Global biopharma supply chain holding together for now: Vertex says supply chain, its business holding steady

Biopharma companies are keeping a close eye on supply chains as the COVID-19 epidemic has expanded from China putting production in other countries at risk. So far the backbone of the industry appears to be holding, but not without some strains.

UPDATED: Friday, March 26 at 9:05 a.m.

It is so far so good for the supply chain of Boston-based Vertex Pharmaceuticals today which says the global COVID-19 outbreak has not had any impact on its ability to manufacture and deliver its supply of approved cystic fibrosis drugs.

“Despite the widespread impact of the COVID-19 pandemic, the outlook for our business remains unchanged and we continue to be highly confident in our supply chain and our ability to supply all of our approved medicines to patients who need them,” CEO Jeffrey Leiden said in a statement. “The COVID-19 pandemic is a rapidly evolving global health crisis that will require unprecedented utilization of health care resources that we expect will have an impact on our clinical trials."

The company says because of the outbreak it will pause some trials, but that it sees no change to its business outlook for 2020. 

UPDATED: Thursday, March 26 at 8:53 a.m.

U.S. generics maker Mylan says its production in Indian will not be hampered by a nationwide lockdown there because pharmaceutical manufacturing is exempt. "Mylan continues to operate its manufacturing facilities without significant disruption," the drugmaker said in a statement after its stock price was gut kicked Wednesday by news of the lockdown. 

Mylan did say that its merger with Pfizer's Upjohn was delayed because of "unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process." 

UPDATED: Wednesday, March 25 at 11:05 a.m.

While the China operation of German CDMO Fresenius Kabi had its challenges during the COVID-19 quarantine, it sidestepped any major interruptions in production at its 60,000 square meter facility in WuXi. With restrictions now off, it says virtually all of its 600 manufacturing staff are back and it is ramping up production so it “can supply the Chinese population with essential pharmaceuticals and medical devices.” Sales operations will soon follow, it said. 

While the situation is easing in China, it is exploding globally and in the U.S. As of Wednesday, global confirmed cases surpassed 435,000, according to Johns Hopkins University's real-time dashboard, and more than 19,600 people had died.

See all of FiercePharma's COVID-19 coverage here 

UPDATED: Friday, March 13 at 1:15 p.m.

AstraZeneca said its supply chain remains "robust" in response to the COVID-19 outbreak. The drugmaker pointed to its "stringent" quality management system to ensure "the safety, quality and efficacy of all our medicines at all times."

UPDATED: Thursday, March 12 at 10:51 a.m.

API maker WuXi AppTec announced that its site in Wuhan, China, epicenter of the outbreak, is back online. It was the last of the company's sites to return to production and will ramp up over weeks and months.

WuXi AppTec said that while it was offline, it was able to transfer operations to other sites, to mitigate interruptions at Wuhan and other sites.

The announcement came as companies also take steps to limit exposure by limiting travel. 

UPDATED: Tuesday, March 9 at 10 a.m.

RELATED: Eli Lilly says its drug supply, including insulins, is safe from COVID-19 for now 

In the U.S., Boston, Massachusetts-based Vertex Pharmaceuticals said its cystic fibrosis drugs, Symdeko, Orkambi, Kalydeco, and more recently Trikafta, remain secure.

“The challenges facing the world with the spread of COVID-19 are significant, but it is important for the medical and patient community to know that we remain highly confident in our ability to continue to supply all of our medicines… CEO Jeffrey Leiden, said today in a statement. “We have not seen any impact from COVID-19 on the Trikafta launch or other elements of our business. We are well-prepared from a business continuity perspective, with ample supply to meet commercial needs well into the future.”

Trikafta, the first CF combo drug, was approved last fall to patients over the age of 12 with either one or two copies of the delF508 CFTR gene mutation. Analysts predicted blockbuster sales for the $311,000 list-price drug as early as this year, at least before COVID-19 blurred global economic picture for all drugmakers. 

RELATED: Drugmakers tell analyst ingredient prices are rising as FDA reports first supply hit tied to COVID-19

Canada’s largest drugmaker, API specialist Apotex has said that its API supplies, as well as finished product supplies, are at low risk or interruptions, “in the short and medium term.”  For the long term, Apotex said it is taking the steps it can to “minimize disruption.”

Eli Lilly last week confirmed its drug supplies, including all of its insulins, are still in production and CDMO WuXi Biologics last month said it was resuming production at its China facilities in Wuxi, Shanghai and Suzhou, after an extended Chinese New Year’s break. 

The FDA so far has said it has heard from one drugmaker about a shortage tied to the outbreak but refused to name the drug or the drugmaker. It said there were alternative meds available to make up for the shortage.

Meanwhile, India has curbed the export of 26 APIs but contends it is a short-term move while it gets a handle on its own needs.