Month: September 2015
Fatty acid amide hydrolase (FAAH) is an intracellular amidase signature family of serine hydrolases enzyme, which catalyzes the hydrolysis of bioactive fatty acid ethanolamides such as anandamide and oleoylethanolamide. FAAH serves as the major metabolic regulator of many of the endogenous fatty acid amides, exhibiting a distribution consistent with its role in terminating their effects at the released sites of action. It is the only well characterized mammalian enzyme bearing their unusual Ser–Ser–Lys catalytic triad.
A remarkable series of potent, selective, and efficacious inhibitors of the enzyme FAAH have now been disclosed, many of which have been utilized to mechanistically and structurally characterize the enzyme. In this regard, it is interesting to note that around 70 million Americans annually suffer from chronic disorders in sleep, making sleep second only to pain in the number of patients seeking medical attention.
Several studies summarized in recent reviews have detailed the discovery of FAAH and defined its potential to serve as a new therapeutic target for the treatment of a range of clinical disorders. The development of inhibitors of FAAH, the enzyme responsible for degradation of endogenous oleamide and anandamide and may prove to be useful therapeutic agents for the treatment of sleep disorders and pain.
Since FAAH is recognized as a drug target, a large number of inhibitors have been synthesized and tested since 1994, and these are reviewed in terms of reversibility, potency, and specificity for FAAH and cannabinoid receptors. An innovative clinical opportunity likely will emerge, from better understanding the fundamental physiological role of the signaling fatty acid amides, which FAAH regulates. This area is still incompletely defined.
Inhibitors of FAAH are considered a potential therapeutic approach, for the treatment of several nervous system disorders, including pain, anxiety, and insomnia. However, for FAAH inhibitors to achieve clinical utility, they must not only display efficacy in vivo but also selectivity for this enzyme relative to the numerous other serine hydrolases present in mammalian proteomes.
Figure 1: Mechanism of Fatty Acid Amide Hydrolase
“The FAAH Inhibitors – Pipeline Insights, 2015” report, provides information of 25+ pipeline drugs with 13+ companies actively involved in drug development. There are 3 drugs in phase II, 2 in phase I, 4 in pre-clinical, 1 in discovery, 14 in inactive and 1 in discontinued. Vernalis plc is developing a lead product V-158866 which is in Phase II.
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DelveInsight’s report provides Assessment over chemical, technology information and comparative analysis at various stages. In addition, FAAH Inhibitors – Pipeline Insights, 2015 report will help to identify the key players of market and the potential market movers and barriers.
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A disease that has not been adopted by the pharmaceutical industry because it provides little financial incentive for the private sector to make and market new medications to treat or prevent it. An orphan disease may be a rare disease or a common disease that has been ignored because it is far more prevalent in developing countries than in the developed world. A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population.
There are thousands of rare diseases. To date, six to seven thousand rare diseases have been discovered and new diseases are regularly described in medical literature. 7% of the population are estimated to be affected by a rare disease at some point in their lives. 75% of rare diseases affect children, and 30% of rare disease patients die before their fifth birthday. Rare diseases include rare cancers such as childhood cancers, sarcoma and some other well known conditions such as cystic fibrosis, Huntington’s disease, Crohn disease, etc.
Drug development strategies
The growth of Pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will lose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model such as orphan drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables Pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols are a further boost for the companies developing orphan drugs.
An orphan drug can be defined as one that is used to treat an orphan disease. For example, haem arginate, used to treat acute intermittent porphyria, variegate porphyria, and hereditary coproporphyria, is an orphan drug. However, it comes as a surprise that ibuprofen can also be categorized as an orphan drug, because it has been used to treat an orphan disease, namely patent ductus arteriosus in neonates. This observation stresses that barriers to the development of orphan drugs do not occur only at the premarketing stage; in some cases it may not be commercially worth mounting an efficacy trial, even for a drug whose efficacy elsewhere is well established.
Orphan drug status
Products intended to treat rare diseases are developed to treat patients suffering from very serious diseases for which no treatment, or at least a satisfactory one, has so far been available. These diseases affect only a small proportion of the population most often at birth or in infancy. The number of rare diseases for which no treatment is currently available is estimated to be between 4,000 and 5,000 worldwide. Few drugs which are withdrawn from the market for some reasons, e.g., thalidomide widely used as a hypnotic drug some years ago for its high teratogenic risk may show a very interesting therapeutic application, i.e., analgesic properties in rare diseases such as leprosy and lupus erythematosus. These are diseases for which no satisfactory treatment is available.
|According to market report 10 top selling orphan drugs|
|Recombinant Factor VIII||Hematology|
Orphan drugs market level
According to market estimate the global orphan drugs market has reached around $112 billion by 2014 growing from $84 billion in 2009. The market is expected to grow at a compound annual growth rate (CAGR) of nearly 7% to reach $125 billion by 2018.
The future of orphan drug
As the Asian pharmaceutical markets grow, so too will opportunities for orphan drugs in Asia. Asian governments are becoming more aware of the importance of orphan drugs, and reimbursements for these products will increase in the future. This encouragement can bring in a revolution among the pharmaceutical and biotechnology companies for developing and marketing orphan drugs.
The issue of orphan drugs becomes more important for third world countries like India, which are affected the most. Why no new drug is coming up or nobody is investing in research and development in malaria, leishmania, etc. Usually we criticize the pharmaceutical industry or manufacturers for this. It is not easy to produce and market orphan drugs. The manufacturers of drugs have to amortize their operational expenses, their research investment, and they have to make reasonable profit so that they can finance new ventures in the future.
DelveInsight Orphan Indications reports
We are a Business Consultant company and serve as a Knowledge partner across the value chain of Pharmaceutical Industry. We made strong presence in Orphan market with 200+ Reports on Orphan based Indications. DelveInsight’s Reports on Orphan Indications provides assessment over advancement in technologies, market trend, partnering & licensing opportunities, pipeline scenario and competitive landscape.
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