With technology, research muscle, Amneal looks to make its mark

PATTERSON, N.J. —A new kind of upstart generic drug supplier is shaking up the U.S. generic drug market.

Amneal Pharmaceuticals has been developing and co-marketing solid-dose multi-source medications for about six years. But in recent months, the company has pulled together all the elements its leaders say are needed to make Amneal a force in generic pharmaceuticals—technologically adept, laser-focused on therapeutic opportunities, backed by a powerful research and development bench and obsessed with quality control.

The company’s tagline, “Generic’s New Generation,” is intended to convey “a new energy, a new flexibility, a new hyper-professionalism” in the me-too drug market, said Jim Luce, executive vice president of sales and marketing.

“We’re different,” asserted Luce, who joined Amneal in January after a 25-year career with AmerisourceBergen and other companies.

Amneal is a U.S. company, but it’s backed by the R&D heritage of a major Indian-based pharmaceutical and medical products manufacturing and distribution business, launched by Kanu Patel, father of Amneal chief executive Chintu Patel and president Chirag Patel. Kanu, who worked for India’s drug regulatory agency in the late 1960s and early 1970s, gained a reputation for ethical business dealings in the midst of a tainted marketplace. “There was such corruption at that point in the [regulatory agency] over there that he pulled himself out of it,” Luce said. “There are great stories about his throwing guys out of his living room for trying to bribe him to approve their plants when they didn’t meet the [drug safety] requirements.”

The family moved to the United States about 21 years ago, but the medical products business Patel ran continues to thrive in India.

The creation of Amneal came much later, in 2001, after Kanu Patel’s sons, Chintu and Chirag, had completed their education and forged successful careers in pharmacy and technology. Chintu, the company’s chief executive officer and founder, was a pharmacy manager with Eckerd Corp. Chirag earned his stripes as a business-development executive with major high-tech companies, who then launched three businesses before joining Amneal.

The company’s first major step came in 2002, when Amneal launched a manufacturing site in northern New Jersey to provide contract manufacturing of over-the-counter medicines for other suppliers. But it quickly moved into the contract manufacturing of pharmaceuticals and the development of new drugs, “working with regional distributors as partners to help fund the [abbreviated new drug] application process,” Luce said.

Amneal now has nine ANDAs on file at the Food and Drug Administration, with another dozen ANDAs in the pipeline for 2008. Longer-term, the company expects to file a minimum of 20 applications for new drug compounds with the FDA each year thereafter.

To assure a continued flow of capital to feed its research and development pipeline, Amneal also entered into a long-term partnership with a deep-pockets investment group in 2005. Bolstered by that investment, Amneal was able to “fully fund all of the R&D internally and not have to find partners that are distributors to help fund that research,” Luce said. The additional financial support also enabled Amneal to evolve into a broad-scale, fully integrated developer and distributor of pharmaceuticals.

“The one gap we had to launching our own label is we didn’t have sales, marketing and distribution functions,” Luce explained.

The solution came through the acquisition in June of Akyma Pharmaceuticals, a regional distributor based in Glasgow, Ky. “They needed a [drug] pipeline, which we were providing,” Luce explained. “We needed a sales and distribution component.”

With 92 retail, wholesale and institutional pharmaceutical customers under contract, Akyma provided that element. Equally important, the company brought to Amneal “a superb software system,” for managing the supply chain and marketing efforts, Luce noted.

The merger with Akyma, he added, “was a big step for us. Our first product that we both manufacture, and sell and distribute, we’ve already gotten to 44 percent market share in just 90 days,” Luce said.

That product is a pain medication, tramadol hydrochloride. Amneal also is shipping more than a half-dozen other generic products covering a wide range of therapeutic classes, with another half-dozen or more me-too medications rolling out by the end of the year. In development are extended release/complex formula medications, six topical ointments, four liquid and suspension products, softgel formulations, niche products and several controlled substances. In partnership with an Indian drug manufacturer, Amneal also is developing a stable of as many as 10 products within the ophthalmic category.

“Solid dosage is what we do now, but we just entered into a joint venture with a 60-year-old Indian company specializing in ophthalmics,” explained Chirag Patel. “They operate the only FDA-approved plant in India for ophthalmics.”

Amneal appears ready to take on the vast U.S. generic pharmaceutical market, with a staff of 65 R&D professionals dedicated to the U.S. market, a high-tech production facility and a national sales, marketing and distribution capability. The firm soon will be backed by a 48,000-square-foot R&D center in India.

“That will double our R&D capacity,” Patel said. “This will allow us to do 20-plus ANDAs per year.”

Added Luce, “We understand that to really build a business in the generic world, we need a large portfolio of ANDAs. We have a very aggressive pipeline.”

In keeping with its aggressive R&D strategy and its determination to bring advanced technology to bear on the drug-development and distribution business, Amneal also has developed the automation and communications capabilities needed to make it one of the first companies to file ANDAs electronically, using the FDA’s new electronic Common Technical Documents and Quality Overall Specifications formats, which the FDA made available at the beginning of this year.

“We were just the third company to file this way, behind a couple of multibillion-dollar companies,” Luce said. The process replaces thousands of pages of application documents with an electronic review and documentation process.