Bionorica Plans to Take the U.S. Market by Storm

My ambitious goal is to ensure that Bionorica´s medicines are established in all the most important markets of the world." Professor Michael Popp announced his mission for the company a few years ago, and in the meantime, he has made considerable progress in realizing his dream. After Bionorica´s highly successful expansion in many Eastern European countries, the latest big project is to gain a foothold in the U.S. market. But this step requires a completely new strategy. "The United States is not just another country on Bionorica´s map," says Professor Popp. "If you want to be successful in America, you have got to be very determined - and extremely creative."

American physician and pharmacist Dr. Narinder Duggal, who also teaches at the University of Washington in Seattle, agrees that the U.S. market is a challenge. He has been following the development of the U.S. pharmaceuticals market for many years now. "While Europeans and much of the world recognize that complementary and allopathic medicine must exist on an equal par to allow for a more comprehensive approach to a patient´s health, the U.S. market is clearly not as sophisticated." The fact that the last time the U.S. Food and Drug Administration approved a herbal medicine was some 45 years ago underlines his point.

According to Narinder Duggal the greatest differences are the lack of patent protection of phytotherapeutic know-how in the U.S. and the incongruity that in Europe phytotherapeutic agents must adhere to the same stringent standards as pharmaceutical agents. This is precisely what is necessary in America in order to provide assurances to physicians and patients in terms of efficacy and safety claims. "The concept in Europe, where scientific methodology and the evidence-based principles of clinical studies are applied to herbal medicines, is not known in this country." This is why there is still no company in the United States with comparable high standards for phytopharmaceuticals as Bionorica.


If Bionorica wants to market its products as dietary supplements in the United States, it faces a very difficult dilemma. "The market is flooded with inferior natural products and copycat generics that lack any kind of scientific or clinical validation," says Dr. Harel Seidenwerg, Bionorica´s CEO in North America. And Dr. Narinder Duggal adds: "The U.S. marketplace for natural products is currently like the Wild West."
But the complexity of the market is not the only problem for Bionorica. The possibilities to advertise your own products are extremely limited - even for such internationally successful and thoroughly investigated medicines like Sinupret.

For example, package labels are not permitted to make any claims about success in healing. Seidenwerg: "You are not even allowed to show a sick person with a hankerchief." The only approved indication claim is "to normalize breathing."

So are these the worst imaginable prerequisites for Bionorica to venture into the U.S. market? "Not at all," says the visionary thinker Professor Popp. "We will just have to take a different approach than in the past."

The first steps have already been initiated. For instance, the company is working on a comprehensive information campaign. "Physicians and consumers alike must be properly educated," says Narinder Duggal. "At the moment, both groups are confused."

A regular newsletter that informs patients and other interested groups about herbal medicines and is published by physicians has already proved to be a success. Seidenwerg: "The response has been extremely positive. As a result of the newsletter alone we were able to generate sales of a half a million U.S. dollars." The important task now is to establish the same reputation in the U.S. that Bionorica has achieved on a global scale.

Duggal: "Bionorica has many of the most clinically tested and validated phytopharmaceutical agents in the world today." This must be communicated to the U.S. market.




Bionorica has thus chosen a focused approach to educating the market with the help of "a very complex mix of activities," explains Seidenwerg. This includes information for consumers as well as for clinicians.

In addition, Bionorica is setting up alliances with universities and associations. Educational programs and "Bionorica Meetings" are communicating to physicians and patients what sort of substantiated safety and therapeutic efficacy they can expect from Bionorica´s products. Duggal is convinced that this education and marketing approach will be welcomed. "There is clearly a demand for effective phytopharmaceuticals." But it is important that their efficacy is substantiated by scientific data. "As a physician, I can only prescribe medicines that are the best for my patients with a good conscience."

Seidenwerg believes that the Americans who are the most open-minded about herbal medicines are the ones who live on the West coast or in New York and its surrounding areas, where there are many centers for physicians who are interested in learning more about natural medicines. Osteopaths, chiropractors and supporters of acupuncture are particularly eager to obtain more information.

The interest in phytopharmaceuticals has also increased as a consequence of recent scandals in which certain synthetic pharmaceuticals had to be withdrawn from the U.S. market. "This rocked many people´s confidence in traditional pharmaceuticals," says Seidenweg.

That is why CEO Professor Michael Popp is so confident that Bionorica will be able to establish itself as the brand which stands for the "development and production of innovative phytopharmaceuticals that lead the way in terms of quality and efficacy." He is convinced that Bionorica "is on the right path in the United States." There is no question that the U.S. market is worth the effort. According to the Nutrition Business Journal, dietary supplements generate sales of more 49 billion U.S. dollars. And herbal medicines are the fastest growing segment of the market for complementary medicine.

�This market is where Bionorica is a clear world leader, and that is validated both in terms of scientific methodology and in respect to the safety and efficacy of its products," stresses Dr. Narinder Duggal.




Bionorica spoke to American naturopathic physician Marcus
Laux about phytoneering in the United States:

Why aren´t phytopharmaceuticals so widely used in the U.S.?
Laux: Considering today´s insurance reimbursement policies, myopic doctors and endless media advertising, it isn´t surprising. Synthetic drugs are promoted as the universal curealls for everything from colds and coughs to cancer. But many people actually do desire a natural, more reliable and safer medicine.

So why aren´t more patients using them?
Laux: Because many people have lost confidence. When clinically proven natural medicine started to gain in popularity, generic versions followed quickly. Most people did not know the difference so they brought the cheaper labels. When these generics did not deliver the advertised results and quality issues started to be widely reported, people became disillusioned.

Isn´t it the responsibility of physicians to educate patients?
Laux: Most U.S. physicians are frankly just plain ignorant when it comes to phytopharmaceuticals.

That doesn´t sound very reassuring for Bionorica.
Laux: There are some advanced doctors who do understand their value. Younger physicians and pharmacists, in particular, are more willing to learn, compare and improve medicine through integration. These professionals are less prejudiced and ready to try new approaches to find out what works best for their patients.

What role do you think Bionorica could play in the U.S. market in the near future?
Laux: Bionorica excels and surpasses all U.S.-based companies with regard to its total phytopharmaceutical package. By their very nature and design, Bionorica´s products are a unique category. Therefore I believe the entering of Bionorica into the U.S. market could stimulate a thrust to develop a whole new class of effective, safe and proven natural drugs through phytoneering. This is my dream as well.

Update: 24-01-2007