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Envi committee final opinion on the SPC manufacturing waiver makes genericists happy

Caterina Lucchini
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Envi committee final opinion on the SPC manufacturing waiver makes genericists happy

About SPC manufacturing waiver we have discussed in different post (here, here and here).

The final Envi committee opinion makes genericists happy

The Envi Committee has essentially confirmed the possibility of producing and stocking the expiring products of SPC in view of the launch to “day 1”, the day when the additional protection ends. The provision concerns only the new SPC. Regarding the notification, the compromise amendments approved by Envi establish that the originator company receives written notification from the generic company – within 60 days before the beginning of production or any other act that falls within the protection conferred by the SPC – without, however, including confidential or commercially sensitive information in such notification. Envi has also canceled the request for special labeling for exports.

EMA General Director comment

Adrian van den Hoven, Director General of Medicines for Europe, said “We welcome the Health Committee’s efforts to improve the SPC manufacturing waiver in relation to day one launch and the protection of confidential business information. We hope that this progress, together with a more reasonable date of application, will be agreed by the Parliament and the Council in a future final agreement. We urge the Parliament’s Legal Committee to adopt a final Opinion that includes these important priorities for health, for jobs and for a robust pharmaceutical eco-system.”

The originator disappointment

On the other hand, EFPIA notes with concern the ENVI Committee’s adoption of the Compromise Amendments on its draft opinion relating to the SPC manufacturing waiver proposed regulation. “allowing the stockpiling of generic medicines while the innovator medicine is still under SPC protection and failing to guarantee a robust system for notifying innovator companies of applications for a manufacturing waiver makes Europe a less attractive destination for life science investment”.

 

 

Ema: patient records and real world data for clinical studies on hemophilia

Caterina Lucchini
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Ema: patient records and real world data for clinical studies on hemophilia

A new step on haemophilia clinical studies arrived from the European Medicines Agency. In fact, the EMA guideline dedicated to clinical studies on haemophilia has been revised, in particular for recombinant products based on factor IX derived from human plasma. The new guideline synergically complements the provisions contained in the guideline dedicated to coagulation factor VIII deficiencies (July 2018).

The new guideline on factor IX refers to:

  • Products for which a new application for marketing authorization is submitted
  • Products already authorized that are subject to significant changes in the production process (i.e. introduction of additional stages of inactivation / virus removal or new purification procedures).

Real world data for patients with new treatment

Patients never treated before are subjects to novelties. The data for the clinical studies, both for the factor VIII and for the factor IX, should be obtained from the registers of patients rather than small-scale clinical trials targeting only these sub-populations.

The more traditional approach, in fact, according to Ema could be not fully representative of the real use of the drug, once on the market, as these are very small groups of highly selected patients. The new haemophilia drug development guidelines have fully embraced the new approach to pharmaceutical development based on the use of high quality real world evidence, the goal of which is facilitated by the suggestion of a set of key data that should always be collected within patient records. The new consolidated approach in the new guidelines started in 2015, with a first workshop on the topic organized by Ema, followed by a public consultation in 2017 and a second workshop on hemophilia registers in June 2018.

Lighting reconstruction of clean rooms

Caterina Lucchini
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Lighting reconstruction of clean rooms

The industrial lighting reconstruction with an energetic purpose is of great importance for the pharmaceutical industry, strongly regulated and presenting the need for a tracked and controlled production.

In the case of clean rooms, lighting reconstruction must meet the following requirements:

  • Hygienic design: smooth and well-worked surfaces are needed. A high degree of IP protection serves to ensure that moisture and dust developed during production do not penetrate the luminaire housing.
  • Resistant surfaces: in compliance with the regulations it is mandatory to clean and / or disinfect systems installed in a clean room regularly. Consequently, it is important to choose materials that resist direct contact with aggressive detergents, that are biologically robust and that do not pose a danger to finished products. Preliminary evaluation of the planned operating hours is essential among the preliminary activities.

In the simplest cases is not necessary to consider applications related to presence sensors, lighting sensors, time programming, exploitation of natural light.

Economic evaluation of lighting reconstruction

The economic aspects to be considered for the lighting reconstruction are mainly linked to the economic savings due to the reduction in electricity consumption. The estimated cost is however subdivided on the 4 macro items related to the project:

– project management: it is estimated on the basis of previous projects for technology affinity, project size and geographic location of the plant.

– design: it is estimated according to the size of the plant to be built taking into consideration a minimum amount linked to the designer’s fixed costs for lighting calculations.

– supply and installation of the plant: it is estimated starting from the customer’s separate system in terms of:

  • number of lighting fixtures present;
  • power;
  • field of application of the plant;
  • current system status.

On the basis of this information, the economic value of supply and installation is estimated using the internal price lists and comparison plants produced as a reference. The installation cost is estimated using internal parameters modified in percentage according to the installation conditions.

– measurement system: the process of estimating the components of the measurement system is divided into two sequential phases. The first one involves the evaluation of the number of electrical panels included by performing a fixed economic estimate associated with each electrical panel, while the second is estimated by performing a precise analysis for each framework also onsidering:

  • dislocation of the paintings on the plans;
  • presence of a general light framework;
  • number and type of switches involved;
  • amperages and structure of the internal wiring of the switchboard (Ex-ante measurement campaign);
  • presence of Wi-Fi networks for wireless communication;
  • presence of wired Ethernet networks.

How to increase turnover at the end of the patent life

Caterina Lucchini
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How to increase turnover at the end of the patent life

They are called “aspirational strategies”, they deal with the issue of patent expiration and generic competition with the aim of maximizing the potential growth of a compound in the market.

Drugs based on small molecules can lose up to 90% of the market share of the brand just a year after the entry of generic products at a lower price, says the report by Arthur D. Little “The big patent expiry question : Why sink when you can sail? “. But what appears to be an inescapable event could actually present very interesting growth opportunities for the future, if we look at the problem pro-actively and from a positive perspective.


The strategies at the expiry of the patent


“The impact on the company of a Loe strategy (Loss of exclusivity) can be assessed using the turnovers as one of the key indicators. Traditional Loe strategies are usually chosen and designed to prevent the rapid decline of revenues, with a success that is achieved if this decline is slow. The aspirational strategies are instead designed to achieve growth, so that success is achieved if you have a turnover increase over time”explains Fabrizio Arena, partner and Head of Healthcare & Life Sciences of Arthur D. Little Italy.


How to maintain growth potential

There is no aspirational strategy that is valid for all cases, each product and therapeutic area must be approached in a specific way. “Ideally, the process of tackling the problem of patenting an active ingredient should start midway through the product cycle growth phase, usually three to four years after launch,” explains Principal Healthcare of Arthur D. Little UK Ben Enejo.


Identification of targets


The companies that hold the intellectual property rights of the expiring active ingredient have many options to draw from, including the development of their own generic version or branded generics of the product, or the modification of its characteristics in order to protect new indications, formulations or methods of administration. “If the objective is to maintain the market share, the situation of the same must be analyzed to verify how this can be achieved. The aspirational strategies are more suitable for producing turnover and profit growth. The financial and market evaluation is part of the development of the business case, which must be made thanks to inputs along the entire value chain of the drug”, explains Emmanuel Aisabokhae, Healthcare & Life Sciences manager of Arthur D. Little UK.

Attention to unexpected needs


The areas of clinical need expressed by physicians, patients, caregivers and payers are among the most interesting objectives for a Loe strategy, which could involve even minor changes to the product whose patent is nearing expiry. In fact, these targets can also provide new opportunities for expanding the company’s portfolio.

Trends and drivers of the sports nutrition industry

Caterina Lucchini
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Trends and drivers of the sports nutrition industry

Consumers worldwide are adopting healthy living and fitness trends, especially across
developed markets where healthy lifestyles have become the new normal; as a result,
this is expanding the consumer base for sports nutrition products.

Sport nutrition industry in numbers

Based on “Trends and drivers of sports nutrition Industry” Report, pubblished by Euromonitor International 2018, sports nutrition is the fastest growing category within consumer health, rising from USD 7.3 billion in 2011 to USD 11.9 billion in 2016. Looking forward, sports nutrition is expected to continue growing at the fastest rate (7.9% CAGR 2016–2021) of any consumer health category over the forecast period. Sports nutrition continues to expand, growing not only among core users but also by benefiting from global health and wellness trends around healthy diets, physical activity practices and efforts to extend healthy lifespans.

Sports Nutrition in the UK

The UK is seeing a growing number of people actively pursuing a healthy lifestyle and
engaging in sport on a regular basis. Consumers are set to expose sports nutrition products to increasingly rigorous scrutiny over 2017–2022, increasing demand for products that can provide certifications of their quality, vegan status and / or organic production. In addition, brands will need to become more transparent and will be aiming to reduce the number of ingredients used as consumers increasingly look for products with fewer, more familiar ingredients.

Sports Nutrition in the US

Sports protein and non-protein products continued to post healthy growth in 2017, with
this expected to continue. Sports protein ready-to-drink (RTD) remained one of the best performing categories, benefiting from brand manufacturers offering simple formulas incorporating new ingredients. Sports protein bars also continued to record solid growth, with sales driven by consumer demand for portable and convenient foods.

Sports Nutrition in China

Sports nutrition recorded strong current value growth in 2017 thanks to various factors, including favourable government policy, manufacturers’ efforts and increasing consumer enthusiasm. In 2016, the Chinese government launched the National Fitness Programme, encouraging consumers to take part in various sporting activities being held throughout the country, such as marathons. Over the forecast period, the growing fitness culture and various sports nutrition players are expected to be the main drivers of sales.

Sports Nutrition in Australia

Australia is the third largest sports nutrition market worldwide after the US and the UK.
Sports nutrition delivered consistent growth over the review period, driven by Australia’s
strong fitness culture and the wide availability of such products, with a plethora of brands
on the market and constant new product launches.  Social media plays a large part in the success of sports nutrition brands, with the use of social media channels including Instagram and Facebook, as well as brand ambassadors having a strong influence on sales.

 

Efpia’s position on the Spc manufacturing waiver issue

Caterina Lucchini
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Efpia’s position on the Spc manufacturing waiver issue

The Efpia position on the Spc manufacturing waiver issue is summarized in a post signed by the Efpia Director General, Nathalie Moll, and published on the Federation website on 25 October.

A weakening signal of IP protection in Europe

According to Moll, the European Commission’s proposal for a derogation from export-related complementary protection certificates could send a negative signal that Europe is weakening its commitment to incentives for intellectual property and innovation. “However – writes Moll – we also recognize efforts to clarify the purpose of the proposal and introduce safeguards, mitigate possible spill-over effects that would further erode IP rights and could have (the perverse effect) of discouraging investment in Europe, putting work and economic growth at risk, as well as advancing patient care”.

Legal clarity and certainty required

The points proposed by Efpia reflect the original proposal of the European Commission:

  • Ensuring transparency & legal certainty for all parties
  • A timely and fair notification system
  • Labelling measures which prevent products manufactured under the Waiver for export from being re-directed back to the EU or being launched on the EU market before SPC expiry
  • Non-retroactive implementation
  • Limited scope as per the European Commission proposal

Nathalie Moll also remembers how the SPC allows to compensate the development time of a new product, which “burn” around half of the useful patent life of a pharmaceutical product. The European innovative drug industry invests 35 billion euros each year in research and development (Efpia data) and assures over 750 thousand jobs in the Old Continent.

 

 

 

Global oral solid dosage pharma formulation market projections

Caterina Lucchini
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Global oral solid dosage pharma formulation market projections

The global oral solid dosage pharmaceutical formulation market to grow from US$ 493.2 Bn in 2017 to US$ 926.3 Bn by 2027 end. This represents a value CAGR of 6.5% over the forecast period 2017– 2027. Several important factors drive this growth.

This is what says the report prepared by Future Market Insights (IMF) before the summer.

North America the largest market …

North America will remain the largest market for oral-controlled release technology, and the trend is projected to continue throughout the forecast period. North America is expected to be the most lucrative among all regions, with a market attractiveness index of 2.7.

Diminishing share of oral solids in the development pipeline

Growing research on biologics molecules and their dominance in treating oncology conditions are hampering the growth of the oral solid dosage pharmaceutical formulation market. Approximately 50% of the pipeline molecules are biologics and the rest in the form of other dosage forms. Companies are betting heavily on biologics owing to their high returns in terms of value. For instance, in 2016, the top 10 drugs generated around US$ 79 Bn in terms of value; among these, 76.8% were from biologics.

5G revolution, are we ready?

Caterina Lucchini
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5G revolution, are we ready?

5G means hyper-connections between an ever-increasing number of connected devices. The implementation of 5G technologies will allow the definitive affirmation of the Internet of Things and the exponential increase of virtual reality solutions and augmented reality in the most disparate environments, starting from entertainment.

How will 5G impact on healthcare?

The “hyperconnections” works to promote a logic of decentralization of health care and centralization of patient data, with a consequent optimization of resources. 5G will allow doctors to use, for example, wearable devices to prevent or diagnose or perform online consultations or follow a patient’s adherence to a distance therapy or post-operative course or allow surgeons to operate from remote, in a much more efficient, reliable and secure way than it is already today.

Are there any health risks?

In order to implement the system, a denser network of cells and antennas is necessary to allow transmission and reception of the very high frequency electromagnetic waves used by the new technology, which, by their nature, have a lower penetration capacity.
And here is the Nimby syndrome looming.
All this technology could impact on the health of everyone: we do not know if and how much the 5G, or the exposure to radio frequencies necessary for the whole system to stand, can hurt. There are simply no studies guaranteeing the safety of living 24/7 in a forest of antennas and in a cloud of electromagnetic radiation; and this goes against the precautionary principle and is not particularly reassuring, especially for those used to reason in terms of real world evidence.
On the other hand, in our country, the auction for the 5G frequencies has been beaten and will bring into the coffers of the state something like 6.5 billion euros by 2022. Milan, Prato, L’Aquila, Matera and Bari are ready to enter, in 2020, in the world of 5G.
What interests will prevail?

Food supplements: the new electronic notification procedure

Caterina Lucchini
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Food supplements: the new electronic notification procedure

The electronic notification procedure for food supplements became officially effective on Monday, 2 July 2018. This procedure covers all “food subject to notification”. Find here all the information.

The procedure

The electronic notification of each food supplement must be send to the Ministry of Health through the system “Food Subject to Notification”.

In case of remarks, the Ministry gave information through a written letter. The operator will also find the requests in the system, but in any case only the registered letter will be valid.

What to do for foods notified with the “old procedure”

For food supplements notified through the previous system and therefore not present in the electronic notification system, a variation procedure must be performed using the new notification mode to enter the foods data. In this case, the operator of the food sector (OSA) at the time of the “new notification” will inform the system that the product has already been notified, including the code previously assigned. In this way the procedure will continue.

The electronic request must be presented using only the electronic notification system.

The Italian OSAs access the system through the “business portal” as indicated in the user manual. The European OSAs or San Marino access the system after having requested the appropriate access key to the office 4, as indicated in the user manual.

Response times

It is possible to verify the outcome of the procedure by connecting to the Institutional Site within 90 days from the sending of the notification request.

African pharmaceutical market

Caterina Lucchini
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African pharmaceutical market

A growth scenario is the one expected on African pharmaceutical market. The predicted growth in the global pharmaceutical market between 2012 and 2021 is estimated at 26% (according to PROPARCO’s SP & D publication), but the African drug market could increase by 200% according to a realistic assumption, or by 300% according to an optimistic hypothesis within this same period. Based on African Pharmaceuticals Market Report of Frost and Sullivan of 2016, the pharmaceuticals market in Africa is expected to reach a business opportunity of $45 billion in 2020. Goldstein Research analyst forecast the Africa pharmaceuticals market size is set to reach USD 160.7 billion by 2024, at a CAGR of 20.4% over the forecast years.

This rapid growth could be dependent of a convergence of changing economic profiles, rapid urbanisation, increased healthcare spending and investment, and increasing incidence of chronic lifestyle diseases. Major driving factor for Africa pharmaceutical market is the expansion of healthcare capacity which according to the World Bank Africa acquired 70,000 new hospital beds, 16,000 doctors, and 60,000 nurses, adding up to a total of 1,050,000 beds, 498,370 doctors, and 1,250,000 nurses between 2005 and 2012.

African pharmaceutical market scenario

The tropical climate of Africa makes the continent the largest reservoir of infectious diseases, particularly malaria, tuberculosis (TB), and acquired immune deficiency syndrome (AIDS), besides frequent outbreaks of polio, meningitis, cholera, pandemic influenza, yellow fever, measles, hepatitis, and tetanus. With the increasing adoption of Western lifestyle in Africa, there has been a paradigm shift in the burden of illness towards non-communicable diseases (NCDs), driving the demand for chronic prescription drugs. Based on World Health Organisation prediction, the proportional contribution of NCDs to the healthcare burden in Africa will rise by 21% through 2030. In the meanwhile, population will continue to suffer from infectious and parasitic illness, but lifestyle diseases such as cardiovascular diseases, diabetes, and cancer will witness high growth rates throughout the forecast period. Limited affordability of governments and the general population for healthcare and pharmaceuticals and a high reliance on donor funding will be the major market restraints.

Market Overview

Half of Africans do not have access to essential drugs. With the provision of the right drugs to treat respiratory infections, diarrheal diseases and malaria, around 10 million lives would have been saved in 2015. Every 30 seconds one African child is killed due to malaria. The 10 largest pharmacy retail chains in Nigeria, Kenya and Ghana manage 186 outlets for a population of almost a quarter of a billion people.

South Africa

According to the Pharmaceutical Industry in South Africa 2017 report of research and markets, the pharmaceutical industry provides the vital service of providing medication to the South African population and was valued at between R 42.6bn (€ 2,72bn) and R 45bn in 2016. Involved in the sector are 276 companies licensed by the Department of Health and the Medical Controls Council. Local manufacturing, valued at R 4.9bn in 2015, is dominated by local companies. In 2015 Aspen had a market share of 15.3% and Adcock Ingram’s market share was 8.9%. South African companies hold the number one position for overall market share, for Pharmaceuticals only and for over-the-counter medication only.

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