Some Big Pharma players face uphill struggles

Roche abandons development of an experimental cholesterol drug as a late- stage trial showed it wasn’t working, FDA staff members question the benefits of an arthritis drug from Pfizer and Novo Nordisk steps up research on diabetes with an ambitious eye toward a difficult goal—a cure

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Three notable names in Big Pharma have madeannouncements this week that leave them with some uphill battles as they moveforward with various therapeutic and strategic goals: Roche, which is losing apromising pipeline drug; Pfizer, which may lose one of its own; and NovoNordisk, which will push toward a cure for a disease that has so far eluded one.
For Roche's part, the company watched its stockprice fall the most that it had in nearly six months of previous trading whenit decided to abandon development of the experimental cholesterol drug Dalcetrapibafter a late-stage trial indicated that the medication wasn't working. The Basel,Switzerland-based company said in a statement that an independent group ofexperts recommended stopping the study of dalcetrapib "due to a lack ofclinically meaningful efficacy."
The drug had been intended to boost high-densitylipoprotein (HDL) cholesterol, the so-called "good cholesterol," and the companyhad originally planned to conduct six trials that, if they had gone forward,could have led to more than 35,000 patients going on the drug.
Roche had in its pipeline nine medications withpotential sales of more than $1.1 billion each that it had planned to introduceby 2016, and Dalcetrapib was one of those nine.
Gbola Amusa, an analyst at UBS AG, had previously estimatedthat dalcetrapbib could generate $6.8 billion in annual sales by 2020 if it hadmade it through trials and gotten approval, and he had given it a roughly25-percent chance of success in doing so. The failure of the drug could have aripple effect, possibly tempting Eli Lilly & Co. and Merck & Co. toabandon their own good cholesterol approach, according to Tim Anderson, ananalyst at Sanford C. Bernstein & Co.
"Lilly may determine that the risk and costassociated with carrying out another mega-trial is simply not worth it giventhe various uncertainties," Anderson wrote of that company's HDL-boosting drug inan investor note.
A Merck spokesperson, however, has said that hercompany remained confident in its development program for anacetrapib, alsoaimed at boosting HDL.
Whereas Roche is facing an struggle to regain lostground with a failed potential blockbuster drug, New York-based Pfizer's uphillbattle may be to keep its own potential blockbuster drug in the running, afterstaff at the U.S. Food and Drug Administration (FDA) raised doubts about whetherthe benefits of the company's experimental treatment for rheumatoid arthritis, tofacitinib,outweighed its risks.
In part, the FDA notes that while tofacitinib'sclinical trials indicate so far that it relieves swelling and tenderness joints,the agency questions the method of analyzing X-rays to prove that claim.
In addition, tofacitinib has been linked to ahigher risk of patients developing cancer, and the FDA staff said the risk ofmalignancies may get worse with higher doses or extended use of the drug.
"Substantial evidence to support a salutary effectof tofacitinib for structural damage progression becomes even more important inlight of the aforementioned malignancy concerns, particularly since othertherapies for (rheumatoid arthritis) are available that may not have a similarmalignancy risk," according to FDA documents posted online May 7.
The FDA will make a final decision in August aboutthe drug.
On a more positive note, Danish drugmaker NovoNordisk's uphill trek involves a path that, for now, is wide open, as NovoNordisk steps up its diabetes research with an expansion in Seattle, Wash., andhopes to find an actual cure for type 1 diabetes rather than amelioratingsymptoms and controlling glucose as has been the approach thus far inhealthcare.
The company already employs 71 people at itsSeattle research center on inflammatory diseases, which opened in 2009, and inJune it will launch a diabetes-research effort there to be led by Dr. Matthiasvon Herrath, director of the nonprofit Center for Type 1 Diabetes Research inLa Jolla, Calif.
According to von Herrath, the diabetes center willhire between 10 and 12 researchers in the near term and could double that bynext year. This follows recent news that Novo Nordisk, which has some 4,400employees in the United States, plans to increase that number by nearly 15percent this year.
A cure for diabetes is an ambitious task, vonHerrath has acknowledged, because unlike type 2 diabetes it is not caused bylifestyle choices such as becoming obese and lacking physical activity. One aimof the new center, he has said, will be to create a "peacekeeper" vaccine forhumans that would regulate the immune response seen in type 1 diabetes, wherebythe beta cells that are supposed to produce insulin are attacked by a person'sown immune system. Such peacekeeper vaccines have worked in animals in previousresearch efforts, but that success has thus far not successfully translatedover to human tests.

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