![• First stage of Hepatitis C diagnosis is Acute Hepatitis C
• General incubation period of 14-180 days
• 75-85% of acute Hepatitis C cases progress to Chronic
Hepatitis C [1]
• 70% of Chronic Hepatitis C cases lead to Chronic Liver Cancer
and cirrhosis [1]
• 130-150 million cases of chronic HCV globally [2]
• 2.7-3.9 million cases in the US [3]
Hepatitis C Overview
5](https://image.slidesharecdn.com/82f2f8e0-699d-4401-88e3-3b9ccddd9b6f-160814182818/85/Olysio-Presentation-Emad-Khan-5-320.jpg)
![• Jointly developed by Janssen R&D Ireland and Medivir AB,
Olysio™ received FDA approval on November 22nd 2013 [4]
• “First once daily protease inhibitor approved for the treatment of
chronic Hepatitis C”
• Olysio™ works as an protease inhibitor, which blocks NS3/4A,
which the HCV requires to replicate.
• It is used as part of a combination therapy, using Olysio™
together with peginterferon-alfa and ribavirin, which are two
other FDA approved HCV drugs, in order to ward off the virus [5]
• The goal is to cure (undetectable levels of HCV in the patient).
Recommended dose includes 12 weeks of Olysio™ in
conjunction with 24 weeks of peg interferon and ribavirin.
Olysio™ Background and Efficacy
8](https://image.slidesharecdn.com/82f2f8e0-699d-4401-88e3-3b9ccddd9b6f-160814182818/85/Olysio-Presentation-Emad-Khan-8-320.jpg)
![• Pooled QUEST 1 and QUEST 2: randomized, double-blind, 2-
arm, placebo-controlled Phase 3 trials to assess efficacy
(SVR12) and safety in 785 adult, treatment-naïve patients with
G1 chronic HCV with compensated liver disease (including
cirrhosis) when treated with OlysioTM (12 weeks) + P/R (for 24
or 48 weeks) vs P/R alone (48 weeks). [6]
• Qualifying patients had HCV RNA of ~10,000 IU/ML
• Endpoint was SVR12, a biological cure, with HCV RNA levels
of <25 IU/ML or undetectable
• End Result: Overall SVR12 of 80% versus 50% for Placebo P/R
Olysio™ Background and Efficacy
11](https://image.slidesharecdn.com/82f2f8e0-699d-4401-88e3-3b9ccddd9b6f-160814182818/85/Olysio-Presentation-Emad-Khan-11-320.jpg)
![• In May 2014, J&J filed an sNDA to the US FDA for Olysio™ use
in conjunction with Gilead Sciences Sofosbuvir (Sovaldi™) [7]
• Sovaldi™ is a NS5B polymerase inhibitor, which binds to the
particular HCV polymerase and stops it from replicating
• Gilead Sciences reported $3.48 billion dollar in Q2 Sovaldi™
sales, with a $12.6 billion dollar FY2014 forecast
• FDA approval may have the potential for increased Olysio™
Sales
Olysio™ Financials
15](https://image.slidesharecdn.com/82f2f8e0-699d-4401-88e3-3b9ccddd9b6f-160814182818/85/Olysio-Presentation-Emad-Khan-15-320.jpg)
![• Janssen has priced Olysio™ at a wholesale acquisition price of
$22,120 per bottle of 28 capsules (150 mg capsules), which is
an approximately one-month supply. That's roughly $66,360 for
a three-month course
• Significant financial investment may deter victims from drug
consumption
• Janssen Therapeutics began the Olysio™ savings program for
patients with commercial insurance [8]
• $25 per prescription fill, subject to 25,000 maximum annual
benefit, or 3 fills, whichever comes first [8]
Cost
20](https://image.slidesharecdn.com/82f2f8e0-699d-4401-88e3-3b9ccddd9b6f-160814182818/85/Olysio-Presentation-Emad-Khan-20-320.jpg)
![• Though J&J earnings had beaten forecasts in Q2, expectations
for the remainder of FY2014 are tempered, largely due to J&J’s
reliance on Olysio™ to boost Pharm sales
• Market share competition with Gilead Science’s Sovaldi™
• Threat of Gilead pairing Sovaldi with their own drug, Ledipasvir,
instead of Olysio™
• Sovaldi/Ledipasvir combination tablet approval tested to treat
100% cure rate among HCV patients [9]
• Market Saturation due to new NS5A HCV drugs (Bristoll Myers-Squibb,
Achilles, Merck etc) [10]
Competition
21](https://image.slidesharecdn.com/82f2f8e0-699d-4401-88e3-3b9ccddd9b6f-160814182818/85/Olysio-Presentation-Emad-Khan-21-320.jpg)
Olysio Presentation, Emad Khan
- 1. Olysio™ Presentation Emad Khan, Venture Capital & Finance Intern, JNJ Innovation/JJDC 1 JNJ Innovation/JJDC
- 2. Today’s Topics (2) Olysio™ Background and Efficacy (1) Hepatitis C Overview (3) Financials (4) Future Barriers to Growth
- 3. Today’s Topics (2) Olysio™ Background and Efficacy (1) Hepatitis C Overview (3) Financials (4) Future Barriers to Growth
- 4. • Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure • Generally transmitted by way of infected blood or bodily fluid • The most common modes of infection are through unsafe injection practices, inadequate sterilization of medical equipment in some health-care settings, and unscreened blood and blood products. (who.gov) • Not contracted through consumption (HEPA) or unprotected sex (HEPB) • No Current Vaccine for Hepatitis C Hepatitis C Overview 4
- 5. • First stage of Hepatitis C diagnosis is Acute Hepatitis C • General incubation period of 14-180 days • 75-85% of acute Hepatitis C cases progress to Chronic Hepatitis C [1] • 70% of Chronic Hepatitis C cases lead to Chronic Liver Cancer and cirrhosis [1] • 130-150 million cases of chronic HCV globally [2] • 2.7-3.9 million cases in the US [3] Hepatitis C Overview 5
- 7. Today’s Topics (2) Olysio™ Background and Efficacy (1) Hepatitis C Overview (3) Financials (4) Future Barriers to Growth
- 8. • Jointly developed by Janssen R&D Ireland and Medivir AB, Olysio™ received FDA approval on November 22nd 2013 [4] • “First once daily protease inhibitor approved for the treatment of chronic Hepatitis C” • Olysio™ works as an protease inhibitor, which blocks NS3/4A, which the HCV requires to replicate. • It is used as part of a combination therapy, using Olysio™ together with peginterferon-alfa and ribavirin, which are two other FDA approved HCV drugs, in order to ward off the virus [5] • The goal is to cure (undetectable levels of HCV in the patient). Recommended dose includes 12 weeks of Olysio™ in conjunction with 24 weeks of peg interferon and ribavirin. Olysio™ Background and Efficacy 8
- 9. Olysio™ Background and Efficacy 9
- 10. Olysio™ Background and Efficacy 10
- 11. • Pooled QUEST 1 and QUEST 2: randomized, double-blind, 2- arm, placebo-controlled Phase 3 trials to assess efficacy (SVR12) and safety in 785 adult, treatment-naïve patients with G1 chronic HCV with compensated liver disease (including cirrhosis) when treated with OlysioTM (12 weeks) + P/R (for 24 or 48 weeks) vs P/R alone (48 weeks). [6] • Qualifying patients had HCV RNA of ~10,000 IU/ML • Endpoint was SVR12, a biological cure, with HCV RNA levels of <25 IU/ML or undetectable • End Result: Overall SVR12 of 80% versus 50% for Placebo P/R Olysio™ Background and Efficacy 11
- 12. Olysio™ Background and Efficacy 12
- 13. Today’s Topics (2) Olysio™ Background and Efficacy (1) Hepatitis C Overview (3) Financials (4) Future Barriers to Growth
- 14. • J&J reported 2Q earnings of $1.66 per share, beating forecast estimate of $1.54, and exceeding 2Q 2013 $1.48 earnings by 12% • Q2 Prescription drug sales were $8.5 million, up 21.1%, largely due to strong Olysio™ sales • In Q1, Olysio™ reported $354 MM in sales, exceeding the $23MM forecast • In Q2, Olysio™ reported $725 million in Q2 sales, beating forecast estimates Olysio™ Financials 14
- 15. • In May 2014, J&J filed an sNDA to the US FDA for Olysio™ use in conjunction with Gilead Sciences Sofosbuvir (Sovaldi™) [7] • Sovaldi™ is a NS5B polymerase inhibitor, which binds to the particular HCV polymerase and stops it from replicating • Gilead Sciences reported $3.48 billion dollar in Q2 Sovaldi™ sales, with a $12.6 billion dollar FY2014 forecast • FDA approval may have the potential for increased Olysio™ Sales Olysio™ Financials 15
- 16. Today’s Topics (2) Olysio™ Background and Efficacy (1) Hepatitis C Overview (3) Financials (4) Future Barriers to Growth
- 17. Cost 17
- 18. Competition 18
- 20. • Janssen has priced Olysio™ at a wholesale acquisition price of $22,120 per bottle of 28 capsules (150 mg capsules), which is an approximately one-month supply. That's roughly $66,360 for a three-month course • Significant financial investment may deter victims from drug consumption • Janssen Therapeutics began the Olysio™ savings program for patients with commercial insurance [8] • $25 per prescription fill, subject to 25,000 maximum annual benefit, or 3 fills, whichever comes first [8] Cost 20
- 21. • Though J&J earnings had beaten forecasts in Q2, expectations for the remainder of FY2014 are tempered, largely due to J&J’s reliance on Olysio™ to boost Pharm sales • Market share competition with Gilead Science’s Sovaldi™ • Threat of Gilead pairing Sovaldi with their own drug, Ledipasvir, instead of Olysio™ • Sovaldi/Ledipasvir combination tablet approval tested to treat 100% cure rate among HCV patients [9] • Market Saturation due to new NS5A HCV drugs (Bristoll Myers-Squibb, Achilles, Merck etc) [10] Competition 21
- 22. • Side effects of using the drug include sensitivity to light. Use precaution when being out in open sunlight for a long period of time. It is recommended that one uses hats and sunblock to mitigate severity. Women who are pregnant or may become pregnant should not use the drug, because it can cause serious birth defects. Swelling, itching, or burning of the throat or hands may be signs of serious complications. Contact your doctor if these symptoms worsen. • Olysio™ has been shown to successfully treat patients with Genotype 1 Chronic Hepatitis C. The efficacy of Olysio™ in combination with peginterferon and ribavirin is greatly decreased in patients who have genotype 1a Q80K • “Preventative cure”: must be taken every day for life to sustain cure. Stopping treatment can potentially lead to virus resistance. Complicating Risk Factors 22
- 23. 1. http://http://www.immunize.org/catg.d/p4075.pdf 2. http://www.who.int/mediacentre/factsheets/fs164/en/ 3. http://www.cdc.gov/hepatitis/Statistics/index.htm 4. http://www.jnj.com/news/all/Olysio-simeprevir-Receives-FDA-Approval-for-Combination- Treatment-of-Chronic-Hepatitis-C 5. http://www.Olysio.com/ 6. http://www.Olysio.com/hcp/treatment-naive 7. http://www.jnj.com/news/all/Janssen-Submits-Supplemental-New-Drug-Application-to-US-FDA- for-Olysio-Simeprevir-for-Once-Daily-Use-in-Combination-with-Sofosbuvir-for-12-Weeks-for-the- Treatment-of-Adult-Patients-with-Genotype-1-Chronic-Hepatitis-C 8. http://www.Olysio.com/hcp/affordability 9. http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4005-croi-2013- sofosbuvirledipasvirribavirin-combo-for-hcv-produces-100-sustained-response 10. http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4005-croi-2013- sofosbuvirledipasvirribavirin-combo-for-hcv-produces-100-sustained-response Resources and Bibliography 23