Takeda is making some serious R&D moves this week and, after announcing that it was handing over much of its clinical development to CRO PRA Health on Monday, it’s also said it will be killing off its deal with MacroGenics ($MGNX) on developing its DART candidate MGD010.
An R&D pact that could have been worth more than $1.6 billion between the Japanese pharma and the Rockville, MD-based biotech was signed back in 2014 that saw Takeda gain an option on MGD010, as well as on other projects on its pipeline.
The drug is currently in Phase I, and in June the biotech posted new data at London’s Annual European Congress of Rheumatology where 49 healthy patients took the drug, with the biotech reporting it “was well tolerated at all dose levels and no serious adverse effects were reported.”
But Takeda, which has been re-tooling its R&D across its operations and cutting back on certain programs, has today decided not to use its option on the med, and has given full rights back for the drug back to MacroGenics. MGD010 is a humanized DART molecule that simultaneously targets CD32B and CD79B and is designed to target autoimmune disorders.
The biotech, which says it sees this as an “opportunity,” explained that it has nothing to do with the data coming out of the drug’s early trial, but rather as a result of Takeda’s shift in R&D focus--although a decision has come quicker than was originally planned.
“Takeda’s decision comes earlier than the predefined expiration of its option exercise period and follows Takeda’s recently announced therapeutic area re-prioritization,” MacroGenics, a 2013 Fierce 15 company with about 300 staffers, said in a statement. “MacroGenics plans to continue to advance the development of this product candidate based on the positive study results reported to date,” it added.
Scott Koenig, president and CEO of MacroGenics, said: “We view Takeda’s early decision to not exercise its option as an opportunity for MacroGenics. This enables us to further develop MGD010 on our own or explore future strategic partnering opportunities with this program.” To date, MacroGenics has led all MGD010 product development activities.
Indeed, giving back unwanted meds is nothing new for the company in 2016 as back in June, Osaka-based Takeda also returned Japan rights for Amgen ($AMGN) oncology candidates fulranumab (AMG-403) and trebananib (AMG-386) as it continues the fast-paced reshuffle of its development portfolio to focus on potential first-in-class therapies in gastroenterology, oncology and CNS.
It has at the same time been signing deals in these areas, including with Theravance ($THRX) on GI motility disorder candidate TD-8954 as well as an investment of $65 million to co-develop as many as 6 product candidates to treat rare diseases, working with biotech Ultragenyx Pharmaceutical ($RARE) in a further early-stage effort.
But in a major shake-up, Takeda announced today that, in essence, it was handing over the lead of much of its clinical operations to PRA Health ($PRAH), a Raleigh, NC-based CRO, in what it a first in the sector.
Under this deal, financial terms of which were not disclosed, Takeda could see around 300 staffers from its Phase I-IV drug development units move over to PRA Health in Europe and the U.S. Talks with its Japanese workers, which will be more far more difficult for the company, are still ongoing.
PRA will “deliver on the company’s pipeline, marketed products, clinical development and post-approval needs” under the deal.
MacroGenics, which has a market cap just shy of $1 billion, was up by 3.1% at the end of Monday trading.