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.

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.

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)

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.

She also said there should be no fear that foreign firms would be affected with Monday’s verdict since as long as they have genuine inventions, patents will be given to them. In its judgement, the apex court also held that ‘imatinib mesylate’ used in Glivec is a known substance and Novartis can’t claim patent over the drug for using this chemical. Novartis had approached the apex court in 2009 against the order of Chennai-based Intellectual Property Appellate Board (IPAB), which had rejected its claim for patent. The multinational company (MNC) had applied for patent in 2006. Novartis’ claim was opposed by Indian pharma companies, which are manufacturing generic drugs, as well as by health aid activists in the apex court.

They had claimed that the MNC is not entitled for patent and it is indulging in “ever-greening” of patent by simply changing the composition of the ingredients of the drug. Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire. A patent on the new form would have given Novartis a 20-year monopoly on the drug. Earlier, the Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law.

Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products. During the arguments earlier, Novartis had tried to dispel the impression that its drug would be beyond reach of poor cancer patients due to its high cost.“The purpose is not to make money from the poor. This is not the purpose, but am I not entitled for patent for our drug? We are fighting the case on principle,” senior advocate Gopal Subramanium, appearing for the company, had said. He had submitted that there should be no cause of concern that the poor would not get treatment and had claimed that 85 per cent of such patients are treated free under its scheme.

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.

“With molecular profiling, a newly diagnosed cancer patient does not have to go down treatment paths that are not a good match or will not work for them,” explains oncologist Sandeep Reddy, MD, a clinical associate professor of medicine at the Geffen/UCLA School of Medicine. “Molecular profiling also can help in the treatment of advanced cancers, when standard therapies have been exhausted and new treatment options are needed. Molecular profiling is truly transforming cancer care today.”

According to Dr. Reddy, the earlier the most appropriate cancer treatment can be identified and used, the better it is for the patient. Today, molecular tumor profiling technology called Caris Target Now is helping doctors like Reddy make these critical decisions and treat cancer smarter.
Caris Target Now molecular tumor profiling identifies the genetic and molecular structure of a tumor -; its biomarkers -; and then matches this complex information with information about how these biomarkers respond to different cancer drugs. The service provides a list of available cancer drug options that may be more likely to work, including perhaps some that might not have even been considered, as well as drugs that may be less likely to work. Also, based on a patient’s specific tumor biomarkers, it can identify open clinical trials that might provide patients with additional options to consider.
Personalized cancer treatment like this can also increase quality of life for cancer patients and cut healthcare costs for patients and the system.

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.

Reporter: Researchers now report on the safety of this treatment in five more patients. What we saw just blew us away the cancers went away in a matter of weeks even days. Reporter: Days?

Days in one case. Reporter: That one case was david. The treatment almost killed him but after eight days in a coma, not a trace of cancer.

He went on to a bone marrow transplant. I will take every day that i can. Make it count.

Got it. Reporter: While fewer than 3,000 patients have the type of leukemia. The approach has a much broader reach.

If offers hope that it can also work in bigger tumors such as colon cancer, breast cancer, and lung cancer. Hope tonight. So, rich, what’s next?

Reporter: Well, I mean, i think this approach is incredibly exciting. This was a small safety study. They’re enrolling more people in that.

They’re going to do a longer study looking at benefits and risks. Other researchers are saying, can you use this for any type of cancer? It’s early days, but this kind of approach is so promising

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”.

“Although advances in equipment and surgical techniques reduce this complication, patients still experience erectile dysfunction after radical prostatectomy,” he explained.

Treatment of phosphodiesterase 5 inhibitors shows insufficient effectiveness in the treatment of post-prostatectomy ED and it is believed that the transplantation of stem cells cultivated on the surface of nanofibrous meshes can promote cavernous neuronal regeneration and repair erectile dysfunction.

In the course of the study, the synthesised polymer was electrospun in a rotating drum to prepare nanofibrous meshes and hMSCs were prepared and confirmed. Eight week old male Sprague-Dawley rats were divided into 4 groups of 10 each, including sham operation (group 1), CN injury (group 2), hMSCs treatment after CN injury (group 3) and nano-hMSCs treatment after CN injury (group 4). Immediately after the CN injury in group 4, nano-hMSCs encircled the injured CN. Erectile response was assessed by CN stimulation at 2, 4 weeks. Thereafter, penile tissue samples were harvested and examined using morphological analysis and immuno-histochemical stain against nerves (nestin, tubulin βIII and map2), endothelium (CD31,vWF) and smooth muscle (smooth muscle actin).
The results of the study revealed that at 2, 4 weeks, transplantation of nano-hMSCs increased the expression levels of cavernous neuronal, endothelial and smooth muscle makers more than hMSCs alone.
Additionally, nano-hMSCs increased the neuronal differentiation of mesenchymal stem cells more than hMSCs alone. At 2, 4 weeks, the mean percent collagen area of caversnosum increased following CN injury and recovered after transplantation of nano-hMSCs more than hMSCs alone.
At 2, 4 weeks, the group with CN injury had significantly lower erectile function than the group without CN injury (p<0.05). The group transplanted with hMSCs showed higher erectile function than the sham operation group (p<0.05), whereas the group transplanted with nano-hMSCs showed higher erectile function than the group with hMSCs alone (p<0.05).
The authors of the study concluded that nano-hMSCs differentiated into neuron-like cells and their transplantation repair erectile dysfunction in the rats with CN injury. These findings have high potential for the development of follow-up research projects.
“The outcomes of the current study could be a starting point for investigating clinical application of autologous adipocyte derived mesenchymal stem cells cultivated on the nonofiber to the injured caverneous nerve after radical prostatectomy,” said Prof. Song.
“This is necessary to evaluate the effectiveness and safety of transplantated human mesenchymal stem cells cultivated on the surface of nanofibrous meshes against post-prostatectomy erectile dysfunction in patients with cavernous nerve injury.”

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.

he company’s consolidated net sales for the last four trailing quarters have grown 28 per cent to over Rs 600 crore. Its operating profit has doubled to over Rs 130 crore during the same period. While its API and retail pharmacy business are growing well, its formulations business has got impacted on account of slowdown in the domestic pharma market. With new product launches in the US market, its revenues from the formulations business are likely to pick up. According to data from Bloomberg, out of the total analyst recommendations, 5 are buy recommendations and one is a sell. The average target price is Rs 530 – 22 per cent more from the current market price of the stock.

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.

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.

India’s patent law allows authorities to order holders of drug patents to license their products for local manufacturing if they are priced beyond the reach of patients. The patent authority’s March 2012 order on Nexavar represented the first instance of a compulsory license being granted in the country.

India says there is a need to balance intellectual property rights with the rights of people to get access to new and expensive medicines. Foreign producers argue India is discouraging innovation by weakening patents, reducing the incentive for big companies to invest time and money to discover drugs.

The appellate board, which is based in the southern city of Chennai, said the patent authority was right in allowing a compulsory license for Nexavar as Bayer hadn’t priced the drug at “reasonably affordable” rates.

Bayer said it “strongly disagrees” with the conclusions of the appellate board and will pursue the case at the high court in Mumbai.

The order “weakens the international patent system and endangers pharmaceutical research,” the company said in a statement.

Natco welcomed the order.

“This is a reasoned and detailed order that can be sustained in any court of law,” said M. Adinarayana, Natco’s company secretary.

The appeals body’s ruling Monday could set a precedent for similar cases.

“It will pave the way for future [compulsory] licenses, given that many of these [patented] drugs are exorbitantly priced” and aren’t affordable for most people in India, said Shamnad Basheer, professor of IP Law at the National University of Juridical Sciences in the eastern city of Kolkata.

Bayer got India patent for Nexavar in 2008.

Last year, the patent authority noted that Bayer’s branded drug Nexavar sells for $5,181, or 284,428 rupees, for a month’s supply. Natco Pharma, the generics competitor which brought the case to the patent authority, sought to sell a month’s supply of the generic version at $160.

The patent body allowed Natco to legally make and sell the low-cost version of Bayer’s drug on the condition that it pay a royalty of about 6% of the net sales from the drug to the German company.

The appellate board Monday ordered Natco to pay 7% of its net sales from the drug to Bayer.

Medecins Sans Frontieres said it was “relieved” with the decision by the board to uphold India’s first compulsory license.

“Most importantly, the decision means that the way has been paved for compulsory licenses to be issued on other drugs, now patented in India and priced out of affordable reach, to be produced by generic companies and sold at a fraction of the price,” said Leena Menghaney, India manager of its advocacy program which pushes for greater access to lifesaving medicines.

“We hope that, in the near future, compulsory licenses will be issued for the newest drugs to treat HIV and affordable generic versions will be available not only in India, but in the rest of the developing world,” Ms. Menghaney added.

To get patent protection under India’s laws, companies need to prove that new versions of their products are therapeutically more beneficial than earlier versions on which patents have expired.

Under this rule, India had refused to patent Swiss Novartis SA’s cancer drug Glivec. Novartis has taken the patent battle to India’s Supreme Court, which is expected to give its final order on the case shortly.

An Indian government panel late last month published a set of proposals to control the prices of patented drugs. If implemented, these guidelines could lead to multinational drug companies being forced to sell some medicines at a third of their current prices.