by Max Jones, Unlimited Hangout:
In the face of a potentially industry-ending slew of patent cliffs, Big Pharma has begun acquiring biotechnology companies to stave off collapse. To get these drugs to market, the industry is pursuing the only solution left for their dying model: a full takeover of the WHO to capture the global regulatory system.
Big Pharma must soon confront an industry-wide hazard that reaches magnitudes far greater than the typical concerns of corporate profit margins and business politics. Through years of industry consolidation, it has essentially made itself “too big to fail.” Only now, the model which it once could never fail within — that is, the practice of obtaining patent exclusivity over drugs that are approved through clinical trials and regulations — has become obsolete, even impossible, under the current conditions of the industry.
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In this new climate, the trials and regulations Big Pharma once successfully navigated may very well lead to its total demise. However, the pharmaceutical sector has set its eyes on the only solution that can keep its money and power intact; the full takeover of the public sector, specifically the World Health Organization (WHO), and the regulatory system that now holds the entire market hostage.
The problem begins with the looming financial threat that the top 20 Big Pharma companies face: from now until 2030, $180 billion in sales will be at risk. This threat, called a patent cliff, is a regularly occurring problem for the pharmaceutical industry. Big Pharma has long made its money by attaining patent exclusivity of certain drugs, thereby monopolizing all potential profits made off of them for a finite amount of time. When that patent exclusivity ends, the drug rolls head first off of a “patent cliff,” and tens of billions of dollars in revenue are put at risk.
Typically, companies address patent cliffs through mergers and acquisitions (M&A) of other, often smaller drug companies that produce products with market potential. This time around, however, according to Biopharma Dive, “after years of industry consolidation, there are not many major large drugmakers left as attractive merger targets.” In other words, Big Pharma has become “too big to fail” and – over the next 6 years – faces a new round of potentially disastrous patent cliffs. Further, traditional chemical drugs already exist for many diseases and regulators have increased approval standards for them, delaying the time in which new products obtained from M&As can be taken to market.
As a result, companies facing patent cliffs have shifted their patent cliff response efforts to acquiring biotech and biologic companies that produce products that, compared to their more typical chemical-based counterparts, are more complex, unpredictable and difficult and expensive to make. The race for future blockbuster drugs will therefore take place “in big drugmakers’ own laboratories or in those of smaller biotechnology companies” as opposed to mergers with other large corporations.
To understand what makes biologics so complex and unpredictable, their vast difference in function and origin compared to chemical-based drugs must be understood. Biologics are taken from different natural sources, such as humans, animals or microorganisms and “may be produced by biotechnology…and other cutting-edge technologies.” While chemical drugs activate one’s entire immune system in a general manner, biologics target “certain proteins or cells in your immune system to create specific responses,” hence the use of cutting-edge technology to achieve these more specific medical goals.
There are multiple reasons Pharma companies might be interested in biotech — but three are clear from a market perspective. The complex nature of biologics makes them impossible to replicate in the way a typical chemical-based drug would be, forcing companies to make “biosimilar” versions of the drugs as opposed to generics. This means that biosimilar versions of biologics cannot be interchanged without consequence during a patient’s treatment in the way a generic could be, for example. Their costly development also makes their off-label counterparts more difficult to sell at significant discounts, making biosimilars not as financially appealing to consumers as generic drugs. There are also complex regulatory obstacles in getting biosimilars to market, even after they’re approved by the Food and Drug Administration (FDA). These attractive characteristics have made biotech the hopeful solution of the coming patent cliff Big Pharma companies are preparing to face, with a slew of top Pharma corporations acquiring gene editing, antibody-drug conjugate and other biotech companies to offset their potential losses (see here, here, here, here, here and here).
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