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Wednesday, February 27, 2013
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 The End Is Near
Civilization as we know it ends on Friday. That, of course, is when the so-called "sequester" kicks in, forcing broad, blunt cuts across the government. Nobody wants it to happen, and yet such is the state of our political leadership that, barring a last-minute miracle, it's going to happen anyway. More...
More By Karl Thiel
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Gilead Sciences took another step forward with its sofosbuvir regimen (NS5B polymerase inhibitor), this time showing a strong success signal in patients who had previously failed interferon-based therapies. The company plans to submit for U.S. and European approval in the second quarter.
AbbVie (the former Abbott Labs) has been counting on ABT-199 to help it diversify its revenue stream away from rheumatoid arthritis drug Humira, so patient deaths in mid-stage trials are certainly bad news. But the deaths were due to tumor lysis syndrome, which is caused by the breakdown products of malignant cells and can be caused when tumor cells are killed off too quickly. (Sort of like the cancer equivalent of sepsis caused by bacterial endotoxins). AbbVie believes they'll be able to tune the administration of the drug and begin phase 3 trials this year.
-KT
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So nice to see more news of hiring. Genentech is looking to fill a sizeable number of positions that pretty much run the gamut at its South San Francisco headquarters and elsewhere. Amgen, meanwhile, is dealing with the realities that come with maturity. The company has a strong late-stage pipeline but expects to see slowing growth this year. It is making some tough choices about where to put its resources, focusing on a "pick-the-winners" strategy (which presumably means killing the losers). There's even a strong push into biosimilars. Short term, that means some modest job cuts.
-KT
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Merck came out swinging in 2008 with a bold plan to launch six biosimilars between 2012 and 2017. Then reality set in and the company closed its biosimilars unit, Merck BioVentures. Now its deal with Samsung shows it is still interested--although in this case it looks like Samsung is doing all the heavy lifting while Merck is the marketing partner. (Samsung, incidentally, announced its own problems with its biosimilar efforts back in October.)
Biogen is putting some of its offshore cash to work in capturing full rights to multiple sclerosis drug Tysabri, while Genetech shows some interest in the oft-neglected field of antibiotics in a deal with RQx Pharmaceuticals. Alnylam is well behind larger competitors like Regeneron, Sanofi-Aventis, and Roche when it comes to developing a cholesterol drug targeting the enzyme PCSK9. But the company believes its unique mechanism of action may give it the best and class drug, and The Medicines Co. is convinced enough to pay $25 million upfront, as well as further milestones and double-digit scaled royalties.
-KT
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• Biotech Bay (Sunnyvale, California)
Pharmacyclics, Inc.
Vice President, Information Technology
Reporting directly to the EVP, Finance the VP of IT’s role is to plan and directs all aspects of the organization's technical infrastructure. Oversee build-out, implementation and maintenance of enterprise-wide system tools and ensures scalability and accessibility of applications and services. Establish and approve operating policies to mitigate risk. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals.
• Biotech Bay (San Carlos, California)
NovaBay Pharmaceuticals, Inc.
Vice President of Product Development
Selected candidate will direct all product development activities for NovaBay’s lead compound currently in Phase II/III clinical trials for three indications. The successful candidate will have line responsibility for the following disciplines currently managed by in-house professional and consultants.
• Biotech Beach (San Diego, California)
Halozyme Therapeutics, Inc.
Head Of Biostatistics and Data Management
The successful candidate will establish a new department of Biostatistics and Data Management within Halozyme. As such, he or she will initially direct the design, development and implementation of a technical infrastructure capable of receiving, storing and processing clinical trial data. The incumbent will be responsible for recruiting appropriate staff and building out functional capabilities that will support the full spectrum of clinical development activities
• Genetown (Cambridge, Massachusetts)
Vertex
Sr. Director, ICSR
Responsibilities include the maintenance of structural organization within the Department, as well as the technical and managerial coordination of its groups and staff. Additionally, the Sr. Director will have full support from the other functions within Global Patient Safety as well the ability to work cross functionally with other areas in the organization.
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Last year saw booming prices for biotech stocks, and now here come the IPOs! We're not just seeing huge spin-offs like Pfizer's or blasts from the past like, but also re-emboldened start-ups like Ambit Biosciences (which withdrew its first IPO bid in 2011), and TetraPhase which hopes to tap into the growing interest in novel antibiotics (novel tetracyclines, more specifically).
Meanwhile, Jounce Therapeutics scored a mighty $47 million Series A round from just one investor: Third Rock Ventures. Inspired by the success of Bristol's melanoma drug Yervoy, the company is working on cancer immunotherapies, but using a "broader" approach than its competitors. (What exactly this means, the company isn't yet disclosing.)
-KT
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Keep your friends close and your consultants even closer. That may be the lesson for Express Scripts, which says that a (now-former) Ernst & Young employee, working with the company on its merger with Medco Health, stole trade secrets over a period of months. E&Y, for its part, did admit to Pharmalot that "there was a violation of EY policies and the company's policies" but says it caught the problem early enough to prevent permanent harm to Express Scripts.
Eli Lilly, meanwhile, is getting fed up with Canada's tendency to invalidate patents at the drop of a hat. Having just lost protection for three of its key drugs, the company is talking about pulling operations out of the country. Lilly isn't the only one--a number of pharma companies scaled back Canadian operations. Nor is it just a tussle between the industry and Canada's government. One of the many stumbling blocks to a trade deal between Canada and the EU has hinged on Europe's insistence that Canada give more expansive protection to drug patents. Canada understandably wants to keep feeding its national healthcare system with cheap drugs, but innovators are unlikely to stop pushing back.
-KT
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The approval of Roche's Kadcyla (T-DM1) for metastatic breast cancer marks another big step forward for antibody drug conjugates. Seattle Genetics, of course, got a lot of attention for its lymphoma drug Adcetris in 2011, although this wasn't the first ADC approved (remember Mylotarg?). But we're certain to see a lot more of these in the coming years. Kadcyla is approved for front-line treatment of metastatic breast cancer, which wasn't entirely expected, and could help peak sales reach as high as $5 billion.
The approval of Celgene's Pomalyst wasn't quite such a high-profile event, but the drug--another thalidomide analog--could reach blockbuster status in the treatment of second- and third-line multiple myeloma, with other potential indications to come.
-KT
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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.
You may contact Karl Thiel at Karl.thiel@biospace.com.
BioSpace, Inc.
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BioSpace, Inc.
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Phone: 877-277-7585
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