• The pharmaceutical company Salvat has received FDA approval to manufacture Otovel, an ear drop solution for the treatment of acute otitis media, at its Pharmaloop facility in Alcalá de Henares for distribution in the U.S. market.
• In addition to Otovel, Salvat is expected to produce three more products from its otolaryngology and ophthalmology lines for the U.S. market in the coming months.
• The launch of Pharmaloop and the FDA authorization have led to the creation of more than 150 highly skilled jobs and an investment of over €80 million.
• This new milestone further consolidates Salvat’s position as a leader in ophthalmology and otolaryngology, with four lines of single-dose products and one of sterile multi-dose products.

Salvat, an international pharmaceutical company and manufacturer of products such as Cristalmina, Relive, Otovel, Tebarat, and Cetraxal, is significantly expanding its presence in the global market. The Pharmaloop plant, located in Alcalá de Henares (Madrid), has become the first facility in Spain to receive FDA authorization for the manufacturing of sterile products using BFS technology for the U.S. market. The approval from the U.S. Food and Drug Administration (FDA) covers the production of Otovel, an ear drop solution for the treatment of acute otitis media.

Pharmaloop is also working towards obtaining FDA approval to manufacture three additional solutions: Cetraxal, for the treatment of acute external otitis; Clotrimazole, an antifungal solution for the treatment of otomycosis; and Clobetasol, a corticosteroid for post-surgical ophthalmic treatment. These solutions will be produced in Spain and are expected to be shipped to the U.S. in 2025.

With this manufacturing authorization, Salvat Laboratories not only completes its business chain but also opens the door to manufacturing for third-party companies interested in distributing BFS technology-based solutions in the U.S. market.

A State-of-the-Art Facility

Designed from the outset to meet FDA standards, the construction of the plant in 2019 involved an investment of €65 million. With the addition of personnel, energy activation, and machinery setup, the total investment has reached €80 million.

In 2023, Pharmaloop generated more than 100 jobs, and today, it has created over 150. Given the high-tech nature of the plant, these positions are filled by highly qualified professionals, including pharmacists, technicians, mechanics, and engineers, all trained to operate the sophisticated technology at Pharmaloop.

Focus on Ophthalmology and Otolaryngology

This latest milestone consolidates Salvat Laboratories as a leading player in the fields of ophthalmology and otolaryngology, with four lines of single-dose sterile products and one line of multi-dose products.

The company already offers several BFS technology-based solutions in European markets, targeting conditions such as glaucoma, conjunctivitis, post-surgical ophthalmic care, external otitis, acute otitis media, and allergic rhinitis, among others.

Alberto Bueno, CEO of Salvat Laboratories, highlighted the importance of the FDA approval: “We believe this is a key milestone in our international strategy. Having FDA clearance to manufacture certain sterile medications at Pharmaloop for the U.S. market gives third parties the confidence to rely on our facility. This not only boosts our business potential but also enhances our ability to provide the public with sophisticated solutions for their health needs,” he explained.

• Phase III clinical trials conducted in adults confirm the efficacy and excellent safety profile of SVT-15473 ophthalmic clobetasol, formulated with IMPACT-SVT® patented nanoemulsion technology, for the treatment of inflammation and pain following ocular surgery.
• This is the first clinical study conducted in Europe in pediatric patients with a topical ophthalmic corticosteroid.
• With the new study, which is being carried out in six Spanish hospitals, its safety in pediatric patients aged 0 to 3 years is expected to be also demonstrated.
• With this project, which has involved a total investment of over 20 million euros, Salvat Laboratories takes another step in its strategy to establish itself as a key international player in the field of ophthalmology.

Salvat, an international laboratory that develops, manufactures, and markets products such as Cristalmina®, Gama Relive®, Tebarat®, and Cetraxal® Plus, has initiated a new study with SVT-15473 clobetasol, the first ocular corticosteroid formulated with IMPACT-SVT® patented nanoemulsion technology, to treat inflammation and pain in patients undergoing ocular surgery. In this case, the trial will include children aged 0 to 3 years with cataracts, aiming to demonstrate the drug’s safety in this population as well.

Cataracts in pediatric patients can be congenital or acquired as part of certain diseases. Overall, the incidence of pediatric cataracts ranges from 1 to 5 cases per 10,000 individuals.

The new study, which is the first to be conducted in Europe with topical corticosteroids in this pathology and population, will include 60 cases randomly divided into two equal groups. One group will be treated with SVT-15473, and the other, as a control group, with Prednisolone. The study will take place in six Spanish hospitals, with coordination led by Dr. Marta Morales, Head of the Ophthalmology Department at Hospital Sant Joan de Déu in Barcelona. The participating hospitals include Vall d’Hebron Hospital and Germans Trias i Pujol Hospital, both in Barcelona, La Paz Hospital in Madrid, Cruces Hospital in Bilbao, and Miguel Servet Hospital in Zaragoza. Currently, there are already 4 patients included and treated.

The conduct of this new study was agreed upon with the Food and Drug Administration (FDA), as part of the approval process that has already been initiated, based on the results of clinical trials involving 400 adult patients from 50 hospitals in the United States. These trials demonstrated the effectiveness and safety of SVT-15473 in treating inflammation and ocular pain following cataract surgery.

This new study, which aims to demonstrate the safety of SVT-15473 in patients aged 0 to 3 years, is complementary and does not interfere with the ongoing approval process, which is expected to conclude soon. “Once we have completed this study in the pediatric population, the indication could be expanded to include this age group, allowing the use of SVT-15473 clobetasol in any patient, regardless of their age,” explains Enrique Jiménez, Medical Director of Salvat Laboratories.

Innovation in the Industry

Salvat has developed IMPACT-SVT®, a patented nanoemulsion technology (emulsion with nanometer-sized droplets) for drug administration, promoting its penetration and accelerating the onset of its action, while providing excellent ocular comfort. IMPACT-SVT® has enabled the development of SVT-15473 using clobetasol, a “superpotent” corticosteroid that has never been used in the form of eye drops before.

Manufactured with BFS (Blow-Fill-Seal) technology, a sterile, advanced, and automated single-dose vial manufacturing system, SVT-15473 will be produced in the manufacturing line of Salvat USA Inc. in Miami, Florida, and in Pharmaloop S.L., Salvat’s facility in Alcalá de Henares, Madrid.

With this project, which has involved a total investment of over 20 million euros, Salvat Laboratories takes another step in its strategy to establish itself as a key international player in the field of ophthalmology.

• The new drug will be the only one on the market in the United States and Europe specifically formulated and indicated for the topical treatment of fungal otitis externa.
• Salvat has invested 22 million euros in this project with which reinforces its position as a leading laboratory in the field of otology at an international level.

Salvat, an international pharmaceutical company focused on the development, manufacturing and commercialization through partners worldwide of products such as Otovel and Cetraxal, has submitted the new drug application (NDA) for Clotrimazole to the FDA, the new treatment for fungal otitis externa.

The company thus begins the procedures to launch the new drug in the American market, where it is expected to be available in summer 2023.

For Alberto Bueno, CEO of Salvat, “this project is a reflection of the firm commitment we have made to R+D 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”.

Single and cutting-edge drug in otology

Salvat’s Clotrimazole represents a breakthrough in the treatment of this type of otitis externa since it will be the first and only existing drug in the United States and Europe specifically indicated to treat this pathology. While there are other medications or formulations on the market that can help managing the symptoms of this condition, Salvat’s bet is the only one focused on effectively treating otomycosis.

Salvat has specifically formulated Clotrimazole for otic use in the form of single-dose vials, making it easier for patients to use. This format also ensures the sterility of the product and, by containing the necessary amount of active ingredient, also warrants the correct use of the drug.

Years of research with exceptionally good results

The new drug has undergone two demanding clinical trials to evaluate its efficacy and safety. The trials have been conducted over 3 years in more than 400 adult patients affected by otomycosis, from hospitals in the United States, Mexico, and Europe.

Both studies have concluded with very positive results that confirm the efficacy and safety of the new drug for the eradication of the fungus that causes otomycosis and the associated clinical symptoms (pain, itching, feeling of fullness and hearing loss).

Investment and manufacturing

Since 2019, Salvat has invested more than 22 million euros in the development of this formulation of Clotrimazole, whose manufacture will be carried out in the plants of Salvat USA Inc. in Tamarac (Florida) and in the plant of Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A.

Salvat, pioneer in Otolaryngology

Salvat is one of the top pharmaceutical companies in developing and commercializing innovative otology products. Also, Salvat is the first to develop and commercialize otic drug products in single-dose vials worldwide. Otolaryngologists recognize Salvat as the number 1 company in the development of treatments for otology. This new drug for the treatment of otomycosis confirms Salvat’s commitment to this medical specialty and the company’s willingness to strengthen its leadership in the treatment of ear diseases.

• It is an innovative project based on pre-differentiated mesenchymal stem cells designed to treat patients with bone consolidation problems post-fracture (atrophic pseudoarthrosis).
• A Phase II clinical trial has been completed, with very promising results in terms of efficacy and safety, in patients with pseudoarthrosis of long bones.
• Salvat has invested more than 10 million Euros in this project in collaboration with the biopharmaceutical company Histocell, a company specialized in regenerative medicine and cell therapies.

Salvat, an international laboratory with its headquarters in Barcelona, Spain, has completed the Phase II clinical trial of a new treatment for non-consolidated long-bone fractures (pseudoarthrosis). The clinical trial design was agreed with the Spanish Agency for Medicines and Medical Devices (AEMPS). After the application of the product, patients were followed for two years to test its efficacy and safety, by assessing the fracture healing and the appearance of adverse events. This project has been carried out in collaboration with the biopharmaceutical company Histocell, which specializes in regenerative medicine and cell therapies.

Salvat’s new treatment is based on pre-differentiated allogeneic mesenchymal stem cells that are implanted in a calcium phosphate biomaterial and applied directly into the lesion site. Salvat has invested more than 10 million Euros in developing this innovative therapy.

 

Very positive results

Salvat has completed the Phase II clinical trial and the results are very promising. The research has been 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 fracture. In fact, in many cases, the fractures must be re-intervened surgically on several occasions, and nowadays there is no effective treatment for these situations. This condition has a big impact on patients’ daily functionality, as well as a very high health expenditure due to the cost of medical care. BONECURE is intended to achieve a good and faster bone consolidation allowing for a more complete functional recovery.

Based on these good results, Salvat plans now to continue with the clinical development, which will be discussed with the European Medicines Agency (EMA) in a Scientific Advice Meeting. The possibility of extending the research to other bone pathologies will also be discussed.

 

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 correctly. 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 surgeries, being also highly painful and dysfunctional.

Long bones are the ones that break most easily and cost the most to consolidate. The fracture of the tibia is one of the most common bone fractures and one of the most likely to develop pseudoarthrosis.

• 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.