Evaluation: Giant pharma firms do little new drug innovation

Analysis: Large pharma companies do little new drug innovation
December 10, 2019 0 Comments

Large pharmaceutical firms oppose laws being thought-about by Congress to decrease the costs of prescribed drugs. Lowering their revenues, they contend, will cut back their funding in drug growth and the invention of recent medicines, and thus result in a decline in drug innovation.

If that argument is credible, there needs to be proof to point out that the massive pharmaceutical firms are accountable for discovering revolutionary new medication.

To check that declare, we examined the provenance of the highest-selling prescription medicines of Pfizer and Johnson & Johnson, the 2 largest pharmaceutical and biotechnology firms in 2018.

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We discovered that these giant pharmaceutical firms didn’t really invent a lot of the medication they promote. Certainly, it seems they’ve already lowered their funding within the discovery of recent medicines to the purpose the place the specter of further reductions rings hole and is now not a persuasive motive for opposing laws to decrease drug costs.

Pfizer’s and J&J’s annual stories establish the medicines that account for many of every firm’s gross sales of prescribed drugs. We gathered info on the invention and early growth of those merchandise from peer-reviewed publications, media stories, and firm press releases.

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We scoured the businesses’ 2017 annual stories. A complete of 62 merchandise — 44 from Pfizer and 18 from J&J — had been listed in them. The invention and early growth work had been performed in home for simply 10 of Pfizer’s 44 merchandise (23%), as listed in Desk 1. Solely two of J&J’s 18 main merchandise (11%) had been found in home, as proven in Desk 2.

For instance, sildenafil, the phosphodiesterase inhibitor that’s the lively compound within the erectile dysfunction drug Viagra and the pulmonary hypertension drug Revatio, was synthesized at Pfizer within the Eighties, initially as a cardiovascular medication. Analysis resulting in the event of risperidone (Risperdal), one in every of a number of newer-generation atypical antipsychotic medication, started at J&J within the Eighties.

The bulk (81%) of different merchandise had been found and initially developed by third events. A few of them got here to Pfizer and J&J from the acquisition of different pharmaceutical firms. For instance, Pfizer’s highest-selling product, Prevnar 13, a vaccine for pneumococcal illness, was developed at Wyeth, which Pfizer acquired in 2009. Pfizer’s palbociclib (Ibrance), used to deal with breast most cancers, had its origins at Warner-Lambert and Onyx Prescription drugs. J&J’s rivaroxaban (Xarelto), an anticoagulant, originated at Bayer.

Analysis resulting in the invention and growth of different Pfizer and J&J medication originated in universities and educational facilities. J&J’s highest-selling product, infliximab (Remicade), is a monoclonal antibody that was synthesized by researchers at New York College in 1989 in collaboration with the biotechnology firm Centocor. The unique work displaying its efficacy in rheumatoid arthritis was led by Marc Feldmann and Ravinder Maini at Imperial School London.

Etanercept (Enbrel), tofacitinib (Xeljanz), darunavir (Prezista), and daratumumab (Darzalex) are different merchandise for which key discovery or growth steps occurred in educational settings.

The 34 Pfizer merchandise found by third events accounted for 86% of the $37.6 billion in income that its 44 main merchandise generated. The 16 J&J merchandise invented elsewhere accounted for 89% of the $31.4 billion that its 18 main merchandise generated. Clearly, the existence of Pfizer and J&J as worthwhile pharmaceutical producers depends on the acquisition of medicine invented by third events.

Our discovering that few of the top-selling medication made by Pfizer and J&J had been found in-house enhances a current Authorities Accountability Workplace report analyzing the place giant pharmaceutical firms spend most of their analysis {dollars}. It is usually in step with the newest member survey performed by PhRMA, which indicated that final 12 months solely $13 billion was spent on preclinical research — the fundamental and translational science that’s the basis for the invention of revolutionary medication.

That’s solely a fraction of the $39.2 billion taxpayers spent to assist the medical analysis performed by the Nationwide Institutes of Well being. Greater than 80% of the NIH’s funding is awarded by virtually 50,000 aggressive grants to greater than 300,000 researchers at 2,500+ universities, medical colleges, and different analysis establishments in each state and world wide. Whereas you will need to give truthful consideration to the price and danger concerned within the growth of recent medication, Pfizer and J&J had been largely shopping for medication that had already been proven to have efficacy.

The shortage of in-house innovation at Pfizer and J&J is related to present efforts within the Senate (S. 2543) to restrict annual drug worth will increase to the speed of inflation, and within the Home of Representatives (H.R. 3) to cap drug worth will increase and restrict costs primarily based on what’s charged for a similar drug in different developed nations.

Giant pharmaceutical producers have claimed that enactment of this laws could be an “innovation killer” and set off a “nuclear winter for the U.S. biopharmaceutical ecosystem.” And President Trump tweeted late final month that the Pelosi drug pricing invoice “doesn’t do the trick. FEWER cures! FEWER remedies!”

 

If our findings are consultant of the extent of innovation at different giant pharmaceutical producers, a discount in pharmaceutical revenues wouldn’t have the supposed devastating influence on the extent of biopharmaceutical innovation. Reasonably, a discount in revenues because of decrease drug costs could cut back the astronomical acquisition costs now being paid by the massive producers to amass improvements made by others.

However the biopharmaceutical ecosystem will proceed to thrive so long as those that really innovate are supplied with the sources to take action whereas those that play different roles in bringing new medication to market are pretty compensated for his or her contributions to these facets of the event course of.

As a current report from the Nationwide Academies of Medication concluded, “medication that aren’t inexpensive are of little worth and medicines that don’t exist are of no worth.” The issue of affordability won’t be solved if Congress continues to succumb to questionable assertions by lobbyists claiming that excessively excessive drug costs are important to sustaining biopharmaceutical innovation.

Passage of laws to curb ridiculously excessive medicine costs and worth will increase won’t solely make medicines extra accessible to sufferers however can even cut back authorities expenditures on medication by greater than $345 billion {dollars} over 10 years, in response to the Congressional Finances Workplace. That can allow the federal government to make better investments in NIH and produce an much more sturdy biomedical innovation ecosystem than now exists.

Emily H. Jung is a first-year medical pupil at Emory College of Medication in Atlanta and a former analysis assistant on the Program On Regulation, Therapeutics, And Legislation (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Girls’s Hospital. Alfred Engelberg, J.D., is a retired pharmaceutical mental property lawyer and philanthropist. Aaron S. Kesselheim, M.D., is a professor of drugs at Harvard Medical College and director of PORTAL. Funding for this work was offered by the Engelberg Basis, a charitable basis that focuses on well being coverage analysis. Kesselheim’s work can be supported by the Harvard-MIT Middle for Regulatory Science and Arnold Ventures.

Desk 1. Origins of drug merchandise manufactured by Pfizer in 2017*

Product 2017 Income Key origins
Pneumococcal 13-valent Conjugate Vaccine (Prevnar 13) $5.6 billion Wyeth Prescription drugs, acquired by Pfizer in 2009
Pregabalin (Lyrica) $5.1 billion Northwestern College within the Eighties; later entered right into a licensing settlement with Warner-Lambert, which was acquired by Pfizer in 2000
Palbociclib (Ibrance) $3.1 billion Warner-Lambert and Onyx Prescription drugs within the Nineties; Warner-Lambert was acquired by Pfizer in 2000
Apixaban (Eliquis) $2.5 billion DuPont Prescription drugs in 1995; acquired by Bristol-Myers Squibb in 2001; Bristol-Myers Squibb and Pfizer entered into an settlement to collectively develop apixaban in 2007
Etanercept (Enbrel) $2.5 billion Etanercept synthesized at Massachusetts Basic Hospital within the Eighties, with non-public funding from Hoechst AG; entered right into a licensing settlement with Immunex Company within the late Nineties; Immunex entered right into a co-promotion settlement with Wyeth-Ayerst Laboratories; Immunex was acquired by Amgen in 2002; Wyeth Prescription drugs was acquired by Pfizer in 2009. For the reason that expiration of the co-promotion settlement in 2013, Pfizer and Amgen have held advertising and marketing rights exterior of and within the US and Canada, respectively
Atorvastatin (Lipitor) $1.9 billion Warner-Lambert within the Eighties, acquired by Pfizer in 2000
Tofacitinib (Xeljanz) $1.3 billion Nationwide Institutes of Well being within the Nineties, which later entered right into a collaboration with Pfizer
Sildenafil (Viagra) $1.2 billion Sandwich laboratories of Pfizer (U.Okay.) within the late Eighties; Pfizer scientists initially examined sildenafil as a remedy for angina, however throughout scientific trials within the Nineties, noticed sildenafil’s potential to deal with erectile dysfunction; within the late Nineties and early 2000s, found proof demonstrating sildenafil’s potential to deal with pulmonary hypertension
Sunitinib (Sutent) $1.1 billion Sugen, a biotechnology firm based by kinase researchers at New York College and the Max Planck Institute for Biochemistry; Sugen was acquired by Pharmacia & Upjohn in 1999; which was acquired by Pfizer in 2003
Varenicline (Chantix) $997 million Pfizer within the Nineties
Conjugated estrogens (Premarin) $977 million Ayerst, McKenna & Harrison and McGill College within the Twenties; Ayerst, McKenna & Harrison was acquired by American Dwelling Merchandise in 1943, which acquired Wyeth in 1931 and adjusted the corporate title to Wyeth in 2002; Wyeth was acquired by Pfizer in 2009
Amlodipine (Norvasc) $926 million Pfizer within the Eighties
Celecoxib (Celebrex) $775 million G.D. Searle within the Nineties, the pharmaceutical division of Monsanto Firm, acquired by Pharmacia & Upjohn in 2000; Pharmacia was acquired by Pfizer in 2003
Coagulation issue IX recombinant, nonacog alfa (BeneFIX) $604 million British Expertise Group and Oxford College, which licensed Issue IX expertise to Genetics Institute, a biotechnology firm discovered by molecular biologists at Harvard College; the Genetics Institute was acquired by Wyeth in 1996; Wyeth was acquired by Pfizer in 2009
Crizotinib (Xalkori) $594 million Sugen in 1996, a biotechnology firm based by kinase researchers at New York College and the Max Planck Institute for Biochemistry; Sugen was acquired by Pharmacia & Upjohn in 1999; Pharmacia was acquired by Pfizer in 2003
Enzalutamide (Xtandi) $590 million College of California, Los Angeles, within the early 2000s, which later licensed the drug’s patent to Medivation, which entered into a world settlement with Astellas to collectively commercialize enzalutamide in 2009; Medivation was acquired by Pfizer in 2016
Antihemophilic issue recombinant, moroctocog alfa (Refacto AF/Xyntha) $551 million Dyax Company, which licensed phage show expertise to Wyeth; Wyeth was acquired by Pfizer in 2009
Somatropin (Genotropin) $532 million Genentech developed the primary recombinant model of pituitary development hormone, which had been utilized in remedy for a lot of many years primarily based on analysis at a number of educational facilities. This model originated with Pharmacia Company, which was acquired by Pfizer in 2003.
Methylprednisolone (Medrol) $483 million million Pharmacia Company, which was acquired by Pfizer in 2003.
Sulbactam/cefoperazone (Sulperazon) $471 million Pfizer within the Nineteen Seventies
Voriconazole (Vfend) $421 million Pfizer within the Eighties
Infliximab (Inflectra/Remsima) $419 million Pfizer manufactures follow-on biologics to Johnson & Johnson’s infliximab (Remicade)
Axitinib (Inlyta) $339 million Pfizer within the 2000s
Latanoprost (Xalatan/Xalacom) $335 million Columbia College within the Nineteen Seventies, which later entered right into a collaboration with Pharmacia, which was acquired by Pfizer in 2003
Dalteparin (Fragmin) $306 million Fresenius Kabi, a pharmaceutical firm, within the Nineteen Seventies, which later entered right into a collaboration with Pharmacia, which was acquired by Pfizer in 2003
Desvenlafaxine (Pristiq) $303 million Wyeth, acquired by Pfizer in 2009
Venlafaxine (Effexor) $297 million Wyeth, acquired by Pfizer in 2009
Sertraline (Zoloft) $291 million Pfizer within the Nineteen Seventies
Epinephrine (EpiPen) $290 million Epinephrine was first marketed within the early 1900s by Parke, Davis & Firm, which was acquired by Warner-Lambert in 1970; Warner-Lambert was acquired by Pfizer in 2000. The machine was invented in Nineteen Seventies at Survival Expertise, which grew to become Meridian Medical Applied sciences in 1996; Meridian was acquired by King Prescription drugs, which was later acquired by Pfizer in 2010. Pfizer manufactures the EpiPen, which Mylan markets and distributes.
Linezolid (Zyvox) $281 million DuPont within the Eighties, the place oxazolidinones had been first found; Pharmacia (previously Pharmacia & Upjohn) within the Nineties, which was acquired by Pfizer in 2003
Azithromycin (Zithromax) $270 million Pliva (now a subsidiary of Teva) within the Nineteen Seventies, a pharmaceutical firm, which later entered right into a licensing settlement with Pfizer in 1986
Dibotermin alfa (BMP-2) $261 million Genetics Institute, a biotechnology firm discovered by molecular biologists at Harvard; Genetics Institute was acquired by Wyeth in 1996, which was acquired by Pfizer in 2009
Tigecycline (Tygacil) $260 million Lederle Laboratories, the pharmaceutical division of American Cyanamid Firm, which was later acquired by American Dwelling Merchandise in 1994, which acquired Wyeth in 1931 and adjusted the corporate title to Wyeth in 2002; Wyeth was acquired by Pfizer in 2009
Fesoterodine (Toviaz) $257 million Schwarz BioSciences, a pharmaceutical firm, which later licensed fesoterodine to Pfizer in 2006
Pegvisomant (Somavert) $254 million Ohio College within the Nineties, the place molecular biologists helped discovered Sensus Drug Growth Company and used expertise from Genentech; Sensus was acquired by Pharmacia in 2001, which was acquired by Pfizer in 2003
Sildenafil (Revatio) $252 million See Viagra, above
Dexmedetomidine (Precedex) $243 million Orion Pharma within the Nineties, a pharmaceutical manufacturing firm which later licensed dexmedetomidine to Hospira, a spin-off of Abbott Laboratories; Hospira was acquired by Pfizer in 2015
Eletriptan (Relpax) $236 million Pfizer
Bosutinib (Bosulif) $233 million Wyeth, which was acquired by Pfizer in 2009
Alprazolam (Xanax) $225 million Hoffman-La Roche within the Fifties, the place the primary benzodiazepines had been found; Upjohn within the Sixties, which merged with Pharmacia Company in 1995; Pharmacia was acquired by Pfizer in 2003
Piperacillin; tazobactam (Zosyn/Tazocin) $194 million SynPhar Laboratories, a three way partnership between a scientist on the College of Alberta (Canada) and Taiho Prescription drugs; SynPhar licensed tazobactam/piperacillin to Wyeth, which was acquired by Pfizer in 2009
FSME-IMMUN/TicoVac $134 million Hyland-Immuno within the Eighties, a division of Baxter Worldwide; Pfizer acquired Baxter’s portfolio of marketed vaccines in 2014
Crisaborole (Eucrisa) $67 million Anacor, a biopharmaceutical firm based by researchers at Stanford College and Penn State College; Anacor was acquired by Pfizer in 2016
Sildenafil $56 million Pfizer manufactures a generic model of Viagra

* Origins listed for every drug primarily based on strategies described in article and don’t exclude the potential for contributions from different scientists or organizations.


Desk 2. Origins of drug merchandise manufactured by J&J in 2017
*

Product 2017 Income Key origins
Infliximab (Remicade) $6.3 billion Synthesized at New York College within the Eighties in collaboration with Centocor Ortho Biotech, which was acquired by J&J in 1999
Ustekinumab (Stelara) $4.0 billion Centocor, which licensed Medarex’s UltiMAb expertise to generate ustekinumab in 1997; Centocor was acquired by J&J in 1999
Paliperidone (Invega Sustenna/Xeplion/Trinza/Trevicta) $2.6 billion J&J
Abiraterone (Zytiga) $2.5 billion UK Institute of Most cancers Analysis within the Nineties, which later assigned rights for the event of abiraterone to British Expertise Group Worldwide, which licensed abiraterone to Ortho Biotech Oncology Analysis & Growth, a unit of Cougar Biotechnology, in 2004. Cougar was acquired by J&J in 2009
Rivaroxaban (Xarelto) $2.5 billion Bayer within the Nineties, which later entered right into a collaboration with J&J to collectively develop rivaroxaban
Ibrutinib (Imbruvica) $1.9 billion Celera Genomics in 2005, an organization based by a geneticist as a unit of biotechnology firm Applera. Pharmacyclis acquired a few of Celera’s drug discovery applications, together with ibrutinib, and entered into an settlement with J&J to collectively develop and market ibrutinib in 2011
Golimumab (Simponi/Simponi Aria) $1.8 billion Centocor, which licensed Medarex’s UltiMAb expertise to develop golimumab; Centocor was acquired by J&J in 1999
Darunavir (Prezista/Prezcobix/Rezolsta/Symtuza) $1.8 billion College of Illinois at Chicago, in collaboration with the Nationwide Institutes of Well being and Purdue College, which later licensed darunavir to Tibotec, a pharmaceutical firm based by researchers on the Rega Institute for Medical Analysis, which was acquired by J&J in 2002
Daratumumab (Darzalex) $1.2 billion Genmab, a European spinoff of U.S.-based Medarex, in collaboration with the College Hospital in Utrecht; Genmab licensed daratumumab to J&J in 2012
Bortezomib (Velcade) $1.1 billion ProScript, initially based as MyoGenics by scientists at Harvard; ProScript later collaborated with the Nationwide Most cancers Institute to additional develop the drug. ProScript merged with LeukoSite, which was acquired by Millennium Prescription drugs in 1999. Millennium was acquired by Takeda in 2008, which entered right into a co-promotion settlement in J&J in 2010
Canagliflozin (Invokana/Invokamet) $1.1 billion Mitsubishi Tanabe Pharm, which later licensed canagliflozin to J&J
Epoetin alfa (Procrit/Eprex) $972 million Amgen, which later assigned rights for non-dialysis indications within the U.S. and for all indications authorized exterior the U.S. to J&J
Risperidone (Risperdal Consta) $805 million J&J within the Eighties
Methylphenidate (Concerta) $791 million Ciba-Geigy within the Forties. ALZA Company, which developed another formulation of methylphenidate, was acquired by J&J in 2001
Rilpivirine (Edurant) $714 million Tibotec, which was acquired by J&J in 2002
Macitentan (Opsumit) $573 million Actelion in 2002, which was acquired by J&J in 2017
Bosentan (Tracleer) $403 million Hoffman-La Roche, which later licensed bosentan to Actelion, which was acquired by J&J in 2017
Selexipag (Uptravi) $263 million Nippon Shinyaku, which later entered into an settlement with Actelion to collectively develop selexipag in 2008, Actelion was acquired by J&J in 2017

* Origins listed for every drug primarily based on strategies described in article and don’t exclude the potential for contributions from different scientists or organizations.

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