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A Pharma Success Story

Duchesnay’s focus on maternal health stems from personal experience. We are a family-owned company and, back in the 1980s, a member of the owner’s family experienced an issue with her pregnancy. She discovered that the information provided by her physician and her pharmacist was very different – her physician thought that a drug was safe to use, but when she went to obtain the drug she discovered that her pharmacist was unwilling to dispense it, as they felt there was a lack of information available to show the drug was safe in pregnancy. Ultimately, she found that the decision on whether or not to take the drug was down to her alone. The family felt that this was a lot of responsibility to place on individual pregnant women, and so the decision was made to transition away from the former focus on over the counter drugs in favor of a new mission: to become a pharmaceutical company that could provide reliable medical information and medications to women and their unborn children.

We consider ourselves pioneers in this domain. A limited number of other companies are developing drugs for use during childbirth, but developing drugs for use during pregnancy remains a challenge and there are no other companies doing quite what we do. There are many issues to consider, including the fact that regulatory agencies in different countries don’t have a lot of experience in this space, as there are so few companies developing drugs for pregnancy. There are ethical issues, as you need to ensure you are not putting pregnant women at risk. And don’t forget the legal issues: you don’t want to put yourself at risk either. The lack of existing data is also a problem. Regulatory agencies aren’t even sure what to ask you – or what research you should be doing to prove your drug is safe! The area is so new that everything you do, you have to figure out by yourself. You can’t simply look to what other companies have done, or seek advice and guidance from regulators. Nevertheless, here at Duchesnay, we decided to take on these challenges… And it has paid off.

Successfully sailing uncharted waters

Studying pregnant women isn’t the most straightforward of tasks, but personally, I think the biggest issue isn’t that pharma companies don’t want to do more – it’s that regulators and governments need to step in and help them. For example, in the US, Congress passed the Pediatric Research Equity Act in 2003, which provided pharma companies with an extension of marketing exclusivity when they carried out pediatric trials – providing a financial and regulatory incentive to do the work. If governments could do the same for pregnant women, it would encourage pharma to tackle this tricky area. Pharma companies know how to do research, but it is very complicated to develop drugs for pregnant women – a great deal of resilience is required as it takes so many years of research to get a treatment that is safe and effective. Time and resources are expensive, and so the process needs to be financially viable.

On the other hand, where there is a will, there is a way – and Duchesnay is living proof of that. Whether we study pregnant women or not, they will be exposed to many different drugs. You don’t stop being sick when you get pregnant – if you have a chronic disease, it won’t magically disappear when you conceive, and it’s not as simple as just stopping your medication either. It’s incredible to consider the amount of drugs that pregnant women are taking every day without proper research. There’s so much we still don’t know, but the information is out there – women are making these medication decisions every day, and that represents a wealth of data we could be collecting and using to help women make more informed decisions.

When Duchesnay first moved into this field, I think it’s safe to say that we didn’t know quite what we were getting into. We had to turn to specialists – teratology and mother and baby expert groups, the NIH and so on – to understand what we needed to do and how we should provide data to gain approval. Where we are today represents years and years of research and hard work – but being able to develop drugs to help women has been hugely rewarding.

The area is so new that everything you do, you have to figure out by yourself.
Making a real difference

I believe our nausea and sickness drugs, marketed in the US and Canada, are having a huge impact on women’s lives. It’s a common misconception that morning sickness during pregnancy is normal and benign. For some women it is very severe – and there is also the more extreme version known as hyperemesis gravidarum to consider. It can be so debilitating that women might need to be hospitalized, and may even feel unable to continue with their pregnancy. Having access to a drug that can treat the condition allows women to continue with their pregnancies – and even give them the confidence to go on to have another child. It’s incredibly gratifying to know that our work is able to change women’s lives.

Taking the Initiative

Not all regulators and pharma companies are avoiding the issue of pregnancy and drug development – the FDA has recently released draft guidance for industry on the ethical considerations for inclusion of pregnant women in clinical trials (1). The finalized guidance will aim to provide the FDA’s recommendations on how and when to best include pregnant women in trials for the development of drugs and biological products.

“This is specific advice for industry, which aims to highlight both scientific and ethical considerations and provide guidance for both the premarket and postmarket settings. It looks at both considerations for women who are pregnant, and those who become pregnant during clinical trials,” says Catherine Spong. “Importantly, it is currently in draft form – the FDA are keen to receive comments to understand if there are aspects that people would like to see changed.” Once finalized, the guidance should offer drug developers a better understanding of how to approach pregnancy in clinical trials and how to provide this information to the FDA.

On the other side of the table, some pharma companies are taking the initiative to better understand how existing drugs affect pregnant women: the GSK pregnancy registry is a series of observational studies tracking the effects of a number of prescription medications and vaccines on pregnancy outcomes in consultation with the CDC (1). The studies aim to record outcomes in women who have been exposed to the drugs at any time during their pregnancy – and interim results have been made available to assist in toxicology studies and to allow clinicians access to information that may be relevant to their patients.

“As social awareness of this issue increases, I think it presents a unique opportunity for us to be able to pull together industry, regulators, physicians, scientists, and patients and their advocates to really address these outstanding questions and provide the best information we can on how to move forward with drug development in these populations,” adds Spong.

Whether we study pregnant women or not, they will be exposed to many different drugs.

We exist in a niche market in terms of competition – but the unmet need is gigantic. If you want to develop a treatment for depression or diabetes, the competition is fierce. But if you are offering a diabetes or depression treatment for all the pregnant women suffering from these chronic conditions who aren’t sure which treatments are safe to take, it’s a very different story. The potential rewards of being able to offer something proven to be safe are significant. And the possibilities are almost endless; there is so much work still to be done, so I’m certain that pharma companies who choose to embrace the same mission would see a return on investment with perseverance.

I personally believe that most existing drugs must be fairly safe during pregnancy. Around 50 percent of pregnancies are unplanned, so if every single drug a women might be taking when she finds herself unexpectedly pregnant was teratogenic, the rates of birth defects would be far higher than what we see in reality. But clearly, that’s not enough. Access to comprehensive information that allows informed decision-making is every pregnant woman’s right. It’s time we all put our shoulders to the wheel – governments, industry, and advocacy groups – to make sure women don’t have to spend any longer in the dark about their medication choices.

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  1. USA FDA, “Pregnant women: scientific and ethical considerations for inclusion in clinical trials guidance for industry”, (2018). Available at: Accessed October 2, 2018.
  2. GSK, “GSK pregnancy registries”, (2018). Available at: Accessed October 2, 2018.
About the Author
Eric Gervais

Eric Gervais is Executive Vice-President at Duchesnay, Canada.

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