Tenapanor from $ARDX.

PTLA: Andexanet alfa commercial prospects

Dew, what are your specific concerns about the commercial viability of andexanet alfa? Are you skeptical about whether there is truly an unmet need for an antidote, or are you anticipating that PTLA's collaborators are developing their own antidotes?

From what I see, TGTX currently have a single-arm trial for ublituximab + ibrutinib. Has TGTX already put forward their development plan for ublituximab assuming that this Phase 1/2 trial is successful or are you just speculating?

I think it's quite premature to make assumptions about the combo when we haven't yet seen the results for this trial, let alone a randomized, head-to-head trial comparing the regimen to Rituxan + ibrutinib.

A few days ago, @andybiotech tweeted this little tidbit about the recent IRAK-4 license agreement with LGND from the 8-K:

https://twitter.com/AndyBiotech/statuses/482655058170224640

Ah, I didn't realize Genentech are co-developing ABT199. Makes sense now why they haven't started any combo trials with ibrutinib....but I don't think this prevents them from doing so in the future, especially if the TGTX combo has stellar results.

What's stopping Roche (or Janssen/PCYC) from doing a combination trial of Gazyva + ibrutinib?

Thanks for the tip. Just took a quick look at their pipeline - not sure I would invest in MGNX for margetuximab (very crowded space even if it works), but the DART candidates look interesting.

MITI was one that I unfortunately never pulled the trigger on. I remember having it on my watchlist - at the time, their technology seemed pretty unique and it would have been a platform play for me. I'm sure it was the same for AMGN. Even if blinatumomab itself isn't commercially successful, I agree that additional BiTE candidates could more than justify AMGN's purchase price.

Do you know of any other companies that are developing bispecific antibodies that engage the immune system in a similar fashion?

If that abysmal PR had come from ARRY, it would've prompted me to sell all my shares.

I don't see it as much of an issue for trial enrollment for other MEK inhibitors - there are plenty of incentives for patients and physicians to participate in clinical trials.

The biomarker trials are a long shot. They are exploratory in nature and will probably require larger confirmatory trials anyway.

I just have my fingers crossed that tivozanib shows some promising activity in CRC or breast cancer, otherwise AVEO is toast. The rest of the pipeline doesn't really excite me.

The second line market for RCC is too crowded. From an investment perspective, it's not worth pursuing, IMO. I don't think Astellas would be interested in this indication either.

Using Nexavar as a comparator for 2nd line trial would be an outdated approach. Afinitor would be more appropriate (and from a clinical point of view, it would answer the question of whether patients would benefit more from continued antiangiogenic therapy or an mTOR inhibitor after failing 1st line antiangiogenic therapy).

AVEO - Another offering is almost certain to happen, IMO. They don't have much of a pipeline apart from tivozanib, so they are going to have to invest in more trials.

The biomarker studies are interesting, but they are far from conclusive. I certainly wouldn't want to see them enriching a phase III trial based on these studies just yet.

At this point, a head-to-head efficacy trial against Votrient seems like the best option if they are still interested in pursuing approval for mRCC. But given the expense for a relatively small and highly competitive market, it may make more sense targeting a larger market like breast cancer or colorectal cancer. The risk for these cancers would be higher, given that other oral antiangiogenics have all failed, but the payoff would be bigger.

It would be a real shame if this is the end of the road for tivozanib. There are many oral antiangiogenic agents out there, but not very many highly selective ones.

IMO, a head-to-head efficacy trial vs. Sutent or Votrient would have been necessary anyway. I believe management has said as much in the past. This seems like the logical next step if they want to keep the drug alive.

Another possibility is that they forget about RCC entirely and focus instead on breast cancer or colorectal cancer.

Thanks, mcbio. I have a little bit of catching up to do on ARRY. This is definitely encouraging news.

Something that I found interesting in the main presentation was that INCY seem to be pushing ahead quite eagerly with trials of Jakafi in solid tumors. In addition to the ongoing trial in 2nd line pancreatic cancer, Jim Daly mentioned that they are also planning a trial in first line pancreatic cancer as well as NSCLC.

Table S6 in the SA is pretty interesting. Changes in most food groups were minimal - most weren't significantly different compared to the control group. On the other hand, olive oil consumption increased in both "Mediterranean diet" groups.

Of course, it's not sufficient to conclude that olive oil is behind the improvement in CV outcomes. However, it'll definitely raise some interest. Is olive oil the new fish oil?

Teva, Gilead settle US patent dispute over generic version of Viread

That's not bad, considering that approval for listing on public formularies in the major EU countries is probably still pending.

US sales of Zytiga decreased from $136m in Q3 to $114m in Q4. Overall sales were flat (~265m). In the Q&A, JNJ attributed this primarily to their patient assistance program, and said that Zytiga scripts are still growing. However, the remarks were not specific to any region.

Astellas will report earnings on Feb 4th, so it will be interesting to see how Xtandi is doing.

It appears to be a single-arm trial with 32 patients, so I'm not sure if we'll be able to really see how effective selumetinib is in this tumor type, unless they observed a very high response rate.
http://www.clinicaltrials.gov/ct2/show/NCT01116271?term=selumetinib+KRAS+colorectal&rank=1

Irinotecan as a single agent would have a fairly low response rate. One study showed a 7% response rate:
http://jco.ascopubs.org/content/26/28/4544.long

I'm not sure if the response rate would be different when selecting only patients with KRAS or BRAF mutations.

It's definitely concerning and puts more pressure on RIMM in terms of ensuring that the launch of their new generation of devices is a success. Their margins in the hardware business have been dwindling and they probably aren't making any money off it at the moment, but hopefully that will change. Part of the issue is the delay in launching Blackberry 10 - their last major launch was the Blackberry Bold 9900 in 2011, and so that's put a lot of pressure on the average selling price of their devices in recent quarters.

I think the new devices will salvage some market share in North America, but I'm curious to see how well they sell in emerging markets. The new devices are high-end models, but I'm assuming that the bulk of their sales in emerging markets are currently from their low-cost models.

They still haven't provided any color on whether they will license the OS to other manufacturers, but I think that would make sense if they are able to monetize some of their other features such as Blackberry Messenger.

ADCC is also one of the putative MOAs of anti-EGFR antibodies, but I would argue that if that were a significant component, then Erbitux and Vectibix would show some efficacy against tumors with KRAS mutations.

The news is disappointing for me as an ARRY long, but I suppose that the high rate of toxicity seen in the prior phase II trial warrants some attention before they plough ahead with a phase III trial. It looks like they may only begin that in 2014.

At least we can look forward to the initiation of phase III trials for MEK162 in 2013.

I have to admit that I like it better now that I know it is pronounced EYE-clusig rather the EE-clusig. I still don't think it's the best name they could have come up with.

It's a terrible name - I prefer the generic names of many of the newer launches. Axitinib and ponatinib sound better than Inlyta and Inclusig.

That explains why INCY's share price took a hit this morning.