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14.03.2014.

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10.03.2014.

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Alkermes plc alks ceo hosts r day weddingesoutletlondon transcript Would our ceo please take a seat?Okay, we're good on the webcast.Everyone, thank you very much for joining us today.We're very excited to have you.And i think you will see today how productive alkermes r engine really has been.And we will be unveiling some new programs that richard will talk about indepth, and running through some of our laterstage programs as well.Before we begin, however, i need to remind you that we will make forwardlooking statements within the meaning of the private securities litigation reform act.Inherent in biotechnology, there are risks.We try to articulate these risks in our filings and encourage you to review them.So today, richard will kick it off;Talking about our approach to r and what makes it unique and different and the fact that it's reallyDriven by patient needs and truly is patient inspired.And hopefully, by the end of today, you'll see frankly how productive the r engine has been.Dr.Elliot ehrich who leads and he's our chief medical officer, he leads all of our development activities.He will put forth a lofty ambition about rethinking psychiatry and how we're doing so visa vis opioid modulation.And he'll explain that a little bit more, and he'll also use alks 5461 as an example of how we are able to leverage our unique insights and how we run clinical trials frankly very fastidiously in order to successfully run studies in the cns area. And we're pleased to have with us today,Dr.Marlene freeman, who is a clinical psychiatrist at mgh and harvard medical school.And she will help us give some real patient perspectives and talk about the disease and how she currently treats it, and why new treatment options are needed.Dr.Freeman also has expertise in running clinical studies, so i think that will be helpful insight for all of you and as you try to evaluate companies and their programs and pipeline. Then we'll have a Q with those three folks, and we'll switch gears then, we'll take a brief break, and thenDr.Bernie silverman will talk about alks 3831.And we're going to talk about that program more indepth today than we ever previously have.And really, how we're looking at leveraging dual pharmacology to really address the needs of two distinct subpopulations within schizophrenia.And i think both are really important opportunities, both from a commercial perspective, but more importantly for the patients.And then our chief commercial officer, mark stejbach, who for many of you, this is the first time you'll meet mark, but he has been running the vivitrol commercial efforts, and has put forth a plan.And frankly, folks are in motion getting ready for the launch of aripiprazole cheap cocktail dresses online lauroxil.We'll then have another group q and some closing remarks by richard.But we think it's an exciting day, it's sort of jam packed with new news and we invite your interaction and we're very pleased to have you here.So without further ado, i will hand over the podium to richard.All right.Thank you,(Harland)For the applause.Okay, is the webcast good?Are we the audio is fine?Fantastic.Okay, hi, everybody.Are you ready?We're going to cover some ground now.I couldn't be more excited to be here today and welcome you and give you a glimpse of some work that's been going on for years within the company, we're opening the curtain on work that's been happening, that we've known about, but you haven't known about for quite some time.It's no secret, right, that we have the ambition of building what's going to be one of the next major bio pharmaceutical companies.And what you're going to hear about today, is an r engine that is incredibly distinctive.It's differentiated because it derives from, evolves from many, many years of arduous development work that we've been doing at the highest level of sophistication with pharmaceutical company partners and on our own.It's also incredibly patient focused.Almost everything we do, has, at its core, a perspective of an individual patient taking a medicine for long periods of time.The other thing you're going to see is that it's incredibly productive.We're in that magic moment in the company's history, where the people and the experience and the technology and the ip and the culture really start to gel.And it's a really heady time for us at alkermes.So, let's start with kind of the highest conceptual level, and that's our interest in chronic disease.So in this figure, we plotted diseases, as a function of a number of patients suffering from that disease and the number of treatments that might be available for that disease.So historically, you would have thought the big pharma was happy in that topright quadrant.Deal with the major chronic diseases, cardiovascular disease, diabetes, asthma, and the like.Whereas biotechs, origins and much biotech action still stay in the lower left, in orphan indications, where often, it's the first medicine ever developed for a patient population.What's so interesting is pharma's migration now down into that space, attracted by the freedom of pricing, and the more favorable regulatory environment, often.But well that it may not even make sense for pharma to do that.It neglects the fact that the top right quadrant is still where the burden of disease lies.These are millions of people, these are the diseases that are going to break the bank of this country, and other counties, and this is where there's still so much unmet medical need and economic opportunity.So, alkermes is running against this current.We're really excited about that topright quadrant, and we're quite excited about playing in places, where there are big diseases, with unmet medical needs that we still can improve patient outcomes.But we're taking a biotech approach to this, in a sense that so you'll hear today most of the programs that we're working on, we're looking for subsegment or further refine the definition of a fairly of an incoherent definition.Schizophrenia, what does it mean?There's all kinds of schizophrenic patients.And by picking specific subsets and creating medicines that are directly focused on solving particular needs for those, it changes the risk profile, it changes the regulatory interaction, and i think provides us with a really broad opportunity.This, i think, is a critical differentiating feature in this company. We're playing in big xafss with bigDrug opportunities using modern science, and it's a theme you'll hear throughout the day.So what do we do?Here's what we do.We're making now, valuable new medicines.And the words are chosen deliberately. TheseDrugs need to be valuable, and they need to be new. This is essentially a checklist that we run through when we think about ourDrug development programs and advancing programs in our development portfolio. First, we focus on specific problems with patient experience living with chronic disease because taking aDrug for a long period of time is taking is different than taking aDrug on an asneeded basis.We identify at the outset, the general parameters of the value proposition for key stakeholders.We don't have to solve it at the outset, but we have to be cognizant of the value proposition for everybody involved, not just the patient, and the caregiver and the provider, but the fda, the payers, and the whole ecosystem that's affected by the new medicine.

10.03.2014.

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