New clinical data at the ASCO meeting support Pfizer's PFE growing competitive positioning in oncology, including strong early-stage data with 4-1BB drug utomilumab, less threatening competitive data to Pfizer’s Ibrance, and reaffirming data with the CTLA4/PD1combination. We still view Pfizer as undervalued, largely due to an underappreciated pipeline, which was further strengthened with the ASCO data that reinforced our $3 billion peak estimate for Pfizer’s immuno-oncology drugs. Additionally, we view the strong pipeline as a core element of the company’s wide moat. The early-stage data with utomilumab in combination with Merck’s Keytruda showed an overall response rate of 26% in relapsed patients with severa l cancer types. While no control arm was used and the total patient count was only 23, the efficacy, lack of increased toxicity, and no interference with Keytruda’s mechanism of action is encouraging. With only Bristol having a potential competitive agent in the clinic and Bristol’s drug looking more toxic, Pfizer has a significant lead in this class of immunotherapy. Turning to Pfizer’s non-immuno-oncology cancer drug Ibrance, we believe Lilly's phase 2 abemaciclib data will not support approval, giving Pfizer more time to entrench Ibrance in the market. Nevertheless, we expect abemaciclib will reach the market following phase 3 data in 2017. For the entire note, click here. Damien Conover, CFA
Pfizer, Medivation analyst commentary at Piper Jaffray Pfizer acquisition 'a good fit strategically,' says Piper Jaffray. After Pfizer (PFE) agreed to buy Medivation (MDVN), Piper Jaffray analyst Richard Purkiss says that Pfizer has obtained Xtandi, "a blockbuster prostate cancer treatment," and "a close-to-market and late-stage pipeline." The analyst thinks that Xtandi's expansion to use in adjuvant prostate cancer could increase its sales by 65%-70%. He keeps a $54 price target and Overweight rating on Pfizer.
Pfizer Inc. (NYSE: PFE) today announced that it has entered into an accelerated share repurchase agreement with Citibank N.A. (Citibank) to repurchase $5 billion of Pfizer's common stock. This agreement is part of Pfizer's existing share repurchase authorization.
Approximately 126 million of the shares to be repurchased under the transaction will be received by Pfizer on February 6, 2017. At settlement of the agreement, which is expected to occur during or prior to the third quarter of 2017, Citibank may be required to deliver additional shares of common stock to Pfizer, or, under certain circumstances, Pfizer may be required to deliver shares of its common stock or may elect to make a cash payment to Citibank, with the number of shares to be delivered or the amount of such payment based on the volume-weighted average price of Pfizer's common stock during the term of the transaction.
Pfizer to Build Gene Therapy Facility in North Carolina August 17, 2017 Pfizer to Build Gene Therapy Facility in North Carolina Pfizer has committed to building a $100 million gene therapy manufacturing facility in North Carolina. Specifically, Pfizer will expand an 11,000-square-foot plant in Sanford, North Carolina that it acquired last year when it bought Bamboo Therapeutics, a biotech company that specializes in gene therapies for certain rare diseases. Bamboo had previously acquired the facility from the University of North Carolina.
In December 2014, Pfizer entered a collaboration with Spark Therapeutics with the goal of developing and commercializing novel gene therapy-based treatments for hemophilia B using Spark’s bioengineered adeno-associated viruses (AAVs). Spark’s proprietary AAVs are delivery vehicles, or vectors, that carry the genetic codes that prompt the production of the factor IX (FIX) protein that is deficient in individuals with hemophilia B. AAVs deliver the genetic material into living cells via a single injection into the liver, to sustain therapeutic effect without causing disease or triggering significant immune responses. In early 2016 Pfizer also entered an exclusive license agreement with King’s College of London (KCL), to develop a series of AAVs to treat hemophilia.
“Pfizer is proud to further expand our presence in North Carolina, particularly as we build our leadership in gene therapy,” Lynn Bottone, site leader at Pfizer Sanford said in a statement. “We look forward to the next phase of this expansion as we build a clinical and commercial manufacturing facility.”
Cost-saving plans and recent product launches should help mitigate patent losses. by Damien Conover Sector Director Authors can be reached at Analyst Feedback Morningstar's Editorial Policies Analyst Note Pfizer’s Plans to Divest the Consumer Business Lead to No Major Impact on Valuation or Moat by Damien Conover, 10/10/2017 Discuss See what other investors are saying about PFE Analyst Note 10/10/2017 Pfizer’s announced plans to potentially divest the consumer healthcare segment don’t change our fair value estimate or wide moat rating. We still view Pfizer as fairly valued with a strong competitive positioning within the branded drug segment. A shift away from consumer healthcare would reduce the brand power moat source for the firm, but with only 6% of sales derived from consumer healthcare products, the loss of branding power is not material for the company.
We estimate the value of Pfizer’s consumer division at close to $17 billion based on recent comparable sales, which suggests a divestiture would create a minor level of valuation (low-single-digit percentage gain) for shareholders. Over the past three years, the price/sales multiples for major consumer healthcare divisions have ranged from 4 to 6 times, with Bayer’s purchase of Merck’s consumer healthcare group coming in at the high end of this range, while Sanofi’s asset swap for Boehringer Ingelheim’s consumer group was at the lower end of the range. If Pfizer were to pursue a sale of the consumer group, the tax implications would likely erase any valuation creation from the deal. However, a spin-off or split-off would likely create a minor level of value-creation for shareholders.
With no major Rx (prescription) to OTC (over-the-counter) switches likely over the near term, we view the synergy of holding the consumer health business with Pfizer’s prescription business as less important. While cholesterol lowering drug Lipitor and erectile dysfunction drug Viagra hold potential for a Rx-to-OTC switch, we are skeptical the major regulatory agencies will approve the label change. Further, with Pfizer focusing more on critical-care areas such as oncology in its prescription business, future Rx-to-OTC switches seem less likely.
Investment Thesis 12/12/2016 Pfizer's foundation remains solid, based on strong cash flows generated from a basket of diverse drugs. The company's large size confers significant competitive advantages in developing new drugs. This unmatched heft, combined with a broad portfolio of patent-protected drugs, has helped Pfizer build a wide economic moat around its business.
Pfizer's size establishes one of the largest economies of scale in the pharmaceutical industry. In a business where drug development needs a lot of shots on goal to be successful, Pfizer has the financial resources and the established research power to support the development of more new drugs. Also, after many years of struggling to bring out important new drugs, Pfizer is now launching several potential blockbusters in cancer, heart disease, and immunology.
Pfizer's vast financial resources support a leading salesforce. Pfizer's commitment to postapproval studies provides its salespeople with an armamentarium of data for their marketing campaigns. Further, Pfizer's leading salesforces in emerging countries position the company to benefit from the dramatically increasing wealth in nations such as Brazil, Russia, India, China, and Turkey.
While entrenched as an industry leader, Pfizer faces challenges in the near term. The loss of patent protection on several drugs will weigh on future growth. In particular, the 2017 patent loss on Viagra and the eventual 2019 U.S. patent loss on Lyrica will slow long-term growth.
However, we believe Pfizer's operations can withstand the upcoming generic competition, and the 2009 acquisition of Wyeth helps insulate Pfizer from any one particular patent loss. Following the merger, Pfizer has a much stronger position in the vaccine industry with meningitis vaccine Prevnar 13. Vaccines tend to be more resistant to generic competition because of the manufacturing complexity and relatively lower prices.
Economic Moat 12/12/2016 Patents, economies of scale, and a powerful distribution network support Pfizer’s wide moat. Pfizer’s patent-protected drugs carry strong pricing power that enables the firm to generate returns on invested capital in excess of its cost of capital. Further, the patents give the company time to develop the next generation of drugs before generic competition arises. Additionally, while Pfizer holds a diversified product portfolio, there is some product concentration, with the company’s largest product Prevnar representing just over 10% of total sales. However, we don't expect typical generic competition for the vaccine due to complex manufacturing and relatively low prices for the product. Further, we expect new products will mitigate the eventual generic competition of other key drugs. Also, Pfizer’s operating structure allows for cost-cutting following patent losses to reduce the margin pressure from lost high-margin drug sales. Overall, Pfizer’s established product line creates the enormous cash flows needed to fund the average $800 million in development costs per new drug. In addition, the company's powerful distribution network sets up the company as a strong partner for smaller drug companies that lack Pfizer’s resources. Also, Pfizer’s entrenched consumer and vaccine franchises create an added layer of competitive advantage, stemming from brand power in consumer healthcare and manufacturing cost advantages in the vaccines division.
Valuation 12/12/2016 We are maintaining our fair value estimate of $37. In looking at the core business of Pfizer, we expect 6% annual sales growth over the next three years (including acquisitions) as new drugs offset generic competition. However, on the bottom line we project a slightly healthier annual growth rate of 9% during the next three years as cost-cutting plans and share buybacks take shape. Over the long term, we believe the more diversified lineup of drugs should reduce the volatility of earnings. We anticipate restructuring efforts and the elimination of duplicate positions will help alleviate some margin pressure, as some high-margin products lose exclusivity. From a cost of capital perspective, we estimate Pfizer's cost of equity at 7.5% and weighted average cost of capital at 7% as well, in line with the company's peer group.
Risk 12/12/2016 Pfizer faces generic competition, an increasingly stringent FDA, and stronger managed-care negotiating power. New drug development has become challenging in several disease areas with a more risk-conscious FDA. Additionally, managed care has grown during the past two decades into a powerful entity that can negotiate lower drug prices. Although more remote, litigation risks remain, as evidenced by Merck's high settlement costs involving Vioxx. Also, several of Pfizer's pipeline drugs are reaching markets behind competitors, which may increase the risk of commercialization failure and put downward pricing pressure on the drugs if the clinical data lacks positive differentiation.
Management 12/12/2016 We rate Pfizer's stewardship as Standard. While the company has made many poor capital-allocation decisions over the past decade, the current management appears to be focusing on significantly better uses of cash, including share buybacks and dividends. Also, the decisions to divest the nutritional and animal healthcare businesses appear to have created value for shareholders. On the M&A front, the acquisition of Hospira should strengthen Pfizer's moat in its established drug group, and the price looks reasonable. However, the high price paid for Medivation and the failed attempts to acquire AstraZeneca and Allergan are concerning.
Looking back to 2010, in a surprising move, Pfizer named longtime veteran Ian Read to the CEO post, abruptly replacing Jeffrey Kindler. We believe the earlier-than-anticipated departure of Kindler was largely due to personal reasons and don't believe the transition raises any red flags. Read brings more than 30 years of experience at Pfizer to the post and was most recently in charge of the company's biopharmaceutical business. As CEO, Read has already brought his stamp to the post by signaling a strong willingness to cut R&D and buy back shares. We believe Read's leadership is bringing changes needed to increase the company's growth potential. On the reporting side, accounting transparency is not ideal, largely because of financial distortions caused by frequent acquisitions. Reconciliation between generally accepted accounting practices results and adjusted results is complex, diluting the clarity of earnings statements.
Pfizer (NYSE:PFE) is giving up on discovering new drugs for Alzheimer's and Parkinson's disease, abandoning costly efforts to find effective treatments for the disorders. The cutback will result in 300 layoffs over the next several months. "This was an exercise to reallocate [spending] across our portfolio, to focus on those areas where our pipeline, and our scientific expertise, is strongest," Pfizer said in a statement.
Good morning, everybody. I'm Chris Schott from J.P. Morgan. And very pleased today to be introducing Pfizer. From Pfizer, we have Mikael Dolsten, the company's president of R&D.
For the format today, we're going to do a short presentation from Mikael. Then we're going to break to a fireside chat type format. And we will not be doing a breakout session afterwards.
So, with that, I'll turn it over to Mikael. Thank you.
Mikael Dolsten Thank you very much, Chris. And a pleasure to share with you what we think is the new era of Pfizer R&D productivity at a higher level.
But as always, before I go into sharing some of our progress, please look at the forward-looking statement. Details are on the slides and will be available at our filings and webpages.
So, we have been working since 2010 together with our CEO, Ian Reed, to really look at the way to transform how we do R&D.
And I take you back to the period 2005 to 2010, you can note, as an indicator of R&D productivity, that Pfizer had a moderate output with two blockbusters, Sutent and then Prevnar 13 in infant that was approved just after the acquisition of Wyeth closed.
So, at that time point, we took a hard look at how do you impact the R&D productivity, how do you transform how we work together from R&D and commercial.
And we focused on rigorous science, crisp decision-making, early development for go, no-go, we looked at ways to put our key biomedical innovators in the right geographies. We looked at how you get early alignment between commercial and science in the program and how do you focus on the areas where you can win.
And that led to a reduction from our rather broad therapeutic area span of 14 to now 5 areas. And indeed, actually, last week, we announced that we are exiting research and early development in neuroscience in order to focus and reallocate our resources into the other five areas where we think we can give them most value near to midterm for shareholders and for patients. So, that's part of making sure you put your resources where you can make the biggest impact on where you can win.
With all of those changes in place, we started to look at an uptick in our R&D productivity. And again, you've seen blockbuster approval as a measure of that. You can now see, between 2011 and 2016, that we got five products approved with blockbuster potential, four of them, actually, have already reached blockbuster status in the marketplace – Prevnar, Sutent, Advil, Eliquis, Xeljanz and Ibrance – and the fifth was approved quite recently, Eucrisa, which we think has a multibillion-dollar blockbuster potential.
At the same time, from 2011 and if I extend to 2017, we, actually, got 38 approvals in major markets, US/EU, and we got – 17 of them were new medical entities and we started 45 new pivotal study starts to refill the pipeline.
So, that gives us on average four or more approvals per year, of which two or more NMEs and six or more pivotal study starts annually. And we think we can now take that momentum and even augment it to project upward exciting slope of R&D productivity to augment growth for the company.
And that's really the focus of the next few minutes, our opportunity to deliver up to 15 blockbusters in five years, of course, subject to attrition.
You can see, they are spanning the five therapeutic areas. And starting at the top, we have the immune-oncology portfolio, particularly focusing on the drug combinations, combining Bavencio, our PD-L1 drug, partnered with German Merck, with a variety of Pfizer-targeted agents. Most recently, we got breakthrough designation for Bavencio combined with Inlyta in renal cell cancer and we're starting now multiple trials, combining with other targeted agents and immune-oncology agents.
Recently, we got the readout from one of the IO/IO studies with 4-1BB where we did not see any incremental gain in adding a second immune-oncology agent. And we, obviously, are looking at exploratory sub analysis to see, as the data mature, what we can learn. But it clearly shows the importance of having a broad portfolio because the ability to predict isn't always possible to perfection.
And in the IO/IO space, we're particular now excited about our OX40 combination with Bavencio as we have seen single agent activity of OX40 and interest in immune-pharmacology profile.
You can see the third bucket related to targeted cancer agents where you see four different indicated, all of them are projected to be for regulatory submissions this year.
Then we have our two oncology anchor product, Ibrance going from metastatic to early breast cancer, where we have seen in our smaller focused adjuvant study, promising effect on tumor shrinkage and also antiproliferative markers.
In this setting, where we're leaders when it comes to CDK inhibitors for breast cancer, I'm also pleased to share that we are starting soon a next-generation CDK inhibitor for breast cancer resistance in both breast and other non-breast indications.
We shared last year our JAK1 proof of concept and that we were the first to start Phase II in atopic dermatitis. We are pleased with our C. difficile vaccine and we are now the leading late-stage vaccine in this space after competitor had a setback. It's such an important unmet need and a great opportunity.
And then, we have our last bucket where we have multiple rare disease and internal medicine opportunities. You can see, overall, it's a real exciting cohort of up to 15 blockbusters over the next five years, of course, subject to attrition. And they are part of a larger approval cohort of some 25 to 30 opportunities, again, of course, subject to attrition.
And let me just now close with a brief touch on what's going to happen in 2018. And I think you will see that it will be a busy year, starting at the top. We plan to be back here in San Francisco and share the data from the PROSPER study at ASCO GU. The study was reported to be positive on its primary endpoint and we are on track with our partner Astellas to put it into filing for registration this first half of the year.
You can see filing for talazoparib, multiple readouts in the first half of the year in lung cancer, in cardiomyopathy. Please note how our JAK portfolio in the early stage started to deliver readouts. Rheumatoid arthritis with our unique next-generation JAK2 inhibitor.
And later, second half, you can see a number of selective JAKs with readouts in new areas such as alopecia, psoriasis. You can note, in the vaccine space, in the early phase, we have readout of the 20-valent follow-on vaccine to Prevenar 13. And then, during the second half, in the later stage, you can see an action date for Xeljanz in its first indication outside rheumatology, ulcerative colitis, middle of the year in US, later in EU. Readout for rivipansel in sickle-cell.
And exciting novel pain class, tanezumab has a readout in a very large Phase III study where we again are leading the development of this innovative drug class.
And then, finally, we have our triplet in immuno-oncology with OX40, 4-1BB at the end of the year. And our NASH portfolio that has emerged with a proof-of-concept study on ACC and are close to mention, GLP-1. And this is one of the few – maybe the first for oral small molecule GLP-1 that we see an opportunity to study for NASH and other metabolic disorders.
So, I'll close to say, 2018 will be a rich data delivery year, will allow us to follow the progress with delivering the up to 15 in 5 blockbusters and continue to augment the growth of Pfizer and the productivity gain we have over the last few years.
And now, back to the dialog with Chris here. Thank you.
Question-and-Answer Session Q - Chris Schott Thank you for those comments. Maybe just to kick off our discussion here, it seems like the company is increasingly confident with regards to its late-stage pipeline. We've seen rapid buildout of these, the portfolio. Can you help me just understand what's happened within the organization that has allowed for this accelerated productivity that we've been seeing?
Mikael Dolsten I think it's been, as I alluded to, a number of key things. On one hand, a focus on the rigor in the science and making sure that we are selecting the most promising areas where our science and technology can lead. We focus far more now on being the company that will drive with breakthrough potential than just being someone that is a follow-on company. And the ability to integrate science and business has allowed us to, I think, to have an opportunity to really have the company come together and do proper risk assessment of which areas will be the most promising and do it in a very unbiased manner.
A lot of effort has been around decision-making. How do you do unbiased decision-making? How do you do multivariate analysis on the probability of technical, regulatory or commercial success in your pipeline?
And then, finally, obviously, we have done a lot of work when it comes to ownership culture that everyone in the organization needs to own the outcome of your program, whether you decide to stop or continue. You own that important dialogue with the management.
Chris Schott Digging into some of the individual opportunities here, immune-oncology, obviously, a huge focus across the industry. Can you just give us a snapshot of how you see Pfizer positioned in this very rapidly evolving field?
You've got a lot of assets. You've done a lot of studies. But there are some that are a bit ahead in development. So, how do you think about your role in the market? How do you catchup in certain areas where maybe you started development a bit later than others?
Mikael Dolsten Yeah. For us, we look at oncology as a comprehensive approach. And we see a future where most cancer patients will likely have two or three or more different cancer drugs, addressing the immune-oncology aspect, the cancer biology and the tumor microenvironment.
So, for us, having such a large portfolio of targeted therapies, of course, with leadership in breast, CDK and Ibrance; growing in urology with prostate and renal; and also significant presence in lung and blood, to have a backbone of IO agents that can be, over time, combined in the right fashion is important.
And we think we have made a lot of progress together with German Merck when Bavencio registered into smaller indications. As you noted, we have, every year, now a readout in various indications.
Inlyta breakthrough designation is a hallmark for when you get those combinations right, we saw more than 60% response rate in renal cell carcinoma and many deep responses. So, that's how we're thinking to be a company that has the abilities to combine richly across our portfolio, gives us much more flexibility going forward.
Of course, we are very eager, and this is a great meeting place, to look at other biotechs or specialized pharma that may have unique assets that could fit and combine with our comprehensive portfolio. And that's really how we're seeing quality develop over the next years.
Chris Schott So, along those lines, is a core part of your strategy monotherapy? It sounds like it's more about combinations for Pfizer as I think about this going forward.
Mikael Dolsten That's true. We participate in the first wave of monotherapy and that's why we've got the first registration. It gives physicians experience with Bavencio. It allows some segments to be a participant, but we do see over time that the field will evolve. And most tumor types and segments will be combinations. And that's where really our major focus is.
Chris Schott Yeah. And when I look at the market right now, there seems to be either PD1 monotherapy or even some IO combos being established a standard of care in some very large tumor types, what challenge does that present in terms of study design and trying to develop new therapies when it seems like the bar is moving a bit higher in terms of the therapies that patients are able to receive today?
Mikael Dolsten Clearly, you need to put your investments in various ways since the field hasn't moved as much. So, we feel that in most indications, you see 20% to 30% response rate. There are very few complete responses, with a few exceptions of indications.
So, I think there is still ample opportunity to build on those initial promising data, but we need to have formal meaningful level of durable and also complete responses.
Obviously, there are subset of cancers. Some of them are called cold tumors. And we're putting particular efforts there, looking at combinations that would heat up those tumors, whether it's chemo combinations, radio immunotherapy or antibody drug candidate. And more recently, we're also advancing cancer vaccines into this space.
We have prostate cancer vaccine, Phase I now. We're planning to move lung cancer vaccine into clinical this year as well as bifunctional antibodies. Last year, we started a study in myeloma with a bifunctional antibody.
So, I think for each different tumor segment, we'll ask the critical question that you did where is the biggest unmet medical need, how do you build on the current standard of care, but the problems we have seen is just the very start of a long journey. There is a lot more we should be offering patients over the next 5 to 10 years in progress.
Chris Schott When I think about IO/IO combos, I think you mentioned OX40, what other targets are you particularly excited about as you think about combining your PD-L1 with other agents?
Mikael Dolsten So, we have an array of IO molecules in our pipeline and working with ambition to – every year put in another or so IO molecule into the clinic. Right now, in the pure IO segment, it is the data we have seen with OX40 single agent and its ability to activate a different arm of the immune system, the helper cells versus the more cytotoxic cells being activated by PD-L1 and 4-1BB.
See, that's the reason why we see a more comprehensive immune response being engaged. A lot of our efforts is also to look at the combination of IO with targeted therapies. And I mentioned Inlyta, we have now studies with talazoparib drug combinations. Bavencio with talazoparib. Bavencio with lorlatinib in lung. And together with investigator-initiated studies, we look at combination with Ibrance, combination with glasdegib in blood malignancies.
So, we see in parallel a great opportunity for PD-X targeted therapies as well as trying to figure out which IO combination can make the immune part of that equation stronger.
Chris Schott Sure, sure. Maybe switching gears a little bit, staying on oncology, Ibrance, the adjuvant opportunity seems to be a fairly substantial one. Can you talk a little bit about how you see that opportunity playing out and what gives you confidence that we can see efficacy for the product in this setting?
Mikael Dolsten Yes, thank you very much for that question. So, in general, for targeted therapies, we have seen good translation between more advanced metastatic disease and moving to earlier lines. In most cases, responses actually get better.
But, specifically, for Ibrance, we have a number of studies, smaller Phase I/II studies that have reported out on early breast cancer patients in more [indiscernible] adjuvant setting where we have seen robust responses of Ibrance alone or on top of estrogen blockade related to tumor shrinkage or looking at antiproliferative markers, like Ki67.
So, that gave us a lot of confidence. And more recently, we had a readout also on patient readout on breast cancer that are on the drug for two years and again showing good tolerability, which is important when you move into earlier lines.
So, we feel very strong about that opportunity. It's a large opportunity that more patients with early breast cancer than advancement metastatic and we will, hopefully, see them treated successfully for longer time periods.
Some of the studies that we have, like the PALLAS study, includes two-year treatment duration. So, that opportunity, you see, is very substantial for Pfizer and. Hopefully, for patients, pending outcome of the study.
Chris Schott Can you give us a timeline? So, I know there's a couple adjuvant studies running, but when should we start thinking about data potentially coming for these opportunities?
Mikael Dolsten Yeah. The early breast cancer readouts are a few years away. We tend to say it's probably 2020 period. At the same time, we actually have a readout also of Ibrance together with HER2 blockade in tumors that are double positive for HER2 and Herceptin receptors. So, there is lots of opportunities for growth of Ibrance. And I wanted to close on this question, to say, that we have like a 100,000 patients currently treated in the marketplace with Ibrance. And, of course, unfortunately, some of them will progress, as often happens, on targeted therapies. And that's why we're so excited to bringing this year to clinical studies a new generation of CDK inhibitors that based on our leadership in the science have been tailored to particularly address major assistance mechanisms that will possibly or likely happen in these patients.
And we've also identified that type of resistance mechanism may be present in tumors outside breasts, so they are intrinsically not eligible for Ibrance non-breast cancer and this drug, in our scientific analysis, show a lot of promise. So, that's another major advance we are looking at in the 2018 and 2019 period.
Chris Schott Sure, that's great. Switching gears, nerve growth factor, tanezumab, seems like we're getting close to the big data readouts. Remind us here just on the efficacy profile that we've seen for this drug. How you would see this kind of fitting into the pain landscape we have right now?
And then, the second piece with that, I know there were some challenges initially with the study and submissions in knee failure. Remind us how you are addressing that in the Phase III and your confidence that we can kind of get around some of those issues that led to a delay in the product initially?
Mikael Dolsten Yeah, it's a great question. And I think our confidence here lies very much in what it means to be a leader in developing way ahead of others these breakthrough therapies.
Of course, when we were – a number of years ago, in the first trials, the view, unfortunately, externally, was that maybe there isn't a lot of need for new pain medications.
I think we have suffered from that conservative view, as we see how the current excessive use of opioids have led to tremendous abuse and addiction. So, now, of course, we were pleased to see we've got faster track designation for this monoclonal antibody. And I think there is a completely different perspective on unmet need.
We had very strong proof-of-concept data earlier with that antibody that showed similar or, in some cases, better pain relief than opioids or NSAIDs.
And we took all the learning from those early studies when we had to take a pause on the development after some concern about how do you develop these drugs optimally. This, particularly, related to some rare events that was determined of possible deterioration of osteoarthritis.
And we redesigned the next set of studies. So, we went in in osteoarthritis with slightly lower dose. We went with subcutaneous regimens, very convenient, every eight weeks. And in chronic lower back pain, we didn't see that problem. So, we continue with the dose.
We limited the use of NSAIDs, which we learned from a competitor failure, seemed to be an issue when you have a high dose of NSAID chronic use. We have limited use of NSAID. And we have introduced a number of risk minimization plans when it comes to how you monitor and have stopping rules at individual levels for patients in these studies.
So, the study has now performed extremely well and we look forward to the readout early second half of the year here, we hope, and we think it has the potential to be a major transformative therapy where there is such an urgent need. And we certainly learned a lot, but we would have wished that we could have been a few years earlier into the market to help out with this opioid addiction.
Chris Schott Yeah. Hopefully, this time around, you'll be there. There's been a lot of talk about potential consolidation across the pharma group, including large M&A.
You run a very large R&D organization. It's been through consolidation over time. To the extent there is activity and Pfizer is involved, how do you think about maintaining the momentum that you currently have in the organization, again, if a deal were to happen.
And we've seen in the past, when you get large consolidation, there can be disruption. Are there learnings you have in place? Or your comfort that if a deal were to happen, you can kind of keep this going, how do you think about managing that challenge?
Mikael Dolsten For large companies, it's important always to look at opportunity to augment, accelerate growth. And whether that's smaller or midsize bolt-on or assessing larger opportunities in order to maximize shareholder value and return, so that's, obviously, a capability that we have and do it regularly, routinely.
When it comes to the specific questions, and let me simplify from the Wyeth decision, where I think the recipe for success is the experience that our organization has in moving swiftly and engaging in that case with another company, looking at best practice across the two companies, rolling out the roadmap how you combine, in this case, the R&D, the strength in each therapeutic areas, the technical design of drugs, and quickly create one single pipeline go forward.
We did all of that work with Wyeth-Pfizer acquisition basically in less than a month. And then took firm, but important and difficult decision, on where to focus, which therapeutic areas, which sides and how to allocate our resources.
And I think that culture, that capability is very strong at Pfizer, possibly uniquely strong in the industry.
And, of course, we saw that also, at a smaller scale, I spoke today about the PROSPER trial, the positive readout and our on-track plans to file first half of the year with Astellas, we accelerated after the acquisition of Medivation that started with two years.
And then, finally, the Anacor acquisition and the drug Eucrisa, we were able at just registration phase to resolve a number of issues, given our capability in CMC and pharmaceutical sciences that allowed a very fast registration to occur.
So, I think independence and scale, that's a key capability that our company has. And, of course, it's important to look at such opportunities in a very unbiased manner as part of your running a business.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6