erinconsulting - would you happen to know the price of the transaction? If so, please list the price.
With regard to rucaparib, these early results strongly suggest it to be singular in its affect on ovarian cancer. What is needed are more patients and time. That would appear to be Clovis Oncology's opinion since they are not intending to apply for an NDA with the FDA until the middle of 2016.
Rociletinib and AZD9291 seem to be at comparable developmental stages. It would not surprise me if the FDA approved both products at the same time for the same indications.
From Seeking Alpha.
......... the potency of Rociletinib in treating patients without the T790M tumor (negative). An ORR of 37% was seen throughout all dosage cohorts with a median PFS of around 7.5 months, underscoring its characteristics as a best-in-class treatment of this nature. ............Trials continue to progress for this part of the broad NSCLC indication, but the data to date is extremely encouraging.
Source: Clovis ASCO 2015 Presentation
...........AstraZeneca is also testing AZD9291 in T790M-negative patients, but the drug exhibits sub-par efficacy and potency data. At ASCO 2014, the company presented an ORR of 23% with a median PFS of only 2.8 months. With such a big difference in PFS durations, Rociletinib's differentiated profile shines under the spotlight as a high-potential treatment for T790M negative patients.
hi windsor, thx for your response. i knew rocetinib was effective in T790m- pts but did not know 9291 was not effective in this population. do you have reference for this claim?
couple other questions: how far ahead in development is rociletinib as compared to AZD9291? with rucaparib clearly superior to lynparza in ovarian ca... how do you value clvs's third candidate luci
tanib? appreciate your expertise on CLVS...
Rociletinib has less adverse effects than AZD9291. While both meds have similar results in the T790M+ populations of nsclc patients, rociletinib seems to be markedly superior in the T790M- population. Bottom line is that the target population for rociletinib compared to AZD9291 will be multiples higher.
looking to add to my CLVS holding during this market downturn but would like to hear people's opinion on the competitive landscape. are folks here concerned at all about AZ's EGFR TKI targeting same patient population?
Clovis Oncology, Inc. (CLVS) announced today that it has submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.
In addition, Clovis has also submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the treatment of adult patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
“The submissions of our first NDA and MAA for rociletinib represent a major step forward for our company,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “These two submissions – completed on the same day, no less -- were made possible through the tremendous commitment and hard work of Clovis employees and our clinical collaborators at leading U.S. and international academic institutions over the last many months, and I am grateful for their tireless efforts. We are actively preparing for what we hope to be our first U.S. commercial launch, and the opportunity to address the needs of patients with T790M-positive EGFR-mutant non-small cell lung cancer. We are also actively building our commercial organization in Europe to prepare for a potential launch next year.”
When do you think this stock will start to move higher? How low short term do you think we are going?
(1) " Lynparza is currently the only FDA-approved PARP inhibitor, but when Clovis Oncology's Rucaparib is released to the public, Lynparza may see its sales suffer. "
(2) " Market expansion could allow both drugs to thrive, allowing Lynparza to reach, or even surpass, its predicted potential."
(3) "......the soon-to-be-approved Rucaparib has proven to be superior and may decrease Lynparza's value as an asset. "
(4) "Threatening that is Clovis Oncology's (NASDAQ:CLVS) Rucaparib. Rucaparib has recently finished phase 2 studies, and is scheduled to file its new drug application in 2016. It has received recognition from the FDA as a breakthrough therapy - something Lynparza failed to acquire - and for all intents and purposes, is Lynparza's superior."
(5) "The breakthrough therapy designates priority treatment and an expedited review. Another reason for Rucaparib's superiority is that phase 2 study results have shown the drug boasting a much higher response rate in patients than Lynparza. Rucaparib measured at 82% versus Lynparza's 34%."
(6) "I have no doubt it[rucparib] will be considered first in class upon its release to the public."
A more complete statement, "Flynn added shares of Clovis Oncology Inc (NASDAQ: CLVS) to Goldman Sach's "Americas Conviction List" given the assumption that Rocilentinib (Roci) will be approved for a subset of lung cancer in the first quarter 2016. In the near-term, the company is "on track" to complete its regulatory filing Monday morning.
Flynn added that he is "confident" the company can successfully move Roci into the front-line setting, where a Phase 2/3 trial is ongoing. In addition, the analyst is projecting peak sales of $2 billion in 2018 ($2.8 billion unadjusted), which assumes a probability of success in the 70 to 90 percent range."
Of note here is the expectation that the NDA for rociletinib should be completed this week. Also, with expanded studies the "subset" of patients approved for Roci should be a multiple of the current subset.
Clovis Oncology Inc. (NASDAQ: CLVS) was reiterated as Buy at Goldman Sachs, but the firm added it to the prized Conviction Buy List with a $110 price target (versus an $87.06 close).