Cumberland Pharmaceuticals To Acquire VIBATIV®
VIBATIV® (telavancin) is a patented,
Under the terms of the agreement, Cumberland will assume full responsibility for the product including its marketing, distribution, manufacturing and regulatory activities. Cumberland will support VIBATIV in
The financial terms include a
"VIBATIV is a lifesaving product for certain difficult to treat infections, and we are honored to be selected to acquire and transition the brand to our existing hospital acute care infrastructure," said
"Following an extensive process involving discussions with several interested parties, we determined that Cumberland was best positioned to optimize the value of the VIBATIV brand and ensure the product's important therapeutic benefits reach as many patients as possible," said Rick E Winningham, chairman and chief executive officer of Theravance Biopharma. "We believe that Cumberland's track record of successfully marketing and selling hospital-based products, combined with VIBATIV's existing base of hospital formulary inclusions, positions the company to drive commercial success for VIBATIV as a flagship product."
The transaction is expected to close in mid-November, pending satisfaction of customary closing conditions. Cumberland will provide additional remarks on its upcoming third quarter 2018 earnings call.
VIBATIV® (telavancin, injection) was discovered in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. VIBATIV is a once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours, and penetration into target infection sites. The drug is approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of VIBATIV in treating patients whose pneumonia or skin infection is complicated by concurrent bacteremia. The product's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date. Importantly, these studies demonstrated significantly higher cure rates for VIBATIV as compared to vancomycin in HABP/VABP due to any single Gram-positive pathogen or S. aureus with vancomycin MIC ≥1 µg/mL. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. For full prescribing information, visit www.vibativ.com.
For more information, please visit www.cumberlandpharma.com.
For more information, please visit www.theravance.com.
This release contains forward-looking statements within the meaning of the federal securities laws, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. These forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from them. Some important factors which may cause results to differ from expectations include: market conditions; competition; an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers; maintaining an effective sales and marketing infrastructure; availability of additional debt and equity capital required to finance the business model; market conditions at the time additional capital is required; our ability to continue to acquire branded products; product sales; management of our growth and integration of our acquisitions; our ability to close the transaction, as well as other risks discussed in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K, and other filings with the
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Erin Smith, Investor, Corporate Relations, (615) 255-0068; Jeff Bradford, Media, the Bradford Group, (615) 515-4880