Thought Leaders: Playing field in biotech/pharma partnerships levels - Pharmaceutical Executive


Thought Leaders: Playing field in biotech/pharma partnerships levels

Pharmaceutical Executive

Probably three or four years ago, I thought that the pharmaceutical companies would start to decline. They have declined faster than I thought they would. I think it has been a combination of not being able to bring new products along, and the fact that it is very difficult if you only have one or two new approvals a year.

So when I look at our industry, which I think of as biotech versus pharma, I think biotech's potential for growth is much greater than pharma's. And I think a lot of people in the biotech industry would like to build businesses that can grow in a sustained way. I don't know how many of us will succeed. But I think that is the desire and that it will change the way new products are brought to the market.

If we do a co-development deal for our first or second product, perhaps we can afford to develop the third product ourselves. I think there is at least a desire to grow companies to be like Biogen, and then Genentech—sort of growing in a stepwise fashion. I hope that we see more biotech companies succeed in that way.

Is there anything else that the pharma industry could do better, to form more fruitful partnerships with biotech companies?

Believing that people from companies outside your own could have good development ideas and good plans for moving forward is key. Some people believe they are very good at what they do, which they may well be. But that does not mean other people are not good, too.

Drakeman on Genmab What does Genmab have in the pipeline? We hope the CD4 program goes to Phase III soon. That one is really directed at an unmet medical need. It is for a form of T-cell lymphoma that appears on the skin. We were granted fast-track status from the FDA for it.

How did you get the fast track? You have to go to the FDA and demonstrate that there is what they call an "unmet medical need," which means there is not an adequate treatment—that despite what is available, patients do not have treatment alternatives. And you put together data about your product that shows it has the potential to be a new treatment. So it is a combination of your preclinical and clinical data, with what you know about the existing marketplace and what is available.

We have a fast track from FDA for our Humex CD20 antibody, also. In that case, it is for patients who have chronic lymphocytic leukemia that have failed first-line therapy, Fludarabine. There is general acceptance that patients who have failed Fludarabine do not have a treatment alternative. In the case of CTCL, the fast track is for patients who have tried everything that is on the market, and they still have active disease.


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here