Ranbaxy, the Company

Neil Laboratories

Women’s Health Clearinghouse

EchoCath’s New Heart Technology

Corrections or additions?

These articles by Barbara Fox by Peter Mladineo were published in U.S. 1 Newspaper on

May 13, 1998. All rights reserved.

Generic Drugs: Ranbaxy

Everybody knows about the big pharmaceutical companies

that dot New Jersey’s corporate landscape. We are all familiar with

how their research contributes to the financial health of the state

and the physical health of the nation. Drug firms here produce 43

percent of the nation’s prescription drugs and contribute more than

$8 billion to the state economy.

What few stop to consider are the number of firms that manufacture

drugs that are identical to but cheaper than those pioneered by the

major firms. Generic drug makers are indeed important to New Jersey’s

economy, and Princeton has just acquired another one. The United

States

office of a publicly traded India-based company has moved to Princeton

from Raleigh, North Carolina. Last year Ranbaxy Pharmaceuticals Inc.

bought North Brunswick-based Ohm Laboratories and now is settling

into its new regional headquarters at 600 College Road.

Ranbaxy joins neighboring private-label manufacturers such as

Apothecon,

a Bristol-Myers Squibb generic manufacturer on Scudders Mill Road;

Guardian Drug, a 13-year-old firm which makes stomach remedies on

Prince Street in Trenton; Xechem, which researches and produces

proprietary

and generic drugs on Jersey Avenue in New Brunswick; and Neil

Laboratories,

located at 55 Lake Drive in Hightstown.

Dipak Chattaraj is regional director of the worldwide company, Ranbaxy

Laboratories Ltd., based in New Delhi and publicly traded in India

and Luxembourg. He is president of Ranbaxy Pharmaceuticals Inc., a

wholly owned subsidiary. Incorporated in Delaware, it started out

in North Carolina in 1994. Together with Ohm Laboratories, Ranbaxy

has more than 140 employees.

Ranbaxy makes both over-the-counter and ethical (prescription drug)

generic products for all of the various components of the United

States

healthcare market, from supermarket drugstores to managed care

organizations.

About 40 percent of Ranbaxy’s ethical drugs are made in India, but

the rest are made here. Its ethical drugs will be in these therapeutic

areas: antiinfectives, analgesics, nonsteroid anti-inflammatories,

cardio vascular agents, anti-allergenics, and gastrointestinal.

At Ohm Laboratories Ranbaxy manufactures private label brands of

over-the-counter

products primarily for the United States market. It specializes in

analgesics, gastrointestinal medicine, and cough and cold

preparations.

Arun Heble, founder of Ohm Laboratories, was a

pharmaceutical

major at the University of Kansas, Class of 1967. He went directly

into pharmaceutical manufacturing, started the firm on Black Horse

Lane in 1982, and sold it to Ranbaxy Pharmaceuticals in September,

1995.

Chuck Caprariello, Ranbaxy’s executive director of marketing and

business

development, calls this area the "fertile crescent of the

pharmaceutical

industry" and hopes to develop business alliances here. Ranbaxy

in India has a marketing alliance with Indianapolis-based Eli Lilly

and Company.

"We take pride in saying we are a vertically integrated company

— we make products from the very beginning to the very end,"

says Caprariello. "We take raw material, put it in dosage form,

and market the product."

Ranbaxy’s sales and marketing strategies are devised from the College

Road headquarters, but it contracts its sales representatives from

HMS Sales and Marketing, based in Jacksonville. "We promote the

product as a generic alternative to buyers such as at Pathmark and

ShopRite," says Caprariello.

An alumnus of Columbia, Class of 1971, Caprariello has spent his

career

until now working at major pharmaceutical firms: "I had had

experience

in sales management, product management, group product management,

strategic development, and business development." As one of the

first members of Ranbaxy’s core management team, he is enjoying the

opportunity to wrap all those jobs into one.

Caprariello did not seek out publicity and, in fact, was reticent

to give an interview: "We are a conservative global company and

are very careful about growing our business." But he is willing

to say that though his 35-year-old company is new to the U.S., it

is "well established on a global basis, and we are very effective

because this is the last market on the globe that we have focused

on."

Top Of Page
Ranbaxy, the Company

From New Delhi, India, Ranbaxy moved to the Middle East, the Pacific

Rim, and Europe, before starting 3 1/2 years ago in North Carolina.

Three-fourths of the research needed to formulate the compound of

a "new" generic product is done in India, and the rest is

done at Ohm Laboratories. The FDA audits products and sites in both

locations.

"Our products are approved by the FDA based on the composition

of the product, but there is some possibility of variation with shape

and color and size of the actual dosage form," he says. "We

say we have the generic equivalent, thoroughly reviewed and approved

by the Food and Drug Administration. The FDA says it is in every way

equivalent to the brand and will give the desired therapeutic

outcome."

The original, or pioneer, drugs go through rigorous testing for

efficacy,

toxicity and interactions with the body. Beth Leahy, corporate vice

president of communications at Covance, says it takes about $500

million

and up to 15 years to bring a product from discovery to market.

Headquartered

at the Carnegie Center, her firm operates in 17 countries and recently

handled the clinical tests for Pfizer’s impotence drug Viagra.

But given the narrow profit margins that generics yield, the FDA

approval

process could be considered comparably demanding and significant in

terms of time and cost. "It is an extensive process that many

people characterize as simplistic," says Caprariello, "but

the review process can be as long as 24 months."

He cites the essential chemical work needed to substantiate the

application

to show the substance is equivalent to the pioneer drug. "You

have to develop and formulate the product in a dosage form, to show

that all the inactive and active ingredients are compatible, to show

good manufacturing practice, and to show bioequivalency."

Top Of Page
Neil Laboratories

Bharat Patel, president of Neil Laboratories, agrees. Particularly

to a small start-up like Patel’s, the FDA review process usurps large

chunks of a budget. He is about to enter a period of very rapid

growth,

from 12 to 40 or 50 employees, but he now markets 12 over-the-counter

products.

"Out of my 12 employees, I have six people doing quality

assurance.

They do insist that one person cannot do too many things. Even if

you don’t have enough work they don’t care about it." Patel

estimates

that to get even an over-the-counter product appropriately registered

with the FDA costs from $15,000 to $50,000.

The ethical or prescription generics, in contrast, require from

$250,000

up to a $1 million to get through the FDA. Ranbaxy has managed to

take two of its ethical products over those FDA hurdles: an

antiinfective

and antibiotic drug named cefaclor (an equivalent to Lilly’s Ceclor)

and an anti-ulcer drug, ranitidine, that can substitute for

Glaxo-Wellcome’s

Zantac.

Though its primary focus is pharmaceutical products, Ranbaxy also

has certain nutritional items. Like Xechem in New Brunswick, it is

importing ginseng — taken as an "energy booster" —

and is selling it under private label.

The pressures brought on by the economics of managed care can only

help the growth of generic drug companies. Says Caprariello:

"Overall,

generic prescriptions have been written in greater numbers than for

branded, and that is expected to increase over time."

— Barbara Fox

Ranbaxy Pharmaceuticals, 600 College Road East,

Suite 2100, Princeton 08540. Dipak Chattaraj, managing director.

609-720-9200;

fax, 609-720-1155.

OHM Laboratories Inc., 464 Black Horse Lane, Suite

C, North Brunswick. Also at 1385 Livingston Avenue, New Brunswick.

Mailing address: Box 279, Franklin Park 08823-0279. Arun Heble,

president.

Top Of Page
Women’s Health Clearinghouse

A national clearinghouse for women’s health information

will expand to New Brunswick next July. "We link consumers with

local and national health resources — we conduct topic-specific

information searches on behalf of women," says Amy Niles,

executive

director. "And we disseminate information on the Internet and

partner with leading organizations and corporations to develop

national

women’s health initiatives."

Until last July her organization was part of Columbia Hospital for

Women, though it operated nationally. "By being independent, we

can better fulfill our national mission," says Niles.

The center will keep its offices at 5255 Loughboro Road in Washington,

D.C., but Niles will spend "a good deal of time up there"

and marketing director Elizabeth Battaglino will move to New

Brunswick.

Heidi Rosvald, editor of the bimonthly newsletter, National Women’s

Health Report, will remain in Washington.

Niles said the move resulted from a cold mailing from Christopher

Palladino, the president of the New Brunswick Development Corporation,

which is opening a shared office/incubator for healthcare corporations

at its Albany Street headquarters.

"I respond to everything that crosses my desk because you never

know what will be of interest. So I got on the phone and invited them

down," says Niles. "The concept of being together in a

building

with other nonprofits and sharing resources is an admirable goal.

And there are a tremendous amount of health resources in New Jersey.

It was many months of thinking and decision making, but we thought

it was worth taking a risk."

Amy Lefkowitch Niles grew up in Manhattan where her

mother was a music educator at a Brooklyn high school and her father

owned a large sheet music store on the Lower East Side. After going

premed at the University of Rochester, Class of 1979, she went into

healthcare administration at a medical center, eventually becoming

a vice president for planning, and then worked in the Washington area

for Medlantic Health Care Group and Columbia Hospital for Women, and

became full time executive director of the clearinghouse in 1992.

Niles’ $300,000 budget is covered by memberships and private grants

and contributions, and she hopes to expand the funding to include

contributions from foundations and government grants. She says that

though the organization receives money from pharmaceutical companies

it is not influenced by these contributions.

"We identify the subjects we want to cover next year, and then

we might seek funding for one of the topics. But we specify that the

newsletter and our other initiatives must present a comprehensive,

balanced picture to the consumer and must not be influenced by the

sponsors. The pharmaceutical industry in the past has clearly

understand

our mission and what the consumers need and I expect to have continued

positive relations with the industry."

— Barbara Fox

National Women’s Health Resource Center, 120 Albany

Street Plaza, 8th Floor, New Brunswick. Amy Niles, executive director.

202-537-4015; fax, 301-320-3762. E-mail: natlwhrc@aol.com. Home

page: http://www.healthywomen.org.

Top Of Page
EchoCath’s New Heart Technology

Another Princeton area company making progress in heart

health is EchoCath. In a press release dated Friday, May 8, the Route

1 North-based medical device manufacturer announced that the efficacy

of its blood-flow measurement system, EchoFlow, had been validated

in pre-clinical tests at the University of Louisville.

EchoFlow is a tool to aid cardiovascular surgery: a sensor is placed

on the surface of an artery where blood-flow velocity measurements

are taken and data about blockages in the artery can be collected.

"The surgeons can use this to explore along the surfaces of an

artery to choose where best to place the attachment of the bypass,

the anastomosis," says Frank A. DeBernardis, the president and

CEO of EchoCath. "Secondly after you’ve done anastomosis and made

the bypass into an artery it helps to assess the procedure.

He suggests that the device could be used on several types of arteries

and could also help to perform dialysis access grafts, as well as

other applications. "One possibility is to make this into an implantable

sensor so it could be a long-term monitor of the performance of bypass

procedures of arteries," he says.

The system was successfully tested on a carotid artery at Mt. Sinai

Hospital. The test at the University of Louisville saw the sensor

placed on a coronary artery of a beating heart. The positive results

will allow EchoCath to receive roughly $315,000 in product development

funding per a licensing agreement with Medtronic, a Minneapolis-based

partner. "This is multifaceted," says DeBernardis. "It’s

a core platform technology. What we’ve demonstrated is an epivascular

approach."

EchoCath Inc., 4326 Route 1 North, Princeton 08543-7224.

609-987-8400; fax, 609-987-1019. E-mail: echocath@erols.com.

Stock symbol: ECHTA


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