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Refractive Surgery | Oct 2010

From Humble Roots, Croma Aims High in Ophthalmology

Founded 35 years ago, the company has grown from a husband-and-wife team to a fully integrated business offering products in ophthalmology, orthopedics, and aesthetics.

Croma Pharma, GmbH, is an Austrian pharmaceutical and medical device company located in Leobendorf, with an increasingly international reach. Founded in the 1970s in the back of a pharmacy, the company has grown to include subsidiaries in several European countries and to maintain distribution throughout the continent. From its beginnings as a distributor and then as a manufacturer of an ophthalmic viscosurgical device (OVD), the company has diversified into other areas of medical and surgical ophthalmology, including recently expanding its medical device line with the purchase of two IOL manufacturers. Additionally, last year the company signed a European codistribution agreement with Bausch + Lomb (Rochester, New York) for the topical NSAID bromfenac, pending Europe-wide regulatory approval.

CRST Europe recently spoke with Andreas Prinz, Managing Director for Sales/Marketing and Business Development at Croma, and son of the company's founder and president, Gerhard Prinz, about the growth of the company and its place in the world of ophthalmology.

CRST Europe: Tell us about the history of Croma and how it came to be where it is today.

Andreas Prinz: The company was founded roughly 35 years ago by my parents, Gerhard and Karin Prinz—like any good pharma company, in the back of a pharmacy. The first 15 years or so, my father and mother ran the business by themselves. There was no real focus on any particular type of product or area of medicine; they registered, imported, and distributed a variety of pharmaceutical products in Austria. Some of the products from these times, urologic and dermatologic products, we still have in our portfolio.

Around 1990, they began to concentrate on the ophthalmic market. They in-licensed an antiglaucoma agent, and then my father began to distribute IOLs in Austria made by the German company Adatomed. That was an important development, because Adatomed was subsequently acquired by Chiron, and then Chiron by Bausch + Lomb. In those early days, the people at Adatomed asked my father if he could manufacture syringes filled with a viscoelastic product. My father is a very hands-on person, and he was not afraid to try new things. He refurbished a room in the back of his uncle's pharmacy to conform to Good Manufacturing Practices (GMP) standards, and he started to manufacture OVDs.

At that time, two directions for the company were developing simultaneously. One was distribution; we started distributing IOLs to ophthalmologists in Austria and then added other medical equipment such as lasers, suture materials, and over-the-counter and pharmaceutical products, constituting a nice portfolio in ophthalmology for the Austrian market. In parallel, we developed the contract OVD manufacturing for Adatomed. In the first year, we made approximately 10,000 syringes filled with OVD in the back of the pharmacy.

The contract manufacturing grew, and by 1994 we had to relocate the company because there were more people working for Croma in the back of the pharmacy than were working in the pharmacy itself. In 1999, we moved outside of Vienna and began manufacturing in a small building in Leobendorf. Everything was then fully automated, and we started to industrially produce viscoelastic syringes. At that same time we slowly began to develop our own products, so that we were eventually doing research and development, manufacturing, and sales of products not only in Austria but also via distributors in other countries. The next step was that we formed subsidiaries in other European countries to increase our international presence.

So, from humble beginnings, we grew into a fully integrated company, from research and development to manufacturing to sales. In 2007, we completed our full portfolio for the ophthalmic surgeon when we acquired two IOL manufacturers, the Swiss company Xcelens and the ophthalmic branch of the French company Corneal, both makers of hydrophilic acrylic IOLs. In addition to ophthalmology, we currently offer products in the fields of orthopedics and aesthetics.

CRST Europe: Are your products distributed throughout Europe at this time?

Prinz: We have sales offices in six European countries where we have direct sales forces—in total about 90 sales representatives located in Germany, Spain, France, Poland, Romania, and Austria. We use distributors in the rest of Europe, but we are now on track to grow. For the past 2 years, since we acquired Corneal, we have been occupied with integrating the two companies. Now that this process is complete, we are looking at new territories to establish additional sales offices.

CRST Europe: How difficult was the process of integrating with Corneal? Were there different corporate cultures or other issues?

Prinz: The acquisition of Corneal was an important step for us. We thought it was vital to have a complete portfolio to offer our customers, including IOLs. The integration has taken great effort in the past 2 years. We had to unify two quality control systems and computer systems, as well as repackage, rename, and rebrand products.

Actually, if one thing was easy in the acquisition, it was the corporate culture issue. Corneal was also privately owned, so the culture was quite similar. We had a lot of different understandings in many areas, but from an organizational point of view both companies had a similar hands-on philosophy.

The biggest difference had to do with quality systems and manufacturing. It was a challenging but fruitful process, because it helped us achieve what we want, which is to offer innovative products with a high level of safety and industrial manufacturing.

We actually purchased Corneal's IOL business from Allergan, Inc. (Irvine, California), which had purchased Groupe Corneal Laboratoire in early 2007. In the 6 months that Allergan owned the IOL business, they began transferring the manufacturing to a new facility in Poland. We have taken over that facility and finalized the transfer. In the past 2 years, we have had extensive movement of people back and forth from Austria to Poland. We have looked at every step in the manufacturing process and implemented GMP and pharma quality standards. You won't see the difference from the outside, because the products look the same as they did previously, but each and every part has been analyzed. It was a tremendous effort to question everything, but we had not become accustomed to the existing processes and therefore were able to look at everything with a fresh, objective eye.

CRST Europe: Last year, you signed a European codistribution deal with Bausch + Lomb for bromfenac. How will that work?

Prinz: We acquired the license for European development rights to bromfenac in 2005 from Senju Pharmaceutical Co. Ltd. (Osaka, Japan), and we have submitted the drug to the European Medicines Agency (EMEA) for centralized approval throughout Europe. For a small company like us, it was a big deal to aim for Europe-wide marketing authorization at EMEA. The fees alone are a couple of hundred thousand euros, nonrefundable. Bromfenac is a highly innovative product. As Xibrom, it is marketed by Ista Pharmaceuticals (Irvine, California) in the United States. It is expected to be the first topical NSAID approved in Europe for twice-daily dosing. It is a drug that Europe is waiting for.

Thinking about the prospect that, after EMEA approval, we would have marketing authorization for bromfenac in 27 countries, and given the differences among European countries regarding pricing, distribution, positioning, and so on, we thought it would be in the best interest of the product to find a partner. Bausch + Lomb is an ideal partner for this drug, because the company has a good growth strategy and a focus on worldwide and Europe-wide products. Croma will copromote the drug in countries where we have direct sales and, in the other countries, Bausch + Lomb will distribute the product—pending EMEA approval.

CRST Europe: We understand you are planning to start a subsidiary in the United States. Is this a good time for that undertaking?

Prinz: After submitting a centralized European distribution application at EMEA, the next challenge for us must be the US Food and Drug Administration (laughs).

Let's say we are preparing. You cannot enter the US market in 1 day; the entry barriers are quite high. We initiated the process this year, first identifying the products we want to launch in the United States, then looking at the relevant regulatory hurdles. There are many questions. But we are starting to develop European sales forces in new countries, and the United States is a potential target market.

For us it is a good time. The last 2 years we were working on the integration, and in 2010 we are again seeing good growth, double-digit percentage growth. So we have to look to our future, and that will definitely include the United States.

CRST Europe: What is Licht für die Welt (Light for the World), and why is it important to Croma?

Prinz: We have been sponsors of Licht für die Welt for many years, and as a lifetime platinum sponsor we are one of their main supporters. Licht für die Welt is part of Vision 20/20, the World Health Organization program attempting to eliminate preventable blindness. The program does two things. First, it sends surgeons to developing countries to perform surgery. Second, it provides education for the surgeons in these same underdeveloped countries. Every year, we donate a few hundred thousand euros to this organization. We also donate materials for the surgeries.

In Europe, cataract surgery is a short, safe operation. In developing countries, however, cataract surgery is not available in many situations. When someone becomes blind from cataract, children in the family are assigned to care for them, because in these countries you cannot survive if you cannot see. Someone must help you manage your life, or you die. These young caregivers are not available for schooling; they get no education, and as a result they have no future. So supporting Licht für die Welt brings a double benefit: Not only does it benefit the people who get the surgery and have their sight restored, but also kids in their families gain access to normal lives. We think this is a strong argument for supporting this program.

We are also supporters of physician education here in Austria. Soon we will be opening an education center in the city where we will conduct workshops for physicians.

CRST Europe: What can you tell us about new or forthcoming products?

Prinz: On the pharmaceutical side, we are interested in the surface of the eye. We have been working on the technology of thiomers—mucoadhesive polymers that can provide a mimicry of nature on the surface of the eye. One of the components of the tear film is the mucin layer. We have modified polymers such as hyaluronic acid so that a chemical covalent bond is formed between this mucous gel layer and the polymer. We have now finished preclinical work and are starting clinical studies of this compound.

State-of-the-art topical eye drops last 5 minutes on the eye before everything is washed out. Animal studies have shown that the retention time of our polymer on the surface of the eye is 22 hours. With a polymer that resides that long, the first indication one thinks of is dry eye, to provide a protective layer on the surface. But you might think as well, can we put a pharmacologic ingredient inside this matrix? For a lot of drugs that might have applications in ophthalmology; bioavailability is a barrier. You cannot get enough drug at the right time, in the right place, and at the right concentration. With the technology we have developed, we expect market entry in Europe in the second or third quarter of 2011. That is our main research and development project at present.

For surgical applications, we recently launched Cornea_Protect, a hydroxymethylcellulose product made to protect the corneal epithelium during cataract surgery. There are many products made to wet the corneal surface, but this is the only one made specifically for use in a surgical setting.

Regarding surgical equipment, we have a modular phaco machine in the final stages of development. In the IOL sector, there are many areas to be explored, including new optics, different optical systems, and designs for microincision surgery. I am sure all IOL companies are working on these same things, so we want to take our time. We have not recently launched any new products in the field of IOLs because we want to work on them diligently. Before we took over Corneal 2 years ago, we had no history of manufacturing IOLs. A year ago, we started a program looking at development of new implants. In the next few years, there will be important and interesting products coming out of that effort.

Andreas Prinz is the Managing Director for Sales/Marketing and Business Development at Croma Pharma, GmbH. Mr. Prinz may be reached at e-mail: Andreas.Prinz@croma.at.