J&J claims higher R&D productivity than peers

Dive Brief:

  • At its biennial Pharmaceutical Business Review Meeting, Johnson & Johnson announced that its pharma arm, Janssen Pharmaceutical, expected to submit or launch around 14 new drugs between now and 2021, with more than 10 having potential blockbuster status.
  • Also planned are over 50 line-extension filings. The company has received approval for 11 new molecular entities from the Food and Drug Administration since 2011. 
  • Janssen expects to add a sixth therapeutic area, pulmonary arterial hypertension, as it closes its acquisition of Actelion this year. It currently focuses on immunology, infectious Diseases & vaccines, neuroscience, cardiovascular & metabolism, and oncology.

Dive Insight:

Johnson & Johnson expects the 12 blockbusters in the current portfolio, with growth of these predicted as by volume rather than price, and the innovation in its current pipeline to rocket growth over the next two years.

In 2016, the company invested $7 billion into R&D, 55% more than was spent on sales and marketing. While the  anticipated acquisition of Actelion, which will add in marketed and late-stage pipeline products in pulmonary arterial hypertension, to be another major growth driver. 

"We have made more submissions to the FDA since 2011 than any other pharma company," said William N. Hait, global head of R&D. "Since 2010, our Phase 1 to Phase 3 median cycle time has fallen. We can now move drugs through the cycle 1.5 years faster than our competitors. Our success rate has tripled whereas that of others has doubled; we can now expect to start development of seven pre-clinical assets per successful launch, compared with 16 for other pharma companies," said Hait.

Janssen's immunology franchise currently has three blockbuster products – Remicade (infliximab), Simponi (golimumab) and Stelara (ustekinumab), but Remicade is facing biosimilar competition and so its sales are in decline. As Joaquin Duato, worldwide chair of pharmaceuticals, explained, this franchise will be boosted by the addition of guselkumab for psoriasis and sirukumab for rheumatoid arthritis, both of which are expected to be approved in 2017.

"We expect five products to be the cornerstone of our portfolio in the next five years, bringing in more than $4 billion by 2021," said Duato. "These are Darzalex (daratumumab) for multiple myeloma, the oral anticoagulant Xarelto (rivaroxaban), Invega Sustenna/Xeplion (paliperidone palmitate), Imbruvica (ibrutinib) in chronic lymphocytic leukemia and Stelara."

The company isn't just focusing on diversification across products, but geographies, as well. China is rapidly becoming one of the most important markets globally. Johnson and Johnson has R&D operations in Shanghai and Beijing.

"We are working to develop drugs for diseases that are unique to people in China. As an example, lung cancer is a massive problem in China, and a focus for the Chinese R&D group," said Hait.

While the management team on the call would not confirm the Chinese R&D budget, they confirmed that money in the global budget could be allocated to work in China.

It's not necessarily going to go all J&J's way over the next few years, however, despite the very upbeat tone of the call, as Duato said: "There are some headwinds putting pressure on pricing. The company has also hit a snag with its type 2 diabetes drug Involana/Invokamet (canagliflozin), and yesterday, the FDA issued a warning about an increased risk of leg and foot amputations.

"We have seen this in patients that are at high risk of cardiovascular events, or who have had prior amputations. The incidence is low and we have to put this in context," said Hait.

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Filed Under: Clinical Trials Corporate News