Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Stream of consciousness thoughts on 2017 Q1 CC as I read through the transcript.

Surprised by the low revenue #s for Folotyn (9.3M) and Evomela (6.3M). As mentioned recently, during 1st Q 2016 Folotyn was selling 15.2M. With regards to Evomela, if last Qtr they had 35% penetration why weren’t they able to increase that penetration in this Qtr? Are the other 65% of market happy w generic melphalan? Weren’t there any other big hospitals of the remaining 65% that would want to store supplies. Etc?

Interesting that Analysts didn’t ask for more color on the drop in sales especially Evomela. That leads me to believe that Raj and Co are slowly succeeding in getting the street to view that their company’s value is based on the commercial potential of their future drugs.

That was exciting news about the 65 yr old non-smoker female patient with the stage IV adenocarcinoma of lung, consisting of the exon 20 insertion mutation living 5.5 months w stable disease. I realize it's only one patient but very exciting nevertheless and bodes well for the the trial they are running right now.

Regarding the Rolontis trial going from 580 to 400 is promising on several fronts. It always seemed like overkill to me to have 580 pts to test for what essentially is a basic laboratory blood parameter, ANC. This is confirmed in a way by the looking at the # of pts for the EU trial, 218. This is telling me you only need 218 pts to get SS for the trial. And more importantly, what this is telling me is that the FDA is comfortable w the safety profile of Rolontis since they are not expecting any AEs or immunogenicity issues with it and the power to detect such a problem is not helped by having 580 pts. Very big in a way, besides making the trial go quicker it removes an elephant in the room.

Also regarding the Rolontis trial, it was good to get some color on recruitment where he mentioned recruiting 135 pts between Jan and April 30th and approximately 75% of patients have been enrolled in this study. Doing the math, recruitment should be completed in around 3-4 months.

After 2016 SABCS, I noted that for the US metastatic BC trial, poziotinib was essentially being giving double the dose of its Korean counterpart. That was a revelation to me since the protocol did not go into detail on dosing. It appears they revised the protocol after they started the US trial. Couple that with not hearing any news on the Korean study which finished dosing in Feb 2016, and I don’t think you’ll hear anything too positive regarding the Korean study when they eventually do release info. News release will probably coincide w hearing something positive on the EGFR exon 20 mutation trial.

Interesting they are looking to do a combination study with TDM-1 in second line targeted to begin later this year. So this means interest from a big pharma company regarding poziotinib I think.

Regarding QAPZOLA, several things. Although they say they’ll start the trial later this year, there is no harm in delaying it even more if you assume as I do they don’t have strong patent protection after 2021-22. Whenever, they get a NDA for the drug, they’ll have 5 yrs of market protection even if the patent has expired. I always thought after previous results came out that Qapzola is a good drug that was in a bad trial. The info they got from the previous trials, has enabled them to have the confidence to reduce the # of pts by ~72% and to add intermediate-risk patients, in addition to low risk pts, to boot.

Just thinking what a game changer Poziotinib is when interim data comes out on the EGFR exon 20 mutation trial. Raj gives an example Xalkori selling ~500M per year with less pts than those that EGFR exon 20 mutations. And in post 1639 I gave the example of Tagrsso

Seeing Poziotinib’s sales potential through Tagrisso’s eyes. Tagrisso (osimertinib) from AstraZeneca is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations. It was just approved in the US for patients with metastatic epidermal growth factor receptor (EGFR); it’s approved in China and the EU too. T790M mutation-positive non-small cell lung cancer (NSCLC) occurs in 10-15% of NSCLC patients. This is info I got from AZs March 31st PR. And according to Thomson Reuters, consensus forecasts is for $2.5 billion by 2022.

Now, let’s look at Poziotinib that started dosing patients in a P2 trial this month as per the recent PR. It is being tested in patients with EGFR exon 20 insertion mutations. Their PR from Nov indicated that 10% of NSCLC patients may have this condition...

So crossing my fingers but starting to get really excited about poziotinib for EGFR exon 20 mutations.

Here's a Shout out to Ed White asking about the Marqibo P3 trial in sGermany in NHL. Haven’t heard about this trial in a long time. It seems it's still in Spectrum’s radar.

And a heckle to Laura Engle. She didn’t do her homework asking about the Qapzola trial.