Investors Look Beyond Isis Recent
Stumble To New Drugs
2 advance; 1 stumbles
• Isis has announced its kicking off phase 1 trials on
two new compounds, triggering milestone
payme...
Isis-DMPK
• Isis-DMPK is part of a collaboration with Biogen to
develop Antisense drugs for neuromuscular
disease.
– Isis-...
Isis-AR Rx
• Isis-AR Rx is part of a collaboration with
AstraZeneca to develop antisense drugs to treat
cancer.
– Isis-AR ...
iCo-007 Fails In Trials
• Ico Therapeutics phase 2 trial of Isis’ iCo-007
doesn’t achieve its endpoint.
– 187 patient mid ...
Shifting focus to other candidates
• So far Isis only approved drug is Kynamro, a treatment for
the ultra-rare homozygous ...
Fool-worthy final thoughts
Expectations for iCo-007 were low, so its not surprising that investors looked
beyond the disap...
Will this stock be your next multi-bagger?
Give us five minutes and we'll show how you could own the best stock for 2014.
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Investors Look Beyond Isis Recent Stumble To New Drugs

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Isis Pharmaceuticals (NASDAQ: ISIS) shares have surged this past week on news that it has received two milestone payments for advancing new drugs into phase 1 trials.
Those milestone payments from Biogen and AstraZeneca successfully shifted attention away from the failed phase 2 trial of a once-promising treatment for diabetic macular edema, or DME, an indication generating hundreds of millions of dollars in sales for Novartis. In the following slideshow you'll learn more about Isis two new phase 1 drugs and the disappointing results for its DME drug.

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Investors Look Beyond Isis Recent Stumble To New Drugs

  1. 1. Investors Look Beyond Isis Recent Stumble To New Drugs
  2. 2. 2 advance; 1 stumbles • Isis has announced its kicking off phase 1 trials on two new compounds, triggering milestone payments from Biogen and AstraZeneca. – Isis-DMPK Rx for Myotonic Dystrophy Type 1 (Biogen). – Isis-AR Rx for prostate cancer (AstraZeneca). • Isis’ iCo-007 fails in mid stage trials for partner iCo Therapeutics.
  3. 3. Isis-DMPK • Isis-DMPK is part of a collaboration with Biogen to develop Antisense drugs for neuromuscular disease. – Isis-DMPK targets a toxic RNA that is created by a genetic defect in the DMPK gene and prevents the normal production of proteins necessary for normal cell function. – DM1 is the most common form of muscular dystrophy in adults, affecting 150,000 patients in the U.S., Europe, and Japan. – There are no direct therapeutic options for DM1 patients. – Isis receives a $14 million milestone payment for advancing Isis- DMPK into phase 1 trials.
  4. 4. Isis-AR Rx • Isis-AR Rx is part of a collaboration with AstraZeneca to develop antisense drugs to treat cancer. – Isis-AR Rx is designed to limit production of the androgen receptor that is associated with prostate cancer growth, proliferation, and progression. – Prostate cancer is the 2nd leading cause of cancer death in men. • 2.7 million cases in the U.S. in 2011. • 233,000 new cases diagnosed annually. – Isis receives a $15 million milestone payment from AstraZeneca for advancing Isis-AR Rx into phase 1 trials.
  5. 5. iCo-007 Fails In Trials • Ico Therapeutics phase 2 trial of Isis’ iCo-007 doesn’t achieve its endpoint. – 187 patient mid stage trial evaluating iCo-007 in patients with diabetic macular edema, a common cause of vision loss in diabetics affecting more than 1 million people. The trials sought to show that iCo-007, when used alone or alongside Lucentis, improved visual acuity at 8 months. • Low dose iCo-007 monotherapy resulted in a loss of visual acuity of 11 letters. • High dose iCo-007 monotherapy resulted in a loss of visual acuity of 21 letters. • Low dose iCo-007 + Lucentis resulted in a loss of visual acuity of 14 letters. – The failure to improve visual acuity in patients casts doubt over the future of iCo-007, including any future potential milestones and royalty payments. Source: http://finance.yahoo.com/news/ico-therapeutics-announces-top-line-120000315.html
  6. 6. Shifting focus to other candidates • So far Isis only approved drug is Kynamro, a treatment for the ultra-rare homozygous familial hypercholesterolemia. – Won approval in January 2013. – Sales aren’t yet material and aren’t broken out in Isis financials. • Isis has a promising late stage pipeline. – Isis-APOCIII Rx for patients with abnormally high levels of triglycerides is heading into phase 3 this year. – Isis-GCGR Rx for controlling glucose in diabetes patients resistant to metformin improved glycemic control without elevating blood pressure in phase 2 trials. – ISIS-FXI Rx for the prevention of blood clots in patients undergoing total knee replacement surgery outperformed Sanofi’s Lovenox in phase 2 trials. • Prior to losing patent protection, Lovenox sales totaled $1.8 billion annually in 2010.
  7. 7. Fool-worthy final thoughts Expectations for iCo-007 were low, so its not surprising that investors looked beyond the disappointing results to the promise of additional drugs entering clinical trials. That said, Isis will need to see late stage programs succeed in order to justify investor enthusiasm, which has resulted in shares doubling since the end of 2012. Given that the RNAi space remains commercially unproven, Isis is best suited for aggressive investors.
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