Vladislav Gurin :: BioTech & Pharma consulting

Researching & Promoting on-line pharmaceutical market


The leadership role of the United States in the biotech and life-science industry has previously been explained by the real option approach to investments.
For high-risk and extensive R&D projects such as those leading to innovative original drugs, the investment approach is staged. These projects were characterized as sequential compound options. Concurrent investment into subsequent stages depends on the level of uncertainty that determines the critical cost to invest. At least two sources of heterogeneity between the U.S. and Europe, so goes the argument of this research, have helped the U.S. to identify and execute real options in the emerging biotech industry while preventing the EU from doing so.

  1. Regulatory uncertainty, as one key uncertainty in the drug development and approval process, has been higher in Europe than in the U.S., and has elevated the critical threshold to invest in for innovative R&D projects. For one, European drug approval agencies were less structured and slower in the approval rate than the U.S. FDA.
  2. Further, consumer concerns about the merits of modern biotechnology were much stronger in Europe.

In addition, as the drug development process tends to be a continious one, the rate of investment for the time to build & strengthen option is crucial for the option owner to fully execute all sequential steps of the compounded real options. In the U.S., at least within the early stages of the emerging biotech industry, there was much more capital, and specifically risk capital, available to support these real option owners.

In the XXI century, we are much more enthusiastic about outlooks of nanotechnologies for our life and environment. Nanotechnology, when fused with biotechnology, creates nanobiotechnology and nanobiomedical technology; the products of which hardly resemble the parent biotechnology products. These new scientific disciplines, by overall opinion, can even change the face of our civilization in this century. The important point is that dealing with nanotechnologies, we faced new phenomenon: the transition of compounds to nanostate dramatically changes their characteristics such as electrical, magnetic, optical, mechanical, biological and etc. This really great phenomenon permits creation of novel functional materials with unique custom-made properties.
Development of completely new technologies and innovative nanomaterials and nanosystems with exceptional desirable functional properties lead to a new generation of products that will improve the quality of life and environment in the years to come. There are numerous new generation nanomaterial products of high quality including biocompatible biomaterials, antimicrobial biodevices, surgical tools, implants, decorative and optical devices, and, finally, nanocarriers and nanosystems.
One of the most important applications of the so-called nanomedicine/nanotherapy appeared to be the targeting of medicines or additives to the desired organs and tissues using special nanoparticles and nanocapsules of various nature to cure human diseases. Because of their unique features, nanosystems enhance the medicines’ performance by improving their solubility and bioavailability, increasing their in vivo stability, creation of high local concentrations of bioactives in target cells and cellular compartments in order to gain therapeutic efficiency.
Nanocarrier systems used for medicine targeting are mainly consisting of lipid molecules, surfactants, and certain polymers, such as dendrimers, which are specially designed to be drug carriers. Hybrid organic/inorganic materials have also become popular now. Carbon-based nanostructures (nanotubes, etc.) are used for implant construction and as nanosystems for drug targeting.

Amgen, Biogen Idec and Genentech represent three pioneering biopharmaceutical companies that remain and grow in business.
Founded in the 1980s as AMGen (Applied Molecular Genetics), Amgen now employs over 9000 people worldwide, making it one of the largest dedicated biotechnology companies in existence. Its headquarters are situated in Thousand Oaks, California, although it has research, manufacturing, distribution and sales facilities worldwide. Company activities focus upon developing novel (mainly protein) therapeutics for application in oncology, inflammation, bone disease, neurology, metabolism and nephrology. By mid-2002, six of its recombinant products had been approved for general medical use (the erythropoietin-based products, ‘Aranesp’ and ‘Epogen’, the colony stimulating factor-based products, ‘Neupogen’ and ‘Neulasta’ as well as the interleukin-1 receptor antagonist, ‘Kineret’ and the anti-rheumatoid arthritis fusion protein, Enbrel). Total product sales for 2001 reached US$ 3.5 billion and the company reinvested 25% of this in R&D. In July 2002, Amgen acquired Immunex Corporation, another dedicated biopharmaceutical company founded in Seattle in the early 1980s.
Biogen was founded in Geneva, Switzerland in 1978 by a group of leading molecular biologists. Currently, its international headquarters are located in Paris and it employs in excess of 2000 people worldwide. The company developed and directly markets the interferon-based product, ‘Avonex’, but also generates revenues from sales of other Biogen-discovered products which are licensed to various other pharmaceutical companies. These include Schering-Plough’s ‘Intron A’ as well as a number of hepatitis B-based vaccines sold by GlaxoSmithKline (GSK) and Merck. By 2001, worldwide sales of Biogen-discovered products had reached US$ 3 billion. Biogen reinvests ca. 33% of its revenues back into R&D and has ongoing collaborations with several other pharmaceutical and biotechnology companies.
Genentech was founded in 1976 by scientist Herbert Boyer and the venture capitalist, Robert Swanson. Headquartered in San Francisco, it employs almost 5000 staff worldwide and has 10 protein-based products on the market. These include human growth hormones (‘Nutropin’), the antibody-based products ‘Herceptin’ and ‘Rituxan’ and the thrombolytic agents ‘Activase’ and ‘TNKase’. The company also has 20 or so products in clinical trials. In 2001, it generated some US$ 2.2 billion in revenues, 24% of which it reinvested in R&D.

A measure of the educational infrastructure in biotech is the annual investment in tools that support the biological and computer sciences. According to the National Science Board, about 9% of the annual budget for the biosciences is spent on tools like genomic sequencers, electron microscopes, and biological databases. In comparison, about 27% of the educational investment in computer sciences is devoted to infrastructure, predominantly on networks, software, data repositories, and data communications systems.

Given the increasing need for academic biological centers to create, maintain, and update vast genomic databases, the National Science Foundation (NSF) has earmarked the biosciences as one area in which the infrastructure investments have not kept up with expanding needs and opportunities. This is reflected in a preliminary estimate of NSF future infrastructure needs, based on reports from the NSF directorates and the Office of Polar Programs (OPP).

In virtually every industry, there is a considerable lag between the discovery or invention of a new technology and a practical, marketable product based on the technology. This incubation time represents a delay in acceptance by the market, which is traditionally modeled as a sigmoidal adoption curve of early, middle, and late adopters. Slow acceptance of a new technology can be caused by issues of price, immature technology, or simply the human tendency to resist change.
For example, in the case of the Western pharmaceutical market, economic events linked to war served as a catalyst to significantly shorten adoption time.
In the United States, the Civil War (1861–1865) catapulted E.R. Squibb’s nascent laboratory virtually overnight to the status of the US Army’s primary supplier of painkillers and other pharmaceuticals used on wounded soldiers. Spurred on in part by Squibb’s success, the next several decades were marked by a flurry of activity in the US pharmaceutical industry, including the founding of Parke, Davis & Company (1867), Eli Lilly Company (1876), Abbott Alkaloidal Company (1888), and Merck and Company (1891).
Much of the economic success in the pharmaceutical market in the United States and Europe in the mid-to-late 19th century is attributed to the development of pills as alternatives to the elixirs, powders, and loose herbs used until that time. With the introduction of drugs compressed in pill form, the mass production methodologies developed during the industrial revolution could be applied to the production, packaging, and distribution of medicine. Furthermore, pills were readily accepted by the medical community because they delivered standardized, reproducible dosages of drugs. Pills were considered safer and more effective than alternative forms of drug delivery, because the quantity of active ingredients in tea made from loose herbs varied as a function of the freshness of the herb as well as the time the patient spent steeping the tea, for example.
Although the technologies of pill production were developed in Europe, they were initially exploited by firms in the United States. For example, in the first half of the 19th century, the French developed mass production of sugarcoated pills, and the English developed the first tablet compression machine. In addition, a tablet compression machine was developed in the US during the Civil War. However, the pill wasn’t fully utilized until the spurt of market activity in the US following the Civil War. William Warner began producing pills in 1866, and Parke, Davis & Company commercialized the gelatin capsule in 1875.
Paradoxically, Silas Burroughs and Henry Wellcome, who trained in the United States, brought mass-produced pills to Britain in 1880, where they patented their pill production process. Although not as popular as pills for adult patients, salves, ointments, creams, syrups, and injectables also benefited from the mass production and quality control techniques developed during the industrial revolution.
Leading up to World War I, the chemical revolution was in full swing in Germany, where organic chemists used by-products of coal tar to synthesize dyes, such as indigo, that were costly to extract from natural sources. Germany enjoyed a virtual monopoly on the synthetic dye market.
By chance, many of these dyes and their derivatives, proved to be therapeutically useful. As a result, several pharmaceutical companies were started, often as offshoots of large chemical production facilities. Because of Germany’s expertise in the chemical industry, and its close ties with university laboratories, it became the center of pharmaceutical development. However, to attribute the modern pharmaceutical industry to German entrepreneurship would be to ignore the numerous contributions of scientists and entrepreneurs in other countries.
Consider the path of aspirin to the consumer market. Folk medicine had long identified the medicinal qualities of willow bark. However, it took two Italian scientists to identify the active ingredient in the bark in 1826, and a French chemist to purify it in 1829. A Swiss pharmacist extracted the same substance from a plant, which a German chemist identified. The molecular structure of this compound was identified by a French chemistry professor. Another German modified the compound to its present form so that it wouldn’t cause as much stomach upset. By 1899, the synthetic compound became known as aspirin, and in 1900, the German drug company, Bayer, secured patents on the compound.
Bayer’s success was short-lived, however, even though aspirin eventually became the most popular drug of all time. With the start of World War I in 1914, the patents and trademarks of German factories in countries at war with Germany were sequestered. Forced to stop trade with Germany, many of the countries at war with Germany began manufacturing dyes on their own. What’s more, the 1919 Treaty of Versailles forced Germany to provide its former enemies with large quantities of drugs and dyes as part of war reparations. The United States government confiscated and auctioned off all of Bayer’s American assets, including the names “Bayer” and “aspirin” and associated trademarks—which remained outside the German company’s control until it bought them back from SmithKline Beecham in 1994.
Despite major setbacks from the pre-war pharmaceutical boom, by the 1930s, the German pharmaceutical industry was in modest recovery, producing insulin under license from Canadian researchers, and synthesizing sulfa antibiotics from dyes. In addition, German companies such as Hoechst manufactured penicillin on a large scale through the early 1940s and into World War II. The demand for antibiotics increased dramatically during World War II, sparing the lives of many soldiers with wounds that would have been considered lethal in World War I.
The aftermath of World War II also accelerated the development and production of antibiotics for civilian use, and several new pharmaceutical companies sprang up worldwide to fill the growing demand for antibiotics.
Growth was fueled by the brisk demand for second-generation antibiotics, such as streptomycin and neomycin, because of the bacterial resistance that developed in response to the liberal use of penicillin. The biotech startup phenomena of the 1970s, which was centered in the US, sparked further development in the pharmaceutical industry. These biotech companies were technology driven and primarily run by those with little real experience in the pharmaceutical industry, and with little knowledge of the lengthy drug development process and its associated regulatory hurdles. As a result, most of these firms failed. The ones that survived did so through mergers with other startups and by being acquired by established pharmaceutical companies.