Obesity and diabetes are a global epidemic contributing to an increasing prevalence of related systemic disorders, including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Nonalcoholic Steatohepatitis (NASH) is a subtype of NAFLD (Nonalcoholic Fatty Liver disease) that is characterized by an accumulation of the abnormal amount of fat in the liver. This excessive buildup of fat in the liver leads to hepatocyte injury, liver inflammation and progression of fibrosis. NASH is becoming increasingly common with the alarming epidemic of obesity and carries the risk for more aggressive liver diseases such as fibrosis, cirrhosis, liver failure, and in some rare instances, hepatocellular cancer. The exact cause of the NASH has not been illuminated because generally, it is different for each patient. NASH occurs in people who don’t abuse alcohol, however its symptoms, though none or very few, are similar to those of the liver disease that occurs in people due to long-term, heavy consumption of alcohol Presence of certain metabolic syndromes like type II diabetes, obesity, and insulin resistance are symptoms of NASH.
A large population-based study conducted in the United States recently, utilizing data from the National Health and Nutrition Examination Surveys from 2009-2010 (NHANES), reported obesity rates of 35.5% among men and 35.8% among women. The prevalence of NASH is believed to have increased by a similar rate over the same period.
DelveInsight believes that the number of prevalent cases of NASH in 7MM will grow by 2.82% during the forecasted period 2015-2027, and will reach upto 18.6 million cases by 2027. The United States will continue to have the highest number of prevalent cases in the 7MM during 2015-2027 and by the end of this period is estimated to account for almost 55.71% (10.36 million cases) of all prevalent cases in 7MM.
NASH is widely being seen as the major cause of various liver transplants. With the growing prevalence of the disease NASH, there is a rising need for the development of approved therapies for this disease. Though various companies are trying to develop a treatment for NASH, as of today, there are no approved therapies for this disease which limits doctors to prescribing certain off-label drugs for containing the disease. Lifestyle modifications remain the first line of treatment (active exercise program, weight loss, diet, control of the metabolic syndrome, and liver-directed pharmacotherapy) for NASH.
A number of companies have various drugs in their pipeline at different stages of development. These include Elafibranor (Genfit Pharma), Obeticholic acid (Intercept Pharmaceuticals), Selonsertib (Gilead Sciences), Cenicriviroc (Allergan) etc.
Cancer, a highly morbid disease, has one of the worst incidence and mortality statistics across the globe. As reported by the American Cancer Society, the estimated annual incidence for 2016 has crossed 40,000 cases or more in USA alone.
Source: Most Common Cancers
Estrogen Receptor Positive Breast Cancer is the most common type of breast cancer diagnosed in the world.
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According to National Society of Health, approximately 26 million patients are suffering from heart failure worldwide, with the increased economic burden of USD 30.7 billion each year. The advent of a novel class of drugs, i.e., the angiotensin receptor-neprilysin inhibitor, gives hope to the patients.
Neprilysin is a zinc-dependent metallopetidase enzyme that helps breakdown of the biologically active natriuretic peptides and several other vasoactive compounds. It catalyses the degradation of various peptides including atrial natriuretic peptide, brain natriuretic peptide, and bradykinin, as well as contributes to the breakdown of angiotensin II. Inhibition of neprilysin is a promising target in cardiovascular disease as it increases circulating levels of Natriuretic peptides.
The first neprilysin inhibitor, Candoxatril, was developed by Pfizer during 1998. However, the drug was discontinued in Phase III stage due to lack of efficacy and side effects. Then, in year 2000, Bristol-Myers Squibb developed Omapatrilat, but the drug was also not able to pass FDA review due to lack of efficacy. In the year 2001, Bayer discontinued the development of Ecadotril in Phase II stage after disappointing results. Around 2004-2005, Pharmacia’s RAAS-NEP inhibitor, Eplerenone (Inspra), did not receive FDA approval due to angioedema side effects.
After 10 years, Novartis Pharmaceuticals’ drug LCZ696 found success in Phase III trials. It has demonstrated greater efficacy than enalapril in a phase 3 trial assessing heart failure with reduced ejection fraction. It is composed of 2 molecular moieties in a single crystalline complex—and possessed the ability to inhibit the renin-angiotensin-aldosterone axis and augment the endogenous natriuretic peptide system to provide a distinctive mechanism of action in cardiovascular disease. Theravance Biopharma is also working on developing TD-0714 neprilysin inhibitor product. The company has completed Phase I trial of TD-0714.
The market of neprilysin inhibitor is gaining success from year 2014, after long time of failure since 1990s. The hope is still present that it can be a new era of treatment in heart failure therapy.
DelveInsight Business Research
Today’s opportunity for Indian companies in biosimilars is not much different from that of the generics industry in 1984. According to Ministry of Commerce and Industry, India’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014. With biologic treatments introduced for diseases such as diabetes, cancer, multiple sclerosis, and rheumatoid arthritis, potentially lucrative biosimilar market could emerge as another growth driver of India’s pharmaceutical sector. India has a strong potential to emerge as a key player in the manufacture and marketing of biosimilars.
There are few Indian pharmaceutical companies substantially investing resources towards expanding their biosimilar portfolios. Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, is one of the key players in the forefront of the biosimilar segment and has developed Reditux™, the world’s first biosimilar antibody. Biocon Ltd, which received its first approval for insulin glargine in a developed market (Japan) in March this year, is gearing up to submit application for approval in Europe and the US for its four products in FY17.
To increase global reach and market acceptance of their products, Indian companies are setting up manufacturing base overseas. For example, Biocon has reportedly invested $ 200 million on its just commissioned insulin plant in Malaysia. Similarly, Cipla is investing about Rs 600 crore (Rand 1.3 billion) in the new biosimilar manufacturing facility in South Africa, which the company intends to use to serve local as well export markets such as US, Europe and Asia.
Though biosimilars have emerged as important tool to treat cancer and autoimmune diseases, they are only used by about 8 percent of patients worldwide due to the high costs of these drugs. As more companies join the bio-generics race, prices are likely to fall resulting in higher usage. Although India does not have stringent regulations, it has a big potential for biosimilars. Most innovator biotherapeutics are unaffordable to the average patient in India, even though the price in the local market is usually lower than that in Western countries.
DelveInsight Business Research
Before approving an investigational drug, safety and effectivity needs to be proven. Something different happened with Sarepta’s Muscular dystrophy drug Eteplirsen, as its luck changed completely when the U.S. Food and Drug Administration on 19th September 2016 approved Sarepta Therapeutics’ Exondys 51 (eteplirsen) injection to treat patients with Duchenne muscular dystrophy (DMD). Exondys51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. This is the first drug to get approved for this rare disease.
Earlier in March, 2016, FDA had declared that it was not able to decide on Sarepta’s eteplirsen and needed more time to review. In making this decision, FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children and the lack of available therapy. Under the accelerated approval provisions, FDA required Sarepta Therapeutics to conduct a clinical trial to confirm the drug’s clinical benefit. In a complete turn of events, FDA approved Exondys 51 (eteplirsen) for the treatment of Duchenne muscular dystrophy (DMD), leading the stock to more than double in price in just a few days.
Sarepta’s drug has many health insurance providers are on board with it, others like Anthem Inc are still questioning whether it will do its customers any good — given the drug’s accelerated approval. Additionally, on October 5, Sarepta Therapeutics and Summit Therapeutics partnered to advance the development of novel therapies for the treatment of Duchenne muscular dystrophy.
DelveInsight Business Research
The recent outbreak of Dengue in Asia has brought forward the threat of mosquito bite into the spotlight again. Dengue is a kind of viral infection caused by mosquito bite, and the disease has now become a threat to about 390 million people, as these many are estimated to be infected each year. This incidence of infection in recent decades has soared and the world has been a witness to a great number of deaths globally. Asia is emerging to be the most impacted region with about 75% of the global burden of dengue.
According to World Health Organization (WHO), the number of the cases in Malaysia, Philippines, Vietnam and India has increased alarmingly, as compared to what it was two years ago. However, there is hope for its effective treatment and cure, as Sanofi Pasteur has successfully developed a vaccine after investing approximately 20 years in R&D. Sanofi Pasteur is the first company to come up with dengue vaccine named as “Dengvaxia”. According to Sanofi, they want to make the drug available to everyone, particularly to the low income countries. For this they have joined hands with a number of International Organizations like World Health Organization (WHO), United Nations Children’s Fund (UNICEF), and Red Cross.
So far, the drug has got market approval in 11 countries, including Mexico, Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore; Mexico is the one to become the first country to license it. The company is now waiting for its approval from the Indian government which may take some more time as the government has asked to conduct more trials before granting permission.
Neil Ferguson, Director of the MRC center for Outbreak Analysis and Modeling at Imperial College London, conducted a study that used the previous data to determine its effect in various settings found out that the vaccine may not work properly in areas where there is low prevalence of dengue; the WHO has thus not recommended countries to implement a national vaccination program using Dengvaxia. Companies like Sun Pharma, Takeda and Butantan Institute, Brazil are also working on dengue vaccine and we can expect a more efficacy from their products.