CT-868

Roche has already budgeted for future commercial manufacturing builds and established a network of contract manufacturers as it preps for the launch of its GLP-1/GIP drugs. The company discussed its manufacturing plans during an investor call on Friday at the European Association for the Study of Diabetes Annual Meeting. “The organization is gearing up with all of the necessary requirements to supply the medicines [GLP-1/GIPs] that we need not only for clinical [trials], but hopefully for the launch as well,” said Manu Chakravarthy, Roche’s SVP and global head of cardiovascular, renal and metabolism product development. Capacity constraints have been a major issue for pharma companies like Eli Lilly and Novo Nordisk that market GLP-1 drugs. Now, Roche is outlining its production strategy for assets still being tested in mid-stage trials. Roche has a network of contract manufacturers that produce clinical supply of its injectable peptide assets, according to Chakravarthy. Currently, there are no “near-term capacity constraints” for these products, according to the company presentation . As for commercial supply, Roche said it has the runway to build future capacity if necessary and expects its contracted third parties to be able to add capacity by the time its injectable peptide assets are approved and ready to be launched. Novo and Lilly have both dealt with supply constraints of their blockbuster GLP-1 drugs, and have boosted capacity for both drug production and for the injectable pens. Novo has said it’s open to partnering with third-party manufacturers for filling and packaging injectable pens and is also in the process of buying three of Catalent’s fill-finish sites from Novo Holdings, after it acquires Catalent. In terms of developing the injectable devices, Roche said it can manufacture the injection pen in-house, but it’s also looking to secure “strategic partnerships” for device development. Roche has two Phase 2 injectable peptide products. It has a GLP-1/GIP asset called CT-868 that it’s testing for type 1 diabetes and obesity, with data expected in 2025. Meanwhile, its other injectable peptide, CT-388, is being investigated in a mid-stage trial as a GLP-1/GIP treatment for obesity and type 2 diabetes. A third asset, an oral GLP-1 product called CT-996, is in Phase 1. It has a more “straightforward” production process because it is a small molecule, rather than a peptide, Chakravarthy said. Roche plans on using its pre-existing manufacturing network to make CT-996, he added. CT-996 is being investigated as a treatment for type 2 diabetes and obesity, and the Phase 1 data already give Roche “the confidence” to launch into Phase 2 trials, Chakravarthy said. Meanwhile, Novo and Lilly are both focused on boosting their GLP-1 manufacturing footprint as fast as they can, with Lilly recently opening an $800 million extension of a site in Ireland while Novo has earmarked $4.1 billion for a new site in the US.

Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss pharmaceutical giant spent much of its latest quarterly earnings call fielding questions about a pair of experimental weight loss medicines that have fast become important to its future growth.Roche last year acquired those medicines in a $2.7 billion deal for biotechnology company Carmot Therapeutics. One, CT-388, is an injectable therapy, while the other, CT-996, is a pill. Since May, both have since shown the potential in early trials to spur significant weight loss, adding billions to Roches market value and making the company a surprise player in one of the most lucrative areas of drug research.Its going to be a huge market, CEO Thomas Schinecker said on a conference call. By 2035, about 50% of the worlds population will be obese.Like Amgen, Pfizer and biotechnology company Viking Therapeutics, Roche aims to develop a rival to fast-selling medicines from Eli Lilly and Novo Nordisk. Those drugs, Zepbound and Wegovy, have proven powerfully effective at lowering weight. Studies have pointed to other health benefits for these and other so-called incretin medicines as well. But there is room for improvement, as current therapies are injected once-weekly, come with gastrointestinal side effects and can cause people to lose muscle mass along with weight. Demand is currently outstripping the available supply as well.In an earnings presentation Thursday, Roche said its injectable therapy has best-in-class potential, having helped people lose nearly 20% of their body weight over six months, when adjusted for a placebo. Schinecker also noted that Roche can use its existing manufacturing network to quickly scale up production of its oral drug if testing is successful. A third therapy, dubbed CT-868, is specifically designed for Type 2 diabetes, he said.But Roches drugs are well behind others, which could make it difficult for the company to stand out. A Phase 2 study of the injectable medicine will begin this quarter, with a mid-stage study for the oral therapy following next year. Large, late-stage trials would follow, meaning by the time the drugs get to market, one analyst noted, they could be the fourth or fifth of their kind available.Schinecker responded that certain characteristics of Carmots drugs make them unique, which in turn could lead to differentiating results. Roche also acquired an array of assets in the deal, some of which are aimed at separate, unspecified targets. The company intends to combine some of them with drugs from its in-house pipeline to help preserve muscle mass.Schinecker additionally claimed, without offering specifics, that Roche can get to market much more quickly than investors assume and is pumping more money in manufacturing ahead of time.There are many opportunities that we believe can [help] differentiate, he said. We can be very fast on this, and be a very competitive player in space.The company is open to doing other obesity-related deals as well, with Schinecker noting last years Carmot buyout is a template of something you could imagine for this year, depending on the cost and availability of potential assets.Roche will present more data from early-stage trials of CT-388 and CT-996 at a medical meeting in September. That month, on a scheduled investor day, the company also intends to reveal more about its obesity drug development strategy.Beyond obesity, Roche is interested in how incretin drugs may curb systemic inflammation, making them potentially worth exploring as part of combination therapies for neurological conditions like Alzheimers and Parkinsons, said Teresa Graham, the head of the companys pharmaceuticals division.Roche shares climbed about 3% in Thursday trading. '