"This is longer than what Raj has been saying." Summary slide in Jefferies presentation says "SPI-2012 potential NDA filing in 2018". Therefore, topline data in 1H18 sounds reasonable.
Jun 9, 2016
According to The Fly, in a report released yesterday, Chris Howerton from Jefferies reiterated a Hold rating on Spectrum Pharmaceuticals.
Howerton wrote, “Our takeways from presentation and breakout session: 1.) ‘2012 appears to be on-track with mgmt focused on the execution of the ongoing pivotal ph 3 trial. (topline data exp 1H18). 2.) ‘Pozi’ is on-track w/ pot’l ph 2 data from partner by YE16. 3.) FDA has asked for a meeting ~1mth before apazi PDUFA (Dec 11) 4.) Marqibo sales volatility are due to small pt population (~1600) Pipeline Update: SPI-2012: All attention is on ‘2012 in breast cancer (exp topline data 1H18), for which we model as a pot’l (prob adjst) $200M sales opportunity. Mgmt appears thoughtful regarding the study design and execution of ‘2012 by offering in- home blood collection. Recall, ‘2012 requires patients to give blood frequently during the study, therefore mgmt believes by choosing 84 sites and offering convenience, enrollment will be fulfilled quickly & efficiently. Apaziquone: Mgmt reiterated their PDUFA date (Dec-11-2016) set by the FDA for apaziquone (Qapzola) in non-muscle invasive bladder cancer. Interestingly, mgmt added that the FDA has asked for a meeting ~1mth before the set date. While we do not currently value apazi in bladder cancer, we recognize that there is a large unmet clinical need and the FDA is eager for an efficacious product to be available. Poziotinib (‘pozi’): During the presentation, pozi was compared to neratinib, a competing pan-HER 2 inhibitor, comparisons included the ORR b/t the two (60% ORR, n=10 in pozi vs 24% ORR n=63 in neratinib).”
I don't like his statement that they were able to achieve Neulasta effect with 1/2 or 1/3 dose of SPI-2012. Simply not true. Why did he spend a lot of time speaking about Marqibo in the end of presentation as if it was a very important drug for the company? Why not to talk about Beleodaq or Folotyn which is a major source of revenue for the company? Why Evomela market shrunk to $80-100M from $100M and $100-120M?
"If CIs overlap, that means no statistical significance." When 95% confidence intervals for the means of two independent populations don’t overlap, there will indeed be a statistically significant difference between the means (at the 0.05 level of significance). However, the opposite is not necessarily true. CI’s may overlap, yet there may be a statistically significant difference between the means.
No, I think it is initiation of a new Phase 3 study. Also it could be an expectation of positive updated OS data from NEMO study which will be featured during an oral presentation today at 1:15 p.m. CT.
Oncothyreon Presents Phase 1b Results of ONT-380 in Combination with T-DM1 in HER2+ Metastatic Breast Cancer at ASCO
Encouraging results in ONT-380 combination therapy in patients with and without brain metastases
•Median progression-free survival (PFS) was 8.2 months.
•In 34 patients with measurable disease evaluable per RECIST 1.1, an overall response rate of 47% was achieved. Best responses in patients were:
•One patient with a complete response and 15 patients with partial responses.
•14 (41%) with stable disease, and four patients (12%) with progressive disease.
•Many of the patients with brain metastases in the study had long-term control of both brain metastases and systemic disease.
•Progression-free survival in the 30 patients with brain metastases was similar to patients without brain metastases.
•There were no patients without brain metastases at baseline who developed new clinically apparent brain metastases while on the study.
Array BioPharma (ARRY), Pierre Fabre and Merck KGaA, Darmstadt, Germany, today jointly initiated the BEACON CRC (Binimetinib, Encorafenib And Cetuximab Combined to treat BRAF-mutant Colorectal Cancer) trial, a randomized, global Phase 3 clinical trial designed to assess the safety and efficacy of binimetinib (MEK inhibitor), encorafenib (BRAF inhibitor) and Erbitux (monoclonal antibody) in comparison to Erbitux and irinotecan-based therapy in patients with BRAF-mutant colorectal cancer (BRAFm CRC).
SELECT-1 is K-Ras mutant NSCLC trial. ASTRA is thyroid cancer trial. Primary completion date for SELECT-1 is May 2016. Expect results in June or July.
Look at slide 6 "Compensation Program Evolution in 2016"
One third of company performance will be evaluated based on relative total stockholder return. Is it something new?
On May 27, 2016, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc. ("Spectrum"), Allos Therapeutics Inc. (the "Company"), and Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, "Dr. Reddy's"), entered into a settlement agreement to resolve their patent litigation relating to Folotyn (pralatrexate injection). As a result of the settlement, Dr. Reddy's will be permitted to market a generic version of Folotyn in the United States on December 1, 2022 or earlier under certain circumstances.
The Company's litigation against other generic filers continues.
"The FDA is also currently reviewing Vanda's application for three years marketing exclusivity based upon the REPRIEVE study submission and subsequent PI changes and expansion now approved in the sNDA."
Most important part of announcement.
Spectrum Pharmaceuticals' wholly owned subsidiary Allos Therapeutics settles its patent litigation with Teva Pharmaceuticals USA related to lymphoma drug Folotyn (pralatrexate injection). The settlement allows Teva to market a generic version of Folotyn in the U.S. on December 1, 2022 or earlier under certain circumstances.
Allos' litigation with other would-be generic competitors continues.
I think Spectrum is also not interested in starting new trials with Folotyn. Composition of matter patent covering Folotyn is due to expire in 2022. Before that, they need to win a case against Folotyn ANDA in a trial which starts on September 12, 2016.
Celgene is not running active studies with Istodax as a lead sponsor. The reason for that, I think, is a patent expiration in 2021. One phase 3 trial with Istodax, Ro-CHOP in PTCL, is run by The Lymphoma Academic Research Organisation. They have a primary completion date as of July 2019.