Noven, which shares technology, information and personnel with its parent company, was a good fit for Hisamitsu since the Japanese concern – founded in 1847 - wanted to develop its presence in the U.S. and diversify its product line, said Eisenberg, an attorney who has worked at Noven since 1998 and took over as CEO in 2009. “We had the technology and market expertise,” he added, “and we are Hisamitsu’s growth platform in the U.S. for prescription pharmaceuticals.”
Noven has about 400 employees at its 10-acre Miami complex, which includes a manufacturing facility, quality control center, transdermal R&D facility and offices. Products made in Miami are shipped to warehouses for delivery to wholesale and distribution centers as well as to sales staff who provide samples to physicians and clinics.
The other 300 employees work at the manufacturing facility in Carlsbad, Calif., at Noven offices in New York City and in sales. The company’s CEO and several executives are based in Miami while executives from clinical and business development and sales and marketing are located in New York.
Noven makes several products in Miami for the U.S. and European markets, including Vivelle-Dot, the world’s smallest transdermal estrogen patch; CombiPatch, a patch that combines estrogen and progestogen; Estradot, the Vivelle-Dot patch made for Europe and other international markets and marketed by Novartis, and Daytrana, a once-daily patch for symptoms of ADHD.
Physicians typically do not comment publicly on specific medications unless they are making presentations at professional conferences, offering results of clinical tests or representing a product manufacturer.
“Transdermal medicine is becoming more and more of a trend,” said Mary Jane Minkin, M.D., who is clinical professor of obstetrics and gynecology at Yale Medical School and has a private practice in New Haven, Conn., in a phone interview. “The patches give you a much smoother delivery than pills,” added Minkin, who co-authored, with Carol Wright, A Woman’s Guide to Menopause and Perimenopause and The Yale Guide to Women’s Reproductive Health.
She noted that Noven’s Vivelle-Dot estrogen patch is widely used in her specialty and, because of its design, can deliver the medication effectively in a very small patch. The Dot in Vivelle-Dot, she added, doesn’t refer to the small size of the patch but to “delivery optimized thermodynamics,” the Noven design that provides a drug/acrylic blend mixed with silicone adhesive to form evenly dispersed, concentrated drug pockets.
Christopher Estes, M.D., assistant professor of obstetrics and gynecology at the University of Miami Miller School of Medicine, said that he frequently prescribes hormonal patches for hormonal replacement in menopausal women and for birth control. They are “pretty common,” he said and can be an alternative to pills, which sometimes cause gastrointestinal problems. “The more options I can give my patients for drug delivery, the better – patches, pills or implantable or injectable devices.”
While Noven would not provide specific financial figures, CEO Eisenberg said the company’s sales were up 30 percent in the last fiscal year, and that Noven represented just under 10 percent of Hisamitsu’s global sales.
“Our challenge – like all pharmaceutical companies – is to maintain a constant stream of new products,” said Eisenberg. Developing new drugs is a long, costly and complex process, he noted. It takes from five to 10 years between the time a medical need is identified, a drug is developed and passes through multiple stages of animal and human testing and FDA evaluation until it is either approved for sale to the public - or not. One new drug application Noven made digitally to the FDA recently represented more than 20,000 pages of documents, data and studies.
“Our most important customer is the patient,” he added. “We must provide benefit and value.”