Merck & Lilly: Aliados contra el cáncer.

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The Food and Drug Administration approved Keytruda in combination with Eli Lilly's Alimta, the chemotherapy drug used in the study that led to the agency's decision.

 Merck & Co said on Wednesday U.S. health regulators approved its Keytruda in combination with chemotherapy for previously untreated advanced lung cancer, solidifying the drugmaker's lead position in the field of medicines that help the immune system fight cancer. 

Lung cancer is by far the largest oncology market and the approval significantly expands the number of patients available for Keytruda therapy. 

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Merck shares were up 3.2 percent at $65.99 in extended trading. 

"This is the key game changer for Keytruda," said Leerink Partners analyst Seamus Fernandez, adding that he expects physician acceptance to be "pretty robust." 

The accelerated approval was based on data from a study of 123 previously untreated patients with metastatic non-squamous non-small cell lung cancer (NSCLC). 

"It was a small trial but the results were really quite striking," said Roy Baynes, head of global clinical development for Merck Research Labs.(...) 

Merck scored a coup last year, when Keytruda extended patient survival in a first-line lung cancer trial, supplanting Bristol-Myers Squibb  as the perceived leader in the field. Bristol's rival drug Opdivo surprisingly failed to show a survival benefit compared with chemotherapy in a similar study.  

Both drugs and one from Roche  were already approved for lung cancer once a prior treatment fails or stops working. 

The medicines belong to a new class of cancer drugs, called PD-1 or PD-L1 inhibitors, that block a mechanism tumors use to evade detection by the immune system. There are now five approved for a variety of cancers, but all companies involved are aiming for a slice of the lung cancer market. 

Bristol-Myers is testing Opdivo with its other immunotherapy, Yervoy, as a first-line NSCLC treatment, but did not seek accelerated approval. AstraZeneca  is also testing an all immuno-oncology combination with highly anticipated data expected mid-year. 

 The original Keytruda first-line approval allowed for treatment of about 30 percent of NSCLC cases. The combination could be used on all patients with non-squamous NSCLC, which accounts for about 75 percent of lung cancer cases. (Más)

Pfizer, Roche y Novartis dominarán mercado en 2018

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Uno de los informes más esperados sobre la industria farmacéutica es el que realiza cada año la consultora Evaluate con las previsiones de sus analistas para el ejercicio entrante. Se trata del barómetro para medir la presión a la que estarán sometidas las farmacéuticas y conocer también qué laboratorios crecerán más este ejercicio o cuáles serán los lanzamientos con mayor impacto de ventas en el mercado. 

El ranking de ingresos por compañías lo encabezará Pfizer en 2018, con un total de 47.600 millones de dólares, seguida de las dos grandes farmacéuticas suizas -Novartis y Roche, con unos ingresos superiores a los 42.000 millones-. Por su parte, los mayores incrementos de ventas los protagonizarán Johnson&Johnson, Abbvie y Celgene, según estas mismas previsiones de Evaluate.

Entre las diez compañías que más facturan, solo Gilead sufrirá un retroceso como resultado de los menores ingresos generados por los nuevos antivirales contra la hepatitis C que se han convertido en las terapias más efectivas que se han lanzado en los últimos años al curar esta enfermedad. 

Las nuevas inmunoterapias en cáncer permitirán a la industria farmacéutica seguir aspirando a mantener el ritmo de crecimiento de los últimos años, gracias no solo a los nuevos anticuerpos monoclonales en cáncer, sino también a la aprobación de nuevas técnicas de edición genética o terapias adoptivas de células T, así como a su poder de negociar condiciones económicas ventajosas en precios en un área tan sensible para los pacientes. Este objetivo de crecimiento, que la consultora no concreta, no será sencillo si se tiene en cuenta que solo dos fármacos lanzados en Estados Unidos en 2014 -Keytruda y Opdivo- generaron unas ventas acumuladas de 8.000 millones de dólares, mientras que la facturación de los cinco anticuerpos anti PD-1 y PD-L1 presentes en el mercado superarán los 10.000 millones de dólares en 2017, según las previsiones del sector. 

Especial seguimiento, subraya la consultora, tendrán los nuevos ensayos de terapias combinadas en curso o la aprobación de nuevas indicaciones. El combo más adelantado lo impulsa Incyte y los datos de su fase III podrían conocerse en la primera mitad de 2018. Se trata de una combinación de su molécula epacadostat con Keytruda, el tratamiento de primera línea del melanoma de MSD. De su éxito o fracaso, apuntan los analistas, dependerán muchos otros combos con esta molécula que llegó a disparar el valor en bolsa de Incyte hasta los 30.000 millones de dólares en marzo de 2017. 

Otros ensayos combinados destacados son los desarrollados por BristolMyers Squibb y Nektar, en combinación con fármacos superventas ya comercializados como Keytruda, Opdivo (BMS) o Tecentriq (Roche).

Las expectativas de ventas de estas inmunoterapias son millonarias y en 2022 se podrían disparar por encima de los 9.000 millones en el caso de Keytruda y Opdivo, y alcanzar los 3.800 millones en el tratamiento de Roche y los 2.700 millones en Imfinzi (durvalumab), la terapia de AstraZeneca contra el cáncer avanzado de vejiga. Solo gracias a Keytruda, MSD prevé añadir a sus ventas 2.280 millones de dólares generados solo en el presente ejercicio. 

Nuevos lanzamientos 

Las farmacéuticas también están investigando con éxito en otras áreas terapéuticas. Entre las grandes compañías, el tratamiento contra la hemofilia de Roche (emicizumab) tiene mucho recorrido, como también lo pueden tener las nuevas terapias anti CGRP contra la migraña si demuestran su valor. Las expectativas fallidas de la nueva clase de medicamentos contra el colesterol, cuya introducción está siendo muy lenta por las resistencias de los financiadores a hacerse cargo de sus costes, son un aviso tanto para la industria como para los propios analistas, destaca el informe de Evaluate. 

Otro de los lanzamientos más esperados este año es el nuevo antirretroviral de Gilead contra el VIH (Bictegravir), que se encuentra en fase III y que, en combinación con emtricitabine/tenofovir alafenamide, ha demostrado una gran eficacia. Se trata del tratamiento que tiene mayor potencial de ventas en 2018, con unos ingresos previstos de 5.000 millones de dólares en 2022. 

Los altos precios de terapias CAR-T, como Yescarta y Kymriah, están siendo también analizados con lupa y decidirán si son rentables desembolsos como el realizado por Gilead al adquirir Kite Pharma, especializada en terapia celular, por 12.000 millones de dólares o la compra de Cell Design Lab, el pasado mes de diciembre. 

Lo que resulta incuestionable a estas alturas es que la industria está viviendo una auténtica revolución en su investigación, que está permitiendo a las compañías lanzar terapias en enfermedades que no tenían cura ni tratamiento hasta el momento, por lo que el acceso a estos medicamentos se ha convertido en la máxima prioridad para los reguladores, gestores, compañías y, por supuesto, pacientes. 

En este sentido, una de las mayores incertidumbres que tendrá el sector en Europa en los próximos años es si el cambio a Ámsterdam de la sede de la Agencia Europea del Medicamento provocará retrasos en la aprobación del lanzamiento de nuevas moléculas al mercado. Los analistas recuerdan que la EMA autorizó 35 nuevas moléculas en 2017, frente a los 46 tratamientos que la FDA había dado luz verde. La presión de ventas acumuladas de estas terapias superaría los 32.000 millones de dólares en los próximos cinco años solo en Estados Unidos, según el informe de Evaluate. El elevado registro de fármacos contrasta con el análisis de rentabilidad de la inversión en I+D que efectúa Deloitte y que reduce al 3,2 por ciento en el caso de las 12 mayores farmacéuticas, según su último análisis de diciembre. 

Muchas de las nuevas terapias aprobadas en 2017 se hicieron a través de procedimientos acelerados por su relevancia terapéutica y fueron en enfermedades raras y en subtipos de cáncer que están dirigidas a pequeños grupos de población con precios, en consecuencia, muy elevados.(Ver)

Merck launches first TV advertising for cruising Keytruda in lung cancer

Merck’s immuno-oncology drug Keytruda is finally on TV. 
The first TV ad began airing this week, featuring one patient and her “Tru Story” of lung cancer survival. The ad highlights the importance of PD-L1 biomarkers in Keytruda treatment. 

From Keytruda's launch in 2015, Merck has taken a decidedly different approach to marketing than has its key competitor, Opdivo-maker Bristol-Myers Squibb. Merck has, until now, mostly pushed its checkpoint inhibitor through professional journal advertising targeting healthcare professionals, while BMS moved quickly after Opdivo's rollout to the mass market with a big TV campaign.

Ver:
 The Great DTC Shake-Up Patient perspectives on direct-to-consumer advertising

 In just a few days, Merck has spent $1.2 million on TV ads, while Bristol-Myers Squibb has spent more than $140 million on two Opdivo TV ads since launching the campaign in late September 2015, according to realtime TV tracker iSpot.tv. BMS has also faced a backlash for the TV ads, spurred by a New York Times op-ed—penned by a man whose wife died of lung cancer after failing to respond to the therapy—that labeled Opdivo TV advertising "misleading and exploitive." 
That piece stirred up controversy and hundreds of comments.(Más)

The next pharma Blockbusters...Merck, BMS, AstraZeneca, Roche.

  
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y descargar informe

In September, Merck's PD-1 blocker Keytruda (pembrolizumab) received accelerated approval from the FDA to treat melanoma and the company is researching the drug against non-small cell lung cancer (NSCLC) and other indications. In its World Preview 2014 Outlook report, EvaluatePharma forecasts Keytruda sales of $4.06 billion by 2020.

That's a great start, but it's unclear whether Merck's advantage will hold out over the long haul. The competition will be fierce in the PD-1/PD-L1 space. With the huge potential market, this could be the equivalent of the Oklahoma land rush for the usual pharma titans. However, Stephanie Hawthorne, senior director at Kantar Health, notes that, for now in melanoma, Merck is in the driver's seat compared to BMS's PD-1 inhibitor Opdivo (nivolumab), which is a few months (or possibly longer) behind Keytruda in the US. 

"It's a big advantage for Merck being first-to-market," says Hawthorne. "Based on the available data, they both look really efficacious, and they're fairly well tolerated compared to Yervoy. BMS's saving grace might be the combination of Opdivo and Yervoy they are studying. The survival data we've seen for it so far is really impressive, and that could trump Merck's lead." 

Hawthorne's point was underscored in late September when BMS released data at the European Society for Medical Oncology (ESMO) showing that Opdivo achieved a 32% response rate against advanced melanoma in patients who had previously been treated with Yervoy. The control group, which received traditional chemo, had an 11 % response. 

While Keytruda was first in the US, Opdivo was approved for melanoma in Japan in July, under a deal with BMS partner Ono Pharmaceuticals. The ESMO data will only support BMS's showing in the US. The FDA has given Opdivo fast track designation in NSCLC, melanoma, and renal cell carcinoma (RCC) and breakthrough therapy designation for Hodgkin's lymphoma. In September, BMS announced that both the FDA and European Medicines Agency (EMA) have accepted Opdivo for accelerated review for melanoma. The FDA PDUFA date is March 30, 2015. 

"Opdivo is the most valuable pipeline drug in development at the moment," says Lisa Urquhart, editor of Evaluate's editorial team, EP Vantage. "The data from studies is showing some impressive advances in both overall survival and disease progression." 

EvaluatePharma pegs Opdivo's potential sales at $6 billion by 2020. The company believes Opdivo could be approved for melanoma in the US next year. Meanwhile, Hawthorne expects approval for the Opdivo/Yervoy combination in early 2016. 

That's in melanoma. Opdivo may even have a more clear-cut advantage in being first-to-market for NSCLC, where BMS has already submitted its drug for approval while Merck is still completing Phase III trials. 

 Genentech/Roche's PD-L1 offering, MPDL3280A (RG-7446), is in trials for NSCLC, melanoma, RCC, and bladder cancer. The company received breakthrough designation for this last indication. EvaluatePharma puts sales at $2.93 billion by 2020, while the Thomson Reuters Cortellis database puts them at $1.2 billion by 2019. 

MedImmune/AstraZeneca is also in the race with PD-L1 drug MEDI-4736, primarily targeting NSCLC. Also shared at ESMO, a small 18-person study showed a 28% response to MEDI-4736 combined with the CTLA-4-directed antibody tremelimumab. Cortellis projects MEDI-4736 sales at close to $1.1 billion by 2019. 

"We're just at the tip of the iceberg for immuno-oncology, but the enthusiasm is certainly warranted because of the kinds of responses and the tumors being opened up," says Fernandez. "The field is about as exciting and confusing as you could possibly imagine." (Más)

Medicamentos 2020

AstraZeneca destacará entre los laboratorios y el Keytruda, de MSD, entre los productos. 

Eduardo Ortega Socorro 24 enero, 2020

2020 ha empezado y promete ser un año importante para la industria farmacéutica a escala global. Aparcado el debate sobre los precios de los medicamentos en el mercado más importante del mundo, Estados Unidos, por la campaña electoral, la eclosión del desarrollo de varios productos contra el cáncer conlleva pingües ventas para determinados laboratorios, con sorpresas entre los que más facturación adicional van a tener.

Y es que en el top ten de empresas que más van a impulsar el mercado (ojo, esto no significa que sean las que más facturen) llama la atención que no estén viejas conocidas como Pfizer o Roche, multinacionales que en cambio sí figurarán, salvo sorpresa mayúscula, en el podio de facturación total.

Así lo indica el análisis al que ha tenido acceso EL ESPAÑOL de la consultora Evaluate, y que precisa que la gran triunfadora de 2020 será el laboratorio británico AstraZeneca. Mientras Boris Johnson negocia el brexit con la Unión Europea, la compañía británica seguramente se embolse unos 3.250 millones de dólares adicionales respecto a 2019.

De absorción a la gloria

La historia de AstraZeneca es curiosa. En 2014, la compañía anglosajona acordó su compra por la todopoderosa Pfizer. Sin embargo, la operación fue percibida por la Administración Obama como una fórmula por parte del fabricante de Viagra para acogerse a la fiscalidad británica, inferior a la yanqui en aquel entonces.

Ver:

Pfizer y AstraZeneca: Son rumores? (y de otros mergers...)

Santander propone un dividendo de 0,13 euros: consulta las fechas clav El efectivo será de 0,10 eros y el scrip de 0,03 euros Sus acciones cayeron ante el freno a la compra, pero Pascal Soriot, su CEO, aprovechó para para reconstruir la compañía. A través de un nuevo modelo de I+D basado en la open innovation, es decir, en la colaboración con grupos de investigación, públicos y privados, externos, ha logrado formular un interesante pipeline destinado a lanzar sus ventas en el área oncológica.

Ver:

AZ: Se busca...conductor de recambio?

Tagrisso (osimertinib es su nombre por principio activo) es el principal producto que va a conducir a esta compañía a esta posición de liderazgo en 2020. 
De hecho, será el séptimo producto que más nuevas ventas generará este año.

La inmunooncología, en lo alto

Sin embargo, el medicamento más destacado en este sentido será Keytruda, el exitoso pembrolizumab de MSD (también conocida como la 'Merck americana' en España) que no hace sino ganar indicaciones en diferentes tipos de cáncer y mutaciones tumorales en los últimos años.

Ver todo sobre Keytruda en PHARMACOSERÍAS

De hecho, solo con las nuevas ventas de este fármaco MSD facturará unos 3.290 millones de dólares. Muy de lejos, en segundo lugar, queda el Biktarvy, la triple terapia en VIH de Gilead (compañía que en su momento lanzó el conocido sofosbuvir, el primer fármaco curativo en hepatitis C) de la que se esperan unos ingresos adicionales de 1.170 millones de euros.

Ver:

Una docena de blockbusters para 2018...

Con la medalla de bronce, según Evaluate, se quedará Revlimid, cuyo principio activo es lenalidomida. Este fármaco para el tratamiento del mieloma múltiple y la leucemia linfática crónica se pronostica que logre en 2020 unos 1.170 millones.

Una compra el éxito 

Este producto es fruto de la investigación de Celgene y de cuya facturación se va a beneficiar Bristol Myers-Squibb (BMS) tras comprar la compañía biotecnológica americana. De hecho, permite que sea la segunda compañía con más expectativas de ventas nuevas

Ver:

BMS to acquire Celgene for $74 billion in biggest-ever pharma deal

Sin embargo, Evaluate también avisa de que en 2022 BMS perderá la patente de Revlimid, así que la farmacéutica se tendrá que poner las pilas para buscar productos que acompañen su inmunoterapia oncológica Opdivo.

Precisamente, su gran rival en este campo, MSD, es la tercera compañía (un gigante farmacéutico, con patas en casi todas las áreas terapéuticas, incluida la de las vacunas y la veterinaria) con mayores expectativas de lograr más ventas adicionales y dinamizar el mercado.

MSD: Keytruda en el top de ventas...

Fin de ciclo para Humira. 

Keytruda, una terapia que combate distintos tumores, se ha convertido en el medicamento más vendido del mundo desbancando el fármaco de Abbvie, que durante una década se ha mantenido líder en los ránkings de facturación (con excepción de la vacuna contra el Covid-19 de Pfizer), según elEconomista.

La americana MSD ha registrado cifras de ventas por valor de 12.000 millones de dólares durante 2023, mientras que la desbancada Abbvie, ha cerrado el curso con una facturación de 7.500 millones de dólares, afectada por la pérdida de patentes y la fuerte competencia en el sector, en una caída prorrogada desde la llegada de la pandemia hasta la fecha.

Por su parte, la llegada al trono de Keytruda se espera se mantenga, hasta, al menos, 2028, en un año en el que se prevé que la facturación de MSD por este medicamento represente el 50% de los ingresos de su división farmacéutica.

En esta pugna en el sector farmacéutico, sube con fuerza un medicamento para adelgazar de Novo Nordisk llamado Ozempic, el cual ocupa el tercer puesto en terapias más vendidas con tan solo un año de vida en el mercado.

Ver:

Todo sobre Ozempic en PHARMACOSERÍAS

Este fármaco ha supuesto ingresos por valor de 6.700 millones de dólares a la compañía danesa, superando a uno de los anticoagulantes más vendidos de la historia, Eliquis, patentado por Bristol Myers Squibb de la mano de Pfizer.

No todo es color de...: Merck achica estructura.

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Merck & Co.’s cancer wunderkind Keytruda continues to turn in supercharged sales, $2.27 billion in the first quarter, which bodes well for the future of biologics manufacturing jobs at the company. But woe to those who work at other facilities, because the company has undertaken a manufacturing restructuring that could cost up to $1.2 billion when the dust settles.

The cuts, which were not announced in the company's earnings release but slipped (PDF) into a securities filing Tuesday, have essentially begun and are expected to take up to five years, the company said. The Kenilworth, New Jersey-based drugmaker did not provide specifics about how many jobs or facilities will fall in the restructuring but said about 55% of the costs are expected to go to severance and separation and 45% to “accelerated depreciation of facilities to be closed or divested.”

“We will share information about our plans as decisions are finalized,” spokesperson Pam Eisele said in an email. “This plan is part of our ongoing efforts to optimize our manufacturing and supply network and reduce our global real estate footprint.”

The drugmaker expects to take about $500 million in charges for the effort this year, including $187 million that were tallied in the first quarter. It said in total the restructuring should run $800 million to $1.2 billion when it is complete in 2023.

Merck is building its future around new drugs like Keytruda and other cancer fighters under development, as well as a drug for treating hospital-acquired pneumonia and a new antibacterial agent.

Merck has steadily closed older facilities while it pours money into biologics manufacturing. In fact, one site in Ireland that was slated to be closed was salvaged last year by the drugmaker’s hot-selling Keytruda. The company said it would build a new biologics plant at its Swords site near Dublin to produce the blockbuster immuno-oncology therapy. It didn't disclose the size of the investment but said it would create 350 jobs as part of the deal. The company is shooting to have that operational by 2021.(Ver)

Investigación Clínica: Competitive trial management (CTM) / Stan Bernard*

Originally, pharmaceutical clinical trials had two fundamental, interdependent roles: regulatory and clinical. In the US, the 1962 Kefauver-Harris Amendment, or “Drug Efficacy Amendment” to the 1938 Federal Food, Drug, and Cosmetic Act, required that drugs demonstrate efficacy and safety to be approved for patient use. In 1966, the Fair Packaging and Labeling Act required that all drugs have specific labeling to assist doctors and patients in the clinical use of these products. Four years later, the FDA required the first patient package insert (for oral contraceptives), which contained information for patients about specific risks and benefits. 

Soon thereafter, pharma companies began to leverage clinical trials for promotional purposes by seeking to highlight product details or differentiation from other products, which the FDA and other agencies over time progressively regulated. Over the past few decades, companies have been compelled or inclined to use clinical trials for reimbursement or payer purposes, as product cost-effectiveness and value have become increasingly important worldwide. Complete with their own unique and memorable brand names, clinical trials have progressed to embody battles in the larger brand wars and are now increasingly being used for competitive purposes in what can be termed “competitive trial management,” or CTM. 

Competitive trial management examples (CTM)

Pharma companies have leveraged CTM in a variety of ways to gain competitive advantages and steal market share: 

• Better: The most direct form of CTM is competitors’ head-to-head clinical trials against market leaders, almost unheard of 15 years ago. For example, over the last three years, Janssen has conducted several head-to-head studies with its SGLT-2 agent Invokana, demonstrating advantages in glucose-lowering, weight loss, and cost-effectiveness versus the market-leading ral T2D agent Januvia. Similarly, Amgen recently announced interim results demonstrating that Kyprolis helped patients with orelapsed multiple myeloma live twice as long before their blood cancer worsened compared to a regimen containing rival drug Velcade.  


• Counter: In a 2007 head-to-head study published in The New England Journal of Medicine, the experimental anticlotting drug Effient from Daiichi Sankyo and Lilly reduced heart attacks in patients with heart disease by 24% compared with market leader Plavix from Sanofi and Bristol-Myers Squibb. However, BMS planned ahead and leveraged CTM techniques to counter a head-to-head trial. Months prior to the announcement of the trial results, BMS conducted a systematic campaign among key US market stakeholders to highlight the significantly higher bleeding risks associated with Effient, ultimately undermining the study’s and the product’s benefits.  


• Faster: For its new PD-1 cancer agent, Keytruda, Merck & Co. streamlined its clinical trial package and transformed a first-in-human study into a registrational study in order to beat BMS’s rival Opdivo to the US melanoma market. According to Merck’s VP of early oncology clinical research, Eric Rubin, Keytruda’s rapid development required “less than four years from the first patient that we enrolled to approval.”  


• Broader and higher: Not to be outdone, BMS worked collaboratively with the FDA to obtain expedited approval for Opdivo and beat Keytruda to the larger US lung cancer market months ahead of schedule. Moreover, despite its initial submission for the third-line setting in squamous-type non-small cell lung cancer, BMS leveraged two studies to obtain labeling in both second- and third-line use, a much broader competitive opportunity, and an overall survival benefit.  


• Bolder: At the 2014 American Society of Hematology Conference, Janssen took out a full-page advertisement showing several different studies the company was planning to conduct with its investigational multiple myeloma agent daratumumab—not the ones that the company had completed. Janssen took this step to try to create the impression that its CD38-targeting monoclonal antibody could potentially be used across different patient segments and lines of therapy.  


• Newer: For its investigational submental fat treatment Kybella, Kythera Biopharmaceuticals worked extensively with the FDA to create a new patient-reported outcomes assessment tool called the “Patient-Reported Submental Fat Impact Scale.” As a result of the patient survey results, the company achieved novel product labeling that includes improvements in overall patient-reported satisfaction and self-perceived visual attributes. (Más)

(*) Stan Bernard MD, MBA is President of Bernard Associates, LLC, a leading global pharmaceutical industry competition consulting firm. He is also a member of Pharm Exec’s EAB Board. He can be reached at SBernardMD @BernardAssociatesLL C.com

KEYTRUDA / MSD lider de ventas mundial

 

Un medicamento del área oncológica encabezará el ranking de ventas farmacéuticas en cinco años. Se trata de uno de los grandes fármacos de este siglo: Keytruda, del laboratorio estadounidense MSD -conocido como Merck & Co., Inc. en Estados Unidos y Canadá-, un tratamiento contra el cáncer de pulmón no microcítico mestastásico y algunos casos de melanoma avanzado que se convertirá en la gallina de los huevos de oro de la farmacéutica.

El medicamento de inmunooncología facturará 30.000 millones de dólares en 2028, según un reciente informe publicado por la consultora Evaluate Pharme. De esta forma, el gran impulsor de las ventas de MSD, que obtuvo una facturación de 20.937 millones de dólares en 2022, frente a 17.186 millones en 2021, registrará un crecimiento anual del 16%. Será el fármaco más vendido en el mundo por un amplio margen, ya que ninguna otra terapia alcanzará los 20.000 millones de dólares, según refleja el estudio.

Desde MSD señalan que el crecimiento de las ventas globales de Keytruda refleja el «fuerte impulso continuo» de las indicaciones metastásicas, incluidos ciertos carcinomas de células renales, cáncer de mama triple negativo, cánceres con alta inestabilidad de microsatélites y carcinoma de células escamosas de cabeza y cuello.

La proyección de los diez medicamentos principales de Evaluate es una actualización de su clasificación de 2022 e incluye dos nuevos tratamientos: Mounjaro, la creciente terapia para la diabetes de Eli Lilly, que alcanza el puesto número cuatro con una estimación de 17.000 millones de dólares, y Gardasil, también de MSD, una vacuna contra el virus del papiloma humano (VPH) que entra ocupando la novena posición con unas ventas proyectadas de 12.000 millones de dólares.

Gardasil (que para 2028 llevará dos décadas en el mercado) ha generado al fabricante estadounidense 2.500 millones de dólares en ventas en el segundo trimestre de este año, superando las expectativas de los analistas, como consecuencia del reciente aumento que ha experimentado la vacuna contra el VPH en países menos desarrollados.

El segundo mayor blockbuster (superventas) será Dupixent, de la francesa Sanofi, un medicamento para tratar a adultos y adolescentes con dermatitis atópica. Dupixent facturará cerca de 20.000 millones de dólares. Ozempic, el tratamiento para la diabetes de Novo Nordisk, pasó del puesto número cinco en la proyección del año pasado al número tres, con una estimación de ventas de 12.000 millones de dólares en 2028, frente a los casi 5.000 actuales. Sin embargo, la estimación de Ozempic, al igual que en la de Mounjaro, no incluye sus formulaciones como terapia para la obesidad. Incluyendo estas terapias para tratar el sobrepeso, las proyecciones serían de unos 33.000 millones, superando a Kenytruda. Según un informe de Bloomberg Intelligence, las ventas de estos medicamentos contra la obesidad podrían alcanzar los 44.000 millones de dólares en 2030, una revolución solo vista hace 25 años con la Viagra,

GSK fortalece en cáncer...con Merck KGaA

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U.K.-based GlaxoSmithKline  and Germany-based Merck KGaA  are entering a partnership to develop and commercialize a therapy for patients with advanced non-small cell lung cancer (NSCLC) in a deal worth up to $4.23 billion, the companies announced Tuesday.

The therapy, dubbed M7824, is a bifunctional antibody designed to simultaneously target two pathways in the body that act as immune checkpoints: one that involves a protein called transforming growth factor-beta (TGF-B) and another involving a protein called programmed death ligand-1 (PD-L1). A subset of patients with advanced NSCLC produce too much TGF-B and PD-L1, which can lead to tumor cell growth.

Under the terms of the deal, Merck KGaA will receive an upfront payment of €300 million and will be eligible for potential development milestone payments of up to €500 million. Merck KGaA will also be eligible for further payments upon approval and commercial milestones of up to €2.9 billion for a potential total deal value up to €3.7 billion.

Merck KGaA wins GSK...

Both GSK and Merck KGaA will be involved in development and commercialization and all profits and costs will be shared equally, the companies said.

“M7824 brings together two different biological functions in a single molecule and we have observed encouraging clinical results in treating certain cancer patients,” said Hal Barron, GSK’s chief scientific officer and president of research and development. “I’m excited by the potential impact this first-in-class immunotherapy could have on the lives of cancer patients.”

M7824 is currently in Phase 1 studies for the treatment of solid tumors, as well as a randomized Phase 2 trial to evaluate the safety and efficacy of M7824 compared with pembrolizumab for treatment for patients with NSCLC whose tumors are producing too much PD-L1. 
Pembrolizumab is the generic name for Merck & Co. Inc.’s MRK, +0.31% blockbuster oncology drug Keytruda, which brought in an eye-opening $2.15 billion in the fourth quarter — nearly 20% of the company’s total revenue. 

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Todo sobre Keytruda en PHARMACOSERÍAS

The partnership is another step in the development of GSK’s oncology-focused pipeline. In December, the company acquired Tesaro, an oncology-focused company based in Waltham, Mass., in a $4.16 billion cash deal.

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GSK compra Tesaro por 4.500 millones para reforzarar su oferta en oncológia.

Shares of GSK were up 1.6% in London.

The deal “helps crystallize the value of an underappreciated asset by bringing on board a credible partner,” AB Bernstein analyst Wimal Kapadia wrote in a note to investors Tuesday morning. He called M7824 an “interesting drug, designed on solid science.”

“GSK clearly emerged as the ideal partner due to their strong commitment to oncology, and the complementary talent and capabilities they will bring to our alliance," said Belén Garijo, CEO of Merck KGaA’s health care segment.

Shares of GSK have gained 17% in the year to date, while shares of Merck KGaA have gained 13%.
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World’s Top Ten Cancer Drugs by 2020

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According to the World Health Organization, around 8.2 million people die from cancer every year and it comprises an estimated 13% of all deaths worldwide. It is also predicted by the WHO that there will be a 70% increase in new cases of cancer in the next two decades. Fortunately, many pharma and biotech companies are now focusing on this need. 

A 2016 statistical report from Statista (www.statista.com) has displayed the projected top 10 oncology drugs worldwide by 2020. The drugs are ranked by revenue. The list is expected to be headed by Revlimid, a cancer drug manufactured by U.S.-based company Celgene, forecasted to manufacture five of the leading six cancer drugs by 2020. Here are the top oncology medicines in detail: 

1. Revlimid (Celgene) Generic Name: Lenalidomide Projected Sales in 2020: $10,110 Million Revlimid is used to treat multiple myeloma and mantle cell lymphoma. It is used also in patients with myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality 

2. Imbruvica (AbbVie/J&J) Generic Name: Ibrutinib Projected Sales in 2020: $8,213 Million Imbruvica is indicated for chronic lymphocytic leukemia (CLL), chronic lymphocytic leukemia (CLL) with 17p deletion, Waldenström’s macroglobulinemia (WM) and mantle cell lymphoma (MCL) who have received at least one prior treatment. 

3. Avastin (Roche) Generic Name: Bevacizumab Projected Sales in 2020: $ 6,733 Million Avastin is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, platinum-resistant recurrent epithelial ovarian and fallopian tube or primary peritoneal cancer. 

4. Opdivo (BMS) Generic Name: Nivolumab Projected Sales in 2020: $ 6,201 Million Opdivo is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma, metastatic non-small cell lung cancer and advanced renal cell carcinoma. 

5. Xtandi (Medivation) Generic Name: Enzalutamide Projected Sales in 2020: $5,700 Million Xtandi is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 

6. Rituxan (Roche) Generic Name: Rituximab Projected Sales in 2020: $5,407 Million Rituxan is indicated for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Granulomatosis with Polyangiitis (GPA), (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). It was one of the world’s 10 best selling drugs last year, hauling in $7.5 billion worldwide but the patent on the drug expires in 2018. 

7. Ibrance (Pfizer) Generic Name: Palbociclib Projected Sales in 2020: $4,722 Million Ibrance is used to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other parts of the body (metastatic) 

8. Perjeta (Roche) Generic Name: Pertuzumab Projected Sales in 2020: $4,669 Million Perjeta is indicated for metastatic breast cancer. It may also be used for HER2-positive, locally advanced, inflammatory, or early stage breast cancer. 

9. Herceptin (Roche) Generic Name: Trastuzumab Projected Sales in 2020: $4,573 Million Herceptin is used in the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. It is also used in metastatic breast cancer and in gastric cancer. The patent in 2019 in the United States. 

10. Keytruda (Merck) Generic Name: Pembrolizumab Projected Sales in 2020: $3,560 Million Merck’s immunotherapy Keytruda is indicated in patients with unresectable or metastatic melanoma and metastatic non-small cell lung cancer.

(Ver)

USA: Top 20 TV ad spenders

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Pharma spending on national TV ads for 2017 climbed even higher than in 2016—by more than $330 million. The total tally was $3.45 billion, compared with $3.11 billion in 2016, according to data from real-time TV tracker iSpot.tv.

AbbVie antiinflammatory Humira led the way with $341 million spent on 16 commercials across three of its different indications: arthritis, psoriasis, and Crohn’s disease and ulcerative colitis. However, the drug fell short of topping its 2016 total of $344 million. 
Broken out by indication, AbbVie spent $179 million on arthritis, $114 million on Crohn's and colitis, and another $48 million on psoriasis Humira commercials.

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Novartis joins biosimilar Humira push in US


Another repeat for 2017 at No. 2 was Pfizer’s Lyrica, which spent more than $216 million for the year, although it also fell behind its 2016 total of $221 million. Pfizer also took third place with Xeljanz, spending $166 million and moving up from the fourth spot when it spent $139 million last year.

All of the top-10-spending drugs broke the $100 million mark for TV media spending in 2017, according to iSpot, while only nine did last year.

New to the top of the list was cancer-fighting drug Keytruda from Merck; it joined rival Opdivo from Bristol-Myers Squibb, which was No. 13 on last year’s list. Both landed in the top 20, although Keytruda’s $127 million put it at No. 6, versus Opdivo’s $82 million at No. 14.

Gone from the top 20 are former reliable TV-spending erectile dysfunction drugs Cialis from Eli Lilly and Viagra from Pfizer. Both halted TV advertising earlier this year—Viagra in May and Cialis at the end of August—facing the loss of patent exclusivity and new competition.

There were also more drug brands on TV last year. In all, 73 branded pharma drugs spent at least some money on national TV advertising, an increase from the 65 brands that spent in 2016, according to iSpot data. (Ver)

2017 Seven pharma trends

Industry uncertainty:

  

Perhaps the biggest hallmark of 2016-going-into-2017 is the sense of hesitation and uncertainty as the industry waits with bated breath in the wake of the two biggest and most indisputable game-changers, not just for pharma, but for the world: Brexit and Trump. As we sit in the eye of the storm and they loom on the horizon, many industry figures are finding it difficult to strategise accurately for the future. 

Throughout the year we asked for insight on these titanic events and what they might mean from a number of legal teams including Morgan Lewis, finnCap and BonelliErede. Be sure not to miss UK Biopharma and life after Brexit and The impact of Brexit on the pharmaceutical industry: Some preliminary considerations. 

In the new year, companies will have to tread carefully until we better understand where these new factors will take us. Look out for our focus on how president Trump could shake up the industry in the upcoming issue of Pharmafocus.

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Big Pharma: Is Trump friend or foe/amigo o enemigo?

Y el "Brexit" se hizo... (III): Brexit Will Be Bad For Pharma (Forbes)

Price hiking:

The Mylan EpiPen scandal brought the issue of price hiking back into the public eye, and all the controversy that comes with it. After it was revealed that the company had raised the price of its flagship auto-injector by 400% since 2008, an indignant industry watched as CEO Heather Bresch was called before US lawmakers to explain the decision along with her own almost-700% pay rise over the same period. To calm the controversy, the company has finally launched a generic alternative, months late and still flashing a hefty price tag.

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"Shitstorm" en torno a precios / De Martin Shkreli a Epipen...

The wider issue featured heavily during the US presidential race as Clinton and Trump clashed over ways to curb outrageous pricing, and since then, former-democrat candidate and Vermont senator Bernie Sanders has led the charge against big pharma’s unjust measures, calling out Sanofi, Lilly and Novo for allegedly colluding to raise their prices. And as Trump was named president, price control measure proposition 61 was defeated by popular vote. We delved into the pricing crisis facing the US in our feature Price hiking: US pharma’s elephant in the room. 

The problem has also been rife in the UK, as NHS suppliers were investigated over hiking the price of the drugs they provided by as much as 1000%, while Pfizer broke records by being hit with a massive £84.2 million fine for overcharging the health service by 2600%.

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UK: Multa record a PFIZER, £84.2m

This is a problem that never went away and is only now being placed under harsh scrutiny, so expect more pricing scandals to erupt in the coming year. 

Collaboration in the digital sector: 

20116 was characterised by a number of high-profile collaborations between tech and pharma giants in a bid to harness new and developing technologies to supercharge R&D, pharmacovigilance and more. In the latter half of the year, Google and its parent company Alphabet stepped into the pharma ring forming partnerships with GSK and Sanofi, while IBM forged alliances with Teva, Celgene and Quest Diagnostics. 

Even Facebook chairman and CEO Mark Zuckerberg took centre stage in the industry, launching his $3 billion Chan Zuckerberg Health Initiative alongside his wife Priscilla Chan with a remit to “cure, prevent or manage all disease within [their] children’s lifetime”. The initiative also managed to snatch up former chair of AstraZeneca’s genomics advisory panel Cornelia Bargmann as its president of science.

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Puerta giratoria...?: Zuckerberg appoints AstraZeneca’s Cornelia Bargmann

Looking forward to 2017, expect these types of deals to become the norm as the industry increasingly recognises the value and warms to the adoption of powerful new technologies.

 Bigger mergers and acquisitions:

  

2016 saw, after much deliberation, the biggest-ever acquisition by a German firm across any industry, the massive $66 billion Bayer-Monsanto deal, and ripples are still felt throughout the pharma world. Its long-term effects are still being determined, but we asked Winckworth Sherwood to analyse its potential impact and what it means for the industry, which you can find here: Looking back at the biggest deal of 2016: Bayer-Monsanto.

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BAYER se echa "al monte"...Monsanto. Will pharma suffer? Monsanto quiere más...

Acquisitions are just part of the industry’s lifeblood, but as the precedent of increasingly larger deals is set, pharma companies may be seen to dig deeper in their pockets in future when looking to seize vital portfolio-expanding assets. 

Vaccine R&D for the developing world and beyond:

In the past year, the devastation wrought by recent outbreaks of zika, ebola and dengue in developing parts of the world has seen pharma companies rushing to both calm and capitalise on the crises. 

 2016 saw the roll-out of the world’s first public immunisation programme against the dengue virus, courtesy of Sanofi. The company also announced its intention to co-author a vaccine for zika with the US government, later securing $43 million for its development. 

The wildly different nature of developing markets and the challenges they present prompted GSK to pitch a global biopreparedness unit to pre-emptively tackle outbreaks in non-lucrative areas, while a new UN declaration to help fight the rising threat of drug-resistant infection saw signatures from 193 countries. With the issue taking centre stage in global affairs while remaining a crisis issue, it will surely remain something the big players will be keeping an eye on in the coming months.

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Todo sobre vacunas en PHARMACOSERÍAS

El valor de las vacunas / Encuesta Network ANIS

Movement towards more equitable attitudes:

Another trend seen throughout the year was the shift by pharma companies to take up fairer, more consumer-friendly values through pledges to keep prices low or commit to more ethical practices.  

Allergan CEO Brent Saunders outlined the company’s new “social contract” with its consumers, with pricing, quality and safety of its products playing core roles. Novo Nordisk later pledged no higher than single-digit price increases on its products, and GSK vowed to put a stop to its previous practice of paying doctors to promote its products.

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This new attitude is increasingly becoming the expected standard with debates on the topic burning tirelessly; earlier in the year, we looked at these discussions in depth with our feature The ethical battle for the future of pharma. 

As the big players go on record with these commitments, the pressure is on for their rivals to follow suit, so expect more companies to make it clear they will be pursuing more equitable practices in 2017. 

Competition in the immuno-oncology sphere:

2016 was a big year for immuno-oncology, particularly for Bristol-Myers Squibb’s Opdivo – it dominated sales and indications, that is until the surprise failure in October of Opdivo as first-line treatment for lung cancer patients. Later that month, Keytruda was found to be more effective than chemotherapy in first-line treatment of lung cancer patients with high expression of the protein PD-L1. In the same month, Keytruda was then given approval by the FDA for use in the same indication. 

It is battle that will continue into 2017, with a fight between the lead medications expected over new indications whilst new players also come to the fore. As yet, Tecentriq has not entered into the field with as much force but positive results are boosting sales. 

On top of this, the new field is exploding with research as everyone tries to enter the game. Pfizer has also recently announced a partnership with IBM Watson Drug Discovery to try find new targets within immuno-oncology. 2017 is expected to reveal far more research and a far more competitive field. (Ver)

De todo ello hablamos ya en...PHARMACOSERÍAS