RE:SeaGen's Tivdak analyst view.
I am not sure how analysts based their annual revenues based on, presuming the patients stay on the drug industry hat 90k wouldn’t add up!
As per the online information:
“The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.”
“With an FDA nod in hand, Genmab and Seagen’s tisotumab vedotin-tftc is now the only approved antibody-drug conjugate (ADC) to treat adults with recurrent or metastatic cervical cancer. But the pair face an uphill battle with Merck’s heavyweight Keytruda, which is touting its own recent trial win in the front-line setting.
Federal regulators on Monday awarded tisotumab vedotin, now to be sold as Tivdak, an accelerated approval for patients whose disease progresses while on or after chemotherapy.
The companies will set Tivdak's list price at $5,885 per 40mg single-dose vial, which will vary depending on a patient's weight and treatment duration, a Seagen spokesperson said. That should equal out to $34,000 on average for a month's worth of treatment in the U.S. before discounts and rebates are applied, the spokesperson added.”
Seagen, Genmab gun for Merck's Keytruda in cervical cancer with accelerated FDA nod for ADC therapy Tivdak | FiercePharma
Wino115 wrote: Looks like pricing is lower than earlier post says ($70-90k net/year) not $400,000. Keytruda moving down to 1L in cervical, if effective, may reduce the patient pop for 2L some, or at least delay it longer.
Roughly a $500-350mil annual revenue stream and it added 6% to SeaGen market cap today (or $1.7bil ) and roughly 4% to Genmab (their partner, or $1.5bil). I don't know the ownership split, but that's $3bil between the two of them for a $500-350mil annual revenue oncology drug. Seems rich to me, but you could say some of today's move is bounceback from yesterday.
Key takeaways: SGEN announced accelerated approval of Tivdak (tisotumab vedotin), with a label for 2L+ recurrent or metastatic cervical cancer (r/mCC). The approval was largely expected, although the black box warning for ocular toxicities and requirement of eye monitoring was slightly surprising, given the relatively low Gr3+ event rate (4%, vs 45% keratopathy for Blenrep). Additional color from the call included: 1) Tivdak's WAC price was expected to be $90-120K per yr or $70-90K net price (vs. our prior estimate $90k); 2) supporting measures would be implemented to facilitate eye exams required for each dose; 3) Keytruda potentially moving to 1L may change the future development plan.
FDA label included 2L+ r/mCC; black box warning on ocular toxicity. According to mgmt, risk of loss of vision was well characterized and proved to be manageable in the clinical trials with proper prophylaxis. Based on the label, pts were required to have eye examined prior to each dose and take multiple premedication. Although the exact workflow in practice remained unclear, SGEN's commercial team would implement supporting measures to facilitate coordination between the oncologists and the ophthalmologists and mitigate the potential impact on adoption.
Additional color on launch preparation and shifting competitive landscape. Launch preparation had been ongoing for several months, promoting physician awareness and driving payer engagement. With an attractive value proposition in the 2L+ setting, mgmt expected easy reimbursement. Tivdak commercial products were ready for shipment in the next day. While Tivadak currently competed with Keytruda in the 2L setting, the situation may change substantially with Keytruda likely moving to 1L based on recent data from KEYNOTE-826 (See ESMO 2021 Takeaways – Weekend, 09/21/2021).