by Thomas Meek

LONDON, Aug 9 (APM) - Kite Pharma will be ready to launch its CAR-T therapy axicabtagene ciloleucel in the U.S. in September, the company’s chief commercial officer has said.

Speaking in a conference call on Tuesday to discuss the company’s second quarter financial results, Shawn Tomasello told investors the product is “fast approaching” potential approval in the U.S., having been accepted in May this year for priority review by the Food and Drug Administration (FDA) for use in patients with non-Hodgkin lymphoma (APMMA 53260).

“We will be launch-ready by September, to ensure that we're prepared for an approval at any time. Our commercial headquarters and field-based teams are fully staffed, trained and ready for launch," said Tomasello in a transcript of the call available on Seeking Alpha.

Tomasello emphasised that building awareness of this new type of immunotherapy - which involves removing and enhancing a patient's own T cells to attack foreign cancer cells - will be key to a good start for the company in the U.S.

“We know from research that those healthcare providers who are aware of CAR-T therapy are more likely to refer or prescribe CAR-T therapy. Speed, service, reliability and ease-of-use will drive success.”

Launch plans in the U.S.

Tomasello went into more details of the company’s launch plans in the Q&A section, saying that at launch the company will have at least 10 hospitals ready to provide the treatment.

With these, there will be some overlap with other companies, such as Novartis and Juno, which are also competing among potential early entrants onto market with a CAR-T therapy.

“What we've found early on and engaging with key opinion leaders is what they're focused on is making sure that their patients get a transformational therapy like this. And so we will be launching with sites that have experience with other CAR-Ts.”

About three months after launch, Tomasello said he expects to have 20 hospital sites ready to provide treatment, representing 43% of the eligible patient population the company is targeting with axicabtagene ciloleucel. After six months, the intention is to have 40 sites up and running covering 66% of the eligible population, and then by 20 months to have enough sites to cover about 90% of the patient populaton.

“So we have been preparing for launch for 18 months at least and we feel pretty confident that we'll be ready to make the therapy available to the patients upon approval.”

Getting ready in Europe

Kite’s executives also discussed launch plans in Europe, where in July it became the first company to file a CAR-T therapy when it submitted axicabtagene ciloleucel to the European Medicines Agency (EMA) for review as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant (APMMA 54134).

The company’s chief medical officer David Chang said Kite’s commercial plans in the region will be supported by the initiation this month of a clinical programme for the drug in Europe.

“We believe this growing, firsthand experience with axicabtagene ciloleucel in key European lymphoma and transplant institutions will be critical for the future of axicabtagene ciloleucel in this market.”

Tomasello added that “many of the critical components needed to unlock the value of axicabtagene ciloleucel in Europe are in place”, including new hires such as a general manager in Germany.

“We're fully engaged with healthcare authorities and opinion leaders in the EU and are executing early marketing preparation and commercialisation activities. Our clinical teams are working closely with EU investigators to ensure they understand Kite's CAR-T technology as well as adverse event medical management.”

Pricing in Europe

A key issue for the company in Europe will be getting the pricing right in order for the product to pass through the market access processes of individual countries.

Tomasello said Kite’s initial wave of pricing research in the region came back “incredibly encouraging” and hinted its strategy will differ from the U.S. plan.

“We're planning on a business model that builds in a range of differential. And we'll know more as we fully engage with the healthcare authorities in the reimbursement discussions after we receive approval.”

tm/clg