#Dolutegravir Pricing | Explore Tumblr posts and blogs

chemanalystdata · 7 months ago

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Dolutegravir is an antiretroviral medication primarily used in the treatment of HIV/AIDS. As part of the class of drugs known as integrase inhibitors, Dolutegravir works by blocking the action of an enzyme called integrase, which the HIV virus uses to replicate. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, Dolutegravir has become a crucial component in many HIV treatment regimens. However, one of the most significant concerns around the world, especially in low-income and middle-income countries, has been the pricing of Dolutegravir. Pricing influences access to this essential medication, and efforts are ongoing to make it more affordable for those who need it most.

The cost of Dolutegravir varies widely depending on geographic location, patent laws, and whether the drug is branded or generic. In high-income countries such as the United States, Dolutegravir is often sold under the brand name Tivicay, manufactured by ViiV Healthcare. The brand-name version of Dolutegravir tends to be expensive, with prices in the U.S. being notably higher than in other regions. For example, a month's supply of Tivicay can cost thousands of dollars. This high cost is driven by research and development expenses, regulatory costs, and the need to recoup the investment in bringing a new drug to market. However, the high cost in wealthier nations often makes it difficult for those without adequate health insurance or government assistance to access the medication.

Get Real Time Prices for Dolutegravir : https://www.chemanalyst.com/Pricing-data/dolutegravir-1534

In contrast, many low- and middle-income countries rely on generic versions of Dolutegravir, which are significantly less expensive. Generic Dolutegravir became available after licensing agreements and patent waivers were negotiated between pharmaceutical companies, non-governmental organizations, and international agencies. These agreements allowed for the production of more affordable versions of the drug, making it accessible to larger populations. In countries such as India, which has a robust generic pharmaceutical industry, the price of Dolutegravir can be as low as a few dollars per month. This drastic reduction in price has been crucial in improving access to HIV treatment, particularly in regions that are heavily burdened by the epidemic, such as sub-Saharan Africa.

Global health organizations like the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have played a pivotal role in advocating for lower prices for HIV medications, including Dolutegravir. The Medicines Patent Pool (MPP) is another initiative that has helped to lower the cost of Dolutegravir. By facilitating voluntary licensing agreements, the MPP enables generic drug manufacturers to produce and sell Dolutegravir at a fraction of the price of the branded version. These efforts have resulted in broader availability of the drug, but challenges remain in ensuring that everyone who needs Dolutegravir can afford it.

The introduction of Dolutegravir as part of first-line HIV treatment regimens in many countries has been a game-changer. Not only is Dolutegravir highly effective in suppressing the HIV virus, but it also has a high barrier to resistance, meaning that patients are less likely to develop resistance to the drug over time. Moreover, Dolutegravir has fewer side effects compared to older antiretroviral medications, making it a preferred option for many patients and healthcare providers. Given its effectiveness, there has been a global push to make Dolutegravir the standard of care in HIV treatment. However, pricing remains a barrier in some parts of the world, where even the generic versions may be out of reach for the most vulnerable populations.

Efforts to reduce the price of Dolutegravir are ongoing, with various international partnerships and coalitions working to negotiate lower costs. For example, the Global Fund to Fight AIDS, Tuberculosis and Malaria has been instrumental in securing lower prices for Dolutegravir through bulk purchasing agreements. These agreements allow for large quantities of the drug to be purchased at a reduced cost, which can then be distributed to countries in need. Additionally, some countries have implemented pricing controls or subsidies to make Dolutegravir more affordable for their populations. These strategies have been successful to varying degrees, depending on the political and economic landscape of each country.

Another factor influencing the price of Dolutegravir is the expiration of patents. As patents on the drug begin to expire in more countries, the opportunity for increased competition among generic manufacturers grows. This competition is expected to drive prices down even further, making Dolutegravir more accessible to a wider range of people. However, patent expirations are staggered across different regions, meaning that some countries may experience price reductions sooner than others. In countries where the patent is still in effect, advocacy efforts are focused on encouraging pharmaceutical companies to voluntarily lower their prices or enter into more licensing agreements that would allow for the production of generics.

In recent years, there has been a growing emphasis on the importance of affordable HIV treatment as part of global health initiatives. The United Nations has set ambitious goals for reducing the number of new HIV infections and ensuring that those living with HIV have access to treatment. Dolutegravir is central to these efforts, but its price remains a critical issue. Without continued pressure on pharmaceutical companies and governments, there is a risk that some populations will continue to be left behind in the fight against HIV/AIDS.

In conclusion, the pricing of Dolutegravir reflects a complex interplay of factors, including patent laws, production costs, and global health policies. While progress has been made in making the drug more affordable, particularly in low- and middle-income countries, there is still work to be done to ensure that everyone who needs Dolutegravir can access it. The future of HIV treatment depends not only on the development of new and effective medications but also on the ability to make these treatments affordable and accessible to all. Through continued international cooperation and advocacy, it is possible to further reduce the price of Dolutegravir and ensure that it reaches those who need it most.

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#Dolutegravir #Dolutegravir Price #Dolutegravir Prices #Dolutegravir News #Dolutegravir Market #Dolutegravir Pricing

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reasonsforhope · 9 months ago

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"A first-of-its-kind report has discovered that altering the ingredients list or manufacturing methods of widely used medication can really cut back on carbon emissions.

They found a reduction of 26 million tons, enough to cancel out the whole carbon footprint of the city of Geneva for a decade. Best of all, it’s already happening, and in fact, is almost done—those emissions were already saved.

The lifesaving HIV treatment dolutegravir (DTG) is used by 24 million people worldwide.

Today, over 110 low and middle-income countries have adopted DTG as the preferred treatment option. Rapid voluntary licensing of the medicine, including its pediatric version, to over a dozen generic manufacturers, significantly drove down prices, and it’s estimated that 1.1 million lives will be saved from HIV/AIDS-related deaths by 2027.

Its predecessor, efavirenz, contained 1200 milligrams of active ingredient across the three active compounds present, while DTG contains 650 milligrams of just one compound. This small difference—literally measurable in single digits of paper clips by weight—was enough to change the carbon emissions footprint of the medication by a factor of 2.6.

The incredible discovery was made in a recent report by Unitaid, a global public-private partnership that invests in new health products and solutions for low and middle-income countries, called Milligrams to Megatons, and is the first published research to compare carbon footprints between commonly used medications.

“This magnitude of carbon footprint reduction surpasses many hard-won achievements of climate mitigation in health and other sectors,” the authors of the report write.

At the rate at which DTG is produced, since it entered into production and treatment regime in 2017, 2.6 million fewer tons of CO2 have entered the atmosphere every year than if efavirenz was still the standard treatment option.

Health Policy Watch reports that the global medical sector’s carbon emissions stand at roughly 5% of the global carbon emissions and are larger than the emissions of many big countries, and 2.5 times as much as aviation.

“This report demonstrates that we can achieve significant health improvements while also making strides in reducing carbon emissions. By adopting innovative practices and prioritizing sustainability, we can ensure that medicines like DTG are not only effective but also environmentally responsible,” Vincent Bretin, Director of Unitaid’s Results and Climate Team told Health Policy Watch."

-via Good News Network, July 17, 2024

#had never occurred to me before this was a way to reduce emissions #awesome #now someone make pharma companies actually give a shit #still really encouraging for the future. every little bit helps #and apparently this bit is pretty big #hiv #hiv treatment #medical news #carbon emissions #pharma #climate change #good news #hope

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daisydeborahh · 1 year ago

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THE DOLUTEGRAVIR OPPORTUNITY

DTG is a relatively new ARV available in generic form in low- and middle-income countries. It is an integrase inhibitor that blocks an HIV enzyme (a protein that starts or increases the speed of a chemical reaction) called integrase. By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body. As a single dose, in conjunction with other drugs to form a regimen, 50mg DTG single has been on the market in developing countries for a couple of years. However, its relatively high price and unavailability in a triple fixed-dose form limited significant uptake. Botswana, however, was an early adopter of the DTG single through a special initiative of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).

In August 2017, the US Food and Drug Administration (FDA) provided tentative approval for two Indian generic ARV suppliers – Aurobindo Pharma and Mylan Laboratories Limited – for the fixed-dose combination of tenofovir 300mg /lamivudine 300mg /dolutegravir 50mg (TLD), reducing one barrier for adoption in developing countries.

#DOLUTEGRAVIR

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nullarysources · 1 year ago

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South Africa, Colombia and others are fighting drugmakers over access to TB and HIV drugs

Gerald Imray and Maria Cheng for the AP:

In July, J&J's patent on the [tuberculosis drug bedaquiline] expired in South Africa, but the company had it extended until 2027, enraging activists who accused it of profiteering.

The South African government then began investigating the company's pricing policies. It had been paying about 5,400 rand ($282) per treatment course, more than twice as much as poor countries that got the drug via a global effort called the Stop TB partnership.

In September, about a week after South Africa's probe began, J&J announced that it would drop its patent in more than 130 countries, allowing generic-makers to copy the drug.

…

Meanwhile, in Colombia, the government declared last month that it would issue a compulsory license for the HIV drug dolutegravir without permission from the drug's patent-holder, Viiv Healthcare. The decision came after more than 120 groups asked the Colombian government to expand access to the WHO-recommended drug.

Ya love to see it

#news #medicine #capitalism #South Africa #Colomboa

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pharmaffiliatesanalytics · 3 years ago

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CAS No : 2249814-82-0 | Product Name : Dolutegravir-d5 | Pharmaffiliates

Buy highly pure Dolutegravir-d5, CAS No : 2249814-82-0, Mol.Formula : C20H14D5F2N3O5, Mol.Weight : 424.42, from Pharmaffiliates. Login as registered user for prices, availability and discounts.

#CAS No : 2249814-82-0 #Product Name : Dolutegravir-d5 #PA STI 088987

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wealthzi · 4 years ago

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Vijaya Diagnostic, Ami Organics IPOs open; Should you invest?

Two IPOs have hit the street on monday, with Hyderabad based Vijaya Diagnostic and Gujarat based Ami Organics seeking to raise a combined sum of about Rs 2,500 crore. Amid the stock markets hitting new highs every day, the IPO mania continues in full swing. Here are all the details you wanted. 1. Vijaya Diagnostic Vijaya Diagnostic Centre Limited (“VDCL”) was incorporated on June 5, 2002. VDCL is the largest integrated diagnostic chain in southern India, by operating revenue, and also one of the fastest growing diagnostic chains by revenue for fiscal year 2020. VDCL offers an one-stop solution for pathology and radiology testing services to their customers through their extensive operational network, which comprises 80 diagnostic centres and 11 reference laboratories across 13 cities and towns in the states of Telangana; Andhra Pradesh; the National Capital Region and Kolkata.

Vijaya Diagnostic is offering IPO shares in the price band of Rs 522 to Rs 531 per share. The face value of shares is Re 1. The implied market cap at issue price is about Rs 5,400 crore. The issue opens on September 1 and closes on September 3. The lot size for IPO application is 28 shares, which means the minimum investment is Rs 14,868. The IPO shares will be listed around September 14. The IPO is an offer for sale of Rs 1,895 crore. The objects of the offer are to (i) carry out the OFS of up to 35,688,064 equity shares by selling shareholders; (ii) achieve the benefits of listing the equity shares on the stock exchanges. At the upper band of Rs 531, the Vijaya Diagnostic IPO is valued at P/E of 64 times its FY21 EPS of Rs 8.26. Here is what top brokers have to say about Vijaya Diagnostic IPO. IIFL Securities: “At the upper price band, Vijaya Diagnostic Centre Limited valuation is lower than the industry average of 90.8 times. Considering the future growth potential of healthcare industry, revenue from operation, EBITDA and PAT growth of 13.5%, 23.9% and 35.5% CAGR during FY19 to FY21, respectively, strong ROE and ROCE of 23.64% and 42%, respectively in FY21, debt-free company with plans for acquisition and expansions, diversified service offerings and strong technical capabilities of the company, we recommend ‘Subscribe’ to the issue with a long-term perspective.” KR Choksey: ” Vijaya has consistently posted strong performance in terms of operating growth and profitability in last few years. Revenues have grown at a CAGR of 13.5% over FY19-21 to Rs 377 crore. VDCL’s ‘hub and spoke’ model has provided economies of scale and cost optimization benefits, resulting in EBITDA growth of 23.9% and even stronger 35.5% growth in PAT over FY19-21. Integrated network and high B2C business has translated into higher cash flow conversion. Company also recorded strong return on net worth of 23.64% and return on capital employed (pre cash) of 42.00% during FY21.” 2. Ami Organics IPO Ami Organics Limited is a research and development (“R&D”) driven manufacturer of specialty chemicals with varied end usage, focussed towards the development and manufacturing of advanced pharmaceutical intermediates (“Pharma Intermediates”) for regulated and generic active pharmaceutical ingredients (“APIs”) and New Chemical Entities (“NCE”) and key starting material for agrochemical and fine chemicals, especially from their recent acquisition of the business of Gujarat Organics Limited (“GOL”)(“Acquisition”). They are one of the major manufacturers of Pharma Intermediates for certain key APIs, including Dolutegravir, Trazodone, Entacapone, Nintedanib and Rivaroxaban. The Company have developed and commercialised over 450 Pharma Intermediates for APIs across 17 key therapeutic areas since inception and NCE, with a strong focus on R&D across select high-growth high margin therapeutic areas such as anti-retroviral, anti-inflammatory, anti-psychotic, anti-cancer, anti-Parkinson, antidepressant and anticoagulant, for use across the global pharmaceutical market. Their Pharma Intermediates used for manufacturing of APIs and NCEs portfolio has expanded from over 425 products as of March 31, 2019, to over 450 products as of March 31, 2021.

Ami Organics is offering IPO shares in the price band of Rs 603 to 610 per share. The face value of shares is Rs 10. The issue opens on September 1 and closes on September 3. The lot size for IPO application is 24 shares, which means the minimum investment is Rs 14,640. The IPO shares will be listed around September 14. The Ami Organics IPO comprises a fresh issue of Rs 200 crore for repayment/prepayment of certain financial facilities availed, funding working capital requirements and general corporate purposes. The other IPO component is the OFS of Rs 369.6 crore where the company will not receive any proceeds from. With an EPS of Rs 17.14 as of 31st March 2021, the issue is priced at 35.59 times calculated at the upper price band of Rs 610 per share. The P/BV is 11.51 at a NAV of Rs 52.99 per share. Here is what top brokers have to say about Ami Organics IPO.

Anand Rathi: “The company has shown consistent financial performance with sales growth at CAGR of 19.5% and restated profit after tax growth at CAGR of 52.3% between the Fiscals 2019 and 2021. The financials for 2020- 21 doesn’t include revenue from the acquisition of the two plants. We are positive on the long-term prospects of the Company. Hence, we recommend a “Subscribe” rating to this IPO.” Marwadi Financial Services: “The competitive strengths of the company are strong and diversified product portfolio ably supported by strong R&D and process chemistry skills. Extensive geographical presence and diversified customer base with long standing relationships. High entry barriers in the chemicals manufacturing industry in which the Company operates. Strong sales and marketing capabilities. Experienced and dedicated management team. Consistent financial performance.”

#Vijaya Diagnostic IPO #Ami Organics IPO #IPO Reviews Pictureijaya Diagnostic

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radhika677 · 4 years ago

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Buy Sorafenib medication at an affordable range of price on Magicine Pharma. This antiretroviral medication comprises Dolutegravir as an active agent and it is available in the form of a tablet. sorafenib tablets is recommended for the treatment of HIV (Human immunodeficiency virus) infection.

#Sorafin #Sorafenib #sorafenib tablets price #sorafenib tablets

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chemanalystdata · 1 year ago

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Dolutegravir Prices, Pricing, Trend, Supply & Demand and Forecast | ChemAnalyst

Dolutegravir Prices a revolutionary antiretroviral medication used in the treatment of HIV/AIDS, has garnered significant attention in recent years due to its efficacy and accessibility concerns. This integrase inhibitor has emerged as a frontline drug in combating the HIV epidemic, offering potent viral suppression with fewer side effects compared to previous therapies. However, amidst its clinical success, the pricing of dolutegravir has become a contentious issue, posing challenges for patients, healthcare systems, and advocacy groups worldwide.

The cost of dolutegravir has been a focal point of debate, particularly in low- and middle-income countries where access to affordable medication is critical. Developed by pharmaceutical company ViiV Healthcare, dolutegravir's pricing strategies have drawn scrutiny, with concerns raised over its affordability and accessibility for those in need. Despite efforts to negotiate lower prices for generic versions, the expense of patented dolutegravir remains a barrier for many individuals living with HIV/AIDS, especially in resource-limited settings.

In high-income countries, the price of dolutegravir is often managed through healthcare systems or insurance coverage, mitigating the financial burden on patients. However, even in these settings, the cost of treatment can strain healthcare budgets, prompting discussions on value-based pricing and cost-effectiveness. Additionally, concerns have been raised regarding potential price hikes and monopolistic practices by pharmaceutical companies, which could further exacerbate the financial challenges associated with accessing dolutegravir.

Get Real Time Prices of Dolutegravir: https://www.chemanalyst.com/Pricing-data/dolutegravir-1534

The situation is more acute in low- and middle-income countries, where the affordability of essential medications like dolutegravir directly impacts public health outcomes. While initiatives such as the Medicines Patent Pool seek to facilitate access to generic versions of dolutegravir, patent restrictions and licensing agreements can limit the availability of affordable alternatives. This leaves governments, healthcare organizations, and advocacy groups grappling with the dilemma of balancing treatment access with the financial constraints of healthcare budgets.

Despite these challenges, progress has been made in expanding access to dolutegravir through various channels. Strategic partnerships between pharmaceutical companies, governments, and international organizations have led to price reductions and voluntary licensing agreements, enabling broader availability of the medication. Moreover, advocacy efforts by civil society groups have highlighted the importance of equitable access to essential medicines, amplifying the voices of those affected by high drug prices.

In addition to pricing concerns, the safety and efficacy of dolutegravir have also come under scrutiny, particularly regarding potential side effects such as neural tube defects in pregnant individuals. While studies have shown dolutegravir to be highly effective in viral suppression, ongoing research is needed to better understand its long-term effects and optimal use in diverse patient populations. This underscores the importance of comprehensive healthcare strategies that address both affordability and safety considerations.

Looking ahead, addressing the pricing of dolutegravir requires a multi-stakeholder approach that considers the interests of patients, healthcare providers, policymakers, and pharmaceutical companies. Efforts to promote transparency in drug pricing, foster competition through generic production, and advocate for equitable access to essential medicines are essential components of this endeavor. Furthermore, investment in research and development of alternative treatment options can help diversify the HIV/AIDS therapeutic landscape and mitigate reliance on high-priced medications.

In conclusion, while dolutegravir represents a significant advancement in HIV/AIDS treatment, its pricing presents complex challenges that necessitate collaborative solutions. By prioritizing affordability, accessibility, and safety, stakeholders can work towards ensuring that individuals living with HIV/AIDS have access to the medications they need to lead healthy and productive lives. As the global community continues its fight against the HIV epidemic, addressing the pricing of dolutegravir remains a critical imperative in advancing public health and healthcare equity.

Get Real Time Prices of Dolutegravir: https://www.chemanalyst.com/Pricing-data/dolutegravir-1534

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#Dolutegravir Prices

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bigyack-com · 5 years ago

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New Strawberry-Flavored H.I.V. Drugs for Babies Are Offered at $1 a Day

About 80,000 babies and toddlers die of AIDS each year, mostly in Africa, in part because their medicines come in hard pills or bitter syrups that are very difficult for small children to swallow or keep down.But on Friday, the Indian generic drug manufacturer Cipla announced a new, more palatable pediatric formulation. The new drug, called Quadrimune, comes in strawberry-flavored granules the size of grains of sugar that can be mixed with milk or sprinkled on baby cereal. Experts said it could save the lives of thousands of children each year.“This is excellent news for all children living with H.I.V.,” said Winnie Byanyima, the new executive director of UNAIDS, the United Nations agency in charge of the fight against the disease. “We have been eagerly waiting for child-friendly medicines that are easy to use and good to taste.”Cipla revolutionized the provision of AIDS drugs for adults almost two decades ago, pricing them at $1 a day. The new pediatric formulation will likewise be priced at $1 a day. The announcement by Cipla and the Drugs for Neglected Diseases Initiative, an offshoot of Doctors Without Borders that supported the development of the drug, was timed to coincide with World AIDS Day, which is Sunday.Despite big advances in the prevention of mother-child transmission of H.I.V., about 160,000 children are still born infected each year, according to UNAIDS, mostly in the poorest towns and villages of Africa. Almost half of them die before the age of 2, usually because they have no access to drugs or cannot tolerate them.Quadrimune is still under review by the Food and Drug Administration, and F.D.A. approval almost inevitably leads to rapid certification by the World Health Organization. The company hopes to get a decision by May. Trials in healthy adults showed that the new formulation gets the drugs into the blood; the four drugs in it were approved in the 1990s and are used in many combinations.A clinical trial in H.I.V.-infected infants, run by Epicentre, the research arm of Doctors Without Borders, is now underway in Uganda to prove to African health ministries that children accept the new formulation. Most of the research costs have been paid by UNITAID, a Geneva-based organization set up by France, Norway, Brazil and some other countries which imposed special taxes on airline flights that are dedicated to bettering global health. Currently, the most common pediatric drug combination includes a syrup that is 40 percent alcohol, has a bitter metallic taste that lingers for hours and must be transported in cold trucks and then kept in a refrigerator — something that many poor rural families do not own.“Some families try to bury it in wet sand or dirt to keep it cool,” said Dr. Bernard Pécoul, executive director of the neglected diseases initiative. “And the children are vomiting it on a regular basis.” Moreover, each drug must be squirted into a child’s mouth with a separate syringe, so a mother must have up to four syringes on hand and clean them for each subsequent use. Children generally have to take the medicines twice a day for the first four years of life. When liquid versions are unavailable, some pills cannot be crushed and mixed in juice; they must be swallowed whole. In contrast, Quadrimune contains four H.I.V. drugs: ritonavir, lopinavir, abacavir and lamivudine. The granules are coated first in a polymer that doesn’t melt until it reaches the stomach, and then with sweet, fruity flavoring. Dr. Kogie Naidoo, who heads treatment research at Caprisa, an AIDS treatment and research group based in Durban, South Africa, who was not involved in Quadrimune’s development, said the new formulation could solve many problems she and her colleagues encounter while treating children. Cipla, founded in 1935, was the first generic drug company to offer H.I.V. drugs in Africa. In 2001, its chairman, Yusuf K. Hamied, upended the global pharmaceutical industry by offering to supply a three-drug cocktail to Doctors Without Borders for $1 a day. At the time, multinational drug companies were charging up to $15,000 for their regimens and refusing to lower prices except in secret negotiations with a few countries and were working to block generic competitors from the market. An estimated 25 million Africans were then infected and thousands were dying every day. (The industry was also suing South Africa’s president, Nelson Mandela, over a law he had signed authorizing the government to cancel drug patents and award them to generic makers.)In 2001, Dr. Hamied said he was losing money at the $350 a year price; his break-even point was $600, he said, and he offered it to other buyers for that.But he said he acceded to requests from AIDS activists for the $1 a day price to deliver a shock to his Western competitors and because such a nice round figure was likely to make headlines (a gambit he is clearly repeating now).In the decades since, increased generic competition has driven the price of triple therapy in poor countries to below $100 a year.“Over the past 20 years, Cipla has pioneered fixed-dose combinations for children and I do believe our Quadrimune could be a winner,” Dr. Hamied said in an interview this week. Because all four drugs in the formulation are older and no longer patented, Cipla might eventually offer it in wealthy countries too, he said. But that market is quite small because most pregnant women in the West are tested for H.I.V. and immediately put on antiretroviral drugs, which reduces to near zero the chances that they will infect their babies in the womb, during birth or through breastfeeding.The $1 a day price is for Quadrimune doses appropriate for children of between 20 and 30 pounds, he noted, so the cost for newborns would be even lower.Paradoxically, treating infants with H.I.V. has actually become harder in recent years than it was two decades ago.In the early 2000s, Cipla produced Triomune Baby and Triomune Junior, two pediatric formulations of the world’s first adult three-in-one pill, introduced in 2001. But they contained nevirapine, a drug that in those days was often given to pregnant women to prevent mother-child transmission. As a result, many babies were born with nevirapine-resistant forms of the virus, and the efficacy of pediatric Triomune fell by about half, Dr. Pécoul said.Some nevirapine substitutes that work in adults do not work well in children, and the combination that does work has the bitter taste.Nowadays, many pediatric H.I.V. specialists are frustrated that they cannot prescribe some of the newest drugs, such as tenofovir and dolutegravir, because there is little or no data on how safe they are in small children. The major drugmakers have little incentive to test their products in children because there are so few customers who can pay high prices.If a child’s virus develops resistance to any regimen, a new one must be tried, so more research is needed, said Dr. Naidoo, the AIDS researcher in Durban.But by any measure, she said, Cipla’s new, gentler formulation for children is a major advance: “This is indeed great news for treating pediatric H.I.V.” Source link Read the full article

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pharmaphorumuk · 6 years ago

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ViiV hopes for blockbuster with HIV drug combo approval

The FDA has approved ViiV’s Dovato, a single-tablet, two drug HIV drug regimen of dolutegravir and lamivudine for treatment-naïve patients, making it the only company to have such a drug on the market.

The approval follows a priority review by the FDA and is supported by the global GEMINI 1 and 2 studies, which showed that the two drug combination is as effective at suppressing the disease as a commonly-used three drug combination, but with fewer side effects.

This is important for patients who have to keep taking the drugs to ensure the virus is kept at bay and does not progress to cause AIDS.

Christopher Pace, senior director of infectious diseases and respiratory at GlobalData, said that he expects the drug to achieve blockbuster status in the coming years.

He noted that the approval allows the GSK-led joint venture to more effectively compete against its main rival Gilead, whose Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [TAF]) has dominated the market with sales of over $1.1 billion globally since its approval in February 2018.

“Based on the solid data from the GEMINI 1 and 2 studies, I expect Dovato will quickly gain traction as a first-line option for patients newly diagnosed with HIV,” he said, “particularly those who would otherwise be precluded from receiving Triumeq (abacavir/dolutegravir/lamivudine) due to abacavir hypersensitivity.

“Juluca (dolutegravir/rilpivirine), ViiV’s other marketed 2-drug regimen, has struggled out of the gate against Biktarvy, largely due to the fact that it is only approved for HIV patients who have achieved viral suppression with another antiretroviral therapy. While recently reported data from the SWORD 1 and 2 studies have strengthened Juluca’s position as an attractive long-term maintenance therapy, its inability to access treatment-naïve patients remains a key limitation in a market where switching patients from one regimen to another can prove challenging.”

He added that ViiV’s pricing strategy with Dovato will be worth closely monitoring, as inexpensive generic versions of lamivudine are widely available.

“Historically, payers have been willing to reimburse branded 3- and 4-drug STRs to ensure improved compliance over less expensive, multi-tablet regimens, but it remains to be seen whether or not the same will be true for 2-drug STRs such as Dovato.

“If the cost of prescribing Tivicay (dolutegravir) plus generic lamivudine is substantially lower than the cost of Dovato, it’s possible clinicians and payers could consider this approach.”

Dovato is also currently under review by the EMA.

ViiV is also working with Janssen to develop a once-monthly injectable HIV combo regimen, which recently reported positive phase 3 trial results.

The post ViiV hopes for blockbuster with HIV drug combo approval appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/viiv-hopes-blockbuster-hiv-drug-combo-approval/

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abrreports-blog · 5 years ago

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Dolutegravir Market Key Trends, Drivers, Growth Opportunities, and 2025 Industry Chain Structure Analysis

The research study Dolutegravir market 2020 launched by ABRReports.com provides the detailed analysis of current market status, investment plans, production and consumption, price trends, leading key companies, growth drivers and future prospect. The base year considered for the study is 2019, and the market size is projected from 2020 to 2025

Get the Sample Copy of Dolutegravir market report at https://www.abrreports.com/industry-insights/2020-2025-global-and-regional-dolutegravir-industry-production-sales-and-consumption-status-and-prospects-professional-market-research-report?form=request-report-sample

The segmentation of Dolutegravir study as mentioned below:

By Market Players:

ViiV Healthcare (GSK), Shanghai Desano Pharmaceuticals, Mylan, Aurobindo Pharma, LAURUS Labs, Adcock Ingram Limited

By Application

Prevent HIV Infection Following Potential Exposure, Other10mg Tablets, 50mg Tablets

The points that are discussed within the report are the major market players that are involved in the market such as manufacturers, raw material suppliers, equipment suppliers, end users, traders, distributors and etc. The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. The historical data from 2014 to 2019 and forecast data from 2020 to 2025.

The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail. Data and information by manufacturer, by region, by type, by application and etc, and custom research can be added according to specific requirements. The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

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The key objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth. The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

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Key pointers of the Table of Contents:

Chapter 1 Industry Overview

Chapter 2 Major Segmentation (Classification, Application and etc.) Analysis

Chapter 3 Production Market Analysis

Chapter 4 Sales Market Analysis

Chapter 5 Consumption Market Analysis

Chapter 6 Production, Sales and Consumption Market Comparison Analysis

Chapter 7 Major Manufacturers Production and Sales Market Comparison Analysis

Chapter 8 Marketing Channel Analysis

Chapter 9 Industry Chain Analysis

Chapter 10 Global and Regional Market Forecast

Chapter 11 Major Manufacturers Analysis

Chapter 12 New Project Investment Feasibility Analysis

Chapter 13 Conclusions

Continued…

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azveille · 5 years ago

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GSK's ViiV seeks marketing license for baby-friendly HIV pill

British drugmaker GSK applied on Friday for a license to market its HIV drug dolutegravir in a formulation designed to be easier for babies and children who are living with the virus to swallow.

About 1.7 million children have HIV, most of them in sub-Saharan Africa, the United Nations agency UNAIDS says.

If approved by regulators, the medicine will be the first new generation HIV medicine available in baby-friendly form.

Doctors wanting to use dolutegravir in children with HIV have had no licensed child formulations, meaning they often have to prescribe older HIV medicines that can be less potent, harder for children to take, and have more side effects.

“Children in today’s world, still have fewer options in terms of HIV therapies compared to adults,” said Harmony Garges, chief medical officer for ViiV Healthcare, GSK’s HIV drugs division. She said she hoped the license application would “enable approval of dolutegravir across the pediatric spectrum”.

ViiV’s CEO Deborah Waterhouse added in a statement: “For parents living in resource-poor countries, the ability to give medicine to children in a format that they can swallow and tolerate can mean the difference between life and death.”

Dolutegravir is a so-called integrase inhibitor and was originally developed by ViiV, in which Pfizer Inc and Shionogi & Co have small stakes. For the adult formulation, ViiV has already agreed licensing deals with generic companies to sell low-cost versions in poor countries.

New HIV infections among children have fallen by 41% since 2010, but there were 160,000 new cases in babies and children in 2018, and 100,000 children died of AIDS last year, partly due to lack of access to HIV medicines.

Helen McDowell, ViiV’s head of government affairs and global public health, said that subject to licenses being granted by U.S. and European drug regulators, the company was planning for an initial roll-out in sub-Saharan Africa next year.

ViiV’s version of the child formulation will be priced at “cost of production” she said but declined to give more detail.

ViiV is planning licensing agreements with two generic drugmakers, Mylan Laboratories and Macleods Pharmaceuticals, who aim to make cheaper generic versions of the dispersible pill available within months of ViiV’s coming to market, she added.

Indian generic drugmaker Cipla said last month it was seeking regulatory approval for a four-in-one HIV drug combination called Quadimmune, which it promised to price at below $1 a day.

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biofunmy · 5 years ago

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New Strawberry-Flavored H.I.V. Drugs for Babies Are Offered at $1 a Day

About 80,000 babies and toddlers die of AIDS each year, mostly in Africa, in part because their medicines come in hard pills or bitter syrups that are very difficult for small children to swallow or keep down.

But on Friday, the Indian generic drug manufacturer Cipla announced a new, more palatable pediatric formulation. The new drug, called Quadrimune, comes in strawberry-flavored granules the size of grains of sugar that can be mixed with milk or sprinkled on baby cereal. Experts said it could save the lives of thousands of children each year.

“This is excellent news for all children living with H.I.V.,” said Winnie Byanyima, the new executive director of UNAIDS, the United Nations agency in charge of the fight against the disease. “We have been eagerly waiting for child-friendly medicines that are easy to use and good to taste.”

Cipla revolutionized the provision of AIDS drugs for adults almost two decades ago, pricing them at $1 a day. The new pediatric formulation will likewise be priced at $1 a day. The announcement by Cipla and the Drugs for Neglected Diseases Initiative, an offshoot of Doctors Without Borders that supported the development of the drug, was timed to coincide with World AIDS Day, which is Sunday.

Despite big advances in the prevention of mother-child transmission of H.I.V., about 160,000 children are still born infected each year, according to UNAIDS, mostly in the poorest towns and villages of Africa. Almost half of them die before the age of 2, usually because they have no access to drugs or cannot tolerate them.

Quadrimune is still under review by the Food and Drug Administration, and F.D.A. approval almost inevitably leads to rapid certification by the World Health Organization. The company hopes to get a decision by May.

Trials in healthy adults showed that the new formulation gets the drugs into the blood; the four drugs in it were approved in the 1990s and are used in many combinations.

A clinical trial in H.I.V.-infected infants, run by Epicentre, the research arm of Doctors Without Borders, is now underway in Uganda to prove to African health ministries that children accept the new formulation. Most of the research costs have been paid by UNITAID, a Geneva-based organization set up by France, Norway, Brazil and some other countries which imposed special taxes on airline flights that are dedicated to bettering global health.

Currently, the most common pediatric drug combination includes a syrup that is 40 percent alcohol, has a bitter metallic taste that lingers for hours and must be transported in cold trucks and then kept in a refrigerator — something that many poor rural families do not own.

“Some families try to bury it in wet sand or dirt to keep it cool,” said Dr. Bernard Pécoul, executive director of the neglected diseases initiative. “And the children are vomiting it on a regular basis.”

Moreover, each drug must be squirted into a child’s mouth with a separate syringe, so a mother must have up to four syringes on hand and clean them for each subsequent use. Children generally have to take the medicines twice a day for the first four years of life. When liquid versions are unavailable, some pills cannot be crushed and mixed in juice; they must be swallowed whole.

In contrast, Quadrimune contains four H.I.V. drugs: ritonavir, lopinavir, abacavir and lamivudine. The granules are coated first in a polymer that doesn’t melt until it reaches the stomach, and then with sweet, fruity flavoring.

Dr. Kogie Naidoo, who heads treatment research at Caprisa, an AIDS treatment and research group based in Durban, South Africa, who was not involved in Quadrimune’s development, said the new formulation could solve many problems she and her colleagues encounter while treating children.

Cipla, founded in 1935, was the first generic drug company to offer H.I.V. drugs in Africa. In 2001, its chairman, Yusuf K. Hamied, upended the global pharmaceutical industry by offering to supply a three-drug cocktail to Doctors Without Borders for $1 a day.

At the time, multinational drug companies were charging up to $15,000 for their regimens and refusing to lower prices except in secret negotiations with a few countries and were working to block generic competitors from the market. An estimated 25 million Africans were then infected and thousands were dying every day. (The industry was also suing South Africa’s president, Nelson Mandela, over a law he had signed authorizing the government to cancel drug patents and award them to generic makers.)

In 2001, Dr. Hamied said he was losing money at the $350 a year price; his break-even point was $600, he said, and he offered it to other buyers for that.

But he said he acceded to requests from AIDS activists for the $1 a day price to deliver a shock to his Western competitors and because such a nice round figure was likely to make headlines (a gambit he is clearly repeating now).

In the decades since, increased generic competition has driven the price of triple therapy in poor countries to below $100 a year.

“Over the past 20 years, Cipla has pioneered fixed-dose combinations for children and I do believe our Quadrimune could be a winner,” Dr. Hamied said in an interview this week.

Because all four drugs in the formulation are older and no longer patented, Cipla might eventually offer it in wealthy countries too, he said. But that market is quite small because most pregnant women in the West are tested for H.I.V. and immediately put on antiretroviral drugs, which reduces to near zero the chances that they will infect their babies in the womb, during birth or through breastfeeding.

The $1 a day price is for Quadrimune doses appropriate for children of between 20 and 30 pounds, he noted, so the cost for newborns would be even lower.

Paradoxically, treating infants with H.I.V. has actually become harder in recent years than it was two decades ago.

In the early 2000s, Cipla produced Triomune Baby and Triomune Junior, two pediatric formulations of the world’s first adult three-in-one pill, introduced in 2001.

But they contained nevirapine, a drug that in those days was often given to pregnant women to prevent mother-child transmission. As a result, many babies were born with nevirapine-resistant forms of the virus, and the efficacy of pediatric Triomune fell by about half, Dr. Pécoul said.

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Some nevirapine substitutes that work in adults do not work well in children, and the combination that does work has the bitter taste.

Nowadays, many pediatric H.I.V. specialists are frustrated that they cannot prescribe some of the newest drugs, such as tenofovir and dolutegravir, because there is little or no data on how safe they are in small children. The major drugmakers have little incentive to test their products in children because there are so few customers who can pay high prices.

If a child’s virus develops resistance to any regimen, a new one must be tried, so more research is needed, said Dr. Naidoo, the AIDS researcher in Durban.

But by any measure, she said, Cipla’s new, gentler formulation for children is a major advance: “This is indeed great news for treating pediatric H.I.V.”

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radhika677 · 4 years ago

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Sorafenib tablets price

Buy Sorafenib medication at an affordable range of price on Magicine Pharma. This antiretroviral medication comprises Dolutegravir as an active agent and it is available in the form of a tablet. sorafenib tablets is recommended for the treatment of HIV (Human immunodeficiency virus) infection.

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jamieclawhorn · 6 years ago

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Why I believe the GSK share price could soon return to 1,700p

A couple of times over the past few years, the GlaxoSmithKline (LSE: GSK) share price has briefly peered above the 1,700p barrier. But it’s never hung on for long. Can the shares again climb above that benchmark and stay there? I think so.

Glaxo’s troubles stem from losing key patent protections on some blockbuster drugs a few years ago while facing increased competition from generic manufacturers. It’s a problem it shared with fellow pharma giant AstraZeneca, which recruited new boss Pascal Soriot whose radical strategy has refocused that company on its core strengths.

Turnaround

Glaxo’s turnaround has perhaps been a little less high-profile, but it’s been delivering the goods, and we’ve had three years of rising earnings per share since 2016. But the share price recovery looks to have been stalled by a forecast EPS dip of 8% this year before a modest regain of 5% next year. That’s not the sustained growth I think investors need to justify a new share price growth phase.

But the drug development timeline is a long one and involves considerable expense. It’s an endeavour with potentially very long-term rewards too, and I think a number of factors are building to deliver a new golden period for GlaxoSmithKline.

The first is that the developed world is looking more and more like an old folks’ home. In that, I mean longevity is increasing, age-related ailments are rising (and that include biggies like cancer, with lengthening lifetimes raising the overall probabilities), and there’s an increasingly lucrative market for successful drugs.

The other key, ongoing, development is that Glaxo’s investment in its production pipeline is increasingly paying off. A look over the company’s news releases shows a long list of key development milestones being hit.

HIV

One very smart move, in my opinion, was Glaxo’s partnering with US drugs giant Pfizer in the battle against HIV. The two companies formed joint venture ViiV Healthcare in 2009, pooling their HIV research and development. I think it makes a lot of sense, especially when targeting the US healthcare market, to form a partnership than go head to head in competition.

In early April, the US Food and Drug Administration (FDA) bestowed its approval on Dovato, a single-tablet, two-drug combination of dolutegravir and lamivudine for the treatment of HIV-1 in adults. The dual-drug combination is also under review by the European Medicines Agency (EMA) and by authorities in Canada, Australia, Switzerland, and South Africa — and, just a few days ago, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a “Positive Opinion recommending marketing authorisation for Dovato.”

Drag

February’s full-year results statement showed impressive sales increases across the board for Glaxo’s newest commercial products, though the continued effect of generic competition continues to exert a drag on sales of older drugs. The expected 8% EPS drop this year is in large part due to the approval of a generic competitor to Advair in the US.

But that drag will end and, as GlaxoSmithKline’s sales come more and more to focus on new drugs, I can see serious EPS growth becoming established. I rate Glaxo as a long-term buy.

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