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alcobra' s share price has lost most of its value since september 2014, when the main trial of alcobra' s flagship drug for treating adhd was unsuccessful. a trial of another drug has since failed .
brett johnson: we are here with david baker from alcobra pharmaceuticals talking about the company and this development of their adhd drug. thanks for joining us today. can you tell us, what does alcobra do ?
regenera’s shareholders believe that their offer will be beneficial and create value for both companies and their shareholders. to back this belief, regenera’s shareholders have committed to purchase from alcobra’s current shareholders, shares worth $ 10 million at company valuation of $ 47. 5m for alcobra .
about alcobra alcobra ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of medications to treat cns and cognitive disorders. for more information, please visit the company' s website, urltoken, the content of which is not incorporated herein by reference .
pre - ind meeting held on alcobra’s proprietary a buse - d eterrent, a mphetamine i mmediate r elease (adair) product candidate .
alcobra will continue to explore the promise of mdx in other conditions, including fragile x syndrome, potentially with a partner in europe, daniely added .
alcobra acknowledged today that its attention - deficit / hyperactivity disorder (adhd) candidate metadoxine extended release (mdx) has failed a phase iii trial .
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regenera pharma ltd. shareholders have submitted a formal offer to the board of alcobra pharmaceutical ltd (nasdaq: adhd) to buy their shares in exchange for 66. 6% of the combined company. as part of the proposed deal, regenera’s shareholders will launch a $ 10 million tender offer to alcobra’s shareholders at a valuation of $ 47. 5 million for alcobra, a 50% premium on last night' s closing market cap of $ 31. 42 million .
david baker: alcobra is a cns specialty pharma company. we only have focused on cns products up until now. our lead area of focus has been adhd .
alcobra said its topline data analysis was conducted on measure’s full analysis set, which included all of the study’s 283 randomized subjects with at least one post - baseline efficacy assessment .
about alcobra alcobra ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of mdx (metadoxine extended release), a proprietary drug candidate, to treat cognitive disorders including adhd and fragile x syndrome. for more information, please visit the company' s website, urltoken, the content of which is not incorporated herein by reference .
the official minutes reflect the fda’s agreement to review the data collected thus far in alcobra’s phase 3 measure study and consider it in a future nda submission of mdx for treatment of adhd. the fda and alcobra agreed that such an analysis could provide important information with regard to the effectiveness of mdx, as well as information on its safety and tolerability, allowing a more informed discussion of future development activities, as needed. alcobra has already begun processing the available measure study data and expects to report top - line results for measure in the coming weeks .
alcobra ltd. , founded by dr. dalia megiddo and udi gilboa, is a privately held pharmaceutical company operating out of israel focused on the research, development and commercialization of novel products for the treatment and control of cns disorders. alcobra' s lead drug candidate, mg01ci, an extended - release formulation of metadoxine, is developed for adhd and other cognitive disorders .
adhd, a cognitive disorder characterized by inattention and / or hyperactivity - impulsivity that interferes with functioning or development, affects about 4 percent to 5 percent of adults globally, according to alcobra .
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alcobra took a body blow last year when the fda placed a clinical hold on its lead drug metadoxine, but a failed phase 3 trial has now delivered a coup de grâce for the program .
alcobra will hold an investor conference call and webcast on tuesday, february 7, 2017 at 8: 30 am est. members of alcobra’s senior management team, including dr. daniely, dr. tomer berkovitz, cfo & chief operating officer, and mr. david baker, chief commercial officer, will provide additional insights into plans for the development and market opportunity of adair. details are provided below .
meanwhile, alcobra is sitting on around $ 50 million in cash, according to chief operating officer tomer berkovitz, who said the company will look for ways to reduce its costs in the coming months .
the drug has a checkered past. the u. s. food and drug administration earlier this month recommended alcobra conduct a an extra six - month mdx trial to expel safety concerns emanating from preclinical data .
the finding dashes alcobra' s hopes of shaking up the market for adhd drugs with a drug specifically developed for adult patients with the condition, and shares in the company had already slid more than 40% this morning .
following the successful completion of the phase i study of mg01ci in 2010, teva took an equity position in alcobra, in addition to the right to acquire the company in stages up to full ownership upon regulatory approval of mg01ci .
in 2014, alcobra said it was encouraged by mdx' s impact versus a placebo in a prior late - stage adult adhd trial, only after excluding four patients from the analysis, citing
extreme placebo responses .
( urltoken )
investor contact: alcobra investor relations debbie kaye us: 212 - 390 - 8964, intl: + 972 - 3 - 7299871 ir @ urltoken media inquiries: sam brown, inc. mike beyer 312 - 961 - 2502 mikebeyer @ urltoken
we consider the negative findings of the study to be conclusive ,
said alcobra' s chief executive yaron daniely on a call with investors today, saying it is now unlikely that the company will invest further in metadoxine for adhd .
( reuters) - alcobra ltd said it would abandon evaluating its only experimental drug to treat attention deficit hyperactivity disorder (adhd), after a failed late - stage study, wiping away more than half the company’s value before the bell on tuesday .
the failure announcement came a week after alcobra won fda agreement to review data collected to date in the measure study and consider it in a future nda submission of mdx for adhd. the fda also agreed to change a full clinical hold for the trial to a partial clinical hold pending review and approval of the company’s proposed protocol for a 6 - month, phase i study to assess the potential relevance of adverse findings observed in long - term animal studies of metadoxine in relation to human exposure, alcobra said .
investors responded to the failure announcement with a stock sell - off that sent the price of alcobra shares tumbling nearly 52% in premarket trading as of 8: 55 a. m. , to 92 cents from the friday close of $ 1. 90 .
i don' t believe the efficacy outcome of this study has any bearing on fragile x or any other cognitive disorder ,
said daniely. alcobra may explore studying the drug in fragile x in europe, but would need a partner for that project, he suggested .
options could be to continue to develop metadoxine in other indications—notably fragile x syndrome outside the u. s—or indeed other pipeline projects, but there were few details to be had on the latter other than assertions that alcobra has been stepping up efforts to identify promising projects since last year .
u. s. investor contacts lifesci advisors, llc michael rice 646 - 597 - 6979 mrice @ urltoken media inquiries sam brown, inc. mike beyer 312 - 961 - 2502 mikebeyer @ urltoken israel investor contact: alcobra investor relations debbie kaye + 972 - 72 2204661 debbie @ urltoken
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db: well, i think alcobra’s got a great, experienced management team. i think we have an underappreciated asset and the adhd market space is a very attractive space. it’s close to $ 10 billion a year in revenue in the u. s. alone and in many ways, it’s an underappreciated space .
“we are exceedingly disappointed with these topline results, ” alcobra president and ceo yaron daniely, ph. d. , mba, said in a statement. “in the coming weeks, the company intends to review the full dataset from measure. consequently, we will evaluate our options and communicate our strategic plan to investors. ”
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we are very pleased with the phase ii data announced today ,
said dr. aharon schwartz, head of teva' s innovative ventures .
our collaboration with alcobra on the development of mg01ci for adhd complements teva' s focus on developing a portfolio of products within our core specialty area of expertise - neurological disorders .
mdx is an extended - release oral formulation of metadoxine (pyridoxol l - 2 - pyrrolidone - 5 - carboxylate), an inhibitor of the gamma - aminobutyric acid (gaba) transaminase enzyme responsible for the degradation of gaba. in addition to adhd, alcobra is developing mdx as a treatment for fragile x syndrome and cognitive impairment .
alcobra just announced results from their trial of a proprietary formulation of metadoxine in fragile x syndrome subjects, and there is a glimmer of hope in their announcement urltoken. while the drug did not show any beneficial effect on the primary outcome measure (essentially, an adhd scale) it did result in some statistically significant improvement on 2 secondary measures .
forward looking statements this press release contains forward - looking statements within the meaning of the
safe harbor
provisions of the private securities litigation reform act of 1995 and other federal securities laws. because such statements deal with future events and are based on alcobra' s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of alcobra could differ materially from those described in or implied by the statements in this press release. for example, forward - looking statements include statements regarding the timing of future development activities and clinical studies (if the same are initiated at all and under what circumstances) and the timing and status of the results thereof, whether and when the clinical hold will be lifted and under what conditions, whether and when alcobra will submit an nda and whether it will be approved by the fda and timing of future communications to investors. in addition, historic results of scientific research do not guarantee that the conclusions of future research would suggest similar conclusions or that historic results referred to in this press release would be interpreted similarly in light of additional research or otherwise. the forward - looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “risk factors” in alcobra' s annual report on form 20 - f for the fiscal year ended december 31, 2015, filed with the securities and exchange commission (sec) and in subsequent filings with the sec. except as otherwise required by law, alcobra disclaims any intention or obligation to update or revise any forward - looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise .
in the process of doing that, i stumbled across alcobra as they were reporting out some phase 2 clinical data on the earlier compound that we spoke about. as they were getting ready to enter phase 3, i reconnected with their ceo and joined them at that point to become the first commercial person in the organization. i’ve been there 3 years now .
these results confirm previous clinical experience indicating mg01ci may have a quick onset of activity with few side effects, distinguishing it from other non - stimulant adhd treatments ,
said dr. yaron daniely, ceo of alcobra .
based on the positive results of this phase ii trial and the high unmet need for novel adhd treatments, we intend to commence phase iii studies in adults in 2012 and later on in children .
- alcobra and fda agree on review of available data from the phase 3 measure study in a future nda submission - top - line results from the measure study to be reported in the coming weeks - fda to modify clinical hold from full to partial to allow the conduct of a phase i safety study - management to hold a conference call & webcast today, january 9th at 8: 00 a. m. eastern time / 5: 00 a. m. pacific time
the fda also agreed to modify the full clinical hold to a partial hold, pending review and approval of alcobra’s proposed protocol for a 6 - month, phase 1 clinical study to directly assess the potential relevance of adverse findings observed in long - term, non - clinical (animal) studies of metadoxine with regard to human exposure. the fda will review results from this safety study and consider the complete lifting of the full clinical hold currently in place on the mdx programs .
“we are encouraged by this productive meeting with the fda and the progress made in outlining the development path for a future nda submission of mdx for treatment of pediatric and adult adhd, ” said dr. yaron daniely, president and ceo of alcobra. “our focus now is on analyzing the topline data from measure and working closely with the fda to resume clinical development activities with the goal of bringing mdx to market for the benefit of patients affected by adhd or other cognitive disorders. ”
the folks at alcobra rightly note that this is the best showing to date for any drug in fragile x, and that both the kitap and vabs are appropriate and relevant outcome measures, and either could have been designated the primary outcome measure. the scale which was chosen as the primary endpoint, the adhd rs - iv inattentive subscale, was apparently chosen because the drug is thought to work mainly by enhancing attention, but the precise effect in fragile x could not have been anticipated .
it is possible that the vabs and kitap are just better or more useful scales for fragile x research, but it is also worth remembering that sometimes one or two secondary measures show apparent improvement which can’t be reproduced in subsequent trials. alcobra has expressed interest in pursuing these findings, and they will presumably feature the vabs and kitap more prominently in the next round of metadoxine trials for fragile x. if they are able to reproduce these results, then there would be hope for this line of inquiry .
about mdx mdx (metadoxine extended release) is a proprietary investigational new drug candidate being developed by alcobra for the potential treatment of adhd and fragile x syndrome. mdx is not a stimulant and acts as a monoamine - independent modulator of gaba (gamma - aminobutyric acid) transmission. in pre - clinical studies to date, metadoxine has shown no potential for abuse or addiction. mdx is currently in phase iii development for adults with adhd, phase ii development for pediatric adhd, and phase ii development for fragile x syndrome .
alcobra ltd will be conducting a clinical trial of metadoxine extended release (mdx) in adults and adolescents, 15 to 55 years old, with fragile x syndrome. the planned phase iib mdx clinical trial will be a multi - center, randomized, placebo - controlled study, conducted primarily in the us. the study is supported by positive data collected from multiple earlier animal studies using metadoxine. results from these studies demonstrated significant improvement in behavioral and cognitive outcomes in mice based on testing and performance of memory, learning, and social interaction .
jerusalem, sep 07, 2011 (business wire) - - teva pharmaceutical industries ltd. (nasdaq: teva) and alcobra ltd. announced today top - line results from a six week, randomized, placebo - controlled, phase ii multi - center study designed to assess the safety and efficacy of mg01ci in adults with attention deficit hyperactivity disorder (adhd). results showed mg01ci met the primary efficacy outcome, demonstrating a significant improvement on the conners' adult adhd rating scale - investigator rated total adhd symptoms score (caars - inv) compared to placebo (p < 0. 03) .
“for more than a year, we have collaborated with capsugel to leverage our combined expertise towards the development of a novel treatment option for adhd. we believe this proprietary, investigational product, if approved, has the potential to be the first abuse - deterrent, immediate - release stimulant, offering additional protection and peace of mind for patients, parents and physicians, ” said dr. yaron daniely, president & ceo of alcobra. “our work on adair recently culminated in a productive pre - ind meeting with the fda, which confirmed a potentially rapid development path towards a 2018 nda submission for adhd. ”
about adair alcobra’s a buse - d eterrent a mphetamine i mmediate - r elease (adair) product candidate is a proprietary, abuse - deterrent oral formulation of immediate - release (short - acting) dextroamphetamine that is currently under development for the treatment of adhd. adair is being specifically designed to limit abuse by snorting or injecting. the u. s. department of health and human services reports that nearly two million people misuse or abuse prescription stimulants annually with studies reporting that 40 percent or more do so by snorting or injecting these products. the adair formulation was developed in close collaboration with capsugel, a global leader in delivering high - quality, innovative dosage forms and solutions .
this announcement has been posted as a courtesy by the national fragile x foundation (nfxf) on behalf of alcobra ltd. the announcement and the parties conducting and sponsoring the research meet guidelines established by the nfxf regarding relevancy and appropriateness to fragile x. the nfxf takes no position and makes no claims as to the potential benefits of the study including those studies involving medications, and cannot be responsible for any outcomes, lack of outcomes or unintended side effects. your name or other personal information have not been shared with the researchers / company / institution. if interested in participating in this research, it is your responsibility to use the contact information in this announcement. additional opportunities for being part of research studies can be found at urltoken .
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the israeli drug developer is evaluating assets - both internal and external - and will present its strategic direction to shareholders in the coming weeks, chief executive dr. yaron daniely said on a conference call .
at first, it was believed to only affect children, but adhd is now known to persist into adolescence and adulthood .
the drug, mdx, did not induce a statistically significant benefit over a placebo in the 283 - patient “measure” trial, the company said .
the regulator had placed a clinical hold on the long - acting therapy in september in light of this data .
about 80 patients discontinued treatment in the measure study after the imposition of the hold, daniely said on tuesday .
in 2015, the drug failed a mid - stage study in fragile x syndrome, a rare genetic condition that causes a range of developmental problems. (urltoken )
shares of the company, which said it expects to end 2016 with a cash balance of $ 50 million and has less than 20 employees, were down 52. 6 percent at 90 cents on the nasdaq in premarket trading .
the israeli drug developer is prepared to buy shares in exchange for 66. 6% of the combined company .
regenera is a clinical stage company led by check point software technologies ltd. (nasdaq: chkp) chairman marius nacht, teva pharmaceutical industries ltd. (nyse: teva; tase: teva) interim president and ceo prof. yitzhak peterburg and dr. zadik hazan, founder of regenera, which is developing a novel drug that is applicable for a wide range of neurodegenerative diseases with a vast market potential .
regenera has successfully completed phase iia in, naion (optic nerve neuropathy, a disease with no treatment available today), receiving good feedback from the fda. regenera is preparing for a phase iii naion trial, meaning it may be as close as 30 months from commercialization .
pre - clinical data shows that the novel drug may be applicable to both rare and more common neurodegenerative diseases such as msa / parkinsonism and dementia. regenera is also aiming at the veterinary market with encouraging early signs .
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in 2015, nearly 25 million prescriptions were filled in the u. s. for immediate - release (ir) stimulants, which represent the fastest growing class of adhd drugs in both the pediatric and adult adhd segments. while effective in the treatment of adhd, cns stimulants have been shown to have high potential for abuse and addiction and are scheduled as class ii controlled substances by the u. s. drug enforcement agency (dea) and other similar agencies outside the u. s. the risks of stimulants are not limited to those who are prescribed the medications. published studies report that between 25 - 60% of teenagers and college students with adhd report being approached to give away or sell their adhd stimulants. other published studies report that 40% or more of the people who misuse stimulants, particularly immediate release stimulants, do so by snorting or injecting them .
attention deficit hyperactivity disorder (adhd) is a group of behavioral symptoms that include inattentiveness, hyperactivity and impulsiveness, with symptoms including disorganized work habits, procrastination and inability to sustain attention on tasks or activities. there are a total of 61 products in development for this indication, by 40 companies and five academic institutions. key companies operating in this pipeline space include nls pharma group and shire .
depression is a mood disorder that causes a persistent feeling of sadness and loss of interest. signs and symptoms include sleep disturbances, including insomnia or sleeping too much, changes in appetite, anxiety, agitation or restlessness and physical problems, such as back pain or headaches. there are a total of 191 products in development for this indication, by 112 companies and 20 academic institutions. key companies operating in this pipeline space include johnson & johnson, sumitomo dainippon pharma, luye pharma group, otsuka holdings and vanderbilt university .
schizophrenia is a chronic, severe, and disabling brain disorder that generally appears in late adolescence or early adulthood. symptoms include delusions, hallucinations, disorganized speech and disorganized behavior. there are a total of 134 products in development for this indication, by 85 companies and nine academic institutions. key companies operating in this pipeline space include omeros corp, suven life sciences, heptares therapeutics, merck & co, sumitomo dainippon pharma and vanderbilt university .
finally, tourette syndrome is a neurological disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics. symptoms include eye blinking and other eye movements, facial grimacing, shoulder shrugging, and head or shoulder jerking. there are a total of 11 products in development for this indication, by nine companies and one academic institution. key companies operating in this pipeline space include catalyst pharmaceuticals, who are fielding two pipeline products .
across all four of these indications, transporters and receptors of neurotransmitters such as dopamine and serotonin are the most common targets, closely reflecting the current treatment landscape of these diseases .
research and markets laura wood, senior manager press @ urltoken for e. s. t office hours call 1 - 917 - 300 - 0470 for u. s. / can toll free call 1 - 800 - 526 - 8630 for gmt office hours call + 353 - 1 - 416 - 8900 u. s. fax: 646 - 607 - 1907 fax (outside u. s .): + 353 - 1 - 481 - 1716 related topics: drug discovery
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bj: the company has had some changes in strategy over the last six months. can you talk a little bit about that ?
db: i wouldn’t necessarily characterize it as a change in strategy, but we’ve clearly changed the focus in terms of the development program. the company was founded in 2008 and went public in 2013 and was mostly focused on the development on what was our former lead asset, mdx, metadoxine extended release, which is a compound that we were developing for adhd and also for other cognitive impairments including fragile x syndrome where we have fast track designation orphan drug status .
we put most of the effort, in term of the clinical development, into the adhd program and starting with an adult adhd program. unfortunately, in january we had the read out of our second phase 3 adult adhd trial and unfortunately we did not separate from placebo. based on that set back, i think we’ve come to appreciate how much of a challenge it is to show efficacy in adult adhd, particularly with non - stimulant product. in fact, we are one of three companies that had setbacks in a matter of the last 3 months in failing clinical trials in adult adhd .
based on that experience, we decided to put that effort on the side. we’re looking to monetize that asset for its possible application in fragile x syndrome but we have turned our attention to a new lead candidate which we refer to as adair. it’s an abuse deterrent amphetamine immediate release. this is a program that we have been working on for about the last 18 months under a service agreement with capsugel, a global leader in developing various formulations, different capsule formulations .
essentially what we are trying to do is to develop a product which would have abuse deterrent products to minimize the risk of abuse, particularly through snorting or injecting. that is, unfortunately, very common with psychostimulants such as ritalin or adderall .
db: what we do is we take dextroamphetamine, which is the active ingredient, and it is essentially embedded into a semi - solid, waxy, gel - like matrix. by essentially sequestering the api, the dextroamphetamine, in this gel or this paste that’s inserted in the capsule, you’re not really changing the activity of the amphetamine if it’s taken as it’s prescribed .
if it’s swallowed, we’ve done dissolution work to show that it releases very similarly to dextroamphetamine so we would expect it’s going to have the same clinical effect. but by embedding this dextroamphetamine in this paste, this matrix, this gel it makes it extremely difficult for someone to grind it up and snort it or to mix it in water or ethanol and inject it .
snorting or injecting are much more serious routes of misuse, actually, abuse of the stimulants which have much more serious consequences. essentially what we are doing is we are trying to minimize the maximum risk that’s associated with these stimulants .
db: sure. the psychostimulants, the adderalls, the ritalins, the concertas, the vyvanses of the world, these are are very effective drugs for treating adhd. they have been used since the 1950’s to treat adhd. unfortunately, because they are controlled substances and they have potential for abuse and misuse, they are very frequently misused .
they are one of the most commonly misused or abused medications that’s available. the u. s. government, through their nsduh, the national survey of drug use and health survey, estimates that 5 million people a year end up misusing or abusing psychostimulants. interestingly enough, when we dug into those data, we found that 90% of those 5 million people who are misusing or abusing a prescription psychostimulant, it’s an amphetamine type of product. an adderall type of product. that’s the compound, the active ingredient we are working with .
db: so the idea here is that instead of prescribing a dextroamphetamine or mixed amphetamine salt tablet, which can easily be crushed and mixed with water and injected or crushed and snorted, we would offer this capsule which offers this extra protection so that we would minimize that potential risk. we’ve gone out and we have spoken to high prescribing physicians of adhd products .
we’ve introduced them to the product concept because we wanted to see the reaction. the physicians were very favorable in their reaction. their point of view was, “look, if this is not cost prohibitive then why wouldn’t i prescribe this instead of generic adderall or generic dextrostat or dexedrine, because it’s giving me, from what you’re telling me, all the same clinical efficacy, the same side effect profile except it’s going to protect against the patient who might misuse or abuse it or it’s going to protect against the non - patient who this medication, unfortunately, may get diverted to by being sold or given away. ”
unfortunately, it is really common with psychostimulants. if fact, there’s reports in the literature that over 60% of college students who have a diagnosis of adhd and are prescribed stimulants admit that at some point they have diverted. they have given away or sold their prescription medication to someone who doesn’t even have the condition .
db: sure, it’s a great question. so, if you look at the cost of the branded adhd drugs, the prices range from about $ 200 a month to about $ 350 a month, depending on which medications you’re talking about. our best understanding is that the generics, like a generic stimulant, a generic adderall, is probably costing about $ 50 a month .
our view is that, in order to make this attractive for patients, for parents of patients, and for manage care payers, we are looking at pricing this probably on the low end of the branded pricing range. in our discussions with payers, when we presented them with this concept and said, “we’re looking to charge at the low end of this $ 200 - $ 350 price range” they, the manage care payers, thought that was reasonable .
they said, “number 1: we expect you as a new product, you’re a branded product, and you’re going to charge branded prices. ” relative to what they’re paying for generics, they didn’t think it was a substantial premium. they didn’t think it was an egregious kind of premium we were proposing. the other component is for the payers. when you’re talking about a product that’s $ 200 - $ 350 a prescription, that’s not a big ticket item for them on an absolute basis. therefore, it’s not something that gets a lot of their attention .
they told us, “we don’t manage the adhd category the same way we manage other categories like the new cholesterol agents or hepatitis c medications or other specialty pharma products that are costing them thousands of dollars a month. in fact, you may be aware, until you get to about $ 600 a month, you don’t trigger this kind of specialty pharma level in the minds of managed care payers or various government payers. we’re trying to stay below that threshold so that we are charging a brand price premium over generic but it’s not a tenfold, twentyfold kind of increase that they don’t like .
the other component of this that, i think is very important is talking to the consumers. we’ve done research with parents of teenagers and young adults who have adhd and are prescribed these short acting stimulants and showed them the product concept .
they were very intrigued by the concept. they said that if the product were available, they’d ask their physician about it. most importantly, they said that they’d be willing to pay a higher insurance copay for their medication. i can’t remember the exact figures but i think 75% of them said they would pay $ 10, $ 20, $ 40 more a month .
basically, from their perspective, depending on what a parent was paying right now in the way of a copay, they’re willing to pay up to about twice the copay that they were currently paying in order to have this medication that would have this extra protection built in .
db: if you look at the adhd market overall today, or in 2015 there were about 67 million prescriptions written. we estimate that as 10 - 11 million people who are taking these medications. of those 67 million prescriptions, 24 million were for immediate release or short acting stimulants, which is kind of the segment that we are focusing on .
in our mind, we feel that if we can just penetrate of the ir stimulants, even just a subset of that as the ir stimulant amphetamine based products, we can get 1 out of 10 or 1 out of 12 prescriptions. that makes this a very financially attractive product for us .
db: we’ve calculated, based on that estimate with pricing at the low end of the branded pricing range and capturing 1 out of 12 scripts for immediate release amphetamines, within 3 to 4 years we would be talking net sales in excess of $ 300 million a year .
db: what i can say is that dextroamphetamine as an api is not an expensive api. even the technology that we are working with, the platform that we’re working on with capsugel as our partner; it’s not very expensive. let’s just say you’re in the range of what you would expect for typical traditional pharmaceutical margins .
db: cost of goods sold for most pharmaceutical products, to my understanding, is well under 10% .
db: sure. i’m kind of a career pharmaceutical guy. i came out of graduate school and was recruited by merck and worked in a variety of sales, marketing, market research and development positions. i was at merck for about 14 years. i’ve worked in a number of therapeutic areas: cholesterol management, osteoporosis, migraine. i was recruited over to shire to head up the marketing of their adhd products back in 2004 .
i was at shire for about 10 years in various positions, mostly commercial positions leading the commercialization of their adhd product line. i eventually became the global manager for vyvanse, which i think is still shire’s biggest product. it sells over $ 1. 5 billion a year now. in my last couple of years, when i was at shire, i started working with colleagues on the r & d side of things to do assessments for new cns products to potentially bring in and fill shire’s pipeline of cns products .
this whole idea of developing and abuse deterrent product, i think is an underappreciated opportunity. we feel that just by tapping into a very small segment of what is and continues to be a growing market, we have something that can be very financially attractive and, frankly, can be the launching point for us expanding into other areas within cns .
phillip polakoff md on the biggest challenges in health and the delivery of healthcare in the u. s. a and worldwide
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we face competition from established pharmaceutical and biotechnology companies that currently market a wide range of drugs to treat adhd. all of these competitors have far greater marketing and research capabilities than us. we also face potential competition from academic institutions, government agencies and private and public research institutions, among others, which may in the future develop products to treat adhd. all of these companies and institutions may have products in development that are superior to mg01ci. our commercial opportunity would be reduced significantly if our competitors develop and commercialize products that are safer, more effective, more convenient, have fewer side effects or are less expensive than mg01ci. public announcements regarding the development of competing drugs could adversely affect the commercial potential of mg01ci .
we are an emerging biopharmaceutical company primarily focused on the development and commercialization of our proprietary drug, mg01ci, to treat attention deficit hyperactivity disorder, or adhd. the most common currently available treatments for adhd are stimulants that increase the brain
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in the study, 56 percent of subjects treated with mg01ci experienced an improvement in their caars - inv score of at least 25 percent, compared to 36 percent of patients in the placebo group (p < 0. 03). additionally, 44 percent of the subjects treated with mg01ci demonstrated an improvement of more than 40 percent in their caars - inv score versus only 25 percent in the placebo group (p < 0. 04). mg01ci was well tolerated, with no drug - related serious adverse events reported and no clinically or statistically significant differences in adverse event profiles between the mg01ci and placebo treatment arms. nausea and initial insomnia were more frequently reported in the mg01ci arm, yet the rate of patient discontinuation due to adverse events was similar in both groups (1. 7 %). importantly, no increase in blood pressure or appetite suppression was recorded in the treatment group .
adhd is the most commonly studied and diagnosed chronic psychiatric disorder in children and adults, affecting about 3 to 5 percent of the population ,
said iris manor m. d. , director of the adhd unit, geha mental health center in petach tikva, israel .
i am very encouraged by the results of this trial, which warrants further clinical development of mg01ci, a novel non - stimulant drug that may benefit many people with adhd .
in the trial, mgo1ci also demonstrated significant improvement on secondary endpoints, including the adult adhd quality of life scale (aaqol) and the test of variables of attention (t. o. v. a. ®) scores .
additional phase ii study results for mg01ci in adhd are planned to be presented at international scientific meetings later this year .
mg01ci is an extended release formulation of metadoxine (pyridoxol l - 2 - pyrrolidone - 5 - carboxylate). immediate - release metadoxine has been used in the treatment of acute alcohol intoxication and treatment of alcohol withdrawal syndrome for more than 30 years. mg01ci allows the prolonging of the exposure to metadoxine and improves its clinical performance. mg01ci was investigated in three pilot studies conducted in healthy adult volunteers at the hadassah medical center liver unit (jerusalem, israel), and in a phase iia study in adhd subjects at the geha mental health center adhd unit (petach tikva, israel) .
teva pharmaceutical industries ltd. (nasdaq: teva) is a leading global pharmaceutical company, committed to increasing access to high - quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. headquartered in israel, teva is the world' s largest generic drug maker, with a global product portfolio of more than 1, 300 molecules and a direct presence in about 60 countries. teva' s branded businesses focus on neurological, respiratory and women' s health therapeutic areas as well as biologics. teva currently employs approximately 42, 000 people around the world and reached $ 16. 1 billion in net sales in 2010 .
teva' s safe harbor statement under the u. s. private securities litigation reform act of 1995 :
mdx did not meet the primary endpoint of the measure clinical trial, namely demonstrating a statistically significant difference from placebo in the change from baseline as measured using the conners’ adult adhd rating scales (caars).
alcobra ltd. is a public , specialty pharmaceutical company . the company is focused on the development of new medications to help patients with cognitive disorders , including attention deficit hyperactivity disorder ( adhd ) and fragile x syndrome . alcobra is headquartered in tel aviv , israel , and also has a u.s. office located outside of philadelphia in plymouth meeting , pennsylvania . 
alcobra ltd. is a public, specialty pharmaceutical company. the company is focused on the development of new medications to help patients with cognitive disorders, including attention deficit hyperactivity disorder (adhd) and fragile x syndrome. alcobra is headquartered in tel aviv, israel, and also has a u.s. office located outside of philadelphia in plymouth meeting, pennsylvania.
alcobra ltd. is a public, specialty pharmaceutical company. the company is focused on the development of new medications to help patients with cognitive disorders, including attention deficit hyperactivity disorder (adhd) and fragile x syndrome. alcobra is headquartered in tel aviv, israel, and also has a u.s. office located outside of philadelphia in plymouth meeting, pennsylvania.