Print this article
 View as PDF
Send us your comments

Warren P. Levy, Ph.D., is the president and CEO of Unigene Laboratories, Inc.

Even in the super-fast world of business and technology, where deals are made in nanoseconds, there is nothing that brings one's world crashing to a sudden halt faster than debilitating illness. Not the kind of illness that keeps you home for a day or two. The kind that catapults you wildly into the world of doctors, hospitals, medications and thoughts of having to alter your lifestyle. And, with Baby Boomers hitting retirement age, ailments that afflict our aging population are hot properties.

Take osteoporosis, for example. Osteoporosis is a disease in which bone mass is lost and bones become fragile and more likely to break. If not prevented or if left untreated, osteoporosis can progress painlessly until a bone breaks. These broken bones, also known as fractures, occur typically in the hip, spine, and wrist. Will it kill you? Maybe not. But certainly anyone who has suffered a fracture understands why osteoporosis – which afflicts more than 10 million Americans alone – is now considered a major health concern. According to the National Osteoporosis Foundation, more than half of the population over age 50 are at risk of developing osteoporosis, and the number of Americans who have low bone mass is approaching 50 million

Warren P. Levy, Ph.D., and president and CEO of Unigene Laboratories, Inc. of Fairfield, N.J., is making sure his company not only understands the growing osteoporosis problem, but will be part of the solution. Unigene is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies, to address these unmet needs.

Early Beginnings
More than 25 years ago, in 1980, Dr. Levy was involved in the purification, sequencing and cloning of interferon while he was working at the Roche Institute of Molecular Biology (the academic unit of Hoffmann-La Roche in New Jersey) interferon was used early on as a cancer drug, and, because of its antiviral properties, is now also approved to combat certain viruses. In fact, interferon, according to Dr. Levy, was the first important biotech molecule with commercial potential.

Very few companies back then had biotechnology capabilities, but the concept was interesting to many. Therefore, Unigene became involved in doing research and selling it to larger companies. "In those early days, our first focus was on contract research. The techniques we used for interferon were unique and we thought we could build this knowledge base into a business," Dr. Levy explained.

But Big Pharma had other ideas. As the biotech sector – and its potential – grew, so did its interest in bringing capabilities inhouse. The larger pharmaceutical companies started to do more and more of their own research. Bottom line: Big Pharma decided to focus on its own research services – not buy it from small biotechs. So a few years into the business, when the technology demand began to catch up with Unigene’s foresightedness, Unigene's proprietary edge began to disappear.

The company's ingenuity, however, never faltered. The company's founders, Dr. Levy and his brother Ronald S. Levy, executive vice president of the company, focused on growing the company's unique position in the biotech market. Peptides,(small proteins consisting of two or more amino acids linked end to end) they decided, were the key to Unigene's success.

When the company went public in 1987, its main business was licensing its manufacturing technology to the large pharmaceutical firms so they could create drugs using peptides. Drugs that are created using peptides have many advantages.

At facilities in Fairfield and Boonton, N.J.,Unigene employs over 95 scientists and support staff focused on the oral and nasal delivery of large-market peptide drugs.

"Peptides are natural; they are already floating around in your bloodstream. Therefore, the side effects of medications made from peptides are less because they are natural to the body," the CEO explained.

"For a while, we tried to license the manufacturing technology for peptides, but there wasn’t much interest, because the only way to deliver them was by injection, a route of administration that is not desirable for most patients," Dr. Levy recalled. "Peptides weren’t the focus of Big Pharma. We tried to develop relationships with other companies who were interested in delivering peptides using non-injectible methods, but couldn’t find anyone who could do it."

So Unigene developed the delivery technologies itself. The Company has patented technologies that allow peptides to be used in the creation of nasally and orally delivered pharmaceuticals primarily focusing on the osteoporosis market place. It's a win-win for all involved.

"We decided that the best way to increase the demand for peptides was to improve the method of administering of peptides. We needed to get away from injections and chose nasal and oral routes which people prefer," Dr. Levy added.

Unigene has developed and patented two technology platforms that can be applied to a lot of different products. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Further, Unigene's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics.

"Unigene is unique in the marketplace. It is the only biopharma company that manufactures peptides and has the ability to orally or nasally deliver them. Our niche is peptides. The strength of the company has been validated by patents and relationships with other companies," Dr. Levy said.

In fact, Fortical, Unigene's nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical to Upsher-Smith Laboratories. Furthermore, Unigene has licensed its worldwide rights for its oral PTH technology to GlaxoSmithKline, and worldwide rights for its calcitonin manufacturing technology to Novartis Pharma AG. While Unigene understands that the growing population will be served well by its osteoporosis drug, the company isn't stopping there. Diabetes and cardiovascular disease, for example, present new therapeutic targets for Unigene and its proven peptide technologies. "For a small company to have gotten a product approved in the marketplace, that is huge," Dr. Levy said. "There are only a handful of companies in our industry that have accomplished that feat. Our nasal product has a 28 percent market share. And, our two platform technologies can be applied to dozens of other products that address almost every type of disease. This is attractive to pharma and patients. Ultimately, our goal is to improve the lives of people with chronic disease."

Doing Business in New Jersey
In the early stages of the company's development, it is always a challenge to have sufficient capital. "Although we were able to raise capital, sometimes it wasn’t on the best of terms," Dr. Levy said. "Similarly, at the early stages of having new technology, it is often hard to convince licensing partners of the viability of the technology. With the success of Fortical and our success in licensing the technologies to pharmaceutical companies, our credibility has improved. Now, there are many new opportunities we can explore that wouldn't have been available previously."

One of the things Dr. Levy is most happy with is Unigene's relationship with its advisors – lawyers, accountants and others who, together with the company's internal management team, provide for unique expertise that has guided the company through 25 years of growth and, he hopes, beyond.

Amper Politziner & Mattia, LLP is one partner, Dr. Levy said, that brings a level of knowledge to the table.

"This is not a facility that produces pencils; we produce complex products and there is a complicated production process," Dr. Levy added. "You need a background in this area to understand finances. Amper provides financial experience and substantial value to our team."

Perhaps most importantly, Unigene is treated by the Amper team as a "very important client," despite its relatively smaller size. "We have always had the sense from the organization that we are a very important client and we are treated accordingly with all the resources they have to bear – which are significant resources for a company their size," Dr. Levy concluded. "Amper's general expertise in the life science area puts them in a strong position to be able to provide consulting and financial services to companies in this industry."