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Seattle Genetics, Inc. (NASDAQ:SGEN)

Q3 2010 Earnings Call

November 1, 2010 5:00 PM EST

Executives

Peggy Pinkston – Director, Corporate Communications

Clay Siegall – President and CEO

Todd Simpson – CFO

Bruce Seeley – EVP, Commercial

Tom Reynolds – Chief Medical Officer

Eric Dobmeier – Chief Business Officer

Analysts

Adnan Bhat – RBC Capital Markets

Mark Monane – Needham & Company

Marko Kozul – ThinkEquity

Matt Lowe – JPMorgan

John Eckard – Leerink Swann

John Sonnier – William Blair

George Farmer – Canaccord Genuity

Brett Holley – Oppenheimer & Co.

Keay Nakae – Chardan Capital

David Miller – Biotech Stock Research

Chris Schaefer – UBS

Ling Wang – Brean Murray

Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the Seattle Genetics third quarter 2010 financial results conference call. During today’s presentation, all participants will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator Instructions).

As a reminder, today’s conference is being recorded, Monday, the 1st of November, 2010.

I’d now like to hand the conference over to Ms. Peggy Pinkston, Director of Corporate Communications. Please go ahead, ma’am.

Peggy Pinkston

Thank you, operator. I’d like to welcome all of you to the Seattle Genetics third quarter 2010 conference call. With me today are Clay Siegall, President and Chief Executive Officer; Todd Simpson, Chief Financial Officer; Eric Dobmeier, Chief Business Officer; Tom Reynolds, Chief Medical Officer; and Bruce Seeley, Executive Vice President, Commercial.

This afternoon, Clay will provide an update on our programs, including recent highlights and upcoming activities, and Todd will discuss our third quarter and year-to-date 2010 financial results. After that, we’ll open the call for your questions.

Today’s conference call will include forward-looking statements based on current expectations. Such statements are only predictions and actual results may vary materially from those projected. Please refer to the documents that we filed from time to time with the SEC and which are available on our website for information concerning the factors that could affect the company.

I’ll now turn the call over to Clay.

Clay Siegall

Thanks Peg, and thank you all for joining us this afternoon. It’s been a fantastic past couple of months for brentuximab vedotin and Seattle Genetics. The remarkable top line data we reported from both our pivotal Hodgkin lymphoma and our Phase II anaplastic large cell lymphoma trials are an important step towards our goal of bringing this promising product candidate to patients in need.

We believe the data strongly position us for a planned PLA submission in the first half of 2011. And we are executing on the initiatives necessary for a potential product launch in the second half of 2011.

We have also demonstrated substantial progress with our other programs, including encouraging early data from our ongoing SGN-75 Phase I trial and initiation of a second Phase I trial with ASG-5ME. In addition, our proprietary ADC technology is driving an increasing number of programs in clinical trials by our collaborators and we received more than $40 million under our ADC deals this year alone. We have strong positive momentum and are poised to achieve substantial milestones before the end of 2010 and throughout 2011.

This afternoon, I’ll summarize our recent progress and upcoming activities, starting with brentuximab vedotin, also known as SGN-35 or B-vedotin. This is an ADC targeting CD30, the defining marker for Hodgkin lymphoma and target also highly expressed on a number of T-cell lymphomas, including anaplastic large cell lymphoma or ALCL.

In September, we reported top line data from our pivotal trial in relapsed and refractory Hodgkin lymphoma that is being conducted under a special protocol assessment. In this trial, 75% of the 102 patients enrolled achieved an objective response based on independent central review. The median duration of response was greater than six months.

And in October, we reported top line data from another clinical trial with B-vedotin, a Phase II trial in patients with relapsed or refractory ALCL. In the Phase II study, 86% or 50 of the 58 patients enrolled achieved and objective response based on independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months.

The safety profile of B-vedotin in both of these trials was generally consistent with prior clinical trial experience.

These data confirm our high expectations for this program. Few single agents have demonstrated this level of response in a relapsed refractory cancer setting. We are particularly encouraged by these results, given that we tried a difficult patient population.

All patients in both trials had previously failed multiple lines of therapy and most had primary refractory disease, defined as patients who would either failed to respond to or who relapsed within three months of receiving frontline treatments. And in the Hodgkin trial, all patients had relapsed followed an autologous stem cell transplant.

We believe these data underscore the importance of targeting CD30 in the treatment of Hodgkin lymphoma and ALCL and providing provide validation for our proprietary ADC technology.

We’re looking forward to reporting more complete data sets from these trials in two oral sessions during the ASH Annual Meeting in December. The Hodgkin lymphoma data will be presented on Monday morning, December 6th at 7:00 AM. And the ALCL data will be presented on Tuesday morning, December 7th at 7:30 AM. The presentations will include further details on durability of response and the safety profile, as well as secondary endpoints including complete response rate and progression-free survival.

Based on the strength of the data from these two trials, we are optimistic about our regulatory path forward with B-vedotin. We plan to meet with the FDA later this year to discuss the BLA submission plan for the first half of 2011, including our goal getting approval for relapsed, refractory Hodgkin lymphoma and ALCL.

In addition, Millennium, our collaborator on the commercialization of brentuximab vedotin outside of the US and Canada intends to discuss these data with European regulators towards its goal of submitting a marketing authorization application to the European Medicines Agency in 2011.

After recent international symposium on Hodgkin lymphoma meeting in Germany, we presented clinical and preclinical data on B-vedotin in multiple poster presentations. We were gratified by the enthusiasm against Hodgkin lymphoma physicians for the potential of B-vedotin to address the unmet needs of patients, including exploration of its use in earlier lines of therapy through clinical trials.

We believe there is a substantial opportunity for B-vedotin in the treatment of relapsed refractory Hodgkin lymphoma and ALCL. B-vedotin has a potential to be the first targeted therapy approved in these indications and the first major advancement in many years for these patients. Although front line treatments for Hodgkin lymphoma results in a high percentage of durable remissions in cures, approximately 25% to 30% of patients relapse or refractory and require additional therapies following frontline treatment.

Based on a combined incidence, prevalence model, we estimate that there are approximately 8,000 to 9,000 individuals in the US, with relapsed or refractory Hodgkin lymphoma and ALCL. Another important area of clinical development for B-vedotin is in the retreatment setting.

We reported data at ASCO and at the recent international symposium on Hodgkin lymphoma demonstrating that B-vedotin induced tumor reduction in 10 out of 11 retreatment experiences, seven of which were objective responses. B-vedotin is well tolerated in the retreatment setting. We are further evaluating retreatments in our ongoing Phase II clinical trial.

Together with Millennium, we are exploring B-vedotin’s potential in earlier lines of treatment, the Phase III AETHERA trial is being conducted in post autologous transplant Hodgkin lymphoma patients who are at high risk for residual disease. This is a randomized double-blind placebo-controlled study comparing progression-free survival in approximately 325 patients.

I this trial, patients can receive B-vedotin every three weeks for up to approximately one year. In addition, we are pursuing approaches for B-vedotin and frontline lymphoma. We are currently conducting a Phase I clinical trial for the treatment of front line Hodgkin lymphoma in combination with ABBD, a standard chemotherapy regimen used in the setting. We’re also planning a frontline trial in ALCL to begin early next year.

We believe there are development opportunities for B-vedotin and other CD30 positive hematologic malignancies, such as cutaneous lymphomas, peripheral T-cell lymphomas, and subsets of B-cell lymphomas. We are planning clinical trials to evaluate these broader opportunities and believe that B-vedotin has the potential to become an important therapy for multiple types of CD30 expressing cancers.

Next in our pipeline is SGN-75, and ADC targeting CD70, which has a broad expression profile on both solid tumors and hematologic malignancies. We are conducting a Phase I dose escalation clinical trial with SGN-75 in non-Hodgkin lymphoma and renal cell carcinoma.

At the European Society for Medical Oncology meeting in October, we reported encouraging interim data. In the first 16 patients treated, SGN-75 was generally well tolerated and demonstrated antitumor activity, including two objective responses, a complete remission in mantle cell lymphoma and a partial response in renal cell cancer.

We have not reached an MTD in the study and are continuing dose escalate to further assess the safety and activity of SGN-75.

Following SGN-75 is ASG-5ME, an ADC that we are co-developing with Agensys, an affiliate of Astellas. ASG-5ME is targeted to the SLC44A4 antigen which is highly expressed on many solid tumors. We initiated the first clinical trial with this program in July. It is a Phase I study in metastatic pancreatic cancer, the fourth leading cause of cancer related death.

And last month, a second Phase I trial was initiated in advanced prostate cancer, the second most commonly diagnosed form of cancer. These single agent trials are evaluating the safety, tolerability, pharmacokinetic profile and antitumor activity of escalating doses of ASG-5ME. We are excited about the potential for this program based on the favorable expression profile of the target, encouraging preclinical data and substantial unmet medical needs in pancreatic and prostate cancers.

Our ADC collaborators have also been making progress with programs using our technology, including the three programs in our pipeline that I have mentioned, there are a total of 9 ADCs using our technology in clinical development.

During the third quarter, we achieved milestones under our ADC collaborations with Genentech, Agensys and Millennium. In addition, we expanded our ADC collaboration with Genentech, generating a $12 million upfront payment and the potential to receive over $900 million in additional fees and milestones, plus mid single digit royalties on ADC product sales.

We also recently entered into an ADC research collaboration with Genmab. Under this deal, Genmab has rights to our technology for use with an antibody that targets numerous types of solid tumors. Importantly, as part of this collaboration, we have the right to exercise a co-development option for any resulting ADC after Phase I.

Our recent ADC deals reflect our strategy to enter into ADC collaborations that include either higher financial terms or provide us with opportunities to augment, our product pipeline.

At this point, I’d like to turn the call over to Todd, to discuss our financials.

Todd Simpson

All right, thanks Clay, and thanks to everyone for joining us on the call this afternoon. We continue to be in a strong financial position as we prepare for the planned BLA submission for brentuximab vedotin in the first half of next year. Assuming a priority review by the FDA, we expect approval in the second half of 2011, and we’re building our capabilities to support that successful launch.

Today, I’ll highlight our financial results for the quarter and year-to-date, and also provide a brief update on our financial outlook for the remainder of the year. Third quarter revenues were $16 million in 2010 and $99.3 million for the year-to-date.

These are increases from $11.6 million in the third quarter of 2009 and $30.2 million for the first nine months of 2009. The increase in quarter-over-quarter revenues was driven by amounts earned under our ADC collaborations, most notably the expansion of our collaboration with Genentech.

2010 quarterly revenues also reflect amounts earned under our Millennium collaboration, but none under the dacetuzumab collaboration that ended in June. The increase in year-to-date revenues reflects approximately $70 million recorded in the first half of this year under the dacetuzumab collaboration with Genentech as we’ve discussed during our previous calls. Our ongoing revenues are driven by the brentuximab vedotin with Millennium and by our nine ADC collaborations.

Operating expenses were $51.3 million in the third quarter of 2010 and $132.6 million for the year-to-date. This compares to $32.2 million in the third quarter and $102.4 million for the year-to-date in 2009. These planned increases were primarily driven by continued investment in brentuximab vedotin to drive our clinical programs forward, manufacture drug supply, and prepare for the BLA submission. These increases were partially offset by lower clinical costs for the dacetuzumab and lintuzumab programs.

Brentuximab vedotin related activities will continue to be the primary driver of our finance results moving forward. Just as a reminder, 50% of joint brentuximab vedotin development costs are funded by Millennium under the collaboration. Development activities performed by us are charged to R&D expense as incurred. Development funding along with the upfront payment and other payments are amortized into revenue over the development period of the collaboration. Lastly, noncash share-based compensation expense for the year-to-date in 2010 was $10.1 million, compared to $8.5 million in 2009.

We ended the third quarter in a strong financial position with $315.6 million in cash and investments compared to $287.7 million at the end of 2009, an increase of approximately $28 million for the year-to-date. This increase reflects the $60 million upfront payment received in the first quarter of this year as well as reimbursement payments received under our B-vedotin collaboration with Millennium. Additionally, as Clay mentioned, more than $40 million has been received this year in upfront payments, milestones and renewal fees under our ADC deals.

I’ll close with a few comments regarding our financial outlook for the end of the year, which is positively impacted by recent ADC licensing activities. Most notably, we expanded our Genentech ADC collaboration which generated a $12 million upfront payment, a portion of which was recognized as revenue in the third quarter. As a result, we now project that revenues for 2010 will exceed the top end of our previous guidance which was $105 million. Additionally, we now expect to end to 2010 with more than $280 million in cash and investments, higher than our previous guidance and strongly positioning us as we enter 2011.

We expect that our 2011 operating expenses and cash used to fund operating activities will increase over 2010 as we initiate additional brentuximab vedotin clinical trials and continue to build our commercial infrastructure in anticipation of product launch in the second half of 2011. We remain well positioned to continue advancing our programs and look forward to providing additional updates on our progress, including giving financial guidance for 2011 during our year-end call early next year.

With that, I’ll turn the call back over to Clay.

Clay Siegall

Thanks Todd. Before we open for questions, I’ll quickly recap our key upcoming activities. For brentuximab vedotin, we will report additional data from our pivotal Hodgkin lymphoma and Phase II ALCL trials in two oral sessions at ASH.

We expect to meet with the FDA later this year to discuss our regulatory pathway towards our goal of a BLA submission in the first half of 2011 for both relapse and refractory Hodgkin lymphoma and ALCL. We’re collaborating with Millennium on as planned EU submission during 2011 and we will continue our ongoing and planned clinical development activities to evaluate additional indications for this CD30 targeting program.

For SGN-75, we’re continuing to dose escalate in the ongoing Phase I trial for CD70 positive non-Hodgkin lymphoma and renal cell carcinoma. And for ASG-5ME we and Agensys are advancing in the Phase I clinical trials for pancreatic and prostate cancer. We have an opportunity to make a meaningful impact on patients with cancer.

We are focused on our BLA submission for B-vedotin, executing on a strong commercial launch, and evaluating additional opportunities in earlier lines of therapy and other CD30 positive diseases. We are advancing a strong pipeline of clinical and preclinical ADCs and enhancing the value of our technologies through collaboration that generate milestones and future royalties or that provide opportunity to broadening our product pipeline.

We look forward to seeing you at upcoming conferences as well as the ASH Annual Meeting in December, hence keep you posted on our progress.

Operator, we’d like to open the call for questions.

Question-and-Answer Session

Operator

Yes, sir. (Operator Instructions). Our first question comes from the line of Jason Kantor with RBC Capital Markets. Please go ahead.

Adnan Bhat – RBC Capital Markets

It’s Adnan on Jason’s behalf. Thank you so much for taking our question. The first question about SGN-35, do anymore analysis or does any further trials need to be completed before you hold discussions with the FDA. And in terms of filing a BLA potentially, can you educate us will that be a combined or a separate BLA?

And then my second question is related to the pipeline. In terms of the Phase I trials that are partnered with Agensys, Astellas, do you think it’s reasonable to expect some kind of a preliminary data next year sometime?

Clay Siegall

Okay, thanks, Adnan. A lot questions here, I’m making sure I get all of them jotted down, so I can address them all. So as far as other trials needed for us to submit the BLA that we’ve been discussing, there are no other trials for submitting BLA for what we are discussing. So we feel that the trials that we have basically completed or still following will be used for submission.

Now, as far as now submission for both BLAs, it’s a company goal to submit for both. We guided to – we will be planning – that we’re planning to submit for Hodgkin lymphoma and we have not – in the first half of 2011 – and we’ve not made formal guidance on a submission for a BLA for ALCL. But we are planning to speak with the agency prior to the end of this year. And clearly, our corporate goal is to submit both, and we’d love to do that at the same time. But we’ll be able to guide on that better in the future after we’ve met with the agency.

And as far as our joint program, ASG-5ME that we are jointly working on with the Agensys unit of Astellas, I think that 2011 would be a fine year for us to perhaps present some information there. We’re excited with our trials, moving forward there, and certainly there are many different opportunities at important medical conferences in 2011 that would be prime place for us to present some of our data there from our clinical trials.

Adnan Bhat – RBC Capital Markets

Thanks Clay, and just one follow-up. In terms of your partner Takeda Millennium have they decided yet if it will be a Hodgkin submission or a ALCL or both? And then, I’ll jump back in queue. Thanks.

Clay Siegall

Yes, thanks for that question. I think that like Seattle Genetics, Millennium Takeda has been very excited about the data we have that we presented to date. And I think for them it’s also a goal to submit for both indications, but I don’t want to speak on their behalf of the exact strategy for how they’re going to do their submissions with the European regulators. But clearly just as for Seattle Genetics, we’re both excited about both the indications for Hodgkin lymphoma and ALCL an attempt to submit for both.

Adnan Bhat – RBC Capital Markets

Okay congrats, and I’ll jump back in queue. Thanks.

Operator

Thank you. Our next question comes from line of Mark Monane with Needham & Company. Please go ahead.

Mark Monane – Needham & Company

Hi, good afternoon from New York City, it’s getting mighty cool over here and time to bundle up when you go outside. Speaking of bundling, let’s talk about different kinds of payment strategies that are making their way to the marketplace into the newspaper. We recently saw some of the insurance companies paying people, physicians to think about decreasing the use of expensive off-label medications.

We know that there is some challenges on pricing pressures, we’ve seen for a number of the big pharma, as well as some of the biotech companies. So could you allow – could you step back a little bit and tell us what you hear from your market research, Bruce and the team, concerning the sensitivity for pricing and how one might think about pricing such an agent?

Clay Siegall

Yes, this is Clay. I’ll start out by discussing this a little bit and then turn it over to Bruce to see if he wants to add anything to that Mark. And thank you once again for the weather report we always look forward to that. It’s getting colder in Seattle as well I may point out, and in this time of the year wetter.

So as far as pricing goes, it’s a very important topic. And it’s a really fair game for questions and I’m glad that you brought it out. We’ve not made any pricing decisions, it’s really premature for us to discuss pricing, I know you’re not specifically asking that for right now.

But our goal as a company is to make sure that Seattle Genetics does everything possible to bring this potentially important treatment to the lymphoma patients, and our goal is to make brentuximab vedotin accessible to as many patients if not all the patients that really need this product, and pricing is definitely driven by some of the things you discussed.

The factors include our data, what that label will be, what’s the reimbursement environment, market dynamics. But in general Mark, we believe our data support that we have a very strong value proposition for patients who are in need of better therapeutic options.

And when you look at pricing into the future, I think that products that really have profound activity, at a very high response rate, are the type of products that are going to be able to command premium pricing, because they work in a predominant amount of patients and that’s really what’s important here. And based on our data, we’re very excited with the prospects of our product. And with the sheer number of patients that we can really – the percent – the high percentage of patients that we can really potentially benefit. Bruce, you would probably – some more thoughts on this.

Bruce Seeley

Yes, so Mark, I think the first thing I would say is that, we are aware of the ever-changing reimbursement environment, and that’s one of the reasons to echo what Clay is that, we’ve not made a pricing decision at this point.

The reimbursement of our continues to change and ultimately we’re going to evaluate that environment as time goes on, as we approach launch, we’re going to assess what the impact of healthcare reform is going to be, we’re going to read about and talk with folks about how that is going to impact the adoption of the product in the marketplace.

And ultimately when we’re ready to make that pricing decision, I think we’ll be very comfortable that we’ll have all the information in hand to be able to make the appropriate pricing decision.

Mark Monane – Needham & Company

That was some deep background. I know that’s the best you can do right now, I appreciate the added information. And then, in follow-up, when we think about again pricing again, but more about therapy for the patient, right now you – you’ve shown some great data with B-vedotin as a single agent. But maybe you could talk about ADCs in combination with traditional chemotherapy or maybe even other targeted therapy. Are there any sequencing issues one might consider or were there any agents that may make better conditions with B-vedotin or SGN-75 going on forward?

Clay Siegall

Yes, Mark, it’s an excellent question. I’ll turn it over to Tom Reynolds, our Chief Medical Officer, to comment on it. But we absolutely are excited about single agent, the brentuximab vedotin has a drug conjugate, et cetera, a potent molecule. But there’s also ways to use it in other settings and we are doing that. And Tom, do you want to discuss some of those?

Tom Reynolds

Hi Mark, good to hear your voice.

Mark Monane – Needham & Company

Thanks Tom.

Tom Reynolds

We’ve got quite a lot of interest from physicians and from our own researchers on how to combine brentuximab vedotin effectively in many different diseases and lines of therapy. As you’re aware we’ve got a frontline study going on in combination with ABVD, which is standard frontline therapy for Hodgkin lymphoma in this country.

We’ve also presented some preclinical data both at ASCO and more recently at Cologne showing that there is a strategy to combine this with other novel agents, especially mTOR inhibitors. So that’s something that there is a lot of interest about. And we are – have received quite a bit of input especially in the last few months from thought leaders in the area, proposing study designs and combination with other types of therapeutics, both in the salvage prior to transplant area as well as in frontline.

And a number of issues people are trying to do is, one, is improve efficacy in the refractory patients in frontline, but the second thing is really to not to over treat those patients in frontline that are getting more therapy currently than they need. And a question that’s open is for certain populations like the old patients with Hodgkin lymphoma or patients with comorbidities, whether one could drop some of the pieces of the ABVD regimen and substitute brentuximab vedotin there.

In addition, you’re aware that there’s early stage Hodgkin lymphoma when it’s diagnosed, when there is very little disease, and currently those patients get some chemotherapy and then radiation therapy. And it’s become clear that radiation therapy is in many cases a contributor to late toxicity and secondary malignancies. So we’ve clearly had interest from a number of investigators, they’re trying to substitute brentuximab vedotin for radiation therapy.

And we see all of those things that we will be exploring in the next near term, both as corporate studies as well as investigator initiated trials. So we would expect that as well as continuing to broaden out the use of brentuximab vedotin in another indications, other types of lymphoma, CTCL, PTCL, B-cell lymphomas as Clay mentioned.

Mark Monane – Needham & Company

Thanks very much for the added information, and congrats on your progress.

Tom Reynolds

Thank you.

Operator

Thank you. And our next question comes from the line of Marko Kozul with ThinkEquity. Please go ahead.

Marko Kozul – ThinkEquity

Hi, good afternoon, and congrats on the quarter. I have a related question. What do your KOLs and market research suggest would be the impact of a clean and positive Phase I brentuximab ABVD combination study in terms of advocating frontline use and then to reimbursement? And I have a quick follow-up after that.

Clay Siegall

Yes, first of all – and Marko thanks for the question – we are in a Phase I study as I’ve said, as Tom said with ABVD. And that’s not something the Phase I study on its own that we will be seeking a label for. Tom do you want to add anything to that?

Tom Reynolds

Yes, so, Marko thanks for the question. We’ve designed a fairly careful safety study to find out can you combine brentuximab vedotin with standard frontline ABVD, we’re still dose escalating and we’re looking forward to the data from that. I think your question really is if that’s – if that shows the components are combinable and that there is a possibility of enhanced efficacy over the long haul, I think we would plan on embarking on to a study to demonstrate that unequivocally so that physicians could use good information as they decide what patients might best benefit from this.

We do hear things from KOLs about adoption, but I think it’s pretty premature at this point given that we have not released any data on that study yet, and we’re looking forward to doing that, and the study is enrolling well, we’re very pleased with the progress of our investigators and the patients on the study, and we hope to share that with you in the next little while as the data mature.

Marko Kozul – ThinkEquity

Tom, thanks for the answer. The other question I had is could you describe a little bit what the frontline ALCL study that you’ve planned for 2011 might look like?

Tom Reynolds

So Marko, we haven’t disclosed a lot about that and we’re in the final refinement at that, suffice it to say that the current standard of care for ALCL upfront under the NCCN guidelines is either chopped or a multi-agent chemotherapy regimen or a clinical trial. So as you’re aware there is very few prospective studies done with ALCL alone to look for the best therapy.

What we are attempting to do with this study that we’ve planned to conduct is to try to build on the chop backbone on consider different ways in which that could be combined or sequenced with SGN-35 to really enhance the ability of those patients to undergo long term and durable remissions and/or cures. And we would expect to be able to share information with you about that in more detail early next year.

Marko Kozul – ThinkEquity

Perfect. I look forward to it. Thank you.

Operator

Thank you. And our next question comes from the line of Matt Lowe with JPMorgan.

Matt Lowe – JPMorgan

Hi, just a couple of quick questions on Cory’s behalf. I’m just wondering what CMC work is left there before you file SGN-35? And then secondly when we might hear the next update for SGN-75? Thanks very much.

Clay Siegall

Two good questions. Thanks for calling in on behalf of Cory. So as far as the CMC portion of brentuximab vedotin BLA submission that we’re working on, we think that the progress that we’ve made is very strong, we’ve done to work in the conformance area and the stability area, and also it’s a different work. We’re trying to make sure we stockpile the correct material that we could ultimately use for commercial launch. So the CMC area is certainly very busy. I don’t want to trivialize it at all there is a lot of people working on it.

We’re planning to meet with the FDA to discuss our entire package at as a pre-BLA meeting just like we are on the clinical front, we’re really working very hard, but we don’t think we’re missing anything. We don’t think that there’s anything that will prevent us from delivering a BLA submission in the earliest possible timeframe. Our guidance is the first half of 2011 and obviously we’re trying to go as fast as we can and to make it happen. And really we’re trying to do that for the patients in need. There are patients that really need this product and we’re excited to deliver this product for them.

Now the second part of your question was when possibly can we see SGN-75 – additional data on SGN-75. At the ASMO Meeting recently, we were delighted to have our very first presentation on SGN-75 and it detailed only a limited number of dose cohorts, we’ve not hit MTD on that, we’re still dose escalating. It’s in both B-cell lymphoma and renal cell cancer. And even though we’re still dose escalating, we’ve now reported on two objective responses during the process and we’re pretty excited with the product.

Yes, it’s early it’s got a long way to go. But I remember only a few years ago, when we were first presenting interim data of brentuximab vedotin with our first few responses while we were dose escalating and gave us a heads up and an inkling that this could be a really exciting product and we’ve gotten a lot further obviously on brentuximab vedotin. But with SGN-75, we’re just starting out now, but a really nice start we’re pretty darn excited about it. And I think it would be highly likely that you’ll be seeing more data at the major medical type conferences in 2011. So expect something that 2011 for sure.

Matt Lowe – JPMorgan

Okay, that’s great. Thank you.

Operator

And our next question comes from the line of Howard Liang with Leerink Swann. Please go ahead.

John Eckard – Leerink Swann

Hello, this is John Eckard in for Howard. Thank you for taking the questions. My first question was regarding – you mentioned a collection of other hematological settings that SGN-35 could potentially be used in, I was wondering off those other settings, are there any that have a higher proportion of CD30 expression or any particular attractiveness?

Clay Siegall

Sure. We’ve mentioned a lot and I can turn it over to Tom in a moment to talk about some of these. But we’re very interested in some of the other T-cell lymphoma types that do have a substantial CD30 population. There is different reports in the literature of the percentage of CD30 on these different diseases. We’re doing our own work as well with patient samples to really look at these, so I don’t want to report or refute anything in literature. Sometimes your own work is better and accurately done. But cutaneous lymphomas and PTCLs will be first off, but Tom you could comment on some other diseases as well.

Tom Reynolds

Yes, so just to put this in the context, we know that Hodgkin diseases is largely a CD30 positive disease over 95% of those patients are positive. And by definition, ALCL was CD30 positive, that’s one of the test used to make the diagnosis.

Other lymphomas have lesser percentages, but we’re impressed by the number of patients with CD30 positive CTCL. As you maybe aware we did a trial a number of years ago with the naked antibody SGN-30, and so a high proportion of responses in cutaneous lymphomas. So we think that that’s a disease worth going after where we think we’ve got proof of concept that CD30 can have a meaningful impact and so we expect to target that with brentuximab vedotin.

We’ve seen in the literature a variety of PTCL numbers in terms of fraction of percentages. We believe it’s in the double digits and we’re trying to refine that a little bit more. But we would expect to move into the clinical arena in PTCL and other of the T-cell malignancies sometime in the near future.

And then, finally, we’re not unaware that there is a variety of B-cell lymphomas with CD30 positive. There’s maybe a sign of B-cell lymphoma and a number – and a fraction of the diffused large B-cell lymphomas. The DLDCL is an interesting market, because it’s relatively large. And even if the overall percentage of CD30 positive disease is somewhat small, we think that that could be a meaningful market for us. So we do plan to attack that as well.

Clay Siegall

Lastly, I’ll add one more thing. There are some different types of solid tumors that are emerging that have some CD30 expressed on them. And we’re trying to understand that digging through and doing a lot of research to determine that and you could look at literature as well.

Like, for example, a fair amount of sarcomas like Ewing's sarcoma has CD30 positive you find that in literature. And so we’re seeing – when we look at brentuximab vedotin, we think of it as a CD30 targeted therapy. This is a type of therapy that can be used in – our vision for this is that doctors will consider and think about CD30.

And in the past, we’ve talked to doctors and they knew about CD30 is a target, but wasn’t something they thought about when they consider a patient that they may have. And they also told us especially doctors have been around a while they said it used to be that way with CD20. They never thought about CD20.

But then along comes Rituxan and doctors look for CD20 in patients, they look for opportunities to use Rituxan on patients that have CD20 related disease or an area where you can knock out CD20s expressing cells and have an impact on disease. And we think that that is where our vision is for this product is to be a product that’s not known as a Hodgkin lymphoma product or an ALCL product, it’s known as a product that could be effective for CD30 in many different disease types and stages.

And one that could be used in frontline, for late-stage patients, one that can be used for retreatment, potentially means we’re looking to make a difference in patients lives with this drug and we think we’re on to something, our first datasets are extremely strong and we’re looking forward to making this in some that can really, really help patients.

John Eckard – Leerink Swann

That’s very helpful, thank you. And then I had another follow-up question on a completely different topic. Regarding commercial supply, what would you – what are the internal plants on building commercial supply and at approximately how much in time, in months or so would you have or would you be expecting at the time of launch?

Clay Siegall

Some of that, I feel good about responding to and about how much we’ll have at the time of launch, et cetera, is really internal right now, that’s not something that I’ll exactly define. But I think that we are in great shape with how we manufacture this product. We do it with a series of contractors. We’re well positioned with contractors to make all the different parts of the product.

Like, for example, we previously decreased at the antibody is manufactured by Abbott, which has a long history of manufacturing antibodies and we do that in their facility in Worcester [ph], Massachusetts. For example, the drug-linker is manufactured by Sigma Aldrich Fine Chemicals, SAFC, and they are a very large, very strong powerful chemical manufacturing company. And because we have a synthetic product, with synthetic drug, we’re able to make our drug-linker unit all at once. That really gives us a competitive advantage in the ADC space as well, where we can make single unit and really attach it to literally any antibody. So when you look at each part and I’m not going to go through all the parts of our supply chain.

But when you look at each part, we have great partnerships with contractors, it’ being done in a very robust scale. We’re going to have plenty of material to supply the market. We’ve evaluated market opportunity, we think there’s a lot of upside in the market opportunity, and we’re going to make sure that when we manufacture and we have material on hand at product launch and pass there, that we have enough material to hit what potential could be a very important launch and a high-end launch. We’re not going to try to sell ourselves short if we do not have enough material on hand at all to cover what we need. So we’re going to really make sure that we manufacture enough to meet even a high-end demand that may occur here, because of the how remarkable our data is with this product.

John Eckard – Leerink Swann

Very helpful, thank you for taking the questions.

Operator

Thank you. And our next question comes from the line of John Sonnier with William Blair. Please go ahead.

John Sonnier – William Blair

Thanks for taking the question, and Clay, congrats on a very formative quarter for the company. I appreciated your commentary on your vision for the use of EBITDA and then a number of CD30 positive malignancies overtime, all these are potential for that. I think emerging debate is for the near-term market potential for the drug. You provided some nice granularity on what the patient population looks like for the first indication or the first likely indication. But can you give us a little bit more help what are in your opinion realistic duration of used expectations both in the first indication and in the retreatment populations? And talk a little bit more about how you guys see the patient populations for the ongoing studies? Thanks.

Clay Siegall

Okay. Let me address it one at a time. First, there is duration of use and then patient population. So maybe let me touch on duration of use and maybe I’ll turn Tom over for patient population question.

On duration of use, John, I think that will be in a much better position to discuss that after ASH. We’ve really not put out a lot of information right now on that. And we’re excited to go to ASH, we’re very excited looking forward to sharing with the – the first and foremost the doctors in the medical community at ASH.

Sorry to say that that we’re not going to ASH to present just to investors, but we really are going to share this with the medical community, that’s what that meeting is all about. I know a lot of the investment community and analyst come to ASH. But it’s actually we’ve had just a phenomenal time at going to these medical conferences and the enthusiasm that we get from the medical community is [inaudible], is really amazing.

They say we just haven’t seen responses like this with almost any therapy in the relapse, refractory setting, heck in almost any disease with cancer. So we have something really exciting here and we’re looking forward to presenting our ASH data, so I just don’t have a fully answered for you on the duration of use.

But suffice it to say that we’re not only just looking at what we’ll be using initially, but we’ve also reported on retreatment. So duration of use is a little bit of trick question and it could be used multiple times such as like Rituxan, which is not just a one duration, but often patients can get at many times. But Tom you want to touch on this or go forward.

Tom Reynolds

Yes, we’re looking forward to presenting the duration on the treatment and the durability of responses, TFS, and things like that at ASH, and hoping that you’ll be there to share that with us and to make some assessments on your own.

In terms of patient population, for the Hodgkin pivotal study it was very, very clean population. It was a 100% post ASCT, we’ll be providing a lot of information about prior therapies and how tough of a patient population this was to treat, and shell activity in.

What’s interesting is that we also ran – have been running a drug-drug interaction study and a cardiac safety study, and both of those studies have been a little bit more expensive. And by that I mean is they’ve included not only post transplant patients, but also patients that are refractory and unable to achieve a transplant patients that had progressed further than that and gotten to allotransplant and failed that. So we’ve got a continuum of patients in the Hodgkin and ALCL that range from their refractory population, all the way to patients that are very far down the therapeutic chain. And we’re collecting data about those that will help us best understand how to use the drug.

In addition, we opened those trials up to patients with any CD30 positive malignancies and so I think one of the pieces that will come out of our analysis is some really preliminary, but interesting hints of how this drug may work in another CD30 positive malignancies outside of the two core indications. So look for that coming to you in probably in 2011 at some point as we do those analysis and are able to share with you. I’m not sure I’ve exactly answered your full question about the populations. John do you want to expand on that?

John Sonnier – William Blair

No, it’s – that’s actually quite helpful. But I guess when you think about moving up the treatment paradigm even in Hodgkin lymphoma how do you guys see the patient populations there in terms of patient numbers?

Tom Reynolds

Well, I guess that’s a Bruce question.

Bruce Seeley

Yes, so the – yes, when you look at the frontline population of patients, it basically is just a straight incident population and that’s about 8,500 for HL.

John Sonnier – William Blair

In the US.

Tom Reynolds

If you – sorry – if you look at ALCL that’s somewhere to the tune of 1,500 to 2,000 incident patients.

John Sonnier – William Blair

Thank you.

Operator

Thank you. And our next question comes from the line of George Farmer with Canaccord Genuity. Please go ahead.

George Farmer – Canaccord Genuity

Hi, good afternoon. Thanks for taking my questions. Clay, can you comment again on your ALCL filing strategy? I know that wasn’t part of the SPA. And what sort of argument do you think you can make to FDA that this should be a registration trial, the Phase II that you just completed? Also, can you comment on some of the retreatment data you collected? I understand that this retreatment data has come from a larger extension trial according to clinicaltrials.gov it looks like you’re targeting a 125 patients, yet you’ve only reported on a handful since that trial officially began summer ’09. And perhaps you could comment on the pace of retreatment and what’s holding that up.

Clay Siegall

Yes, I’ll comment initially on ALCL, and then I’ll turn it over to Tom, to talk about the retreatment strategy. As far as ALCL goes, the trial that we have completed enrollment and now report a top line data on with a 86% objective response rate is the largest ALCL only trial that we’re aware of, so that’s a really good point that it’s not a small trial.

And out of the 58 patients that we enrolled in this trial, we had 50 objective response rates, so responses. And that’s a very high percentage. I would put that up there with almost any cancer drug that I can remember with that level of response rate. So when you take those into account I think that this becomes something that we’re proud to go and speak with the FDA about and then looking to ways that we can potentially move forward on this.

Almost laughable here George is, when you have a 50 out of 58 responses in a trial, if you were say to be Clay, well what if you need a 100 patients. I would come back to you and say, okay, let’s just say the next 42 patients didn’t respond, we still have a 50% response rate and it would be somewhat unprecedented in this disease, in the relapse refractory setting. So we’re at such a high response rate with albeit relatively a small number 58 patients, but it’s a – it’s the largest single ALCL trial ever put together. So we think we’re in good shape, we’re looking forward to speaking with the FDA.

Tom Reynolds

Yes, and I’ll just follow-up on that in the retreatment question. And one of the thing to remember on the ALCL study, it was – the design is identical to the Hodgkin study under the SPA’s same degree of rigor, same degree of screening, same independent review. So all the things to do to make this potentially submittable, we did those things. The really the only two differences is that, one, the disease, two, the patient numbers are a little bit lower. And as Clay says with a response rate this high, adding more patients may give us a little bit more precision, but really isn’t going to change the basic evaluation of activity of this compound.

Moving on the retreatment, you are right, clinictrials.gov does say it’s a 125 patients. That study has two pieces to it. One is an extension arm that allows patients to go longer than a year and also to rollover all the patients from our drug-drug interaction study on to that to receive a full – up to a full-year therapy after choosing. So a large number out of the 125 are actually coming from those two things and we’re targeting roughly 50 patients for a retreatment experience.

And the pace of that has been reasonably good. One has to remember that all of these patients need to come from trials have already been completed, they have to be patients that have achieved either a CR or PR, and then they have to be patients that relapsed. And since they are somewhere south of 400 patients that have ever received this drug in the world, it’s not a big pool to drawn right yet. We are seeing steady enrollment and we do expect that to accelerate over time. And we’re looking to having a large dataset there similar to what Rituxan had to have retreatment added into their label. So we’re looking forward to those data to help our physicians understand how best to use this drug.

George Farmer – Canaccord Genuity

Great, and one more question if I may, in both of the Phase II trials, were patients dosed through progression or was – were they all stopped after a finite number of cycles?

Tom Reynolds

So patients could receive drug up to a total of 16 cycles. If they had progression they then went off treatment, but we continued to follow them on study. They could also discontinue therapy for adverse events or if they chose to do something different. And so those were all potential outcomes to go off of study treatment.

George Farmer – Canaccord Genuity

Okay, thanks Tom.

Operator

Thank you. And our next question comes from the line of Brett Holley with Oppenheimer & Co. Please go ahead.

Brett Holley – Oppenheimer & Co.

Yes, thanks for taking the question. I’m just wondering if you can give us some historical perspective on why I guess the FDA was hesitant to have the ALCL trial to be a pivotal trial. I guess way [inaudible] obviously data can change a lot. But I’m just wondering what were some of the fundamental hesitations they had that you might have to come overcome with the ALCL filing?

Clay Siegall

Okay. Well, I’m going to turn this over to Tom to address. But please keep in mind that we had reported – all that was reported publicly until these data were – a grand total of seven patients that we treated with ALCL, seven. Now we had six CR as we reported, but it was a grand total of seven. Tom.

Tom Reynolds

Yes, so I think there were couple issues with ALCL and a feedback from FDA about a special protocol assessment. I think one thing they were concerned about is that if we had marginal activity like a 20% plus response rate that 55 patients might not be enough. And they were clear about that, that that was a risk and they were a little worried about that. And so they were thinking potentially a larger study might be something that would be necessary. With the response rate that we’ve observed that would only give us more precision wouldn’t really help us.

The other thing that was at the time that we were having these dialogs, they were aware that they had a submission coming for proyltrakse [ph]. The proyltrakse [ph] had shown activity in PTCL and that a component of that of our ALCL patients. And I think FDA has to be a little bit careful when they have more mature dataset coming about what they’re going to set is a bar for special protocol assessment for another compound, because they don’t know if that drug will now become the new standard of care if they give us a special protocol assessment and say we can get approval, but that other drug then gains a full approval, then we haven’t run against the comparator and it’s a challenge for them. So that was in the mix as well.

I think acknowledging that ALOS [ph] had 17 patients with ALCL and are now approved to sell drug to ALCL patients based on a response rate in the 20s with very few CRs, that may bode well for the FDA to think about this drug with the activity we’ve seen so far. And we’re looking forward to discussions with them later this year about that.

Brett Holley – Oppenheimer & Co.

Thanks, thanks a lot.

Operator

Thank you. And our next question comes from the line of Keay Nakae with Chardan Capital. Please go ahead.

Keay Nakae – Chardan Capital

Yes, thank you. Question about Millennium. You’re less precise about the timeline for their filing. I’m just wondering – and I realize you’re not calling the shorts there, but I’m wondering is there any other clinical data or data that EMEA might be looking for?

Clay Siegall

I appreciate the questions on Millennium, and perhaps Bruce you want to add to this, but what we’ve said is that we have discussed with Millennium their interest in submission in 2011. And anything pass there exactly is really not appropriate to talk much about. Bruce or Todd you want to add anything more than that Millennium has – we’ve discussed with Millennium, they’re interested or their expectations of submitting in Europe.

Tom Reynolds

Yes, this is Tom. We’ve worked really closely with Millennium to try to dovetail our submission package, so that as much as possible of what we’re preparing for the United States can be used in Europe and to do that seamlessly without a lot of duplicative work. So we’re working hard on that. And since our package it will be going in the first half of the year we expect that to be available to them.

Europe has some different things that they like, we’re aware of what we think most of those are and are trying to address those as quickly as we can. And I think from what we’ve heard from our colleagues at Millennium they are very interested in getting this in front of the European agencies as quickly as they can. So we can’t be anymore specific about guidance and timing on that. But as one of the members of the committee that oversees this joint alliance they are very motivated to do this as quickly as they can.

Bruce Seeley

The only thing I would add from a commercial perspective that we have an excellent working relationship with Millennium and I can tell you that they’re extremely eager to get the drug on the market and it’s available for patients in their territory. We don’t have a partnership in our territory. So the two territories are separate, but I can tell you that we have very good meetings with them and their energy and enthusiasm for bringing a product to market in their territory is [inaudible].

Keay Nakae – Chardan Capital

Okay. And just one last question for you, last week, another company Compugen announced that they had signed an agreement with you, you were going to take one of their new MAB targets. And just wondered if you could add anything to that since you guys did not press release. And then maybe more just a kind of a fundamental strategy question; if you have a new target that you’re going to evaluate, does it still make sense to try to do so first with an optimize, make it antibody or can you – or is that a necessary step to go forward with an ADC compound?

Clay Siegall

As far as the deal goes, Eric, do you want to take?

Eric Dobmeier

Sure. Yes, this is Eric Dobmeier. So yes, we – there was an announcement that Compugen made about a license and an option agreement we did with them recently. And it involves a very and novel target that they’ve indentified that we’re really interested in for a solid tumors.

We haven’t disclosed any specifics. It’s something that they wanted to announce in terms of I think validating their platform. It’s not something we would have announced on our own. But we do have a number of these type of efforts ongoing to look for novel targets that we can utilize with our ADC technology. So it’s not something we talk a lot about, but there’s a lot of effort going on in our research group to do these types of things.

Clay Siegall

And then the second part of your question, really, and so we have a number of targets. We have some internal targets that we were not discussing yet. We have some that we have discussed that and represented on that are novel targets that we’re working on different antibody based therapies for. Historically if you look at Seattle Genetics, we’ve taken every target that we were excited about. We’ve made an antibody out of it. We’ve assessed it as both, and make it antibody and as an antibody drug conjugate.

I think moving forward, what’s happening is our antibody drug conjugate technology and our systems for testing it and actually manufacturing even small scale and the rapid high throughput screening techniques that we’ve developed with our ADC technology have really led to some exciting early stage programs and it’s becoming harder and harder for a naked antibody to really beat our antibody drug conjugate in preclinical models. And I don’t want to rule out that we’re not going to have any other empowered naked antibodies that have a strong effect or function or things like that.

I certainly don’t want to rule that out. But we always look at the ADC of every antibody, ADC configuration of every – of any antibody that comes into our shop. And the data is often very strong and compelling for moving forward. And I think that when you look at our pipeline moving forward, you’re going to see a predominant amount of the programs and maybe all and maybe not all, but a predominant amount being ADCs, for the reason that their preclinical data packaged looked incredibly strong. And our first ADC out of the gate with our [inaudible] synthetic drug-linker units is exciting.

Keay Nakae – Chardan Capital

Okay. Well that’s great to hear. Thanks.

Operator

Thank you. And our next question comes from the line of David Miller with Biotech Stock Research. Please go ahead.

David Miller – Biotech Stock Research

Hi, good afternoon, and thanks for taking my questions. On the BLA, if we assume that the FDA is okay with you submitting for both HL and ALCL, from that point forward, what’s the rate limiting step from your side about how fast that you can get this done?

Clay Siegall

Well, David, there’s a lot of unknowns that we have. Let’s just say that we meet with the FDA and they are okay with us submitting a dual BLA for both Hodgkin lymphoma and ALCL, we don’t know if they’re going to do an ODAC panel for this. We have to go under the assumption that they will, but that’s not something they have to do.

And so, our assumption would be once we submit, and like I said, we’re planning to submit in the first half of 2011, obviously we’re trying to do it as early as possible, because we feel compel to and we’re excited to do that, we’re working hard at doing that. And we normally one would look at a six months time period from submission to really having some sort of word on that. And so –

David Miller – Biotech Stock Research

Yes, I’m talking more about from you side. What’s the rate limiting steps on after your initial FDA meeting that you’re going to have this year, your pre-BLA meeting, between that and filing the BLA, what are steps from you side? Is it you’re still correlating the manufacturing data, getting some inspections done? I mean, what’s – off the components of the BLA, what’s still left to be done?

Clay Siegall

There’s a lot of different things that still have to be put together. And there are some CMC activities that are still being completed. There are certainly – we’re still watching patients and collecting durability data. The more, the better, the longer, the better, those are all good things. I would say just standard normal things that we are trying to put together to make this a great package as soon as possible to submit to the agency. But we’re really excited about meeting them later this year.

David Miller – Biotech Stock Research

All right. There’s been quite a bit of lot in the news lately about CMS and FDA working together, kind of from an application forward. Can you talk to us about any changes, advantages, or disadvantages that you can see that this might hold for you and the [inaudible] application and launch?

Clay Siegall

Yes, David, it’s an interesting question. I really don’t have any insight into that right now. We’re constantly talking to the agency, meeting with them, and keeping our ears open. But right now I don’t have any specific insider guidance on that.

David Miller – Biotech Stock Research

Okay. And then the last one is, you mentioned in your press release that you had a milestone triggered for a new drug that Genentech has in the clinic. Can you talk a little bit about what the target for that drug is?

Clay Siegall

I really can’t. It’s really a Genentech-specific event. So we’re thrilled that Genentech is embracing our technology and using it and going toward clinic development with our technologies. We, of course, like any milestone payments, but what’s even more important than that is getting forward in developments with any products that could potentially help patients using our technology, using other company’s proprietary antibodies.

We have our own set of antibodies, but we can help patients on a much more broad scale by allowing some other companies to utilize our technology with their own antibodies, if they have a lot of IP on, that we probably we would have never worked on, because they have IP on certain antibodies and certain targets, so why not get our technology, involve with those targets that these other companies hold and try to make a difference in patient’s life. So we’re thrilled to support Genentech. But the most – the best way to get information on any product from any of our partners in this technology is really to ask them.

David Miller – Biotech Stock Research

Great, all right. Thanks for taking my questions.

Operator

Thank you. And our next question comes from the line of Chris Schaefer with UBS. Please go ahead.

Chris Schaefer – UBS

Hi, thanks for taking my question. Just going back to sort of I guess the EU question, but I guess in a little different way is, that when you designed the pivotal HL and the Phase II ALCL, did you also discuss the trial design and approval ability of these studies with the EMEA or did you strictly just get feedback from the FDA?

Tom Reynolds

So when we were designing these studies, we actually did go and meet with European authorities and outlined what our plan was for Hodgkin lymphoma for the pivotal study and especially to get consensus on the confirmatory study, the AETHERA study that’s running right now of which is a randomized placed-controlled study of brentuximab vedotin, following autologous stem cell transplant. So we’ve had substantive dialog with the EU authorities, and Millennium is now following up with that in preparation for their submission as well. So they are well aware of what we were planning and what our request was.

Chris Schaefer – UBS

Okay. So that sort of sounds like that they were okay with the way the Phase II was, but they were – it’d be more they wanted to see basically if their study be sort of performed and see the data from that prior to approving. I guess I was trying to figure out whether or not they agreed that that would potentially be an approvable trial, the Phase II trials?

Tom Reynolds

So the focus of the discussion with the EU regard to AETHERA was whether the end points were appropriate, the design of the study, the patient population as a relatively large randomized study to confirm benefits, much as the FDA was interested in knowing what the response data were before saying whether our Phase II study or pivotal studies could be approvable.

EU took the same approach and said with compelling data these are things that we can consider for approval. But with without seeing any data, it was really difficult for them to make a firm judgment. And as you’re aware they have somewhat of a different pathway in Europe, we have accelerated approval and full approval here, they have exceptional circumstances for fairly rare populations, conditional approval which is kind of like accelerated approval here, again with relatively orphan populations, and then to a full approval process.

So it’s a little apples and oranges, but suffice to say we had a very good substantive discussion with them, and then well aware of what we were doing. And we’re not aware that they have made any comments to the effect that one would need to wait for the AETHERA study, prior to seeking approval.

Chris Schaefer – UBS

Okay, thank you.

Operator

Thank you. And our next question comes from the line of Ling Wang with Brean Murray. Please go ahead.

Ling Wang – Brean Murray

Thank you for taking my questions. I was wondering whether you can provide more details on the Phase I combination trial in frontline HL patients? I guess how many dose cohorts have you done so far and when we might see some data from this trial? And then with regard to the Phase III trial in frontline study, I was wondering whether you can share with us your thoughts on trial design including the patient population or the key end points here?

Tom Reynolds

Yes, so, we haven’t disclosed the exact information about our current Phase I. When the data are more mature we’ll put that out there as soon as we can. As we said, we are still dose escalating and enrollment is proceeding well, so we’re exciting about that. And we also have not disclosed exactly what our study would be for a large Phase III in frontline Hodgkin lymphoma. We’ve had a quite a lot of dialog with key opinion leaders and with our partner. We’re actively working on that. And when the appropriate time comes we will share those that information with you all and get it out there.

Ling Wang – Brean Murray

Thank you. Just a follow-up; in the Phase I combination trial, I just want to make sure – you’re actually holding the ADVB [inaudible] and then just dose escalating SGN-35, is that right?

Tom Reynolds

That is correct.

Ling Wang – Brean Murray

All right. Thank you very much.

Operator

Thank you. And management, I have no further questions in the queue. Please continue with any further remarks.

Clay Siegall

Thank you, operator, and thanks everyone for joining us this afternoon. Have a good evening.

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