Mostrando las entradas para la consulta ALL TRIALS ordenadas por fecha. Ordenar por relevancia Mostrar todas las entradas
Mostrando las entradas para la consulta ALL TRIALS ordenadas por fecha. Ordenar por relevancia Mostrar todas las entradas

miércoles, 17 de julio de 2024

The renaissance of Alzheimer´s drug development


 

With 14 million people in Europe expected to suffer from Alzheimer’s and other forms of dementia by 2030, the race is on to find a treatment to not only slow its course, but even prevent the development of the disease.

Historically, market authorisations for neurological diseases have had significantly lower rates of success compared with other indications.

Between 2000 to 2015, the likelihood of approval for neurological drugs that entered phase 1 trials (8.4%) was below the mean across all indications (9.6%) and far below haematology (26.1%) and infectious diseases (19.1%). When considering neurodegenerative diseases and specifically Alzheimer’s disease (AD), the rate is even lower with only four drugs: donepezil; galantamine; memantine, and rivastigmine approved between 1996 and 2020.

These drugs, however, only treat the disease’s symptoms rather than the causes. This has largely been due to a lack of understanding of the mechanisms behind disease pathogenesis, with advances in AD happening at a significantly slower rate relative to other diseases. Despite being first discovered over 100 years ago, the complexity of the brain and limitations surrounding research/diagnostic methods and models have acted as barriers for AD drug development.

Recently, however, this trend has begun to shift. In 2021, while cancer drugs accounted for 30% of all new FDA approvals, neurology saw the second most approvals for the third time in a row (10%). 


The AD pipeline in particular saw major advancements with the (controversial) FDA accelerated approval of Biogen’s Aduhelm (aducanumab) in 2021, the first amyloid-targeting antibody for AD. The FDA approval of Eisai’s Leqembi (lecanemab) in July 2023 – with Lilly’s donanemab submitted but awaiting a currently delayed advisory committee meeting in 2024 (both of which also target amyloid) – continue to highlight the advancements happening in AD therapeutics.


A closer look at amyloid targeting treatments and beyond

Amyloid plaques, targeted by the aforementioned therapeutics, form from a protein known as amyloid-beta (Aβ), which is produced through the proteolytic cleavage of amyloid precursor protein (APP). The cleavage of APP has two different pathways known as the non-amyloidogenic and the amyloidogenic pathway. The non-amyloidogenic pathway results in soluble APP (sAPP) and a fragment known as P3 being released, with both being cleared from the brain. Alternatively, the amyloidogenic pathway, which is the main interest in AD, results in the generation of oligomeric Aβ40 or Aβ42, which are deposited within the brain and over time, through a process known as aggregation, form insoluble plaques.

.../... 

In the next 12 months, it is also likely there will be the approval of at least one more amyloid drug in Eli Lilly’s donanemab globally. In addition, potential approval of a subcutaneous formulation of Eisai’s Leqembi (currently requesting an FDA Fast Track designation) will offer patients greater accessibility due to not requiring access to a transfusion centre, with data showing increased efficacy and comparable safety to the current intravenous Leqembi.

Beyond 2024, the general consensus among HCPs and key opinion leaders active in the AD clinical space is that combination therapies with existing drugs for AD will start being developed, with therapeutic efficacy further enhanced by doing so. These could manifest in several ways including combining Aβ (Leqembi/donanemab) and TREM2-targeting drugs (AL002) or Aβ and tau (E2814)-targeting combination therapies.

Increased funding and greater public awareness of AD impact on people’s lives will continue to influence future innovation in these areas. The potential financial benefits are also certainly an incentive for drug developers with the Alzheimer’s market estimated to be $4.2bn in 2022 and expected to grow to $15.6bn by 2030. The financial burden on payers and governments has led to the recognition by regulatory bodies of an unmet need and is also contributing to advancements in AD therapeutics. With AD and other dementias responsible for a cost of $2.8trn in 2019 and expected to cost $4.7trn by 2023 globally, the race is truly on.

How the pipeline continues to develop may be dependent on the success of Leqembi, but as the first amyloid drug to be covered for reimbursement, it has paved the way for subsequent developments. While the actual clinical and commercial success of Leqembi is still to be determined, the market remains open, highlighting the requirement for further development.

 

Más...

jueves, 11 de julio de 2024

AZ: FDA autoriza Imfinzi para "endometrial cancer"


 

AstraZeneca’s (AZ) Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) as part of a combination therapy for a subset of endometrial cancer patients.

Imfinzi plus carboplatin and paclitaxel, followed by Imfinzi monotherapy, is now authorised to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The FDA’s decision was supported by positive results from the late-stage DUO-E trial, in which the Imfinzi regimen reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone.

The safety and tolerability profile of the regimen was generally manageable, well tolerated and broadly consistent with prior clinical trials, AZ said.

Endometrial cancer is the sixth most common cancer in women globally and dMMR disease accounts for up to 30% of all cases.

Patients diagnosed at an early stage of disease have a five-year survival rate of up to 90%, but AZ outlined that there remains a “significant need” for new treatment options for those with advanced disease, where the survival rate falls to less than 20%.


Imfinzi, which already holds approvals in lung cancer, biliary tract cancer and hepatocellular carcinoma, is a human monoclonal antibody designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Commenting on the latest authorisation for the drug, Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future.

Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting and the approval of Imfinzi offers an important new option for patients with dMMR disease.


DUO-E has also been evaluating Imfinzi plus chemotherapy, followed by Imfinzi plus Lynparza (olaparib), as a maintenance therapy. Regulatory applications for both Imfinzi and Imfinzi/Lynparza regimens are currently under review in the EU and several other countries based on results from the study.

Ver

jueves, 14 de diciembre de 2023

Fué Ozempic, ahora Zepbound antidiabéticos que bajan de peso...


El último tratamiento aprobado por la agencia regulatoria de fármacos en Estados Unidos, la FDA (Food and Drug Administration), no es nuevo. Al igual que ocurriera con Ozempic, Zepbound es un tratamiento contra la diabetes tipo 2 al que se le ha encontrado un nuevo uso: tratar la obesidad.

Un “nuevo” tratamiento… En los EE UU. 

Y con esa función, la de luchar contra la obesidad, este tratamiento ha sido aprobado para su uso en los Estados Unidos. Zepbound se consolida así como la primera alternativa al fármaco que más ha dado de qué hablar desde el final de la pandemia, la semaglutida. 

 


Zepbound.
 

Zepbound es el segundo nombre comercial que se ha dado a la tirzepatida, un compuesto desarrollado por la farmacéutica estadounidense Eli Lilly. Este compuesto también es la base del tratamiento contra la diabetes tipo 2 Mounjaro

La FDA ahora ha aprobado el uso de este fármaco como tratamiento contra la obesidad y el sobrepeso.


 

Al igual que la semaglutida se comercializa con dos nombres, Ozempic (contra la diabetes) y Wegovy (para la pérdida de peso), la tirzepatida también estará presente en las farmacias estadounidenses bajo dos marcas, cada una orientada hacia un uso.

Más
 

 

 

 The FDA announced Wednesday that it has approved Eli Lilly's dual GIP and GLP-1 agonist tirzepatide for chronic weight management. Specifically, the weekly injectable medication will be marketed under the name Zepbound for adult patients with obesity, or for those who are overweight and have at least one weight-related condition.

 


"In light of increasing rates of both obesity and overweight in the US, today's approval addresses an unmet medical need," commented John Sharretts, director of the division of diabetes, lipid disorders and obesity in the FDA's Center for Drug Evaluation and Research. Tirzepatide has been cleared in the US as a treatment for diabetes since 2022 under the name Mounjaro

The latest FDA decision was based on the Phase III SURMOUNT-1 and SURMOUNT-2 trials. Results from SURMOUNT-1, which included about 2500 participants, demonstrated that at the highest dose of 15mg, patients taking Zepbound lost an average 48 pounds, while at the lowest dose of 5mg, they shed 34 pounds on average. By contrast, participants who received placebo lost 7 pounds (for more, see ViewPoints: ADA 2023 – Tirzepatide study lead investigator says weight loss in type 2 diabetes and ensuing health benefits now a 'SURMOUNT'-able goal). List price of $1060 per month.

 

Eli Lilly said Zepbound should be available in the US by the end of the year in six doses, and carry a list price of about $1060 for a month's supply. Zepbound is the latest entrant into the field of GLP-1 agonists that already includes Novo Nordisk's semaglutide, which is marketed under the names Ozempic for diabetes and Wegovy for weight loss. Eli Lilly said the list price for its drug is about 20% lower than Wegovy

Mike Mason, president of Eli Lilly's diabetes and obesity unit, stated that "broader access to [weight loss] medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it.

According to the company, people who are commercially insured with coverage for Zepbound may be eligible to pay as low as $25 for a one-month or three-month prescription. Those who are commercially insured without coverage for Zepbound may be eligible to pay as low as $550 for a one-month prescription. 

 Eli Lilly reported earlier this month that Mounjaro garnered sales of $1.4 billion in the third quarter, up from $187.3 million in the prior year, and surpassing estimates by about $100 million. At the time, Bloomberg Intelligence analysts Sam Fazeli and John Murphy suggested that nothing comes close "to matching Mounjaro's importance to the company's near-term earnings.

All-time bestseller? 

 Zepbound's approval further establishes Eli Lilly as a formidable competitor to Novo Nordisk in the budding market for weight-loss treatments, with some analysts suggesting it could become one of the best-selling drugs in history. A FirstWord survey from July of 150 US physicians found that nearly all saw an increase in the number of patients seeking treatment for obesity over the past 12 months, although payer resistance had set up a notable barrier to access. FirstWord is working on a new physician's survey, with data to be released in the coming days. 

 Guggenheim analyst Seamus Fernandez said "we think [Zepbound] has a very, very strong shot at being the biggest [selling] drug of all time; obviously competing very closely with Novo Nordisk's Ozempic and Wegovy.

He noted that the GLP-1 category "for sure, will be the largest selling pharmaceutical market of all time," with the main challenge being reimbursement. "That being said, we do have some really important data coming this weekend from Novo Nordisk's…SELECT study, and that could really prove out…the benefits of [Wegovy] for patients who have high cardiovascular risk, so this may turn out to be more of a cardiovascular drug at the end of the day.

Más


jueves, 1 de junio de 2023

FDA: La justicia, con Hydergina, también a veces...se retracta.

 

A finales de la década de los 70´s (siglo pasado), entre las múltiples responsabilidades que me tocó desempeñar en mis 12 años en Sandoz Venezuela, tuve la de ser Product Manager de Hydergina.

El producto estaba posicionado y promovido, como indicación principal, en los "síntomas precoces del envejecimiento cerebral".

Venezuela, por su demografía, no es un país de viejos...sin embargo Hydergina era aceptado, muy prescrito y uno de nuestros líderes de ventas.

Coincidencialmente por esas fechas en USA, la FDA aprueba el uso del producto en esas indicaciones.

 

"Known γ-secretase inhibitors or modulators display an undesirable pharmacokinetic profile and toxicity and have therefore not been successful in clinical trials for Alzheimer’s disease (AD). So far, no compounds from natural products have been identified as direct inhibitors of γ-secretase. To search for bioactive molecules that can reduce the amount of amyloid-beta peptides (Aβ) and that have better pharmacokinetics and an improved safety profile, we completed a screen of ~400 natural products by using cell-based and cell-free γ-secretase activity assays. We identified dihydroergocristine (DHEC), a component of an FDA- (Food and Drug Administration)-approved drug, to be a direct inhibitor of γ-secretase.

Oportunidad fabulosa que no desaprovechamos y que nos movió a intensificar nuestra creatividad, énfasis en el marketing y en la promoción.

Es el momento de crear un concepto / gadget que plasme el hecho.

Y ahi nace: 

"Juzgado y aprobado"  y el martillo de la justicia que, a pesar de su inutilidad, como siempre ocurre a lo regalado, tiene muy buena aceptación por el cuerpo médico...


El producto continua siendo un lider de ventas no solo en Venezuela sino en USA.

 


"The FDA has spent 13 years trying to stop Americans from obtaining low-cost Hydergine from overseas suppliers. Prices in Europe for Hydergine products are at an all-time low, but FDA enforcement remains high, thus causing Americans to pay protectionist prices for Hydergine.

As you will read in a new report appearing in this issue, Hydergine may be one of the more effective agents to prevent brain aging. Yet as nursing homes fill with senile "brain dead" Americans, the FDA sends its agents on "European vacations" at taxpayer expense to raid companies that ship low-priced Hydergine to Americans.

Some European suppliers are offering 100 5-mg ergoloid mesylates (generic Hydergine) tablets to Americans for under $20. This same amount of generic Hydergine costs about $175 in the U.S. Is it any wonder that the FDA is taking such aggressive actions against offshore companies that offer lower-cost medications? The FDA's actions are protecting the profits of the pharmaceutical industry. In doing so, it is squandering millions of tax dollars to force American consumers to pay eight times more for Hydergine than it would cost in Europe.

In September 1997, the FDA convinced a British government bureaucracy called the Medicines Control Agency to raid companies in England that ship medications to Americans for personal use. The MCA seized these medications under the guise of protecting the public against dangerous drugs. As detailed in last month's issue of Life Extension, the mca took the unprecedented step of sending letters to Americans who bought Hydergine, stating that the product had been tested, the quality was "suspect" and the tablets were "not of the efficacy that legitimate manufacturers would have produced." 

Ver.

Pasan los años. Yo soy trasferido a Perú, luego México, otra vez Perú y a España donde terminan mis días en la industria (1999) no ya en el Sandoz con el que di mis primeros pasos sino a consecuencia de la "mergermanía" en Novartis.

Como editor de este blog y también como Profesor en el curso de Postgrado de Marketing Farmacéutico en la Universidad Central de Venezuela (UCV)  no me desvinculo del "mundo farmacéutico".

Un día una noticia me sorprende...

Desde hoy mismo, 11 de diciembre, se dejará de comercializar el principio activo dihidroergotoxina un fármaco que hasta ahora se utilizaba para indicaciones oftalmológicas, otorrinolaringológicas, vasculares y neurológicas relacionadas con alteraciones vasculares en diversos órganos y sistemas.

En el mes de julio Comité de Medicamentos de Uso Humano (CHMP) de la Agencia Europea de Medicamentos (EMA) llevó a cabo una reevaluación del beneficio riesgo de los fármacos que contienen este principio activo y llegó a la conclusión de pueden provocar la aparición de fibrosis y/o ergotismo, siendo reacciones adversas que pueden llegar a ser mortales. Además, en el caso de aparición de fibrosis, esta puede ser irreversible, y debido a la aparición tardía de la sintomatología, puede ser de difícil diagnóstico. Por otra parte, se ha considerado que la evidencia disponible sobre el beneficio clínico es muy limitada, concluyéndose que el balance beneficio-riesgo de estos medicamentos en las indicaciones mencionadas es desfavorable.

El laboratorio titular del principio activo no estaba de acuerdo con la valoración desfavorable del CHMP y pidió que reexaminaran los disponibles y la revisión de la opinión respecto a dihidroergotoxina, pero las conclusiones han vuelto a ser las mismas, el balance beneficio riesgo de los medicamentos con dihidroergotoxina es desfavorable.

En España dihidroergotoxina se encuentra disponible como Hydergina en forma de comprimidos y de solución en gotas, y el titular de la autorización en España ha solicitado la anulación de la autorización de comercialización de este medicamento en España, anulación que la AEMPS ha concedido con fecha 11 de diciembre, por lo que desde hoy mismo no se puede prescribir ni comercializar.

Ver


  Sic transit gloria mundi...

jueves, 2 de febrero de 2023

FDA: Evalua decisiones sobre "legal cannabis & CBD"


 As cannabis becomes legalized in an increasing number of states – New York State is set to open its first legal recreational marijuana dispensary Thursday – the Food and Drug Administration is weighing how it will regulate the substance as well as cannabis-derived CBD.

Ver:

First licensed retail cannabis dispensary opens in NY

The agency plans to make recommendations on how to regulate CBD, or cannabidiol, in food and supplements in the coming months.


While CBD doesn’t cause the “high” that tetrahydrocannabinol, or THC, does, products containing it are still not technically FDA-approved, aside from Epidiolex, a CBD treatment for rare seizure disorders.

Ver:

Todo sobre Epidiolex en PHARMACOSERÍAS

In 2018, Congress removed hemp (and thus hemp-derived CBD) from the federal Controlled Substances Act, leaving it to states to decide whether to allow the sale of CBD products.

As of now, the FDA has dictated that CBD can’t be added to foods or marketed as supplements, and companies must provide evidence from clinical trials if they claim their CBD products are therapeutic. Aside from that, however, companies selling CBD products haven’t had specific federal rules on how to market their products.

The agency is thus preparing to develop clearer ones after investigating whether CBD can be considered a food or supplement as opposed to simply a drug.

In an interview with The Wall Street Journal this week, FDA principal deputy commissioner Janet Woodcock, MD noted that CBD “raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance.”

In particular, the FDA wants to examine whether CBD can be ingested every day and over long-term periods safely, and whether it’s safe during pregnancy. They’re also aiming to better educate consumers on the wide variety of CBD products that are already out there – all of which have different levels of quality and safety.

The safety profiles around these products are not what they are generally accustomed to and not the same as what they get from other products when they walk into a wellness store or grocery store or even a gas station,” Norman Birenbaum, a senior adviser at the FDA, told The Wall Street Journal.

Still, the CBD and cannabis-derived products industry has expanded in recent years, expected to grow from a $4.6 billion market in 2021 to nearly four times that by 2026.

The National Cannabis Industry Association, a trade group for cannabis businesses, has argued that any federal guidelines should fall into place with current state guidelines that allow the sale of CBD.

The states are decades ahead of the federal government,” Aaron Smith, CEO of the trade group, told The Wall Street Journal. Medical marketers, meanwhile, have long jumped on the opportunity to begin exploring how to market legal cannabis brands as more states allow the sale of it.

miércoles, 31 de agosto de 2022

Alzheimer: No Clinical Benefit From Drug Targeting Amyloid (Aduhelm)


 

A recent review article in the Journal of Alzheimer Disease identified 9 compounds targeting amyloid that had failed in phase 3 trials since 2018.


In January 2019, Roche, Genentech’s parent company, announced it was discontinuing 2 phase 3 trials of crenezumab in patients with mild, sporadic Alzheimer disease because preplanned interim analyses concluded that the treatment was unlikely to meet its primary end point of slowing cognitive decline.

And a year before the findings of the Colombia crenezumab trial were reported, the US Food and Drug Administration (FDA) approved aducanumab (Aduhelm), another antiamyloid monoclonal antibody, even though none of the agency’s panel of outside experts had voted “yes” when asked whether clinical trials had shown it to be effective in treating Alzheimer disease.


Ver:

Todo sobre Aduhelm en PHARMACOSERÍAS

The agency granted aducanumab “accelerated approval,” which is based on a surrogate end point—in this case, a reduction in amyloid-β plaque in the brain—that, according to the FDA, “is reasonably likely to predict a clinical benefit to patients.” Aducanumab, the only antiamyloid drug that has ever received FDA approval, is the first Alzheimer therapy designed to modify the underlying disease process and not just treat symptoms.

After the FDA approved aducanumab, the Centers for Medicare & Medicaid Services (CMS) released a national coverage policy for the therapy as well as future antiamyloid antibodies to spur the collection of more information about their safety and effectiveness.

Medicare will cover aducanumab and other such therapies granted accelerated approval based on a surrogate end point, such as amyloid reduction, only for beneficiaries participating in FDA-sanctioned randomized clinical trials to determine clinical effectiveness. Aducanumab isn’t cheap. In January, Biogen cut the drug’s wholesale acquisition cost in half, to $28 200 per year for an average-size patient (dosing is based on patients’ weight).

For monoclonal antibodies that receive FDA approval via the conventional pathway, which involves demonstrating clinical benefit, Medicare will still only cover the cost for patients in CMS-approved or NIH-supported studies.

.../...


No matter their opinion about the usefulness of targeting amyloid, dementia experts seem to agree that the complexity of Alzheimer disease calls for a multipronged treatment approach tailored to the particular patient, depending on such factors as the stage of their disease.

I have a hard time imagining how targeting any single molecule or any single pathology is likely to yield a meaningful clinical benefit,” Gandy said.

 (Sam Gandy, MD, PhD, director of the Mount Sinai Center for Cognitive Health in New York)

Although the final answer on amyloid may not yet be in, researchers are branching out in their search for tools—both drugs and lifestyle changes—that could at least slow the development or progression of Alzheimer disease.

A decade ago, there wasn’t much in terms of alternative targets” to amyloid, Hodes said. To illustrate his point, he noted that 5 of the 8 late-stage Alzheimer trials funded by the NIA involve antiamyloid therapies. However, Hodes said, only 13 of the 61 phase 1 or phase 2 trials receiving NIA funding target amyloid.

 (Richard Hodes, MD, director of the National Institute on Aging (NIA))

Nonamyloid therapeutic targets include other proteins, such as tau—tau neurofibrillary tangles are a hallmark of Alzheimer disease that haven’t received as much attention as amyloid plaques—TDP-43 (transactive response DNA-binding protein 43), the accumulation of which in the central nervous system is also a feature of other neurodegenerative diseases; and α-synuclein, which appears to interact with tau in neurodegenerative diseases, Hodes said. Besides proteins, other Alzheimer therapeutic targets for which the NIA is funding trials include inflammation, genetics, and vascular system changes, he said.

The NIA is also supporting 131 studies of nonpharmacological interventions focused on cognitive training, sleep, and exercise, among others, Hodes said. One NIA-funded phase 3 trial presented at the Alzheimer’s Association conference evaluated whether regular exercise could benefit people with amnesic mild cognitive impairment (MCI), which primarily affects memory and increases the risk of Alzheimer disease or related dementias.

The trial randomized 296 adults to either moderate-intensity aerobic training or low-intensity stretching, balance, and range-of-motion exercises for 18 months.

Exercise sessions took place at a YMCA 4 times a week for a total of 120 minutes to 150 minutes per week. In the first 12 months, a trainer supervised 2 sessions a week, while the other 2 were unsupervised. All exercise was unsupervised in the last 6 months. Neither group showed significant declines from baseline in the primary measure of cognitive function over 12 months, suggesting that both the moderate- and low-intensity exercise, and, possibly, the socialization participants received with it, stalled cognitive decline, researchers reported at the meeting. In contrast, cognitive function did decline over a year in similar adults with MCI who participated in a large “usual care” observational study.

Approximately 6.5 million people aged 65 years or older in the US are living with Alzheimer disease, and that number is expected to nearly double by 2050, according to the Alzheimer’s Association.

The stakes are too high just to focus on amyloid,” Reiman said.

(Eric Reiman, executive director of the Banner Alzheimer Institute in Phoenix)

Más

viernes, 29 de abril de 2022

Cinema Paradiso: Clinical trials The Heart and Soul of Science

 



 

 


For all the conversation about the need to increase awareness of opportunities to participate in clinical research — and even more crucially, to diversify the cohort of trial participants — few efforts have pushed those goals in a manner that’s clever or creative. That’s why we’re very much on board with “Clinical Trials: The Heart and Soul of Science,” an animated short that plays up the importance of clinical research while acknowledging the history of racism in medicine. 

The short, produced by the Louisiana Community Engagement Alliance against COVID-19 Disparities and the health educators at NoiseFilter, shares information about the workings of the trial process and details the many scientific breakthroughs that have emerged from clinical research. The creators had the good sense to bring in Irma Thomas, the Soul Queen of New Orleans, to voice her animated self.

Clinical trials are the foundation of scientific research, but they can be hard to understand. 

Two doctors join Irma Thomas, the Soul Queen of New Orleans, to explain how clinical trials work, illustrate how these studies play a vital role in our daily lives, and confront the history of structural racism in medicine.

LA-CEAL is led by academic partners at Tulane University and Xavier University of Louisiana and funded by the National Institute of Health (NIH)


 

miércoles, 16 de marzo de 2022

PHARMA...en la guerra


 

Pharmaceutical industry response to the war in Ukraine

14 March 2022

The research-based pharmaceutical industry in Europe stands in solidarity with the people of Ukraine

We condemn the invasion of their country and express our sorrow at the suffering it has caused. As an industry dedicated to saving and improving lives, we stand for peace.

Our first priority is to ensure that medicines reach the patients that need them in Ukraine, in the neighbouring EU Member States, in Russia and in other countries where access to medicines may be negatively impacted. We call on all parties to facilitate the safe passage of medicines and vaccines to those in need.

As a health-based industry and part of the wider EU healthcare community, we will work together to address the health needs of all those affected by this war, in Ukraine and in neighbouring countries as part of the wider humanitarian relief effort.

Our Member Companies and Associations are offering humanitarian support both in Ukraine and for the emerging refugee crisis in neighbouring EU Member States. To date this includes in over 4.7 million doses of essential medicines and more than €28 million in financial support to NGOs.

Ver

Although many multinational companies have stopped operations in Russia or aren't sending their products there, large pharmaceutical companies are still shipping drugs to the country.

However, some companies are curtailing further investment or advertising activities.

GlaxoSmithKline, for example, said that it is stopping all advertising in the country and will not enter into contracts with the Russian government of military.

However, because the company believes everyone has a right to medicines, it will continue to supply its products to the country.

Pfizer CEO Albert Bourla said that while the company is stopping further investment in the country, Pfizer too will continue to provide Russia with its medicines.

AstraZeneca  EVP, biopharmaceuticals unit, Ruud Dobber, speaking at the recent Cowen Healthcare Conference, said that the company has paused some of its trials in Russia and Ukraine, Endpoints News reported.

Endpoints also reported that Merck has stopped recruitment in some clinical trials in the two countries and Bristol-Myers Squibb suspended recruitment for trials in Ukraine, Russia, and Belarus.

The Wall Street Journal reported on Saturday that Johnson & Johnson will continue to provide essential products to Russia, while AmerisourceBergen will continue to supply certain cancer drugs and complete clinical trials there.


Several companies have also announced they are donating medicines and making contributions to non-profit organizations to support Ukraine. Novartis has donated essential medicines as well as made a $3M donation to three humanitarian organizations.

AbbVie is also donating drugs to the Ukrainian government and has donated $1M to non-profits

Ver


jueves, 11 de noviembre de 2021

2021: Expiring drug patents (cont)

 


Ver anterior:

2021: Expiring drug patents

 

1. Lucentis

Originally approved in 2006 for wet age-related macular degeneration (AMD), Roche’s Lucentis reached sales of $1.61 billion in 2020. However, despite approvals for other indications such as macular edema in patients with diabetes, its decline in sales is already underway, and started in 2019 when Novartis launched another drug in this class.

Now, analysts think biosimilars will create an even larger threat to Roche and a biosim application for Lucentis from Samsung Bioepis is already under review by the FDA.

Earlier this year, Novartis, which owns a large stake in Roche, reported that sales for Lucentis plummeted by 25% in Q2.

Ver: 

Novartis de_Roche de acciones...

2. Adasuve

Manufactured in the U.S. by Galen, Adasuve is an inhaled powder used to treat extreme agitation in adults with bipolar I or schizophrenia. Several of its patents expire in October 2021, potentially opening doors for generic versions.

However, it could be a while before that happens, mainly because there’s no news yet of other manufacturers seizing those opportunities.

Alternatively, a different threat to Galen’s profits may come via newer alternative methods of treating agitation such as BioXcel’s had a sublingual thin film of dexmedetomidine, which is in phase 3 trials.

3. Perforomist

In June, Mylan’s Perforomist, which treats ongoing lung conditions, including emphysema and chronic bronchitis, lost its patent. In the same month, Teva Pharmaceuticals Industries launched the first generic version of the drug, targeting patients with chronic obstructive pulmonary disease (COPD).

According to Teva, Perforomist reaches annual sales in the U.S. of $299 million. So far, its generic version is the only one to hit the scene.

4. Northera

When Denmark-based Lundbeck, loses patent exclusivity for one of its top-sellers — Northera — this year, the impact for the company will be huge.

According to Reuters, the company has forecasted that sales for Northera, which is used to treat symptoms related to neurogenic orthostatic hypotension, will plummet by half this year as the drug comes off patent.

Overall, the drop in Northera sales will contribute to the company seeing its revenue fall from 17.7 billion Danish crowns in 2020 to 16.3-16.9 billion this year.

5. Narcan

Emergent BioSolutions has had its hands full this year with several COVID-19 vaccine-related manufacturing challenges. On top of that, the company is gearing up to lose exclusivity of one of its key products — the opioid overdose drug, Narcan.

The company is currently locked in a patent dispute with Teva Pharmaceutical Industries related to a generic version of the nasal spray. As of June, judges ruled in favor of Teva, but Emergent will appeal.

In 2019, U.S. regulators approved the first generic naloxone nasal spray for people without medical training to use in community settings. Thus, Emergent has already faced competition from generics before losing the patent protection this year. But in 2020, Emergent looked to combat the threat by winning approval for a new version of the drug with an extended shelf life.

6. Brovana

Another drug targeting patients with COPD, Sunovion’s Brovana already faced competition in the crowded field for inhalation treatments. Now, with all of its patents expiring this year, the competition from more generics is coming quickly.

In June, Lupin Limited announced that it is launching a generic version of the drug, and numerous other copycats are expected to follow in the second half of 2021.

7. Bystolic

With sales of $600 million in 2019, Bystolic, a high blood pressure drug made by AbbVie, is one of the largest-growing medications to lose its patent this year. And thanks to a settlement in 2013, a number of generics will be teed up to launch in September.

Not only that, AbbVie was hit with a class-action lawsuit this month alleging that the company’s subsidiary Forest Laboratories paid off rivals to delay copycats of Bystolic from hitting the market.

8. Saphris

With AbbVie’s Saphris, which is used to treat certain patients with bipolar disorder and schizophrenia, losing its patent, generics have already hit the market.

In December, Breckenridge Pharmaceutical’s generic version won FDA approval along with others from Alembic Pharmaceuticals and Sigmapharm Laboratories.

Industry analysts estimate that Saphris had a market value of about $239 million between Sept. 2019 and Sept. 2020.

9. Amitiza

The patent loss of Amitiza earlier this year was another blow in a series of difficulties for Mallinckrodt.

Weighed down by opioid marketing-related litigation and a class-action lawsuit accusing the company of securities fraud related to its Acthar Gel, the drugmaker is in the midst of bankruptcy proceedings.

In addition, Amitiza, an irritable bowel syndrome and constipation drug that generated an estimated $180 million in profits for the company in 2020, began facing generics competition earlier this year.

10. Atripla

Gilead Pharmaceuticals’ triple-combination Atripla was developed to prevent the reproduction of the human immunodeficiency virus (HIV) in the body, but has not generated as much income as some of the company’s other HIV treatments. Truvada, for example, pulled in $753 million in sales in the first half of 2020, while Atripla obtained $176 million in sales.

But with several of the drug’s patents expiring this year, including one related to pediatric exclusivity, Teva has already pounced on the opportunity to launch a copycat.

In late 2020, Teva introduced a generic version of Atripla, one of several now on the market. 

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jueves, 25 de marzo de 2021

COVID-19 Vacunas: Es la política...? (I) Nacionalismo


 

Vaccine Politics: global inequality during the COVID-19 pandemic

By Fonie Mitsopoulou -24.2.2021 

Nothing can be of national or international importance without being imbued with the edge of politics. An event as impactful as the pandemic, which has afflicted an estimated 81.5 million, and led to 1.78 million deaths to date, was always going to be politicized; leveraged for gain, superiority, and influence over other countries. The war against the virus comes hand-in-hand with an international propaganda war.

In the case of the pandemic, wealthy and powerful countries like the United Kingdom, the United States, Russia and China are able to use the virus for political gain. Vaccine nationalism is employed to gain influence and wield power among their national populations, as well as against other countries, while vaccine diplomacy is used to mend coronavirus-induced tensions and to curry favour among potential allies.

Less developed countries face a different set of problems, wherein their vulnerability to economic downturns caused by lockdowns around the world, and their lack of an infrastructure to deal with such a health crisis were already threats to their populations. This is exacerbated through phenomena such as vaccine hoarding, wherein only the wealthiest of countries reserve the bulk of the life-saving vaccines being produced. Internationalist movements such as COVAX are attempts at reducing global inequalities in terms of access to these vaccines. Hence, nationalist and internationalist approaches to the pandemic coexist in a world where a deadly threat provides new opportunities for actions to be taken on the political stage.


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 COVAX en PHARMACOSERÍAS

 

Nationalism

A resurgence in nationalism can be seen recently in trends in Europe, the US, and other countries worldwide, notably rising in association with and concurrent to right-wing parties and leaders. Nationalism is the sentiment of one’s country being superior to others, with their interests deserving to come before those of others. From Germany’s AfD, to Spain’s VOX, to America’s President Trump’s “America First” mantra, perhaps the rise in political nationalism primed the world for vaccine nationalism.

The two main culprits of nationalist behaviour are the US and the UK. These are two of the countries most affected by COVID-19, but counterintuitively so. They are relatively sufficiently developed, wealthy, and have the organisational capacity to have confronted the pandemic in a way which would have mitigated its subsequent overwhelming spread. Yet, even the leaders- the global representatives- of both of these countries fell to the coronavirus, in a stroke of irony that was not lost on anyone. The UK and the US still made sure to manipulate the events of the pandemic for political gain.

The most glaring case of “vaccine nationalism” is exemplified in the race for the vaccine, as countries raced to be the first on the moon five decades back, and as they scrambled to snatch up regions in Africa at the turn of the century. It is not a novel phenomenon; he who gets there first is able to laud it over the others. It is a source of national pride. Being the first, the biggest, the best, has always been the aim of governments in competition both domestically, with other parties, and internationally, with other states. This has often manifested itself through proxy competitions, seemingly unrelated to a state’s political strength. Nationalist competition can even be found in sports, as, during times of heightened political tensions, countries vie for first place. This was the case in the 1936 Berlin Olympics, with national athletes acting as vehicles for their governments as countries tried to prove national supremacy in the lead-up to a World War.

Furthermore, vaccine nationalism is not just reflected in attempts to produce or approve a vaccine first, but more importantly, it is fundamentally about which country is able to provide for its citizens by securing sufficient doses of the vaccine so as to halt the rising death toll. According to the Duke Global Health Innovation Center, higher income countries had collectively reserved nearly 5 billion vaccine doses by the 8th of December through bilateral “advance market commitments”. The US has entered into six of these deals, thus securing more than 1 billion doses, a surplus of vaccines to ensure that if any of the trials fail, the other trials can offer them some security. However, the problem this poses is that vaccine production cannot keep up with global demand, therefore, for some years, many less-wealthy countries will be bereft of vaccines while the coronavirus continues to spread. From a scientific perspective, the global dissemination of COVID will be tackled most effectively if vaccines are distributed equitably, so that all countries can inoculate populations so as to achieve some degree of herd immunity while vaccines continue to be produced. A nationalist stance, therefore, will only prove to be deleterious in time.


UK

Expressions of vaccine nationalism

With two American companies (Pfizer-BioNTech, Moderna) and an English one (AstraZeneca, in collaboration with the University of Oxford) in the lead, this particular race has always been intolerably tight. Even though Pfizer was able to get approved by the UK, the EU, and the US, in a similar timeframe, the UK could still take pride in being the first to sign a deal with them and be the first to distribute the vaccine, thus “lead[ing] humanity’s charge against this disease”, as a tweet from Alok Sharma, Secretary of State for Business, Energy and Industrial Strategy, read. This does not go to say that the English agreed with this sentiment, as the top commenters retorted with “Lose the jingoism – it’s not even a UK vaccine” and “alternatively they’ll remember the UK having one of the worst death rates and the worst economic impact due to poor governance”. The UK was also the first country to approve the Oxford-AstraZeneca vaccine on the 30th of December 2020, coinciding with a period which has seen daily COVID cases in the UK at an all-time high: on December 29th, there were 53,135 new cases.

Therefore, vaccine-related nationalist narratives were a tool used by the UK government to salvage some public support and credibility. The methods with which this occurred was through public statements: Health Secretary Matt Hancock and Tory MPs Jacob Rees-Mogg and Nadine Dorries all made the claim (on either Times Radio or Question Time) that the rapidity with which the vaccine was approved was a result of no longer being constrained by the European Medicines Agency. Education Secretary Gavin Williamson has publicly stated “I just think we have the very best people in this country and we’ve got the best medical regulators. Much better than the French have, much better than the Belgians have, much better than the Americans have. That doesn’t surprise me at all, as we’re a much better country than every single one of them, aren’t we?”. The Tory government have engaged in discussions about branding vaccine kits with the Union Jack–a potent national visual symbol that makes it very obvious who the British citizens should thank. In line with such symbolism, the UK called it’s immunisation programme “V-Day”, alluding to the language used for their victory in the Second World War, thus further inciting patriotic fervour around the topic of the vaccine.

Political incentives

The current Conservative government stands to gain from setting up the quick approval of a vaccine as a metric for a successful state. This is a strategy that can be described as setting milestones at accessible points, and celebrating when they have been achieved. This is to detract from the recent highly-publicised political losses the UK government has seen, both on the domestic and international fronts. On its local stomping-ground, the Conservative party has been accused of having failed to tackle the coronavirus crisis with any semblance of competence, with charges ranging from spending extortionate amounts (£12 billion) on a sub-par Track and Trace system which yielded few returns, to discriminatory lockdown regulations being placed on northern cities such as Manchester, compared to London, with only a fraction of the financial support. The government has further come under fire for failing to address child food poverty, limiting free school meals over vacations and obligating UNICEF to provide aid for these English children for the first time, undermining the UK’s credentials as a leading developed global power. The UK appears to onlookers as though it has been overwhelmed by a global health crisis disproportionately to other- potentially less wealthy and well-equipped- countries.

Internationally, the UK was seen to be hurtling towards the 31st of December–the date of the final deadline for a Brexit deal with the EU–without a deal in sight. In the worst-case-scenario of a no-deal-Brexit, there were fears of the Pfizer-BioNTech vaccines being held up due to disruptions in the movement of goods between Belgium and the UK, which would be an issue given that these vaccines must be refrigerated at -70C. While the Conservative government, under Prime Minister Boris Johnson, was able to negotiate a deal at the eleventh hour, issues with trade and borders made the government appear as though they are frantically trying to make momentous, wide-reaching decisions with little time and little bargaining power.

Most significantly, in the UK, the vaccine has become yet another battleground for Brexit: a vessel for the anti- or pro-European sentiments held by nationals. Depending on who you ask, British rapid vaccine rollout is either a national triumph, resulting from Britain removing themselves from the shackles of tedious European Union bureaucracy and legislation, or, alternatively, it was only made possible through international collaboration (BioNTech is a German company, and the drug will be produced in Belgium, the home of the EU headquarters).

Implications

Attempts to import politics into the vaccine may have adverse impacts. Firstly, according to Stephen Reicher, a social psychologist at the University of St Andrews, the stance of those who are hesitant or against the vaccine is informed by mistrust of politicians, who are accused of lying about the vaccine for political or monetary gain, and such propaganda only confirms these suspicions. Furthermore, in the eyes of those who give more credence to science, these government spokespeople are exposed as either being scientifically illiterate-having very poor knowledge of how the vaccine-rollout process occurred- or being prepared to lie about it for political gain, which does not inspire particular faith in them. This can have both negative effects on attempts to finally end the pandemic, as well be counterproductive for the government, politically.


US

Vaccine hesitancy

President Trump’s methods to use the vaccine for political advantage are exemplified in his attempt, in the early days of the pandemic, to ensure that the CureVac vaccine would be “only for the USA”, in exchange for $1 billion. In an act akin to this one, the US was accused in April of diverting mask shipments meant for Germany for itself, in a scramble for scarce PPE in the midst of “mask wars”.

It is important, however, to place such actions within the context of American vaccine scepticism. All efforts to secure vaccines for the entire population are futile if the internal political implications behind the vaccine are not dispelled. This debate is wrought on a grassroots level. Within the wider conversation about whether the government and these big pharma companies are to be trusted- which has been waged on adjacent battlefields, such as that of mandatory mask-wearing and on the oppressiveness of the lockdown restrictions- the vaccine has not gotten through without intensive scrutiny. With a massive anti-vax movement having already taken root in the US, the coronavirus vaccines are treated with suspicion, especially given that vaccines are known to take up to a decade to produce. Operation Warp Speed, the name given to the US efforts to funnel billions into vaccine research and cut through red tape during this time of urgency, significantly expedited this process, thus inciting unease among sceptics. Only 60% of Americans have indicated they plan on being vaccinated, while 21% are reluctant to do so under any circumstances. Cynics wondered whether the October target for the completion of the vaccine would be rushing it unduly (and potentially dangerously) for the sake of having it out before the elections in November.

The link between the vaccine and politics is bidirectional; not only does the existence and supply of vaccines inform whether or not a government is perceived as effective or successful, but the inverse also holds true. When high-profile public figures and politicians put their weight behind the vaccine, this inspires faith in it among a dubious public. When individuals such as president-elect Joe Biden receive the vaccine on public television, this contributes towards the reduction of vaccine hesitancy. That being said, someone who is deeply convinced by the conspiracy theories is unlikely to be swayed by such a display; radical groups are always equipped with some response to rebut any information that runs counter to their beliefs.


RUSSIA

In August, the Russian government claimed to have created a successful vaccine, which, in a propagandist nod to the aforementioned space race, is called “Sputnik V’. On its website, it claims to be “the first registered vaccine against COVID-19”, establishing itself as the winner of this implicit competition. This did not go without significant resistance, however, as the US, the UK, and Canada accused Russia of sending hackers to steal vaccine information from their drug companies and research groups. Russia responded by calling this a smear campaign, attempting to undermine what could “potentially be the most effective vaccine out there”.

It must be noted that President Putin had a political incentive to make this announcement prematurely, and to have produced a vaccine first even if – by scientific standards – it was not ready (skipping Phase-3 trials, it had only been tested on 100 people). Currently, his trust ratings are experiencing one of their deepest troughs, and he just passed the constitutional amendment to presidential terms which would allow him to stay in power indefinitely. If he is to be around for a while, he has to be well-liked. It is a regime-preserving strategy, akin to those employed by other non-democratic governments. Furthermore, in an exigent parallel to the Cold War, this can be perceived as a move for Russia to stake itself as an alternative pole of power, to carve out its own sphere of influence in a competition that so far has been dominated by Western countries. The fact that the vaccine was only to be released on a limited-scale (for healthcare workers and at-risk populations) seems only to indicate that it was done for political gain, and not because the vaccine was actually safe and ready for distribution.


CHINA

COVID-inspired anti-Chinese racism

The final key player is China. The source of what is dubbed by people like President Trump the “China virus”, or “Wuhan virus”, many are thus made fully aware of who to blame for the pandemic and this wanton loss of life. The tale of the virus having originated from “bat soup” provides the context for which people can attribute tragedy to foreign customs. The virus acts as a guise, which enables racist behaviour. Asian Americans are subjected to virulent hostilities. Justin Tsui was told to “go back to [his] country”, Abraham Choi was spat on, called a “Chinese f-ck”, and that “all of you should die, and all of you have the Chinese virus.” Jay Koo was threatened with murder by strangers on the street, which he closely escaped by coughing and pretending to have the virus. In America, those of Chinese descent have historically been accused of bringing disease, with landmark legal cases like that of Jew Ho v. Williamson revealing how pandemia and racism go hand in hand. This is an age where political tensions between the US and China are at an all-time high, as signified by the breakdown of diplomatic relations in July with the US ordering China to close its consulate in Texas, and China doing the same with the US consulate in Chengdu. In this modern Cold War, both countries paint the other as the evil counterpart to their force of good, as they vie for global influence through diplomacy, military force and mercantilism, the coronavirus is just another means through which this animosity can be manifested.

Vaccine diplomacy

China is determined to utilize vaccine diplomacy to rectify the negative image the coronavirus has tainted them with. Their leading vaccine (among nine candidates), aptly named Coronavac, is borne from biotech giant Sinovac. China intends to utilise this as a tool with which to endear themselves to other countries: Brazil, which was the country third-worst affected by the virus, has been promised 6 million doses of the vaccine by January.

Terms native to the field of international relations can be imported into discourses around vaccine politics, which have presented themselves as a new channel through which to exercise power. Along with “vaccine nationalism” and “vaccine diplomacy”, one also encounters accounts of China attempting to become a “vaccine superpower” by providing vaccines for masses of people. In May, President Xi Jinping promised to share the vaccine with the world, setting China up to be favourably compared to the US, where President Trump was preoccupied with buying up a large bulk of production of new vaccines in a nationalist, protectionist move which only antagonised other countries. Another example of vaccine diplomacy can be seen in China’s proposal to prioritise distribution of their vaccine to Brazil, Indonesia, Pakistan, Russia and the Philippines, in a clear attempt to take advantage of the health crisis to forge or strengthen alliances.