Picture
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharma and clinical business news, views and data. 

 "Two drug makers with sometimes stormy pasts, Biovail and Valeant Pharmaceuticals International, said Monday that they had agreed to merge in a $3.2 billion deal." The new company "will retain the Valeant name," and "will focus on four areas, including treatments for the skin and for neurology, and is expected to have more than $175 million in savings by the second year."  

 Up "to 20 percent of the workers of the combined company will lose their jobs." The AP also adds that Biovail's "most advanced" drug "is Staccato loxapine, which is designed to treat agitation in patients with schizophrenia and bipolar disorder. The Food and Drug Administration is scheduled to make a ruling on the drug in the fall."  

The new company, which will be based in Mississauga, Ontario, also will focus on specialty drugs for the central nervous system and dermatology, in addition to branded generics in Canada and in emerging markets. Biovail CEO Bill Wells told that the deal solidified the company's position in specialty neurology, adding, "We've achieved with this deal what I only hoped we'd be able to do in 10 years."  

References-
http://www.nytimes.com/2010/06/22/business/22drug.html?src=busln
http://www.forbes.com/feeds/ap/2010/06/21/business-health-care-providers-us-biovail-valeant_7706755.html
http://online.wsj.com/article/BT-CO-20100621-709413.html?mod=WSJ_World_MIDDLEHeadlinesAmericas
http://www.bloomberg.com/news/2010-06-21/valeant-pharma-canada-s-biovail-corp-agree-to-merge-in-stock-transaction.html
http://www.pharm-education.com/2010/06/pharma-industry-updates-biovail-and.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10  

Do you have questions for the author? 
 
 
Picture
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharma and clinical business news, views and data.
 


Glaxo CEO Plans To Announce Two "Small" Acquisitions Soon.
GlaxoSmithKline Plc  Chief Executive Officer Andrew Witty plans to announce two 'small' acquisitions soon, after walking away from five potential purchases or partnerships since October. In an interview on Friday with Bloomberg News, Witty "said prices are still being pushed up by competition. He declined to elaborate on the planned acquisitions." In addition, "the drug maker will continue to defend keeping Avandia [rosiglitazone] on the market at a July meeting of a US Food and Drug Administration advisory board, Witty said." He stated, "The only thing I ask for is that qualified scientists with the right evidence and data calmly look at the information." 

Cheap Inhalable Measles Vaccine May One Day Replace Syringes.
A cheap inhalable measles vaccine, developed by scientists at the University of Colorado-Boulder, "could soon be available to families that could pave the way for an end to treatment by syringe for children." Within a few weeks, "human trials of the treatment are scheduled to begin," and they "could lead to inexpensive vaccines for illnesses ranging from tuberculosis to cervical cancer." The researchers are "also hope the trials, which come after five years of development, could reduce the need for painful injections." 

Teva Poised To Dominate Generic Drug Industry.
The New York Times reported on Teva Pharmaceutical Industries, "an Israeli enterprise that, despite not being a household name, is the biggest generic drug maker in the world." The Times added, "Teva's size gives it huge advantages." In fact, "it has enough cash to buy up a strategically located rival generic maker about every other year." It also "has the bravado, and muscle, to mount patent challenges against name-brand drug makers and wring favourable settlements from them." Still, the Times notes that FDA regulators "raised concerns about bacterial contamination of generic propofol, an intravenous anesthetic used in surgery, made at" one of its US plants, and though "Teva recalled thousands of vials of propofol last year," the "regulators said the company hadn't adequately ensured that the problem wouldn't repeat itself." 

Pfizer, Merck Post Large 1Q Revenue Increases, Lower Income.Net 
The world's two largest drug makers, Pfizer Inc. and Merck & Co., posted big revenue jumps but lower net income for the first quarter, as they enjoyed new revenue from big rivals acquired last year but absorbed billions in severance pay and other costs." The AP adds that their "relatively upbeat profit forecasts for this year and beyond are a sign the acquisitions are starting to pay off." In addition, both "companies beat Wall Street profit expectations widely and edged out revenue expectations, partly due to favourable currency exchange rates." 

Eli Lilly & Co. Sues Watson Pharmaceuticals To Block Generic Version Of Osteoporosis Drug.
The Indianapolis Business Journal  reported that "Eli Lilly and Co. sued Watson Pharmaceuticals Inc. to prevent the sale of a generic version of its osteoporosis drug Evista [raloxifene] in the United States."  In its application for Food and Drug Administration "approval to sell a low-cost version of the Lilly medicine," Watson asserted that Lilly's "patents are invalid, unenforceable, or not infringed, according to a complaint filed by Lilly on May 3 in federal court in Indianapolis."

Expiring Patents, Price Controls Expected To Slow Drug Sales.
Pharmaceutical sales growth worldwide will slow this year due to expiring patents for blockbuster drugs and tighter price controls imposed by European governments." In fact, according to "health industry data firm IMS Health...global prescription drug sales growth" may "slow to between 4 percent and 6 percent compared with 7 percent in 2009. Pharmaceutical companies are expected to "face new competition from lower cost generics" for "drugs worth more than $142 billion." Meanwhile, "European governments will tighten price cost controls to manage increasing healthcare expenses of aging baby boomers."       

As increasing demand in developing countries offsets price drops tied to generic competition," drug sales "may grow at least 5 percent worldwide...according to IMS." Emerging markets, including those in "China and India, are expected to grow by as much as 17 percent a year, helping offset the $136 billion a year worth of medicines that will lose patent protection." Notably, "the top disease areas for growth will be in diabetes, cancer, HIV, and multiple sclerosis, IMS said."

http://www.pharm-education.com/2010/05/pharmaceutical-r-business-news-updates.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Do you have questions for the author? 
 
 
Picture

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news-


Abbott Labs Completes Purchase Of Starlims.  
"Abbott Laboratories said Monday it completed its purchase of Starlims Technology" for $123 million, or $14 per share. Abbott said that Starlims will "increase its position in the diagnostic testing market. 

WHO: Drug-Resistant TB Killed 150,000 In 2008.  
The New York Times reported that the WHO announced data last week showing that "drug-resistant tuberculosis killed about 150,000 people in 2008, and half of all the world's cases are thought in be in China and India." The report found that "progress has been made in parts of Siberia, but in another region of Russia, more than a quarter of all cases are drug-resistant. And in Africa, a vast majority of cases have probably not even been diagnosed, the report said."  

Transgene Sells Novartis Option On Rights To Experimental Cancer Vaccine.
Bloomberg News reported that French biotechnology company Transgene SA "sold Novartis AG an option on rights to the experimental TG4010 cancer vaccine in a deal that may fetch as much as $960 million." Under the terms of the agreement, "Novartis will pay an initial $10 million for a worldwide license...Transgene said." The vaccine received FDA "fast-track status" in December. For its part, "Transgene will fund the next phase of the product's development and retain control of it until early 2012, when the first results of the trial emerge." At that point, "Novartis will...have 90 days to exercise its option, Transgene said."  

Pharmaceutical Industry Prepares For New Business Under Health Reform Law.
The US drug industry fended off price curbs and other hefty restrictions in President Obama's healthcare law even as it prepares for plenty of new business when an estimated 32 million uninsured Americans gain health coverage. Noted provisions that may help the industry include: "brand-name biotech drugs won 12 years of protection against cheaper generic competitors," Medicare beneficiaries' drug "price cuts plus gradually rising federal subsidies will mean more elderly people will purchase more drugs," and lobbyists "beat back proposals to allow importation of low-cost medicines and to have Medicare negotiate drug prices with companies."  

FDA clears Vytorin and Zetia of suspected link to cancer.
The Los Angeles Times blog reported "Booster Shots" that after examining two previous studies, a Food and Drug Administration review committee has determined that it is "unlikely" the cholesterol-lowering drugs Vytorin and Zetia "increase the risk of cancer or cancer-related deaths." The agency said the trials were expected to be finished in 2010 and 2012, and advised physicians "to use their best judgment in evaluating potential risks and benefits of the drugs" until they are completed.  

Roche Seeks Acquisitions To Boost Its Research Programs.
Roche Holding AG Chief Executive Officer Severin Schwan said he seeks acquisitions that will bolster the company's research programs, rather than 'mega-mergers' designed to add immediate revenue." In addition, the company "is interested in partnerships or acquisitions that would strengthen" its position as the "world's biggest maker of cancer medicines," and "expand its work on Alzheimer's disease and diabetes, Schwan said in an interview." 
He added that Roche's drugs to treat melanoma and "good" HDL cholesterol could change the treatment of cancer and heart disease.  

Roche To Introduce At Least Six New Drugs By 2015.
In a separate story, Roche also expects to introduce "at least six new medicines by 2015." Roche "wants to expand" the use of its cancer drugs "by testing them in different tumors and earlier in the disease." The company "also is seeking to expand beyond cancer and tap markets for conditions such as diabetes and diseases of the central nervous system."  

Pharmaceutical Thefts Becoming More Common.
The $75 million heist at" Eli Lilly's "warehouse in Connecticut was just the most audacious example of a growing phenomenon: Thieves are stealing large quantities of prescription drugs for resale on the black market." The increase is blamed on "spotty security and high drug prices," while Freight Watch spokesman Ron Greene also blamed thefts on "a fragmented supply chain." FDA spokesman Tom Gasparoli said, "Some of these thieves completely redo labels, and they pass muster if no one's looking too closely." In response, "drug makers are taking steps" and "the FDA has stepped up its own efforts, issuing alerts to the public, working with manufacturers, wholesalers, pharmacies and law enforcement, and publishing lot numbers of stolen drugs on a website." 

http://www.pharm-education.com/2010/04/who-drug-resistant-tb-killed-150000-in.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS    
 
 
Picture
Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. 


I've done extensive work within the healthcare sector over the last many years; this is one industry where the rapidity of scientific driven change is simply unprecedented. Think about what is really happening around us, and about what needs to be done:

A transformative shift - Personalized medicine drives the agenda: the big picture item is that we are in the midst of a fundamental, significant shift in healthcare philosophy and medical research: from a world in which we “react” to disease and illness after it has happened, to one in which we will be doing far more to “prevent” health care problems through highly personalized medicine.

This is primarily coming about because of furious rates of discovery related to genomics. This more than anything will dominate the health care / pharmaceutical research / delivery agenda through the next years.

Knowledge growth becomes exponential; pace of innovation / discovery picks up: medical knowledge is now doubling every eight years. Expect it to be doubling every two years by 2010 -- with the result that medical professionals will be struggling to an even greater degree in keeping up than they are today. Research taps out practical results faster than ever before. The key for everyone is tapping into global collaborative discoveries / keeping up / developing agility for rapid innovation, response, development, and implementation. For pharmaceutical and health care suppliers, it's about rapid development and rapid time to market.

Discovery moves offshore: for a good chunk of the pharmaceutical industry, the proces of R&D, approval and application will increasingly move offshore, particularly to China / India, due to different regulatory requirements (or lack thereof). Also, such things as stem-cell research limitations, US visa policies and other factors play a factor in the diminishing role of the US as a pharmaceutical industry hub. The pharmaceutical industry will continue to spend a huge amount of time learning to work within the new shifting zones of influence in the world of research.

Theory into practice becomes the primary focus; operational excellence is key: already, health care can’t keep up with the rate of scientific discovery: “Because of the rapid discovery of new medical knowledge, you'll get the most up to date treatment today only 50% of the time” is one key stat to remember. Tomorrow, the prime focus in the medical community will be how to ingest and incorporate this new knowledge into practice. In terms of the pharmaceutical industry, the key goal will be “operational excellence,” i.e. ….from the Financial Times 6 Jun article on Roche, “…the Avastin story also highlights a central issue for innovation-led companies: how to make sure advances in the laboratory are brought to market quickly and efficiently.” There’s a whole line of thinking emerging in that article and elsewhere that puts into perspective that collaborative excellence in managing complex teams is quickly becoming a key and critical success factor.

Skills fragment and a battle for skills drives decisions: hyper-growth in knowledge and new medical discoveries means that every medical profession is becoming more specialized, leading to a greater degree of niche-oriented medical skills than we see today. In the pharmaceutical industry, small biotech companies will continue to dominate the research agenda over big-pharma, by focusing on ever tighter niche markets, as well as by discovering disease-oriented drugs based on specific genetic markers. Skills fragmentation results in challenges, but so does the looming baby boomer retirement wave. A war for medical talent drives much of the agenda of the industry by 2010, and the battleground is global in scope.

Complexity partnerships take on an increasing role: because of the skills crisis, rapid discovery, need for operational excellence, knowledge growth and discovery, big/medium the pharmaceutical industry will continue to look to shed additional component pieces of the discovery / regulatory approval process; outsourcing takes on a whole new meaning.

Bio-informatics emerges, core competence becomes critical: Microsoft estimates that at least 50,000 people worldwide are working in the field of bio-informatics – the folks who are developing the highly sophisticated computer databases and computational methodologies that can do the billions of measurements on an individual patient that is leading us into the era of personalized medicine.

Bio-connectivity becomes the next big thing: a new generation of intelligent, Internet-connected medical devices flood the industry, providing new opportunities for monitoring and management of difficult health care conditions. Furious pace of innovation occurs here as consumer tech trends (collapsing product lifecycles) come to medical devices and medical technology.

Hospitals get “de-physical”, customer service comes to the industry: today, a health care institution is thought of as the building or campus that makes up its constituent parts. Tomorrow, it will be defined by the reach of its virtual network, and the hospital will be thought of as the extended community network by which a good portion of its services are provided. Walmart is coming to health care; the Minute-Clinic business model and others like it mean that we are seeing a revolution in customer service come to the industry.

Generational attitude transforms the system: the entrance of Gen-Y -- kids who are in 2005 aged 15 -- into the health care system -- will bring a flood of new ideas, innovation and new ways of thinking helping to break some of the organizational sclerosis that has clogged up the opportunity for change in the world of health care. 

http://www.pharm-education.com/2010/03/walmart-coming-to-healthcare-how-do-we.html  
Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

 Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
Do you have questions for the author?  
 
 
Picture
Dr.Shruti Bhat, Generics and Specialty Pharmaceutical Expert.

Technology may allow vaccines to be preserved without refrigeration.A new technology, developed by British firm Nova Bio-Pharma Technologies and tested at Oxford University, may represent a sea change in vaccine preservation -- minimizing the need for long-term storage in refrigerators or freezers, and improving access and global health as a result...   Watson To Pay $47 Million For Drug To Prevent Premature Birth. Watson Pharmaceuticals Inc. press reported that it will pay $47 million upfront for a Columbia Laboratories Inc. drug that is being developed for the prevention of premature birth...   Bristol-Myers Has 60 Potential Drugs In Its Pipeline.
Executives at Bristol-Myers Squibb Co. told analysts at a business briefing that the drug maker has 60 potential drugs in development, seven in late-stage studies." Bristol-Myers "said it expects future revenue from those medicines and growing sales from existing drugs to help offset an expected plunge in Plavix sales in 2012...  

Glaxo Looks To Expand In India.
The Wall Street Journal reports that GlaxoSmithKline PLC seeks to expand in India through both acquisitions and core business growth, Glaxo CEO Andrew Witty said, "Opportunities will be evaluated based on a variety of factors, including the strategic nature of the fit...  

Synta Pharmaceuticals To Restart Development Of Skin Cancer Drug.
Synta Pharmaceuticals Corp. announced that "it will restart development of its skin cancer drug candidate elesclomol," a decision reached "after consulting with the Food and Drug Administration...  

Roche Expects Increase In Sales From China.
Bloomberg News reports, "Roche Holding AG expects sales of drugs in China to account for about half of all pharmaceutical revenue from the Asia-Pacific region within three years, spurred by higher incomes and the nation's health reforms...

Perrigo To Buy Orion Laboratories For $48 Million.
Perrigo Co., a maker of the over-the-counter drugs, "said it would buy Orion Laboratories for $48 million in cash, expanding its market in Australia and New Zealand... 

Full article at http://www.pharm-education.com/2010/03/can-vaccines-be-preserved-without.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
 
 
Picture
Over the last quarter of the twentieth century, medical research made substantial advances in defining our understanding of diseases, their etiologies, and the biochemical pathways through which they were mediated. Our understanding was further augmented by human genome research. As the pathways of disease were clearly identified, pharmaceutical research largely focused on a “lab to market” approach, which involved identifying/synthesizing molecules that could mediate a disease pathway, characterizing their various attributes, and then commercializing them. In several cases, new molecules had characteristics that were marginally different from others already on the market, and therefore, did not address any unmet clinical need. Commercial success was often determined by the intensity of the sales and marketing effort behind the product, which resulted in an “arms race” (a battle for maximizing share of voice by investing in larger and larger sales teams) and the emergence of “blockbusters.”  

The last 10 years have seen a seismic shift in the dynamics of pharmaceutical sales and marketing. The return on investment in sales force expansion is shrinking, causing almost all major pharmaceutical companies to reduce their head counts. Further, it is increasingly evident that the market and regulators are interested in new therapies that address an unmet need rather than yet another product in an existing class of molecules with little or no clinical or economic benefit.  

Over the last few years, most of the innovations in pharmaceutical development have been only incremental — for most indications, there are significant therapy options available and it is unlikely that a radically better “wonder drug” will become available soon. Consequently, a disproportionate amount of ongoing research and development (R&D) effort has gone into products already in the market to expand the spectrum of indications where they can be used. A look at the number of drugs approved by the US FDA over the years indicate 35 new drugs approved in 2005 as against only 20 last year.. The decline in approvals is a clear indication of how difficult it will be for pharmaceutical companies to continue to show revenue growth in future.  

As they grapple with shrinking pipelines, stricter safety requirements of the regulator, and spiraling costs to bring a product to market, pharmaceutical companies need to ensure that their products genuinely fulfill an unmet market need. Therefore, it is imperative that the R&D effort follow a “market to lab” approach—one that reverses the conventional approach used over the last few decades. 

Aligning the organization to the Goals of Clinical Development-
Clinical R&D is a complicated process involving several steps and multiple stakeholders, both internal and external, in a pharmaceutical organization. Over the last 50 years, the journey of a product from laboratory to the market has not only become more arduous and time-consuming, but also more risky. Furthermore, since more and more clinical development plans (CDPs) include global, multi-centric clinical trials, their formulation and execution are broken into several sub-elements, each of which have become the responsibility of different functional silos in a pharmaceutical company. Consequently, clinical R&D at present involves stakeholders from the strategic, marketing, sales, medical, R&D, clinical operations, regulatory affairs, documentation, and health economics teams.  

Given that the collective objective of all the teams involved in the CDP is to achieve a desirable Target Product Profile (TPP) and therefore a superior product label, pharmaceutical companies must ensure that all stakeholders are aligned and share a common line of sight to the end objective. This is not always easy, but is a critical challenge that must be overcome. Failure to do so runs the risk of a CDP not being in step with current and future market needs, and oblivious to the competitive scenario in the future.  

The essence of “claims-based R&D” lies in taking a backward “market to lab” approach so as to ensure that the CDP is designed to address specific unmet market needs. It also involves the systematic benchmarking of a product’s CDP to current and future competition while continuously evaluating scientific and market threats and opportunities. It involves the integration of multiple inputs to develop the CDP and then prospectively simulate the likely TPP of the product and a SWOT analysis vis-à-vis its inline and pipeline competitors. 

The Process of Developing a CDP-
The process of claims-based R&D is iterative since it attempts to temper the desire to develop an “ideal” product with scientific and operational feasibility. With the ever-growing volume of information and data available in the secondary domain, it is now possible to pursue claims-based R&D to a far greater level of granularity than before. It also enables TPP simulation on a near real-time basis as pivotal information becomes available. 

Customer Insights-
In an earlier era of pharmaceutical development, unmet market needs were determined almost exclusively from the opinions of physicians and medical key opinion leaders (KOLs). In the modern era, however, there has been a significant shift in the level of influence exerted by different stakeholders (customers) on the patterns of pharmaceutical consumption. These stakeholders (customers) include the patient, the payor, and the regulator. 

While pursuing claims-based R&D, it is critical to ensure that the insights and opinions of all the key stakeholders (customers) are accurately captured so that the product(s) developed can genuinely claim to deliver a clinical and/or economic benefit. 

These insights are most often captured through primary research and intelligence initiatives, which include engagement with physician groups, patient and caregiver groups, insurance agencies, etc. However, such initiatives can be effectively complemented by research of secondary sources of information such as online patient discussions boards and transcripts of regulatory proceedings. 

Scientific Insights-
The volume of scientific research has been growing at an astounding rate. A search on www.pubmed.com (the online index of the National Library of Medicine) reveals that approximately 725,000 articles were published over the last year alone. Journal articles and congress presentations constitute a wealth of information about cutting-edge scientific developments.  

A thorough analysis of such publications and academic congresses is critical at the time of developing a CDP and simulating the TPP because:
It serves as an advanced warning system about novel scientific developments that could threaten to make obsolete a particular product
It could reveal alternate approaches to addressing the unmet clinical need at an early stage, and therefore throw up opportunities for partnerships or ideas for development
It presents the successes and failures of competitive development programs, thereby sparing a lot of unnecessary effort and investment
It is a good source to unveil new information about the epidemiology of a disease and therefore the size of the addressable market opportunity. 

Competitor Insights-
Ultimately, pharmaceutical R&D needs to be viewed in the context of competition because of the underlying commercial objectives associated with the process. Consequently, an understanding of the development, licensing, and marketing strategies of the competition constitutes a critical input into the development of the CDP.  

It is important to note that competition needs to be viewed not merely in today’s context but also in context of what lies ahead. Therefore, it is recommended that any CDP and its derived TPP be benchmarked to the claims and positioning strategies of competitive products already in the market as well as the likely claims and strategies of pipeline products.  

Fortunately, substantial amount of information about clinical trials—completed and ongoing—is available in the public domain through sources such as product labels and clinical trial registries. The main source for clinical trial information is www.clinicaltrials.gov (the official site of the US FDA), which contains several essential details about all registered clinical trials.

Although the information is accessible through sources such as the ones cited above, it is essential to note that deriving insights, simulating competitive claims, etc., is an exercise that requires substantial human expertise. 

The Ideal Target Product Profile-
As a first step of an iterative process to design a CDP, it is recommended to build an “ideal TPP.” To do this, one would need to integrate the various insights and inferences described above and evolve a TPP that would address all the unmet needs of the market while also yielding superior marketing claims across all product attributes.  

Therefore, an “ideal TPP” would represent best-in-class performance for efficacy, safety (ideally, would result in no adverse effects), tolerability, convenience, drug and food interactions, and perhaps, even cost. In addition, the “ideal TPP” would cover a wider patient population than all competitors. 

The Real Target Product Profile (TPP)-
Much as we may aspire for an “ideal TPP,” it is necessary to recognize that in the real world, we cannot get every product attribute we desire. Therefore, we must modify the “ideal TPP” by prioritizing the attributes and claims that the CDP must focus on and compromising on others to arrive at the “real TPP.” This can be done by classifying the product attributes in the “ideal TPP” as either essential or desirable.  

The essential features of the TPP would represent a set of product attributes that represent either superiority over competing products or, at the very least, non-inferiority to competing products. Without these features, the product would enjoy no unique selling point when launched.  

The desirable features of the TPP would represent additional product attributes that could enhance the product’s marketability. These additional attributes could include some side indications, tolerability improvement, application for specific subpopulations, or even improved product stability. They all represent features that are not absolutely mandatory for commercial success but would certainly amplify the claim of superiority.  

Full text article is available to interested readers as a Free technical white paper. To register click here. 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
Do you have questions for the author?  
 
 
Picture
Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma industry news.
Web-enabled research and development? But of course. The Internet, built by researchers has been used to extend their reach for nearly 30 years. High-tech organizations that live and die by new product development have exploited the Web to speed communications and share information. 

More recently, but just as enthusiastically, biotech and pharmaceutical companies have turned to Web-enabled research and development (R&D) processes. But the landscape of Web-enabled research and development is changing. New tools and approaches may now enable organizations to make their R&D processes faster, more reliable and also more innovative.  

What have also evolved are two clearly different approaches to Web-enabled research and development: For pharmaceutical and biotech companies, it is how the Web can be used to supercharge a research hotbed. For high-tech computer, communications and electronics companies, the focus is on using the Web to create a seamless product-development process.  

Within these two different approaches lies the potential of Web-enabled capabilities to smooth the handoff between research and development. This potential has caught the attention of C-level executives who recognize the need to champion what is, for many companies, a fundamentally new way of developing products.  

Looking ahead, executives at pharmaceutical and biotech companies and at high-tech companies may be able to make even bigger strides by learning from one another. By evaluating and adapting the innovative approaches each industry is using, they can stimulate research and streamline development through the Web.  

Wish to Improve your research and development performance? Be competitive for today and miles ahead for tomorrow? A free technical whitepaper is available for interested readers who wish to know more about this very important topic. 

Also at http://www.pharm-education.com/2010/02/research-and-development-in-21st.html 

Disclaimer -The views and opinions expressed in this article are meant to stimulate thought and discussion. As each business has unique requirements and objectives, these ideas should not be viewed as professional advice with respect to your business. 

Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
Do you have questions for the author? 
 
 
Picture
The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.  

So why read Pharma R&D, business news? Because it offers following benefits-

1.     Enables investors to take “wise decisions”.
2.     Assists Job seekers to realize “where to invest their career”.
3.     Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news-

Pfizer's Viagra patent partially rejected.
"Pfizer Inc.'s patent on its impotence drug Viagra [sildenafil citrate] was partially rejected after the US Patent and Trademark Office said it wasn't different enough from a Chinese herb known as Horny Goat Weed." An agency appeals board "upheld the decision that an element, or claim, of the patent for a method of treating male erectile dysfunction didn't cover a new invention." The claim "was key to an infringement suit Pfizer filed in 2002 against Eli Lilly & Co. over its rival Cialis [tadalafil] drug." Now, "Pfizer has until April 12 to seek a rehearing from the PTO's Board of Patent Appeals and Interferences, or appeal to the US Court of Appeals for the Federal Circuit in Washington, which specializes in patent law, according to a letter Lilly lawyer Richard K. Herrmann." Bloomberg News . 

Potential kidney transplant drug wins orphan drug designation from FDA."Quark Pharmaceuticals Inc.'s potential treatment for kidney transplant patients won orphan drug designation from the Food and Drug Administration." The company "said QPI-1002 is a synthetic small interfering RNA, or siRNA, that blocks expression of a gene called p53 and, as a result, could protect normal cells from injury." QPI-1002 also "is in a Phase I/II study," and "is the first systemic siRNA drug to enter human clinical trials." The San Francisco Business Times.     Lilly, Arkansas settle Zyprexa marketing suit for $18.5 million. Arkansas Attorney General Dustin McDaniel on Tuesday announced an $18.5 million settlement of a lawsuit with Eli Lilly & Co. over off-label marketing of the anti-psychotic drug Zyprexa [olanzapine]." McDaniel had accused Lilly of engaging in "illegal and fraudulent off-label marketing of Zyprexa," alleging that "the company promoted the drug for unapproved use in children." The American Press.

Spending on cancer drugs in UK is 40 percent less than in other European countries.
NHS cancer patients have 40 percent less spent on their medicines than those in other European countries,according to a "report from the centre-right think tank Policy Exchange." The analysis "says cancer currently costs the economy more than £18billion a year, and the figure is expected to rise to almost £25billion over the next decade." The report notes that "spending on cancer medicines is only about 60 percent of that in the EU and other advanced European countries." The UK's Daily Mail.

Roche ordered to pay $25 million in Accutane damages.  
Roche Holding AG "must pay $25.16 million in damages to a former user of its Accutane [isotretinoin] drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled." Most of the jurors "agreed that Roche failed to provide an adequate warning, and that the company's failure was a 'proximate cause' of...inflammatory bowel disease" in the plaintiff. The drug maker now "faces almost 1,000 other lawsuits over Accutane." Sales of the drug were halted "in June 2009" over "generic competition and the high cost of defending personal injury lawsuits." Bloomberg News.

India's generic drug industry may attract more interest from larger companies.
India's generic-drug industry has more FDA-approved facilities than any other country outside the US, which is boosting speculation that larger foreign pharmaceutical companies will join the industry. However, the Journal notes that the future of India's generic drug makers is more likely to see intense competition and dwindling margins than high-priced buyouts. The Journal also adds that foreign drug companies have plenty of reason to wait on expensive acquisitions in India for now. The Wall Street Journal.

AstraZeneca purchases RA treatment from Rigel for up to $1.2 billion.
AstraZeneca has signed a deal worth up to $1.2 billion with Rigel for its rheumatoid arthritis drug, called R788, which is "the furthest developed in a new class of oral drugs being tested for treating RA and is designed for patients who do not respond to the older drug, methotrexate." Under the deal, "AstraZeneca will make an up-front payment of $100m to Rigel for its R788 drug, with up to $345m more payable after achieving regulatory and first-sale milestones, plus a potential $800m on further sales-related payments." AstraZeneca will also design a phase III trial to begin later this year. The Daily Telegraph (UK).

Merck may seek approval to sell Gardasil for new uses.
Merck's "Gardasil is about 89 percent effective in blocking cervical cancer, genital warts and lingering HPV infections in women aged 24 to 45." Another new study "shows it is about 77 percent effective in blocking anal cancer and precancerous lesions in homosexual men." The drug maker plans to "seek approval to sell the vaccine for those uses." The American Press.

New Medicare rules may help Affymax grab market share from Amgen.
New Medicare rules "will cap fees for kidney dialysis, including the cost of anemia drugs, at about $250 per treatment starting on Jan. 1, 2011, and combine all services under one bill or 'bundle,' said Yaron Werber, a Citibank analyst." The move "may push dialysis clinics to use smaller amounts of cheaper drugs, Werber said." The rules could help "Affymax Inc., a 10-year-old company with no marketed products," grab "market share from Amgen Inc.'s $2.6 billion anemia drug Epogen [epoetin alfa] with a treatment in line to be approved next year." The company has yet to announce "a price for its treatment, called Hematide," but the drug is "given only once a month while Epogen is usually administered three times a week." Bloomberg News.

Affymax readies blockbuster alternative to Epogen.
Affymax hopes to get an FDA approval for its experimental anemia treatment Hematide next year, and that could leave the developer perfectly positioned to take advantage of new Medicare rules capping the cost of kidney dialysis at $250. And if Affymax can scoot into the market under the hefty price for Amgen's Epogen, analysts say the new drug could easily squeeze out what has long been the standard of care. "When we go under the bundle, everything's going to be about money," specialist Julia Inrig at UT Southwestern Medical Center tells Bloomberg. If Hematide is cheaper to buy and use than Epogen, "its use could significantly increase, and it could potentially drive Epogen out of the market." Cowen & Co. analyst Phil Nadeau says an approval next year would leave Affymax poised to reap $1.1 billion in blockbuster sales by 2015. Amgen, which currently has the only anemia drugs used in kidney dialysis, charges $8,445 per year for Epogen. And as a synthetic peptide Hematide should be cheaper to make than Epogen. Bloomberg news. http://www.bloomberg.com/apps/news?pid=20601202&sid=a1meTJTyj3g8  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.  
 
 
Picture
The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.  

So why read Pharma R&D, business news? Because it offers following benefits- 

1.     Enables investors to take “wise decisions”.
2.     Assists Job seekers to realize “where to invest their career”.
3.     Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”. 

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some updates from current pharma business news- 

Big pharma companies look to tap generic drug business in emerging markets.
On the front of its Business Day section, the New York Times reported, "Some prestigious brand-name pharmaceutical companies that once looked askance at the high-volume, low-cost business of generic drugs are now becoming major purveyors of generic medicines." Drug makers, such as Sanofi-Aventis and GlaxoSmithKline "are pursuing a growing consumer base in emerging markets like Eastern Europe, Asia and Latin America where many people pay out of pocket for their medicines but often cannot afford expensive brand-name drugs." In addition, "in some emerging markets, where the fear of counterfeit drugs or low-quality medicines runs high, consumers who can afford it are willing to pay a premium for generics from well-known makers, industry analysts said." 

Quintiles to invest in more drug development research.
Quintiles Transnational Corp., which is the world's biggest contract research organization, is now using its deep pockets to entwine itself with the pharmaceutical companies, fronting them cash and services for a piece of the profits once a drug is approved. Last month, Quintiles also said it wants to invest even more in drug development and is hoping its new investments will produce enormous payoffs in the future, but the buffer between drug makers and testers are again blurred. However, Ron Wooten, a Quintiles executive vice president who heads the company's capital investment group, doesn't see his company's increased interest in bringing drugs to the market affecting its testing objectivity. Instead Quintiles is the outsider turning a hard eye on which pharmaceuticals will become profitable.

Medicare recipients have appeal options when coverage for certain drugs is denied.
The Wall Street Journal reported that, each year, millions of Medicare recipients discover that their drugs are no longer covered by their Part D plans. While seniors in this situation can often substitute generic drugs for brand-name ones, they also have the option of appealing the denial, particularly if their plan did not notify them in a timely manner of the changes. The Journal said that typically, seniors who appeal have a good chance of success, but, in case their appeal is denied, they have 60 days to file a second appeal to Maximus Federal Services (www.medicarepartDappeals.com ). 
 
Lilly to use outside contractors to help its drug pipeline.
The Wall Street Journal reported that Eli Lilly & Co. is hiring outside contractors to run tests on its drug candidates as part of new efforts to be more productive. Lilly will use scientists outside of its own research team to decide whether to move a promising molecule to treat rheumatoid arthritis into late-stage testing, based on mid-stage data. The Journal adds that Lilly is among a number of pharmaceutical companies adopting new strategies to stimulate its research-and-development and to reduce the chance that compounds will fail in more expensive late-stage trials.  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D
Translates innovative concepts to PROFITS. 
 
 
 
Here are some important developments in pharma business world-  

Pfizer to enter Japan's generic drug market as early as 2011.
Pfizer Inc. "will enter the generic-drug market in Japan as early as 2011 to bolster sales of its medicines that have lost patent protection." Matsumori, head of the off-patent and generic drugs business at Pfizer Japan, said the company "will establish a new unit to sell 68 generic and off-patent drugs." Pfizer "will also expand the sales force in Japan to sell more brand-name products, Ichiro Umeda, appointed president of Pfizer Japan Inc." 

India introduces new ethics policy for physicians.
The Wall Street Journal "Health" blog reports that India has become the latest country to place restrictions prohibiting doctors from accepting drug-industry gifts. However, India's Business Standard says that the new ethics rules from the Medical Council of India may not be effective unless penalties for violating them are also introduced.  

UN applauds efforts to end HIV travel restrictions.
The United Nations praised the United States and South Korea on Monday for lifting travel bans on people with HIV and urged 57 other countries with travel restrictions to end them quickly.UN Secretary-General Ban Ki-moon "applauded South Korea's President Lee Myung-bak on Monday 'for his country's leadership in ending restrictions towards people living with HIV that have no public health benefit.Likewise, UNAIDS executive director Michel Sidibe said the policy changes were "a victory for human rights on two sides of the globe. 

US healthcare spending in 2008 increased at slowest pace in 48 years.
The New York Times reported that, "Health spending grew in 2008 at the slowest pace in 48 years as the recession throttled back the explosive growth of health costs," according to a CMS report. "Health spending topped $2.3 trillion in 2008, up 4.4 percent from the previous year," but "the rate of growth in 2008 was down from 6 percent in 2007 and an average increase of 7 percent a year in the decade from 1998 to 2008." The Times adds, "By slowing the growth of health spending, the recession achieved what a generation of public officials tried unsuccessfully to accomplish."  

The Wall Street Journal noted that while healthcare spending growth did slow, it still grew faster than the overall economy in 2008. Government statistician Micah Harman said, "The fact that the recession had a more profound and immediate impact was not something that we've seen in recent history."  

In the report, CMS said that Medicare and Medicaid cost the federal government 8 percent more in 2008 than in 2007. The agency said that national health spending growth continues "to outpace growth in the resources available to pay for it. ... Monitoring the drivers of health-care spending growth will continue to be an important aspect of meeting the nation's health-care needs with the limited resources available in an uncertain fiscal future. 

Merz Pharma to buy BioForm Medical in $253 million deal.
The American Press reported, "Merz Pharma Group of Germany said...it will buy BioForm Medical Inc. for $253 million cash, expanding its aesthetic medicine business." BioForm specializes in "products used in cosmetic medical procedures," such as "Radiesse, which is sued as a dermal filler and as a treatment for vocal fold insufficiency." The company is also responsible for Coaptite, an "injectable implant...used as a treatment for female urinary incontinence."  

The deal has been approved by both companies' boards of directors and is expected to close during the first quarter of 2010. Under the agreement, the Business Journal of Milwaukee reported that Merz "will acquire all of the outstanding shares of BioForm Medical for $5.45 per share in cash under a cash tender offer followed by a second-step merger." After the completed transaction, "BioForm Medical will become a wholly owned subsidiary of Merz and will be renamed Merz Aesthetics."  

Genzyme signs manufacturing deal with Hospira.
Biotechnology company Genzyme Corp. is contracting manufacturing for its key products to Hospira Inc. for an undisclosed amount, according to a Securities and Exchange Commission filing. The "'fill and finish manufacturing services' deal for the genetic disorder drugs Cerezyme [imiglucerase], Fabrazyme [agalsidase beta], Myozyme [alglucosidase alfa], and Thyrogen [thyrotropin alfa for injection]," follows "a series of manufacturing problems at the company's" Allston facility. The FDA "said it found tiny particles of trash in" certain drugs in November, and "recommended that doctors closely inspect vials of" the aforementioned drugs and Aldurazyme [laronidase].  

The deal is contingent upon whether Genzyme can obtain the necessary regulatory approvals to outsource its fill and finish services to Hospira, The agreement, which is set to expire at the end of 2015, will be extended until 2017 unless terminated. 

Genzyme to move operations away from contaminated manufacturing facility.

Genzyme Corp. will move all its filling, packaging, and distribution operations out of its Allston drug manufacturing facility because of the latest problems involving contamination at the plant.The company also said it will "move the bulk of the operations to its own site in Waterford, Ireland."  

Also at http://www.pharm-education.com/2010/02/pharma-business-news.html  

Disclaimer- The information posted is for knowledge purpose only and should not be considered as legal advise.