Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013. 

COMP has been collaborating with FDA in the US since 2008, and with Japanese regulatory authorities since last year. For 2013, COMP is anticipating to work more closely with Health Canada.

COMP is also seeking to collaborate more with health-technology assessment agencies, which provide recommendations on medicines that can be paid for or reimbursed by the healthcare systems in particular European member states.  Specifically, COMP is working with the European Network for Health Technology Assessment to achieve a better understanding of orphan designation, the marketing of orphan medicines and initiatives on the availability of designated orphan medicines. Overall, COMP will be exploring ways of sharing information for the benefit of patients and the financial sustainability of the healthcare system. 

Patient integration is another goal of COMP. COMP will proactively request contributions from expert patients where there advice is considered key, such as improvement of quality of life. COMP is also intending to increase its interactions with the European Organisation for Rare Diseases and other, disease-specific patient organisations. 

“The work of the COMP is evolving and constantly adapting to better serve and address patients’ needs, the growing scientific knowledge on rare diseases, and the regulatory framework,” Bruno Sepodes, chair of COMP, said in a 

In Europe, the success of orphan incentives and the Orphan Medicinal Product Regulation has been underlined by an increase in orphan-designated medicines; 107 designations were granted in 2011, 148 in 2012 and more than 150 are expected for 2013. 

Articles

The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.

EMA Seeks to Expand Collaboration on Orphan Medicines

Sanofi is investing EUR 44 million ($58.7 million) in Genzyme’s biotechnology campus in Waterford, Ireland. 

The investment will be used to increase the diversity of products manufactured at the site by adding filling operations for Sanofi’s Lantus (insulin glargine), which is one of the world’s top-selling insulin brands. Commercial production of Lantus at Waterford is expected to commence in 2016. 

According to a statement, Sanofi has been very impressed with the Waterford manufacturing site since it acquired Genzyme in 2011, particularly in terms of the site’s felxibility, professionalism and commitment. 

, Richard Bruton, the Irish Minister for Jobs, Enterprise and Innovation, described the investment as a “major vote of confidence” in the Waterford site, which employs over 500 people, as well as Ireland’s southeast region. “This investment, which comes on top of a €150m investment little more than a year ago, will ensure that this facility can produce the company’s latest product and provides an indication of the Waterford site’s strategic value,” said Bruton. 

As well as producing Lantus, the Waterford facility will also continue to produce other Genzyme products, inlcuding Myosyme, Lumizyme, Cerezyme, Thymoglobulin, Cholestagel, Renbela and Renagel. 

Sanofi is investing EUR 44 million ($58.7 million) in Genzyme?s biotechnology campus in Waterford, Ireland.

Sanofi Invests EUR 44 Million in Genzyme Campus

	Six current and former female pharmaceutical sales representatives have filed a $100-million gender discrimination lawsuit against Daiichi Sankyo in a US district court. The company employs around 3000 people in the US.

 from the law firm Sanford Heisler, which is representing the case, Daiichi Sankyo pays female sales reps less than male employees for the same work, advances female sales reps at a slower rate compared with their male counterparts, treats pregnant employees and working mothers of young children “adversely”, and subjects women to other discriminatory terms and conditions of employment.

	“Female pharmaceutical sales employees, including the Plaintiffs, have been cautioned against committing ‘career suicide’ if they choose to have children while working for Daiichi Sankyo,” Janette Wipper, lead attorney on the matter, said in a statement. “Women who have dared to complain about the unequal treatment have been summarily ‘managed out’ of the company.”

	The lawsuit also alleges that a group of predominantly male executives and senior sales personnel keep a “tight rein” on all employment decisions. “Through this male dominated leadership structure, the Company has approved and implemented policies, practices and decisions that have systemically discriminated against female employees,” said the Sanford Heisler statement.

	Daiichi Sankyo has not released a statement on the matter.

	It’s unfortunate in today’s age of equal rights that so many gender discrimination lawsuits have hit the headlines in the pharmaceutical industry in recent years. In 2010, a gender discrimination lawsuit against 

 in the US (considered the largest lawsuit of its kind to ever go to trial in the US) resulted in the class of 5600 women being awarded payment for punitive damages.

	Last year, Forest laboratories and Pfizer were also in the headlines for gender discrimination. The lawsuit against 

 claims that the company engages in “systematic, company-wide discriminatory treatment” of female employees, particularly with respect to women who are pregnant or have children. Meanwhile at Pfizer, a former employee is suing for sexual discrimination, which the company is vigorously contesting.

Six current and former female pharmaceutical sales representatives have filed a $100-million gender discrimination lawsuit against Daiichi Sankyo in a US district court.

Daiichi Sankyo Faces Gender Discrimination Lawsuit

The biopharmaceutical company lycera has announced a collaboration agreement with Merck, Sharpe & Dohme (MSD) that will focus on developing and commercialising small-molecule therapies for treating a range of autoimmune diseases. 

Under the terms of the agreement, Lycera will receive an upfront payment and research funding, and is also eligible to receive more than $300 million in research, development, regulatory and commercialisation milestone payments. MSD will be responsible for clinical development and will have global marketing and commercialisation rights to any products that may be developed. Lycera will be entitled to royalty payments, and development and sales milestones, on global sales from any products resulting from the collaboration. 

The collaboration builds on a previous agreement between the two companies, announced in 2011, targeting the retinoic acid related orphan receptor (RORγt), which is a key transcription factor coordinating the differentiation of T-helper 17  cells and the production of highly pro-inflammatory mediators, such as interleukin-17.

, Rupert Vessey, senior vice president, global scientific strategy, at Merck Research Laboratories, said, “There are substantial unmet medical needs and opportunities in autoimmune disorders, and new targets representing attractive opportunities that we are very pleased to pursue through our new collaboration with Lycera.” 

The biopharmaceutical company lycera has announced a collaboration agreement with Merck, Sharpe & Dohme (MSD) that will focus on developing and commercializing small-molecule therapies for treating a range of autoimmune diseases.

Lycera and MSD Collaborate on Autoimmune Therapies

An international consortium of pharmaceutical companies, academia, research organisations and other related entities have launched a new platform to help enhance drug discovery in Europe. 

The consortium, the European Lead Factory, aims to help translate academic research more quickly into high-quality lead drug molecules and will initially run for five years. Drug discovery will take place by screening compound libraries for potential new therapeutics. 

Seven pharmaceutical companies, Bayer Pharma, AstraZeneca, Lundbeck, Janssen Pharmaceutica, Merck KGaA, Sanofi and UCB Pharma, have agreed to participate in the platform and will donate at least 300000 chemical compounds to the initiative. A further 200000 compounds are also expected to be developed in the course of the initiative by combining the knowledge of all consortium partners, as well as using open innovation and crowd sourcing. The compound collection will be screened by the pharmaceutical companies using the European Screening Centre, which has been established as part of the initiative, and target proposals will be selected through competitive calls. The screening centre will comprise of two sites, one in Scotland in the UK and one in the Netherlands. Both sites will use state-of-the-art facilities and highput screening techniques to handle the 500000-strong compound library. 

The European Lead Factory is being supported through Europe’s Innovative Medicines Initiative and has received EUR80 million in funding from the European Commission’s Seventh Framework Programme for Research. A further EUR91 million will come from the participating pharmaceutical companies and EUR25 million will come from other contributions, binging the total budget for the platform to EUR196 million. 

In total, 30 different partners are included in the consortium. 

“This unique project is an excellent example of how a public–private partnership can transform the way in which the pharmaceutical sector identifies new medicines. For the first time, it will give European researchers unprecedented access to industry chemical collections and facilitate the translation of their findings into actual treatments for patients,” Michel Goldman, executive director of the IMI, said in a 

. “This project will not only advance the chances of success in the discovery of new medicines by European researchers, but also add value by building research capacity in Europe.”

An international consortium of pharmaceutical companies, academia, research organisations and other related entities have launched a new platform to help enhance drug discovery in Europe.

Drug Discovery Initiative Launched in Europe

	I’ve written frequently about the problem of counterfeit medicines in the United Kingdom and how the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is working to prevent these, but counterfeits are not the only potentially dangerous medicines that are becoming increasingly prevalent. In a recent news release, the MHRA explained it is receiving a growing number of reports of unlicensed medicines being sold across the UK.

	According to the MHRA, many of these products originate from Poland or other Eastern European countries, with the agency investigating 74 cases last year. Several of these medicines fell into the category of pharmacy- and prescription-only medicines. Although the medicines may be licensed in Poland, or other European member states, the MHRA has emphasised that such products cannot be sold or supplied in the UK.

	In a statement, the MHRA added that it is working with the Polish medicines regulator to help communities where these medicines are being sold.

	The big question about why unlicensed medicines are being sold in the UK can perhaps be answered by the fact that there are a growing number of Polish people now living in the UK, who may wish to have access to medicines they have used in their home country. The same can be said for people of any nationality who find that certain medicines they have taken before are not available in the UK.

	Unfortunately, even if a medicine is approved in Poland it doesn’t mean it’s necessarily safe, particularly if taken without adequate supervision. Selling such medicines is also illegal, although it is possible to obtain an MHRA Parallel Import Licence or a Parallel Distribution Notification for certain medicines. Worryingly, it’s also possible that the demand for foreign medicines could lead to counterfeit products being sold in the UK by criminals seeking to take advantage of this opportunity.

	“Polish medicines imported into the UK and sold in Polish language packs have not been approved for sale in the UK and cannot be traded lawfully on the UK market. Medicines offered for sale and supply in the UK must be labelled in English,” Nimo Ahmed, the acting head of enforcement at the MHRA, said in a statement. “We urge people not to buy medicines that are not labelled in English. Medicines are not ordinary consumer products. There are also specific health concerns with certain medicines that should be prescribed and dispensed under the supervision of a healthcare professional, such as a doctor or a pharmacist. Anyone who self-medicates and buys these medicines from shops that are not registered pharmacies could be endangering their health.”

	With globalisation increasing and many people now choosing to emigrate, unlicensed medicines could become a greater issue for regulatory agencies and the situation will need to be closely monitored.

I’ve written frequently about the problem of counterfeit medicines in the United Kingdom and how the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is working to prevent these, but counterfeits are not the only potentially dangerous medicines that are becoming increasingly prevalent.