Salvat Laboratories enters in the Hong Kong market with its first otic medication

  • 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.

Salvat completes Phase III clinical trials of its new ophthalmic corticosteroid nanoemulsion

  • The aim of these trials, which began in 2020, is to prove the efficacy of this innovative drug in treating ocular inflammation and pain after cataract surgery.
  • For the first time in the world, this new product will use nanoparticles applied to the eye in order to help the drug’s absorption and application.
  • With an investment of more than 12 million dollars, the project seeks to strengthen Salvat’s position in the United States. After receiving authorization for its commercialization, the drug will be produced in the Salvat USA Inc. production lines in Miami (Florida).

Salvat, an international laboratory with a wide experience in commercializing ophthalmic products around the world, has completed the Phase III clinical trials they are conducting in the USA on their innovative drug for the treatment of ocular inflammation and pain after cataract surgery.

The trials have been carried out despite the pandemic. They represent a strategic project for Salvat, since, with an investment of more than 12 million dollars, they seek to reinforce the company’s position in the ophthalmology field worldwide. According to Alberto Bueno, Salvat’s CEO, “these trials also prove Laboratorios Salvat’s commitment to R&D and growth in the North American market”, where the drug is expected to be marketed by the end of 2022. Authorization is also expected to be granted in Spain and in most European countries and other geographical areas by 2023.

The clinical trials were agreed with the Food and Drug Administration (FDA), started in 2020 and have involved 400 adult patients who had recently undergone cataract surgery coming from 50 US hospitals, despite the difficulties resulting from the COVID-19 pandemic.

Once the patient recruitment phase has been completed, results are expected to be available early in the second half of 2021 and the registration documentation will be submitted by the end of 2021. After receiving authorization for its commercialization in the USA and Europe, the drug will be produced in the Salvat USA Inc. plants in Miami (Florida) and Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A.

The first eye drug with nanoparticles

This drug, which treats pain and inflammation in patients who have undergone eye surgery, presents two main innovations. First, the type of corticosteroid used, which is classified as “superpotent”, and which had not been used before in eye drops. Secondly, the type of formulation used, a nanoemulsion that has many advantages over current treatments and has never been used before in eye corticosteroids. The nanoemulsion formulation (which is a nanometric-sized emulsion) increases tolerability, easily reaches the entire eye, prevents blurred vision and is more comfortable for the patient.

In the USA alone, around four million cataract surgeries are performed every year. This drug under development will be a great advance in the treatment of pain and inflammation after eye surgery, both because of its active ingredient and its formulation.

Salvat Laboratories, pioneer in Ophthalmology

In addition to developing this ocular corticosteroid, Salvat is working on four more projects in the field of ophthalmology. Two in the area of glaucoma and two in the area of dry eye. This new drug for pain and inflammation after cataract surgery confirms Salvat’s commitment to this medical specialty and the company’s desire to strengthen its leadership in the treatment of eye diseases.

The Secretary General for Industry visits the Pharmaloop plant

  • 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’s Pharmaloop Invests 65 million Euros in Its New Sterile Liquids Plant, located in Alcalá de Henares

  • The Minister of Industry, Reyes Maroto, visited Salvat’s new facility today, accompanied by the Mayor of Alcalá de Henares, Javier Rodriguez Palacios and Salvat CEO, Alberto Bueno
  • The new 8,500 m² plant is equipped with the most advanced technology, highest quality standards and the capacity to produce more than 350 million units of sterile formulations per year
  • This is the first fully autonomous pharmaceutical production center in Spain, with a cogeneration system that creates its own energy and minimizes pollution
  • The activation of this plant has created over 100 qualified jobs and 30 new hires will be added in the coming months

 

Mr. Javier Rodriguez Palacios, Her Excellency Mrs. Reyes Maroto, Mr. Alberto Bueno

 

The Minister of Industry, Reyes Maroto, visited the Pharmaloop new sterile liquids production plant, in Alcalá de Henares. This plant exemplifies Salvat’s commitment to innovation and local job creation.  During the visit, she was accompanied by the Mayor of Alcalá de Henares, Javier Rodriguez Palacios and the CEO of the Salvat Group, Alberto Bueno.

The delegation toured the plant, which is equipped with the highest technology in medical production. The visit also included an in-depth walk through the facility’s laboratory, manufacturing area, automated warehouse and energy cogeneration plant.

This project, now entering its second phase, will reach a total investment of 65 million euros and represents an important commitment to international company growth. Currently, Salvat is present in 60 markets but this new facility will expand its reach to over 70 markets, with special focus on the US, Europe and Asia. Additionally, the new plant will have installations of more than 23.000 m² and will allow Salvat to increase production to 500 million sterile vials per year.

As Alberto Bueno, Salvat’s CEO explains, “With Pharmaloop, we have made a very important commitment to growth at an international level. Thanks to the production capacity of the new plant, 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 group’s annual turnover”.

 

The new Pharmaloop facility enhances production capabilities for the globe

The objective of the new facility is to produce for the world’s sterile liquids market, primarily North American. In addition to the previous need for single dose formats, the COVID-19 pandemic has increased demand dramatically, as this delivery system is a perfect fit for vaccines and other sterile pharmaceuticals.

“The manufacture of sterile single-dose liquids is a complex process that requires very advanced technology. Pharmaloop is a clear example of our commitment to advanced formulations in innovation, and thanks to this commitment, we will strength our presence internationally, especially in the United States” explains Alberto Bueno, CEO of Group Salvat.

The plant has the most advanced technology in medical production, such as the BFS (Blow, Fill and Seal) system. This formulation has exhaustive quality controls that ensure 100% of the vials are checked to avoid leaks.

 

Smart and sustainable facility

Pharmaloop is an 8,500 m², fully automated and sustainable small building that does not generate atmospheric emissions or noise.

It has a cogeneration system that transforms gas into electrical energy and allows it to operate completely autonomous. It also has a system that recovers the residual heat from the gases to produce hot water and steam.

The new facility has generated the creation of 100 qualified jobs, in addition to the 52 employees who already worked at the plant before its expansion. With this amplification, Salvat increases its production capacity and distinguishes itself as a leader in sterile liquid manufacturing with a truly international focus. The Group’s goal is to continue Salvat’s current growth trajectory with the aim of reaching 100 million euros in turnover. The company’s forecast is to grow by 30 people in the coming months and reach more than 70 countries in order to continue serving customers and patients worldwide.

Salvat Laboratories enters in the chinese market with Cetraxal® Plus Clinical Trial

  • 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.

Herpix®, the new oral formula against the Herpes Simplex Virus from Laboratorios Salvat, is chosen as Product of the Year 2021

  • The new product from Laboratorios Salvat has been recognised as this year’s most innovative Food Supplement for the Immune System
  • Herpix® is a food supplement formulated from natural extracts which helps slow the replication of the Herpes Simplex Virus (HSV), acting from the inside right from the appearance of the first symptom

Herpix®, the new oral formula from Laboratorios Salvat that is specifically designed against the Herpes Simplex Virus (HSV), has been recognised as Product of the Year 2021 in the Food Supplement for the Immune System category.

Product of the Year is the only competition where consumers directly vote for the most innovative consumer products of the year. The competition has now been running for 21 years in Spain and is held in over 40 countries worldwide. Its purpose is to promote innovation in the mass market and to bring consumers the latest products.

To receive the award, the candidacy of Herpix® was first validated by the competition’s Ethics Committee. Then it was the most highly rated in its category in a questionnaire conducted by the organisers with a representative sample of 10,000 consumers who voted for the products they considered most innovative among the different candidates. Lastly, a sample of 100 people rated the shopping experience and their satisfaction once they tried it.

Herpix® is an orally administered food supplement containing lysine, dry extract of Echinacea purpurea, vitamin C and zinc, which helps stop the process of replication of the Herpes Simplex virus from the appearance of the first symptom, thus reducing the duration, recurrence, healing time of the lesions and severity of the symptoms and helping to prevent recurrent flares.

With pineapple and coconut flavour, it is gluten-free, lactose-free and sugar-free, and it is also suitable for people with a milk protein allergy. It can be taken by both children and adults.

Salvat pioneers advancement in the treatment of non-consolidated bone fractures (BONECURE project)

  • 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.

Cristalmina increases production sevenfold and prepares to launch in international market

  • A new automated robotic line costing more than €6 million has enabled Cristalmina to increase production from 2.5 million to 15 million units per year
  • By 2021, the company plans to have authorisation to market Cristalmina in more than 26 European countries, which will be followed by Asia and the USA in the years to come
  • Laboratorios Salvat’s flagship brand and Spain’s leading antiseptic has tripled in sales in the last seven years and turnover has rocketed from three to nine million euros
  • The pharmaceutical group has manufactured Cristalmina for almost 35 years, which currently accounts for 11% of global turnover

Salvat Pharmaceutical group is making moves to strengthen its international position with Cristalmina, a chlorhexidine-based antiseptic used to protect wounds, burns and the umbilical cord from infection. The product already accounts for 20% of the group’s total turnover in Spain.

In the last seven years, Salvat’s flagship brand has tripled its sales, with turnover increasing from three to nine million euros. Cristalmina is the market leading antiseptic in Spain with sales of almost three million units per year.

Salvat is now preparing an international launch for the end of next year. The pharmaceutical laboratory commissioned a new automated robotic production line six months ago at its Pharmaloop production plant in Alcalá de Henares, to speed up production of Cristalmina. While production was previously limited to 2.5 million units per year, the new line has a capacity to produce 15 million units, most of which will be exported.

According to Alberto Bueno, General Director of Salvat, “The company intends to sell Cristalmina globally, a strategy made possible by the Pharmaloop plant and our new robotic line that is enabling us to manufacture sufficient units to supply international markets”.

The new line will also include a new product presentation, replacing plastic packaging with recyclable glass bottles, thereby improving the group’s environmental performance.

Europe, Asia and the USA

By year end, the regulatory documentation will have been presented to the Spanish Agency of Medicines and Medical Devices (AEMPS) to start the authorisation process for other European countries, which could take up to a year. By 2022, the company expects to be selling Cristalmina in countries like Germany, France, Belgium and Italy, among others. The second phase will take this product to the Asian market where Salvat is already working in China, South Korea, Indonesia, Malaysia, Singapore, the Philippines and Vietnam, as well as the Middle East and North America.

Alberto Bueno said that “Cristalmina is an example of how a commitment to innovation and use of the latest pharmaceutical manufacturing technologies can help Spanish products to achieve international success.”

Imprescindible en los botiquines caseros

Cristalmina was one of the first products launched by Laboratorios Salvat and soon became the choice product for disinfecting minor wounds and burns in both the home and the workplace. It is recommended by health specialists in Spain, since chlorhexidine is the main antiseptic used in both primary care and in hospitals.

One of the products from the Cristalmina range has been widely used for antiseptic purposes during the COVID-19 pandemic, helping to protect people against the spread of the virus.

Laboratorios Salvat leads the development of the first treatment for otomycosis

  • The research, currently underway both in the United States of America and Europe, will involve an investment of more than $10 million.
  • The worldwide launch of the new medicament to treat this type of external otitis, expected for the end of 2021, reinforces Salvat’s positioning in otology at an international level.
  • The company’s international business represents more than 45% of its revenues.

Salvat, laboratory that manufactures products such as Cristalmina, Monolitum, Relive, Levogastrol and Cetraxal, expects the approval and launch of the first topical medicament for the treatment of otomycosis in just over a year in USA and Europe. This commitment reinforces Salvat’s position as a world leader in the field of otology.

Clinical trials, agreed with the FDA, began at the end of 2019 and are scheduled to end this year. These studies will include 400 adult patients affected by otomycosis, mainly from hospitals in the US and Spain and with the participation of other countries such as Mexico, Portugal, Bulgaria and Romania.

For Alberto Bueno, Salvat’s General Manager, “this project is a reflection of the firm R&D commitment we have made in the area of otology, and reinforces our leadership position in this therapeutic area, without losing focus on other areas of strategic growth for Salvat. Only in 2019, we have invested 10 million dollars in R&D, which represents 15% of our whole turnover”.

Otomycosis is a type of external otitis caused by an acute fungal infection that affects the ear canal. It is estimated that approximately 10% of people living in developed countries suffer from at least one episode of this kind of otitis in their lifetime1.

This medicament in development is a major advance in the treatment of otomycosis. It is hoped that, thanks to its topical and localized application, it will become a more effective solution to otomycosis, which currently has no approved treatment.

In the regard of the expansion of the Pharmaloop plant in Alcalá de Henares (Spain), it is expected to be complete by 2020, which will have involved an investment of more than 35 million euros and the creation of more than 100 jobs.

Laboratorios Salvat, pioneer in Otolaryngology

Otorhinolaryngologist recognize Salvat as the number one company in the development of treatments for otology. This new medicament for the treatment of otomycosis confirms Salvat’s commitment to this medical speciality and the company’s desire to consolidate its leadership in the treatment of ear diseases.

 

[1] https://www.sciencedirect.com/science/article/pii/S0716864016301250

Japanese companies from the pharmaceutical sector visit Pharmaloop’s facilities

Japanese companies from the pharmaceutical sector visit Pharmaloop’s facilities (a Salvat company) through @ICEX and @IcexJapon.