European Pharmaceutical Review’s top 10 stories from 2015

1. The Pfizer and Allergan Merger

There were plenty of mergers and acquisitions  in 2015 – too many to mention in our top ten – so we have focused in on two of the most talked about. In November, a mega merger between Pfizer and Allergan saw Pfizer agreeing to cough up $160 billion for the Dublin-headquartered pharma firm. The companies’ combined pipeline now comprises over 100 mid-to-late stage programmes in development. Criticising the announcement, Senator Bernie Sanders branded the merger a ‘disaster’ for US consumers, saying it ‘would allow another major American corporation to hide its profits overseas’. 

2. Teva makes big acquisitions

A month earlier, biosimilars giant Teva announced that it was to acquire Mexican pharmaceutical company Rimsa, in a deal worth $2.3 billion. That was the second large acquisition made by Teva in 2015, with the company acquiring Allergan’s Actavis generics business in July for $40.5 billion.

3. First 3D-printed drug approved

Three-dimensional (3D)-printing has hit the news a lot recently. In August, the US Food and Drug Administration (FDA) announced that it had approved the first ever 3D-printed drug product. The drug, Spritam (levetiracetam), is approved for oral use as a prescription adjunctive therapy for the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy. While 3D printing has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has received FDA approval.

4. Antibody shows promise in Alzheimer’s 

In the summer, Lilly announced results for its investigational monoclonal antibody solanezumab that suggested it slows the progression of Alzheimer’s in patients with mild disease. Dr Doug Brown, Alzheimer’s Society’s Head of Research, said of the results: “It’s good news that some people have been receiving the antibody for over three years and it appears to be having beneficial effects.” It will likely be a year or more before full results from the Phase 3 study are released.

5. Confusion about antibiotic resistance

Antimicrobial resistance hit the headlines when the World Health Organization published results from a multi-country survey, highlighting that people are confused about antibiotic resistance, with 64% of respondents believing that antibiotics can treat cold and flu.

6. Call for action on antimicrobial resistance

Jim O’Neill’s Review on Antimicrobial Resistance also makes it to our top ten list. The review set out proposals for a vital overhaul of the global antibiotics pipeline over the next ten years. O’Neill recommended several types of targeted interventions, such as committing to give successful drug developers  lump sums  for the highest priority antibiotics.

7. Gene therapy yields encouraging results in CF

In July, a clinical trial of a gene therapy used to treat people with cystic fibrosis (CF) yielded encouraging results. The study reached its primary endpoint with patients who received therapy having a significant, if modest benefit in lung function compared with those receiving a placebo. Researchers are now looking to undertake follow-up studies assessing higher, more frequent doses of the therapy as well as combinations with other treatments.

8. UCART19 used to treat girl with ALL

Another gene therapy to hit the news in 2015 was that of UCART19, an allogeneic engineered T-cell product for treatment of CD19-expressing haematologic malignancies, which was used to treat a one-year-old girl who had relapsed acute lymphoblastic leukaemia (ALL). London’s Great Ormond Street Hospital, which treated the girl, said that the patient is now cancer free.

9. Crowdfunding pharmaceutical research

In October, a team of scientists investigating whether a common malaria drug could have a significant impact on colorectal cancer were successful in raising £50,000 after launching a crowdfunding project to finance their work. The scientists hope to prove that artesunate can have a positive effect on colorectal cancer patients by reducing the multiplication of tumour cells and decreasing the risk of cancer spreading or recurring after surgery.

10. Turing and pricing

With drug pricing battles continuing in the US, Turing Pharmaceuticals came under fire for increasing the price of a drug for the treatment for toxoplasmosis by 5000% in the US. Martin Shkreli, then CEO of the company, said that the company would “lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit”. Turing later said it would not reduce the price of the drug but negotiate volume discounts with hospitals.