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Novartis ophthalmic chief looks to Japan as new frontier
Getting Visudyne into the Japanese market proved to be a considerable challenge.
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Novartis Ophthalmics recently launched Visudyne in Japan, culminating a years-long uphill climb to introduce the therapy for wet age-related macular degeneration into that market without the help of a local partner.
Visudyne (verteporfin for injection) was officially launched in early May after Novartis secured an agreement for reimbursement from the Japanese government. The reimbursement was the crucial last step in its approval process. The product was approved for use in AMD with all types of subfoveal choroidal neovascularization (CNV).
For Flemming Ørnskov, MD, MBA, MPH, president and chief executive officer of Novartis Ophthalmics, the Japanese government’s decision represented a coup for the multinational company, based in Basel, Switzerland. He said many people cautioned him that breaking into that market with Visudyne would prove to be the company’s biggest challenge yet, and some even told him he was foolish not to partner with a Japanese company.
Dr. Ørnskov said he intends to follow the same model used to get Visudyne reimbursed for future projects in Japan. He said he and his team are eager to keep working with Japanese regulatory authorities via the same channels, now that they have tasted success there.
“In Japan we had to think about doing this in a very different way than we have elsewhere in the world. We had to persuade our Japanese colleagues in the eye division to approach this in a different, more aggressive way than they are used to and to think outside the box,” Dr. Ørnskov said in a recent interview with Ocular Surgery News.
Meeting the challenge
The reason for the different approach has to do with the inherently conservative nature of the Japanese Health Ministry, which has “very high and challenging standards for bringing a new product to market,” Dr. Ørnskov explained.
By international standards, the Japanese market is considered among the most challenging markets in the world, Dr. Ørnskov said. To meet the challenge, he created a task force composed of a leader from the Swiss headquarters, a group of people from other countries and a local team.
“In sum, it was about creating a small task force of people who were relatively new to the company and who didn’t know how difficult this would be, motivating them and saying: ‘Go do the impossible.’ And that’s what they did,” he said.
Novartis Ophthalmics also enlisted the help of renowned Japanese ophthalmologists to help educate health authorities about the medical needs of patients with age-related macular degeneration.
Yasuo Tano, MD, of the Osaka University Medical School in Osaka, Japan, has played an instrumental role in this endeavor. As one of the top retinal specialists in Japan, he spearheaded the 12-month clinical trial investigating Visudyne – known as the Japanese AMD Trial (JAT) — that ultimately led to its approval and reimbursement.
Dr. Tano presented the 24-month extension data at this year’s Association for Research in Vision and Ophthalmology meeting. The results confirmed “the safety and efficacy of this modality and are consistent with the efficacy observed in previous studies,” he said during his presentation.
Dr. Tano said he believes the approval of Visudyne will dramatically affect the way Japanese vitreoretinal specialists approach the treatment of CNV secondary to AMD.
“[Photodynamic therapy] is very beneficial to Asian populations. Currently, [transpupillary thermotherapy] is more heavily used in Japan than it is in the United States, but I believe this will change,” he said.
A different approach
Bringing about this shift in treatment modalities is now Novartis’ biggest challenge, according to Dr. Ørnskov. He said his focus for now is less on sales and more on education and training.
“We have had to change from a more typical pharmaceutical model of selling to more of an account management approach in order to help people get established with this new product. We have people out there, not so much selling Visudyne, but getting each new [PDT] center up and running,” he said.
Although Visudyne has already generated its share of enthusiasm worldwide, Dr. Ørnskov feels that the majority of retina specialists in Japan will be slow to accept the concept of photodynamic therapy for CNV secondary to AMD. Bringing about a general acceptance of PDT and Visudyne will require a significant amount of education, he said.
“The top retina specialists who travel the world attending meetings are certainly already very familiar with [Visudyne]. But our success in Japan will depend on our ability to penetrate the deeper layer of specialists,” he said.
Even with all the challenges, Dr. Ørnskov said his decision to tackle the Japanese market in a way that seemed to defy conventional wisdom was guided by three factors: the “clear unmet medical need” in that market, the data that supports Visudyne’s efficacy in Japanese patients and the overall market size and growth.
“There are many more retina specialists [in Japan] on a per-physician basis. We have a good product and we want to invest in this market and to continue to launch products there,” he said.
Approach for the future
Next on the horizon for Novartis Ophthalmics is getting Lucentis (ranibizumab) – an anti-vascular endothelial growth factor (VEGF) antibody that it has in-licensed from Genentech – approved and reimbursed in Japan. The company anticipates that this process could take another 2 or 3 years.
Currently, the only other product that Novartis has available in Japan is the anti-allergic product Zaditor (called Zaditen in Japan).
Asked about the continuing strategy for approaching the Japanese market, Dr. Ørnskov said the company wants to establish itself as the clear leader in retinal treatments while maintaining access to the general ophthalmologist.
“The reason for the two-pronged strategy is that by having access to the general ophthalmologists, we can talk to them about products like Zaditen but also have the opportunity to educate them on wet AMD and to get more patients referred to retina specialists,” he said.
He said he hopes Novartis Ophthalmics will be viewed as a pioneer in Japan now that it has succeeded in getting Visudyne approved and reimbursed without the help of a local partner. Ultimately, however, it will be the Japanese leaders in ophthalmology to decide if Visudyne is worth investing in.
“People are going to look to what the thought leaders are doing. It may be a slower uptake and a slower rollout than we have seen in other markets but I am pretty sure that with the right focus and collaboration with opinion leaders – like Dr. Tano – we’ll see success in Japan,” Dr. Ørnskov said.
For Your Information:
- Flemming Ørnskov, MD, MBA, MPH, can be reached at Novartis Pharma AG, Business Unit Ophthalmics, CH-4002 Basel; 41-61-697-9900; fax: 41-61-697-9501; e-mail: flemming.ornskov@pharma.novartis.com; Web site: www.novartisophthalmics.com.
- Yasuo Tano, MD, can be reached at Osaka University Medical School, Rm E7 2-2 Yamadaoka, Suita, Osaka Japan 565-0871; 81-6-6879-3451; fax: 81-6-6879-3459; e-mail: ytano@ophthal.med.osaka-u.ac.jp.