genglob magazine

NATCO living up to its purpose of “Making speciality medicines accessible to all” has launched Sofosbuvir under the brand name of HEPCINAT. HEPCINAT (Sofosbuvir), a drug that has revolutionised the treatment of Chronic Hepatitis C virus (HCV) infection is made available at a very affordable price. NATCO is the first company in India to launch this product; this is truly a momentous occasion for the HCV care givers, patients and the company.

HCV infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and for many years has hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Initially, Interferon and Ribavirin therapy was the treatment standard of care, but it offered limited performance across the wide spectrum of HCV disease and was fraught with excessive and often limiting side effects.

Sofosbuvir (SOF) is a potent first-in-class nucleotide inhibitor that acts directly on the viral replication enzyme and brings cure in as high as 90 to 100% of patients, which was never heard of in the treatment of HCV. The introduction of SOF, a safe and efficacious drug with the potential to cure HCV that affects 150-200 million people worldwide is indeed a rare event in the history of medicine. This is truly a momentous occasion for all those involved in the HCV care.

SOF is a well tolerated effective antiviral agent that is heralding a new era of all oral therapy for HCV. SOF is safe and can be used across different viral genotypes, disease stages, and special patient groups, such as those co-infected with human immunodeficiency virus. When used in combination with ribavirin or another direct-acting antiviral agent, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients, and new regimens will be tailored to maximize performance. Sofosbuvir is truly an evolution and revolution in the treatment of HCV.

HEPCINAT (Sofosbuvir) is available throughout India and it is dispensed against the prescription of a Hepatologist/Gastroenterologist/HCV treatment specialist.

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI®. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies.

NATCO will price its generic medicine, Hepcinat LP, at an MRP of INR 25,000/- for a bottle of 28 tablets. NATCO was the first licensed company to launch the generic version of this combination drug earlier in Nepal. NATCO had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI®, in 100 other developing countries in addition to India.

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) and its US partner Allergan announce settlement of its pending litigation with Celgene regarding generic Lenalidomide.

Celgene has agreed to provide Natco with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic Lenalidomide in the United States beginning on January 31, 2026.  In addition, Natco will receive a volume-limited license to sell generic Lenalidomide in the United States commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total Lenalidomide capsules dispensed in the United States during the first full year of entry.  The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total Lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license under this agreement.

REVLIMID® had recorded sales of nearly $3.4 billion in the US market for the year ending September 2015 (Source: Celgene Website)

Swiss pharma major Novartis AG on Monday lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company’s plea.A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine. The judgment, which was keenly watched by pharma companies across the world, will clear hurdles coming in the way for the manufacture of generic drugs in India for cancer patients.

While a one-month dose of Glivec costs around Rs. 1.2 lakh, generic drugs, manufactured by Indian companies, for the same period are priced at Rs. 8,000.Advocate Pratibha Singh, appearing for Indian drug firms Ranbaxy and Cipla which had opposed Novartis’ plea, said that the judgment is a victory for Indian companies as they can now manufacture cheaper drugs so long as there is no patent over a medicine.“Patents will now be granted only for genuine inventions and not on repetitive inventions. The Supreme Court said there was no new invention in the Novartis’ drug,” she said. Read the rest of this entry »

More than 1.5 million people in the United States will be diagnosed with cancer this year.
Of the many critical decisions they will have to make, none is more important than the type of treatment that will be used to fight their cancer — especially when patient response rates aren’t very promising.

First line or standard therapies for cancer fail, on average, at least 70 percent of the time, and, when they do, studies show that as few as 5 percent of cancer patients respond to the second standard treatment plan they are given.
However, a recent study in the Journal of Clinical Oncology showed that when molecular profiling was used to guide the selection of cancer therapy, a drug known to target the specific biomarkers of a tumor was found in 98 percent of advanced cancer patients studied. Read the rest of this entry »

Now we turn to what is being hailed as a breakthrough in the fight against cancer. A small group of pioneers sending a big ray of hope. An experimental treatment that appears to stop cancer cells in their tracks in some people. And abc’s dr. Rich about bard besser tells us about the big news today. Reporter: David asponte was out of options.

He was being treated for acute lymphocytic leukemia, a rare and often fatal disease in adults. When chemotherapy failed, doctors turned to an experimental treatment. Robin roberts went to visit him last december.

I think I am on the right road, I think I am on the right road. Reporter: Doctors took out millions of david’s disease-fighting white blood cells, then used a retrovirus, which is great at getting into human immune systems to change those cells to targeted cancer fighters. David’s cells went back in and destroyed the cancer like a living drug.

The first patient to have similar experimental treatment was 7-year-old emma whitehead who went through the procedure last year and now is in complete remission. She has a ton of energy. She’s doing wonderful right now. Read the rest of this entry »

Transplantation of mesenchymal stem cells cultivated on the surface of nanofibrous meshes could be a novel therapeutic strategy against post-prostatectomy erectile dysfunction (ED), conclude the authors of a study presented at the 28th Annual EAU Congress later this week.

The study was conducted by a group of Korean scientists and will be awarded 3rd prize for best abstract in non-oncology research on the opening day of the congress.

During their investigation, the group aimed to examine the differentiation of human mesenchymal stem cells cultivated on the surface of nanofibrous meshes (nano-hMSCs) into neuron-like cells and repair of erectile dysfunction using their transplantation around the injured cavernous nerve (CN) of rats.

“The objectives of the study reflect a very pertinent need in today’s urology practice,” said the lead author of the investigation Prof. Y.S. Song of Soonchunhyang University School of Medicine in South Korea. “Post-prostatectomy erectile dysfunction results from injury to the cavernous nerve that provides the autonomic input to erectile tissue. It is a common complication after radical prostatectomy which decreases the patient’s quality of life”. Read the rest of this entry »

Natco Pharma is back in limelight after the Indian Patents Appellate Board upheld the decision of awarding compulsory license to the drug firm to manufacture Bayer’s cancer drug Nexavar at a significantly reduced price.

The Hyderabad-based drug company is engaged in formulations, active pharmaceutical ingredients ( APIs) and owns a retail pharmacy business in the US. It earns majority of its revenues from oncology drugs. Following the Indian Patent office awarding compulsory license to the company, it has been selling the generic version of Bayer’s drug Nexavar, meant for treating a rare liver and kidney cancer, since April last year. In the months from April to December last year, the company sold the drug worth Rs 14 crore and expects the revenues from this product to range between Rs 15 and 20 crore in the coming years. While the company does not earned significantly from the drug, it achieved the breakthrough of winning a compulsory license for manufacturing the generic version of a life-saving drug – opening inroads for cheaper drugs in the country. Read the rest of this entry »

This chemotherapy and cancer drugs article is about Sorafenib (Nexavar) which is a treatment for advanced kidney cancer.  It is a type of biological therapy, called a protein tyrosine kinase inhibitor (TKI). Tyrosine kinase is a protein which acts as a chemical messenger that encourages cancer cells to grow.  Sorafenib blocks these proteins and thus stops the cancer creating blood vessels (anti-angiogenesis).  It is currently being researched for use with liver cancer.Research published in the NCI Cancer Bulletin, in 2007 showed that sorafenib also  improves the survival of patients with advanced liver cancer. It is taken in tablet form.

Side effects are generally mild and can include:  diarrhoea, soreness and redness in the palm and soles, fatigue, skin rashes, hair thinning, nausea, bruising and bleeding, raised blood pressure, increased risk of infection, loss of appetite, constipation, aches and pains.

India’s patent appeals body Monday rejected Bayer AG’s plea to stop a local company from manufacturing and selling a generic version of its cancer drug Nexavar, a ruling that has wider implications for multinational drug makers operating in the South Asian nation.

The German company last year approached the Intellectual Property Appellate Board after the local patent authority granted a “compulsory license” to Natco Pharma Ltd.to manufacture a generic version of the drug.

The Indian Controller General of Patents, Designs and Trademarks allowed Natco to make copies of the liver- and kidney-cancer drug on the grounds that Nexavar was too expensive for most people in India. The license allowed Natco to sell a generic version at less than one-30th of Bayer’s price. Read the rest of this entry »