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.

Salvat and Pharmaloop were present at the CPhI Worldwide 2019

On the 5th, 6th and 7th of November, the city of Frankfurt hosted one of the largest events worldwide in the pharmaceutical industry, bringing together over 45,000 visiting attendees and 2,500 international exhibitors: CPhI Worldwide 2019.

Salvat and Pharmaloop teams held numerous meetings with current and potential partners from all over the world of the pharmaceutical industry, to explore new business opportunities, both in licensing our products, and in offering our development and manufacturing services.

Salvat was present at The Bio International Convention 2019, at Philadelphia, US.

Salvat was present at the world’s largest pharmaceutical biotechnology event: The Bio International Convention 2019, which took place this year in Philadelphia (USA), from June 3rd to 6th, where meetings were held with companies from the pharmaceutical industry from all over the world. The aim was to explore new business opportunities for licensing our products and offering our development and manufacturing services.

 

 

Salvat participated in the CPhI North America Congress

Salvat participated in the CPhI North America Congress, which annually gathers the most important companies of North America. This year it was held in Chicago, where we held many meetings with other pharmaceutical companies to explore opportunities that allow us to continue developing our activity in the United States.

Salvat and Pharmaloop participated in the CPhI Worldwide Congress

Salvat and Pharmaloop participated in the CPhI Worldwide Congress, which annually gathers the most important companies in the pharmaceutical world. This year it was held in Madrid, where both companies had the opportunity to hold many meetings with other pharmaceutical companies to explore opportunities that allow us to increase our activities internationally.

 

Laboratorios Salvat completes patient recruitment for the CIFLOTEX trial

On August 30th 2018, the enrolment of patients into the CIFLOTEX clinical trial was completed. This study has been carried out in 45 US centers, and 493 patients suffering from Acute Otitis Externa (AOE) have been included. The objective of the study is to assess the efficacy and safety of our combination of Ciprofloxacin + Fluocinolone (OTOVEL® in the US) administered as otic drops in single-use vials, when compared to Ciprofloxacin and Fluocinolone alone. The study had been requested by the FDA in order to obtain data of OTOVEL in the treatment of AOE, before approving this indication, which would be added to the currently approved AOMT (Acute Otitis Media with tympanostomy tubes). The final results of CIFLOTEX will be available before the end of this year.

Laboratorios SALVAT S.A. and Arbor Pharmaceuticals, LLC Announce the Launch of OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution

BARCELONA, Spain and ATLANTA, Aug. 29, 2016 /PRNewswire/ — Laboratorios SALVAT S.A. (SALVAT) and Arbor Pharmaceuticals, LLC (Arbor) jointly announce the launch of OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution, the first and only antibiotic and steroid combination ear drop available in sterile, preservative-free single-dose vials. OTOVEL® is owned by SALVAT, and Arbor will be the exclusive distributor of the product in the U.S.

“We are very pleased to be partnering with SALVAT to represent OTOVEL® in the U.S.,” said Ed Schutter, President and CEO of Arbor. “OTOVEL® is a perfect fit with our other pediatric products that are sold by our team of over 200 sales professionals throughout the country.”

“It is exciting to further expand the international commercial availability of OTOVEL® through the partnership with Arbor in the U.S.,” said Alberto Bueno, CEO of SALVAT. “This new launch of OTOVEL® is a major milestone for SALVAT as we continue to grow our presence in the U.S. market.”

About OTOVEL®

OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa. Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of OTOVEL® compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total 662 pediatric patients (aged 6 months to 12 years old) with AOMT were included. In both trials, the OTOVEL® treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms. In Study 1 and Study 2 the median time to cessation of otorrhea in the OTOVEL® group was 3.75 and 4.94 days, respectively, compared to 7.69 and 6.83 days in the ciprofloxacin alone group1.

OTOVEL® is packaged in sterile, single-use vials, with each vial containing a delivery volume of 0.25 mL sterile, preservative-free solution. OTOVEL® is promoted and distributed by Arbor and is now available nationwide.

About Acute Otitis Media with Tympanostomy Tubes (AOMT)

Acute otitis media (AOM) is an inflammation of the middle ear space, behind the eardrum (tympanic membrane), that usually results from infection. The infection often results in fluid accumulation (effusion) within the middle ear, increasing pressure on the eardrum. This pressure can cause fever, ear pain, and problems with hearing in affected patients. Children that have recurrent AOM may have tympanostomy tubes inserted through a small incision in the eardrum to help facilitate drainage of fluid from the middle ear. Approximately 1 million children undergo placement of tubes in the United States every year2. While the insertion of tubes may help reduce the recurrence of AOM, a study reported that 83% of children with tympanostomy tubes in place for 18 months will experience at least one episode of AOMT3. The clinical presentation of AOMT is different than AOM in children with an intact eardrum in that pain and fever are much less common. The most common symptom of AOMT is fluid drainage from the ear (otorrhea).

IMPORTANT SAFETY INFORMATION FOR OTOVEL®

INDICATION

OTOVEL® is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, Streptococcus S. pneumoniae, H. influenzae, M. catarrhalis and P. aeruginosa.

IMPORTANT SAFETY INFORMATION

Contraindications

OTOVEL® is contraindicated in:

Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL®.
Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.
Warnings and Precautions

Hypersensitivity Reactions – OTOVEL® should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Potential for Microbial Overgrowth with Prolonged Use – Prolonged use of OTOVEL® may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea – If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

Adverse Reactions

Clinical trials experience: the most common adverse events that occurred in >1 patient were, otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling and balance disorder.

For additional safety information, consult the OTOVEL® full Prescribing Information or click the following link http://arborpharma.com/docs/OTOVEL_USPI_Final.pdf

About SALVAT

Laboratorios SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955, SALVAT is headquartered in Barcelona (Spain) and its US subsidiary, SALVAT USA, is located in Miami, FL. SALVAT is present in over 60 countries and keeps strengthening its international presence through the licensing of its own developments. The company launched CETRAXAL® (ciprofloxacin 0.2 %) otic solution in the US in 2009 and received FDA approval for OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution in April 2016. Additional information regarding Laboratorios SALVAT and its products is available at https://www.svt.com

About Arbor

Arbor Pharmaceuticals, LLC, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, neurology, hospital and pediatric markets. The company has over 700 employees including approximately 600 sales professionals promoting its products to physicians, hospitals and pharmacists. Arbor currently markets over twenty-two NDA or ANDA approved products with over 35 more in development.

For more information regarding Arbor Pharmaceuticals or any of its products, visit arborpharma.com or send email inquiries to info@arborpharma.com.

1. OTOVEL Prescribing Information, Arbor Pharmaceuticals, LLC. 2. Dohar JE. Tympanostomy tubes: not the magic bullet for acute otitis media. http://www.medscape.org/viewarticle/730700. Published October 21, 2010. 3. Ah-Tye C, Paradise JL, Colborn DK. Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration. Pediatrics. 2001;107:349-350

SOURCE Arbor Pharmaceuticals, LLC

Related Links

http://www.arborpharma.com