PHARMA TRANSFORMATION
Healthcare innovation takes on new importance as the world works to emerge from the pandemic. By Apiradee Treerutkuarkul
● The Covid-19 pandemic has created urgent demand for health innovations to better serve individuals, organisations and entire societies. The pharmaceutical industry has been on the frontlines of the challenge as it races against time to find solutions.
The development of coronavirus vaccines in a matter of months is an achievement that few would have thought possible. The fact that it happened demonstrates the resilience of the sector and its ability to harness research talent to meet urgent challenges.
With production now up and running, the next challenge is distribution and actually getting the shots into people’s arms. This presents a new set of challenges for the public-sector side of the healthcare system.
Pharmaceutical companies have also been learning on the fly about how to manage complex supply chains and new models for engaging with healthcare professionals, a largely remote workforce and the disruption of many clinical trials.
Germany-based Bayer has been persevering through the pandemic, having invested heavily in external innovation with an unprecedented number of more than 25 collaboration agreements and acquisitions.
The company has doubled down on its commitment to transform its business with breakthrough innovation to help patients suffering from health conditions that are still difficult to treat, executives say.
“The biomedical and technological revolution that is transforming healthcare at an unprecedented pace is taking place now. We are at the forefront of the wave of innovation in cell and gene therapy as well as digital health,” Stefan Oelrich, president of the pharmaceuticals division and a member of the board of management at Bayer, told a virtual conference held recently to showcase the company’s achievements.
“We are driving this transformation and growing our promising development portfolio together with our partners. Our joint goal is to bring breakthrough treatments to patients and make healthcare systems more sustainable in the mid- and long term.”
While many of global pharma’s biggest names have been busy developing and producing coronavirus vaccines over the past year, Bayer has not been directly involved. However, it announced last month that it would help produce a Covid vaccine that Germany-based CureVac is developing.
Mr Oelrich said last month that the company would set aside some of its capacity to start producing the CureVac vaccine in 2022, with a target of 160 million doses in the first 12 months.
CureVac began the final Phase III trials of its vaccine candidate in mid-December, involving more than 35,000 volunteers in Europe and Latin America.
CELL THERAPY INNOVATION
When it comes to treatment innovations, Bayer says that cell and gene therapies, for the first time, offer the possibility to address the root causes of disease. That opens up options for conditions considered intractable, or where the current standard of care only addresses symptoms to different degrees.
The company has just established a new cell and gene therapy platform focusing on areas with high unmet needs, such as neurodegenerative, neuromuscular and cardiovascular conditions, Pompe disease, Parkinson’s disease, haemophilia A and congestive heart failure. It now has at least 15 preclinical assets in the cell and gene therapy field in the pipeline.
“Cell and gene therapies hold the promise to significantly impact patients’ lives by moving from treating symptoms to potentially curative approaches,” said Wolfram Carius, executive vice-president and head of cell and gene therapy at Bayer.
“Together with our partners, we want to accelerate innovation at its source and along the whole value chain to ensure a fast translation of science into therapies for patients who have no time to wait.”
The Bayer subsidiary BlueRock Therapeutics, an engineered cell therapy company, recently announced that the US Food and Drug Administration (FDA) had cleared its application to proceed with a Phase I study in patients with advanced Parkinson’s disease. It will be the first trial in the US to study stem cell-derived dopaminergic neurons in patients with Parkinson’s, seen as a big step forward for the stem cell field.
With a mission to develop regenerative medicines for intractable diseases, BlueRock’s Cell+Gene platform harnesses the power of cells for new medicines for application in neurology, cardiology and autoimmune treatment.
Because heart attack and stroke still represent a major health burden, more effective treatment options in thrombosis prevention are needed, according to Bayer. The company has begun a Phase II-b trial of a new anticoagulant with a plan to enrol more than 4,000 patients.
It is also conducting a Phase II trial on patients with end-stage kidney disease to see if anticoagulants based on FXI-pathway inhibition could offer protection from thromboembolic events — blood clots forming due to blood changes — without increased risk of bleeding. Such events are a major cause of morbidity and mortality and few therapeutic options are available.
Another treatment area where Bayer hopes to make progress is in endometriosis, which affects approximately 10% of women of reproductive age. Many experience severe chronic pain with debilitating effects on their professional, personal and social lives.
A receptor known as P2X3 has a prominent role in endometriosis and several other medical conditions associated with pain and neurogenic hypersensitivity such as chronic cough, overactive bladder and neuropathic pain.
Although these diseases are not life-threatening, they severely affect the quality of life for a large number of patients, and P2X3 antagonists could potentially offer a new treatment approach and relief.
In addition, Bayer has begun Phase II-a clinical studies for overactive bladder and diabetic neuropathic pain. “Our research in the fields of Factor XI inhibitors and P2X3 antagonists are just two promising examples of midstage programmes that demonstrate our ongoing commitment to building and advancing a strong development pipeline,” Mr Oelrich said.
The last trial stage is also under way of a potential blockbuster product that extends survival for men with non-metastatic castrate-resistant prostate cancer. The product has received regulatory approval in the US, the European Union (EU), Brazil, Canada and Japan. A Phase III study on hormone-sensitive prostate cancer is expected to start producing data this year.
In the field of women’s healthcare, Bayer plans to start Phase III trials this year of a treatment for vasomotor symptoms or hot flashes and night sweats during menopause.
The biomedical and technological o og ca revolution that is transforming healthcare at an unprecedented pace is taking place now
STEFAN OELRICH President of the pharmaceuticals division, Bayer AG