Very recently, Pfizer had to pay the highest amount ever, more than $2 billion dollars, to settle civil and criminal allegations in regards to federal violations ruling drug sales.  This pharmaceutical giant was accused of promoting the painkiller Bextra and three other drugs illegally, because it offered doctors benefits such as speaking fees and trips to resorts.

Although it is an important monetary amount, the price that Pfizer will pay indirectly due to lost shareholder value will be huge and more important than the dollar value.

A new research called “Regulatory Exposure of Deceptive Marketing and Its Impact on Firm Value” has put a price on the intangible costs a company has to pay when employing these dark marketing practices.  In order to do this, the research studies the declines in the financial market value of pharmaceutical companies that have been accused of dishonest marketing by the FDA.

In this case the amount Pfizer had to pay drew attention to the risks of employing deceptive marketing campaigns and served as an example to other pharmaceutical companies
.  It is possible that this outcome may help the industry by restoring some credibility towards pharmaceutical companies, which may effect the market value in the longer term.
This case is a  prime example  to illustrate how the FDA and the Justice Department are watching the industry with a view to protecting consumer interests.

The research recognizes that most marketing managers and researchers concentrate in finding ways to increase shareholder value instead of thinking about the consequences of dishonest marketing, which could end up costing much more.  Instead of focusing on value creation, this study evaluates marketing from a value destruction point of view.

The study states that pharmaceutical companies have been spending money on promotion at an annual growth rate of 10.6% since 1996, reaching $3 billion in 2005, and that since 1997, when the FDA allowed for direct costumer marketing, the average annual growth has been of 14.3%.  Merck, for example, in the year 2000, spent more on Vioxx than was spent on the megabrands Budweiser and Pepsi.

The reason why pharma companies invest so much on marketing is because R&D is not delivering enough new products. However, the question the authors ask is whether or not the punishment the industry is receiving is sufficient to discourage  dishonest practices?

In the case of this example it would seem so.
A comparison of the  stock prices before and after the exposure, resulted in important negative returns: a 1% drop in market value/$1 billion loss of shareholder value.

The indirect costs of negative events can really harm a company’s market value and will eventually lead to sharp investor’ response.

Three types of dishonesty were defined:

-    Omission of risk information
-    Effectiveness claims without support
-    Superiority claims without support

The level of value lost due to one or another varies, however it was found that in cases where  the less capable of understanding medical treatments and more vulnerable populations were the victims, the market consequences were worse.

The authors recognize that even though the FDA could catch dishonest companies, many may gain lots of added value from deceiving marketing practices before being caught.  In fact, many think the risk is worth it, since advertising has grown around 270% and the number of citations has decreased around 85%.  This makes pharma companies believe that the gamble may well be worth the risk.

Life sciences consulting firms strive to help companies be their best in an honest and responsible way.  Find someone who can really help your company succeed without sacrificing others’ lives, your personal integrity and your company’s reputation.

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As the debate on whether to use stem cells, or not to use stem cells continues to rage, many people are starting to look to the potential upside of using stem cells as a deciding factor.  Stem cells have remarkable potential to be used to test new drugs, cure previously thought of as incurable diseases, and possibly cure many different types of cancer.  But the application of stem cell research has caused a heated debate over the last 20 years, and much of stem cell research was illegal until only recently.  So what are the reasons for this heated debate about stem cell research, and what are the possible applications of stem cells in the future.

You may wonder why there is any debate at all, over a medical treatment method, which may be able to cure some diseases that 20 years ago were thought of as altogether incurable.  But, as it often is, the discussion is much more complicated than it seems.  At the heart of the stem cell debate is the battle over abortion.  According to many opponents of stem cell research, using living stem cell tissue, usually from living embryos, is likened to abortion, since the embryo will be destroyed after testing.  On the other side of the argument, stem cells hold great promise for millions of families and patients thorough out the world, to cure previously incurable diseases such as Parkinson’s disease, Alzheimer’s disease, and even some forms of cancer.  But what exactly are stem cells, and how can they be used to cure diseases?

Stem cells are found all over our body in differentiated tissue and organ cells.  Stem cells are primarily used in the body to maintain and repair tissue cells, and only divide and repair when needed in case of disease or injury.  Stem cells can be found in bone marrow, brain cells, skeletal cells, blood vessels, even teeth.  Only until recently, scientists have been able to reprogram living stem cells, which provides very promising treatment options for the future.  By being able to reprogram adult stem cells the treatment of serious diseases such as cancer, and even curing blindness, are now thought to be within reach.  Even pharmaceutical firms and pharmaceutical consultancy firms are even coming out openly saying that the application of stem cells to cure disease is a real possibility and needs to be further examined.

However, there may be compromises available that will help stem cell research to move forward and into practical use.  Another method of extracting stem cells is through the process of taking adult stem cells from living blood or organs of healthy adults.  This would end the abortion issue about stem cells, and help research to move forward.  The only problem with this method is that many scientists are finding adult stem cells to be marginally helpful to scientists, and do not show the same promise as using living embryos.

Regardless of the debate over stem cell research, the practical usage of stem cells could ultimately be revolutionary in the field of medicine.  Stem cells could be used to test new drugs, they would allow for a wider range of drug testing for all kinds of drugs, including anti-tumor drugs in cancer cases.  They can be used to regenerate damaged cell tissue or even completely replace damaged tissue in the body.  It could help in the treatment, or possibly cure such diseases as Alzheimer’s disease, Crohn’s disease, diabetes, strokes, spinal cord injuries, severe burns, and heart disease.  Only time will tell what the future use of stem cells will bring to our society as a whole, but at this point many are seeing the possible, future benefit of using stem cells, outweighing any negative stigma regarding stem cell research.

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Until recently, many big name pharmaceutical companies have been gun-shy about entering into the realm of social media.  But recent trends are telling a different story.  Only two weeks after pharmaceutical giant Nova Nordisc announced development of its brand new twitter page, Pfizer quickly followed suit introducing plans for its own page in the next few months.  Both companies plan to use Twitter as a social platform to announce new products, new drug treatments, as well as developing better relationships with their consumers.  But is social media really an effective marketing tool for large pharmaceutical companies? And why now are they starting to jump on the social media bandwagon, after years of resistance?

As the economic downturn continues to adversely affect pharmaceutical companies all over the world, many pharmaceutical consultants are starting to recommend giving social media a try.  Until recently, much of the pharmaceutical industry has shied away from entering into the interactive realm of social media, for various reasons.  The common belief was that implementing effective marketing strategies using social media was too difficult, given the legal and regulatory hurdles.  Also, the lack of a means to measure the financial success of using social media, has kept many pharmaceutical companies away from using these possible lucrative marketing tools.  However, signs are showing that these trends are starting to change.

Many pharmaceutical consulting experts are coming out in droves stating that many of these negative claims about social marketing are highly over exaggerated.  It is true that many pharmaceutical companies have stayed away from blogs and other social media because of legal and regulatory issues, but this trend is beginning to change.  Many pharmaceutical companies, in recent years, are simply bypassing many of these regulatory concerns, or simply finding ways around them.  Many drug companies are hiring outside firms to run blogs and message boards for them, but at the same time not being directly associated with the company.  This is an important step for pharmaceutical companies, as customers can discuss their reaction to different drugs and therapies, without and legal concerns.

With over 80% of Internet consumers, searching online for health and drug information, breaking into social media is absolutely vital for the continued success of pharmaceutical industry in the technologically evolving business climate of the 21st century.  Many pharmaceutical consulting experts are finding it more and more important for the pharmaceutical industry to enter into this realm of social media, and find it will be more common place in the next 5 years.  Because social media is an excellent place for drug companies to utilize online support groups, as well as discuss treatments and medications with patients online, this trend will only continue to grow.  Marketing through social media will help create not only better informed patients, but will help patients to make better health decisions about what kind of medicines or treatments they should be choosing.

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In preparation of a developing pandemic of any kind, whether it be influenza, or some other kind of fast spreading virus, the Food and Drug Administration (FDA) has devised a precautionary plan known as the FDA Pandemic Preparedness Strategic Plan.  The FDA Pandemic Preparedness Strategic Plan is coordinated with the President’s National Strategy for Pandemic Outbreaks, as well the CDC’s Pandemic Implementation Plan.  Under these guidelines the FDA works under federal and local levels to effectively contain a pandemic outbreak, if possible, and do whatever is in their power to minimize the harmful effects of an outbreak.  But what is the FDA’s Pandemic Preparedness Strategic Plan, and what does it mean to a normal citizen, like me or you?

The FDA Pandemic Preparedness Strategic Plan is a plan strategically shaped to coordinate Federal, State, and local levels of government, to work together to prepare for, and ultimately minimize the effects of a pandemic outbreak, such as the Influenza outbreak of 1918, or the recent pandemic, known as the Swine Flu.  The plan involves coordinating federal and local authorities to develop enough domestic vaccine production capacity, sufficient to provide enough vaccines to accommodate for the entire U.S. population.  The FDA would make sure that the vaccines developed are safe and effective enough to give to the population as a whole, as well as providing cross-protective immunity.

The FDA’s Pandemic Preparedness Plan also relies on the availability of improved diagnostic devices, which can be readily available, and can also detect pandemic viruses, as well as differentiate between seasonal viruses, and viruses that have pandemic potential.  This differentiation is important for not only effective patient management, but for effective pandemic preparedness and response.  The FDA will provide proper guidance to the use of the point-of-care tests, in both pre pandemic, and post pandemic phases.

However, some critics have their doubts on whether this plan can actually be fully implemented in an effective manner in case of an actual pandemic emergency event.  Critics are using such emergencies like the aftermath of Hurricane Katrina, as a catalyst of doubt, that the government can effectively handle and control a national crisis.  They are also using other national emergencies such as the terrorist events of 9-11, to point out an example of the lack of coordination between Federal and State authorities in case of a widespread emergency.  Because of these widespread doubts many citizens are taking matters into their own hands, and getting flu vaccinations on their own.

But is this FDA Preparedness Plan actually a viable option response to a real viral pandemic? Many have their doubts.  One of the major doubts people are having is whether the FDA can effectively create enough vaccines to have a real impact on a pandemic outbreak, if one were to break out unexpectedly.  The pharmaceutical industry, as well as many life sciences consulting firms, are having their doubts as well.  Upon witnessing the recent shortage of H1N1 flu vaccines, the pharmaceutical industry as a whole doubts that the FDA could effectively coordinate the mass amounts of vaccines need to quell a real pandemic outbreak.  Only time will tell, but the FDA stands firmly behind their Preparedness Response Program, and stands by its claims that it is ready for anything.

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If a growing biotech company wants to succeed, it must create long-term sustainable value.  Everyone wants to partner with large pharmaceutical companies, however, either they do it very early and give away an important part of their long-term value, or they are unable to build all the capabilities on time to allow for their technological value to be noticed.  These partnerships are difficult to manage given the important cultural differences between organizations, so, even though they are a fast way to build value, they very often fail to deliver.

The most reliable   way for a biotech company to become successful is to develop a product that meets a specific need and thus, is bought by many customers. However, getting there is not easy.

Biotech companies normally strive to partner with a pharmaceutical company as a way to validate their technology and ensure financing.  These partnerships possess many benefits, but also pose challenges and disadvantages, namely: an increasing number of biotech companies seeking partnerships; the fact that pharma companies really do not give extra benefits like better R&D effectiveness and only pay royalties for well-defined product candidates; the difficulty of managing such different working cultures; and the fact that the big company always gets the largest portion of the deal because it acts as the technology integrator.

Pharmaceutical companies have proven to be very inefficient in making the fast decisions needed to take advantage of the opportunities at the drug candidate and clinical proof of concept phase of the drug discovery process, a field where biotechs move very fast and where their business approach can better meet the challenges of this phase.

The problem is that biotechs on their own do not possess the range of capabilities needed to keep product rights after Phase IIa or to give an integrated technology solution.  In order to address this, some biotechs decide to join forces with other biotechs that have complementary capabilities.  Although this seems logical and feasible, since both have similar cultures and complementary skills working together on a common purpose, these partnerships have failed in the past.

What happens is that the partnership relationship works well great until the companies have to commit to additional resources to take an initial lead to a drug candidate, and they start discussions to partner with pharma companies.  Then, they start thinking what’s best: to continue the 50:50 partnership that offers no revenue in the short term, or use their resources to join pharma.  Most commonly, they select pharma because this provides for the fastest solution to market.

Nevertheless, biotech-biotech partnerships are very valuable for these companies to hold on to important value by giving pharma what it wants: integrated technology solutions or product candidates with proof of concept clinical data.

In order to achieve biotech-biotech partnering success, it is vital to design a carefully structured arrangement.  It is necessary to look at the relationship throughout phases, and to define responsibilities, deliverables, and resource commitments for the first phase, always considering that something can change, thus, an alternative plan must be established in the agreement.  At the end of each phase each partner must have the opportunity to commit again or leave, with clear terms that should be agreed upon.

The initial agreement should guide the relationship through the other phases, and it must offer a flexible way to identify responsibilities.  Given the fact that new companies change very rapidly, flexibility is crucial.  In truth, the shorter the partnership, the better.  Since both parts have to compromise, every partnership offers aspects of the relationship that are less desirable for each party.  Each company must be able to develop its own interests and path forward, so as to have a better chance of success.  Three worthy models for biotech-biotech partnerships are:

-    Barter model
-    Baton exchange model
-    Draft model

Pharmaceutical consulting firms can provide information and guidance on these three models and how to best apply them given the case.

Through biotechs partnerships, these companies can control their technologies for high value deals by keeping product rights through Phase IIa or by providing an integrated technology solution.  In this way, biotechs can profit from their strengths and move efficiently through drug discovery and early drug development, giving them the space to consider their next step: continue developing the product alone since it will have the financial capability to do it, or consider a partnership with a pharmaceutical company.

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It is no surprise that as emerging markets, like China and India, continue to grow at a record pace, that drug makers all over the world need to wake up to the fact that the future of their business may depend on markets outside of the United States and Europe.  As these emerging markets in China and India, as well as Brazil continue to grow full speed ahead, it is becoming more evident to the pharmaceutical industry as a whole, that they better start paying more attention to these parts of the world.  But what is behind this recent economic boost? Why is it so important for the pharmaceutical industry to starting taking notice of it?  Could these emerging markets like China and India really surpass the US and Europe as the key players in the pharmaceutical marketplace of the future?

Because of this uninhibited growth in emerging markets all over the world, the pharmaceutical and life sciences industry is beginning to pay attention.  However, as many pharmaceutical consultants are beginning to notice, the same strategy that has worked in large, super-industrialized countries such as the US and Europe, may not be as effective in emerging markets such as Brazil and India.  Many of these consulting firms are recommending completely different strategies when it comes to being successful in these emerging markets such as differential pricing.

Differential pricing is a tactic that most pharmaceutical companies might not try in larger, more developed countries, but might be a good tactic in emerging markets such as India and Brazil.  Differential pricing takes into account the per capita income, when setting prices.  For example, the middle class income rate for Indians or Brazilians is far lower than that of those who reside in the United States and Europe.  By differentiating their pricing structures, this could lead to a widespread increase in business abroad.  However, not everyone is convinced this will be good for business.

Some critics have argued that under the price differential plan, pharmaceutical companies would suffer major loses, unless propped up by large demand or government subsidies.  Others have argued that many will just take these cheap branded medicines and resell them in the black market, to other parts of the world for substantially higher prices.  Regardless of the best method to price these drugs, no one disagrees with the importance of forward thinking drug companies tapping into these untouched emerging markets.  Its seems that whichever company figures out the best plan first to how to successfully tap into these emerging drug markets, will lead the global pharmaceutical marketplace well into the 21st century.

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Companies today face a unique environment, one that demands flexibility and fast response to changing business needs.  In response, many businesses have adopted virtual organizations: decentralized, team-based and distributed structures that are supported by the advances in communication technologies.

Every virtual organization is unique.  They come in all shapes and sizes, in different locations, and have no defined structure.  Such an organization can modify business processes in a dynamic way to meet market demands, to coordinate contacts, to define different boundaries over time or according to customer, and to organize components’ relationships as needed.  In order to do this, the virtual organization’s employees, teams, departments, units, or firms, must be distributed geographically, have to be functionally and culturally varied, electronically linked, and connected through lateral relationships.

Virtual organizations add value to their clients by building networks around them.  No control or direction is required; instead, these want to display processes that demonstrate leadership, coaching, facilitation, and contracting skills.

Virtual organizations help their customers by improving their own performance, careers, and personal lives.   They are collaborative organizations that acknowledge that the old hierarchy-based structures are not valid anymore.

Some fundamental values that guide the work of a virtual organization are:

-    Steady learning
A virtual organization is an educative one.  It knows that behind every true change there is belief, and the education on those beliefs will allow for a fully dynamic environment.

-    Works by example
Successful virtual organizations walk the walk and talk the talk.  Their objectives are clear and achievable, leaving nothing behind.

-    Interdependence
These organizations work to create interdependent relationships with their clients, suppliers, and everyone else related to their business.  They help companies move from dependence, to independence, where it is easier to work and add value.

-    Customer understanding
The real focus of virtual organizations is on the value of a long-term relationship, not on the worth of a short-term transaction.

-    Win/win philosophy
Every relationship started and developed by a virtual organization must be valuable for both parties.  There is no such thing as I win; you lose.

-    Respect and courtesy
The organizations show genuine respect and interest in all of their clients and partners.

These values, in turn, give birth to the following factors, which are critical for success:

-    Value
Every client must feel that they are getting much more worth than what they are paying.

-    Constant improvement
Virtual organizations are always checking their processes to ensure the clients are getting what they need and more.  They always want to do better.

-    Impartiality
A virtual organization works under the premise that all its clients are equally valuable.  Every time a possibility of partiality emerges, the clients should be informed about it and its consequences.

-    Communication
The philosophy is of constant, clear, open, and friendly communication all the time.  In order to be successful, virtual organizations require modern information technology systems 24/7.

In order to be able to survive and excel under the new market panorama, pharmaceutical companies have to implement new practices and invest in the professional pharmaceutical consultancy that will be able to guide them wisely through troubled waters.

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The answer to this question is simple: pay more attention to innovation and not so much to marketing.

Even though big pharma has developed big mergers to support its business infrastructure and best-selling products, it still hasn’t found a solution for the need to develop new business models to address its main problem: the inability  to create unique treatments.

Today, big pharma is suffering due to dry product pipelines, the gruesome competition of generic manufacturers, consumer worries about safety, marketing statements that are not true, and the threat of the government’s increasing role on the purchasing and pricing of drugs.

The healthcare reform has been at the center of the public eye, but drug companies have remained in the background.  In return for promising the Obama administration they would contribute $80 billion in savings to aid in the financing of the proposed reform, the industry’s basic pricing structure would not be touched by the restructuring.  Basically, they avoided the hit and are low in profit growth; nevertheless they are lucky because there are many people in Congress that want to hit them harder.

By expanding the coverage to more than 40 million people that are not insured, the industry will gain a larger customer base and the profit growth would mean pure profit since the cost of creating a medicine is not based in the drugs production but in the research that goes into discovering a new medicine.  Eventually, there could be government demands on pricing, and the launch of new products will be subject to more inspection based on cost through public insurance or exchanges. With all these changes going on, it is certain that the drug industry will be closely regulated after the reform is approved.

Marketing practices are also being inspected at state and federal levels.  The states are tightly restricting the way in which drug marketers relate to doctors. They are putting limits to the gifts and other ways they used to stimulate the prescription of one drug over another.  The states are working on establishing programs where educators, with no specific economical interest, will visit the doctors to keep them informed about new treatments.  We are seeing much more monitoring of direct advertising to the customers due to safety problems.

Also, the generic drug threat is hanging over the pharmaceutical industry.  The generic drug industry is becoming more sophisticated in its efforts to create generic versions of a drug once its patent expires, to the extent that some pharmaceutical companies are thinking about getting into the generic field.

Clearly, there are new ideas being born that could create a meaningful change for the industry, like the fact that pharmaceutical companies are joining forces with biotech companies to create more sophisticated biologically based drugs and products Which may be easier to protect.  Biotech companies are small operations based on science, making them more groundbreaking than the traditional big companies.  In fact, in the next 10 years, large companies will invest more in small research-based operations for new  products, and will reduce or redirect expenditures on centrally based R&D and marketing..

Life sciences consulting firms agree that pharmaceutical companies should start emphasizing the comparative effectiveness of one drug over others for a specific treatment through the use of clinical trials and government approvals, even in the face of the risks this poses.  By keeping up with the actual marketing strategy, companies will only strengthen the already growing customer distrust.  Instead of fearing comparative effectiveness, companies should understand it and use it rationally; their focus should be innovation.

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As the Global economy continues to deteriorate in many parts of the world, the same can’t be said about the booming pharmaceutical industry.  According to researchandmarkets.com the global pharmaceutical market is expected to earn well over one trillion dollars in revenues by the end of 2011.  This forecast is based on many growing trends, which seem to not be affected by the global economic crisis of the past few years.  Some of these trends include the growth of developing pharmaceutical markets in emerging markets, strong growth in bio-tech based drugs, as well as a large increase in the prevalence of generic medicine.  But what other factors are contributing to this large boost in the pharmaceutical sector?

Some of the key research findings researchandmarkets.com found in their report are very conclusive.  With a Compound Annual Growth Rate (CAGR) growing at almost 8% per year, the pharmaceutical industry is one of the fastest growing industries in the global marketplace.  If the CAGR continues to grow at this pace, the global pharmaceutical market is expected to reach upwards to 1045 Billion in 2012.  Other research findings tell the same story.  The report also credits the growth in previously untapped markets, the Asia Pacific market like India and China, as being one of the most lucrative pharmaceutical markets of the future.  The report also credits the recent growth in Latin American markets, such as Mexico and Brazil, as being key players in the pharmaceutical industry, over the next 20 years.

Many pharmaceutical consulting firms are suggesting many other global trends that are factoring into this large boost in the pharmaceutical industry.  Some of these factors include growing market size, favorable government policies, expanding health coverage, and new developments in drug developing technology, just to name a few.  However, not everyone in the industry is convinced this unprecedented growth will sustain itself for much longer.

Many life sciences consulting firms are pointing out, that as patents held to key drugs begin to expire in the next ten years, it could hurt the growth of the North American pharmaceutical market.  Coupled with the growing prevalence of generic drugs all over the world, as well as dwindling drug pipelines, and the development of less blockbuster drugs and less and less economic cooperation, these factors may challenge the growth of the global marketplace in times to come.  Only time will tell.

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Under the Hatch-Waxman Act, every generic candidate has to give the holder of the approved New Drug Application (NDA) notice of the filing of the ANDA.  As soon as they receive it, in turn it files a patent infringement lawsuit that starts a thirty-month stay, making it impossible for the FDA to approve the ANDA without a final court judgment favoring the generic candidate.

With the proposed HR 1427 and HR 1548, the generic candidate has to notify the Biologic License Application (BLA) holder about the filing, however, there is no statutory stay defined if a lawsuit is filed promptly.

In regards to the marketing exclusivity, both views, the current and the proposed, are parallel, giving similar exclusivity periods.  However, most possibly, the patent litigation resulting from a follow-on biologic application will last longer than the period of exclusivity, creating the possibility of a risky launch of the follow-on biologic, where the candidate markets its product before any final judgment is given.  This will definitely increase preliminary injunction filings and appeals to the U.S. Court of Appeals for the Federal Circuit, thus, when deciding where to file suit, BLA holders have to consider the court’s track record on preliminary injunctions and if the court provides for a shorter time to trial so as to minimize the possibility of an at-risk launch.

So, under this new panorama, filled with challenges like the one above, and with lots of uncertainty, how can you be better prepared to face the new structure for approval of follow-on biologics?

President Obama has been clear in showing his support for the progress of a structure for approving follow-on biologics.  His interest is so high that the federal budget for the fiscal year 2010 includes a proposal to develop this structure.  So, no matter what the future brings, these are some considerations you must pay attention to so that you are prepared to face any future follow-on biologics approval process and any patent litigation conditions that may come along.

1.    Understand your patent portfolio
HR 1427 and HR 1548 do not mention the creation of an Orange Book equivalent for follow-on biologics, but require that the BLA holder identify relevant patents when the follow-on biologic candidates request it.  Review your patent portfolio right away to understand which characteristics of your products and processes are protected, what the scope of this protection is, when the patent term ends, and if you own or license-in the technology involved.  In addition, ask for legal counsel and pharmaceutical consultancy to start a full due diligence investigation so that you are ready to identify the patents that cover your biological product.

2.    Understand your product and manufacturing processes
Get your scientists and manufacturing engineers on board and check everything about your product and its creation process, to acknowledge if a generic manufacturer could create something different from your patents but still be biosimilar and interchangeable.  Also, it will help you determine how long it will take a generic manufacturer to develop the follow-on biologic and what problems it faces, alerting you as to when you could be hearing about an application filing.

3.    Think ahead
Since HR 1427 and HR 1548 give extensions based on pediatric studies and new therapeutic advances, talk to your teams in production, clinical research, and regulation, to see if any of these studies are possible or if new uses are being tested.  Never stop thinking about how this new legislation can affect your company and its strategy.

Although nothing is final yet, the new legislation will surely be different from the Hatch-Waxman ANDA litigation.  If anything, staying in the loop will allow you to act based on a plan established under valuable and decisive information.

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