• Salvat has an agreement with Lee’s Pharmaceutical to distribute the otic treatment Cetraxal Plus in China, Hong Kong and Taiwan.
• The product has been available in the Spanish market for twenty years and is exported to more than 50 countries.
• Cetraxal Plus is the only otic treatment in the world that comes in single-dose vials for acute otitis externa and otitis media with tympanostomy tubes.
• With this project, Salvat reinforces its commitment to the Asian market, where it is already present in markets such as Korea, Singapore and Vietnam.

Salvat Laboratories (“Salvat”) and Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”) (SEHK Stock Code:0950) have launched Salvat Cetraxal Plus otic treatment in Hong Kong, marking the first time the laboratory has operated in the Asian country.

Lee’s Pharmaceutical acquired the license rights from Salvat to sell Cetraxal Plus in China, Taiwan and Hong Kong in single-dose vials. Following clinical trials and official approvals the treatment has started to be marketed this October in Hong Kong and is scheduled to be marketed in China and Taiwan next year. “The Asian market, and especially China, are strategic markets for Salvat due to their growth potential and high demand for health and self-care products”, explains Alberto Bueno, CEO of Salvat.

Clinical trials in China

In China, the Phase III clinical trial for the drug is currently underway and most of the necessary patients have already been recruited from 44 centers across the country. The study is led by researchers from Fudan University and is scheduled to be completed before the end of 2021. The final phase will be the regulatory process for the product’s approval in the country.

This clinical trial is the prerequisite for obtaining authorization from the Chinese National Medical Products Administration to market the drug, in their country.

The world’ s first treatment in single-dose vials for both otic conditions

Cetraxal Plus is the only otic treatment in the world for acute otitis externa and otitis media with tympanostomy tubes that comes in single-dose or single-use vials. This presents several benefits over multidose formats, as it facilitates correct administration with the exact amount of product and maintains the sterility of the treatment. “At Salvat, we are committed to technology and innovation in drug development and the single-dose formats allow us to offer increasingly advanced solutions adapted to the needs of the market. We manufacture them in the production lines owned by the Salvat Group: “Salvat (Barcelona), Pharmaloop (Alcalá de Henares, Madrid) and Tamarac (Florida, USA)” explains the CEO of Salvat, Alberto Bueno.

With almost twenty years on the market, Cetraxal Plus has become one of Salvat’s key products. It is a treatment for acute otitis externa and otitis media with tympanostomy tubes that combines an antibiotic and a corticosteroid. Every year more than 1,500,000 units are sold in Spain and more than 3,000,000 are exported to 50 countries around the world.

• Mr. Raúl Blanco, Secretary General for Industry and Small and Medium Enterprises, visited Pharmaloop’s new sterile liquids plant, located in Alcalá de Henares (Madrid).
• Pharmaloop is the first fully autonomous pharmaceutical production center in Spain, with a natural gas cogeneration system that creates its own energy.
• The visit served to reinforce the company’s commitment to product innovation and internationalization with the construction of this 8,500 m² plant, which has also meant the creation of 100 new jobs.

Last April 9, the Secretary General for Industry and Small and Medium Enterprises, Mr. Raúl Blanco, visited Pharmaloop’s new sterile liquids plant located in Alcalá de Henares, which, thanks to its advanced technology and production processes, demonstrates the pharmaceutical group’s commitment to the innovation and internationalization of its products.

The Secretary, who was received by Alberto Bueno, CEO of Laboratorios Salvat, Juan de la Fuente, Site Manager of Pharmaloop, and Marisa Poncela, Non-Executive Director of Laboratorios Salvat, was accompanied by Alejandro Cros, Deputy Director General of Industrial Sector Policies, and Carmen Álvarez, Head of the Pharmaceutical Technologies Area.

During the meeting, held two months after the Minister of Industry, Reyes Maroto, visited Pharmaloop, the delegation toured the more than 8,500 m² of the new plant, considered the first fully autonomous pharmaceutical production center in Spain thanks to its cogeneration system that creates its own energy, making it less polluting.

Innovation and internationalization

The project for the new plant in Alcalá de Henares has involved an investment of 65 million euros for Laboratorios Salvat and, together with the current plant, will allow Pharmaloop to have facilities covering more than 23,000 m².

As Alberto Bueno, CEO of Salvat, explains, “with Pharmaloop, we have made a very important commitment to growth at an international level. Thanks to the new plant’s production capacity, we will be present in more markets and we will continue with the expansion strategy started a few years ago which already generates more than half of our annual turnover as a group.”

The international demand for sterile single-dose units is increasing substantially with the Covid-19 pandemic as they are necessary to produce vaccines and other pharmaceutical products. With the plant completed and fully operational, Salvat will have a production potential of 500 million sterile vials per year.

This plant is at the forefront of technology. It is fully automated and uses some of the most advanced systems for drug production such as BFS (Blow, Fill and Seal). Likewise, it applies the most comprehensive quality tests, with 100% of its vials checked to avoid leaks, not just a random sampling of vials as occurs with other control systems.

The company’s forecast is to increase the number of collaborators in the coming months to reach more than 70 countries – it is currently in 60 – and to position itself as a global benchmark in the manufacture of sterile single-dose liquids.

• Salvat has an agreement with Lee’s Pharmaceuticals to distribute Cetraxal® Plus in China
• Cetraxal® Plus is the only pharmaceutical product in the world that is available in single-dose vials for external otitis and otitis media. It was launched in 2002 in Spain and is already exported to more than 50 countries
• The Phase III clinical trial will include 600 patients from 44 hospitals. This process is a necessary step in order to obtain approval for a medicine in China
• With this project, Salvat reinforces its commitment to the Chinese market, where it has already initiated agreements to commercialize other drugs

Salvat Laboratories (“Salvat”) and Lee’s Pharmaceutical Holding Limited (“Lee’s Pharm”) (SEHK Stock Code:0950) in January 2021, started a the Phase III clinical trial of Salvat’s Cetraxal® Plus otic treatment in China. The study will include 600 patients from 44 centers across the country and will be led by researchers from Fudan University. The trial will be conducted throughout this year, with the expectation of the regulatory approval in 2022.

This clinical trial is the prerequisite for obtaining authorization from the Chinese National Medical Products Administration to market the drug, in their country. Lee’s Pharmaceutical was successful in acquiring the rights from Salvat to sell Cetraxal® Plus in China, in the single-dose vial format.

 
Strategic commitment to the Chinese market

Once approved, this will be the first drug that Salvat markets in China, a market that has become key for the company. “The Chinese market is a market with great growth potential and with a very high demand for health and self-care products. For us, it has already become a strategic market after the US and Europe”, explains Alberto Bueno, CEO of Salvat.
In this regard, the laboratory has already begun negotiations with other companies to present products from its portfolio in China. In the near future, Salvat plans to launch more than five products in this market.

The world´s first otic treatment in single-dose vials

Cetraxal® Plus is a treatment for external otitis and otitis media with tympanostomy tubes, which combines an antibiotic and a corticosteroid. This medication was developed by Salvat and approved in Spain in 2002. Authorizations were subsequently obtained in other European countries, followed by the United States and Canada. Cetraxal® Plus is currently exported to more than 50 countries around the world.

The presentation in single-dose vials of Cetraxal® Plus is a very important advantage compared to other treatments available in multidose. This presents several benefits over competitors as it facilitates correct administration with the exact amount of product and maintains sterility of treatment. “At Salvat, our commitment to technology and innovation in drug development allows us to offer increasingly advanced solutions. One of these improvements is the single-dose format, which we manufacture thanks to the BFS (Blow-Fill-Seal) technology that we have in the 3 manufacturing plants owned by the Salvat Group: Salvat (Barcelona), Pharmaloop (Alcalá de Henares, Madrid) and Tamarac (Florida)” explains the CEO of Salvat, Alberto Bueno.

With almost twenty years on the market, Cetraxal® Plus has become one of Salvat’s star products. Every year more than 1,500,000 units are sold in Spain and more than 3,000,000 are exported to other countries.

• Salvat’s new BONECURE project is an innovative medical advancement based on pre-differentiated mesenchymal cells designed to treat patients with bone consolidation problems post-fracture (atrophic pseudoarthrosis).
• A Phase II clinical trial is being completed with promising results in terms of both efficacy and safety, in patients with long bone pseudoarthrosis.
• Salvat has conducted this project in collaboration with the biopharmaceutical company Histocell, a company specializing in regenerative medicine and cell therapies.

Salvat, an international laboratory that develops and manufactures products such as Cristalmina, Cetraxal, Tebarat, Levogastrol, Monolitum and Relive, is completing the Phase II clinical trial of a new treatment for non-consolidated long-bone fractures (pseudoarthrosis). The clinical trial was approved by the Spanish Agency for Medicines and Medical Devices (AEMPS). In the trial, patients are followed for one year after the product’s application to test its efficacy, by assessing fracture healing. This project has been carried out in collaboration with the biopharmaceutical company Histocell, which specializes in regenerative medicine and cell therapies. All the patients have now been enrolled and included in the follow-up phase which will be completed by the end of 2020.

Salvat’s new treatment is based on pre-differentiated mesenchymal cells that are implanted in a calcium phosphate biomaterial and applied directly into the lesion site. The development of this therapy has required an investment of 6 million euros.

Bonecure results are very positive

Salvat is currently completing the Phase II clinical trial and the results are very promising. The research is being conducted at the Teknon Medical Center in Barcelona and the Hospital Universitario La Paz in Madrid. Patients affected by atrophic pseudoarthrosis have serious problems in consolidating their bone fractures. In fact, in many cases, the fractures must be re-intervened surgically on several occasions, and at the moment, there is no effective treatment in these medical circumstances. This presents a life altering limitation in the daily functionality of patients, as well as a very high health expenditure due to the cost of medical care. BONECURE is intended to achieve a better and faster bone consolidation and due to its mechanism of action, a more complete functional recovery.

After completing this phase II study, Salvat plans to begin phase III clinical trials in 2021. The goal is to reach an agreement with the Spanish and European Health Authorities for this trials, and additionally to assess the possibility of extending the research to other bone pathologies. This new treatment could be marketed in Spain and throughout the European Community by 2023 and thereafter internationally.

 
Long bones are the most difficult to consolidate

The new treatment is indicated for pseudoarthrosis or broken bone that has not consolidated. Usually a period of 9 months is required before a fracture is considered to have healed appropriately. Although it is not a very frequent complication (4% of fractures), pseudoarthrosis requires a great deal of attention from Traumatologists and some cases require more than three operations. In addition, many patients experience a great deal of pain and dysfunction.

Long bones are more susceptible to breaks and are the most difficult to heal and consolidate. For example, the fracture of the tibia is one of the most common bone fractures and also, one of the most likely to develop pseudoarthrosis.