Laboratories - the forgotten stakeholder
"Pathologists and laboratories are often overlooked as key stakeholders by pharma and this factor can have a considerable impact on the uptake of targ...
In garnering rights to GlaxoSmithKline’s portfolio of oncology drugs, Novartis has access to several newly-launched personalized cancer drugs that the company hopes to drive towards blockbuster status, in the company of its own star names Gleevec and Tasigna. Peter Keeling of Diaceutics asks if the move, reinforced by a track record in actively supporting diagnostic testing standards and establishing internal diagnostic capabilities, could give Novartis a leadership role in personalized medicine similar to that held by Roche.
With this deal, Novartis is hoping to add a few more profitable precision medicine products to its cancer drug portfolio, which already includes the personalized medicine blockbusters Gleevec (imatinib) and Tasigna (nilotinib). During a recent call with investors, David Epstein, head of Novartis’s pharmaceuticals division, specifically highlighted three of GSK’s cancer drugs—the MEK inhibitor Mekinist (trametinib), the BRAF inhibitor Tafinlar (dabrafenib) and a TK inhibitor Votrient (pazopanib)—as having annual revenue potential of more than $1 billion.
The deal around GSK’s oncology products comes as Gleevec, Novartis’s best selling product, is slated to lose patent protection in 2015. In anticipation of this, Novartis has focused on growing adoption of Tasigna, hoping it will eventually take the place of Gleevec in the leukemia market.
Last year, Gleevec had revenues of $4.7 billion and Tasigna brought in more than $1 billion. As part of its broader strategy to grow sales of these two leukemia drugs, Novartis has invested in standardizing BCR-ABL testing across labs in Europe. For example, Asuragen and Novartis inked an exclusive agreement in 2010 to develop calibrators and laboratory software reporting tools. Even earlier, starting in 2007, Novartis and the European LeukemiaNet launched the European Treatment Outcome Study (EUTOS) aimed at improving the understanding and treatment of CML through the establishment of a patient registry and molecular monitoring standards, among other things.
“Novartis has taken a very hands-on approach with the support of diagnostic standards to support … the Gleevec/Tasigna franchise with continuous and public [backing] for quality schemes in laboratories like EUTOS,” Peter Keeling, CEO of the personalized medicine-focused consulting firm Diaceutics, told PGx Reporter over email. Keeling suggested that Novartis is poising itself to take a leadership role in personalized medicine, similar to Roche, by establishing internal diagnostic capabilities through its acquisition of Genoptix and Vivacta.
“These initiatives illustrate to us that Novartis understands both the dependencies between quality testing and accurate prescribing and the value of partnering with laboratories (versus just diagnostic suppliers) in the development of the personalized medicine space,” he said. “Novartis and Roche have invested in learning the commercial relationship between test and treatment … and move ever closer than their peers towards leveraging personalized medicine to transform patient pathways. In this regard we [at Diaceutics] would agree [with Novartis’s Epstein] that GSK’s personalized medicine oncology assets will be placed under a brighter spotlight by the Novartis team.”
Novartis believes there are additional market opportunities for Tafinlar, Mekinist and Votrient, in combination with various agents, in different tumor indications and in earlier stages of disease. Epstein projected that the market growth for the three agents will start to reach peak sales after 2018. GSK, meanwhile, has also invested in personalized medicine but in a slower and more reactive fashion, according to Keeling. For example, he pointed out that GSK could have invested in companion diagnostics and biomarkers research to elucidate the mechanistic differences between its HER2 breast cancer drug Tykerb (lapatinib) from Roche/Genentech’s market leading agent Herceptin (trastuzumab).
In 2013, worldwide sales for Herceptin, indicated for HER2-positive gastric cancer as well as adjuvant and metastatic breast cancer, were CHF 6.1 billion ($6.9 billion). Comparatively, Tykerb, indicated for advance HER2-positive, previously treated breast cancer patients, brought in £207 million ($348 million) last year. GSK decided not to advance the drug in gastric or head and neck cancer after studies in these indications failed to meet their primary endpoints.
“We have never been certain if GSK ever really liked the dependencies with diagnostics implicit in personalized medicine,” he said. “GSK decided to abdicate responsibility for development of the HER2 testing franchise to Roche/Genentech and focus on promoting what they knew best, namely their own therapy.” Roche, in contrast, snatched up the leadership position in this space, developing and marketing multiple companion tests and making HER2 testing synonymous with Herceptin, and now follow-on HER2-targeted agents Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).
“Tykerb never got into the race,” Keeling reflected.
GSK had a chance to apply the lessons from Tykerb when last year it launched Mekinist and Tafinlar, two melanoma drugs that will compete with Roche’s BRAF-inhibiting melanoma drug Zelboraf (vemurafenib). And the company seemed to be moving in this direction by partnering with BioMérieux to develop and launch a companion test for Mekinist and Tafinlar. But history repeated itself, according to Keeling, and again GSK didn’t do enough to differentiate its drugs from Zelboraf.
The US Food and Drug Administration first approved Mekinist and Tafinlar alongside the companion test last year as single agents to treat unresectable, metastatic melanoma patients with certain genetic mutations in the BRAF gene. Then, earlier this year , the agency approved the combination of Tafinlar and Mekinist for the same subset of patients. “Of course, new therapies in melanoma are welcome given the paucity of good treatment choices,” Keeling observed. He noted, however, that although GSK advanced a companion test for its drugs, the company didn’t invest in establishing a lab network, for example, that would have helped drive adoption of the FDA-okayed test kit and that drug.
“The concept of truly commercially leveraging the diagnostic and laboratory landscape for GSK’s oncology portfolio is not something we have seen GSK do to date,” Keeling said. “Their exit from oncology and the recent failure of their Mage-A3 [drug] is, in our view, as much an exit from personalized medicine as anything else.”
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