Like the Energizer Bunny, the state’s biotech industry just keeps going… and going… We take a look at what’s new in the most glamorous field in the life sciences.
No matter where you look, it’s hard to deny the impact that the pharmaceutical industry has on New Jersey. Sure, Big Pharma has been hammered with everything from lawsuits to takoevers, but the undustry as a whole remains strong. The staying power of pharmaceutical companies with roots in the state has emboldened scientists and researchers to establish and refine products that have made everyday maladies curable and more serious diseases manageable.
Their perseverance, and the strides made over the decades, keep scientists—and patients—hopeful for cures. Of course, that same progress keeps corporations and shareholders pushing for increased profit margins. The pharmaceutical and biotech industries are worth a reported $27 billion to the state each year, bringing tens of thousands of jobs, sprawling corporate research headquarters, and other revenue streams the state government loves.
The last few years have been eventful for the behemoths. Lawsuits over the alleged affects of some drugs, lost market share over unprotected patents, corporate buyouts, shareholder unrest, and CEO intrigue have infected just about every company here. But the turmoil can’t keep Wall Street from being bullish on the futures of the big drug firms; after all, their brightest minds continue to grind out potential answers for fighting high blood pressure, cancer, and HIV-related disease, among others.
While the big firms dominate the headlines, good or bad, there are a number of other New Jersey-based companies that have been flying beneath the radar. And it’s not just the private sector driving innovation. Government and academic forces play a big role too.
THE GOVERNMENT
The biggest news on the state level has been the creation of Innovation Zones by the state Economic Development Authority. Intended to bring business, academia, and science together in key areas of the state, the Innovation Zones in Camden, New Brunswick, and Newark will be used to encourage businesses to move closer to research facilities so that there can be a more immediate connection between the laboratory and the marketplace.
The Waterfront Technology Center in Camden, which began construction last April, is now a sparkling, 100,000-square-foot glass-and-metal facility designed for both established businesses and startup companies working in fields such as bioscience, microelectronics, and advanced materials. In North Brunswick, the 400,000-square-foot Technology Centre of New Jersey provides modern laboratory and production facilities to both new and established firms, with state-of-the-art clean rooms, wet labs, conference facilities, and more. One building at the Tech Centre known as the Commercialization Center has been expanded to 75,000 square feet, which will provide for additional wet- and dry-lab modules, as well as custom-built facilities available to larger companies. Rutgers University has leased about one-third of the Commercialization Center and will in turn lease it out to technology companies. In Newark, the EDA is working with the University Heights Science Park to develop a dry-lab center at the UHSP Complex, which will become part of the cluster that includes the New Jersey Institute of Technology, the Public Health Research Institute, and the University of Medicine and Dentistry of New Jersey.
Financial incentives that include the Business Employment Incentive Program, technology transfer tax credits, and customized training grants give businesses additional impetus to move to these zones. “The dream, five years from now, will be incredible technology neighborhoods encircling research universities in Camden, New Brunswick, and Newark,” says EDA chief executive officer Caren Franzini.
THE UNIVERSITIES
THE STEM CELL INSTITUTE OF UMDNJ AND RUTGERS
More than a year ago, the state put $8.5 million toward the funding of a stem cell research institute to be managed by UMDNJ and Rutgers. The goal is to bring in top scientists from institutions around the world to conduct biomedical research that could produce new treatments for a host of diseases and disorders. The institute will operate as a clinical unit for the treatment of patients, in close collaboration with Robert Wood Johnson University Hospital in New Brunswick and the adjoining Cancer Institute of New Jersey. They broke ground August 1 and the building should be occupied within two to three years.
The institute is being planned as an outpatient suite, but proximity to the hospital is crucial because that’s where the transplantation work will take place. The institute will be unique in combining basic stem cell biology and clinical applications, doing things like using laboratories to convert bone marrow cells into nerve cells and then taking those applications directly to patients with Parkinson’s disease, Alzheimer’s, spinal-cord injuries, and those who have suffered a stroke.
NEW JERSEY INSTITUTE OF TECHNOLOGY
NJIT, one of the top research universities in the country, does about $80 million a year in sponsored research and development, a hefty sum that comprises about one-third of the school’s operating budget. What exactly does the institute focus on in terms of the biotech industry?
“Biotech still revolves around reverse engineering and deciphers what is happening in nature,” explains Dr. Don Sebastian, senior vice president for research and development at NJIT. “So we do a lot of observation…deciphering complex interactions at the molecular level. For example, we formed a relationship with the Iowa corn promotion board to develop technologies where we would take corn sugars and transform them to feed stock and make additives that can be used in lieu of petroleum.” Based on such research, corn sugars can then be transformed for use in place of petroleum-based materials, creating a bio-renewable resource to replace billions of gallons of oil a year. With this kind of technology going on, NJIT “is like an open tool box in life sciences,” says Sebastian.
Most recently, the institute has become a player in the statewide stem cell program. The institute is working with UMDNJ, PHRI in Newark, and the Coriell Institute in Camden to develop delivery and production technologies for adult, stem cell-based therapies.
RARITAN VALLEY COMMUNITY COLLEGE AND KEAN UNIVERSITY
Raritan Valley Community College is working with Kean University in Union County to motivate more students to pursue life sciences and make it logistically easier for them to get their degrees. Jacki Belin, dean of college advancement at Raritan Valley, says, “We’ve created a partnership with Kean that allows Raritan students who graduate with an associate’s degree in biotech to seamlessly transfer to Kean’s five-year master’s program in biotechnology.” The partnership is moving ahead rapidly. “Besides the biotech partnership, students can also now get a Kean nursing degree on our campus,” she says. “Plus, we have established a health information-management degree, which we are articulating with Kean.”
PRINCETON INSTITUTE FOR THE SCIENCE AND
TECHNOLOGY OF MATERIALS
The ultimate goal of PRISM, the multidisciplinary research center established by Princeton University in November 2003, is to integrate the research and education being done at the center with industrial partners outside the university walls. More and more, PRISM is working in such fields as nanotechnology and biocompatibility—disciplines strictly associated with biotechnology. “This center previously had been focused in areas other than life sciences,” says Joe Montemarano, director for industrial liaison at Princeton. “We are now moving more into the biotech community, doing such work as taking a foreign material and introducing it into the body, but disguising it with some sort of interface so the body thinks it is, for example, natural bone.” Montemarano explains the medical value of this research: “Whether it’s a bone, a stent, or an internal monitoring device, the body usually recognizes it as foreign. Our question is, essentially, how do we fool the body in a way that will serve the body best? We are developing the processes to do that.”
Princeton’s industrial affiliates program, designed not only to transfer science and technology from the university to industry, but to get industry involved in the creation of these technologies as well, has lured such companies as Sarnoff Corp., Global Photonic Energy Corp., and Sanyo Electric Co. In addition, Princeton works with privately held biotech companies such as BioNanomatrix, which Montemarano calls “the ideal demonstration of what we are about,” explaining that they are “a drug platform company that works on the early-stage drug discovery, utilizing Princeton-licensed technology and combining that for biological detection.”
RUTGERS OFFICE OF RESEARCH AND SPONSORED PROGRAMS
At Rutgers, the Office of Research and Sponsored Programs works closely with pharmaceutical and biotech companies in the state, creating partnerships that allow the university to develop and patent products created right in its own laboratories. The ORSP brings in grant money, while the Office of Corporate Liaison and Technology Transfer handles patenting and licensing, as well as new company startups. Both are on the Rutgers campus, and both report to Dr. Mike Breton, associate vice president for research at Rutgers.
“The Bayh-Dole act of 1980 essentially gave universities the patent rights, and that’s what puts us in the business of biotech transfers,” Breton says. “The biotech industry in general is living off of that act, since they now have access to some 40 billion dollars of research being done in universities nationwide.” When combined with the federal government’s sponsorship of “blue sky” discovery research, the kind that doesn’t necessarily focus on producing practical applications, Breton says, these initiatives provide “a terrific investment for our school. Industry would not want to do it because of the financial risk involved. So it is essential that government support the research and that the university patent these things.”
So what does the office focus on these days? “One of the things we do is start companies,” Breton says. “For example, we started this company called Polymerex about five years ago, which focuses on making plastic aspirins. One of the big pushes in biotech is to make better biocompatible plastics that you can put in the body and are not toxic. We actually learned how to combine molecules from aspirin and other drugs into plastic. When they are put into the body, they break down back into the active aspirin form, so the aspirin can be concentrated in a certain area for greater potency. We are still in development with this, but it is hoped that the plastic coating will suppress inflammation of stents of the heart.”
Another one of their companies, TyRx Pharma Inc., which recently received FDA approval for a surgical mesh product for the repair of hernias and other abdominal deficiencies, makes stents out of absorbable biopolymers. “Rutgers is a big player in the stent field,” says Breton. “Our companies are small. What we do is attract venture capital, invest it into developing the drugs and reducing the risk that the potential product will fail. Think of our companies like a farm system in baseball. There are all these potential products we are working on in these companies that the bigger companies don’t want to buy right away. They want to see which ones are reducing the risk, getting through toxicity trials. Then a Pfizer or Merck might come in and buy the technology, or the company itself.”
THE COMPANIES
BARRIER THERAPEUTICS
When Belgium-born Geert Cauwenbergh decided to leave Johnson & Johnson, he saw an opportunity for the development of what had become his passion in medical discovery—dermatological products. “I knew that the dermatology drugs that could really change the way skin disease is treated would get more attention if they were developed outside the framework of a large pharmaceutical company. Many large pharmas have shown a lackluster interest in developing dermatological products. It’s just not a field where you have that many blockbuster drugs, so smaller companies are in a better position to develop them,” says Cauwenbergh.
Thus, in 2001, the Princeton-based Barrier Therapeutics was born. Barrier’s first revenue-producing product was Solage, used for the treatment of age and liver spots; Barrier acquired the product from another company and began marketing last July. Barrier now has a variety of new products in various phases of clinical trials, including Zimycan, an ointment for the treatment of diaper rash; Sebazole, a gel for the treatment of seborrheic dermatitis; Hyphanox, an oral therapeutic for yeast infections; Xolegel, a gel for the topical treatment of seborrheic dermatitis; and Liarozole, an oral therapeutic for congenital ichthyosis, also known as “fish scale disease.” Last summer, Barrier also acquired the Canadian distribution rights for Vaniqa, the only prescription product approved by Health Canada for slowing the growth of unwanted facial hair in women.
CELGENE
Summit-based Celgene, a biotech company that produces drugs for a variety of cancers and inflammatory diseases, is a hot ticket this year after making it onto the Forbes 2006 list of the 25 fastest growing technology companies in the country. According to Keith Brownlie of Ernst & Young, Celgene is the state’s largest biotech company in terms of revenue and profits; in terms of market capital, it is the fifth largest in the world. At the helm is John W. Jackson, formerly of Gemini Medical, the consulting firm Jackson founded that specialized in services and investment advice to start-up medical device and biotechnology companies.
Celgene, which specializes in treatments for incurable hematological and solid-tumor cancers, including non-Hodgkin’s lymphoma, ovarian, pancreatic and prostate cancer, currently has more than 200 ongoing clinical trials at major medical centers around the world. A new study shows that the company’s flagship drug, Thalomid, can triple the life expectancy of patients with the blood cancer multiple myeloma without their disease worsening—a great victory given that the drug, generically called thalidomide, was pulled from the market in 1961 after being linked to birth defects. Meanwhile, another major drug, Revlimid, which treats malignant blood-cell disorders, was granted approval by the FDA in December 2005. The company’s subsidiary, Celgene Cellular Therapeutics, researches stem cell therapies and provides placental stem cell banking.
CYTOGEN
The last couple of years have been very good ones for Princeton-based Cytogen, a company that acquires, develops and commercializes innovative processes that target the origins and stages of cancer progression. In 2005, Cytogen received the Frost & Sullivan Technology Innovation Award in the field of immunotherapies for prostate cancer; its CEO, Michael Becker, was also named a finalist for an Ernst & Young Entrepreneur of the Year Award for the second year in a row. This past spring, the company announced a joint venture with Dowpharma (a business unit of Dow Chemical) to develop an oncology product designed to treat prostate and other cancers.
The company’s flagship product is Quadramet, a rapid-acting, non-narcotic treatment for pain associated with cancer progression to bone, which often occurs in breast, prostate, and other cancers. Cytogen has begun an aggressive program to determine the product’s role in cancer treatment as opposed to pain management. Initial results from the study are expected this year, which could expand the market opportunity for the product.
ProstaScint, the company’s second marketed product, is a molecular imaging agent used to identify the extent and location of cancer, the first and only FDA-approved product used to target metastatic disease in prostate-cancer patients. Meanwhile, products in the pipeline include Combidex, another imaging agent being developed for use in conjunction with magnetic resonance imaging to differentiate cancerous lymph nodes from normal ones; and various therapeutics incorporating prostate-specific membrane antigen, a well-characterized target in prostate and potentially other cancers.
MATRIX LABORATORIES
Matrix Laboratories, Inc., the U.S. subsidiary of Matrix Laboratories Ltd., markets and imports active pharmaceutical ingredients, finished tablets and capsules, and fine chemicals and intermediates. This South Orange–based company works with manufacturers of prescription generic drugs as well as multi-national makers of new drugs. Matrix manufactures its products at one of six FDA-approved plants, with locations in India, South Africa, and China. Matrix is among the Top 10 Indian pharmaceutical companies and one of the largest active pharmaceutical ingredients manufacturers in the world. “New Jersey still has the largest pool of skilled industry professionals available, as we look to expand our employee base in the areas of chemistry and regulatory affairs,” says Matrix president Mark Moshier.
Moshier’s sales and management team, formerly ShorePharm LLC, is running the Matrix operation. In addition, it was recently announced that Mylan Laboratories, one of the largest makers of generic prescription drugs in the U.S., will acquire a majority ownership stake in Matrix; the deal is expected to close later this year.
MEDAREX
President and CEO Don Drakeman started Medarex in 1987 as part of a joint venture with Essex Chemical Corporation and Dartmouth College. The company’s original intent was to develop new treatments for cancer and other life-threatening diseases. But after pioneering a new technology for creating antibodies in the lab, Medarex now focuses on the development of antibody-based therapeutics. As of now, there are 33 Medarex antibodies in various stages of human clinical testing, which could then go on to be marketed as products by such huge pharmas as Eli Lilly, Amgen, Novartis, and Johnson & Johnson. “Our range of products is very wide. We have products for a variety of cancers, autoimmune, and infectious diseases,” says Drakeman, who this year won Ernst & Young’s Entrepreneur of the Year Award for New Jersey. In late 2004, Medarex formed a partnership with Bristol-Myers to develop Medarex’s leading drug, MDX-010, for the treatment of melanoma. The company has also started clinical trials for a series of products to treat autoimmune diseases and inflammatory conditions.
THE MEDICINES COMPANY
The Medicines Company came to Parsippany via Cambridge, Massachusetts, with a mission to discover drugs at other companies or academic labs and take them through the final stages of development. The company focuses on interesting products that might not generate huge revenue by large pharmaceutical-company standards, but would hold potential for a company focused on hospital pharmaceuticals. In 1997, the company acquired Angiomax, its flagship product, a blood-thinning drug that is administered to patients undergoing angioplasty. “Once we commercialized Angiomax, we needed to enhance our commercial talent in sales and marketing. That’s when we decided to move to New Jersey,” says Michael Mitchell, executive director for corporate affairs.
While Angiomax is the centerpiece of the company, it has since acquired two additional products: Clevidipine (an intravenous, fast-acting blood pressure controller, now in phase three of clinical trials) and Cangrelor, similar to Angiomax in that it keeps the blood from clotting. The company continues to pursue promising cardiology-based drugs that are used in hospitals. Notes Mitchell, “We have done clinical trials to test Angiomax in additional ways, such as for use in the emergency department and for cardiac surgery. It’s a synthetic product, an intelligently designed drug that has demonstrated improved outcomes in patients when compared to a drug like Heparin.”
OSTEOTECH
Human tissue technology is the name of the game for Eatontown-based Osteotech, a leading provider of human bone and connective tissue for transplantation. The company is also innovative in developing and marketing biologic systems for musculoskeletal surgery. Since its formation in 1986, Osteotech has become the world’s largest processor of human bone and bone connective tissue, yielding more than 2.3 million grafts for patients. The company, whose clients include the Musculoskeletal Transplant Foundation (the country’s largest tissue transplant organization), consists of two divisions, Demineralized Bone Matrix and Base Allograft Bone Tissue, which yields an array of freeze-dried, frozen, and demineralized allograft bone tissue forms that are used in spinal-fusion procedures, repair and replacement of bone loss, and more. The company also markets and distributes metal spinal implant products.
SAVIENT
An East Brunswick-based specialty pharmaceutical company involved in researching, developing and manufacturing a variety of therapeutics, Savient recently completed phase-two trials for its top product, Puricase, which is designed for patients with symptomatic gout for whom conventional therapy has been unsuccessful. Recently, the company received FDA approval for Nuflexxa, a drug used to treat osteoarthritis, produced by the company’s subsidiary, Bio-Technology General. Meanwhile, the company profits well from its marketing of drugs such as Oxandrin, an oral anabolic agent used to promote weight gain following involuntary weight loss, and Delatestryl, an injectable testosterone product used to treat men with hypogonadism (underactive testes). In 2005, the company announced plans to sell its global biologics manufacturing operations to the Swiss drug maker Ferring so it could focus on new drug development. As part of the deal, Savient and Ferring are promoting Nuflexxa in the U.S.
LIFECELL
When Paul Thomas was named LifeCell CEO in 1998, his mission was to take the then Houston-based company from an R&D house to a marketable biotech company. LifeCell, which specialized in unique tissue preservation technology, was focused on translating its research into viable commercial products. “When I knew which direction the company was going I knew it was time to relocate the company to Branchburg, for all the reasons you probably hear the other biotech firms speak of,” Thomas says. “An enormously talented pool of health and life-science-type folks—from clean-room techs all the way up to senior management—and an attractive set of incentives from the state.”
LifeCell, which also made the Forbes list of the 25 fastest-growing technology companies in 2005, has weathered the transition successfully. It has already commercialized its first clinical product, AlloDerm, which is used for abdominal wall reconstruction and breast reconstruction for mastectomy patients. Other products include GraftJacket for orthopedic surgical procedures and AlloCraft DBM for bone-grafting procedures.
Meanwhile, one of the most exciting things in the company’s pipeline is the development of a product to repair and replace a torn anterior cruciate ligament, which stabilizes the knee joint. “We have been combing our tissue matrix with a novel polymer that we licensed from MIT to create this ACL replacement product. We’ve had great success so far with animal studies and are very excited about the potential to help a lot of patients,” says Thomas. “Now, to repair ACL, you have to take a piece of tendon from somewhere else in the body. So you basically create a wound to heal a wound. This would avoid having to take a tendon from somewhere else.” Thomas’s overall company philosophy? “Our vision is to be a leader in regenerative medicine. And, as we define it, to provide products that harness the ability of the body to heal itself.”