Key approvals see big sales in first months
Among the 22 novel new drugs approved by the Food and Drug Administration in 2016, about half were considered specialty drugs, and Diplomat identified four key specialty approvals that innovate in certain categories. Two of these were in the hepatitis C space, which has driven specialty growth for several years.
(To view the full Category Review, click here.)
Gilead’s Epclusa (velpatasvir and sofosbuvir), approved in January, currently is the only treatment on the market that offers a singletablet regimen for patients with genotype 1–6 chronic hepatitis C — a U.S. patient population estimated between 2.7 million and 3.9 million. Despite being on the market for less than half the year, Gilead reported that Epclusa brought in U.S. sales of $1.6 billion for the company in 2016.
Also in the hepatitis C space was Merck’s Zepatier (elbasvir and graziprevir), which received breakthrough therapy designation for certain genotype 1 patients and genotype 4 patients. The total patient population for the drug is around 71% of the total hepatitis C patient population, and Merck reported Zepatier sales of $488 million in the United States, with $180 million in fourth-quarter U.S. sales.
The drug with the largest patient population (7.5 million) was Eli Lilly’s Taltz (ixekizumab), a new treatment for certain plaque psoriasis patients. Upon approval in March 2016, the drug joined the therapeutic class of such blockbuster drugs as Cosentyx, Enbrel, Humira and Remicade. In 2016, Taltz drew $110 million in sales.
On the other end of the patient population spectrum was AbbVie’s Venclexta (venetoclax), a treatment for certain patients with chronic lymphocytic leukemia that can treat about 20% of CLL patients — 18,960 cases were diagnosed in 2016. The drug was given accelerated approval based on overall response rate, and though AbbVie has not disclosed sales, Thomson Reuters’ “Drugs To Watch 2016” report projected that it would see $1.5 billion in sales by 2020.
Cardinal Health completes Lymphoseek purchase
DUBLIN, Ohio — Cardinal Health completed its purchase of Lymphoseek, a product for lymphatic mapping lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America, from Navidea Biopharmaceuticals.
Navidea received approximately $83 million at closing, and will have the opportunity to earn up to $227 million of contingent consideration based on certain milestones through 2026, with $17.1 million of that amount guaranteed during the next three years.
Cardinal Health will license a portion of the acquired intellectual property back to Navidea to allow Navidea to develop and sell new immunodiagnostic and immunotherapeutic products for specific purposes in North America, and to continue to produce and sell Lymphoseek, mostly under a different brand name, outside of North America.
“This transaction is transformative for Navidea, as we will have the financial flexibility to invest in our deep pipeline of activated macrophage targeted imaging agents and therapeutics. We want to commend Cardinal Health for their professionalism throughout this trying process for Navidea,” said Dr. Michael M. Goldberg, president and CEO of Navidea Biopharmaceuticals.
FDA approves Noctiva
WASHINGTON — The U.S. Food and Drug Administration approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.
Noctiva is marketed by Renaissance Lakewood for Serenity Pharmaceuticals.
“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”
Nocturia (wakening at night to urinate) is a symptom that can be caused by a wide variety of conditions, such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Before considering Noctiva, the FDA advised health care providers should evaluate each patient for possible causes for the nocturia, and optimize the treatment of underlying conditions that may be contributing to the night-time urination.
Noctiva is taken daily, approximately 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys, which leads to less urine production.
Noctiva’s efficacy was established in two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Although these trials showed a small reduction in the average number of night-time urinations with Noctiva compared to placebo, more patients treated with Noctiva were able to at least halve their number of night-time urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations.