Showing posts with label point. Show all posts
Showing posts with label point. Show all posts

Saturday, 28 September 2013

Primary care is at crisis point and under pressure to change

ambulance outside hospital The short term crisis in A&E and the long term need to move care out of hospitals are two pressures facing primary care. Photograph: David Levene for the Guardian

Primary care is about to be seized by a degree of turbulence and change that will make the acute sector look ordered and calm.

The pressures for change are coming from every direction: the short-term crisis in A&E, the long-term need to move care out of hospitals, the need to improve access to GPs while reducing their workload, the tightening economics of general practice and the need to improve clinical quality.

Looming over all this is the determination of Jeremy Hunt, the health secretary, to claim the government has "sorted out primary care". His speech to the King's Fund last week made plain his game: having decided that the Labour's 2004 GP contract is the source of problems ranging from poor care of older people to A&E pressures, he is going to rewrite it by next April, sweeping away bureaucracy and securing a "dramatic simplification" of targets and incentives.

The demands for higher clinical standards and a wider range of community services are combining with the need for GPs to cut costs to eradicate singlehanded practices slowly. While GP federations and networks are growing, others are taking a more radical approach.

The Vitality Partnership in Birmingham, one of the models debated at the King's Fund primary care conference, is standardising procedures, has clinical peer review backed up by its own turnaround team, runs an effective patient records system which is gradually reaching local hospitals and has centralised, low-cost administration. It is now a major provider of services such as rheumatology and dermatology.

GP culture can often present itself as conservative, suspicious, even cynical, but the reaction of groups such as Vitality to the threats and opportunities shows the passionate and entrepreneurial side of primary care. It is also striking how leading players are not waiting for the local area team or clinical commissioning group to tell them what to do; they are leading change themselves.

These organisations are a long way from the public's traditional perceptions of the family doctor. They are increasingly large, multidisciplinary teams with efficient, benchmarked systems run across several sites. Against this background, the independent contractor model for general practice looks archaic. Professor Clare Gerada – soon to begin her part-time role for NHS England as clinical chair for primary care transformation in London – is already preparing us for its demise.

On top of all this, everyone, from NHS England to clinical commissioning groups, now recognises that shunting primary care commissioning to NHS England's local area teams was a bad idea. It will fail to align primary services with the groups' wider goals and it will not deal effectively with substandard doctors.

Involving groups in primary commissioning means solving the issue of GP commissioners facing a conflict of interest. One solution could be for councils' health and wellbeing boards to play a role in awarding primary care contracts, such as overseeing the governance.

With all this change, it is difficult to see how the GP workload is going to fall. The widely claimed 14-hour days are simply unsafe. As the Care Quality Commission's new chief inspector for primary care, professor Steve Field, begins work, there is a risk of GP services becoming the next part of the NHS to be accused of serious failings.

Hunt has promised more primary care funding, and Health Education England has been charged with getting many more GPs into the system, but even the minister admits existing plans may be inadequate. And beneath these national numbers many areas with the worst health are desperately short of GPs.

Overall, significant parts of the primary care system are unsustainable financially and clinically, but elsewhere GPs are building new, integrated care systems in the community which hold out the prospect of reducing emergencies, shifting treatment away from hospitals and improving access. This is a cause for optimism, but it needs more money and more staff. Funding has to be moved from acute to primary care, which means shutting some hospital services.

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.


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Thursday, 29 August 2013

IntelliPharmaCeutics Sell Off On Acura Data Overdone... Compelling Entry Point

IntelliPharmaCeutics' (IPCI) shares were weak (-5%) on the heels of disappointing data from Acura Pharmaceuticals (ACUR) [which was down -20% on the news] for a product ostensibly similar to its Rexista technology. The stock could potentially decline some more as investors digest the news over the next few days, which I believe could be a compelling buying opportunity. The stock has been thinly covered on this Board, and the latest action may prompt some to revisit the story.

First, Some Brief Background

IntelliPharmaCeutics International Inc. (IPCI) is a pharmaceutical company specializing in the research, development and manufacture of generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technologies are a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a range of existing and new pharmaceuticals. Based on its technologies, IntelliPharmaCeutics has a pipeline of product candidates in various stages of development, including eight abbreviated new drug applications (ANDAs) filed with the Food and Drug Administration FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Acura Disappointing Results

On August 27th, Acura announced disappointing Phase II data from its Study 301, in which it did not find statistical significance in the 40 person study among recreational drug users in assessing the abuse liability of snorting a crushed hydrocodone bitartrate with acetaminophen tablet formulated with Acura's abuse deterrent AVERSION technology. Shares declined by 20% reflecting this news, i.e. that AVERSION H&A had slightly lower numeric mean maximum drug liking (Emax: 72.1) compared to an equivalent dose of a generic hydrocodone/acetaminophen tablet (Generic H&A: Emax: 75.6) currently on the market, but that it wasn't statistically significant.

Rexista's Profile: Differentiated

As a refresher, Rexista is a novel abuse resistant drug delivery platform which is in clinical development. It is a unique dosage form for Oxycontin (which had $2.4b in US sales), and protects against intentional or unintentional dose dumping (if tablet crushed or taken with alcohol).

While the company has not disclosed the specifics behind the Rexista technology other than to say that its patent information is not similar to Acura's, there are some interesting tidbits that give comfort that the company would avoid a disappointing trial result. In its July 15th press release, IPCI disclosed that it ended the Phase I study showing Rexista has bio-equivalence to Purdue's Oxycontin, and that it has done anti-tampering studies across a wide range of applications, not only with crushing, but also with variety of alcohol combinations, microwaving, freebasing, and snorting (specifically that it can't be snorted as in contact with an aqueous media, it turns gelatinous). Said another way, results suggest that the formulation promotes the stability of Rexista oxycodone without interfering with oxycodone bioavailability. The alcohol challenge studies, beverage extraction studies, vaporization studies, and pulverization studies show that release of oxycodone will be inefficient/slow/difficult/otherwise not ideal.

This range of tests demonstrate that the company has sought to examine a variety of potential avenues for abuse, and potentially, will show a greater range of efficacy than its competitors. After Acura's results, All eyes remain on Pfizer's (PFE) Ramoxy in the near term, as it will go before the FDA for a 3rd time and could lead the class forward in this respect. Pfizer, although it has had 2 disappointments with the FDA thus far, has previously said they could get 20% of the market from Purdue.

I have seen that the FDA has published guidelines for what will qualify as an abuse-proof form of an opioid formulation. The guidelines review various levels of abuse deterrents. Labeling claims will fall into one (or more) of four tiers, specifying physiochemical barriers, reduction of effects upon abuse, meaningful reduction in abuse, and reduced abuse in community to inform healthcare providers of products predicted or actual abuse potential. These claims will generally require data to support their use.

IPCI will be seeking a special protocol assessment (SPA) for its Ph-III trial (will begin in 1H/14) ahead of the NDA 505b2- which will be a double blind randomized evaluating the analgesic efficacy of Rexista in comparison to a placebo over a 12-week treatment period in patients having pain intensity scores corresponding to moderate-to-severe pain, and will test 2x dosing similar to OxyContin.

The Bigger Picture: Focalin and other ANDAs

Rexista is the most 'sizzling' part of the story (in my view), however, IPCI does have 8 ANDAs for generics filed for FDA, which represent some $4.6b of sales: Focalin, Effexor, Protonix, Glucophage, Seroquel, Lamictal, Keppra, Pristiq. The lead product is the generic Focalin, which generated US sales of $615mm TTM, and is partnered with Par on a 10-year profit sharing arrangement. The company has laid out a series of scenarios as to the bottom line impact of the launches for each of these drugs, based on the dosages they have received first to file (in this case, vs. TEVA for Focalin), as well as the overall MAC discounts (50-70%) and then market penetration (10-20%) and gross profit arrangement (20-50%) assumptions, as well as the overall % of generics in the market & timeline (in this case, 90% within 6 months). In the case of Focalin XR, the company expects between $20-65mm for itself from the partnership. The good news for Focalin XR, and for that matter, any XR product, is that there is a better moat for barrier to entry vs. the Chinese/Indian generics players, with better pricing as a result.

Financial Profile/ Risk-Reward

With the stock at $2 (down 7% as of this writing) the market cap is $43mm, and liquidity is 300k shares traded daily, or $600k notional, which is illiquid, but not terribly so. The company's current cash position is $1.6m, but after their $3.1m financing, they will have a net cash position of $2.5m and has a debt balance of $2.1m as of last filing. Company burn rate is ~$500k a month. About 100k shares are short. The company is covered by 3 banks - Roth Capital, Brean, and Maxim, all of which were involved in the equity raise/underwriting.

Insiders own 35% of the float (21mm shares outstanding overall)… with 28% shares owned by Founders, and some large institutions soaking up much of the float (Broadfin 9%, Ab 9%, H&Q 8%), and others… meaning that the actual true float is likely something like 50% of the share base.

In looking at the consensus estimates, it appears there is a wide range on the top and bottom line. For 2014, the revenue range is from $6m to $44m (wow), and by 2016, the top line range is from $28-58mm… on the bottom line, expected EPS ranges are from $0.13-$1.17 in 2014, and from $0.57-$1.01 in 2016. So clearly not a lot of 'consensus' in these estimates themselves.

At current levels, the risk/reward profile is intriguing: with Focalin approval plus a normalized sales capture from the ANDA pipeline, it is conceivable to have a steady state run rate of ~25mm top line in '14 (notwithstanding the wide range on the Sell Side), which, applying a normalized top line multiple, would put the market cap around $75-100m, or roughly ~2-2.5x upside from current levels. Since the ANDA process has been delayed so long, further delays are already 'in the stock' and the downside is likely 25-30% lower from here, reflecting the push out of the lead product.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in IPCI over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Thursday, 1 August 2013

The point at which the capacity to differentiate between living and non-living beings and environmental awareness develop

Main Category: Psychology / Psychiatry
Also Included In: Pediatrics / Children's Health
Article Date: 31 Jul 2013 - 1:00 PDT Current ratings for:
The point at which the capacity to differentiate between living and non-living beings and environmental awareness develop
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José Domingo Villarroel, a researcher at the Teacher Training College in Bilbao (UPV/EHU-University of the Basque Country) has studied the capacity to differentiate between living and non-living beings and how this relates to environmental awareness.

118 girls and boys between the ages of 4 and 7 from public primary schools in Plentzia, Urduliz and Sopelana participated in the research and were interviewed by Villarroel himself. He himself says that the work was very laborious, "but enjoyable and what is more, the results were very striking."

Each interview consisted of two parts. The aim of the first was to analyse the capacity of the children to differentiate between living beings and inanimate objects. The children were shown eight photos, of which four were close-ups of living beings (a dog, a bird, a tree and a flower); the other four depicted inanimate objects: the sun, clouds, a car and a motorbike. "When each of the photos was shown to them, they were asked what they could see: a living being or an inanimate object."

The images used in the second part of the interview depicted inappropriate behaviour types and they had all been selected from children's books. These examples of bad behaviour could be classified into three groups: the ones that exert a negative effect on the wellbeing of someone else (taking away someone else's possessions or using violence against one's friends); the ones that do not fit in with social rules (picking one's nose or eating in a messy way); and the ones that harm plants (treading on a flower or carving drawings on a tree trunk using a knife).

Villarroel explains that "in the interview the children were presented with a dilemma; in other words, they were shown two examples of bad behaviour, and they had to choose which of the two was worse. They were presented with two kinds of dilemmas: in one they had to choose between breaking social rules or influencing the wellbeing of others; in the other, to break social rules or harm plants".

Moral thinking and the world of emotions

The researcher felt that the results of the work were interesting. "In the first part the responses were the expected ones. In fact, many children, especially young ones, are not capable of differentiating between living beings and non-living ones; for example, they find it very difficult to understand that a tree is a living being, yet they tend to believe that cars and motorbikes are alive," explains Villarroel. Children appear to relate the fact of being alive with movement.

In the second part, he found the results more striking, because he spotted a 'paradox'. Apparently, children believe that hurting another child or plants is more reprehensible that breaking social rules, "also in the cases in which they think that plants are not living beings." In other words, they are not absolutely sure whether the flower is a living thing; but they think it is much worse to tread on a flower than to slurp your soup or stick your fingers up your nose."

According to Villarroel, that paradox suggests that the awareness towards others is developed at an early age and that the development of moral thought is linked to the affective world, in other words, with what they receive from their parents and educators, and not so much through logic or rationality. "In fact, there are two main approaches that seek to explain the development of moral thought: some believe that it has to do with logical capacity; whereas others link it to the emotions and the affective world. The results I got reinforce the second approach," says Villarroel.

The research has been published in the scientific journal SpringerPlus, under the title "Environmental judgment in early childhood and its relationship with the understanding of the concept of living beings". And Villarroel has announced that he will be pursuing his research in the same direction: "Firstly I am very interested in finding out how children develop environmental awareness through their parents. And secondly, I would like to conduct the same research in other contexts, and also by comparing children from large and small populations, for example." He is also planning to publish another article on the same line of research in the specialised journal Journal of Biological Education.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our psychology / psychiatry section for the latest news on this subject.

José Domingo Villarroel (Barakaldo, Basque Country, 1967) is a PhD holder in Biology. For several years he was a teacher of science and mathematics in Statutory Secondary Education. He currently lectures and researches at the Teacher Training College in Bilbao (UPV/EHU), in the Department of the Didactics of Mathematics and Experimental Sciences. He has had various scientific papers and books published; most of them deal with the comprehension and learning processes of basic scientific concepts.

Elhuyar Fundazioa

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