In November 2007, IMS interviewed Robert Ruffolo, President Wyeth Research & Development. In the excerpt below, he discusses the impact of Wyeth's R&D productivity initiatives, the importance of vaccines and biotechnology, and the outlook for some new products…
IMS: "Your new R&D Productivity Model is now on its seventh year of implementation. In brief, what were the major changes in performance?"
Robert Ruffolo: "As a result of that model, plus other changes that we've made in R&D, we have significantly increased the output of our R&D group, not only in terms of the drugs that have been discovered and placed into development, but also their movement down the pipeline entering Phase II, Phase III, and then finally, and most importantly for us, resulting in NDA submissions."
IMS: "What are your targets?"
RR: "The targets for 2008 are the same for 2007. We've targeted 15 new molecules, plus one vaccine entering development, and we will hit that target in 2007. We're targeting 12 INDs being filed with the FDA, and we're going to hit that target as well. We're targeting three Phase III starts; that's our toughest objective and we'll hit that this year. And we're targeting two NDA submissions for 2008, and we believe we'll achieve that. We almost hit the target of two NDA submissions in 2007, but we'll miss it by one. However, in 2006 we had four NDA submissions, so we're averaging over two per year. The model is having that desired impact of allowing us to submit two NDAs per year."
"We don't look to make commodity-type vaccines"
IMS: "What's Wyeth's strategy for vaccines now that competition is set to increase?"
RR: "Well, the competition is going to increase, but so is our vaccine pipeline. Our vaccine strategy is not like that of many the other companies. We don't look to make commodity-type vaccines, so we don't make flu vaccine, for example. We're much more interested in the innovative, higher value vaccines that have a high medical need and bring very significant improvements in health. Prevnar (pneumococcal conjugate vaccine), for example, is that kind of a vaccine."
IMS: "What are your lifecycle plans for Prevnar?"
RR: "Let me break it into two categories for Prevnar lifecycle strategy. One is improving the way that the current vaccine, the 7-valent Prevnar, is provided to patients, with improved delivery systems. The other major strategy is a new vaccine that provides for even greater disease protection than Prevnar. That's really what our 13-valent pneumococcal vaccine is. It covers six additional serotypes that Prevnar doesn't cover. Of course Prevnar covers the main serotypes that are important in the US and Europe, but the 13-valent vaccine captures additional serotypes that may make it more important, not just only in Europe and the US, but other parts of the world as well."
Biotech products projected to make up 50% of Wyeth's revenue in 2010
IMS: "Wyeth is committed to become the world leader in biotechnology. What are you doing to achieve this?"
RR: "We already are a world leader in biotechnology. If you were to take all of our biotech products (we have eight of them) and spin them out as a separate company, Wyeth would currently be the third largest biotechnology company in the world. We currently have the number one or two top selling biotechnology product in the world, Enbrel, and we have the number one biotechnology vaccine in the world, Prevnar. So we are already a biotech leader.
Right now we have what is considered to be one of the top five biotech pipelines in the world, and we are one of the leading manufacturers of biotechnology protein in the world. We have one of the largest biotechnology manufacturing plants in the world, in Grange Castle, Ireland, and in fact all of this is necessary for the biotechnology pipeline that we have.
One-third of our pipeline in R&D represents biotechnology products, and so biotechnology is crucial to Wyeth, and will only become more important over time. Right now, about one-third of our revenues are derived from our biotechnology products, and that will move closer to 45% or 50% in 2010, at least those are the projections."
"We got caught up in FDA conservatism"
IMS: "Wyeth had a few FDA disappointments this year. What happened?"
RR: "First of all, people are focusing on the two FDA disappointments that we had over the summer, and they seem to forget that we had two FDA successes. We had Lybrel (levonorgestrel/ethinylestradiol) approved, the world's first continuous contraceptive that will allow women not to cycle if they choose, and we also had Torisel (temsirolimus) for renal cancer approved, which is the only drug for renal cancer currently that's been shown to increase median overall survival.
Having said that, we did have two disappointments: Pristiq (desvenlafaxine) for vasomotor symptoms associated with menopause, and bifeprunox for schizophrenia. And what happened is that we got caught up in a well-documented period of FDA conservatism. That, from my assessment, is what happened with Pristiq, as the FDA required an additional clinical trial before approval for the treatment of vasomotor symptoms."
IMS: "Research in Alzheimer's disease has been described as "a graveyard of failed drugs", and your Alzheimer's programme is described by industry analysts as "highly risky". How do you respond to that?"
RR: "Well, I just look at it differently. I view an area that is a 'graveyard' for drugs as a potential opportunity for us. That means the medical need is there, because there are no therapies. Yes, it's a risky area, and we know that. But all areas are risky right now. This is maybe a little bit riskier than most, so we're hedging our bets. We're placing more bets in this area of Alzheimer's disease to offset some of the risks.
Right now, we have 12 drugs in development for Alzheimer's disease alone - that's more than any other company in the world that I know of. Those 12 drugs are in all three of our platforms (vaccines, biotechnology and small molecules) and they're at different phases of development, from Phase 0 to nearly Phase III. We're about to enter Phase III with bapineuzumab, the monoclonal antibody that we're developing in conjunction with Elan."
IMS: "Which compound from the current pipeline are you most enthusiastic about? Why?"
RR: "Our HER2 kinase inhibitor, which we believe will soon start Phase III for breast cancer. This is an irreversible inhibitor of HER2 kinase, in contrast to Herceptin (trastuzumab), which is reversible. Based on what we've seen in our trials so far in Phase II (the proof of concept studies), there appears to be the possibility for greater efficacy, possibly because of the irreversible nature of the drug. So I'm excited about that. And I have to say that I'm also excited about bapineuzumab, the monoclonal antibody for Alzheimer's disease, the antibody that's directed against the A-beta peptide. As you pointed out, there's enormous risk with that molecule still ahead of it, but it's about to start Phase III. That therapy could be the first of its kind for such a horrible disease."
The full transcript of this interview is available in the IMS Company Profile on Wyeth, where Robert Ruffalo discusses more with IMS' editor Johanna Kleine about his company's general R&D strategy, new developments in CNS disorders and oncology, his hopes for the future of Pristiq, and Wyeth's research activities in Japan.
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