Date of Report (Date of Earliest Event Reported): April 13, 2018 (April 9, 2018) |
Tennessee | 001-33637 | 62-1765329 | |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | |
2525 West End Avenue, Suite 950, Nashville, Tennessee 37203 | |||
(Address of principal executive offices) (Zip Code) | |||
(615) 255-0068 | |||
(Registrant’s telephone number, including area code) | |||
Not Applicable | |||
(Former name or former address, if changed since last report) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Exhibit No. | Description | |
99.1 | ||
CUMBERLAND PHARMACEUTICALS INC. | ||
April 13, 2018 | By: Michael Bonner | |
Name: Michael Bonner | ||
Title: Chief Financial Officer | ||
• | Ethyol, Cumberland’s first oncology supportive care product, has two FDA-approved indications. |
• | The product is used to protect kidneys in women who are receiving cisplatin, a chemotherapy treatment for ovarian cancer, as well as for the treatment of dry mouth (xerostomia) that can occur in patients receiving radiation treatment for head and neck cancer. |
• | Due to the greater likelihood of positive survival outcomes and length of life, xerostomia is of great concern impacting the patient’s ability to eat, chew, and swallow for the rest of their life. Xerostomia occurs in up to 80 percent of patients undergoing radiotherapy. |
• | More specifically, health care providers are concerned with toxicity levels in patients as a result of cumulative radiation and cisplatin. These toxicity levels can prevent treatment in the future, particularly toxicity to the kidneys (nephrotoxicity) caused by cisplatin. The use of Ethyol results in significantly fewer patients experiencing treatment-limiting nephrotoxicity when compared to patients who did not receive Ethyol treatment. |
• | Totect, Cumberland’s second oncology supportive care product, is an FDA-approved hospital-based emergency oncology intervention drug. |
• | The product is indicated to treat the toxic effects of extravasation which is the leakage associated with anthracycline chemotherapy. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body, causing severe damage and serious complications. Anthracyclines are a class of drugs that includes doxorubicin, epirubicin, and daunorubicin which are used to treat many cancers. The incidence of anthracycline extravasation has been reported to be up to 6.0 percent, although it is widely acknowledged to be both underreported and undertreated. |
• | Totect can limit the damage caused by extravasation without the need for surgery and enable patients to continue their essential anti-cancer treatment. It is the only FDA approved antidote to this dangerous and debilitating problem that can occur when administering anthracyclines. Even with advances in medicine, anthracyclines are still a first line treatment for most solid tumors. In clinical trials, Totect eliminated the need for surgery in 98 percent of patients with anthracycline extravasation. |
• | 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). |
• | 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 the systemic sclerosis (SSc) 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; |
• | RediTrex™ (methotrexate) Injection, an approval submission candidate for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis. |