Teams from the University of Arkansas for Medical Sciences, University of California, San Francisco, Creighton University and the University of Nebraska Medical Center will each receive the national award, sponsored by Teva Pharmaceuticals, at the 2012 AACP Annual Meeting.

In addition to receiving a commemorative prize, the winning pharmacy colleges and schools will receive $10,000 to be used exclusively to support the expansion of the recognized program or new community engaged service projects at the school. Each team receives a $5,000 financial stipend for enhancing or sustaining the recognized program or for travel support to attend and present their projects at professional meetings. The award also includes up to $2,500 to cover travel, lodging, and registration expenses for one designated student and one faculty advisor to attend the national awards ceremony at AACP’s 2012 Annual Meeting and explain their project’s impact on the community during a special session, as well as a $1,000 stipend for the faculty advisor.

A student representative and faculty advisor from each of the following schools (listed in alphabetical order by state) will be honored with a Steuben Glass Star Stream during the 2012 AACP Annual Meeting, July 14-18, at the Gaylord Palms Resort in Kissimmee, Florida.

School: University of Arkansas for Medical Sciences College of Pharmacy

Team leader: Corey J. HayesTeam members: Sara M. Benfer, Christine L. Browning, Alissa J. FerrariFaculty advisor: Schwanda K. Flowers, Pharm.D.

The University of Arkansas for Medical Sciences (UAMS) College of Pharmacy has a longstanding commitment to serving underserved populations. Illustrating this commitment is the college’s partnership with the Consulate of Mexico in Little Rock. As a result of the Consulate’s commitment to improve the living standards of Mexican communities in the region, the Ventanilla de Salud (VDS) was developed. The VDS seeks to provide information and referrals regarding healthcare resources for this vastly underserved population.

The College of Pharmacy became involved with VDS to provide influenza jobs.pharmacy-bg.com/tag/vaccine/”title=”vaccine” >vaccines and other preventative screenings at the Consulate. Patients are screened for diabetes, hyperlipidemia, osteoporosis and hypertension. Student pharmacists, under pharmacist’s supervision, provide H1N1 immunizations. Since the partnership was initiated, a total of 723 patients were immunized for influenza, 258 patients were screened for diabetes, 254 for hypertension and 185 for osteoporosis. In addition, all of these patients were provided verbal and written patient education in Spanish regarding these disease states and healthy living. The project demonstrates to students and participating pharmacists the importance of providing healthcare to underserved populations while promoting an understanding of the growing Latino culture in the area. Understanding different cultures brings better acceptance and better healthcare to these populations. The College of Pharmacy intends to expand the population base to include children because they accompany many of the VDS participants to the Consulate.

School: University of California, San Francisco School of Pharmacy

Team leader: Rebecca HluhanichTeam members: Meghan Frear, Helen Gavrilova, Rebecca Gayle, Nicha Tantipinichwong, Van VuongFaculty advisor: Marilyn R. Stebbins, Pharm.D.

The Partners in D program started at the University of California, San Francisco (UCSF) School of Pharmacy in 2006 when four student pharmacists and faculty identified a need to help underserved Medicare patients understand the Medicare Part D prescription drug program (Part D). Under the supervision of faculty members, students visited low-income housing complexes in the San Francisco Bay Area using personal laptop computers and cell phones to help underserved seniors navigate the complex Part D benefit.

At the same time, the community of current and future prescribers needed help understanding and navigating this complex benefit. When UCSF’s health policy expert, Dr. Helene Lipton, was asked to give a lecture on the components of Part D to 150 UCSF advance practice nursing students, she suggested that student pharmacists enrolled in her health policy class who were working in the field helping seniors with Part D give the lecture. With the support of the Dean’s office, and after receiving training, five student pioneers delivered their first Part D lecture to health professional students, receiving evaluations that far exceeded those typically achieved by faculty. As a result, the Peer Educator teaching initiative became an integral component of the Partners in D program. These lectures, presented by student pharmacists, are delivered to health professional students, trainees and faculty at UCSF and throughout the San Francisco Bay Area.

School: Creighton University School of Pharmacy and Health Professions

Team leader: Edward M. SaitoTeam members: Megan E. Geyer, Shelby M. Mizumoto, Tim J. Schulte, Stuart B. UtleyFaculty advisor: Ann M. Ryan-Haddad, Pharm.D.

The Creighton University Interprofessional Falls Prevention Program assisted Seven Oaks of Florence, an independent living community in Omaha, Neb., in completing its COLLAGE Health Assessments, a customized suite of standardized and systematic resident assessments that evaluate health and wellness in areas such as memory loss, nutrition, balance and mental well-being.

The fall prevention program was comprised of three elements: data collection, assessment and intervention. Pharmacy and nursing students visited with residents on a weekly basis to conduct COLLAGE interviews. During these sessions, students asked residents about their general health and well-being, specifically targeting the issues of balance, vision, hearing, incontinence and medication use. Student pharmacists compiled a complete medication list and past medical history of self-reported diagnoses for each resident. An initial medication review was then performed to screen for drug-related fall risks. After all the data had been collected, adjustments were made to the patient’s medical care and home life to lower the risk of falling.

The project promoted the health and independence of an underserved population while fostering interprofessional teamwork and collaboration. The team, which consisted of 35 physical and occupational therapy, pharmacy and nursing students and six faculty advisors, performed 41 COLLAGE assessments, 19 Berg Balance assessments and six home safety checklists. Benefits to the residents were the assessments to identify risks for falls and recommendations for interventions to prevent falls, while the students were provided with opportunities to communicate with older adults, participate in clinical decision making and contribute to a healthcare team.

School: University of Nebraska Medical Center College of Pharmacy

Team leader: Kyle McCartneyTeam members: Brandon Bohn, Mary Manning-Kechely, Becky SchainostFaculty advisor: Kristen M. Cook, Pharm.D.

The Student Health Alliance Reaching Indigent Needy Groups (SHARING) Clinic is an interdisciplinary program that brings together medical, nursing, pharmacy, physician assistant, physical therapy, medical technology, public health, counseling and nutrition students to provide care to the uninsured and indigent in the Omaha area in various clinic settings. These include a family medicine clinic, a clinic for prevention and treatment of sexually transmitted diseases, and a third clinic providing care for patients with type 2 diabetes. It is unique to the Omaha area in that it is the only clinical program funded and managed by students from the many healthcare disciplines at UNMC.

Pharmacy plays an integral role on the interdisciplinary healthcare team. At the SHARING clinic, the student pharmacists and other student providers obtain a comprehensive patient history, and together they design and implement an optimal therapeutic regimen for the patient. Student pharmacists are utilized specifically during a patient’s medication review and when a patient is counseled on medication use. Students are also an excellent resource for educating patients about other aspects of therapy including the use of medical devices such as glucometers and inhalers. The student providers from other disciplines rely on student pharmacists for up-to-date information about correct dosages, appropriate medication changes, formulary management and substitutions, indications, side effects, and cost effectiveness, demonstrating the value a pharmacist can contribute to patient care. It establishes collaborative practice as a standard of care in one of healthcare students’ first exposure to patients.

About AACP

Founded in 1900, the American Association of Colleges of Pharmacy (AACP) is a national organization representing the interests of pharmacy education and educators. Comprising 124 accredited colleges and schools of pharmacy with more than 6,000 faculty and 60,000 students, AACP is committed to excellence in pharmacy education. Visit www.aacp.org to learn more and stay connected with the Association on Facebook, LinkedIn and Twitter.

Student Pharmacists to Receive National Community Engaged Service Award American Association of Colleges of Pharmacy (AACP) is a post from: Pharmacy in jobs, news, schools

During the week-long celebrations, the  Indian Pharmaceutical Association local branch Belgaum conducted a 2-km rally.   The rally was inaugurated by Prof. Chandrakant Kokate, Vice Chancellor, KLE University, Belgaum along with dignitaries including  Deputy Drug Controller, Drug Inspector, Belgaum district, Prof, F V Manvi, Dean, Faculty of Pharmacy, KLE University, Prof, A D Taranalli, Principal, KLEU’s College of Pharmacy, Prof. M S Ganachari, President, IPA local branch.

With the objective to create awareness on theme “Pharmacist- a healthcare professional”, pharmacists from various colleges participated.  In continuation to these activities, pharmacists and  faculties from KLEU’s College of Pharmacy, Belgaum visited various schools and delivered sessions on  dangers of self medication and the promising prospects of pharmacy as a career.

There was also a “Pharma Exhibition” to create awareness and encourage school going students to learn practical aspects of drug utilization. This event was held at KLE University’s College of Pharmacy premises and inaugurated by Prof. A D Taranalli, Principal. Various schools of Belgaum city participated. The valedictory function concluded to highlight the  message that the  ‘Pharmacist- a friend in need is a friend indeed.”

KLE University’s College of Pharmacy conducts National Pharmacy Week is a post from: Pharmacy in jobs, news, schools

What’s are the root causes of this malaise?   Global economic crises? The FDA raising the bar?  Pharma squeezing our biotechs with back-ended biobuck deals?  All the “low hanging fruit” of the target universe picked?

I’m sure all those have some truth to them, and have mentioned some of them before (e.g., FDA’s view on obesity).  But in the spirit of putting all the issues on the table, I think we also did this to ourselves.

For a few decades now the biotech sector has over-promised and under-delivered, and its now coming back to bite us. Sure, biotechs have discovered some amazing drugs like Epogen, Enbrel, Herceptin, Rituxan, and Erbitux, to name just a few. But these are the rare few.  Most of our sector never delivers drugs like those.  But we have endlessly promised that we will, raised endless monies to support the effort, and allowed structural inefficiencies to persist.

In 2000, the Human Genome Project was supposed to “to lead to a new era of molecular medicine, an era that will bring new ways to prevent,diagnose, treat and cure disease”.  It certainly helped, but if this is the “new era” it doesn’t feel so good.  And the bubble wonders of Millenium, Human Genome Sciences, and many others all made huge, bold predictions about R&D productivity and the future of medicine that never materialized. More recently, RNAi was supposed to enable a drug against every gene.  Red wine’s resveratrol was to be the elixir for lots of diseases.  But its not just over-promising in the  2000s.  In the 1990s, high throughput screening enabled by combinatorial chemistry was supposed to provide the chemical diversity to enable a massive boost in drugability, but probably did the opposite.  Earlier still, drugs like IL2 were hailed by Time magazine as a cancer cure in 1988, and antibodies were pitched as the “magic bullets” to lots of diseases in 1980s.  Yet today, even Avastin, one of the most widely heralded mAbs of our time, isn’t very effective at all without toxic chemotherapy in combination.  Don’t get me wrong – the genome, RNAi, antibodies, etc.. – all are great advancements and are keys to the success of our sector, but we certainly missed the mark on the timelines for their impact.

Through our cycles of over-promising and under-delivering, biotech has relentlessly milked the private and public capital markets.  As Gary Pisano has noted previously, outside of a few huge winners, our sector has probably burnt more capital than its created over the past 30+ years.  The sad fact is that most public biotech companies dilute their existing shareholders into oblivion over time.  The list of supposedly successful companies that got sold or currently trade below their paid in equity capital is staggering.  ”Successful” biotechs like Isis and Amylin have seen their stocks fall -25% and -51% over the two decades  since their IPOs.  The majority of the IPOs of the past decade are below their offering pricesand have been for some time.  We’ve now got a large group of public equity investors who ask why should they buy into an IPO when they know they’re going to be diluted in 18 months at the next financing.

And we wonder why we’re in a somber state of despair about biotech?   The #1 issue doesn’t seem to me to be the FDA’s high hurdle or Pharma’s bad behavior.  It’s us, broadly speaking: it’s all of us that participate in the private and public capital market for biotech: venture investors, management teams, public investors, and importantly Boards.

• Venture investors: VCs are the brunt of a lot of jokes because the truth hurts: pushing for quick flips, lack of patient capital, over-hyping a story, etc…  This is no way to build a sustainable asset class.  Further, we have simultaneously under-funded many areas and over-funded others.  Many firms have fled early stage and do only clinical or commercial stage deals, largely around reformulated spec pharma assets or Pharma’s discarded compounds. The need to put large fund sizes to work drives many into high capital intensity deals and over-capitalize others.  Returns typically fall off quickly with increasing amounts of capital.  In general there are lots of lemmings in the business chasing the same ideas; fortunately for us, early stage is rather sparsely populated so we have to find our own cliffs to jump off.
• Management teams: while many have been great stewards of their shareholders capital, a whole lot more have not. Dilution is the bane of existing biotech shareholders, and many management teams (especially in the public markets) seem to forget this by serially trading down their existing investors in favor of new ones until they make it to market, get sold, or die a whimpering death.  An earlier sale of a business may be smarter for existing shareholders than being washed out to nothing, but most management teams don’t like or execute that choice.  Worse yet, most of the time management teams get reloaded with new options to keep them ‘incentivized’ with upside rewards to watch out for their current shareholders.  This is great if the team is truly aligned around dilution, but sadly this doesn’t often happen, as Peter Kolchinsky of RA Capital has noted.
• Public equity investors: Rightfully burnt by many of the public offerings in the past, many public investors shy away from allocating capital to IPOs or require ‘derisked’ late stage assets.  Its no secret that the vast majority of the IPOs in 2010-2011 were in companies that in-licensed their lead programs or reformulated known actives.  I can’t think of one who’s lead program came out of its discovery organization. [Correction: IRWD's linaclotide was discovered by their team]. This lack of demand for real innovation has skewed the type of startups VCs build and it shows in the ecosystem.  Until public equity investors take a long-term view and help build the next Vertex, Gilead, Cephalon of the world we won’t be able to grow the next crop of mid-sized players.  Sadly this is unlikely in a world where most public investors are traders rather than investors. Since most public investors are just traders, they by nature have abdicated their role in company shaping via shareholder activism.  I know many ‘activists’ get accused of being predatory, and many probably are, but having active, vocal, and well-informed shareholders pushing for better capital allocation from management teams and Boards is a good thing in my view.
• Boards: Many private company boards are full of VCs and lots of folks complain this is a bad thing.  I certainly have experienced the big venture board problems (i.e., whip-sawing between fear and greed in particular), and this is an issue. But at least these boards have a real interest in protecting the current owners of the company.  Most boards of public biotech companies don’t represent the interests of current shareholders.  And though they are ‘independent’ they are often afraid to rock the boat, ask tough questions, challenge management teams on capital allocation and serial rounds of dilution.  The failure of the public biotech universe to succeed – which is a big part of the capital market challenge today – is in many ways a failure of the public biotech board to manage shareholder value. This failure in governance has had profound impact on our ecosystem.

Now that I’ve vented about some of the stakeholders in our ailing capital market, let me reinforce a few themes for how to move forward that involve thinking differently about biotech venture creation and company building, and the nature of equity capital. To that end, at the risk of repeating prior blog posts:

1. We need to change the way we think about building companies.  As I’ve written before, “Go big, go bust” isn’t a viable strategy: raising $100M+ in equity capital and praying for a viable IPO or Pharma takeout is as bad as playing the lottery.  We need to do more than lip service to capital efficiency.  We can and should be building companies that raise far less in equity capital and leverage it through partnerships, non-dilutive funding sources, etc…  This is where the great returns will come from – like Plexxikon and Amira earlier this year, which collectively raised ~$90M in equity and could create upwards of $1.4B in value.  Both were 10x deals because they were “lean on their use of equity” platforms.
2. We should get back to the basics of backing real innovation.  Its hard to get excited about reformulated, retrofitted compounds of yesteryear.  But funding breakthrough medicine is rewarding – both because its great for patients and shareholders. Just ask Vertex’ HCV patients, or Acetelion’s, or Alexion’s.  Now all of those companies were built in a ‘looser’ financing environment, but its still viable to discover great drug candidates on venture capital today.  And great companies are all about great medicines.  Our startups should start with that in mind.
3. We have to embrace the depth and breadth of the virtualization toolbox which enables not only fully virtual enterprises (high quality outsourced labs, lean teams), but also adds superb operating leverage to bigger platform companies.  And real innovation can happen – and does happen – in virtual R&D companies.  Its a huge part of the model going forward.
4. We need new asset-centric liquidity theses that go beyond company–centric IPOs and traditional M&As.  These alternatives include things like LLC-holding company structures and defined liquidity path partnerships.  As these generate returns, they will not only be appreciated by our LP’s, but they will also help create the competitive tension for assets from buysiders and later stage investors that will improve returns to early stage investing.
5. Boards need to be more involved in governance, especially in small cap biotech companies.  This isn’t about Boards trying to micromanage teams, but about the discipline of capital allocation and strategy in a realistic way that maximizes value for current shareholders.  I hope more activist investors enter the small cap biotech world.
6. Lastly, we need closer, better, and more transparent relationships with Pharma.  At the end of the day, we’re partners in this ecosystem and we need to drop the zero-sum game mindsets.  Win-win solutions where rewards are appropriately allocated for risk-taking and risk-sharing.

I certainly agree that the FDA needs to improve, Pharma could be more productive in its biotech relationships, IPO windows could be wider, etc…  So we should work on all those, and I don’t mean to belittle those challenges.  But I think we as a sector – investors, management teams, and boards – also need to look in the mirror and recognize we’re looking at a real part of the problem.

Culprits of Biotech’s Malaise: Let’s Also Look in the Mirror is a post from: Pharmacy in jobs, news, schools

The combination pill will sell for the same price as Januvia alone, about $215 per month. Generic versions of Zocor cost roughly $30 a month.That should make Juvisync attractive for the millions of diabetics currently not taking a statin. Guidelines from the American Diabetes Association recommend that diabetics who have heart disease or are over age 40 take a statin pill daily.”This provides a way to simplify their regimen and improve adherence,” said Dr. Susan Spratt, an endocrinologist at Duke University Medical Center.Spratt said many diabetes patients are taking six or more pills a day, including different types of pills for diabetes, blood pressure and high cholesterol.

It can be hard to consistently take them all at the right time, and even with health insurance, patients’ out-of-pocket costs for their medications and diabetes testing supplies can be very high.”Anything to reduce the cost is going to be helpful to patients,” Spratt said, adding, “When you improve medication adherence, you actually lower health care costs because patients don’t end up in the ER or the hospital.”Merck shares rose 37 cents to $31.79 in late-afternoon trading, after rising nearly 3 percent.In Type 2 diabetes, the body either does not produce enough of the hormone insulin or does not use it efficiently, allowing excess sugar, or glucose, to accumulate in the blood. Over time, that damages blood vessels and crucial organs.Many of the more than 25 million U.S. diabetes patients also have high cholesterol, partly because both conditions often are linked to being overweight. The combination increases risk of heart disease, stroke, kidney disease and other chronic conditions. Diabetics also are at risk of blindness, amputations from wounds that do not heal and heart attacks.

Despite those dangers, Merck scientists estimate that up to 4 million diabetes patients over 40 are not following the medication recommendation.”Perhaps one third of the nation’s eligible patients with type 2 diabetes are not being treated with a statin, so here’s a convenient tool for doctors to target glucose as well as cholesterol levels,” Dr. Sethu Reddy, Merck’s director of clinical affairs for diabetes, said in a statement.Juvisync will be available in six different dosage strengths, to accommodate patients with varying levels of cholesterol and diabetes. Common side effects of the drug include stuffy nose and sore throat, headache, muscle and stomach pain.The approval revives Zocor, which had been Merck’s top-selling medicine before it got generic competition in June 2006. It’s now available in nearly a dozen generic forms as simvastatin.Januvia, Merck’s third-best-selling drug, was approved in October 2006. It was the first diabetes drug in a new class called DPP-4 inhibitors that now includes Bristol-Myers Squibb Co.’s Onglyza and Tradjenta, made by Eli Lilly & Co. and Boehringer Ingelheim.The drugs work by making the body produce more insulin after meals, to reduce levels of glucose in the blood, and by limiting the amount of glucose made by the liver.

Januvia brought in $1.5 billion in the first six months of this year and had sales of $2.4 billion last year. Merck already sells a pill that combines Januvia with a widely used generic diabetes pill, metformin. That combo pill, called Janumet, had sales of $626 million in the first half of this year.With Merck’s top seller, asthma and allergy drug Singulair, getting generic competition next August, the Januvia franchise becomes even more important for the company, which is the world’s third-biggest drugmaker by revenue.Merck, based in Whitehouse Station, N.J., is planning to seek approval of Juvisync in many other countries in the near future, according to spokeswoman Pam Eisele.AP Business Writer Matt Perrone in Washington contributed to this story.

FDA approves first diabetes-cholesterol combo pill is a post from: Pharmacy in jobs, news, schools

* Aims to improve focus, reallocate resources

Oct 12 (Reuters) – Amgen Inc , the world’s largest biotechnology company, has told its research and development staff it is evaluating changes in its R&D programs, a company spokeswoman said on Wednesday.

The company told employees the changes would be aimed at improving focus and reallocating resources to key pipeline assets and activities, Amgen’s Mary Klem said in a statement.

She said additional details of the plans will be given on Oct. 24 when Amgen, based in Thousand Oaks, California, announces its third-quarter financial results.

Last year, Amgen posted revenue of $15.1 billion and spent $2.9 billion, or about 19 percent of its revenue, on R&D — a level that some investors have deemed too high.

“The $3 billion R&D line item annually is high and investors see room to start to trim this,” said RBC Capital Markets analyst Michael Yee.

He estimated that for every $100 million — or 3 percent — of R&D cuts, Amgen’s earnings per share could increase by between 8 cents and 10 cents. Yee has forecast Amgen’s 2011 EPS at $5.20

Worldwide, the company’s staff totals about 17,000.

Shares of Amgen have lost about a third of their value since early 2006, when safety concerns began to emerge about its flagship anemia drugs Epogen and Aranesp.

The company’s shares closed at $56.64 on Wednesday and were unchanged after-hours.

UPDATE 2-Amgen signals R&D changes to employees is a post from: Pharmacy in jobs, news, schools

In a new study, the National Organization for Rare Diseases decided to put the FDA’s professed flexibility to the test, examining 135 non-cancer orphan drugs which had been approved by the agency. And the FDA comes out with a clap on the back, earning NORD’s seal of approval for being willing to demonstrate its flexibility in 90 of those rare drug programs. Writes NORD: “The study supports the FDA assertion that it exercises flexibil­ity when reviewing applications for orphan drugs.”

The study also notes that the FDA can demonstrate its flexibility in a number of ways, most notably by regulators’ willingness to accept a far more limited set of clinical trial data for an orphan drug, including instances where a single trial was enough to warrant an approval. In 58 cases regulators were willing to customize the approval process to the therapy.

The Wall Street Journal notes that not everyone is happy with the FDA’s approach to these orphan drugs. Public Citizen’s Sidney Wolfe, an outspoken critic of the pharma industry, had this to say: “There are all kinds of other benefits already written into law. Why should the standard of approval be different if you have a rare disease than for non-rare diseases?”

NORD does want the FDA to go a step further in spelling out its approach to orphan indications.

“It is time for that policy to be clearly enunciated as a formal FDA policy, and for FDA medical reviewers to incorporate and recognize this flexibility in a systematic way into their evalu­ations of each new therapy in development and under FDA review for Americans with any rare disease.”

Study: Orphan drugs win favored status in FDA reviews is a post from: Pharmacy in jobs, news, schools

Might there more be more such acquisitions? Clearly, CROs are on the radar screen. Why? For one thing, prices are rising. A survey by RW Baird analyst Eric Coldwell found 42 percent of drugmakers say prices rose in this year’s second quarter, up from one-third in the first quarter. The backdrop is a projected 3.6 percent to 8 percent growth in R&D budgets, on average, among drugmakers and biotechs.

Large and mid-sized drugmakers reported fewer price decreases, while small firms, which include biotechs, reported more price decreases in the his most recent survey. However, the magnitude of price decreases was flat to lower across the board. “The vast majority of internal pharma staff surveyed believe that they are spending the same, or more, per unit of outsourced work today than in the recent past,” Coldwell writes in an investor note.

Meanwhile, the 388 drugmakers and biotechs that were surveyed also reported that that CRO clients expect a 9 percent increase in the R&D budget that is outsourced, with total market penetration by CROs increasing from 35 percent last year to 38 percent in 2011. Among large drugmakers, 27 percent expect to outsource, while 47 percent of the smallest companies expect to do likewise.

“Looking ahead several years, we have generally concluded that client R&D budgets will be flattish in total, yet the CRO industry secular market move to higher involvement will continue as clients replace less efficient internal functions with more efficient and cost effective external solutions,” Coldwell opines.

Separately, the Association of Contract Research Organizations conducted a survey of its own members and examined 11,508 trials carried out by ACRO members and found that each CRO was involved, on average, in more than 750 studies. By comparison, ACRO says that about nine of its members worked on roughly 400 trials in 2008. They also contributed to 33 of 38 drugs approved in the US and Europe last year.

Not surprisingly, the CROs were busy with oncology trials – 961, or 19 percent, of 4,964 compounds studied last year were novel cancer meds. Three years ago, oncology amounted to 18 percent of the activity. And overall revenue for ACRO members rose 156 percent since the association was founded in 2001, a compound annualized rate of 11 percent.

As Coldwell sees it, the “ultimate end game” has outsourcing penetration in the pharmaceutical industry reaching between 60 percent and 80 percent in the distant future. “At a time when many people are asking ‘where are the jobs?,’ we have a clear answer,” says ACRO executive director Doug Peddicord. With all that growth, CROs are likely continue to appear attractive. And going private offers an added bonus – a chance to escape the microscopic scrutiny that is regularly applied to publicly traded companies.

Why Contract Research Organizations Are So Hot is a post from: Pharmacy in jobs, news, schools

There may never be another medicine like it. That’s because of fundamental shifts in our understanding of biology, because of the demands made by patients, doctors, and society on new drugs, and because new drugs now have to compete with the super-cheap, generic versions of every medicine ever invented. Already, eight of ten prescriptions are for generics, and the drug industry is focusing on higher priced, specialty products for patients who are not helped by existing options. Good luck creating a new cholesterol drug as potent, safe for most people, and widely tested as Lipitor.

Thanks to aggressive marketing and pricing tactics by Pfizer, Lipitor will remain a big seller for years even as sales drop. Les Funtleyder, a fund manager at Miller, Tabak, says that the the stock, which his fund holds, could perform well partly because Lipitor sales may decline more slowly than investors expect, allowing Pfizer to beat earnings expectations. In fact, Pfizer probably has more to gain in the short term by controlling Lipitor’s descent than it does from any of several experimental drug programs, including a pill for rheumatoid arthritis and the use of its Prevnar 13 pneumonia vaccine in adults, that could show results in the next year. Because Lipitor is that big.

It’s hard to remember now, but Lipitor was introduced at a time before big drug safety scandals such as  Merck‘s Vioxx being linked to heart attacks or worries that antidepressants like Paxil and Zoloft might increase the risk of suicide in some patients. It was a time when Jay Leno routinely joked about Viagra – not a terribly big seller, but one of the biggest drug launches in history – and writer Elizabeth Wurtzel made the talk show rounds talking about her Prozac. It really did seem there would soon be a pill for everything and anything, and cholesterol drugs were the era’s biggest success.

A 1994 study with Merck’s cholesterol drug Zocor proved cholesterol-lowering meds could prevent death – to be specific, four deaths and seven non-fatal heart attacks were prevented for every 100 patients who took the medicine for six years. A study of Pravachol, from Bristol-Myers Squibb, showed similar benefits. When it was introduced in 1996, Lipitor didn’t have any such study proving its worth, but it was way more powerful than those drugs. It instantly grabbed market share, and then Pfizer followed up by running a series of giant clinical trials, some of the biggest ever, in order to get more patients on cholesterol drugs and prove that Lipitor was the best option. Pfizer also got a big boost from a backfiring Bristol study that showed high-dose Lipitor was better than Pravachol in some of the sickest heart patients.

Something like 20 million Americans take cholesterol-lowering drugs, and before Zocor went generic in 2006 more than half of them were on Lipitor. But all those huge, market-expanding clinical trials came with a cost. As heart patients got healthier because of better treatment, and Pfizer sought to expand the cholesterol market by testing patients who were healthier still, the absolute benefit that needed to be shown got smaller. For instance, in one big clinical trial, 100 patients had to be treated to prevent one heart attack. It’s not that the drugs stopped working, but that patients got healthier.

You can argue that it’s still worth taking Lipitor, especially at cheap generic prices, because heart attacks, the leading killer in the developed world, are a lifelong problem and clinical trials only last for a few years. But there’s no arguing that doctors are starting to rebel against the idea of treating everybody with the same pill for years in order to get a small benefit for the average patient. Why not, many say, insist that drug companies find the patients who do great on a medicine, so people who don’t benefit don’t have to take it?

One prominent voice in this changeover is Eric J. Topol of the Scripps Research Institute, who helped establish the one-pill-for-everyone ethos a decade ago by running some of the biggest clinical trials ever, including one of Plavix, a blood thinner that, like Lipitor, prevents heart attacks. It is the second-best-selling drug in the world, with sales of $9 billion, and its U.S. patent expires in 2012, posing Lipitor-like problems to makers Sanofi-Aventis and partner Bristol-Myers.

In a forthcoming book, The Creative Destruction of Medicine, Topol remembers being in the room in an extravagant Paris hotel when he first saw the results of a study comparing Plavix, a $4 a day drug, with aspirin. “The answer was, to my mind, quite disappointing,” he writes. Two patients out of every 100 benefited. That helped launch Plavix to success, but Topol has lately been pushing new work in genetics to help figure out which patients are helped most by a particular drug and electronic health records to track how well medicines are working in the real world. The current, one-size-for-all system just cannot hold, he says.

To see how big this change is for drug companies, you only have to look at the reception to a new drug that was just found to be better when added to Plavix than Plavix alone. The medicine, Xarelto, is expected to become a multi-billion dollar seller for Bayer and marketing partner Johnson & Johnson. It’s one of a class of new blood thinners, called Factor X inhibitors, that are expected to replace the old blood thinner warfarin for many patients with heart valve problems.

But Xarelto is the only one of these drugs that succeeded in a clinical trial to best Plavix in heart patients, and you’d be forgiven for thinking that would mean it would be a Plavix-like success. The drug actually managed to save lives in its large trial, reducing the risk of death by an impressive 30%, despite increasing the risk of major bleeding. One of several Harvard-based physicians who ran the study, C. Michael Gibson, compared the findings for Xarelto to the findings with aspirin. Another, Eugene Braunwald, compared it to Lipitor beating out Bristol’s Pravachol, a study which his research group had also run.

A more revealing statement, though, came from Jessica Mega, another Harvard Medical School-based researcher who helped run the trial. She too argued that the mortality benefit was “hard to ignore,” but also said that part of the reason Xarelto is important is because it provides a new option as we start to better understand how the blood-clotting process goes wrong to cause heart attacks.

“Patients probably have heart attacks for a lot of different reasons,” Mega says. “The more we understand about the biology, the more we’re going to be able to give the patient options.” This is actually the flip side of the main argument against Xarelto, as made by Paul Gurbel of the Sinai Center for Thrombosis Research: that the bleeding rate is too high, and that doctors need a way to test which patients need their blood thinned more and which don’t. Whoever you side with, one-size-fits-all is on its way out.

Analyst Larry Biegelsen of Wells Fargo Securities estimates that there if every patient who could got Xarelto, it would be worth $2.1 billion a year to Bayer and J&J, essentially doubling the drug’s market opportunity. But he thinks that only 10% to 20% of those patients will get the drug – about $300 million of extra sales. Not a Lipitor. Not a Plavix.

That’s why the drugs with the biggest sales forecasts – medicines like Abbott’s Humira for rheumatoid arthritis or Roche’s Rituxan for cancer – are expensive, targeted at less common diseases. Without more Lipitors, the best hope for more progress against common diseases is that new technologies for understanding biology and genetics also make it easier, faster, and cheaper to develop new medicines.

Given the stakes, it should be no surprise that Pfizer is doing everything it can to slow Lipitor’s decline. The efforts started a year ago with a new coupon card that brings the patient’s share of Lipitor costs down to $4, less than a generic. (See: How Bargain Lipitor Could Raise Health Costs) Pfizer has also cut deals with the jobs.pharmacy-bg.com/”title=”pharmacy” >pharmacy-benefit managers to decrease cost to health plans, and even set up its own retail outfits. A web site called LipitorForYou will help patients stay on the brand. Pfizer says its research says a third of people don’t want to switch to generics, even though generics have an excellent track record for safety and efficacy thanks to the FDA’s regulation.

These steps work because only two companies – India’s Ranbaxy and Watson Pharmaceuticals – can make generics for the first six months after the patent expires. Ranbaxy challenged Pfizer’s patent and reached a deal with the drug giant, and Watson has a license from Pfizer. Ranbaxy does not yet have FDA approval for its copy. Watson will pay a 70% royalty to Pfizer, according to Sanford C. Bernstein. This three-way competition will drop Lipitor’s price 20% to 30%. After that, dozens of generic companies will make copies in the U.S., and competition could push Lipitor’s $5-per-pill price well below $1.

Even after cheap generics abound in the U.S., Lipitor will persist, selling more than $1 billion a year in countries where there is not an arbiter like the FDA to make sure generics are safe enough to substitute for brand names. For instance, in South Korea, the price of Lipitor dropped 20% when generics were introduced, but sales are already recovering because more Lipitor is being sold there. So Lipitor will hang around a bit, even though the economic and scientific environment that created it is gone – perhaps forever.

Forbes

Lipitor – Why There Will Never Be Another Drug Like Lipitor is a post from: Pharmacy in jobs, news, schools

Good news! You learn that today, November 30, 2011, a generic version of Lipitor® is going on sale for the first time. You have been using Lipitor® as an adjunct to your diet to reduce your cholesterol, So you run down to the pharmacy and ask to have the generic atorvastatin, at a fraction of the price you have been paying for Lipitor®, the world’s top selling drug made by Pfizer.

What happens? There’s a good chance you’ll be told by the pharmacist that generic atorvastatin is “not available” but brand-name Lipitor® is.

Why?

As Paul Bisaro, President and Chief Executive Officer of Watson Pharmaceuticals [WPI], the maker of generic atorvastatin, explained on CNBC’s Squawkbox this morning:  “What’s happening now is that Pfizer is blocking the ability of the pharmacists to dispense the generic. They can only dispense the Pfizer product. When the pharmacist takes the script and punches in the code and your health insurance number, it says that he can only dispense this brand drug.”

Restraint of trade?

Larry Bossidy, who happened to be on the CNBC set also and who has served on the board of Merck asked, “Isn’t that restraint of trade?”

Declining to answer that particular question, Bisaro said:”The pharmacy benefit managers (PBMs) are an area where [the brand manufacturer] can easily attack the situation, because  they can control the script.

“The thing that bothers me is confusion in the marketplace. We have told people that generics lower the cost of health care. That’s the way people should move. 80 percent of scripts today are filled with generics. That’s good for America. We saved a trillion dollars over the last ten years using generics. Unfortunately what’s happening now is that people are being told that they can’t even get the generic even though they know it is available, because the brand is being sold a lower price than the generic. We don’t need that confusion in the marketplace.“

A concerted effort to block generics

For those who follow developments in big pharma, the blocking of the generic Lipitor® doesn’t exactly come as a surprise. Earlier this month, the top pharmacy benefit managers (PBMs) announced plans to deny reimbursements for the less expensive generic. The move reflects Merck’s success in using rebates to PBMs to continue offering exclusively the more expensive brand drug.

Under the guise of “continued access to affordable prescription drug benefits,” PBMs like Medco Health Solutions [MHS], CatalystRx and Medimpact say they will–at least for now–lower Lipitor co-payments to the price of a generic and reject claims for Atorvastatin, Lipitor’s new generic equivalent.

While on the surface the move looks like a price match, leaders from the PBM watchdog organization Pharmacists United for Truth and Transparency (PUTT) say PBMs have merely disguised their true intent. “While the Lipitor® co-pay will drop on November 30th, plan sponsors will stay the same.”

“Plan sponsors are employers, Medicare Part D patients and taxpayers. PBMs are multi-billion dollar corporations pulling money out of the economy when Main Street needs it most,” said Dr. Kenneth Fields, CEO of ApproRx.

“That means plan sponsors will be forced to pay more for brand Lipitor even though a low cost generic is available,” said Dave Marley, a pharmacist and spokesman for PUTT, who estimates plan sponsors will pay $35 more per prescription for Lipitor® than they would for generic Atorvastatin. “Roughly 70 million Lipitor prescriptions were filled last year. Plan sponsors need to evaluate their contracts to see how much, if any, of the Lipitor rebate money they receive. It is unlikely they will receive any of it.”

A widespread practice

“The Lipitor® case is not rare,” said Fields. “Imagine how many jobs employers could create if they weren’t being fleeced by the PBMs.”

In one instance, an insurance company (Blue Cross/Blue Shield of Texas) is said to have refused to recognize the generic equivalent of Concerta (Methylphenidate ER) as a generic.  Watson Pharmaceutical released the generic form on May 2, 2011. Therefore, the patient is paying $60 for the brand name Concerta rather than $10 for the generic.  The decision is being appealed.

In another instance, customers cannot receive generic Adderall XR. The plan requires use of the brand name drug. The customers believe that there is rebating to the PBM, leaving them with higher copays for the brand name.

In yet another instance, a patient used the brand name eyedrop drug Xalatan for several years.  There was no generic, and she paid a premium price for the drug.  A year or so ago a generic for this drug became available – Latanoprost. She was thrilled, since the cost for the generic was much lower. She recently received the 2012 formulary for our Medicare Advantage plan with Anthem Blue Cross, and were surprised to see that Latanoprost will be a “brand name” drug in 2012 and she will again be required to pay a premium price. When she called Anthem she was told that only a small number of manufacturers are producing this drug (perhaps two), and that the manufacturers are therefore able to set the price.

Ending drug companies’ pay-for-delay deals

On October 24, 2011, the Washington Post said that an upcoming report by the Federal Trade Commission will show that brand-name pharmaceutical makers continue to cut questionable deals with generic manufacturers that delay the introduction of cheaper drugs onto the market.

“Such pay-for-delay arrangements hurt consumers and increase costs for federal programs such as Medicare and Medicaid, according to the report, a copy of which was obtained by the editorial board,”  writes the Post. “These deals are not illegal, but they should be.”

These deals should also give pause to those who believe, like David Brooks who wrote in the New York Times that handing over Medicare to the private sector will “unleash a wave of innovation”. Unfortunately the “wave of innovation” that will be unleashed is rather more likely to benefit the insurance companies and big pharma than it is to benefit patients.

Fixing the big pharma

Fixing these special deals between big pharma and the PBMs by making them illegal is relatively simple.

Fixing big pharma is something else. The fact is that these deals are merely a symptom of a wider problem in which the focus of big pharma is on making short-term profits, rather delivering real value to their customers.

Just as at Apple [AAPL] before Steve Jobs’s return in 1997, big pharma is being driven by the sales and marketing men. As at Apple, that is not a particularly profitable game over the long haul. Intelligent investors should take a look at the ten-year share price of Pfizer, as well as its competitors, Merck [MRK] and GSK [GSK].

This is not to say that big pharma cannot, like Apple, emerge from its death spiral by shifting its focus from short-term profits to delighting the customer. It’s not rocket science. It’s called radical management.

Pfizer’s Lipitor: How Big Pharma Blocks Reimbursement Of Generics is a post from: Pharmacy in jobs, news, schools

Ranbaxy Laboratories Ltd. (RBXY)’s copy of the $10.7 billion Lipitor cholesterol pill was released in the U.S., sending its share up the most in six months and threatening sales for Pfizer Inc. (PFE)

Ranbaxy, India’s biggest drugmaker, won approval to sell generic versions of the world’s top-selling medicine by the Food and Drug Administration yesterday. The company, based near New Delhi, will share profit on the first six months’ sales with Israel’s Teva Pharmaceutical Industries Ltd. (TEVA), Ranbaxy said today, adding that terms of the agreement won’t be disclosed.

Ranbaxy sought to persuade the FDA that its copies are equivalent to the original and that approval shouldn’t be thwarted by an ongoing dispute about plant violations in India. The FDA approval was for products made at a plant in New Jersey which may have been contingent on a deal with Teva, said Bino Pathiparampil, a health-care analyst at IIFL Ltd. in Mumbai.

“It could well be that the Lipitor ingredients could come from Teva,” Pathiparampil said in an interview. In that scenario, “Ranbaxy will assemble the drug at their factory in New Jersey.”

Spokesmen at Ranbaxy and Teva declined to elaborate on today’s statement.

The Indian drugmaker, 64 percent-owned by Daiichi Sankyo Co., surged as much as 11 percent in Mumbai trading. The shares traded 4.7 percent higher at 454.85 rupees, the most since May 30, at 11:22 a.m. local time, while the BSE India Sensitive Index gained 2.8 percent.

Daiichi Sankyo (4568) increased 2.1 percent to 1,402 yen in Tokyo trading at 2:53 p.m. local time. A spokesman for the Tokyo-based company declined to comment on the agreement between Teva and Rabaxy, as well as on the impact on earnings of sales of generic Lipitor sales.

‘Simply Relieved’

“The market is simply relieved to hear that the drug is approved,” said Yasuhiro Nakazawa, a health-care analyst at SMBC Nikko Securities Inc. in Tokyo.

Copycat Lipitor may generate as much as $650 million for Ranbaxy in its first 180 days of sale, according to the median estimate of five Mumbai-based analysts surveyed by Bloomberg.

“This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement released late yesterday in Washington.

Ranbaxy may have sought a marketing deal with Petach Tikva, Israel-based Teva in case it didn’t win timely approval, said Priti Arora, an analyst at Kotak Institutional Securities in Mumbai.

‘Backup Measure’

“There is something more in this deal than meets the eye,” Arora said in a telephone interview. “My feeling is that they allied with Teva as a backup measure in case approval was held back due to its manufacturing issues.”

Teva said on Nov. 2 that if it manages to introduce an “important undisclosed product” in the fourth quarter, it would meet the upper range of its forecast of earnings excluding some costs of $4.92 to $5.02 a share this year. Sanford C. Bernstein & Co. analysts speculated in a report last month that the new product “is ostensibly Lipitor.”

Pfizer’s medicine lost patent protection in the U.S. yesterday. Watson Pharmaceuticals Inc. (WPI) began selling a copy of Lipitor in the U.S. yesterday under an agreement with New York- based Pfizer, the world’s largest drugmaker. Watson’s version didn’t require FDA clearance because Pfizer is providing the drug to sell without the brand label in return for a share of the revenue.

Limited Competition

As the first generic to challenge Pfizer’s patent, Ranbaxy is allowed six months before other generic versions can come on the market under a 1984 law.

Mylan Inc. of Canonsburg, Pennsylvania; Teva; and Dr. Reddy’s Laboratories Ltd. of Hyderabad, India, are among generic-drug makers seeking FDA approval to sell Lipitor copies after Ranbaxy’s six-month exclusivity expires, according to U.S. court filings.

The U.S. enforcement actions against Ranbaxy, India’s biggest drugmaker, began in 2008 when the FDA cited manufacturing defects at two of the company’s plants in India and subsequently barred the company from importing about 30 different drugs. The following year, the agency said one of those plants, in Paonta Sahib, India, falsified data used in drug applications.

No Settlement

U.S. prosecutors had been negotiating a dispute settlement that may cost Ranbaxy more than $1 billion, Fortune Magazine reported in May, without saying where it go the information. There was no mention of a settlement in the FDA’s statement yesterday.

Making generic Lipitor in the U.S. instead of India will reduce the amount of profit Ranbaxy makes on each dollar of sales, Kotak’s Arora said.

“Margins for manufacturing in the India are around 60 percent compared to about 40 percent from the U.S.,” she said. The brokerage had estimated Ranbaxy would generate $560 million in generic-Lipitor sales during the six months of exclusivity.

“We will have to revise our estimates because of this and the Teva deal,” Arora said.

Pfizer Deals

Pfizer has struck deals with companies including Catalyst Health Solutions Inc. (CHSI) and Coventry Health Care Inc. (CVH) to prevent generic Lipitor from reaching some patients until the end of May 2012, according to documents obtained by Bloomberg.

Such deals may help Pfizer retain as much as 40 percent of the Lipitor market during the six-month period in which Ranbaxy and Watson will be the only providers of generic versions, Paul Bisaro, Watson’s chief executive officer, said Nov. 9 in a speech at a Credit Suisse health-care conference.

Pfizer also has reached agreements with health insurers to keep as much of the market as possible. UnitedHealth Group Inc. (UNH), the biggest U.S. health insurer by sales, said Nov. 19 it will charge a lower co-pay for Pfizer’s pill than it does for generics for the next six months, taking advantage of a price reduction from the drugmaker.

That will limit the benefit of Ranbaxy’s exclusivity, said SMBC Nikko’s Nakazawa. Ranbaxy’s copy may generate $300 million for the Indian drugmaker next year, adding 10 billion yen ($129 million) to Daiichi Sankyo’s operating profit for the year ending March 2013, he said.

Ranbaxy’s Lipitor Generic Approved by U.S. FDA, Threatening Pfizer Sales is a post from: Pharmacy in jobs, news, schools