Cumberland Pharmaceuticals Announces Strategic Review
The strategic review follows an accelerated business development initiative that has resulted in a series of transactions over the last thirty six months. Following the Company's acquisition of Vibativ® in late 2018, its commercial portfolio now includes eight
In addition to the product review, Cumberland will also evaluate the appropriate level of sales and medical support for its line of products. The strategic review will seek to ensure national coverage of a majority of each brand's current business, as well as its potential. Both the expansion of the Company's internal sales organization and augmented support from co-promotion partners will be considered during the review.
Cumberland's strategy is to focus on the U.S., which is the largest market for its biopharmaceutical products. The Company has established a network of partners based outside the U.S. to bring its products to patients in other countries. As a result of the Vibativ® acquisition, Cumberland inherited a new group of firms who have licenses to that brand for international markets. The total number of the Company's existing international partners now numbers seventeen. The group includes those with rights to Cumberland products in other countries, as well as those partners who have licensed products to the Company for the U.S. market. The capabilities, status and potential of each partner will be evaluated during the review.
"We have successfully executed on our strategy to expand our commercial product line through a series of transactions," said
Recap of Recent Developments
Cumberland expanded its commercial product line in 2018 with the acquisition of Vibativ® from
Vibativ® is a patented,
Early in 2018, Cumberland submitted an application to the
In late 2018, Cumberland closed on an agreement with
During late 2018, Cumberland completed the submission and then filed with the
Meanwhile, Cumberland continued to advance its clinical programs in 2018, which feature several new product candidates in Phase II studies. The Company completed study enrollment for Portaban®, its Portal Hypertension clinical program. Initial review of the data from the study shows ifetroban to be safe and well tolerated with no unexpected safety findings. Cumberland also continued to advance its Vasculan® and Boxaban® clinical programs, with patient enrollment progressing in each of those Phase II studies.
Through Cumberland Emerging Technologies (CET), the Company is establishing a pipeline of new product candidates and fostering innovation by partnering with academic centers. During
- Acetadote® (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for the treatment of pain and fever;
- Kristalose® (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation;
- Omeclamox®-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
- Vaprisol® (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
- Ethyol® (amifostine) Injection, for the reduction of xerostomia (dry mouth) in patients undergoing post-operative radiation treatment for head and neck cancer and the renal toxicity associated with the administration of cisplatin in patients with advanced ovarian cancer;
- Totect®(dexrazoxane hydrochloride) Injection, for emergency oncology intervention, to treat the toxic effects of anthracycline chemotherapy in case of extravasation (drug leakage from the bloodstream into the tissues); and
- Vibativ® (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
Cumberland's pipeline of product candidates includes:
- Hepatoren® (ifetroban) Injection, a Phase II candidate for the treatment of critically ill patients suffering from liver and kidney failure associated with hepatorenal syndrome ("HRS");
- Boxaban®(ifetroban) Oral Capsules, a Phase II candidate for the treatment of asthma patients with aspirin-exacerbated respiratory disease ("AERD");
- Vasculan®(ifetroban) Oral Capsules, a Phase II candidate for the treatment of patients with systemic sclerosis (SSc) a form of autoimmune disease;
- Portaban®(ifetroban) Injection and Oral Capsules, a Phase II candidate for the treatment of patients with portal hypertension associated with liver disease; and
- RediTrexTM (methotrexate) Injection, an approval submission candidate for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.
For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company's website www.cumberlandpharma.com.
About Cumberland Emerging Technologies (CET)
CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products.
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. Forward-looking statements include, among other things, statements regarding our intent, belief or expectations. 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 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 and other factors discussed in the Company's most recent Form 10-K and subsequent 10-Q's as filed with the
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Investor, Erin Smith, Corporate Relations, (615) 255-0068; Media, Jeff Bradford, the Bradford Group, (615) 515-4880