Pfizer Ahead Of Guidance In India, President Of Established Products Business Unit David Simmons Tells PharmAsia News

David Simmons, President at Pfizer's Established Products Business Unit says he is very positive about his company's deals struck earlier this year with Aurobindo and Claris. The two Indian companies will help Pfizer bulk up more than 100 oral and injectable formulations and turn the business unit cash positive in the next two to three years. Pfizer will sell the loss-of-exclusivity products through its Greenstone arm in the United States will likely launch those in Europe, Japan and a host of emerging markets. PharmAsia News' India bureau sat down with Simmons to find out more about Pfizer's pipeline and plans in India.

PharmAsia News: How is the business environment here in India for Pfizer? How do you assess the pharmaceutical industry here?

David Simmons: I really like coming to this country. It is relatively new to me. I was introduced to companies here with whom we had long-term relationships some two years ago. My first impressions are very positive dealing with companies here, and now we have Aurobindo working very closely with us in introducing products in the U.S., having licensing deals and expanding those. This work that we are doing is more than just contractual stuff and that makes me feel very optimistic and positive about the Indian pharmaceutical industry. This concept of combining the skills of Indian entrepreneurs with sales and marketing infrastructures of multinational companies can be a very powerful force (Also see "Pfizer Signs Big Bang Deal With Aurobindo For Larger Presence in Generics; Biosimilars Next ?" - Scrip, 3 Mar, 2009.).

PharmAsia News: You have spoken recently about having a presence in the loss-of-exclusivity drugs in Japan. Did you say that you will be using the Indian manufacturing plants to supply to that market?

Simmons: I do not think I said that. What I said was that we are keen on supporting the evolution of the Japanese generics market. Our partnerships are very important - not just for Japan - but it is also about many other emerging markets (PharmAsia News, Nov. 19, 2009).

PharmAsia News: How do you see the role of Aurobindo evolving so far as manufacturing goes?

Simmons: It's been a very rapid expansion so far. We started off for a few products only for the United States. But then in a few months, we expanded that to combine other geographies like Europe and emerging markets. We may look at taking that plan further into more products.

PharmAsia News: In which ways can you expand the relationships with Indian companies here?

Simmons: We assess each market were we look at commercializing off-patent products and then we evaluate the portfolios to see what therapeutic areas can be taken by the partners. We essentially go with that shopping list to our partners to build from there.

PharmAsia News: Will you still be looking at collaborating with more Indian companies?

Simmons: We chose to be with Aurobindo after scanning many companies. I think it was easily 50 companies or even more. Our eyes and ears are open to collaborate with solid partners. But I must say that the partners have a very high quality benchmark to meet. Where we see niche capabilities with interesting products we will always be seeing those. Let me [just say] that we cannot go crazy and have a million complex web of partnerships as it will get too complicated to manage. What we do want to do through partnerships is to build a very integrated relationship on the quality front and there is a lot of management that goes into all of these. So when we do partnerships or extensions, we see that those are foundational.

PharmAsia News: In the global context, there are at least two deals in the generics space - Actavis and Ratiopharm. Traditionally, Pfizer has acquired to grow. Will you bid for these companies at all ( (Also see "Pfizer On The Prowl For Generics" - Pink Sheet, 19 Mar, 2009.) )?

Simmons: I do not want to comment on specifics but I can guide you on what we do to grow. Fundamentally, we have to expand our portfolio and our initial strategy has been to build portfolios in solid oral dosage forms and hospital-based sterile injectables and these are the two strategic target areas.

Now, there are three ways in which we can expand. One, we can expand the way we have worked with Aurobindo. Two, we can make those products in our own plants as we have a lot of manufacturing plants and a number of sterile projects are running in Pfizer. And the third option is to do an acquisition.

We will therefore pursue the ones that support our strategy but then should make good financial sense. Thus far as acquisition targets have come up, compared to the return on investments and the benefits that we are getting from these types of partnerships [with Aurobindo], its not even close. I mean the amount of premium that is being paid on the acquisitions is a little bit unbelievable and difficult to understand how it makes sense. Yet, I cannot say we will never do acquisitions if there is an attractive opportunity. It will be logical to pursue it. I do not think it is about acquisitions or no acquisitions; we need to expand our portfolio.

PharmAsia News: So, are you on target for the next three years?

Simmons: The off-patent products business in 2008 for Pfizer has been shrinking. And through partnerships with Ramaprasad Reddy [Aurobindo Pharma's Chairman], we are going to turn that business into a positive growth engine. [Next year] will still have some negative growth but all this work of dossier filings and product registrations will start looking strong, and from 2011 we will grow to have enough for excess money that will get us year-on-year growth. So, given our guidance we are not just on track, we are actually a little bit ahead than that.

PharmAsia News: Biosimilars is an area being looked at by most multinational companies though there is very little visibility on how things will pan out. Will you be taking a closer look at that sector?

Simmons: My sense is that it is going to be very capital intensive and it will require development programs that will be a lot more costly than the interchangeable generics model of the past. And, because of these regulatory and financial hurdles, there are not going to be too many players that will be successful. Also, there needs to be some position in our actions on what products are going to be used. The product interchangeability will again not be driven by the trade channels, so for that we will have to look at sales and marketing infrastructure with specialists in certain therapies.

PharmAsia News: Do you have that capability now and h ow does the acquisition of Wyeth affect Pfizer's interst in pursuing biosimilars?

Simmons: We do have those capabilities. What we are modeling now are the financial implications of all this. Strategically speaking, it fits into what we are doing. We have as part of our plan, niche products which are hard-to-make products and the level of competitive intensity is less and biosimilars come in there completely.

With the acquisition of Wyeth, we now have a set of biologics that are very unique, especially in the monoclonal antibody area. We are analyzing all these issues and seeing what can be done best. We are definitely interested but we have not arrived at decisions around these (Also see "Follow-On Biologics Market Unfolding: Big Pharma Signals An Interest" - Pink Sheet, 6 Oct, 2008.).

- Vikas Dandekar ([email protected])