Complete process to establish a subsidiary in Brazil
Situation
The Company wanted to get into Brazilian market with an innovative drug. As the client did not want to license the product, the challenge was to open a Brazilian subsidiary from scratch and get all licensees till product is available to be commercialized.
Brix team built the plan and presented it to the company with all the steps needed, timelines and estimated costs.
As the product has very unique characteristics the Company wanted confirmation from Brazilian regulatory agency governmental that we were in the right path.
Brix solution
Brix team deeply researched the specific regulation for that kind of drug and approach regulatory agency to clarify the Company's questions.
After the clarification, Brix team adjusted the strategy according to the Company's needs and get a team of vendors and specialized professionals to execute it. Brix team rent a warehouse, set the company in the country and get the due licenses from tax payer's to regulatory approvals. Subsequently Brix team was hired for other jobs by the Company.
Roll out of a global health economic model for hemophilia in LATAM countries
Situation
Hemophilia is a very complex disease. Based on the recommended dosage, the patient therapy have to be carefully thought and tested for each individual. Besides the dosage , all the complexity in the management involves also disease severity, adherence , patient age, amongst other parameters.
We had in hands a very innovative product to treat hemophilia. It has an extended half-life , which at the end results in a lower dosage , with a more spaced posology. The challenge was to roll out a health economic model developed and released by global team throughout the Latin America countries, and adapt such model to each country reality. The main objective was to demonstrate that the use of the innovative drug was more cost effective than the regular drug (current treatment available) using all the parameters involved in the patient management - not only the drug, but also care takers ; adherence (and less hospitalization); reduce bleedings and others
Brix solution
We selected 2 countries to use as reference and studied the available data. After that we worked very close to the global team to propose and get changes in the model that reflected better each country reality. We finally got the positive result we were trying to demonstrate. In this effort we have also to incude KOL’s to get the patient data that was not available publicly . The results were so expressive for one of the countries selected the study was sent for publication in a HE conference.
Orphan drugs policy in LATAM
Situation
Lack of knowledge and policies for Orphan Drugs in Latin America
Brix solution
Development and distribution of an informative and educative material about OD. The main objective was to educate health authorities, pharma associations; KOL’s; patient associations and other LATAM stakeholders about the policies in place for OD in US, Europe and Japan. We got some results in very short timing as the recognition from the authorities that OD should be in another scope of analysis. Others took longer because had to evolve to changes in the laws and regulations, but they came with the time. Currently most of Latin America major markets recognize and have OD policies.
Price approval
Situation
With a strict price regulation in the country in question, the company was going to lose almost 30% in revenues by the time it requests and get the price approval and it was a mandatory step to continue the company activities in the country.
Brix solution
After evaluating all the data available, putting together a very well explained submission and having 3 rounds of negotiation with the pricing agency , we could postpone and minimize the impact of revenues lost. The client was very happy with the results.
License transfer and new approvals
Situation
Client acquired a local distribution plant with facilities for refrigerated products, but was facing issues in transferring the licenses.
Brix Solution
The hurdles to complete the products and distribution plant transfer to the client name were identified and the issues were sorted out. By working closely with the state and federal regulatory agency, in less than 6 months the transfers were completed and pending approvals were released by regulatory agency. Worth to say that the fast results were in great part due to a policy work to educate the agency in orphan drugs concept that didn't exist or were not even recognized in the country by that time.
Strategy for the Latin America Market for a startup
Situation
Company entered the phase III CT of its 1st product, at the same time the senior management wanted to develop a strategy to enter and market the product overseas, including Latin America.
Brix solution
After studying the products we could offer a solution to the client based on product and health system characteristics of each of the major markets in Latin America - Argentina, Brazil, Mexico and Colombia. The strategy included a timeline of events that helped put together an action plan to tackle the best and fast approvals for the product to get into the health system of each target country.