Immediately following the early FDA approval of COPIKTRA, our commercial team was mobilized the same day and began educating physicians, other healthcare professionals, and payers on the clinical benefits, safety profile, and appropriate use of COPIKTRA, and on working to secure access to therapy for patients. Very quickly following approval, COPIKTRA was added to the National Comprehensive Cancer Network clinical practice guidelines in oncology for CLL, SLL, FL, and also marginal zone lymphoma, or MZL, not in an FDA approved indication. The NCCN guidelines are the standard physician resource for determining appropriate course of treatment for patients, and we believe these updated guidelines will help to increase awareness of COPIKTRA and help healthcare providers make informed decisions for patients battling with these difficult-to-treat advanced cancers. I am very proud of our whole team in launching COPIKTRA in the U.S.
This is no small undertaking, it requires a lot of hard work, experience, persistence, and perseverance. The U.S. is clearly the most important market for us. However, we own worldwide rights for COPIKTRA, and we intend to bring COPIKTRA to those patients who could benefit in the major markets of the world. We will mainly do this through collaborating with major pharmaceutical companies in each region. In June 2018, we entered into a license agreement with Yakult Honsha to develop and commercialize COPIKTRA in Japan that carries a total deal value of up to $100 million, including a one-time upfront payment of $10 million.
In late September 2018, on the heels of the U.S. approval, we entered into a license agreement with CSPC to develop and commercialize COPIKTRA in China, Hong Kong, Macau, and Taiwan, that carries a total deal value of up to $175 million, including a one-time upfront payment of $15 million. Both agreements cover the treatment, prevention, and/or diagnosis of all oncology indications in these respective territories, each have a double-digit tiered royalty on eventual commercial sales. We are delighted to be working with both Yakult and CSPC and believe these partnerships highlight the global potential of COPIKTRA, and we welcome the growing list of strategic partners focused on bringing COPIKTRA to patients worldwide.
As we continue to execute the launch of COPIKTRA in the U.S., we'll be working collaboratively with Yakult and CSPC to rapidly advance COPIKTRA through the regulatory processes in Japan and China, and ultimately to the patients there who need it. Before I turn the call over to Joe for a commercial update, I would just like to take a moment to mention another strategic collaboration that came to fruition in late 2018. Peripheral T-cell lymphoma is an aggressive type of non-Hodgkin's lymphoma with an indication where, in the future, we are looking to expand the use of duvelisib. In November, duvelisib was selected for the Leukemia & Lymphoma Society's Therapy Acceleration Program to advance the development of this novel oral agent for treating the patients with PTCL.
The TAP program provides financial and other resources to support the development of therapies for patients with blood cancers. We plan to use the funds from the TAP program to conduct certain translational and clinical activities relating to the development of duvelisib for the treatment of PTCL. Portions of this PTCL program we conduct in collaboration with Memorial Sloan Kettering, the Dana-Farber, Washington University in St. Louis, and Stanford University. With that, I will turn the call over to Joe to provide an update on the commercialization of COPIKTRA.
Thank you, Robert. 2018 was a landmark year for Verastem Oncology with the FDA approval and subsequent launch of COPIKTRA in late September. In terms of our commercial performance, as we disclosed in our financial results press release, in 2018 since launch, we achieved $1.7 million in net product revenues. As Robert mentioned, COPIKTRA was quickly added to the NCCN guidelines following its approval. As of year-end 2018, we have secured reimbursement approval from approximately 75% of major targeted health plans, representing 240 million U.S. lives. As of yesterday, that number has increased to over 90% of health plans providing reimbursement for COPIKTRA. Even with this success, there is still much more for us to do to bring COPIKTRA to patients who could benefit.
As a quick overview of the market opportunity and treatment landscape for COPIKTRA, currently in the U.S., nearly 350,000 patients are living with CLL, SLL, or FL. Once diagnosed, the majority of patients cycle through several lines of therapy due to the chronic incurable nature of this disease. The treatment paths can differ greatly based on the individual profile, including comorbidities, potential intolerance, and non-response to available therapies such as BTKs and BCL-2 inhibitors. When patients cannot tolerate a therapy or their disease stops responding to therapy, options for treating CLL become limited. This is where COPIKTRA, and its dual inhibition of PI3K-delta and PI3K-gamma, fits into the CLL and FL treatment landscape for patients who are post two prior lines of therapies.
We believe COPIKTRA can fill that gap in therapy and provide a chemo-free oral monotherapy alternative once chemotherapy or other treatment options have failed to show additional benefit. For FL, it is important to remember that COPIKTRA was approved on an accelerated basis. We believe this reflects the unmet medical need for patients with relapsed or refractory FL. We are excited to be initiating our education and marketing campaign this quarter with physicians around the benefits and safety profile of using COPIKTRA to treat appropriate FL patients. A key benefit of COPIKTRA for all potential patients is that it is an oral monotherapy that can be taken at home twice daily.
This may be especially advantageous for patients with ambulatory limitations or for patients who live a long way from their doctor's office, infusion center, or tertiary care hospital. The goal of COPIKTRA treatment is for patients to be able to take advantage of an at-home disease management under the guidance of their physician, and to assist those patients in maintaining their lifestyle, family life, standard of living, and productivity. A large part of our commercial efforts to date have revolved around educating physicians about Verastem Oncology, the need for PI3K as a patient option, and the COPIKTRA information. We have been working hard to help physicians overcome some of the negative perceptions that have been created by prior drugs in the class, while being upfront about our safety profile and risk management for the USPI.
Overall, the poor perception of previous PI3Ks and physicians' lack of clinical experience using COPIKTRA have been headwinds. This lack of experience and misperceptions are something that we believe we can overcome with our educational efforts aimed at physicians and other healthcare professionals by helping them understand the COPIKTRA data and the patients who could benefit from COPIKTRA, as well as the management of patients being treated with COPIKTRA. It's still early days in both the overall launch and in 2019. We're receiving positive feedback from the physicians who are prescribing COPIKTRA, including their support for new treatment alternatives, how PI3K is an important mechanism, and the importance of new mechanisms of action for patients who are intolerant to other classes, have comorbidities, or have failed previous regimens.
For CLL, SLL, and FL, we estimate that patient population in need of a new option is approximately 20,000 patients per year. As we projected, it will take time to educate the medical community and have the physician begin prescribing. The natural evolution of a product launch is rarely linear. Instead, it tends to grow as physicians gain experience with the product. We fiercely believe in the importance of COPIKTRA for patients, and our whole team is diligently working to educate healthcare professionals and drive adoption of COPIKTRA. Next, I'll provide a quick summary of our ongoing marketing activities. In 2018, from May to mid-September, we rapidly built the team and the infrastructure needed to deliver on the promise of a novel agent, COPIKTRA.
Our dedicated and experienced sales group of 50 sales representatives were in place prior to launch, and today they continue to be actively supporting healthcare providers and their patients. We established a distribution network and successfully shipped drug on the day we received COPIKTRA's approval in September. We have an exceptional team with extensive experience in launching new drugs, and importantly, in recognizing and understanding the needs that exist for physicians and patients. Our goal is to not only educate, but to support physicians and their patients to confidently manage their disease so that patients can focus on living their lives. In summary, we expect the COPIKTRA launch to be a steady build throughout 2019. To date, the U.S. commercial, medical affairs, and access teams have done a great job establishing appropriate payer, patient advocacy, physician, KOL, nurse, and physician practice relationships.
This, of course, is the relation to the opportunity and a base to grow from in the months ahead. As we continue further into 2019, we are focused on further increasing the number of doctors using COPIKTRA and continuing to work with the leukemia and lymphoma communities to increase awareness and help ensure patients are able to get the treatment and support they need. With that, I'll turn it over to Dan.
Thanks, Joe. Today, we're focused in the near term on the ongoing commercial launch of COPIKTRA in the relapsed refractory setting for patients with CLL, SLL, or FL that have had at least two prior therapies. We're also excited about the significant growth potential of COPIKTRA in other hematologic malignancies and potentially solid tumors in the mid and longer term. The composition of matter for COPIKTRA expires in 2030 before any extensions, so we have time to explore the potential to help patients with other tumors. Our strategy is to first expand the use of COPIKTRA into additional lines of therapy in CLL, SLL, and FL, both as a monotherapy and in combinations, and then into other lymphoid malignancies such as PTCL, an aggressive type of non-Hodgkin's lymphoma.
We see potential for expansion of COPIKTRA to help patients with other aggressive non-Hodgkin's lymphomas, such as diffuse large B-cell lymphoma, marginal zone lymphoma, cutaneous T-cell lymphoma, mantle cell lymphoma, Richter's transformation, and transformed FL. These are all indications where combinations with novel and standard of care agents could really make a difference. Beyond that, we see potential for COPIKTRA in combination with other immunotherapies and CAR T, both in hematologic malignancies and possibly certain solid tumors. This is our vision for the potential for COPIKTRA. I'd like to update you on where we are today with these development programs, both with our company-initiated studies and also with investigator-sponsored studies. Last week, at the 23rd Annual International Congress on Hematologic Malignancies, four abstracts were presented which continue to support the use of COPIKTRA in CLL, SLL, and FL.
A key abstract at the meeting highlighted data from the phase III DUO study evaluating COPIKTRA compared to ofatumumab in patients with relapsed or refractory CLL/SLL after at least two prior therapies. This is the labeled indication for which COPIKTRA received approval in September of 2018. In this analysis, COPIKTRA demonstrated progression-free survival of 16.4 months compared to a PFS of 9.1 months for patients treated with ofatumumab. COPIKTRA also demonstrated an overall response rate of 78% compared to 39% for patients treated with ofatumumab. The other three COPIKTRA posters from the ICHM featured long-term efficacy and safety data from patients treated with COPIKTRA. One abstract described pooled long-term efficacy and safety analysis of four studies evaluating COPIKTRA in patients with relapsed to refractory CLL/SLL that had been on therapy for greater than two years.
The main finding was that this subset of patients who had received duvelisib monotherapy achieved an overall response rate of 89% with a median PFS of 40 months and observed side effects that were consistent with previously described treatment-related events for COPIKTRA. The investigators were able to manage most adverse events through dose reductions and dosing holds, allowing these patients to continue treatment. In an abstract on the DUO crossover study, the 90 patients who crossed over to duvelisib once they had progressed following treatment with ofatumumab, achieved an overall response rate of 77% with a median PFS of 15.2 months. This result was consistent with the strong activity of duvelisib in the parent DUO study and showed that most patients who had failed an additional line of therapy continued to benefit from duvelisib therapy. Some other important data presented in 2018.
At ASH in December, data were presented from an investigator-sponsored phase I trial investigating duvelisib in combination with romidepsin in patients with relapsed refractory T-cell lymphoma, including PTCL and cutaneous T-cell lymphoma. Of the 27 patients with PTCL, the overall response rate was 59%, including 22% who responded deeply enough to allow them to bridge to potentially curative stem cell transplant. The median PFS for patients with PTCL was 6.72 months. However, this was confounded by the six subjects who then proceeded to stem cell transplant. We plan to use funds awarded to us from the LLS TAP program to expand this study and enroll a total of approximately 50 patients.
Then in mid-2018 at the European Hematologic Association annual meeting, data were presented from an investigator-sponsored phase I-B/II trial investigating duvelisib in combination with fludarabine, cyclophosphamide, and rituximab, commonly referred to as FCR, as a frontline therapy in younger patients with CLL. The overall response rate in this study was 94%, with 52% of the patients achieving a complete response or a complete response with incomplete hematologic recovery. Importantly, the MRD negativity rate in response to treatment was 76% in this study. The two-year progression-free survival and overall survival rates for patients in the study were both 97%. These early data demonstrate duvelisib's potential combinability with chemotherapy and potential use in a frontline setting.
The most common adverse reactions occurred in 20% or more patients across these studies were consistent with the COPIKTRA label and included diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. Before I turn the call over to Rob for the financials, I would like to just mention two additional studies that are currently ongoing and worth watching. First is the company-sponsored PRIMO study, an open-label, multi-center, phase II clinical trial evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed to refractory PTCL. This is an important study because it potentially allows us to file for accelerated approval for PTCL if the trial is successful. The other ongoing trial is an investigator-sponsored phase I/II study evaluating duvelisib in combination with venetoclax, an oral selective inhibitor of BCL-2 in patients with relapsed or refractory CLL/SLL.
The primary objectives of the phase I portion of this trial are to determine the maximum tolerated dose and the recommended phase II dose of venetoclax for this combination regimen. This is an important proof of concept study to validate the preclinical synergy that we have seen, to show that venetoclax and duvelisib can be combined, and to potentially broaden the utility of duvelisib into some higher-risk patient populations. We're committed to exploring the use of duvelisib in multiple indications and settings. Long term, we see significant potential to create many new and exciting options for patient care based on the mechanism of action of COPIKTRA, which includes effects on PI3K-delta and PI3K-gamma inhibition on both the tumor directly and the tumor microenvironment.
Our approach is to follow the science and the unique mechanism of COPIKTRA to support the future development of oral agent as both a monotherapy and in combination with both targeted and immuno-oncology agents in a broad range of hematologic and solid tumors. We believe there are many more opportunities to be unlocked. I'll now turn the call over to Rob for financials. Rob?
Thank you, Dan. Since we issued a press release earlier today outlining our fourth quarter and full year 2018 financial results, I'll just review the highlights, beginning with our cash position, then the full year 2018 results. As of December 31st, 2018, Verastem Oncology had cash and investments of $249.7 million, compared to $86.7 million of cash and investments as of December 31st, 2017. Net product revenue for the full year 2018 was $1.7 million compared to zero product revenue for the full year 2017. As a reminder, we recognize product revenue when product arrives at our specialty distributor or specialty pharmacy network from our 3PL. License revenue for the full year 2018 was $25 million and was related to the license agreements with Yakult and CSPC. Research and development expense for the full year 2018 was $43.6 million compared to $46.4 million for the full year 2017.
The $2.8 million decrease was primarily related to a decrease of $6 million in license fees related to a one-time milestone payment pursuant to the Infinity license agreement that was recognized in 2017, and a decrease of approximately $3 million in consulting fees, partially offset by increases of $4 million in personnel-related costs and approximately $2 million in CRO expense. Selling, general, and administrative expense for the full year 2018 was $77.3 million compared to $21.4 million for the full year 2017. The increase of $55.9 million resulted from an increase in personnel-related costs of approximately $27 million related to the hiring and staffing of our sales team, as well as an increase in consulting and professional fees of $24 million related to the support of the commercial launch.
Net loss for the full year 2018 was $72.4 million or $1.12 per share, compared to a net loss of $67.8 million or $1.76 per share for the full year 2017. Before I turn the call over to Robert for closing remarks, I'd like to highlight one other recent transaction that underscores the value of COPIKTRA. Last week, Infinity Pharmaceuticals announced that they had monetized their royalty rights to COPIKTRA to HealthCare Royalty Partners for $30 million upfront and up to an additional $20 million in sales milestones. I'd like to remind everyone that we are obligated to pay Infinity a tiered royalty on sales of COPIKTRA ranging from mid-single to high single digits. This was the portion of the royalty that was sold, and I highlight this point because it represents a small part of the overall product as a whole.
It did not include the additional royalty that the company is obligated to pay to Infinity that is owed to Mundipharma and Purdue Pharma. I will turn the call back to Robert for closing remarks and to open the call for questions.
Thanks, Rob. Looking ahead, 2019 is poised to be an exciting year as we continue to drive awareness and adoption of COPIKTRA and work to expand upon the potential of PI3K inhibition through the investigation of duvelisib as both a monotherapy and in combinations in additional hematologic cancers like PTCL. Our focus for the coming year is to execute on our core business priorities with the goal of bringing COPIKTRA to patients who can benefit to increase the company's revenues and to grow shareholder value. Our priorities include, one, continuing to expand on the commercial traction of COPIKTRA in CLL, SLL, and FL for appropriate patients. Two, initiating a confirmatory phase III study evaluating duvelisib for the treatment of patients with relapsed or refractory FL after at least two prior systemic therapies. The confirmatory study is expected to start in 2019.
Supporting additional investigational studies of duvelisib both through company and investigator-sponsored studies. Four, working with Yakult, CSPC, and the LLS to advance the development and expansion of the COPIKTRA brand. Five, one more ex-U.S. partnership with duvelisib. Six, advancing our focal adhesion kinase inhibitor defactinib, which is currently being evaluated in four separate clinical collaborations in combination with immunotherapeutic agents. As a twice-daily oral monotherapy, we believe that COPIKTRA is an attractive treatment option for both physicians and patients, first in CLL, SLL, and FL, and potentially in other high unmet need lymphoid malignancies in the future. I recognize the challenges of launching a novel therapeutic where there are challenges from perceptions of the class and limited clinical experience. However, we've come a long way since in licensing COPIKTRA in late 2016. We successfully got COPIKTRA approved by the FDA, and it has a long patent life ahead.
I'm confident in our strategic and operational plans, the team we have built, and our ability to execute on our mission to help bring COPIKTRA to patients in need and to change the way cancer is treated one patient at a time. With that, we will now open up the call for your questions. Operator?
Thank you. Today's question and answer session will be conducted electronically. To ask a question, press the star then the one key on your touch tone telephone. Again, to ask a question, press the star then the one key on your touch tone telephone. We'll pause just a moment to assemble the roster. Our first question comes from Robert Hazlett with BTIG. Your line is open.
Hi, this is actually Jake Colby on the line for Bert. Thanks for the question and congrats on the progress.
Thanks, Jake.
I guess just to start, with COPIKTRA on the market for a few months now, has there been any evolution in the sales and education message to physicians to address the PI3K perception headwinds?
Yeah, it's great. Now, obviously, we've had, I'd say, little surprises. Obviously you learn things as you progress. I think we're refining messages rather than sort of going down completely different paths. Let me let Joe comment more deeply about that.
Yes. Jake, thanks for the question. We have been kind of changing as we move along, which is a plan and part of the launch. When we launched, we wanted to come out as that, what is COPIKTRA? This dual inhibitor of delta and gamma. It was really first and only, it was new in the class. We presented it that way. We started giving the information around CLL. What's evolving is more around going away from the dual inhibition to the efficacy and safety of the product, and then also the FL, going from CLL to the FL campaign. We started with CLL. We're now evolving into the FL campaign, which I think is a great spot for us. The message has evolved over the past couple of months. All the messages have been resonating very well with physicians.
Okay. Thank you. That's helpful. Then I was just wondering if we could get any sort of commentary on expenses for 2019 and how we should think about their trajectory throughout the year.
Absolutely. Jake, I'll hand you over to Rob to answer that question on expenses for this year.
Yeah, thanks. As you know, it's very early on in both the launch and the calendar year. As it relates to guidance, we won't be giving guidance until at least the end of the year. We really need to get a solid idea of the ramp and the overall growth patterns before we commit to specific guidance. I will point to you, however, on the expense side, based on as noted in our earnings release today, our operating expenses were about $35 million. That compares to about $37 million in the third quarter. That should give you a sense for where we are in terms of the back half of last year. We won't be giving specific guidance on the projected revenue expense numbers till the end of the year.
Okay. Fair enough. Thanks for the questions, and again, congratulations on the progress.
Thanks, Jake.
Thank you. Our next question comes from H.C. Wainwright. Your line is open.
Thank you. Good afternoon, Robert and team. I have a couple of quick questions. In terms of the education programs that the commercial team is planning so that it can increase the clinician's experience, can you give us some color as to what sort of programs are you thinking about for that to happen in 2019?
Yeah. Thanks, RK. As you know, some of the headwinds that we knew when we brought the drug in was some of the negative perceptions around PI3K, and so we're obviously addressing those head on and really owning the benefits and side effects of the drug. Let me let Joe talk a bit more detail about that.
Sure. Thanks, RK. This kind of builds off Jake's question as well. Again, when we launched, we were really looking at kind of coming out as a novel agent, how we're different in the space, and to introduce COPIKTRA. As we've moved forward, we've done more around the efficacy piece for CLL as well as the management of the profile of the product. Now we're moving into the FL piece of it. What we're also doing around the messaging is to really look at what are the patients that physicians are looking to treat. We just actually came off of our national sales meeting last week, where we had a robust discussion around kind of what are the patients that we're looking to treat. We had two KOLs from the field come in to help work with our sales representatives to identify those patients.
As we look at it, where physicians are trying to fit in, which where does this fit in? I hear the question actually when we're out with investors as well, where does it actually fit in? What we're looking to do is this post 2 prior lines of therapy so that that patient who's now been treated with chemo, ibrutinib, maybe another product like venetoclax, then there's no option for those patients. Where they're being treated right now is really an open space. There's no treatment in that post 2 priors. We're developing those programs around to really identify physicians where we fit in and where our benefit is according to our label. We'll do the same thing now with FL as we've launched the FL campaign going forward, is to really look at what happens post 2 prior chemotherapies in follicular lymphoma.
It's really an open space because there's no ibrutinib, there's no venetoclax. It's really a PI3K space. How do we fit ourselves in as a PI3K of choice? That goes back to how we launched, looking at it as a novel agent, delta gamma, our profile around efficacy, 42% being in double refractory patients, which is different than the other products that are out there. Really our educational programs are established ourselves in CLL post 2 prior lines, which an open space, and in FL post 2 prior lines, which really an open space as well. It's definitely a PI3K space.
We're also working with the medical affairs team to bring more physicians in to having experience with COPIKTRA through clinical programs, through their own ideas as we initiate those, but also through programs that we're looking at for medical affairs, to initiate something like a registry study or something to provide them with that experience. We're hitting them from both ends. Where does it fit in? There's a clear open need in these post 2 priors and then give them the experience.
Joe, with your experience of having launched drugs before, in your world, how does this seem comparing it against your previous experience? Are there things that you feel requires a little bit of a tweak until there probably are certain things which requires a lot of tweak. How do you see this? What is some of the anecdotal information that you're getting, especially now that the drug has been out for close to five to six months? Then the second part of the question then is on the clinical side.
Based on some of the things that you have been hearing, and based on some of the clinical studies that have been highlighted so far in this call, I would like to know what sort of data expectations we should have, and also how you're trying to tie that data in with the message on COPIKTRA, just as you're trying to do this on this call with the physicians.
Okay. There's a lot of great questions in there. I think two main ones. First of all, Joe, can you talk a little bit about your prior experience with other oncology drugs? How do those experiences compare to what you're seeing here? That's the first question.
Okay. Yeah, RK, I think you're right. One of the things you said in terms of the, we've been out now for about five months. That's really the period of time we've had to introduce both Verastem Oncology and COPIKTRA to the marketplace. As you recall, Verastem picked up duvelisib back at the end of 2016, developed it. Most of the experience with clinical trials was in Europe, not within the U.S. It's building that base of support right now that the company's picked up. Over the past five or six months, the team, medical affairs, commercial, has done a great job in building that base. From my experience, that's the important piece of it. Have people touch the product and been able to work with it. We've got some great folks out there who have done that and are supporting us.
We need to continue to pull that through, and I think it's that first part you started with that five to six months since launch. We still have a ways to go, but it's going well and gaining that experience.
Okay, that was I think your first half, the second half was really talk about the clinical studies and maybe more broadly, the brand expansion strategy. I just want to get a couple of quick comments and I'll hand over to Dan. The first thing is we now have an approved drug. We've run the gauntlet of the biology of clinical trials and also through the FDA. We've got long IP, as Dan pointed out, 2030 before extension. We've probably got 13 or 14 years of exclusivity. We've got dollars thanks to Rob, who's raised good capital. We've got a great team. We have got time to really explore the potential for this drug in earlier lines of therapy and also in different indications, both as monotherapy and combination. Maybe with that, let Dan comment a bit more.
Sure. If you look at our growth strategy for COPIKTRA, for those of you who've seen the corporate presentation, we really have our four steps where first and foremost, we want to own our indication. We want to own two or more lines of therapy in CLL or FL. I think you saw some of the data that we presented recently that was really data that was taken out of studies where the top line had already been reported, where we give more information around how well the drug works, how well it works in certain subpopulations, and the tolerability of the drug. That's really job one. When we look at broadening the reach, it's really expanding the use in CLL, SLL and FL.
If you look at the Investigator-Sponsored Studies that are going, Matt Davids's study combining with venetoclax, that's potentially a very important study. As an IST, we don't necessarily control the timing of when that data comes out, but it's moved very rapidly, and we would expect to see something, hopefully in the near future. The PTCL study that we've talked about, PRIMO. Again, the data from that first portion of that study is likely to be reported out in the second half of this year. While we're not releasing any data now, I will tell you it accrued much more quickly than we ever expected, which is usually a good sign that physicians are seeing something they like.
As we start going into more aggressive subtypes of non-Hodgkin's lymphoma, you'll really see a lot of the Investigator-Sponsored Studies we're doing in the more aggressive subtypes, DLBCL, MCL, Richter's, are really supported by some of the combination work that's being done now. Because once we show we can safely give duvelisib together with a drug like venetoclax, you can look at other areas we can go into. We've reported at SITC some of the preclinical data around what I would view kind of the home run for COPIKTRA, which is if we can go into combining with IO CAR T, potentially cross over to solid tumors. We're hoping to get those studies started later this year and really go from there.
It's a combination of mining the data we have from the previous studies, getting readouts from some of the studies that are progressed a little farther, and then moving into the others.
Thank you. Thank you, folks, and good luck.
Thanks, RK.
Thank you. Again, as a reminder, to ask a question, press the star then the one key on your touch tone telephone. Our next question comes from Matthew Cross with Jones Trading. Your line is open.
Hey, guys. Congrats on completing the first full quarter of COPIKTRA sales, thanks for taking my questions this afternoon.
Thanks, Matt.
Starting off, I wanted to ask, you mentioned this increase now up to 90% in reimbursement coverage. I was wondering if you could give some color around what drove that increase, at least if there was one particular driving force, whether that was some data set, greater discussion of FL, given the recent publication and ability to now market beyond a package insert. Is there any reason to expect you could achieve 100% coverage or near 100% coverage sometime in the next few quarters as things progress?
Great question. I can answer the question very easily. We've got a great team that's working incredibly hard. Joe may have more color than that certainly is a large part of it. They really are very dedicated, very experienced, they're really working it. Joe, do you want to add anything to that?
I would totally agree with that, Robert. From the sales team through the market access team, to the medical affairs team that's been backing everybody up. They've done a great job over the past year. Actually, [RK] asked about my experience. We're in a place that usually at this point in time, you're going, "I could do a lot better if I just had reimbursement support." That we have. We've got that reimbursement support, so that's fantastic. What drove it was really the beginning of last year, we had, I think, our first payer meeting back at the beginning of March. I think it might have been the 3rd of March, we were talking then. We've been working very hard with the payers to introduce them to Verastem, introduce COPIKTRA and the data, and we've been pulling that through throughout the year.
Again, the market access team has done a great job, as Robert was saying. We've educated them on the product, on the class that it fits in, and they're aware of it. We've brought in our medical affairs team with physicians to back it up of why is this an important drug for patients. Getting to 100%, do I think we'll get there? I think we will. Maybe 99% of our lives. I think we'll get there. There are a couple other folks we need to pull in. I think we'll get there. Again, the team's done a great job.
Great. Glad to hear it and hope to see that continue. Next one was on just the cadence of sales over maybe the first year, including this quarter and say the first three of 2019. Just hoping to get your expectations for what I would expect would be an initially lumpier period during that first year as you're improving inventory build and improving distribution efficiency, before we make an assessment about the real sales trajectory. Would you expect this to be, say, in this first year, back-end loaded in terms of sales? Is this in any way impacted by the time at which you recognize revenue when that reaches distributors?
Thanks, Matt. That's a great question. It's something that we think about a lot, obviously. We're not giving financial guidance, I think some of the color that you're asking, I think is totally fair to talk about. We see this as being a sort of building year, I think you characterize it more towards the back end. We definitely got some of those headwinds that we knew about that we're overcoming, it does take time. Maybe, Joe, do you want to give a little bit more color? Maybe Rob, do you want to give some guidance off of that? Not official guidance, obviously.
I'd agree, Matt. I think it's a slow build over the year in the first year of sales, as we, one, educate more physicians, get them putting new patients on. As we start getting the annuity of patients continuing onto therapy. One of the abstracts that Dan had mentioned, patients were on for 13 months. That's a great thing for us for the future. As we get patients on, our goal is to keep them on therapy and build that going forward. I think as we deal with some of these headwinds of getting in, talking about how we're a different PI3K, how physicians can use this drug and manage it. Then they just start writing for more patients. I think it'll be a build throughout the year, but I think you're right.
You're looking at the projection is more sales towards the back half of the year.
Hey, Matt, it's Rob. I'll just add to that. You asked about rev recognition. The revenue's recognized when the product is received by the specialty pharmacy or the specialty distributor, and it's shipped from our 3PL. That's how that works, and it's typically a turnaround time of 24 hours.
Perfect. No, I appreciate all that detail and very helpful without obviously getting into specific numbers and guidance here. Just one more before I jump potentially back in the queue here. Was curious, obviously, with so much focus on commercialization right now and that being a crucial driver of the company's growth, wanted to get a sense for, given everything you're doing on the R&D side of things as well, where the focus is. I know there's a lot going on between PTCL, this confirmatory phase III in FL, various combinations. A lot going on beyond, obviously, the PRIMO study that's very much ongoing. What is the focus that we should be paying attention to most maybe, in terms of key catalysts for this year and maybe an initial label expansion?
No, that's a very important question. Job number one. Dan said this very, very well. Job number one is to make sure we execute on the launch. Joe and the team are on point clearly for that. Job number two is to maximize the potential for duvelisib. Again, we have long patent life on this drug. We know mechanistically that this drug has the potential to go into many other tumor types. We need to explore those and explore those quickly and efficiently, both through company-sponsored studies and also through investigator-sponsored trials. We're starting those. We've already started some of those, like the venetoclax combination, the PTCL programs, two of them that are going on. We see a lot of potential there. That's job number two. Job number three is what else? What other products can we bring forward?
Clearly, we have defactinib, and defactinib is in those four programs, and we hope to start to see some data coming out from those trials throughout this year. Defactinib is going to be potentially an important drug. We don't know yet. The jury is still out on it. What else? I think in due course, there may be what else is too. But Dan, I've probably stolen all your thunder. Is there anything else you'd like to add to that?
No, I'd just like to emphasize the PTCL study. That's likely to be the next label expansion. I would say if you looked at the phase I data, it was pretty exciting data. There's almost a halo effect, when we talk to KOLs about the PTCL data and our plans for the future. They're very excited, and we have multiple requests for ISTs, for example, in that area. As we look at the more aggressive lymphomas, I think that's going to be a big area of growth for us.
That's a good point, Dan. Just to emphasize, we've been very focused up until the approval on getting the drug approved. We hadn't initiated a lot of additional studies. We were, again, very focused to get the drug approved. Now that the drug is approved, it is the opportunity to broaden into additional indications and trials. It has been extraordinary the interest that we have received from physicians, KOLs around the country, and in fact, around the world, to try COPIKTRA in different tumor types, different combinations. You're going to start to see those rolling out as the year goes on. It's been very heartening and very exciting to see the scientific interest in taking this drug potentially into new indications.
Perfect. Thank you all for that commentary as well, looking forward to seeing how things expand on the clinical side and in the back half of this year.
Thanks, Matt.
I'll pass it back in the queue.
Thank you. Our next question comes from George Zavoico with B. Riley FBR. Your line is open.
Hi, George.
Hi, everyone. Thanks for the questions. Nice to see the sales progressing as you described. I have a question about the European discussions with the EMA. Where do you stand with getting COPIKTRA approved in Europe?
Great, important question. As you know, we own the worldwide rights to the drug.
Yep.
Clearly, the U.S. is the most important market, we're putting almost all our efforts into the U.S. We want to commercialize in other regions of the world because there's patients everywhere that could benefit from this drug, we want to make sure we bring COPIKTRA to those patients in an effective manner. You saw the CSPC in China, Yakult in Japan.
You should probably expect to see one more collaboration over the rest of this year. However, that is not likely to be in Europe. We are taking a different approach in Europe and a more sort of open approach to Europe. Maybe let Dan talk about that in more detail.
Sure. George, as you can imagine, when we got the priority review in the U.S. and things moved pretty quickly, it kept our regulatory team pretty busy. When we got the early approval for COPIKTRA, we really moved a number of those resources over to focus on the EMA, and we're actively working now in strengthening our KOL network in Europe. As you know, that's very important to the approval process, and then finalizing our regulatory strategy in Europe. There was a question earlier about clinical development as well as on the regulatory side. You probably saw the announcement of when we brought Bob Morgan on recently.
One of the reasons we brought him on was to expand both our capacity on the clinical side, but he also has a great deal of international regulatory experience, which is helpful to us both in the EMA as well as working with our partners in China and Japan. That's a big focus of the team right now. We'll give more guidance on the EMA and timing probably in the latter half of this year.
Okay. Part of the education that you guys need to do, obviously, with the sort of poor perception of PI3Ks, is about handling and recognizing when some of the warnings in the black box actually begin to appear as symptoms. Can you describe a little bit about how that's going, whether the rate of dose vacations or dose reductions have you been tracking that now that COPIKTRA's out on the market, and are you seeing the physicians sort of adapting well? Perhaps the more they use it, they adapt better. Any comment on that would be helpful.
No, it's a really important question. We're taking a very different approach to some other companies in the past around PI3K. We are really owning the side effects and embracing them and providing the materials and the education to the physician, the nurse, the physician's office, and indirectly to the patient. Make sure they know what to expect. Because in general, these side effects are predictable and manageable, and they're side effects that many of these physicians are very familiar with because they're dosing IO drugs. Guess what? They see many of the same side effects. It's much more one of education, much more one of overcoming perceptions than anything else, than anything more real than that. Maybe I'll hand it over to Joe, and maybe Dan, might you want to make a comment as well.
Joe, you want to add to what I just said?
It's been an important part of the launch and will be going forward as well. It goes all the way back to the people that we hired in our oncology account managers or our sales team, that we wanted them to be upfront about the side effects, what to know for a physician, know what to expect, when to expect it, and what to do going forward. That has driven a lot of very robust conversations, which has been great. That's going well, and to date, what we're seeing is patients do well on therapy. Again, just as long as physicians know about it, they feel more comfortable about it and how to manage it as well. It's a big piece of our sales effort. Well, I was just going to comment on what data we have so far on usage in the market.
The nice thing about starting from scratch with all our systems is we've designed our systems. We can actually track that real-life usage and delays in dose reductions and things. I would say it's just way too early right now. The numbers are too small to really draw any conclusions.
Okay. I guess as we go on, we'll learn more about that with every quarter. Okay. Then in terms of, just briefly, maybe again, it's also too early. How many repeat scripts versus new scripts? Can you talk about that, or is it way too early for that, too?
George, it's important data as well. It's too early.
Yeah.
We're just, what, three or four months into the launch. We obviously know that many patients are having repeat scripts, but in terms of the numbers, it's probably too early to make anything of the data.
Okay. All right. Thank you all very much, and let's hope this keeps growing.
Yeah. We're with you on that.
Thank you. Our next question is a follow-up from Matthew Cross with Jones Trading. Your line is open.
Hey, guys. Thanks for taking another one from me here. Just had one kind of as you think about BD opportunities for COPIKTRA beyond geographical deals. I understand you're likely to be opportunistic, but would you say you're committed to commercializing in the U.S. entirely internally, or open to a co-commercial or out licensing situation, maybe for certain indications where there may be some kind of added synergies from the existing offerings of other players in the space?
Matt, it's a very important question. The heart of our business is commercializing in the U.S. We are not open to co-commercializations. Also splitting up indications is not something that is particularly easy to do or to track. No, we believe in this drug. We have the team. We have the right team. We have the capital. We have a great product. We want to commercialize it in the U.S. We want to own that. That's how we can build a nice business here. The second thing is, we're thinking about what we should do in Europe, whether we should be fully commercial in Europe or whether we should partner in Europe. That's something, a decision that we're keeping open. We want to move down the regulatory path a bit more before making that kind of decision.
Definitely in the U.S., we're not open to BD conversations.
Robert, I guess I would add, one of the things we're already starting to hear back from the field is very good feedback on our people and how they interact and how responsive we are as a company. things like that are hard to continue if you try and partner. It's something that we want to continue to be known for the way we do things.
Yeah. Thanks, Dan. That's a good point.
Fair enough. No, and in no way trying to send any negative message about the strong progress Joe and the rest of the team are making here. Just wanted to clarify as far as the strategy and then how we should think about it as we're moving into more mature launch.
We're delighted to own this drug, and we're delighted to have the opportunity to commercialize it in the U.S.
Thanks again, guys.
Thanks, Matt.
Thank you. Ladies and gentlemen, this concludes our question-and-answer portion of today's call. I'd like to turn it back over to Robert now for any additional closing remarks.
Thank you. Thank you all very much for joining and for the great questions. In closing, I'd just like to thank everyone again for dialing in today's call. This is a very exciting time for Verastem Oncology, and we are now delivering on our mission to improve the lives of patients with cancer. Have a good evening.
Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation, and you may now disconnect. Have a great day.