Global Markets

Germany’s Merck fully prepped for a ‘worst-case scenario’ Brexit

Merck Life Science says it has undergone Brexit preparations to limit supply chain issues if the UK leaves the European Union without a deal in place. In 2016, a referendum in the UK resulted in a slight majority of an ill-informed electorate to vote to leave the European Union (EU). Three years on and with no agreement in place as it stands, the UK is set to leave the bloc and the single-market economy on October 31 without any arrangements…

Shingrix a ‘standout’ in GSK’s vaccine strong Q2

GlaxoSmithKline (GSK) has described its shingles vaccine Shingrix as a driving force in its Q2 sales results. The firm is expanding capacity to keep up with demand. For the second quarter 2019, group sales stood at £7.8 billion ($9.8 billion), up 7% year-on-year. GSK saw a 1% decline to £4.3 billion in its pharmaceuticals division but was boosted by strong performances in vaccines and consumer. Management attributed vaccine sales of £1.6 billion – up 23% on the same period last…

Alexion on track with FcRn antibody after manufacturing hitch

After inheriting an impurity in the drug product of early-phase antibody ALXN1830, Alexion Pharmaceuticals says new batches will be available by the end of the year. In November 2018, Alexion Pharmaceuticals acquired Syntimmune in a deal worth up to $1.2 billion, adding ALXN1830, a clinical-stage humanized monoclonal antibody that inhibits the interaction of neonatal Fc receptor (FcRn) in trials for warm autoimmune hemolytic anemia (WAIHA) and generalized myasthenia gravis (gMG). But earlier this year, the firm discovered an issue in…

Politics, patents and pricing: the future of the US biosimilars market

In the US the ongoing political debate about patents and prices will determine the long-term viability of the US biosimilars market, says an industry expert. The US biosimilar drug market was established in 2015 with the approval of Zarxio, Sandoz’s version of the Amgen drug Neupogen (filgrastim). Zarxio quickly established itself – the drug accounted for 45% of all the short-acting filgrastim used in the US last year. In contrast, the wider market has been slow to develop. Legal complexity…

‘Bioprocessing ecosystem is on fire,’ says analyst

Sales grew 21% year-on-year at Sartorius’ H1 2019, while Repligen reported preliminary Q2 growth of nearly 50%. The bioprocessing sector ‘is on fire,’ says Jefferies’ analyst Brandon Couillard. Repligen Corporation published its preliminary Q2 results in an SEC filing last week, saying it expects sales of $70-71 million, compared to $47.7 million for the three months ended June 30, 2018. This would represent a 48% increase year-on-year. “The 8-K did not offer much color on specific drivers, but momentum across…

Multiple myeloma MAb helps drive Q2 as J&J looks to subcu formulation

J&J has reported a 57% year-on-year growth for its multiple myeloma monoclonal antibody Darzalex (daratumumab) and is now hoping to increase adoption through a subcutaneous formulation. For its second quarter 2019, Johnson & Johnson clocked in sales of $10.5 billion (€9.4 billion) in its pharmaceutical division, up 4.4% on the same period last year. The firm attributed this to several of its biological products, not least Darzalex (daratumumab) which grew 57% year-on-year to pull in $774 million in global sales.…

Biocon going digital to fix insulin plant hit with another FDA 483

Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says. An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market. “We believe these 12 observations across…

Teva partnership looks to up its biologics productivity

Teva has teamed with Just Biotherapeutics to develop a high productivity biomanufacturing process as it focuses its efforts towards biopharmaceuticals. The partnership aims to develop methods to lower the cost of biomanufacturing. Just Biotherapeutics – recently acquired by Germany’s Evotec – will design and development a high yielding manufacturing process for one of Teva Pharmaceutical Industries’ complex products. Further details of the process, molecule or the finances of the deal were not answered by either company when contacted by this…

Spark on the evolving commercial cell & gene therapy space

Single-use technologies and CDMO expansions have resolved some of the issues in the cell and gene therapy space but analytical and supply chain challenges still exist, says Spark Therapeutics. Spark Therapeutics is one of a handful of companies to achieve regulatory success with an advanced therapy, specifically its gene therapy for inherited vision loss Luxturna (voretigene neparvovec) which received US approval in December 2017. Speaking as part of a panel discussion at the BPI Theater at BIO in Philadelphia last…

Henlius’ trastuzumab: EU to assess first China-made biosimilar

The European Medicines Agency (EMA) has accepted to review a version of Roche’s cancer drug Herceptin (trastuzumab) developed by Chinese biotech Henlius. The European agency has officially accepted to review the Marketing Authorization Application (MAA) of Shanghai, Henlius’ trastuzumab molecule HLX02, making it he first biosimilar developed and made in China to be up for review. Scott Liu, co-founder and CEO at Henlius, said the review “shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally…