Ensuring access to safe and effective treatments is the main challenge faced by pharmaceutical companies big and small. Value-added medicines offer an efficient method to meet the needs of patients while stimulating innovation in the pharmaceutical industry.
What is a value-added medicine?
Value-added medicines are novel drug products created to provide improvements for patients that can’t be achieved using traditional therapeutic methods.
What type of improvement can value-added medicines deliver?
The improvements offered by value-added medicines are numerous and can benefit every individual connected to the pharmaceutical industry. Doctors, patients, medical researchers, and healthcare reps are advantaged by more efficient, safe, and cost-effective healthcare options.
The potential benefits of value-added medicines include:
- Improving the administration and/or ease of use of pharmaceutical products
- Developing drugs with better efficacy, safety, and tolerability profile
- Increasing health outcomes and patient quality of life
- Creating more agreeable treatments and thereby increasing patient adherence
- Providing more options for doctors and patients
- Preventing therapeutic escalations
- Generating cost-effective healthcare systems and improving access to healthcare
- Finding new innovative uses for already-existing drug products
What is the role of research and development in the pharmaceutical industry?
The purpose of research and development in the pharmaceutical industry is the incremental innovation of medicinal products and treatments. Thanks to R&D, healthcare inefficiencies are addressed and new, life-saving technologies are put in the hands of healthcare professionals.
What R&D efforts are needed to develop value-added medicines?
A considerable R&D investment is required to optimize health systems and develop new drugs and therapeutic devices. A clinical development program may be required for the proper health technology assessment of value-added medicines.
When working with value-added medicines, clinical data is needed to guarantee the safety and efficiency of new products. Evidence-based information helps third parties, such as doctors, patients, and regulatory bodies, understand the different indications and new improvements.
Examples of this include:
- In the case of drug repositioning, new data is required to convey an improved safety profile.
- For drug reformulation, the same can apply with an increased speed of onset.
- Changes in the blood concentration profile of a drug. This can happen due to a change in dosing frequency, dose strength, release profile, route of administration, and other such instances.
- The development of new combination products containing previously unseen combinations of active substances.
- To comply with the law. For instance, European pediatric regulation places certain requirements to support the safety and efficacy of drugs destined to be used on children (source).
Three main R&D processes are used to develop value-added medicines. These are known as drug repositioning, drug reformulation, and drug combination.
Also referred to as drug repurposing, this is the practice of investigating already existing drugs to discover new therapeutic purposes for them. For example, the chemical compound Thalidomide, which was created via drug repurposing, can be used in the treatment of HIV, various forms of cancer, and skin conditions like complications associated with leprosy.
Drug repositioning has become a strategic research approach when treating neglected diseases. This is due to 5 main reasons:
- The required clinical trial steps of a repurposed medicine are fewer than normal. This can drastically reduce the time and money it takes for a repositioned drug to reach the market.
- The formulation and distribution of the drug may be easier to achieve with the current pharmaceutical supply chain infrastructure.
- There is an increased chance of developing more effective treatments by combining other drugs. Accomplished repositioned drugs may be used for future repositions.
- A successful repositioned drug may help with the overall advancement of medical research. New classes of medicines and new mechanisms of action for old drugs may be discovered via drug repositioning.
- Early research stages are not hindered by activation barriers, leading to a more straightforward advancement into disease-oriented research.
As a novel drug development approach, drug repositioning has been crucial to several achievements of modern medicinal research. Sildenafil, better known by the brand name Viagra, is one of the successes of drug repositioning. The repurposing of antimicrobials has led to the development of broad-spectrum therapeutics. Furthermore, drug repositioning has become one of the leading strategies in the fight against covid-19 (source).
The potential of repositioned drugs is currently being considered in the field of psychiatry. According to research, medicines created through drug repurposing may help in the treatment of severe mental illnesses such as mania and polar depression as an adjunctive treatment (source).
Albeit very similar in concept and popularity to drug repurposing, drug reformulation is achieved through a different process. While the former is interested in finding new purposes for already-existing drugs, the latter refers to the development of different formulations for the same pharmaceutical product.
A joint study performed by the London Schools of Hygiene and Economics together with the Belgian KU Leuven estimated how much the development of new drugs costs on average. By using publicly available data, the researchers concluded that the median cost of bringing a new medicine to the market is $1.3 billion. The cost of drug development varies with the disease, with cancer drugs being the most expensive to develop (source).
The restrictively high costs of drug development hinder the efforts of many pharmaceutical companies. Moreover, the competition posed by generic medicines and the high rate of clinical failures make the development of novel medicines a very hefty economic risk. The reformulation of a drug gives developers the strategic advantage of not having to develop a new drug from scratch.
In an effort to reduce regulatory risk and reach the market faster, pharma companies might decide to pursue the approval of medicines with a simple lead formulation. Later, superior formulations can be introduced with fewer challenges to overcome.
This strategy allows the brand recognition of a pharmaceutical product to develop and improve in the eyes of customers with the passage of time. New formulations of successful drugs can expand the patient population by enhancing safety and efficacy while still providing the previously attainable benefits.
Also known as fixed-dose combinations, a drug combination is a medicine characterized by having two or more active ingredients in a single dosage form. This type of medicine was initially devised to target a single disease, such as antiretroviral drugs used in the treatment of AIDS. Nonetheless, current drug combinations are able to target multiple conditions simultaneously, especially if these are related.
Notable prescription drugs that have been achieved via drug combination are:
- Adderall: Used in both the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
- Aspirin/Paracetamol/caffeine: This combination is used for the treatment of pain, especially tension headaches and migraine. It is sold under several region-specific trade names, including Excedrin and Anadin.
- Paxlovid: Created using a combination of nirmatrelvir and ritonavir, this medication has been devised as an oral treatment for covid-19. It was granted emergency use authorization by the United States Food and Drug Administration (FDA) in December 2021 and was fully approved in the United Kingdom, European Union, and Canada soon after.
Value-added medicine development services
By bringing commercially and clinically meaningful improvements to new molecules, Altus Formulations can drive the success of your drug development efforts. Whether you’re working with an NCE, NME, or an older substance, Altus Formulations can help you deliver new medicinal products to the market while creating improvements for patients, healthcare professionals, and payers.
The benefits of working with Altus Formulations include the following:
- Enabling Formulations: The Altus Patent Umbrella protects all your pre-clinical, clinical, or commercial formulations.
- First in Man Formulations: Using pre-clinical and clinical performance data, Altus Formulations can improve the patent application process for new drug products. The same information can also be used to increase a clinical candidate’s value and improve its positioning on the market.
- Branded Products: To succeed in a highly-competitive pharmaceutical market, it is imperative for new formulations of well-established drugs to differentiate themselves. Altus Formulations offers medicinal products with unique features, exclusivity, and price premiums, giving them a substantial competitive edge.
- Market-Protective Formulations: By partnering up with Altus Formulations, a pharmaceutical company can ensure their NMEs and NCEs will always be protected by patent coverage. Both drug products created with the help of Altus Formulations and those produced before a partnership benefit from access to patent protection.