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Outsourcing

Theracos becomes increasingly reliant on contract manufacturing as its drug advances

Piramal sites on different continents have become involved in producing Theracos’s diabetes treatment

by Jean-François Tremblay
June 24, 2018 | APPEARED IN VOLUME 96, ISSUE 26

09626-cover2-digwal.jpg
Credit: Piramal
Piramal produces the active ingredient for Theracos’s drug at this facility in Digwal, India.

Although it has its roots in India, Piramal Pharma Solutions has over time turned itself into a multinational contractor with facilities on several continents. Of the company’s 13 manufacturing sites and labs worldwide, five are in Europe and North America, allowing customers flexibility in deciding where they want their drugs to be made.

COVER STORY

Theracos becomes increasingly reliant on contract manufacturing as its drug advances

Albert Collinson, CEO of the Massachusetts-based drug development firm Theracos, has come to know Piramal well. As Theracos’s lead compound, bexagliflozin, progressed over the years—it’s currently being tested in Phase III clinical trials—the small company entrusted Piramal with an increasing amount of work. The contractor now takes care of the drug candidate at several sites around the world. As a result, Collinson has the contact information of multiple Piramal managers in his mobile phone.

“We have an extensive relationship with Piramal,” Collinson says. Having different Piramal managers in different countries involved in handling parts of bexagliflozin’s manufacturing has turned out well, he adds. “I have contacts across Piramal; the company ensured that I had this level of communications.”

While it might seem unwise for a small company to become critically dependent on a single supplier, Theracos’s managers believe it’s warranted when that supplier has demonstrated it can handle the unexpected. Surprises pop up in all drug development projects because they are by nature complex and risky, Collinson says. A good contract manufacturer distinguishes itself from the rest by not delaying the communication of bad news—such as potential delays or process issues—to its customer, he says. When problems are identified early, they are easier to solve, he adds.

Theracos started developing bexagliflozin in 2008 using research from one of the company’s founders. The drug belongs to the gliflozin family of type 2 diabetes treatments. They work by interfering with a membrane protein called sodium-glucose linked transporter 2 (SGLT2). By blocking SGLT2, gliflozins cause the excretion of glucose in urine, thus lowering the concentration of glucose in blood. Several gliflozins are on the market, including the Janssen drug Invokana and Boehringer Ingelheim’s Jardiance. Bexagliflozin has higher selectivity and potency than others, Collinson claims.

Bexagliflozin

Class: A gliflozin drug used for the treatment of type 2 diabetes.

Mode of action: Like other gliflozins, it interferes with a membrane protein called sodium-glucose linked transporter 2 (SGLT2), causing excretion of glucose in urine and reducing blood glucose concentration.

Discoverer: Theracos. Bexagliflozin is not the first SGLT2 inhibitor, but Theracos claims it has higher specificity.

Status: Phase III clinical trials in progress.

Since 2008, Theracos has partnered with numerous companies for the development of its lead compound. “We operate as a virtual pharmaceutical company, and that means that we outsourced pretty much everything,” Collinson says. “It’s very efficient to work that way.” Collinson joined Theracos as CEO soon after bexagliflozin went into clinical trials in 2009.

09626-cover2-bexagliflozin.jpg

During Phase I trials, Theracos first contracted production of its drug to contractors in China and Europe as the company sought to establish a high-quality and transferable process. There is no rule that European contractors are better than Asian ones, or vice versa, Collinson notes. “Quality is not inherent to a region, but it is dependent on the manufacturer with whom you are working, the choices you make, and relationships that you build,” he says.

Piramal’s relationship with Theracos started small but has grown steadily. The Indian firm came into the picture when the time came to develop the tablet form of bexagliflozin. Theracos entrusted Piramal’s lab in Ahmedabad, India, with the task of establishing the manufacturing process. Satisfied with the results, it selected Piramal’s site in Morpeth, England, to manufacture the actual pill.

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After another positive experience, Theracos awarded Piramal the ultimate responsibility: manufacturing the drug’s active pharmaceutical ingredients (APIs) as well as its regulated starting material.

More recently, Theracos gave Piramal the job of packaging and distributing bexagliflozin to the clinics that are testing it on patients in different countries.

Ramesh Subramanian, Piramal’s senior vice president of strategic marketing, says his company derives great satisfaction from the choices Theracos made. “The decision by Theracos was an important one for them,” he says. “We work with some very large companies that have a portfolio of products, but we are especially proud to assist a firm like Theracos that has one key product and that we are their entire supply chain for.”

Piramal strives to maximize customer satisfaction, Subramanian adds. “Our company’s organization chart is a diagram with the customer at the center,” he says. “We make sure that our employees realize that it’s the customer who’s paying their salary.”

Customer satisfaction is gauged with an unusual degree of thoroughness at Piramal, Subramanian adds. The company employs a team of professionals hired from outside the drug industry to collect data and generate reports about customer experience and satisfaction. Those reports are then distributed throughout the organization, “all the way to the shop floor,” he says.

New customers are typically offered to have all starting materials made economically in India, even in cases when the customer wants the active ingredient and finished drug made in North America or Europe, Subramanian says. When a project involves multiple locations, a single manager is appointed to keep track of the big picture.

The project manager prevents delays by ensuring that production capacity is available when material is shifted from one site to another for additional manufacturing steps. Piramal has completed 70 projects involving several sites, Subramanian says. To handle the future manufacturing requirements of Theracos without delays, he notes, Piramal has invested in expanding its Digwal, India, site where the API is made. “Naturally, a customer appreciates when you do that.”

To satisfy Collinson, a contract manufacturer has to tick all the boxes in terms of quality of product delivered, speed of execution, and cost. “We have very tight deadlines, but we also want to save money,” he says. “As a privately held firm, we don’t have excess capital.”

But what is most important, he says, is how a contractor handles the unforeseen. Although not everything went as planned in the course of bexagliflozin’s development, the project on the whole has kept to the timeline that Theracos managers drafted at the start.

“The work we do is ripe for opportunities for problems to arise,” Collinson says. “The difference between success and failure is how you address problems together with your contract manufacturer.”.

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