Indevus Pharmaceuticals – Just The Right Medicine

If you have not heard of Indevus Pharmaceuticals Inc., you probably will soon. The relatively young publicly-traded life science company is carving out a name and a niche for itself in an industry littered with broken dreams and fallen competitors. “This industry has one of the most capital intensive business models in existence, and it has an unnatural failure rate because most drugs aren’t successful enough to pay the freight of getting them to market,” says Dr.Glenn Cooper, Chairman and CEO of Indevus.

Cooper explains that “the typical time from discovery of a molecule [with potentially therapeutic use] to marketing of a drug is roughly 10 years, and it can easily cost a company in our space $200 million just to get one drug through that pipeline.” He adds that “a team of good lawyers is critical” in navigating the regulatory and statutory framework for government approvals when moving a product from the research phase into clinical studies and then into marketing. “From the time you start working at the research bench, only one out of 10,000 molecules you look at will ever get to be a clinical phase drug, so you need experienced professional help to make it,” he says.

After years of patient work, Indevus is definitely making it now. The company, which focuses primarily on developing drugs for urological and endocrine applications, is well-positioned to serve the needs of an aging population. It has four successful drugs already penetrating the market: SANCTURA for overactive bladder; VANTAS for treatment of prostate cancer; DELATESTRYL for treatment of testosterone deficiency associated with male hypogonadism; and SUPPRELIN for treating precocious puberty.

Furthermore, some of the company’s most exciting drugs are just now emerging from the clinical and regulatory approval phases. PRO 2000, for example, is a topical microbicide for the prevention of sexually transmitted diseases, such as HIV, herpes, Chlamydia and Gonorrhea. “This drug could provide us with one of the key tools needed to break the back of the global pandemic of sexually transmitted diseases,” Cooper says. “It will give women more complete control over their reproductive health in a way that condoms alone cannot,” he adds, noting that clinical trials in Africa have been promising along with the assurance of $150 million of allocated funding from the National Institute of Health and the European Union.

Indevus is also working on postclinical trial regulatory approvals for VALSTAR, which will treat bladder cancer, a disease that will become more problematic with an aging population. It is even seeking approval of a new medical device, a ureteral stent that makes voiding easier for passing kidney stones. The stent also spontaneously dissolves within weeks after insertion, eliminating the need for surgical removal.

“We are also looking at partnerships on other products we have in clinical testing,” says Cooper. Among the drugs in test stages are ALKS 27, which is designed to treat chronic obstructive pulmonary disease, the fourth leading killer among all diseases in the United States. Indevus is also working on partnered development of Naltrexone implants for drug addiction treatment, and IP 751 for the treatment of pain and inflammation associated with interstitial cystitis, a common urological problem.

“With these drugs, we are an emerging player in the biotech sector in Boston, and we expect significant growth in the years to come,” Cooper states, noting that “we have now hit all of our goals for building out a national sales force [with 100 sales reps] handling a promising portfolio of drugs.”

Cooper says the Indevus formula for success is partly based on its “virtual laboratory” for drug development. “We winnow down the risks of development by focusing on the acquisition of drugs developed elsewhere, and often we license those products from European companies and small biotech firms in this country that want assistance in [optimizing] sales,” he explains.

“We also stay focused on a dual mission that is both economic and societal . . . [because] we’re not just making widgets,” Cooper adds. “People with an interest in medicine must get their satisfaction from victories that come incrementally over a period of years,” he says, emphasizing that patient and dedicated professional assistance is also part of the Indevus success story.

Dr. Cooper should know, having embarked on his career in pharmaceutical development only after years of study at Harvard University and Tufts School of Medicine. He also worked in internal medicine at the Beth Israel Hospital and infectious diseases at Massachusetts General Hospital before heading to Eli Lilly to do antibiotics research.

“I decided I loved the blend of science and business and the challenge of being successful at both,” he says, noting that his Lilly career culminated in his heading up all clinical research in Europe for the company. That responsibility led to higher level positions with smaller companies, including a CEO position with Progenitor, a former subsidiary to Interneuron, which was the predecessor to Indevus.

When Cooper took over in 1993 as CEO of the fledgling public company that would become Indevus, he quickly sought after a team of legal professionals that would complement and work well with the medical professionals he had in place.“Early on, I wanted to establish corporate legal relationships with the right kind of firm, and I wanted one large enough to offer all the essential services we needed but small enough to provide amazing levels of attention,” Cooper recalls, adding that Indevus “has really grown up with Burns & Levinson.”

He says “there is a nice parallel story of growth and success here,” asserting that “the relationship with our law firm has become one of our most important corporate partnerships.” Cooper credits Josef B.Volman and George N.Tobia Jr. for spearheading a legal service team that “gives us great support [and] whatever we need in finance, general corporate and SEC work, mergers and acquisitions, intellectual property protection and business litigation.”

Cooper says the law firm not only fits well with his growing company, it provides counsel and advice that is essential to modern public company survival. “As a public company in the post-Sarbanes environment, it is absolutely critical to have dedicated and highly skilled assistance with regulatory and SEC concerns to clear your pathway,” he states. “We get that from Burns & Levinson,” he says, asserting that both Indevus and its law firm are looking down the road to a very bright future.

This interview was published in the Fall 2007 issue
of our newsletter, Focus
Click here to view the entire 2007 Fall Focus