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Wednesday, September 30, 2009
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 Vivus: Savior of the Pharma Industry?
Obesity took center stage in September, with important clinical results released on two key products: Vivus Pharmaceuticals' Qnexa and Arena Pharmaceuticals' Lorcaserin. That follows the release of phase 3 results on Orexigen's Contrave, another serious obesity contender, in July. All had positive results, but--if we may compare apples to slightly different apples for a moment--Vivus was the standout. Patients on Qnexa for 56 weeks lost an average 37 pounds, or 14.7% of body weight. The other drugs, while successful, ranged between 6.1% and 6.5% reduction in body weight--still handily exceeding FDA's general guidelines for a new obesity therapy. Vivus shareholders were, not surprisingly, cheering the news.
Drug developers have long thought of the ideal weight-loss pill--highly effective, safe in a broad audience (to obese and casual dieters alike), with manageable and not-too-unpleasant side effects--as the philosopher's stone of pharmaceuticals. Such a drug could top $10 billion in annual sales and stand shoulder-to-shoulder with the mighty Lipitor. Or reach even higher.
On the other hand, history shows that More...
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Obesity may have dominated headlines, but there were some other interesting developments in the lab announced over the past month. Complete Genomics made a major stride forward in the race for the $1,000 genome, announcing that it had sequenced 14 complete human genomes at about $4,000 a pop. We know, of course, that the original Human Genome Project took 13 years and about $3 billion to complete one genome. Even earlier this year, the cost of a complete human genomic sequence was around $50,000. If we get to $1,000, the thinking goes, it becomes realistic to make a complete sequence part of one's standard medical record. All of a sudden, that's not looking so far off. Right now, the genomes completed by Complete Genomics are being analyzed, so we don't know if speed and low cost requires a trade-off in accuracy. It will go a long way toward verifying the company's claims if the results are ultimately published in a peer-reviewed journal.
And researchers are certainly cheering clinical results showing that at least some people were protected by Sanofi/VaxGen's HIV vaccine. While the results were modest overall, this is the first time a vaccine has shown any success in a clinical setting. Next challenge: Figure out how those who were protected differed from those who weren't.
-KT
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The Genentech shuffle continues, with Roche placing the biotech division right at the top of the food chain. Genentech CEO Pascal Soriot, who was hired earlier this year to replace Art Levinson, will now head Roche's Pharma division, replacing Bill Burns. Ian Clark, recently named head of global product strategy for Roche Pharma, is becoming Genentech's new CEO. Roche is also seeing some changes in its Diagnostics and Research divisions, with the retirement of two top executives. With the integration of Genentech well underway, some changes were inevitable, but Roche CEO Severin Schwan also indicated that he is looking for a younger executive team that is presumably more willing to take risks.
-KT
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Clinical Trials: Phases and Design
Designed for individuals working or interested in the pharmaceutical and biotechnology industries, this course reviews all steps involved in the drug discovery and development process, including nonclinical, clinical, and post-marketing studies. You focus on clinical trial design. A clinical trial, by definition, is a carefully planned and scientifically sound experiment.
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Career Sabotage: The Influence of a Past Employer
A poor or even luke warm reference can sometimes cost you the job you want. If you are worried about what a former boss will say to a prospective employer, consider using a reference checking service as seen in the Wall Street Journal. More...
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Elan got itself in a tough spot when it negotiated a deal with Johnson & Johnson that left its partner Biogen Idec fuming. Biogen argued that a provision giving J&J the option to fund the buyout of Tysabri rights in the case of a change in control at Biogen constituted a breach in their marketing agreement. A federal court has agreed, and Elan and J&J have amended their deal. Now we know exactly how much that option was worth to J&J: $115 million. That's how much it reduced its investment in Elan, although the $500 million in R&D funding remains unchanged.
Feeling its oats, Biogen has turned around and gotten bellicose with Facet Biotech. Biogen's private bid made back in August was rejected by the firm, so it went hostile with a lower bid. Why lower? Because Facet went out in the meantime and entered a deal with Trubion Pharmaceuticals that Biogen thinks lowered the value of the company (and Facet's shareholders appeared to agree, given the drop in share price that followed the deal). Facet and Biogen have been collaborating on monoclonal antibodies for multiple sclerosis and cancer, so the fit is there. Just not the love, it seems.
-KT
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• Biotech Bay (San Mateo, California)
NeurogesX, Inc.
National Sales Manager/Vice President of Sales
Responsible for the recruiting, hiring, and management of a specialty sales force. Key responsibilities include customer development, territory alignment, sales training, and compensation planning. The VP Sales will drive demand creation for the company's launch of its first product Qutenza for post herpetic neuralgia.
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• Southern Pharm (Jupiter, Florida)
Envoy Therapeutics
Vice President, Drug Discovery
You will be responsible for building a pipeline of valuable, proprietary drug compounds, demonstrating the enormous power of our technology, delivering successful results with a select number of partnerships with global pharmaceutical companies and creating a robust intellectual property estate.
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• Pharm Country (New York, New York)
TB Alliance
Vice President Business Development
The Vice President of Business Development will play an integral role in achieving the portfolio development and related financial goals of the TB Alliance. This individual will lead the establishment of successful external agreements and strategic alliances within the context of the product development partnership (PDP) business model.
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• Biotech Beach (San Diego, California)
BioPhase Solutions, Inc.
Chief Technology Officer
The CTO, reporting to and working closely with the CEO, will have the responsibility of co-managing, overseeing and coordinating the science programs of the company. The CTO participates in setting and conducting the scientific research of the company and will ensure that all programs are meeting milestones and key deliverables, in line with the set strategy and customer needs.
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See more than 5,000 job postings in the BioSpace Career Center!
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Biotech Bay Career Fair
San Francisco Airport Marriott,
Tuesday, October 13, 2009. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay area.
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BPI-BioSpace Career Fair
Raleigh Convention Center, Wednesday, October 14, 2009. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Raleigh-Durham area.
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Seemingly every company that had some good news in the clinic, the lab, or at FDA chased it with a financing. No great surprise there--the markets are finally receptive, and many companies have strapped budgets from a long capital drought. So you'll see names like Vivus (following on the heels of Arena and Orexigen, which also raised secondaries earlier this year), Complete Genomics, Gloucester, and others on the list of recent financings. The highlights below focus instead on the accelerating IPO market.
September hosted the busiest week for IPOs since 2007, and some biotech companies are among the debutantes. That includes Bayer spin-out Talecris, which canceled IPO plans once before, then subsequently fetched a $3.1 billion buy-out bid from Australia's CSL (maker of one of the four FDA-approved H1N1 vaccines). That's the biggest of the bunch, but it's perhaps even more interesting that another two, Anthera and Omeros, both focused on inflammation, are throwbacks to an earlier time. They have no revenues and still have clinical and regulatory hurdles to pass. Omeros even does drug discovery, for goodness sake! That kind of risk appetite really suggests that the capital markets are coming back.
-KT
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Global Vaccine Development for World Health Symposium will address the expanding need for discussion on regulatory guidelines for the development of vaccines for infectious diseases.
Professionals from industry and worldwide regulatory agencies will present the current challenges and solutions around this critical field of global healthcare. More information and online registration.
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qPCR Symposium USA. The 3rd qPCR Symposium USA features keynote speech, presentations by experts on latest developments in the industry, applications and academic perspectives from eminent scientists. The Symposium is also hosting exhibition, poster session and related courses. For more information, visit www.qpcrsymposium.com.
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Those of you anxiously waiting on the September 30 deadline for reauthorization of the Small Business Innovative Research (SBIR) program are going to have to just keep waiting. Word from those on the ground is that there has been very little progress in reconciling widely different House and Senate versions of a reauthorization bill. The SBIR program will officially expire at the end of this month if Congress does nothing, but it's likely to pass yet another continuing resolution that keeps the status quo alive for another three to six months. We've been hurrying up and waiting since mid-2008, so what's new? -KT
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We have swine flu vaccine! FDA approved H1N1 vaccines from four manufacturers, acting quickly and decisively in the face of the worldwide pandemic. The bummer is that you're going to have to break it to your kids under 10 that they need not one but two shots--an initial dose and a booster three weeks later. Or maybe not -- MedImmune's version is a nasal spray, and it will be the first one out, but it's not clear who will get that and who will have to wait for an injectable. (Very young children can't take a nasal spray and require injection, so they'll have to wait a little longer). The debate over optimal dosing in those of us over 10 years of age continues, but researchers are reporting acceptable results with a single dose. That's probably what most of us will settle for.
-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.
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