Fri, Mar 6, 2015, 2:57 AM EST - U.S. Markets open in 6 hrs 33 mins


% | $
Quotes you view appear here for quick access.

Isis Pharmaceuticals, Inc. Message Board

you are viewing a single comment's thread.

view the rest of the posts
  • robert.vince robert.vince Sep 20, 2012 7:47 AM Flag

    Isis Pharmaceuticals' Management Presents at UBS Global Life Sciences Conference (Transcript) Part 1

    The principle side effect of the drug is injection side reactions; it is given as a once weakly at home subcutaneous injection; it is a small volume injection with a needle that’s one gauge bigger than the insulin needle. Injection side reactions occur in most patients some of the time, so about 10% of injections it’s a low incident rate that are principally cosmetic, they are mild and they result rapidly. We have occasional flu like symptoms in about 2% of injections and about 8% of the patients in the study had ALT elevations, above three times the upper limit of normal. These were not associated with any other evidence of liver toxicity, so no albumin changes or bilirubin changes, no high (inaudible) cases. And so we believe this is a monitor-able and manageable side effect. So in general, we actually think that the risk benefit profile of this drug is very positive for the patients with extraordinary high cardiovascular risks that we’re planning on treating.

    So in addition to KYNAMRO, which we think represents a significant initial commercial opportunity with the opportunity for commercial market expansion supported by the FOCUS FH study, Isis actually has quite a lot more going on. We have five different drugs which we believe have the potential to be able to launch in the next five years and I am going to talk to talk to you about each of those and in addition, our pipeline is expanding by three to five new drugs every year.

    Over the next 12 to 18 months, we have seven different programs out of which we expect Phase II efficacy data. So again, lots of data is coming out of very a broad and rich pipeline. Our satellite companies, those small companies with the undrugable targets continue to be successful and those drugs continue to march forward as well and of course all of that represents economic and commercial upside for us and we continue to pioneer the technology opening up more and more opportunities for our technology platform.

    With regard to short-term opportunities and I’ll talk a little bit more about each of these programs. Our ISIS-TTRRx is a drug to treat transthyretin amyloidosis. Our initial indication which we are pursuing with GlaxoSmithKline is for the polyneuropathy version of this disease or about 10,000 patients worldwide and we get license fee payments, milestones and double-digit royalties on this drug as it moves forward.

    Our apoC-III drug is very unique triglyceride lowering drug and our initial indication for this drug is patients with extraordinarily high triglyceride, so triglycerides is over 880 milligrams per desolater and these are patients who not only have extremely high cardiovascular risk but also a very high risk of pancreatitis. So a much shorter term and more acute health problem faces these patients.

    Our strategy is to approach our initial indication patients who are [maxed] out on other triglyceride lowering therapy and despite that are still at this very, very high triglyceride levels and they are about 200,000 patients in the US and Europe who meet this criteria.

    Our spinal muscular atrophy drug which we are developing with Biogen Idec is a very interesting drug to treat a lethal disease in infants and a very disabling disease in children’s spinal muscular atrophy. This is a disease in which there are about 35,000 patients worldwide. Our partners OncoGenex are developing a prostate cancer drug with their partners Teva that is in two phase, three clinical trials right now and they are planning on starting a trial on non-small cell lung cancer later this year. And EXC 001 is kind of a sweeper in our portfolio as I said this is a drug that came out of the company one of our satellite companies that we help to start.

    It’s a drug to treat scarring associated with surgery that company was bought by Pfizer and we are very pleased to have Pfizer’s balance sheet behind moving this drug forward into broad Phase 3 clinical trails.

    ISIS-TTRRx is a drug where we showed in Phase I clinical trails extremely robust reductions of TTR and TTR of course is the protein that in its mutant form is responsible for this disease. So we showed over 80% reduction in TTR protein in normal volunteers. On the basis of that, we and GSK are taking this drug directly into a Phase 3 clinical trial which should start later this year.

    ISIS-TTRRx has the possibility to be a best in class treatment for TTR amyloidosis. As the opportunity to treat both our initial indication which is the polyneuropathy form of the disease as well as the larger indications the cardiomyopathy form of the disease which represents about 40,000 patients. It’s a convenient once weekly subcutaneous self administration. And as I said the Phase 3 study should start this year and with a potential for a commercial launch as early as 2016.

71.76+1.60(+2.28%)Mar 5 4:00 PMEST

Trending Tickers

Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.
Geron Corporation
NASDAQThu, Mar 5, 2015 4:00 PM EST
Orbital ATK, Inc.
NYSEThu, Mar 5, 2015 4:02 PM EST