Under the partnership, Meiji Seika Pharma will engage with resident biotech companies operating within MBC BioLabs’ fully equipped research facilities. MBC BioLabs is set up to take away the cost and operational challenges of building and running laboratory infrastructure, allowing early-stage biotech companies to focus on scientific research and development as they move toward commercialization. Within this setting, the drug discovery innovation partnership supports faster exploration of new therapeutic concepts while making early-stage external collaboration easier to pursue.

The collaboration aligns with Meiji Seika Pharma’s open-innovation strategy and supports research and development in its priority therapeutic areas, including infectious diseases, hematologic diseases, and immune-inflammatory diseases. By working directly with entrepreneurs and startup teams based at MBC BioLabs, Meiji Seika Pharma is seeking to uncover promising drug discovery seeds and speed up external collaborations that can complement its internal R&D work. The company sees active engagement with global innovation hubs as an important way to sustain its long-term pipeline, with the Meiji Seika Pharma, MBC BioLabs partnership acting as a practical entry point into the U.S. startup ecosystem.

“We aim to energize our drug discovery research by drawing new ideas from global innovation activities and deepening collaboration with innovation hubs in Japan and overseas. Partnering with MBC BioLabs, which has a proven track record of identifying numerous startups and guiding them toward commercialization, represents a major step forward in these efforts,” said Takeshi Naruse, Managing Executive Officer and Head of R&D at Meiji Seika Pharma.

MBC BioLabs highlighted the mutual value of the collaboration, emphasizing its role in supporting both entrepreneurs and established pharmaceutical innovators.

“MBC BioLabs is excited to partner with Meiji Seika Pharma to empower entrepreneurs and help bring Meiji’s innovations to the U.S. biotechnology ecosystem,” said Flavia Nachbar, Director of Alliances at MBC BioLabs. “This collaboration reflects our shared belief that bold science, backed by the right resources and relationships, can transform human health around the world.”

With an eye on analytical testing, toxicity testing, and fill-and-finish chores, CMOs will be doing more hiring overall in a variety of fields soon. Along with these forecasts, CMOs are already adjusting their operations to provide consumers more choices and the most modern services.

Planning and Offering More Services

Many big organisations are using contract development and manufacturing organisation (CDMO) service packages to improve their procedures even more. Societal CDMO signed two new contracts for manufacturing and contract development in October 2022. These agreements state that diverse testing techniques, technical transfer, preparation, manufacturing, and packing services for new drugs have to be offered.

The initial agreement addresses services including tiny volumes of medications for clinical research, developing and testing novel analysis techniques, knowledge transfer and formulation improvement, and first-time pharmaceutical packing. Conversely, the second transaction is for the services Societal CDMO provides. This cover developing new formulas, moving and verifying analytical techniques, applying good manufacturing procedures (GMP) in batch production, and filling and finishing.

Other businesses concentrate on providing their injectable pharmaceutical CDMO treatments to clients from outside the United States. Including designing pre-filled syringes (PFS), moulding them, preparing the medications, filling them, grouping them, and packing them, Terumo Pharmaceutical Solutions will manage the entire process of manufacturing biotech drugs and small molecules.

The services would span early phases of research all the way through major commercial production for pharmaceutical firms from abroad. For instance, the services might involve assembling PFS with needle safety devices and autoinjectors.

Although the position of CDMOs is continually shifting, deals are still being done to support the broader pharmaceutical industry.

In June 2022 Kindeva Drug Distribution purchased CDMO iPharma Labs. iPharma Labs developed breathing medications. Early on in drug discovery, iPharma has collaborated with nebulisers for both small and large molecules as well as dry powder inhalers and soft mist inhalers. It has knowledge creating liquid, dry powder, and propellant-based therapies as well as medications for breathing.

Growing its clinical supply centre at the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China, Catalent also completed. The rise has made it feasible to expand packaging capacity and add more cold, deep-frozen store space.

Brand-new buildings

More businesses aim to lead the way in enhancing biologics, sterilisation, manufacturing, and other sectors as newly built factories open. Thermo Fisher Scientific is, for instance, building a new plant in Hangzhou, China. Based on proof, the company also undertakes commercial and trial drug material and drug product work; it plans to shortly add commercial packing and labelling work as well.

New structures mean that new owners have to strive to improve the manufacturing of commodities. Recipharm, for instance, indicated that one of their German clean factories would install a new high-speed filling line for pre-filled needles and canisters to raise their CDMO. The line will be capable of managing low- and high- volume jobs.

Current Outsourcing Trends

The most recent CPHI study reveals that hiring practices have changed significantly generally. These days, early on in the pre-clinical stage, developers map out the complete life cycle of a device.

The study’s key discovery was that, contrary to previous belief, pharma-ready synthetic pathways are designed far earlier in the development process. But phase-appropriate development is today considered as an antiquated approach, particularly in relation to quick routes. According to the report, designers will also have to decide between a multi-provider approach and a single end-to- end supplier. Furthermore mentioned was the need of CDMOs reviewing their marketing strategies and development goals.

To boost output and cut costs, biotech contract manufacturing companies (CMOs) will spread into various sectors going forward. They will offer single-use or throwaway systems, innovative treatments like cell and gene therapy, ongoing bioprocessing, and other specialist bioprocessing services.

With a compound annual growth rate (CAGR) of 22.4%, the present bioprocessing market is projected to be worth more than $218 million in 2023 and is expected to reach more than $599 million by 2028, according to one of the market research studies published. The main causes of this development are the rising demand for biopharmaceuticals, the increasing acceptance of continuous bioprocessing among contract manufacturing companies (CMOs) and contract manufacturing organisations (CMOs), and the benefits of continuous bioprocessing over batch and fed-batch modes of production.

Knowledge of Market Dynamics By use of PAT’s application to optimise continuous bioprocesses

Process analytical technology (PAT) is the name given to a system including analytical tools meant for monitoring and control of industrial processes. Apart from sensor technologies, tools for process analysis and testing (PAT) such as spectroscopy and chromatography enable continuous monitoring of important process parameters (CPPs) and critical quality attributes (CQAs) in real time. This helps manufacturers to quickly spot any kind of deviation and implement the required corrections to maintain the integrity of the process as well as the quality of the goods. The PAT advances and helps the producers maximise their operations in several spheres, including the following:

Process knowledge and control: PAT helps to deepen understanding of the bioprocessing environment by means of insights on links between the process parameters and product characteristics. This helps one to grasp the bioprocessing environment better. Manufacturers may make use of this knowledge to create advanced control systems including feedback control loops or even model predictive control, therefore optimising the process performance and ensuring consistency of the product.

By means of PAT-enabled optimisation, which simplifies bioprocessing operations, it is feasible to simplify opportunities for process intensification as well as efficiency gains, thereby reducing cycle durations and increasing productivity. By always monitoring and modifying process parameters, manufacturers may minimise cycle times, boost throughput, and even raise general productivity. This enables their progressive progress and goal attainment.

PAT is in line with the ideas that apply to quality by design (QbD) since it helps to build solid processes that go on to produce things regularly with the necessary quality traits. This enables manufacturers to go forward and include quality into the process from the very start, therefore lowering the risk related to product failures and deviations. One achieves this by including PAT instruments into the phases of design and development.

Apart from a cut in waste, production expenses also reduce. By means of consistent monitoring and control made available by PAT, one may help identify and minimise process inefficiencies, therefore lowering the raw material, energy, and waste generation amounts. Consequently, not only does this save production costs, but it also aids in the accomplishment of sustainability targets by lessening environmental negative effects.

Regarding the facilitation of regulatory compliance, PAT gives manufacturers the tools and the data they need to present to regulatory authorities demonstrating that they have a complete awareness of the process, that they have control over it, and that they are consistent with it. Using PAT helps producers to simplify regulatory filings, speed up product approvals, and guarantee compliance with strict regulatory criteria.

All things considered; PAT-enabled optimization has a significant potential in the continuous bioprocessing industry. This possibility motivates manufacturers to achieve higher degrees of process efficiency, quality, and regulatory compliance, therefore generating more revenues.

In terms of ongoing bioprocessing, high production and cost promote chromatography system appeal.

Product into chromatography systems with filtering systems along with devices; consumables; bioreactors; cell lines, cell culture medium, buffers, and reagents; also, other products divide the market for consistent bioprocessing. This is something one ought to give thought. Among other components, the chromatography systems and the consumables comprise resins, membranes, buffers, solvents, columns, reagents, and other consumables like autosamplers, fittings, and tubing detectors. Consistent chromatography techniques are absolutely essential for continual downstream bioprocessing if one is to get high protein purity. These advanced techniques offer a lot of interesting possibilities. One can keep the process running constantly by running several chromatography columns either countercurrent or even concurrent. This is so because the loading is done in the first column and all the other subsequent processes—elution, regeneration, washing, and re-equilibration—occur inside the next columns. Many chromatographic methods are part of the continuous mode of operation. Countercurrent chromatography (CCT), multicolumn countercurrent solvent gradient purification chromatography (MCSGP), simulated moving bed (SMB) chromatography, and continuous annular chromatography (CAC) among these methods.

Growing demand for biologics has led to the necessity for intensification of the upstream bioprocess in order to raise production and minimise manufacturing costs. This is so due to the growing biologics market. Several studies by the National Centre for Biotechnology Information (NCBI) show how well integrated continuous bioprocessing is applied in manufacturing monoclonal antibodies (mAbs). These studies have indicated that the technique works. For example, one-column continuous chromatography (OCC) and perfusion bioreactor culture using alternative tangential flow technology (ATF) allowed a researcher to get about an eighty percent boost in productivity.

Moreover, companies are fast shifting their focus to chromatography systems in order to fulfil growing industry needs and speed their manufacturing processes. Following that, Waters Corporation and Sartorius AG announced in June of 2023 their cooperation to create integrated analytical solutions for the biomanufacturing process occurring deeper downstream.

The value of approaching farther downstream

Aimed at isolating and purifying the expected biopharmaceutical product from the complex mixture related to cellular components, media, and contaminants generated during upstream production, downstream processes have a sequence of purification steps along with separation techniques. Along with accessories and other products connected with them, these activities sometimes produce items such cell filtration systems, devices, chromatography systems, and consumables. Particularly continuous chromatography systems are reinventing downstream purification by enabling continuous separation as well as the purification of biopharmaceutical products with exceptional precision and throughput. This represents a major advancement in the downstream goods purification process. Large biopharmaceutical companies have effectively applied both aqueous two-phase extraction, also known as ATPS, and periodic countercurrent chromatography, also known as PCC, continuous CTC, MCSGP, and SMB for the aim of continuous capture from the process development scale all the way up to the manufacturing scale. These businesses have been able to avoid the possible process bottlenecks this suggests. These experts help to enhance the cost of the goods, the quality of the output, and the effectiveness of the process. Two among the several resins used in the Protein A resin screening process are MabSelect Sure PCC-Cytiva and Poros ProA-Thermo Fisher Scientific. These resins are reachable all during the process’s continuous capture phase. Apart from compound development and manufacturing companies (CDM), it is expected that more mid-sized biotech companies will arise in the next few years.

Some of the elements driving the high share of the segment in the market are the growing demand for biopharmaceuticals; rising technological advancements like single-pass tangential flow filtration and multicolumn chromatography; the increasing need for intensification of the downstream bioprocess as a result of an increased titer; and lowering production costs in the case of biosimilars and innovator drugs. These elements help the segment to have a significant market share.

An Application-Based Study of the Market for Ongoing Bioprocessing

Among the applications included in the consistent bioprocessing market segmentation are mAbs, vaccines, cell and gene therapy, and other ones. Application drives this segmentation of the market. It so happens that one of the most important subgroups of biotechnology medicine is monoclonal antibodies. The growing pharmaceutical research and development drug pipeline, the increasing emphasis on continuous bioprocessing in the manufacturing of monoclonal antibodies, the expanding clinical pipeline of monoclonal antibodies, and the growing regulatory approvals pertaining to therapeutic antibodies help to explain both the great share as well as the high growth rate inside this segment. These elements taken together have helped the segment to flourish.

Continuous bioprocessing is rapidly gaining speed in monoclonal antibody bioprocessing, so it has the potential to offer several advantages like smaller facility footprints, less investment costs, more flexibility, and economies of process. Once mammalian cell-derived monoclonal antibodies (mAbs) became commercially successful, demand for breakthrough single-use bioreactor systems surged. These technologies can reduce prices and provide far better degrees of flexibility and productivity. The successful proving of the viability of a completely integrated continuous process from the pilot size bioreactor to the therapeutic substance has led to research that has opened the road for its larger application within the industry.

Two more elements driving the growth of the market within this specific category are the increasing frequency of cancer and the growing necessity for cancer therapies. Monoclonal antibodies (mAbs) on the other hand have less side effects than chemotherapy. Another important factor driving the growth of the market is the emergence of new, more efficient and effective monoclonal antibody (mAbs) classes, such anti-PCSK9 monotherapy. Among the most effective monoclonal antibodies (mAbs), including Humira, Rituxan, Avastin, and Pembrolizumab-Keytruda, some have patents set to expire in the next few years. Patents have been lost, hence biopharmaceutical companies have been forced to proceed with including monoclonal antibodies (mAbs) into their drug manufacturing process. Regarding affordable solutions like continuous bioprocessing, demand is predicted to rise given the expanding pharmaceutical drug pipeline as well as the increasing number of regulatory approvals for the modular drug delivery systems (mABs).

Final Thoughts

Now leading the front stage in innovation is the constant bioprocessing sector, which will help to revolutionise manufacturing processes for pharmaceuticals worldwide. This is something one should give careful thought. Consistent bioprocessing provides advantages unmatched in terms of efficiency, productivity, and quality control when compared to conventional batch methods. This is so because continuous, smooth production flow of consistent bioprocessing is what drives An increasing demand for biopharmaceuticals, the rise of integrated end-to–end continuous bioprocessing, government and regulatory initiatives for favourable innovative technologies, and a rising acceptance among both contract manufacturing organisations (CMOs) and contract manufacturing organisations (CMOs) are driving the market under several angles. Indeed, the acceptance of continuous production techniques by pharmaceutical manufacturers is causing the market to develop fast and show diversity. Beginning with the upstream cell culture and fermentation operations and working all the way down to the downstream production processes of purification and formulation, continuous bioprocessing systems are applied across the whole biopharmaceutical manufacturing process. Furthermore adding to the improvement of process control and optimization—which finally yields higher efficiency and guarantees regulatory compliance—process analytical technology, sometimes referred to as PAT, in addition to automation.

The facility helps in improving the efficiency of DSP’s operations in research and development, ranging from drug target discovery to applications for manufacturing and marketing approval.

DSP invested about ¥6.4bn ($64m) for the construction of the new building.

Details of DSP’s R&D facility in Osaka

“The research facility is located within Sumitomo Chemical’s plant at Osaka research centre in Japan.”

The new building has eight floors above the ground. It has a total building area of 2,463m² and total floor space of 16,322m². It has laboratories meant for drug discovery, process chemistry and analytical research and development. It will enhance DSP to promote efficient research and development, and facilitate the creation of highly innovative drugs for unmet medical needs.

The facility will carry out drug research on the central nervous system (CNS) as a focus therapeutic area, and cancer and immune-related diseases as challenge therapeutic areas.

The new building will combine the work of the drug discovery division and the technology research and development division. The work in these two divisions is distributed to Osaka research centre in Osaka, and central research laboratories in Suita City.

The research building will optimise chemistry research-related departments assigned to drug discovery research. DSP will be able to focus on improving the efficiency of the series of operations in research and development of drug target discovery and quality management of investigational new drugs through the facility.

Facilities at Dainippon Sumitomo Pharma’s research building

The new facility of Dainippon Sumitomo Pharma has meeting spaces located on each floor, which enables active communication for the creative research environment for developing highly originated drugs. It is also equipped with video conference rooms for carrying out communication with other research sites worldwide. It also features a stringent security system for chemical reagent storage.

Construction of the Osaka-based pharma building

Ground was broken for the new chemistry research building’s construction in January 2012. The construction was completed in June 2013. The operations are scheduled to begin in July 2013.

The 40m tall building was constructed with a seismic isolation structure to withstand damage caused by earthquakes and liquefaction. It was constructed using foundation improvement methods.

Drugs developed by Japan’s DSP

The key drug products developed and produced by Dainippon Sumitomo Pharma include ephedrine indicated for the treatment of bronchial asthma, Gasmotin, a gastroprokinetic agent and Lonasen, which is used for the treatment of schizophrenia. The new Osaka research facility will further help boosting pharmaceutical research of DSP.

Sustainability of the chemistry research facility

The building was constructed in compliance with environment-friendly methods. It features airflow fume hoods and is installed with solar panels and energy efficient air conditioning and lighting systems. The building is designed to make the best use of natural light.

Marketing commentary for the Japanese company

Dainippon Sumitomo Pharma is a leading international pharmaceuticals company with its head offices located in Osaka and Tokyo, Japan.

“Dainippon Sumitomo Pharma is a leading international pharmaceuticals company.”

The company is engaged in the production, sales and import and export of pharmaceuticals, food additives, veterinary products, diagnostic agents and research materials.

It has more than 7,218 employees with two distribution centres and four manufacturing plants located in Japan.

Its subsidiaries include Sunovion Pharmaceuticals, Boston Biomedical and Sunovion Pharmaceuticals Europe.

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Shionogi Pharmaceutical Research Facility, Osaka, Japan

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Sumitomo Pharmaceutical Manufacturing Plant, Japan

Sumitomo Pharmaceutical Company (now known as Dainippon Sumitomo Pharma) completed the construction of its manufacturing plant in Ibaraki city, near Osaka in Japan in 2000.

It results in weight loss and absorbs fat from diet. The drug acts peripherally to reduce the appetite, without affecting the brain.

In December 2008, Takeda started a Phase III clinical study of cetilistat in Japan. Progress to pivotal Phase III trials followed encouraging Phase II clinical trial data that showed cetilistat promoted significant weight loss and was generally well tolerated in clinically obese patients.

Takeda evaluated European Phase II data of cetilistat in August 2003 and in January 2004 made an agreement with Alizyme to exclusively develop, manufacture and market cetilistat in Japan.

In October 2012, Takeda submitted a New Drug Application (NDA) for Cetilistat to Japan’s Ministry of Health, Labour and Welfare for the treatment of obesity.

Alizyme’s current research and development is focused on treatments for gastrointestinal disorders, obesity, cancer and diabetes.

“Progress to pivotal Phase III trials followed encouraging clinical trial data that showed cetilistat promoted significant weight loss.”

Obesity predisposes to serious illness

Obesity is now the most common nutritional disorder in western industrialised countries. Defined as a body mass index of greater than 30, it arises from the accumulation of excess fat in the body from over consumption of fatty foods.

Prevalence of obesity in the US and Europe has reached epidemic levels. Data from the WHO’s MONICA (Multinational MONItoring of trends and determinants in CArdiovascular disease) project show that in some parts of Europe over 70% of men aged 55 to 64 are clinically obese or overweight (BMI >25) as well as almost 70% of women in this age group. One in five of all Americans is obese and one in three overweight. Furthermore, increasing rates of childhood obesity are likely to exacerbate the trend towards increasing obesity in adulthood.

There is a strong association between obesity and increased risk of cardiovascular disease and diabetes and possibly certain cancers, such as breast and colorectal cancer. The dramatic rise in the incidence of type 2 diabetes is largely due to the increased prevalence of obesity. Increases in body weight lead to changes in blood lipid and cholesterol levels, predisposing to increased risk of atherosclerosis.

Therapeutic approaches to treatment of obesity

The growing prevalence of obesity has stimulated the search for drugs to treat this condition. Various therapeutic strategies have been explored, including:

1. Serotonin and noradrenaline reuptake inhibitors (anorectic agents)
2. Lipase inhibitors
3. b 3-adrenoreceptor agonists
4. Leptin agonists
5. Melanocortin-3 agonists
6. Endocannabinoid receptor antagonists

Cetilistat is a lipase inhibitor, with a similar mode of action to Roche’s anti-obesity medication orlistat (Xenical®) which received regulatory approval in 1997. These drugs act in the gastrointestinal tract to inhibit lipases, enzymes involved in the breakdown of dietary fats. By inhibiting the breakdown and subsequent absorption of fats from the gut, lipase inhibitors reduce fat intake and calories, thus aiding weight loss.

Evidence of efficacy and tolerability in obese adults

The clinical efficacy and safety of cetilistat has been demonstrated in a series of Phase II trials. A Phase IIb clinical trial in 612 clinically obese diabetic patients showed that over a 12-week treatment period, cetilistat 80mg and 120mg promoted significant weight loss compared with placebo (3.85kg and 4.32kg versus 2.86kg respectively), thus meeting the trial’s primary endpoint.

“Cetilistat may have benefits over currently marketed anti-obesity drugs with respect to better toleration.”

Cetilistat-induced weight loss was similar to that achieved with Xenical® (3.78kg). Both active treatments also produced statistically significant reductions in HbA1c, a marker of diabetic control. In this trial, patients had a BMI of between 28 and 45 at study entry and received metformin for control of diabetes.

While cetilistat achieved similar degrees of weight loss to Xenical® in this patient population, it was better tolerated. Rates of premature discontinuation for adverse events were 2.5%, 5.0% and 2.5% for cetilistat 40mg, 80mg and 120mg respectively.

This compared with 6.4% for placebo and 11.6% for Xenical®. Troublesome gastrointestinal side effects are known to reduce the long-term clinical utility of Xenical®.

Safety and tolerability results of cetilistat in this trial were consistent with those seen in earlier trials.

Takeda submitted the NDA for Cetilistat based on data obtained from three Phase III clinical trials. The three studies included a 52-week placebo-controlled study that evaluated the efficacy and safety of Cetilistat, and 24-week and 52-week open-label safety studies that were conducted on obese patients with type 2 diabetes and dyslipidemia.

The results of these studies demonstrated that patients administered with 120mg of Cetilistat three times a day showed 2.776% reduction in average body weight when compared to 1.103% in placebo-administered patients. Cetilistat reduced HbA1c and LDL cholesterol and was also well tolerated in clinical studies.

Marketing commentary

The market for weight-reducing drugs has had a somewhat chequered history, characterised by major product withdrawals. Although the statistics suggest a market with enormous opportunity, pharmaceutical companies have so far been unable to capitalise on the need for anti-obesity agents.

According to the WHO, there are about 400 million clinically obese people while there are 1.6 billion overweight adults globally. However, only 6% are treated pharmacologically since there is a dearth of productive medications. Only two drugs are approved for long-treatment of obesity: orlistat (Xenical®) and sibutramine (Meridia®). Troublesome side effects have, however, reduced their overall clinical effectiveness.

Since successful management of obesity is likely to require long-term compliance with prescribed medication, cetilistat may have benefits over currently marketed anti-obesity drugs with respect to better toleration. Encouragingly, the FDA has allowed Alizyme the opportunity to consider a separate IND for the use of cetilistat for diabetic patients, potentially extending its use in the huge market for diabetes treatments.

In March 2010, Eisai submitted a new drug application for Halaven to the US Food and Drug Administration (FDA). The drug was granted product priority review status by the FDA and was approved on 15 November 2010.

Eisai submitted marketing authorisation application for Halaven to the European Medicines Agency (EMA) in March 2010.

The European Commission (EC) approved the drug for the treatment of advanced or metastatic breast cancer in March 2011.

The drug obtained marketing approval in Japan for the treatment of inoperable and recurrent breast cancer, in April 2011.

Halaven was also approved in Singapore in February 2011 and by Swissmedic in May 2011.

Metastatic breast cancer: the facts

Metastatic breast cancer is the advanced stage of breast cancer during which the cancerous cells are spread to other areas of the body from the original tumour site.

The most common region the disease affects is the bone, followed by lungs and liver. The disease is often fatal, with existing treatments mainly limited to reducing the severity of disease.

Metastatic breast cancer is the leading cause of cancer mortality in women. In 2007, an estimated 155,000 women in the US were affected by the disease. The disease causes 46,000 deaths annually in the US. It is also estimated that about 3.9 million women in the world are affected by the disease.

Halaven mechanism of action

“Halaven disrupts mitotic spindles and kills cancerous cells.”

Halaven contains an antineoplastic agent called eribulin. The drug is derived from marine sponge natural product Halichondrin B. The drug suppresses the growth phase of microtubules, the active matter components of cytoskeleton proteins present in all cells. Microtubules are important for the development and maintenance of cell shape. The drug disrupts mitotic spindles and exerts an anticancer effect by killing the cancerous cells.

The drug is suitable for the treatment of metastatic breast cancer in patients who have already received at least two doses of chemotherapeutic regimens, including vinorelbine, gemcitabine, capecitabine, taxane, anthracycline, other chemotherapy and hormonal therapy.

Clinical trials

Eisai conducted phase I clinical trials on Halaven from August 2003 to July 2005. The study was conducted on 55 patients in the US to determine the maximum tolerated dose.

“Metastatic breast cancer is the leading cause of cancer mortality among women.”

Phase II clinical trials on Halaven were conducted between September 2004 and November 2006. It was an open label study that enrolled 61 female patients.

The primary outcome measure was to find the response rate.

The secondary outcome measures included finding the safety and tolerability of Halaven, duration of response and time to progression of the disease.

The FDA approval of Halaven was based on the results of the global pivotal phase III clinical trials named EMBRACE (Eisai metastatic breast cancer study assessing physicians’ choice vs eribulin). It was an open-label, randomised and multi-centre study conducted on 762 patients who were previously administered with at least two doses of chemotherapeutic regimens.

It was a two-arm study. In the first arm the subjects were randomised to receive Halaven at a dose of 1.4mg/m² on days one and eight for 21 days. In the second arm conducted on a control group, 97% of patients received chemotherapy and 3% hormone therapy.

“Patients treated with Halaven survived 2.5 months longer.”

The most common side effects in the Halaven group were neutropenia, nausea, anaemia and hair loss.

Out of the 508 subjects in the Halaven group, 274 deaths occurred; out of 254 subjects in the control arm group, 148 deaths occurred.

The objective response rate in the Halaven group was 11% and the median response duration was 4.2 months.

The study met its primary end point of overall survival. The patients treated with Halaven survived 2.5 median months longer than patients treated with the control arm therapy.

Halaven was tested in another Phase III clinical trial known as study 301. The trial was an open label, two-parallel arm and multicentre study. It enrolled 1,102 women with metastatic breast cancer. The study evaluated Halaven in comparison to capecitabine (Xeloda).

In July 2012, preliminary results of the study were announced. The results showed that Halaven did not meet the co-primary endpoints of the study, which included overall survival (OS) and progression-free survival (PFS). An improved OS was observed, but was not statistically significant.

Halaven was approved by the European Commission (EC) based on the results obtained from a global phase III clinical study known as EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice (TPC) Versus Eribulin E7389).

The study demonstrated that the patients treated with Halaven showed statistically significant increase in overall survival (OS) when compared with TPC.

Halaven’s approval in Japan was based on results obtained from a Phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389) study and a phase II study.