Takeda's Velcade Replacement: Future Patient-Centric Blockbuster?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Last month, right before the approval of the first U.S. biosimilar, Amgen announced a victory for its myeloma drug, Kyprolis. In the Phase 3 ENDEAVOR clinical trial, injectable Kyprolis, taken in combination with low-dose dexamethasone, outperformed Takeda’s rival injectable Velcade plus dexamethasone. Multiple myeloma patients lived twice as long without their disease worsening when taking Kyprolis.

This news was welcomed by the company, which is looking for alternative paths to new revenues as biosimilar competition looms. Kyprolis, which was part of Amgen’s $10 billion acquisition of Onyx in 2013, garnered $331 million in 2014 sales — quadrupling its 2013 sales record.

However, recent news suggests Takeda isn’t backing down without a fight, and Amgen might find Kyprolis will eventually have a new powerhouse rival to beat. Takeda is currently working on a new drug known as ixazomib, which the company hopes will someday replace its $3 billion blockbuster Velcade. This drug not only could keep Takeda a key player in the oncology market, but it also could hold great significance for patients, as ixazomib is taken orally as opposed to being injected like Velcade and Kyprolis. Velcade is often prescribed as part of a cocktail involving two pills. Multiple myeloma patients can take the two pills easily but must travel to a clinic to receive the injection.

Should ixazomib be approved in the future, it would be the first orally-active proteasome inhibitor for myeloma. Interim results for ixazomib, tested in combination with Celgene’s Revlimid and dexamethasone, showed the drug extended progression-free survival in 700 relapsed patients in the Phase 3 TOURMALINE-MM1 trial — establishing its superiority over the two-drug combination of revlimid and dexamethasone. (As a side note, the three-drug combo is a hot treatment option these days for melanoma. In an interview with OncLive, Sundar Jagannath, director of the Multiple Myeloma Program at the Tisch Cancer Institute, called attention to the ASPIRE and ELOQUENT-2 trials, both of which highlighted the success of three-drug combinations compared to two-drug combos in the treatment of relapsed myeloma.)

Seeing as Velcade’s patent is up for expiration in 2017, ixazomib’s success in the recent trial could be good news for Takeda from a business perspective. One biotech analyst from Leerink Partners told the Boston Globe that the drug “could provide more revenue for Takeda in the long run” compared to Velcade.  

However, given the current work being done in the myeloma treatment space, many analysts are keeping a level head over the drug’s future market performance. According to PM Live, analysts are expecting the myeloma market to become more competitive in the future as several new drugs make their way through late-stage testing, including Bristol-Myers Squibb’s elotozumab, and Genmab/J&J’s daratumumab — both of which are delivered via infusion. Amgen is working on an oral proteasome inhibitor known as oprozomib. The likelihood oprozomib could hit the market before ixazomib is unlikely, however, seeing as a Phase 2 trial suggested the drug might cause some negative gastrointestinal side effects.

Apart from the potential business benefits Takeda could realize, I’m also excited to hear about ixazomib’s promising performance because of the impact it could have on patients should it hit the market.

Analysts’ cautious perspectives about market performance aside, Takeda believes the new drug is going to “transform the market.” Christopher Bianchi, president of Takeda’s global oncology unit, tells the Boston Globe, “When you have a simpler, potentially safer treatment than Velcade, it’s more convenient for patients. … [the pill] doesn’t require patients to visit a clinic.”

In his interview, Bianchi described cancer as a global challenge. “Our enemy is really an enemy without borders, and we have to be borderless to fight it.” Bianchi was most likely referencing the fact Takeda has locations in Japan, Europe, Brazil, Indonesia, and the U.S., and hopes to continue growing through new partnerships with academia and biotechs. However, I think his use of the term “borderless” can also refer to the company’s current efforts to develop a more patient-centric option for cancer treatment.  

Eliminating the need for a patient to visit a clinic to receive an injection removes a barrier to efficient treatment. There is no longer a separation, or border, drawn between the clinic and the patient’s own home/schedule, granting the patient more agency over his or her schedule and treatment.

Takeda’s efforts to seek the most appropriate and efficient formulation for its molecule is representative of every pharma company’s daily work. But nonetheless, I was encouraged by the company’s latest efforts that appear to be seamlessly uniting both financial business and patient interests, suggesting to me that patient centricity is steadily becoming a bigger part of pharma’s business strategy.