What You Need To Know About The Cancer Gilead's Zydelig Treats


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Gilead Sciences (NASDAQ: GILD) has won approval for its promising drug Zydelig in three important cancer indications. As a combination treatment alongside Roche's (NASDAQOTH: RHHBY) top selling Rituxan, the FDA green-light puts Zydelig head-to-head against Pharmacyclics (NASDAQ: PCYC) Imbruvica in relapsing chronic lymphocytic leukemia, or CLL.While the approval also gives Gilead an opportunity in relapsing follicular lymphoma, and small lymphocytic lymphoma as a stand-alone therapy, investors are right to wonder just how big and crowded the market is already.In the following slideshow, you'll learn more about each cancer and what the market opportunity may be for Zydelig.

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What You Need To Know About The Cancer Gilead's Zydelig Treats

  1. 1. Gilead Jumps Into Cancer Treatment
  2. 2. Gilead Sciences • Gilead is already a powerhouse in HIV. – Treatments totaling $9 billion annually. • It’s already become a major player in hepatitis C. – Sovaldi’s sales were north of $3.5 billion in Q2. • And now it’s got a potential major oncology drug too. – The FDA approves Zydelig (idelalisib) for multiple indications.
  3. 3. Zydelig (idelalisib) – The FDA approves Zydelig for relapsed chronic lymphocytic leukemia, or CLL. – Relapsed follicular B-cell non-Hodgkins lymphoma, or FL. – Relapsed small lymphocytic lymphoma, or SLL.
  4. 4. Relapsed chronic lymphocytic leukemia )• CLL is a white blood cell cancer (non-Hodgkins lymphoma) that starts in the bone marrow and can spread over time. • About 15,720 new cases of CLL will be diagnosed this year. • About 4,600 people deaths from CLL this year. • The average age at diagnosis is 72 years. • Most patients relapse after first line treatment. • To be used alongside Roche’s Rituxan. – Rituxan is usually prescribed alongside other treatments in CLL. • The FDA approved Roche’s Gazyva in November 2013. • The FDA approved Pharmacyclics’ and Johnson & Johnson’s Imbruvica in February 2014.
  5. 5. Relapsed Follicular B-cell non-Hodgkins lymphoma )– FL is the most common form of slow-growing NHL (20% to 30% of new cases). – 7k to 13k new cases annually. – Relapsing FL is common. – Rituxan is first line therapy. – Refractory to Rituxan have inferior outcomes to high dose autologous stem cell transplantation (HD-ASCT). – Treatments for relapsed FL include radioimmunotherapy (like Bexxar & Zevalin) and Teva’s Treanda ($180 million in Q1 sales). – Ongoing trials for the indication include Celgene’s Revlimid.
  6. 6. Relapsed small lymphocytic lymphoma ) – A type of non-Hodgkins lymphoma. – Accounts for 4% to 5% of NHLs (~3k new cases a year). – Similar to and treated similarly to CLL. – Slow growing; mean age of 60 at diagnosis. – Relapse is very common.
  7. 7. Non-Hodgkins lymphoma )
  8. 8. Fool-worthy thoughts – None of the approvals are for first line. – Rituxan can be used in relapsing CLL if PFS >1 year. • Rituxan isn’t commonly used as mono-therapy in CLL. • Monotherapy most common in elderly with co-morbities. • Zydelig approval is for use in patients where Rituxan mono- therapy would be used. – Patients often relapse in all 3 indications. • Suggests market can support multiple therapies, including both Zydelig and Imbruvica. – Analysts peak annual sales projection of $1 to $2 billion.
  9. 9. Leaked: A coming blockbuster that could make even Gilead jealous.
  10. 10. Leaked: A coming blockbuster that could make even Gilead jealous.