma price target to $10

Roth Capital Partners has raised its price target for Titan Pharmaceuticals (NASDAQ:TTNP) to $10 from $7.75 after the FDA approved Titan’s six-month Probuphine implant for the treatment of opioid addiction. The stock closed at $7.07 on Friday.

“The hook here is forced compliance,” writes analyst Scott Henry. “The implant removes the risk of noncompliant patients relapsing back to opioids, including heroin. Adding difficulty to the compliance of oral buprenorphine, Suboxone, is the high street value of the drug, which effectively can be sold to support an opioid habit,” he added.

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FDA approves Titan’s Probuphine implant for opioid dependence

The FDA has approved Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.

“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA commissioner Robert M. Califf, M.D. in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

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Titan Pharma’s Probuphine featured on CNBC

CNBC has highlighted Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine six-month implant of buprenorphine in a feature about the treatment of opioid addiction and the crisis of fatal overdoses in the U.S.

The feature discusses the potential benefits of an implant, compared with current sublingual versions of buprenorphine, and the relatively low percentage of doctors authorized to write prescriptions for buprenorphine.

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FDA extends Probuphine action date

The FDA has extended its action date to consider approval of a NDA for Probuphine for the maintenance treatment of opioid addiction by the standard period to May 27 from Feb. 27.

Following the Psychopharmacologic Advisory Committee meeting in January, which recommended approval of Probuphine, the FDA requested additional changes to the Risk Evaluation and Mitigation Strategy (REMS) portion of the NDA, which were promptly submitted by Titan Pharmaceuticals’ (NASDAQ:TTNP) development and commercialization partner, closely-held Braeburn Pharmaceuticals.

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Knight to sublicense Titan Pharma’s Probuphine in Canada

Titan Pharmaceuticals’ (NASDAQ:TTNP) development and marketing partner, closely-held Braeburn Pharmaceuticals, and Knight Therapeutics (TSX:GUD) have entered into an agreement, giving Knight exclusive rights to commercialize Titan’s Probuphine in Canada.

Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, promoting patient compliance and retention, as well as helping to prevent accidental pediatric exposure.

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FDA adcom votes in favor of approving Titan’s Probuphine

The Psychopharmacologic Drugs Advisory Committee of the FDA voted 12-to-5 in favor of approving Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.

The committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The FDA accepted the NDA for Probuphine last September and set an action PDUFA date for Feb. 27.

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