Instead of going into private practice, David Tierney turned for his first job after medical school to a fledgling pharmaceutical company in Ireland, Elan. Tierney gave up a career in prescribing drugs in order to help make and sell drugs in a small company, and he did not look back.
"When I joined Elan, the company was at the stage of 'roll up your sleeves entrepreneurism,'" says Tierney. "I remember saying to myself that my goal was never to work myself up the corporate ladder to be an executive vice president. My goal was always to be the CEO of an entrepreneurial startup and to take it public. I am fortunate to be living through that."
Tierney is CEO of an Exit 8A firm, Valera Pharmaceuticals, founded in 1972 as HydroMed. It began to find new life, with a new name and focus, in 2000, when Tierney arrived. By the end of 2004 he had rescued the technology (which had run into a dead-end when it was licensed to another firm), commercialized it, and started a development pipeline. In so doing he converted a pure R&D firm into a specialty pharmaceutical company, with a focus on urology and endocrinology, and expanded the firm from a dozen people to about 90 employees, including a 35-person field sales team.
Valera's crown jewel technology is a hydrogel implant that can release a drug slowly, over time. An initial version of this, called Vantas, is a 1.5-inch tube made out of hydrogel polymers, similar to those used in soft contact lenses. Surgically inserted into the male patient's bicep muscle, it releases a hormone called histrelin, over a 12-month period to treat prostate cancer.
Vantas went on the market last fall and for the last quarter of the year Valera's revenues shot up from next to nothing to nearly $6 million. This year, while keeping its manufacturing operations at 8 Clarke Drive, the company took an additional 20,000 square feet of office space at 7 Clarke Drive, the former home of EpiGenesis Pharmaceuticals (see page 42).
Preliminary to a public offering, Valera has filed its S-1 registration with the Securities and Exchange Commission, and since it is in a "quiet period," its executives can give only limited interviews. This article was drawn from a brief telephone interview with Tierney about his biography and another telephone conversation about the company's history with Stuart S. Levine, a spokesperson.
Tierney is well on his way to making his ideal career path a reality. Last month, for instance, he won New Jersey's Ernst & Young Entrepreneur of the Year title in the category of manufacturing and is enrolled in the national competition. But potholes have popped up on that path. Tierney had agreed to be an outside independent director of Able Laboratories, a generic drug company that recently ran into major regulatory trouble; he is spending lots of time trying to help that firm sort itself out.
And there have been sacrifices, chief among them that he and his wife are raising their children far away from their home country. "A lot of people are not prepared to up and move their families to a different part of the world," says Tierney.
Tierney, 42, was born and raised in Dublin, Ireland, and is the second of three boys; the eldest is a headhunter and the youngest works in the entertainment industry, arranging commercial sponsorships for rock concerts. His father was a "chartered quantity surveyor," a combination of construction manager and building economist, and two grandparents were doctors. Tierney had planned to study liberal arts but, at the last minute, had a revelation that he wanted to go to medical school.
He graduated in 1987 from the Royal College of Surgeons in Dublin, and, after doing his internship and residency, Tierney looked at his future as a family practitioner and didn't like it: "I realized that I would see the same things day in day out. Knowing I would sit in the same place for the next 30 years of my life did not settle with me."
One option was to specialize, but the Irish government regulates the number of specialists for each hospital. "If you didn't know someone who was retiring, it was not a good choice," says Tierney. "The net result was that most went abroad to do training and to wait the call."
Another option was to work in the pharmaceutical industry. He interviewed for jobs in New York but, without a green card, he was told to work in Ireland first and get an industry transfer. He discovered Elan, which was then a fledgling company looking for a medical director, and joined it in January 1990. (Elan is the Ireland-based pharma that bought Princeton-based firms such as Liposome and Delsys Pharmaceutical).
In 1990 Tierney joined Elan as a director and was promoted to European director of medical affairs. Three years later Tierney emigrated to the United States with his wife, a former pharmaceutical sales representative. At that time she was six months pregnant, and they now have three school-aged children. At first he was director of U.S. clinical research and then director of worldwide clinical research.
He joined Roberts Pharmaceutical, located in Eatontown, as senior vice president of drug development in 1997. As part of that management team he helped turn the company around to be in favor with the Wall Street community, says Levine, who in addition to being Valera's spokesperson was also the former investor relations officer at Roberts. "Roberts became one of the actively followed stocks with a strong buy rating," says Levine. Roberts in-licensed, from HydroMed, the product that would become Vantas, the implant for treating prostate cancer.
Late in 1999, Roberts was merged into Shire Pharmaceuticals, a United Kingdom-based firm, and the Eatontown facility closed.
Tierney then took a job as president of Biovail Technologies, the U.S. subsidiary of a Canadian drug delivery company. Just eight months later, in August, 2000, he was recruited by HydroMed Sciences, which knew him from when he was at Roberts.
As the president and CEO of HydroMed, Tierney aimed to set a new course. "HydroMed was then a subsidiary of GP Strategies," says Levine, "and it was not going anyplace. It has a lot of scientific knowledge in polymer chemistry but its only prospects for growth were to outlicense products from polymer-based science."
Tierney changed the name of the company to a Latin word with a root that means "strength."
"It became pretty apparent to me, the team, and the investor group that we had a different business model, focusing on technology and doing deals, potentially being a contract manufacturer of products using this technology," says Tierney.
"I was not a great proponent of the outlicensing model. When you do the deals with larger companies, you hope the product remains a key product, but it can end up stuck in No Man's Land," says Tierney.
He made retrieving HydroMed's implant product from Shire his high priority. "HydroMed had outlicensed the product to Shire, where I was head of R&D, and it became apparent it would be the poor orphan in the Shire pipeline," says Tierney. "Once we got the rights back it was as clear as day that we had to finish the development and attempt to commercialize the product ourselves, that that was where the real value lay."
"We filed the new drug application, got it approved, and decided to build the sales force," says Tierney. "We took total control of the product."
Valera Pharmaceuticals has a new name, but it is not a new company, far from it. Its hydrogel technology dates back to the 1960s, when more than 100 scientists at Prague's Academy of Sciences were laboring on polymer research projects invented by the late Otto Wichterle.
Hydrogels are a type of plastic - or polymer - with the advantages of both liquids and solids. They can function in a gel state but, like liquids, transport large molecules. They can have controlled thicknesses, and they can control distribution through filters and screens. Because of their ability to absorb water without dissolving, and the fact they are biocompatible, they are being used in huge quantities as superabsorbents for diapers, as ingredients in hair sprays and cosmetics, and also for medical purposes and biotech devices.
In the 1990s, so many Czech scientists moved to the Route 1 corridor, that it was dubbed "Hydrogel Valley." One of them was Petr Kuzma, 62, Valera's vice president for research and development. Kuzma earned a master's degree in Slovakia, and managed to leave Czechoslovakia on a tourist's visa in 1969, joining National Patent in 1975.
National Patent was founded on an unusual alliance between the Communist government of Czechoslovakia and two United States-based lawyers, Gerry Feldman and Martin Pollack, who recognized the opportunity created by hydrogel technology for a soft contact lens. The alliance resulted in a patent for a billion dollar product craved by millions of nearsighted people, and after a legal wrangle, NP licensed the soft contact lens to Bausch & Lomb.
NP became GP Strategies, and HydroMed Sciences held the hydrogel technology that did not go with contact lenses. When Tierney arrived, he changed HydroMed Sciences to being a closely held private company, with GP as a major investor.
Hydrogels can be a silver lining for pharma companies with drugs that are about to go "off patent" and be sold as generic products. Put that drug in a hydrogel implant and, not only does it represent a new revenue stream, but it has real advantages to the patient. For instance, the previous treatment for prostate cancer involved painful monthly or quarterly injections in the stomach with a virtually identical drug. In general, automatic delivery is advantageous for those with chronic diseases, or for those with Alzheimer's or arthritis or psychotic disorders who don't remember to take their medication.
Last fall Valera completed an $11.5 million series C financing that included investment from the NJTC Venture Fund. The lead investors are Psilos Group Managers, a New York-based venture capital firm, Sanders Morris Harris, based in Houston.
Last month, the firm's Irish subsidiary submitted Vantas to the Danish regulatory authority for approval.
Tierney admits that in the past several months he has had to spend time working with Able Laboratories, the generic pharmaceutical manufacturing firm at Exit 8A that got into regulatory difficulties with the Food and Drug Administration. The top executives resigned and Able recalled all its products and lay off three fourths of its 440 employees. A public company, it filed for Chapter 11 bankruptcy on July 18 and has hired two consultants as interim executives.
Tierney was unable to comment, specifically, on Able Laboratory's situation, but had this general note: "When you get involved in difficult situations, there are a number of things you can do. You can pretend it didn't happen and run away and hide, or take your responsibility seriously, step up to the plate, and try to do the right thing. I believe the right thing to do is the latter."
Says Tierney: "I am a strong believer that you've got to be prepared to sacrifice. This is what I have wanted to do, to fulfill the business dream of building a company like this, taking it public, and seeing how far I can take it."
Valera Pharmaceuticals, 7 and 8 Clarke Drive, Cedar Brook Corporate Center, Cranbury 08512. David Tierney, president and CEO. 609-409-9010; fax, 609-409-1650. www.valerapharma.com
Medarex (MEDX), 707 State Road, Princeton 08540. Donald L. Drakeman, president and CEO. 609-430-2880; fax, 609-430-2850. Home page: www.medarex.com
Donald Drakeman received Ernst & Young's New Jersey Entrepreneur of the Year award in the category of biology and life sciences. Medarex is a biopharmaceutical firm that uses the UltiMAb mouse to develop monoclonal antibody-based therapeutics for cancer, inflammation, autoimmune, and infectious diseases.
The selection committee included Kenneth W. Freeman, former CEO of Quest Diagnostics, Jim Gunton, of the NJTC Venture Fund, and Robert O. Carr, CEO of Heartland Payment Systems, among others.
Rhodia Inc. (RHA), 259 Prospect Plains Road, CN 7500, Cranbury 08512-7500. James Harton, president, North America. 609-860-4000; fax, 609-860-0074. Home Page: www.us.rhodia.com
When Rhodia sold its Prospect Plains campus it began looking for a new site, either near its current home at Exit 8A or in Pennsylvania. Then the competition began, as both New Jersey and Pennsylvania began to compete for the company's presence.
Sources say now that Rhodia plans to move to a new 90,000-square foot building in Cedar Brook Corporate Center that was developed by Eastern Properties. Rhodia would not confirm this decision, saying only that it planned to make an announcement later this month.
Rhodia currently occupies an 83-acre site that has 14 buildings with 350,000 square feet.
The current owner of the Prospect Road campus is Preferred Real Estate Investments Inc., based in Conshohocken, Pennsylvania.
Symbiance, 231 Clarksville Road, Suite 1, West Windsor 08550. Shawki Salem Ph.D, president. 609-243-9050; fax, 609-243-9007. www.symbiance.com
Symbiance, which provides clinical research services to pharmaceutical companies, has moved from 3,200 square feet at 12 Roszel Road to 5,100 feet on Clarksville Road.
Hinkson's Stationers, 28 Spring Street, Princeton 08542. Andrew Mangone, manager. 609-924-0112; fax, 609-924-3612. Home page: www.Hinksons.com
Hinkson's, the longtime Princeton stationary and office supply retailer, has moved from Nassau Street to 28 Spring Street, on the first floor of the new municipal parking garage.
According to store manager Andrew Mangone, the move sprang from the shift in buying trends of Hinkson's customers. "We've always gotten off-the-street retail business, where clients will come in to pick-up items, like a convenience store, and there's still a need for that. So we wanted to keep that street presence. Now, three-quarters of our business is done over the Internet, or by fax or phone. In fact, most of our customers didn't even know we move. Because with free, overnight delivery, they never have to come into the store. Although we had occupied the old location since 1962, we were able to move into smaller space by eliminating the furniture display. Other than that, we have everything we've always offered."
Psion TekLogix (PON), 7 Centre Drive, Suite 9, Jamesburg 08831. John Streppone, regional vice president. 609-409-0666; fax, 609-409-8159. Home page: www.psionteklogix.com
Psion Teklogix, a global firm that sells radio frequency identification devices, moved to a smaller space within the same office complex. It provides mobile workers with anytime, anywhere access to enterprise IT systems in demanding, rugged environments.
Among its clients are the Port of Newark and other facilities with more than 1 million square feet of warehouse space, including L'Oreal, Cosmair, and Volkswagen at Exit 8A, McCormick spice company in Baltimore, several college campuses, and slaughterhouses, where the devices are used to track carcasses.
PA Consulting Group, 600 College Road East, Suite 1120, Princeton 08540. Dan Walsh, member of management group. 609-806-0800; fax, 609-936-8811. www.PAConsulting.com
PA Consulting has moved its offices from Enterprise Drive in Plainsboro to Princeton Forrestal Center and with this move, it acquires a Princeton address. Providing management and technology consulting to electronics, manufacturing, communications, and healthcare companies, the company employs approximately 40 consultants. Its phone number has changed; all other contact information remains the same.
Trade Management Services Inc., 196 Princeton-Hightstown Road, Building 2-A, #9, Princeton Junction 08550. Steve Hagen, vice president. 609-750-9881; fax, 609-750-0374. www.credit-link.net
Credit Link, also known as Trade Management Services, has moved from 55 to 196 Princeton-Hightstown Road. The company provides credit reporting information to the interior decorating industry, including fabric, floor covering, and window treatment manufacturers, warehouses and wholesalers. Dan Goldstein has been replaced as the person in charge by vice president Steve Hagen. All other contact information remains the same.
YWCA Princeton, 59 Paul Robeson Place, Princeton 08540. Micky Weyeneth, board president. 609-497-2100; fax, 609-683-5674. Home page: www.ywcaprinceton.org
Eileen Conway has resigned from the position after four years as executive director. Under Conway's direction, says Micky Weyeneth, board chairman, the YWCA refocused its commitment to its mission of eliminating racism and empowering women through programming and advocacy, and the expanding of community relations. The organization grew its after school programs, revamped its adult programming efforts, and in 2005 established a new literacy initiative.
To American Metro
Accelera Corporation, 240 Princeton Avenue, American Metro Center, Suite 176, Hamilton 08619. 609-221-2988; fax, 609-912-0607. Home page: www.accelera.com
The pharmaceutical communications firm is expanding from 3131 Princeton Pike to American Metro Center and plans to move in by the end of July. It offers custom content for life-sciences industry to support sales training, product launches, virtual preceptorships, case-based learning, continuing medical education, and medical video production.
Mactec, 240 Princeton Avenue, Suite 238, Hamilton 08619. Deborah A. Barsotti, principal scientist. 609-936-0700; fax, 609-936-1020. Home page: www.mactec.com
Mactec, which provides environmental and consulting services to commercial, industrial, and government clients, expanded from 8,000 feet at 14 Washington Road in Princeton Junction to 12,000 square feet in American Metro Center in Hamilton. The company employs 25 consultants and continues to hire. Both phone and fax numbers have changed.
"This location at the Hamilton train station serves both our employees and our clients better by eliminating the need to travel the congested Route 1 corridor," says Deborah Barsotti, senior principal scientist and operations manager. "In addition, this is a Brownfield site, where older buildings have been renovated to provide useful service once more. As environmental consultants, that's exactly what we help our clients do."