Business Monday

Noven’s niche: The Miami company is key producer of transdermal patches

 

The Miami company, a subsidiary of Japan’s Hisamitsu Pharmaceutical, is a key producer of prescription medicinal patches.

Noven Pharmaceuticals

•  Business: Engages in research, development, manufacturing, marketing and sales of specialty pharmaceutical products, with a focus on transdermal drug delivery systems, or medicated skin patches, for U.S. and foreign markets. Products are marketed through Noven Therapeutics, Novogyne Pharmaceuticals (jointly owned by Noven and Novartis Pharmaceuticals) and others.

•  Founded: 1987

•  Headquarters and plant: Miami, with other offices in New York City and a plant in Carlsbad, CA.

•  President and CEO: Jeffrey F. Eisenberg

•  Ownership: Noven, formerly a publicly traded company, was acquired by Japan’s Hisamitsu Pharmaceutical Co. in 2009.

•  Employees: about 700, including 400 in Miami

•  Website: www.noven.com

Source: Noven Pharmaceuticals


At the Noven Pharmaceuticals plant in southwest Miami, scientists and technicians use highly specialized machinery to blend prescription medications and adhesives to make layered transdermal patches that release precise quantities of drugs over time after being applied to a patient’s skin.

Noven, a subsidiary of Japan’s Hisamitsu Pharmaceutical, has about 700 employees nationwide and ranks as a relatively small player among pharma giants. Nonetheless, the company, a leading research and development center for medicinal patches, produces a line of specialty pharmaceuticals and is the U.S. market leader in sales of estrogen patches for women.

“By industry standards, Noven is a small company,” said Jeffrey F. Eisenberg, Noven’s Miami-based president and CEO. “But we have a line of specialized products that competes successfully in the U.S. and overseas. We are experts in developing transdermal patches and produce other pharmaceutical products.”

In one key market — estrogen patches for women — Noven holds about a 68 percent share, he added. And the company has a robust research and development department in Miami at work on a variety of new drugs.

Medications may be delivered to patients orally, via injection or through transdermal patches, which can administer drugs slowly over an extended period of time. While Noven makes products other than medicinal patches, it devotes an important share of resources to transdermal patch technology.

“We have a talented group of scientists who are at the forefront of this specialty,” Eisenberg said. “We have M.D.s, PhDs in biology and chemistry and chemical engineers who specialize in pressure-sensitive adhesives and polymer chemistry.”

Noven has won more than 30 U.S. and 100 international patents and is developing several new drugs. The company recently announced it is making progress on studies to evaluate a new, amphetamine-based transdermal patch for treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Currently, there is no such patch approved for use with ADHD, the company said.

Noven also has applied to the U.S. Food & Drug Administration for approval of a new oral, non-hormonal medication to treat menopausal hot flashes.

Making patches is a complex process that requires the design and development of an ideal combination of drug, adhesive and backing, Eisenberg said. Patches must be formulated so that they will deliver a safe and effective dose of medication over a period of time and adhere to the skin as required.

At the Noven patch facility, which has the capacity for making 500 million patches per year, active drug compounds are mixed with custom adhesives in large, specialized kettles. The mix of drug and adhesive is then applied to sheets of release liner material under very precise tolerances. Noven removes a blending solvent from the compound and applies the backing material, making a three-layer patch. Laminate rolls subsequently are sent to punching, pouching and packing machines (Patches are punched into different sizes.). All of this occurs under strict quality control procedures and is not open to the public.

Noven was founded in 1987 by Steven Sablotsky, a chemical engineer, who had worked for another pharmaceutical firm and was an expert in transdermal patches. Noven went public in 1988 and operated as a publicly-traded company until it was taken over in 2009 by Hisamitsu, a Japanese pharmaceutical company that also manufactures and markets transdermal patches. (Salonpas, an over-the-counter analgesic patch widely advertised in South Florida, is made by Hisamitsu.)

Read more Business Monday stories from the Miami Herald

Miami Herald

Join the
Discussion

The Miami Herald is pleased to provide this opportunity to share information, experiences and observations about what's in the news. Some of the comments may be reprinted elsewhere on the site or in the newspaper. We encourage lively, open debate on the issues of the day, and ask that you refrain from profanity, hate speech, personal comments and remarks that are off point. Thank you for taking the time to offer your thoughts.

The Miami Herald uses Facebook's commenting system. You need to log in with a Facebook account in order to comment. If you have questions about commenting with your Facebook account, click here.

Have a news tip? You can send it anonymously. Click here to send us your tip - or - consider joining the Public Insight Network and become a source for The Miami Herald and el Nuevo Herald.

Hide Comments

This affects comments on all stories.

Cancel OK

  • Videos

  • Quick Job Search

Enter Keyword(s) Enter City Select a State Select a Category