Category: Medytox fda

Medytox fda

Botulinum toxin type A BoNTA products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable.

Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable.

Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication.

MEDY-TOX TO COLLABORATE ON BOTULINUM TOXIN PRODUCTS

Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.

Click here to view. Botulinum neurotoxins BoNTs are bacterial exotoxins that inhibit vesicular neurotransmitter release by interacting with the exocytotic release mechanism. Their ability to reduce muscular contraction led to the idea that local injection of BoNTs may be useful for overactive muscle conditions, and in the late s, botulinum toxin type A BoNTA was tested in human patients with strabismus.

Due to differences in clinical performance duration, dose, efficacy, immunogenicity, etcBoNTA products cannot be considered interchangeable.

These clinical differences result from underlying differences in basic manufacturing processes, formulation, and potency testing methods that result in distinct unit potencies and dose response curves for each product.

The apparent existence of conflicting information in the literature regarding the differences between products that are evident in some studies but not others suggests that the products act differently depending on the clinical and experimental conditions.

It is not uniformly possible to predict which parameters, systems, tissues, species, indications, etc will show differences; nevertheless, based on the scientific body of knowledge, significant conclusions can be drawn. Controversy in the literature over potential dose conversion factors reflects the underlying differences between products, which, because of their biological nature, simply do not fit into a neat, one-size-fits-all interchangeability package as may chemically synthesized drugs.

In this review, we provide evidence as to why BoNTA products are not interchangeable and shed light on reasons that most published studies show differences between products while others do not.

We discuss the fundamental properties of these medications that impart their unique biological characteristics and consider how these differences influence their in vivo activity as evident in both preclinical and clinical studies.

In addition, in order to obtain regulatory approval, each medication must be individually investigated to establish appropriate efficacy and safety parameters for use in a given indication. Finally, we consider implications of non-interchangeability regarding BoNTA products and approval status. A prerequisite to understanding why BoNTA products are not interchangeable is an appreciation of their biological nature. Unlike chemically synthesized drugs that are produced through a series of well-defined chemical reactions, biological products are produced by living organisms or cells.

Import Alert 65-02

Biological products are principally proteins, as are BoNTAs. Proteins are typically much larger and more structurally complex than chemically synthesized drugs; for example, with a molecular weight of kDa, the BoNTA core protein is hundreds or even a thousand times larger than most conventional synthetic drugs.

Due to their size and chemical composition, proteins twist and fold in characteristic ways ie, secondary and tertiary structures that are critical to their biological activity, including cellular binding and activation. An important example of this occurred with an erythropoietin product that led to an unexpectedly high incidence of pure red-cell aplasia among patients following a change in manufacturing process.

In another example, the biological product alglucosidase alfa acquired an alteration in its carbohydrate structure when production was upscaled, which involved growing the protein in larger tanks.

BoNTA production and formulation for clinical use was pioneered by Professor Edward Schantz, who described the procedure in several reviews. Table 2 shows the general manufacturing steps for each of the main BoNTA products, illustrating some similarities and differences. Notes: Allergan, Inc. Ipsen Ltd Slough, UK. In nature, these bacteria exclusively produce BoNTs as protein complexes of various sizes, with the neurotoxin serotype and protein composition of the complex dependent on the strain of the organism.

The bulk drug substance BoNTA preparations are reconstituted and diluted for biological activity testing. Although international standards for the activity of many biological products are established by the World Health Organization, 25 no international standard exists for BoNTA products. As a result, each manufacturer employs its own proprietary assay methods for testing potency units that includes a product-specific reference standard.

For this reason, units of biological activity are specific to each BoNTA product and unit doses are not interchangeable.Pursuant to the agreement, Allergan has also agreed to make additional contingent payments, including up to an aggregate of U. The closing of the transaction is contingent on obtaining certain government approvals. Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential.

medytox fda

From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and customers who rely on our products and the employees and communities in which we live and work.

For more information regarding Allergan, go to: www. Medytox is a research-based bio pharmaceutical company which developed a botulinum toxin product for the first time in Korea the fourth in the worldand engages in the development, manufacture, marketing and sales of neurotoxin products as its main business.

We are committed to providing people safe and high-quality products through biotechnology for better health and quality of life. For more information regarding Medytox, go to: www. This press release contains "forward-looking statements", including but not limited to statements regarding closing the transaction, product candidates, as well as certain development, regulatory and commercial milestones. These statements are based on current expectations of future events.

If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public filings with the U. Copies of Allergan's press releases and additional information about Allergan are available at www.

About Allergan Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. About Medytox Medytox is a research-based bio pharmaceutical company which developed a botulinum toxin product for the first time in Korea the fourth in the worldand engages in the development, manufacture, marketing and sales of neurotoxin products as its main business.

Forward-Looking Statements This press release contains "forward-looking statements", including but not limited to statements regarding closing the transaction, product candidates, as well as certain development, regulatory and commercial milestones.

Irvine, CA Log In Sign Up.Thomas Mendolia is a retired gastroenterologist in Elkin, North Carolina. Mendolia has been in clinical practice for 17 years of which he spent most of his time in private practice at Tri-County Gastroenterology. He ran Northwest Piedmont Clinical Research where he oversaw 40 different clinical trials mainly focused on compounds related to various GI diseases.

Mendolia is a founder of Medytox Solutions, Inc. A frequent lecturer, radio and television guest, and a member of the Institute of Medicine of the National Academy of Sciences, the Industry Standard dubbed Dr. Prior to CollabRx, Dr. Prior to his military service, Dr.

Lundberg completed a clinical internship in Hawaii and a pathology residency in San Antonio. His major professional interests are toxicology, violence, communication, physician behavior, patient safety, and health system reform.

Billings is a nationally recognized author, lecturer, consultant, professor and thought leader in genomic medicine and has served as the director of CollabRx, Inc. A board certified internist and clinical geneticist, Dr.

Billings holds a B. He then did two simultaneous post-doctoral fellowships at Yale: 1. Mason worked on gene patents, eventually leading to his work as an expert witness in the Supreme Court in Myriad v. AMP in Ajami attended Harvard Medical School and is a surgical pathologist with subspecialties in Gyn, Breast and Neuro- pathology.

Asad R. He has been involved with the development of heart valves, artificial coronary arteries, membrane oxygenators, dialyzers and various in-vitro-diagnostic and biomedical devices since His experience of over 25 years spans the growth of biomedical devices in companies such as Shiley PfizerC. He has been responsible for licensing and transferring medical device manufacturing technology from Latin America to Canada and to England. His areas of expertise range from product development to patenting and production.

Scientific Advisory Committee. Thomas Mendolia Chairman Dr. Paul Billings Dr. Christopher Mason Dr. Kamran Ajami Dr.

Asad Zaidi Asad R.South Korean biopharmaceutical company Medytox, Inc. Scientific evidence, however, shows this unique strain cannot be isolated from any soil.

There are glaring incongruities about the strain used for the botulinum product in the Evolus BLA, and therefore we are asking FDA to study and validate the data to assure public health and safety.

Knowing the identity and source of the strain is essential to ensure the safety, purity, and effectiveness of a neurotoxin product. A false statement about such a material fact calls into question the integrity of other statements and data showing safety and effectiveness in the BLA.

In addition, the adequacy of the testing during manufacturing depends on the identity and characteristics of the strain. Ivan C. Hall was an American researcher who discovered thousands of C. One of the Type A Hall strains was found to have the ability to produce more toxin per unit of culture than any other strain tested, and became the botulinum neurotoxin strain of choice in basic research and for commercial uses.

Medytox, Inc. Since the approval of Neuronox, Medytox has continued moving forward by maintaining a strong position in medical aesthetics as well as therapeutic indications associated with movement disorder. About Medytox Medytox, Inc. Log In Sign Up.What are some of the biggest accomplishment and changes Medytox has undergone since ?

This has been a major accomplishment for us, as it makes us the most valuable pharmaceutical business in Korea. Inyour biggest competitor was botox manufacturer Allergan; today the situation is very different.

medytox fda

Why have you decided to participate in this partnership? It is true that we have given Allergan exclusive commercialization rights for our new products in all countries excluding Korea and Japan. We are collaborating with Allergan on new products, but it is important to note that Medytox is only company in the world that has three different types of botulinum toxin products.

The first product is our existing botulinum product, while the second is the improved formulation that we have licensed-out to Allergan. The third product is nearly finished clinical trials and will be introduced in Korea in the third quarter of this year. We have three types, and all of them will soon be on the market. So, while we will work together with Allergan on the new-formulation botulinum toxin product, we will also compete against them with two other products, so I would call our relationship Partner and Competitor.

That said, Allergan has approximately 80 percent of the global botulinum market at the moment, which is why we decided to collaborate with them to get our new-formulation botulinum toxin product on the market globally as soon as possible.

Despite this interesting marketing strategy, were you not tempted to develop your own brand? When I started Medytox, I did not start the business to pursue only botulinum toxin products. Could you tell us how your new formulation is innovative, and what Allergan finds attractive about the product? The new formulation botulinum product has competitive advantages. The most important fact is that the product is liquid formulation, whereas all of the existing products are lyophilized or vacuum-dried powder.

Doctors have to reconstitute these freeze or vacuum-dried products with saline solution, and then draw and inject it with a syringe. The liquid formulation product does not require this process which mean very convenient, and it minimizes a potential contamination can occur during reconstitution process.

There could be some inaccuracy in the concentration of the reconstituted solution for these freeze-dried products, as measurement errors can occur at reconstitution stage.

medytox fda

With a liquid formulation, the solution will always be the same concentration, exactly as it leaves our manufacturing facility, allowing doctors to treat patients with more precision and safety, while being more convenient for them as well. Second big advantage is that is produced without any animal sourced products. As you know, we culture the Hall strain of Clostridium botulinum that produces botulinum toxin, and this C.

Usually this medium is made from some sort of animal product, and in the botulinum toxin market, Medytox is the first to use an animal-free culture medium.

We believe that this is very important in terms of safety, as there is always potential for contamination or exposure to contagious diseases when you use animal products, and being animal-product free is also a positive in terms of environmental and ethical responsibility, which means marketability.

But this is yet theoretical advantages yet since we have no data proving safety issue due to using animal source. Lastly, this product is human serum albumin free. All of the existing products use human serum albumin or something similar as a stabilizing compound, but we have succeeded in stabilizing the product without human albumin.

This will be another big advantage for long-term safety of our product, because it can remove the all of possible risks of transmissible disease from plasma-derived albumin.

As one of the most successful Korean biotech companies, your story gets a lot of attention. You are active internationally with product registered in 27 different countries. In addition, in preparation for the entry into advanced markets such as U. Continuing its robust growth, Medytox will prepare the foundation to become a true global biopharmaceutical company.Our comprehensive services range from urine drug testing for prescription medications, drugs of abuse and comprehensive pain management to a full range of clinical testing and esoteric services such as neurotransmitter testing.

In every case, for every patient, the highest levels of expertise, service and security are crucial. You can also quickly and easily order tests, track samples and view reports online with Advantage, our industry-leading, proprietary web-based laboratory ordering and reporting software. We continue to expand our range of testing options and are adopting exciting new methodologies across our growing roster of laboratory facilities.

Medytox Diagnostics is unparalleled in urine drug testing and comprehensive pain medication testing.

Evolus Gets FDA Nod For First Product

Medytox Labs supports the unique diagnostic needs for testing alcohol, prescription medications, drugs of abuse and other substances. Innovative testing to help physicians identify biochemical factors contributing to clinical pathology. Rennova Health offers a complete solution, with faster turnaround times and more reliable and accurate results, in a manner that is safe, secure and HIPAA-compliant in all respects. Medytox Diagnostics.

Key Features. Setting a New Service Standard. You need answers fast. We deliver. Ahead of the Curve. Medytox Diagnostics Solutions.

New face filler, Voluma, approved by the FDA

Toxicology Testing Medytox Diagnostics is unparalleled in urine drug testing and comprehensive pain medication testing. Test Menu. Esoteric Testing Innovative testing to help physicians identify biochemical factors contributing to clinical pathology. Become a Client. About Rennova Health offers a complete solution, with faster turnaround times and more reliable and accurate results, in a manner that is safe, secure and HIPAA-compliant in all respects.

Learn More. Solutions Learn more about our proprietary suite of vital, integrated solutions. View Solutions.Medytox concentrates our research capacity on botulinum toxin products as the main pipeline. Based on this, we are discovering various research technologies such as biofriendly filler development, toxin testing kit, anti-toxin drug development to to become a global biotech company.

The Best at Botulinum Toxin Industry. The best technology in botulinum toxin industry. Furthermore, Medytoxin developed a next-generation botulinum toxin pharmaceutical distinguished in its safety, efficacy, and stability. The Best at Medical Aesthetics.

Eye on Pharma: Mylan Could Develop the First True Botox Biosimilar

The best technology in aesthetic plastic surgery industry. After succeeding in developing botulinum toxin pharmaceuticals, Medytox developed a dermal filler, one of the major products in the aesthetic market. We succeeded in developing a filler using most biofriendly material hyaluronic acid and developed the manufacturing process and the analytical method and built GMP compliant facility for production.

Medytox successfully secured the botulinum toxin and the filler in global medical aesthetic industry to become the best company in the global aesthetic industry. Global Biotech Company. Medytox has been working towards the vision of growing as a global biotech company. By utilizing infrastructure and biopharmaceutical development capacity built from botulinum toxin pharmaceutical development, we generate profit and reinvest it in developing innovative biopharmaceuticals.

Medytox is continually growing as a global biotech company through continuous product development and investment. First In-house development of 3 types of botulinum toxin, each with unique strengths in the world. Development of various hyaluronic acid filler with distinct technology. Signed a License Agreement between Allergan Inc. US for new formulation of new botulinum toxin type A product.

medytox fda

Sales Unit: million KRW. International: Holiday: Closed.


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