Genzyme Executive VP-Legal And Corporate Development Peter Wirth: An Interview With “The Pink Sheet” DAILY (Part 3 of 3)
This article was originally published in The Pink Sheet Daily
Executive Summary
Wirth discusses personalized medicine and Genzyme’s development pipeline, including further plans for Mozobil.
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[Editor's note: Parts one and two of this interview appeared in the issues dated 1 (Also see "Genzyme Executive VP-Legal And Corporate Development Peter Wirth: An Interview With “The Pink Sheet” DAILY (Part 1 of 3)" - Pink Sheet, 8 Jun, 2007.), and 2 (Also see "Genzyme Executive VP-Legal And Corporate Development Peter Wirth: An Interview With “The Pink Sheet” DAILY (Part 2 of 3)" - Pink Sheet, 11 Jun, 2007.).] "The Pink Sheet" DAILY : Do you go into the development of a new therapy with the idea in mind of having a complementary diagnostic that can be used to target the patient populations that might best benefit? Peter Wirth: When possible, yes. We really think that the next stage of medicine will be tailoring therapeutics to really identify the people that are going to benefit, and that is a relatively long-term strategy. We've done a little bit of that with our oncology franchise and are working quite closely between [our B-cell chronic lymphocytic leukemia therapy] Campath [alemtuzumab] and the diagnostics for people who will benefit from Campath. What we've done a little bit more of is inlicensing technologies on biomarkers from various academic groups into our Genzyme Genetics group because we think that really trying to link diagnostics and therapeutics is going to allow the much more efficient delivery of health care. But we think, truthfully, that that's a very long-term proposition. That's definitely where the industry is going, but we think it'll take many years to really have a fundamental impact on how disease is treated. So, we're really positioning ourselves for a sustainable effort in that area. "The Pink Sheet" DAILY: Mozobil, the lead product you acquired with your purchase of AnorMED, is in late-stage studies for hematopoietic stem cell transplantation. Does it have other potential applications in oncology? Wirth: There's a lot more there. Mozobil interferes with a biological pathway that anchors stem cells into the bone marrow. What AnorMED did initially was develop this product to mobilize stem cells. When people are candidates for bone marrow transplant, the first thing you have to do is harvest stem cells to reconstitute the immune system, and then you give them the chemotherapy to ablate the cancer, and then you reinfuse the stem cells, and that's really the product that they've done their Phase III trials on. The other thing that people have gotten very excited about is the notion that if you can cause these cells to move from the marrow into the peripheral blood, you can also treat them more effectively with chemotherapy. That is called chemosensitization, and there's some interesting preliminary data on that application. We are in the process of designing clinical trials to more fully develop that, and if that in fact works, it would be a huge advance. That is part of the reason ... Mozobil [is not only] very interesting to our transplant group, which took the lead in the transaction, but it's also very interesting to our oncology group, and in fact, it's the reason Millennium competed for that asset, because the call point is a hematology/oncology call point, which we approach from two different directions, which they thought was also very applicable to their [multiple myeloma therapy] Velcade' s [bortezomib's] call point. [Genzyme successfully outbid Millennium Pharmaceuticals for the purchase of AnorMED and its Mozobil asset last fall, paying approximately $580 million for the Vancouver, British Columbia, company (3 (Also see "Genzyme Wins AnorMED As Millennium Backs Out Of Bidding War" - Pink Sheet, 18 Oct, 2006.)).] So, it's a very interesting molecule. It's a very interesting biological pathway, and I think it's something that we think will surprise people in its broad applicability. "The Pink Sheet" DAILY: You have a very active pipeline of late-stage work going on. Do you consider Genzyme's pipeline a good balance between new products and franchise extensions? Wirth: Yes. In fact, we've been quite lucky. We have, I think, ten trials that are pivotal trials that will produce data this year. Mozobil obviously is a new product for us. Tolevamer is a very exciting new product for us. It's really a paradigm shift in treating C. difficile with a non-antibiotic. This is a non-absorbed polymer, which absorbs the toxin that's secreted by the bug. [Genzyme anticipates results from a Phase III trial evaluating Tolevamer in the treatment of Clostridium difficile-associated colitis in the second half of this year (4 (Also see "Genzyme Tolevamer Represents New Market Opportunity" - Pink Sheet, 14 Feb, 2007.)).] Myozyme [alglucosidase alfa] is in very early launch phase, a new product for lysosomal storage diseases. [Myozyme is the first FDA-approved therapy for patients with Pompe disease. The agency approved the BLA April 28, 2006 (5 (Also see "Myozyme Is First FDA-Approved Inherited Muscle Disorder Therapy" - Pink Sheet, 1 May, 2006.)).] Campath for MS is an existing product but going into a dramatically different application in multiple sclerosis. That'll go into Phase III clinical trials this year. So, quite a lot of new franchise for us. [Genzyme anticipates moving the oncologic Campath into Phase III studies for MS during the second half of this year after addressing safety issues that arose last fall in a Phase II MS trial (6 (Also see "Genzyme Campath MS Launch Could Be Delayed Two Years" - Pink Sheet, 2 May, 2007.))] In the terms of product extensions, obviously Renvela [sevelamer carbonate] is the successor to Renagel [sevelamer], [for control of serum phosphorous in patients with chronic kidney disease] and that is being developed not only for the dialysis population but also for the people who are pre-dialysis. [Genzyme submitted the Renvela NDA in December (7 (Also see "Genzyme Will Look To Differentiate Renvela With Improved Dosing" - Pink Sheet, 21 Dec, 2006.).] And then we have Synvisc-One , which is a single injection of our Synvisc [hylan G-F 20] product [for osteoarthritis], which we think has the potential for dramatically reshaping that marketplace because it's tremendously more convenient to patients, and it offers relatively the same level of efficacy that the three-injection regime offers and much superior efficacy to the competitive products. [Genzyme bought back Synvisc rights in the U.S. from Wyeth in 2005 (8 (Also see "Genzyme Synvisc OA Therapy Boosts Margins, Holds Promise For New Claims" - Pink Sheet, 1 Mar, 2005.)] So, we're really blessed with a quite robust late-stage pipeline, which will generate clinical data this year and next and really start to impact our top-line growth toward the end of next year, starting really robustly in 2009. "The Pink Sheet" DAILY: Is MS a new area for Genzyme? What is your approach to the neurology space? Wirth: It's a new area in the sense that we don't have any existing commercial presence there. We have worked very actively in the neurology area for many, many years. We've done extensive clinical trials in Parkinson's disease. We have some gene therapy programs in that area that are ongoing. We have some cell therapy programs that unfortunately didn't work. And we're looking at the neuromuscular diseases. I mean, in a sense, Myozyme [treats] a neuromuscular disease. [Pompe disease is an inherited disorder that attacks a patient's muscle and respiratory function.] So, we have a lot of medical expertise in the area. We have a real interest in impacting the CNS, and we've been looking at various treatment modalities. Campath - the efficacy that the product has shown in the Phase II trials is just spectacular, so we really don't think that there's a choice. I mean, you have to take these kinds of therapies forward, and we're quite excited about that. But it would be a new commercial presence for us. "The Pink Sheet" DAILY: Are you exploring any new therapeutic areas or mechanisms? Wirth: We are definitely looking at things where we do not have a commercial presence or where we would like a larger commercial presence. So, for example, we started working in oncology in the mid-1990s, initially focusing on cancer gene therapy and angiogenesis inhibition. We transformed that effort with the acquisition of Ilex [Oncology], focusing much more on more traditional therapies - small molecules and monoclonal antibodies. We continue to want to have a larger presence in oncology. [Genzyme completed its acquisition of Ilex, with which it gained Campath, in the fall of 2004 (9 (Also see "Genzyme Eyeing Fourth Quarter Close For Ilex Merger" - Pink Sheet, 20 Oct, 2004.)).] We've been active in the immunology space for quite a long time. We have a presence in that space, in the transplant part of it, with Thymoglobulin [anti-thymocyte globulin [rabbit]], [for treating acute rejection in renal transplant patients]. But we'd like a larger presence, and we think that AnorMED offers us that. We have been active in the neurology space in a research sense for many years. We haven't succeeded in establishing a commercial presence in that area. So, I think the answer is yes, but as we mature as a company, we will tend more to build out capabilities that we have rather than move into new capabilities. Tolevamer is a great example. We've been developing tolevamer in the infectious disease area. That will be a paradigm shift if it's successful, and we will know that in a very short period of time. And then if that product is successful, we will have two choices. One is we can build out our own commercial infrastructure from scratch, which we've done in a number of cases. Or we can look at acquisitions of people with complementary infrastructure to accelerate our development in that space. So, we're always looking to build from something that we have, and sometimes that's a research effort. Sometimes it's a commercial presence. But it's easier to conclude that an asset in your hands is worth more than the asset in the hands of the existing owner if you have something to bring to the party. -Shirley Haley ([email protected]) |