Nonalcoholic Steatohepatitis (NASH): Highly Epidemic

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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.NASH


Cervical Cancer: Current Scenario

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Cervical cancer is the second most common cause of death in women globally. Increased awareness and early diagnosis has reduced the death toll over the years; but still there is considerable risk that exists. According to the estimated of American Cancer Society, approximately 12,990 new cases of invasive cervical cancer will be diagnosed and about 4,120 women might die from cervical cancer in United States in 2016. There are many risk factors associated with the cause of cervical cancer and the most common is the persistent HPV (Human papillomavirus) infection which accounts 90% of the total cases.

Research showed that psychosocial stress is one of the crucial contributors of the prolonged infection of HPV. Women who smoke, take drugs etc. are more prone to HPV infection which further increases the chances of developing cervical cancer. Women suffering from Systemic Lupus Erythematosus (SLE) and Inflammation Bowel Syndrome (IBD) like Crohn’s disease should take extra care as they can be more likely to develop cervical cancer. Age is also an important factor. Trends indicate that occurrence of cervical cancer rises between late teens and mid 30s. Women with lowered immunity are at high risk of developing this cancer. Other factors such as multiple pregnancies, oral contraceptives, more than one sex partners etc. are more likely to contribute to the occurrence of cervical cancer.

Since cervical cancer has a large scope for treatment if detected in early stages, researchers are focusing on developing better ways of detecting precancer and cervical cancer. Prevention has always been better than cure, and in case of cancer early diagnosis increases the survival rate. Regular screening (Pap test and HPV Test) and vaccination is suggested for prevention. Cervical Cancer treatment is based on use of surgery, Chemotherapy, Radiation therapy and targeted therapy.

Several chemotherapeutics such as Cisplatin (Platinol; Bristol-Myers Squibb Company), Carboplatin (Paraplatin; Bristol-Myers Squibb Company), Paclitaxel (Taxol; Bristol-Myers Squibb), Topotecan (Hycamtin; GlaxoSmithKline), Gemcitabine (Gemzar; Eli Lilly and Company), Bevacizumab (Avastin; Genentech) are available for the treatment of advanced stages of cervical cancer. Researchers and pharmaceutical companies are focusing on targeted therapies, drugs for treating early detection, palliative care and use of biomarkers for accurate detection of cervical cancer.

Insight by
Jyoti Kumari
Associate Analyst 
DelveInsight Business Research, LLP


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GSK appoints its first female CEO

Emma Walmsley has been appointed as GlaxoSmithKline‘s new CEO, and has broken the mould as she is the first woman to lead a top global drug maker, being a consumer brands guru rather than a prescription medicines expert. Walmsley’s appointment suggests GSK will continue the diversified strategy pioneered by outgoing CEO Andrew Witty. “Obviously, R&D is the beating heart of our company and our success is and will continue to be defined most fundamentally by the strength of our pipeline,” she said in an in-house video recorded to mark her appointment.

Johnson & Johnson to Buy Abbott’s Vision Unit for $4.33B

Johnson & Johnson announced that it will acquire Abbott Medical Optics for $4.325 billion. The deal is expected to close in the first quarter of 2017. The deal comes as JNJ plans to grow its vision business by entering into the cataract surgery market, apart from its Acuvue contact lenses. Abbott has decided to sell this part of business so that it can focus more on treatment for heart and arteries and disease testing equipment.

Essai Launches Collaborative R&D Unit in Boston Area

Eisai Inc., the U.S. subsidiary of Japan’s Eisai Co., Ltd.announced  that it is launching a research-and-discovery unit in the Boston area. The new unit will be called the Eisai Andover Innovative Medicines (AiM) Institute. It will target three therapeutic areas, immuno-dementia, immuno-oncology, and autoimmune indications. Within immuno-dementia, AiM will focus on a subset of dementia patients whose disease is driven by immune dysfunction. In immuno-oncology, it will focus on discovering precision immunotherapies that target myeloid lineage cells. In autoimmune studies, it will look at toll-like receptors and prostaglandins to develop therapies for diseases like systemic lupus erythematosus (SLE).

Novartis intensifies marketing plan for Entresto

Novartis on Monday intensified its bid to convince doctors to prescribe its heart failure drug Entresto, releasing an analysis that concluded the medicine contributed to higher quality of life scores compared with an older drug. Launched with much fanfare last year, Entresto sales have so far disappointed investors and the company, forcing Novartis to spend hundreds of millions more on marketing as it seeks to hit a modest target of $200 million in revenue from the drug this year.

U.S. FDA approves Bayer contraceptive device Kyleena

The U.S. Food and Drug Administration approved Bayer AG‘s hormonal contraceptive device, Kyleena, to prevent pregnancy for up to five years. Kyleena, which will be available from October, is a long-acting reversible contraceptive (LARC), a category of potent contraceptives that has returned to popularity. LARCs, including IUDs and implants, are more effective than other contraceptives such as pills and patches, and are nearly as effective as sterilization, according to the U.S. Centers for Disease Control and Prevention.


The Snippet : PI3Kγ is a molecular switch that controls immune suppression

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Macrophages play critical role in acute and chronic inflammation and cancer. In response to pathogens or injury, inflammatory macrophages express cytokines that stimulate cytotoxic T cells. Macrophage PI(3)Kinase γ controls a critical switch between immune stimulation and suppression during inflammation and cancer. PI3KC signaling through Akt and mTor inhibits NFκB activation while stimulating C/EBPβ activation. This induces a transcriptional program that promotes immune suppression during inflammation and tumor growth. However, selective inactivation of macrophage PI3Kγ stimulates and prolongs NFκB activation and inhibits C/EBPβ activation, thus promoting an immunostimulatory transcriptional program that restores CD8+ T cell activation and cytotoxicity and synergizes with checkpoint inhibitor therapy to promote tumor regression and extend survival. The therapeutic targeting of intracellular signaling pathways that regulate the switch between macrophage polarization states can control immune suppression in cancer and other disorders.

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Graft vs. Host Disease: Gruesome complications of allogeneic bone marrow transplant- Treatment is on the way

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It is a well-known fact that where there is stem cell transplantation, there is Graft vs Host Disease (GVHD). The concept arose 2 decades ago and is not rare- it is a common complication of allogeneic hematopoietic stem cell transplantation (HSCT) that occurs when the donated (graft) cells are rejected, and attack the host’s cells as foreign. Chronic GVHD is a major area of concern as it can last for years or a lifetime, leading to debilitated and life-threatening condition.

Approximately 40 percent of patients develop chronic GVHD after 100 days of transplant. The number of cases of GVHD depends on the number of allogeneic cell transplants (HCTs) and the transplantation occurs more than 20,000 times annually. So, the utmost concern is how GVHD should be treated.

The most effective approach includes Monoclonal antibodies. The use of Monoclonal antibodies in Graft Versus Host Disease has been increasing from last 20 years. Several drugs such as Alemtuzumab, Infliximab and Rituximab are already approved for the treatment of GVHD. Pipeline of GVHD contains Neihulizumab, Begelomab, Milatuzumab and MGD010 that targets activated T Cells.

Cell therapy is also making its way for the treatment as Enlivex Therapeutics and Kiadis Pharma are actively involved in developing their own technologies. Besides that, more than 52 companies are in the development race for GVHD treatment. Novartis Pharmaceuticals is currently leading the race with 3 products in pipeline. Incyte Corporation and ImmuNext are the next leaders in the upcoming GVHD market with two products respectively. Endonovo Therapeutics is developing a next-generation; off-the-shelf treatment for Graft-Versus-Host Disease (GVHD) using Cytotronics expanded and ex vivo enhanced stem cells from the human umbilical cord. Dr. Falk Pharma GmbH, Mallinckrodt and Adienne Pharma & Biotech are expected to launch their products in coming years as the products are in Phase III stage of development.

GVHD is treated by suppressing the immune system, which means the treatment also increases the risk of infection. Each year, thousands of patients with hematologic malignancies undergo allogeneic (donor) stem cell transplantation (SCT). Thus, treatment of GVHD by enhancing immune system is very important. Pharmaceutical companies, clinicians and researchers are continually working to reduce the rate of GVHD occurrence and improve patient outcomes.

Insight by Shakshi Sikrewal
Associate Analyst
DelveInsight Business Research, LLP


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Roche’s drug candidate for Multiple Sclerosis touted to be better than Merck’s Rebif

The much anticipated multiple sclerosis drug from Roche, ocrelizumab, has overtaken Merck’s Rebif according to the results of Phase III data, and has also shown great stats that could prove that it might have an edge in the hotly contested market. If the candidate is approved, Ocrevus is expected to be a tough rival, given its data in progressive MS; no other MS drug has yet proven to be effective in those hard-to-treat patients, and that success is expected to help Ocrevus in the market as well.

Risk info on cancer drugs on various websites skimpy, may give patients false hope

The researchers from the Office of Prescription Drug Promotion and RTI International analyzed 65 sites for branded cancer meds, and found out that almost all of them cited specific numbers on their effectiveness and side effects- which is not enough. It has not come as a surprise as the regulations require disclosure of effectiveness as well as side effects. The FDA agency has also found that these sites list far more treatment benefits as compared to risks, and are seriously harming the patients by providing incomplete information.

The FDA norms likely to punch a Rs 5,000 crore hole in Indian Pharma Industry

The Compliance to the US Food and Drug Administration norms might turn out to be a costly affair for Indian Pharma companies. The main reflection of this is in the way legal and professional costs have surged for many companies, more than some’s annual revenues. For 135 listed pharma companies, this has jumped threefold to Rs 5,071 crore in past five years, based on their annual reports.

Takeda sets aside $15B for U.S. M&A deals

Takeda has shown a great shift in R&D philosophy after it set aside the major part of drug research and development responsibilities and took up other development deals in oncology, vaccines and CNS. Also, it has set aside close to $15 billion for M&A deals in the USA, to buy companies that fit in with the vision Takeda has for itself.

The Snippet : HER2 Expression and its Dynamic Functional States within Circulating Breast Cancer Cells

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A research published in Nature recently identified some dynamic functional states in the breast cancer cells of HER2 breast cancer. The research postulates that women who have advanced oestrogen-receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, are prone to acquire a HER2-positive subpopulation after multiple courses of therapy. This acquired heterogeneity during the cancer evolution was previously unknown, and to find out the same the researchers evaluated women with ER+/HER2 primary tumours. The results show that the HER2 circulating tumour cells have shown activation of Notch and DNA damage pathways, which results in resistance to cytotoxic chemotherapy. HER2+ and HER2 circulating tumour cells are able to convert among themselves and produce daughter cells that are opposite within four cell doublings. Even though both HER2+ and HER2 tumour cells found in circulation were comparable in tumour initiating potential, differential proliferation favours the HER2+ state, while oxidative stress or cytotoxic chemotherapy enhances transition to the HER2 phenotype. Thus, these results point to some very distinct yet interconverting phenotypes present within patient population and also contributes in the progression of breast cancer and acquisition of drug resistance.

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