Hello, Thank You Very Much In Advance For Your Help,

Question : Hello,

Thank you very much in advance for your help, Doctor.

re: Competition and products: Zenpep versus Creon

I am trying to understand why a patient would take Zenpep versus Creon

1. For which indication do these two drugs overlap?

2. Within this indication, is there a specific benefit to one over the other?

3. Are the two products considered direct competitors?

4. What is the most popular treatment for Exocrine Pancreatic Insufficiency? Pancreatic Disorders?

5 Do you have any market share information of the offerings of the indications above? How do Zenpep and Creon compare?

6. Which mechanisms of action do Zenpep and Creon have in common?

7. Are there any competitors below that are missing or irrelevant?

Mechanism of Action: Pancrelipase replacements
Marketed
Creon (AbbVie)
Zenpep (Allergan)
Pancreaze (Janssen (J&J); Vivus)
Pertzye (Digestive Care; Chisei USA)
Pancrelipase (generic)

Pipeline
MS1819 (AzurRx, US Phase II)

8. Are there any ADDITIONAL pipeline products to be aware of within the indication?

9. Are there any other places where the two drugs can compete?

10. I have done the following research for the two drugs. Am I missing anything here?

Approved Name
(Alternate names)     
Pancrelipase delayed-release capsules
(Zenpep, Zentase, Enzepi, EUR-1008, APT-1008)

Stage     Launched

Sales ($m)     $266m (‘20E)

Indication     
Pancreatic disorders; EPI

Mechanism of Action     
Pancrelipase replacements

Companies Involved
Samil (Korea), Takeda (Japan): Licensee
Eurand (USA): Originator
Allergan (US): Associated

Developed by Eurand; acquired by Axcan (changed to Aptalis Pharma, acquired by Forest, acquired by Actavis (Allergan).

Launch, Geographic Details     
US FDA approved in Aug-09 and launched in the US as Zenpep in Nov-09. In Jul-11, high strength dose was approved, which is the highest strength currently approved by the FDA. In Europe, the regulatory application was withdrawn by Allergan in Jul-17. For pancreatic disorders, launched in the US and Puerto Rico.

Patent Details
In Feb-10, Eurand was granted US Patent entitled “Stable Digestive Enzyme Compositions”, providing coverage until at least 20-Feb-28.


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Approved Name
(Alternate names)
Pancrelipase delayed-release capsules
(Creon, SA-001, Lipacreon)

Stage     Launched

Sales ($m)     $1.1bn (‘20E)

Indication     
EPI

Mechanism of Action     
Pancrelipase replacements

Companies Involved
Eisai (Japan): Licensee
Solvay (Belgium): Originator
AbbVie (USA): Associated

In Feb-10, Solvay was acquired and merged into Abbott and AbbVie was spun-off from Abbott in 2013.

Launch, Geographic Details
For EPI, launched in 18 countries including the US, Europe, Japan, South XXXXXXX China and Russia. In May-10, the US FDA approved dosing guidance for EPI due to chronic pancreatitis or removal of the pancreas. Previously dosing guidance was based on patients with cystic fibrosis.

Patent Details
--

Hello,

Thank you very much in advance for your help, Doctor.

re: Competition and products: Zenpep versus Creon

I am trying to understand why a patient would take Zenpep versus Creon

1. For which indication do these two drugs overlap?

2. Within this indication, is there a specific benefit to one over the other?

3. Are the two products considered direct competitors?

4. What is the most popular treatment for Exocrine Pancreatic Insufficiency? Pancreatic Disorders?

5 Do you have any market share information of the offerings of the indications above? How do Zenpep and Creon compare?

6. Which mechanisms of action do Zenpep and Creon have in common?

7. Are there any competitors below that are missing or irrelevant?

Mechanism of Action: Pancrelipase replacements
Marketed
Creon (AbbVie)
Zenpep (Allergan)
Pancreaze (Janssen (J&J); Vivus)
Pertzye (Digestive Care; Chisei USA)
Pancrelipase (generic)

Pipeline
MS1819 (AzurRx, US Phase II)

8. Are there any ADDITIONAL pipeline products to be aware of within the indication?

9. Are there any other places where the two drugs can compete?

10. I have done the following research for the two drugs. Am I missing anything here?

Approved Name
(Alternate names)     
Pancrelipase delayed-release capsules
(Zenpep, Zentase, Enzepi, EUR-1008, APT-1008)

Stage     Launched

Sales ($m)     $266m (‘20E)

Indication     
Pancreatic disorders; EPI

Mechanism of Action     
Pancrelipase replacements

Companies Involved
Samil (Korea), Takeda (Japan): Licensee
Eurand (USA): Originator
Allergan (US): Associated

Developed by Eurand; acquired by Axcan (changed to Aptalis Pharma, acquired by Forest, acquired by Actavis (Allergan).

Launch, Geographic Details     
US FDA approved in Aug-09 and launched in the US as Zenpep in Nov-09. In Jul-11, high strength dose was approved, which is the highest strength currently approved by the FDA. In Europe, the regulatory application was withdrawn by Allergan in Jul-17. For pancreatic disorders, launched in the US and Puerto Rico.

Patent Details
In Feb-10, Eurand was granted US Patent entitled “Stable Digestive Enzyme Compositions”, providing coverage until at least 20-Feb-28.


------------------------------------------

Approved Name
(Alternate names)
Pancrelipase delayed-release capsules
(Creon, SA-001, Lipacreon)

Stage     Launched

Sales ($m)     $1.1bn (‘20E)

Indication     
EPI

Mechanism of Action     
Pancrelipase replacements

Companies Involved
Eisai (Japan): Licensee
Solvay (Belgium): Originator
AbbVie (USA): Associated

In Feb-10, Solvay was acquired and merged into Abbott and AbbVie was spun-off from Abbott in 2013.

Launch, Geographic Details
For EPI, launched in 18 countries including the US, Europe, Japan, South XXXXXXX China and Russia. In May-10, the US FDA approved dosing guidance for EPI due to chronic pancreatitis or removal of the pancreas. Previously dosing guidance was based on patients with cystic fibrosis.

Patent Details
--

please can you answer this question? I thought specialists replied to questions within 24 hours?

please can you answer this question? I thought specialists replied to questions within 24 hours?

Hi Dr XXXXXXX apologies, I had another question (accidentally closed down my prior one):

Why is Skyrizi (risankizumab; Phase III, AbbVie) expected to be such a great drug if it comes to the market to treat:
1. Ulcerative Colitis, and
2. Crohn’s Disease?

For example, what makes it so much better than:
3. Stelara (ustekinumab; J&J, marketed in CD but Phase III in UC)?
4. other IL-23-p19-inhibitors?
5. Humira?

Thank you
Rod

Hi Dr XXXXXXX apologies, I had another question (accidentally closed down my prior one):

Why is Skyrizi (risankizumab; Phase III, AbbVie) expected to be such a great drug if it comes to the market to treat:
1. Ulcerative Colitis, and
2. Crohn’s Disease?

For example, what makes it so much better than:
3. Stelara (ustekinumab; J&J, marketed in CD but Phase III in UC)?
4. other IL-23-p19-inhibitors?
5. Humira?

Thank you
Rod