Today's Top News Tuesday, March 8, 2016 | By Damian Garde
Amgen ($AMGN) is returning to the world of transformational dealmaking, executives said, looking to capitalize on a market-wide dip in valuations without overspending on hype. | | David Meline, Amgen chief financial officer |
Speaking to Bloomberg's Caroline Chen, Amgen Chief Financial Officer David Meline said the company is ready to scout for big-ticket deals again, moving on from the integration of Onyx Pharmaceuticals, acquired for $10 billion in 2013, and a broad restructuring effort that led to about 4,000 layoffs. Amgen is sitting on about $30 billion in cash and equivalents and relying on its business development staff to ferret out buyout opportunities around the globe. The company is "more energetic about being out there," Meline told Bloomberg, but it's being careful to pursue only targets that jibe with its core strengths. "The hardest thing to do when you have money in the bank is to be disciplined," Meline said. Amgen joins a group of Big Biotechs with major cash reserves and eyes on M&A. Gilead Sciences ($GILD) and Biogen ($BIIB) have said they're looking outside their own walls for new drugs, citing the downturn in biopharma price tags as an opportunity to pick up promising assets on the cheap. Amgen's open discussion of dealmaking follows a November Financial Times report that the company was looking for acquisitions in the $10 billion range, spurring market rumors that presaged the firm's current buyout scouting. - read the Bloomberg story Related Articles:
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Tuesday, March 8, 2016 | By Damian Garde
South San Francisco biotech Tizona Therapeutics is coming out of stealth with more than $70 million raised through two funding rounds and a pair of projects it believes can stand out in the fast-moving field of immuno-oncology. Led by Onyx Pharmaceuticals veteran Pablo Cagnoni, Tizona just wrapped up a $43 million B round co-led by Abingworth and Canaan Partners with help from Lightstone Ventures and a pack of prior investors. The latest funds pile onto a previously unannounced Series A, which totaled roughly $27 million and brought together MPM Capital, Amgen ($AMGN) Ventures, Astellas Venture Management and InterWest Partners. That cash will keep the doors open for about two years, Tizona said, and the biotech is pressing forward on two immunological targets with applications in cancer. The first is an antibody for the CCR4 protein, designed to modulate the regulatory T cells that help cancer skate past the immune system. Other agents in immuno-oncology have proven effective at releasing the brakes on effector T cells to help the body fight malignancies, but the micro-environment surrounding tumors remains highly immunosuppressive, Cagnoni said. Blocking CCR4, the company believes, can deplete the regulatory T cells, or T-regs, that protect cancer cells in that micro-environment, making Tizona's antibody a potentially potent part of a one-two punch in oncology. The company's second disclosed candidate is an antibody against interleukin-35, a protein secreted by T-regs to tamp down immunological response. Tizona's ambitions in IL-35 are two-fold: The biotech is at work on an antibody that can block it and thus help the body fight cancer, while at the same time crafting an IL-35 booster that could help slow down the inflammatory process in autoimmune disorders like Crohn's disease. Tizona said it's on track to get its CCR4 therapy into clinical trials next year, and the company hopes to get one new treatment into Phase I each year thereafter. Behind its CCR4 and IL-35 candidates, the company has three more as-yet-undisclosed projects, Cagnoni said. To get there, Tizona is planning to double its current staff of 13, scouting for talent as it builds out its pipeline. Tizona's plan is to take its candidates as far as that $70 million will take them, after which the biotech will look to either raise more money or extend its runway through a partnership, Cagnoni said. Cagnoni took the reins at Tizona last year following a stint as president of Onyx Pharmaceuticals that concluded after Amgen completed its $10 billion acquisition of the company. Before that, Cagnoni served as head of clinical development at Novartis' ($NVS) oncology division, playing a role in the successes of Afinitor, Exjade, Glivec and other cancer treatments. In leaving the world of big-time drugmakers for the startup scene, Cagnoni joins a growing group of pharma expats who have decamped to lead smaller companies in recent years. Former AstraZeneca ($AZN) R&D boss Briggs Morrison followed a similar path when he took over Syndax ($SNDX), as did ex-Merck KGaA research chief Annalisa Jenkins at Dimension Therapeutics ($DMTX) and one-time Biogen ($BIIB) R&D leader Doug Williams at Codiak BioSciences. But "it's not about big versus small," Cagnoni said. His experience with companies whose payroll measures in the thousands was "invaluable" as Tizona came together, even if he's still getting used to handling his own literature searches. "In a small company, you have to do certain things you haven't done in a while," Cagnoni said. "But at the same time, the amount of time you spend in a large company on decisionmaking bodies, restructurings, off-site--I'll take fixing the paper jam any day." - read the statement Related Articles:
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Amgen puts R&D chief in charge at newly-acquired Onyx Tuesday, March 8, 2016 | By John Carroll
Don't look for Capella Bioscience to try and compete with anyone in terms of staff size and facilities. The year-old, London-based biotech fledgling is operated by one full-timer--Chief Operating Officer Steve Holmes--aligned with a trio of investors/advisers who have all known each other for years, three CROs and two academic group collaborators split between the U.S. and the U.K. The venture investors have now put up a $15.7 million A round to fund a lineup of preclinical programs aimed at cherry-picking one very promising antibody that can be taken into clinical development in a couple of years. Over the past year, Holmes and his partners have been sussing out the potential of new antibodies that are being aimed at some hard targets. Antibodies, of course, are not new in biotech. And Capella isn't claiming the creation of any radical new antibody platform tech. "Antibody development can be routine," says Holmes, a veteran of Domantis, GlaxoSmithKline ($GSK) and Kymab. The big opportunity is finding the right target, complete with the kind of biomarkers and genetic profiles that can clearly illuminate commercial potential at an early stage of development. "The target is the key," says the COO of the virtual biotech, "not the technology for getting there." Holmes is working with three key venture figures: Raj Parekh with Advent Life Sciences, Don Drakeman, who co-founded Medarex and Genmab before joining Advent, and Kevin Johnson, a partner at Medicxi Ventures, made up of the life sciences team at Index, which recently split from the tech group to focus on biotech. Johnson's background includes his own work in antibodies, including a stint at Cambridge Antibody Technology, or CAT, which was acquired by AstraZeneca ($AZN). Advent, Medicxi and Osage University Partners put up the funds. In many ways, Capella is a great, perhaps extreme, example of the kind of R&D work that Medicxi--which just completed a $230 million fund--likes to invest in. The team is skeptical of the showy, $100-million-plus megarounds that have become popular in biotech on both sides of the Atlantic, preferring to stick with lean-and-mean biotechs/projects run by experienced execs sharing relationships that can extend back decades. Familiarity with the science is given a premium, all ambitious development efforts are considered hard and risky and if something doesn't work, they're quick to get out and go hunt up something new. Overhead tends to stay tight and low, if not semiclaustrophobic. It helps that the academic collaborators in San Diego and the U.K. are doing much of the work, along with the CROs, and the investors are providing some hands-on assistance as Holmes offers up the targets. Right now, there are two lead preclinical programs being worked on at Capella, focusing on Crohn's disease/ulcerative colitis and fibrosis, with two backups in the works. And if a pharma company likes what it sees over the next couple of years, Capella and its backers will be ready to talk terms as it tinkers with the early-stage pipeline. To be sure, antibody development may be somewhat routine now, but KaloBios set out with a plan to build an antibody company based on existing tech, and after repeated failures finds itself trying to regroup in bankruptcy. That cautionary tale underscores the notion that antibody development is harder than it may look at first blush. "It'll come down to the commercial attractiveness, or otherwise, of what we develop," noted Medicxi's Kevin Johnson in a message to me. "We have a few heavy duty mab/Pharma people such as Don Drakeman associated with the company. But the main thing is we're not wedded to any particular technology or target. We started with several targets and specified up front what characteristics a mab would need be truly outstanding, and shot for that. If we didn't get it, fine, we killed the program and moved on. What we have now is a couple of programs that have survived (we didn't expect any of them to work actually) and will cherry pick one of those to develop further. "What we have left looks pretty exciting in my opinion!" Related Articles:
Backed by J&J and Glaxo, veteran VC group splits from Index, unveils $227M fund
Biotech notches another $2B VC quarter, but can it last?
Index Ventures banks €650M for its new tech fund Tuesday, March 8, 2016 | By John Carroll
| | Sanofi CEO Olivier Brandicourt |
Just weeks after Bloomberg reported that Sanofi's ($SNY) new CEO, Olivier Brandicourt, was mulling over the fate of its 20-year-old European joint vaccine development and commercialization venture with Merck ($MRK), the two pharma giants have agreed to call it quits. The original news story highlighted Brandicourt's disenchantment with Sanofi Pasteur MSD's development pipeline. Based in Lyon, the joint venture was given little credit for productivity at a time that Brandicourt is in the middle of a reorganization, searching for new ways to cut costs. The group reported $330 million in revenue in the first 6 months of 2015. But while the JV supplies about half of Europe's vaccines, it's reported little growth in the last two years. Both companies, meanwhile, have big vaccine R&D operations of their own. Sanofi has finally begun commercializing its dengue vaccine after 20 years of development and Merck has been at work on an Ebola vaccine--being prepped for a 2017 regulatory filing--and other jabs. The split comes as the fast spread of the Zika virus is inspiring the latest in a series of rush campaigns to develop a new vaccine as leading companies try to deploy new technologies that promise to compress development timelines. Sanofi's ongoing restructuring has heightened fears of cutbacks, particularly in France, where its research operations have been given little credit for innovation. The pharma giant has been steadily shifting its focus to the Boston area, though, where it acquired Genzyme. "After carefully considering our individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the European Union, we have mutually agreed that it is in our best interests to manage our vaccine product portfolios independently," the two companies said in a joint communique. "We believe that focusing our efforts on opportunities unique to our respective companies will better position us to drive growth, execute in a more efficient manner and optimize vaccine coverage. By bringing vaccines more rapidly to market, both companies would deliver greater value to all stakeholders." - here's the release Related Articles:
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Sanofi's back-to-growth strategy fails to impress analysts Tuesday, March 8, 2016 | By John Carroll
Belgian biotech TiGenix claimed a rare Phase III win for a stem cell product last year when it reported that its lead program hit the primary endpoint among patients with Crohn's disease 24 weeks after therapy. And now it says the 52-week follow-up continued to reflect the treatment's success as it angles for a $57 million IPO on Nasdaq and a late-stage R&D drive in the U.S. By the numbers: 54.2% of patients who had a single injection of Cx601 to treat fistulas in Crohn's disease patients were in remission after a year, compared to 37.1% of the placebo arm. Three out of four patients--75%--of the patients in remission 24 weeks after treatment with the stem cell therapy remained in remission after a year, compared to 55.9% of the placebo arm. All the patients recruited for the study were resistant to currently used drugs. Cx601 uses off-the-shelf stem cells extracted from fat and injected intralesionally. The data fit the pattern the biotech touted as it filed for a $57 million IPO. And it marked an uncommon advance for a stem cell therapy--a once-lauded field that has fallen on hard times as treatments either foundered in the clinic or took longer than expected during the frenzy for stem cell treatments a decade ago. TiGenix is already on the market in Europe (EBR:TIG), where it saw an 8% rise in its share price after the data were released. The biotech has already filed for a European approval and says it's on track to launch a Phase III program in the U.S. Whether the biotech can raise money on Nasdaq, with low-profile biotechs as well as stem cell therapies out of favor with investors, remains to be seen. TiGenix has a follow-up stem cell program in the clinic for severe sepsis. - here's the release Related Articles:
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TiGenix snags $13.7M for Phase III cell therapy Sunday, March 6, 2016 | By EJ Lane
| | Chi-Med CEO Christian Hogg |
Hong Kong-based Hutchison China MediTech, or Chi-Med, has detailed its plans to raise $100 million on the Nasdaq in an IPO this month, placing its overall value at nearly $2 billion and joining a surge of investor interest in China-focused biopharma plays regionally and abroad. A price of $16.33 a share has been set for 6.1 million American Depositary Shares (ADS) for a Nasdaq listing on an amended Form F-1 filing with the U.S. SEC. Bank of America Merrill Lynch and Deutsche Bank Securities will serve as joint global coordinators and book runners for the offer expected to be priced during the week starting March 14 and trade under the symbol HCM, according to the filing. Read more from FiercePharmaAsia >> | 