We will hear about their plans for Apaz NDA, SPI-2012 and, possibly, Poziotinib, as always. We will not hear about Marqibo in ALL, Apaz multiple instillation trials, SPI-1620, Renazorb and Ozarelix, as always. Unless somebody asks a question. Remember, it's all about the future. Past is just an annoying distraction.
It 1stQ, recurrent revenue was 0.761M euro. 1,219,000 - 761,000 = 458,000. It is their revenue for 2ndQ. Assuming 15% royalty and no significant contribution from Sitavig, Beleodaq sales are around 3M euro or $3.3M in 2ndQ.
Not a good news for Spectrum. Searching Hanmi's pipeline after the deal with Spectrum, I noticed the compound HM61713 there and wondered why Spectrum did not buy that one. My only explanation was that it was too expensive. Look at the deal with Boehringer. Hanmi received $50m and is entitled to potential milestone payments of $680m plus tiered double-digit royalties. How much Spectrum paid for poziotinib, nobody knows. I think it was much lower. And it was for a good reason. It turned out that in NSLCL, HM61713 demonstrated "95.2% disease control rate (DCR) in 59 patients (of 62) with T790M positive mutation in who developed resistance to previous EGFR TKI" (ASCO 2015). In this same indication, poziotinib did not work. Now we have another competitor (out of how many?) with much stronger profile.
My understanding is that drugs injected subcutaneously end up in bloodstream. Insulin is an example. You can deliver it topically, but how you provide hypoxic environment?
Problem is how are you going to administer Apaz for oral cancer therapy?
I don’t like an idea of buyout. I would prefer ARRY to stand alone and find a good European partner which will fund more phase 3 trials with binimetinib and encorafenub. I expect that in 3-5 years ARRY’s market cap will be in $3B to $5B range with good prospects for further growth in next 10 years.
for scientific reasons.
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma, NCT01801358. Quick reaction from Novartis.
Reread the paper and found under the Discussion "The major limitation of this study is the low patient number, resulting from early closure of the study because of low accrual."
Selumetinib in thyroid cancer is a small potential revenue source. Projected worldwide peak sales is about $100M, meaning ~$10M in royalty payment to ARRY. Same for uveal melanoma. Therefore, today's phase 3 failure was not a critical event for the company.
Temozolomide and dacarbazine have the same active metabolite. Dacarbazine does not require liver metabolism for activation. Clinically, dacarbazine is the only chemotherapy approved for use in the treatment
of melanoma and is the most commonly prescribed chemotherapy for both metastatic cutaneous and uveal melanoma.
EXEL has one drug on the market, Cometriq. Another drug, Cobimetinib, is under review by FDA for potential approval in November 2015.
The eye opener is a phase 3 study, SPINOZA, NCT00491491, run by Sheba Medical Center. The results are described in the article published in Cancer 2012;118:4706-14. They analyzed only 43 of 158 patients that should have been recruited in the study. It was completed in February 2015. It would be interesting to see the results obtained from 158 patients.
published in Exp Hematol Oncol. 2015 Jul 4;4:18.
Interesting, Z-BEAM and Z-BeEAM are two different regiments. The rationale to test Z-BeEAM is that availability of carmustine, a component of BEAM, became difficult. In Z-BeEAM, carmustine is replaced by bendamustine. Z stands for Zevalin.
"We met with the FDA. Based on our discussions with the FDA, we're starting another study, a Phase III study. That study is with the FDA right now. We'll shortly hear back from them. And in addition to that, we intend to file the new drug application. So that's where we are with apaziquone."
Two years passed. Why it is so difficult to start a study?
XOMA is going to partner XmetA and XmetS. Could be a substantial upfront payment.