CEO Address – Special Meeting 4 December 2018

Promisia Integrative Limited – Special Meeting 4 December 2018

CEO Address

Medsafe Alerts 15

February, 27 November 2018
• Medsafe Alerts are based on reports produced by the Centre for Adverse Reaction
Monitoring (CARM).
• At the time of the February Alert, we had not had access to a detailed report of the
adverse reactions from CARM.
• Following the original Alert, there were a number of new reports, mainly from the
public. This was expected considering the media coverage.
• All reports related to a time period prior to the February Medsafe Alert. Some were
as much as one year old.
• Since the Alert, there have been 4 adverse reactions reported. 3 related to elevated
liver enzymes and are detected by routine blood tests rather than an adverse
reaction. This is not uncommon and can be caused many things and not necessarily
Arthrem. The fourth related to a case of cirrhosis of the liver in an 81 year old man.
There is no evidence that Arthrem can cause cirrhosis of the liver. No evidence was
provided as to his history and in addition, he was taking at least 2 other medicines
that are known to cause liver issues.
• Promisia’s product Arthrem has a recommended dose of one 150mg capsule taken
twice a day, morning and night.
• Competing products released in early 2017 all had a recommended dose of one
300mg capsule taken once daily.
• At least 3 competing products were launched in early 2017. The main competitor
was Go-Arthri Remedy, part of the Go Healthy range. Competing products were
being sold as “the same as Arthrem but in a single dose at a lower price”.
• It is important to note that following the launch of competing products, the adverse
reactions increased by a factor of 6.
• The graph below tracks the monthly bottle sales of Arthrem, the actual monthly
reported adverse reactions, and the cumulative number of reported adverse
reactions.
• It is clear that the introduction of competing products in February 2017 had an
immediate impact in the form of both a reduction in the sales of Arthrem and the
increase in the number of adverse reactions.
• It follows that the number of reported adverse reactions cannot be attributed solely
to Arthrem as claimed by Medsafe.

Arthrem Sales Vs Adverse Reactions



Genericization

• Promisia believes that a significant level of genericization occurred with Arthrem.
• Customers using Arthrem were persuaded to buy a competing product on the basis
that “it was the same as Arthrem” but at a lower price and only 1 pill per day.
• Many customers considered that they were still taking Arthrem even through they
were taking a competing product.
• Taking a single 300mg capsule is not the same as taking 1x 150mg capsule twice a
day. Artemisia annua is a powerful herb and dose size matters.

Detailed Analysis of CARM Adverse Reaction Reports

• Of the 25 reported adverse reactions relating to the liver only 4 occurred after the
Medsafe Alert in February
• 2 of the patients were taking Go-Arthri Remedy so definitely don’t relate to Arthrem.
1 said that the patient took Arthrem for 6 months with no adverse reaction but
switched to a named competitor and had an adverse reaction.
• 4 claim a 300mg dose was taken and thus were likely taking competing product.
Arthrem’s recommended dose is 150mg.
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Arthrem Sales vs Adverse Reactions
Adverse reactionsBottles Sold x1000Cum AR's
Competingproducts
launched
Medsafe Alert
Competing products
withdrawn

• 5 of the patients claim to be taking only 1 pill per day. This is unlikely to be Arthrem
as the recommended dose is 2 pills per day
• 9 of the reports have no information about dose so Medsafe is unable to confirm
that these patients were taking Arthrem.
• This highlights that in 44% of the reports, the patients were either definitely not
taking Arthrem or (due to dose information) were unlikely to be taking Arthrem
• A further 36% cannot be attributed directly to Arthrem as there is no clear evidence
that they were taking Arthrem as there is no information about dose.
• Therefore as many as 80% of the reports are questionable
• 12 patients claim to be taking medications for a variety of conditions. Ten of those
people were taking at least one medication that is also known to have a negative
impact on liver function.
• 13 reports suggest that Arthrem was the only product patients were taking. This is
unlikely for people in their 60s, 70s and 80s. It is Promisia’s view that a person who
has chosen to take Arthrem may well be taking some form of medication, especially
pain medication, if they are suffering from joint pain.

Medsafe’s claims Arthrem is an Unlicensed Medicine

• Medsafe continues to claim Arthrem has breached the Medicines Act as it is being
advertised and sold for therapeutic purpose. This is disputed by Promisia.
• All media content and advertising is approved by the Therapeutic Advisory Pre-
vetting Service (TAPS) and deemed to be appropriate for the sale of a dietary
supplement
• Medsafe claims that our clinical trial proves efficacy and thus Arthrem is a medicine
• Arthrem is a Listed Complimentary Medicine in Australia, a category that does not
exist in New Zealand
• Promisia has had to GEO block websites and social media designed for the Australian
market
• Promisia has been required to remove all announcements on its corporate website
as Medsafe deems them to be advertising (e.g. announcement that Arthrem was
approved as a Listed Complimentary Medicine in Australia).
• The treatment of Promisia by Medsafe is targeted, unfair and inconsistent with how
others in the industry are treated.

Summary
• There is clear evidence that the CARM reporting process is flawed due to the
inadequacy and inaccuracy of the information collected. It cannot be relied on for
the purpose of creating Alerts and certainly questioning the safety of specific
products such as Arthrem.
• The evidence supports the view that the majority of reported adverse reactions
related to products in the form of a single 300mg capsule rather than a 150 mg
capsule taken twice a day.
• The reporting of adverse reactions has stopped since competing high dose products
competing with Arthrem have been withdrawn from sale in pharmacies.
• We continue to try and engage with Medsafe

• We have requested mediation and been declined
• We have accepted legal advice from a barrister and a QC
• A complaint has been laid with the Office of the Ombudsman
• We are unable to comment publicly at this point
• A legal challenge against Medsafe will cost at least 6 figures

What’s new?

• Promisia will soon launch two new products in the joint care sector
• Promisia is in final stages of testing a new product for the animal health sector
• Arthrem remains in 1000 pharmacies in NZ
• Arthrem is now in 900 pharmacies in Australia.
• Artevite is undergoing a major promotion and a price reduction to drive volume

Thank you