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Thursday, February 23, 2023 8:23:52 PM
Jessica Fye
Great. Good afternoon. Thanks for taking the questions. First, can you elaborate a little bit on the studies -- the profile enhancing studies mentioned on the last slide of the deck regarding patient preference and on-body device. Just curious to learn a little more there. And then, second, following up on an earlier question about Merck’s subcu pembro that sounds like it’s using hyaluronidase as well. Can you walk through why you would not be worried about partners trying to pursue a similar approach, creating their own ENHANZE-ish products with hyaluronidase and/or whether you expect Merck to infringe any IP? Thank you.
Dr. Helen Torley
Thanks for those questions, Jess. I will begin with the profile enhancing studies and for everybody that’s on slide 18 of the deck that we showed. And I think, Jess, you particularly wanted to hear about the patient preference study on the on-body device.
These are studies that partners are doing for already commercialized or late-stage development drugs. And it’s all -- these types of studies are done to enhance the profile or provide additional information to inform patients and/or physicians with regard to how the drug can be used.
These are trials that are actually listed on clinicaltrials.gov, but we didn’t have permission from our partners to actually list them here, but you can find more about them and pretty routine and I think exciting that partners are continuing to explore and expand the profile on all drugs that are in development.
With regard to Merck, I think, the reason we are not worried about our current partners wanting to move and develop their own hyaluronidase and start incorporating that really focuses on a number of factors.
The first one is that we bring a very strong safety track record. The issue when you combine two biologics together is a worry about immunogenicity and with 600,000 patients treated, they know that, that has been a very well-characterized safety profile. First question that comes up in all of our new deal negotiations is that worry. I think that’s the first one, Jess.
We also have established a very strong relationship with all of our partners, demonstrating our expertise in development and regulatory and reliability of supply. And if you like the phrase of the aims broken, why fix it, I think, that is another reason that would not consider doing that. We obviously are very conscious about being reliable and a low-cost supplier to our partners. So then thinking about that would make no sense.
And then the third one, I think, is a little bit more strategic for the partners, and they are, as we look at our partners, many of them are more focused on developing new molecular entities to deliver new large revenue speeds rather than take the time and resources to focus on in modest reduction to what it’s costing, for example, in a royalty rate. And so for all of those factors, we think it’s highly unlikely that our partners would want to develop their own rUpH20 and with no indication there.
Corinne Jenkins
Thanks. Maybe just one last one for me. We have got a couple of product launches coming this year. How should we think about the path to co-formulation patents for those products? Is that something we can get some visibility on in the near-term?
Dr. Helen Torley
Yeah. I can say that all of our currently marketed products have received or pending patents for co-formulation patents. I can also say, Corinne, that all of our development partners are very actively engaged in a number of the ones who have got advanced- to late-stage development have already filed applications for co-formulation patents.
Specific by partner is not something we can talk about because that’s partner confidential information and I think the visibility will come as patents are issued, those become public domain, and at that point in time, you will be able to find them and we will be able to talk about them.
But our partners have been unanimous in their support or protecting their inventions and filing co-form patents, which obviously, we are very pleased about and support, because, in general, those have benefits to us in terms of the duration of time we get royalties and they can also push out the time for the spec down. So we are very -- we are aligned and our very active focus on new co-form submissions.
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