PHARMACY

Cardinal Health completes Lymphoseek purchase

BY Brian Berk

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.

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FDA approves Noctiva

BY Brian Berk

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.

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J.M. Smith names new CEO

BY David Salazar
SPARTANBURG, S.C. — J.M. Smith announced recently that there is a new face at the helm of the company. Effective March 1, A. Alan Turfe is the company’s CEO and chairman of its board of directors, having been selected by the board after a nationwide search. He joins the company from Fresenius Medical Care, where he was SVP and chief procurement officer. 
 
“In a pool of incredibly qualified candidates, Alan demonstrated the leadership skills, business acumen and background best suited to lead J M Smith Corporation into the future,” board member and search committee chair Terry Cash said. “Alan is growth-minded and believes, as we do, that the future is bright for J M Smith Corporation. We believe he will both honor the proud history of this organization while leading it through the dynamic times ahead.”
 
At Fresenius, Turfe leveraged global manufacturing and distribution in pharmaceuticals and other medical categories to expand margins and drive profitability. He got his start on the assembly line at General Motors while working toward his MBA, after which he became a GM financial analyst, eventually moving up the ranks to become co-CEO of a GM joint venture company he led the company into in his tole as CFO of GM Worldwide Purchasing and Logisitics. 
 
After GM, Turfe joined Fisher Scientific, then to IDEX, where he was president of Micropump, overseeing sites in the U.S. and overseas with full profit-and-loss responsibilities, and growing the bueinesses through strategic acquisitions and new product development. 
 
“J.M. Smith Corp. is a phenomenal organization with a proud history,” Turfe said. “I am looking forward to working with everyone within the company as we write its next chapters together. I believe in the importance of listening to employees and to customers on a personal level, asking ‘How can we help them achieve?’ and then working with them to do just that.”
 
In his new role leading J.M. Smith, Turfe will head up the third-largest privately held company in South Carolina, which does business through such units as Smith Drug, QS/1, Integral Solutions Group, RxMedic Systems, Integra LTC Solutions and Burlington Drug Company. He will be based in Spartanburg. 
 
“One of the things that drew me to this opportunity is the longevity of both the employee and customer relationships,” Turfe said. Long-term relationships such as these are evidence of the quality of the organization, the caliber of its people and of its service. I am proud to be part of that.”  
 
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