Welcome to the latest edition of our weekly EuroBiotech Report.
1. After a rethink, Eli Lilly jumps back into diabetes pact with Adocia
2. U.K.'s Cell Therapy Catapult blueprints $85M manufacturing center
3. Roche's pRED adds $589M antibody buyout to its string of deals
4. Novo Nordisk partners with Xencor on bispecific antibodies
5. Cancer drug developer BerGenBio gets $15M round to fund new studies
And more >>
Back in the summer of 2013, Eli Lilly walked away from its partnership with France's Adocia, unwilling to push ahead on its fast-acting insulin analog. But today the pharma giant is back, and it's willing to pay more than ever to get its hands back on the technology.
Lilly ($LLY) put down $50 million to get back into the clinic with Adocia's BioChaperone Lispro, a treatment in people with Type 1 and Type 2 diabetes. In exchange for development and commercialization rights Lilly has agreed to pay up to $570 million. And Adocia also gets a reimbursement on some of its R&D expenses.
|Enrique Conterno, president of Lilly Diabetes|
"An ultra-rapid acting insulin, if approved by regulators, could provide a new important treatment option for people with Type 1 and Type 2 diabetes," said Enrique Conterno, president of Lilly Diabetes. "An ultra-rapid acting insulin would be a natural fit in our growing portfolio."
Why the change of heart?
"They were more cautious and conservative and wanted to stay in healthy volunteers," Adocia CEO Gérard Soula told BioWorld Today. "We disagreed deeply--and we proved that we were right. But they proved they are not stupid." -- read the release
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Looking to boost clinical research programs into cutting-edge cell therapies--and capitalize on what it hopes will bloom into a major commercial opportunity--British officials with Cell Therapy Catapult have outlined plans for a $85 million cell therapy manufacturing center at the Stevenage Bioscience Catalyst campus.
The idea for the new manufacturing center sprung from a 2013 survey that identified cell therapy manufacturing and supply chain as big hurdles to pushing new therapies through development and onto the market. And it shadows the rapid clinical progress of modified T cells being used to combat cancer.
Earlier this week investigators dosed the first patient in a T cell therapy which is being advanced by a consortium that includes Cell Therapy Catapult, UCL Business and Imperial Innovations. Imperial College did the lab work on the TCR program, which modifies patients' T cells to hunt down cancer. In this case they are targeting WT1-expressing cells for leukemia and myelodysplastic syndrome.
This technology is closely related to the CAR-T therapies in development at Juno ($JUNO), Novartis ($NVS) and other companies. The U.K.'s Adaptimmune, meanwhile, is partnered with GlaxoSmithKline ($GSK) on TCR treatments. And the U.K. wants to see more of it.
|U.K. Business Secretary Vince Cable|
"This therapy is at the very cutting edge of medical research, and is using our own cells in the fight against life-threatening diseases including cancer," noted U.K. Business Secretary Vince Cable. "This state of the art facility in Stevenage will ensure Britain can be a real leader in this industry. Supporting British scientists is crucial for our long-term economic growth and that is why we are publishing a Science and Innovation Strategy this week--a blueprint for building our future innovation infrastructure."
Politicians say this center will create 150 jobs for an enterprise expected to generate £1.2 billion by 2020--fully 80% of which is expected to come from companies outside the U.K. -- read the release
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Back at the beginning of 2014, John Reed and Sophie Kornowski-Bonnet--the head of Roche's ($RHHBY) Basel-based pRED and the company's head of partnering--sat down with FierceBiotech to spell out their vision for the two years ahead. Adding new technologies and more than a dozen therapeutic programs for the research group was at the top. And on Thursday they marked another step in that journey, nailing down the Austrian biotech Dutalys and its new-and-improved bispecific antibodies in a deal worth $133.8 million upfront with $355 million more on the table for milestones.
Reed called their bispecific formula "breakthrough technology" able to deliver breakthrough drugs, doing away with the sometimes troublesome linkers used by the pioneers in the field in favor of two antibodies designed to meld with each other.
Over the past 12 months Reed and Kornowski-Bonnet have been busy making a number of such deals, including:
- Snapping up rights to Barcelona-based Oryzon's orphan cancer blocker ORY-1001, now being studied in the clinic for acute myeloid leukemia. The cost: $21 million in upfront and near-term payouts, with more than $500 million in biobuck prizes;
- Striking a $450 million deal to buy Santaris' LNA (locked nucleic acid) platform, which the biotech claims can overcome the limitations of antisense and siRNA technologies and deliver new therapies that can do what antibodies and small molecules are incapable of doing: hitting some currently undruggable targets with mRNA and microRNA-targeted therapies that are much better targeted than some of the current RNA therapies in the pipeline; and
- Bagging an option to buy the Cambridge, MA-based upstart Spero Therapeutics as Roche pursues a renewed interest in antibiotics. That deal followed a move in February to team up with Cambridge, U.K.'s Discuva to discover and develop new treatments for deadly infections using the biotech's novel platform.
Roche also paid $8.3 billion for InterMune, while the Genentech side of research, gRED, handed over $725 million in cash for the fledgling biotech Seragon Pharmaceuticals--which was spun off from Aragon after the Johnson & Johnson ($JNJ) deal--and promising up to $1 billion in milestones.
This year has had its ups and downs at Roche. On Friday, the downs outnumbered the ups as gantenerumab flopped in a late-stage study for Alzheimer's and Kadycla failed in breast cancer. MetMab also failed at Genentech this year. And pRED's schizophrenia drug bitopertin--tapped by Reed as a top prospect--failed three straight Phase III studies.
But Reed is still very much focused on the future. After Roche shut down the big campus in Nutley, NJ, and laid off hundreds of staffers in the process, he vowed that he would keep things stable for the scientists. Now, instead of tearing down, Roche--the top R&D spender in the world with a 2013 budget of $10.3 billion--is building. Back in October the pharma giant committed $1.8 billion to build a new research center in Switzerland that will encompass four new office and lab buildings to house 1,900 R&D staffers.
And Reed and Kornoski-Bonnet are still doing deals. -- read the FierceBiotech story
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This was a big week for bispecific antibody deals in Europe. Denmark's diabetes powerhouse Novo Nordisk ($NVO) turned to Monrovia, CA-based Xencor for the latest in bispecific and immune inhibitor programs.
Novo Nordisk will pay up to $175 million if Xencor can deliver with its XmAb bispecific tech platform.
Bispecifics are able to bind to two different targets, a combo approach that is widely applicable in drug development.
The technology "consists of stable and easily expressed heterodimeric Fc domains that allow us to build robust molecules in a variety of formats that preserve many beneficial features of antibodies," noted Xencor CEO Bassil Dahiyat. "The combination of our bispecific Fc domains with our unique FcγRIIb targeting technology allows us to create novel molecular structures and to explore a range of functional properties during discovery."
Getting a marquee player like Novo Nordisk to sign on as a partner should help Xencor line up more of these deals, and Dahiyat wasn't in the least bit shy about exhibiting his wares.
Said Dahiyat, "This collaboration demonstrates how the comprehensive and diverse capabilities of our XmAb toolkit and robust plug-and-play nature of our bispecifics technology platform can lead to creative alliances with global partners such as Novo Nordisk." - read the release
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Norway's BerGenBio has finished up a $15 million round to push its lead Axl kinase inhibitor into new Phase I and Phase II studies for acute myeloid leukemia.
BerGenBio is in the early stages of developing a pipeline of epithelial-mesenchymal transition (EMT) inhibitors, with three antibodies and a small molecule for triple negative breast cancer in the lead optimization phase. In addition to AML, lead drug BGB324 is also being studied for non-small cell lung cancer, liver fibrosis and CML.
The latest round brings the biotech's haul to $33.5 million, if you add in a $12.5 million round in the spring and a seed round of $6 million. Sarsia Seed and Investinor A.S. have both invested in the fledgling company.
|BerGenBio CEO Richard Godfrey|
"Our recent research findings have shown broader potential clinical application for BGB324, and we intend to evaluate these in additional Phase I and Phase II clinical trials starting in 2015," noted CEO Richard Godfrey. "In aggressive drug resistant cancers our on-going Phase 1b trial in AML is expected to report towards the end of 2015 and in non-small-cell-lung-cancer we will start enrolling patients very soon."
Over the last few years a number of cancer drug developers have sprung up around Oslo, many hoping to imitate the success of Algeta, which was bought out by Bayer in a $2.9 billion deal. -- read the release
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Troubled Lundbeck writes off $52M, scraps stroke drug
Lundbeck opted to take a $52 million write down in order to dispose of desmoteplase after looking over all the data in hand. Lundbeck claimed they made the decision after seeing signs of efficacy and safety for ischemic stroke, but added that they had no sure idea of how to recruit patients for future studies. The Danish biotech had once had high hopes for desmoteplase, a genetically engineered version of a clot-dissolving protein found in vampire bat saliva. Lundbeck's release notes that the company is looking at alternative strategies for the drug, including a possible "divestiture." It's questionable, though, why anyone else would see value in the drug at this point. This has been a tough year for Lundbeck. Just weeks ago CEO Ulf Wiinberg got the boot after acknowledging a "gift" of some shares in a London-based biotech services outfit called Stratified Medical. After the gift arrived, Lundbeck invested 19 million Danish krone--a little more than $3 million--into the company, a serious ethics breach. Release
Acesion grabs $2.5M for atrial fibrillation drug work; Olaparib gets an OK in Europe
> Denmark's Acesion Pharma has raised $2.5 million from a group of investors that includes Boston-based Broadview Ventures as well as the local Novo Seeds. The biotech is developing a small molecule-based drug for atrial fibrillation in a program funded by the Wellcome Trust. The company plans to select a development candidate next year. "Broadview has a strict and dedicated focus on treatment of cardiovascular diseases and has established a unique network among leading cardiologists and entrepreneurs in this field," noted CEO Ulrik Sørensen. "We look forward to their participation and to our future interaction with Broadview and see this as an opportunity to open new doors to US based cardiology experts and investors." Release
> AstraZeneca's ($AZN) olaparib may be stymied in the U.S., but European officials have sanctioned its sale for ovarian cancer. The drug will be sold as Lynparza. FierceBiotech
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