BioSpace BioPharm Exec
Wednesday, February 24, 2010
This Is Recovery: Less Money, Less Risk Appetite, Fewer Jobs

Here in Oregon, it looks like an early Spring, with early February's green shoots already full-blown daffodils and the cherry blossoms already doing their thing. But for biotech, the economic green shoots that started to push up last year may be withering under an unexpected blanket of snow. (Hey, you East Coasters will understand the metaphor.)

An IPO market that was starting to heat up may now be winding down, as a number of companies currently in the queue start to have second thoughts in the wake of Ironwood Pharmaceuticals' not-so-stunning success (see Money Talk, below). That's a problem when it comes to financial exits, but there's an entrance problem, too. Banks have been doing rather well lately, but they are continuing to use these relatively good times to heal their balance sheets and are not doing much lending. Venture capitalists continue their appetite for big, mature companies with near-term market opportunities, not big ideas that need to be developed. Overall U.S. venture investments dropped 31% from 2008 to 2009, according to Dow Jones VentureSource. More...

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Gilead Sciences got a nice boost from some very promising-looking mid-stage data just released on its closely watched "quad" pill that combines four anti-HIV medications. The same can't be said of Isis, which reported positive phase 3 results on Mipomersen, its drug for familial hypercholesterolemia, but saw its stock plummet nonetheless. Concerns about liver toxicity remain, and Isis is, quite sensibly, going to initially seek approval in patients with a homozygous form of the disorder. While much rarer, this form of the disease is also more severe and FDA will presumably be more tolerant of potential safety concerns. (Pssst, Isis and Genzyme will also charge more money for it. Don't you know rare diseases are all the rage?) In any case, Isis hopes to eventually reach a broader audience by showing that elevated liver enzymes do not actually lead to liver damage.
-KT

Gilead Sciences, Inc. (GILD)'s Single-Tablet "Quad" Regimen for HIV Achieves a High Rate of Virologic Suppression in Phase II Study
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Amgen (AMGN) (JOBS): Denosumab Prostate Cancer Trial Meets Goals
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Isis Pharmaceuticals, Inc. (ISIS) (JOBS) Says Cholesterol Drug Works; But Safety Weighs
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Regeneron Pharmaceuticals, Inc. (REGN), Bayer HealthCare Pharmaceuticals (BAY) Say Eye Drug Meets Mid-stage Goal
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BioSante Pharmaceuticals, Inc. (BPAX) Reports Positive LibiGel(R) Safety Data in Phase III Program
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More Bench To Clinic News
CSU: Professional Biotechnology Project Management Certificate in Quality Assurance CSU: Professional Biotechnology Project Management Certificate in Quality Assurance: This new, online, graduate-level certificate has been co-developed with professionals from the American Society of Quality and the biotechnology industry. The certificate program incorporates four existing courses that are being offered together by the CSU for the first time, starting January 2010. Click here to learn more or contact 619-594-3954, rbhathal@mail.sdsu.edu. Aptuit Discover why more and more biotech and pharmaceutical companies are turning to Aptuit: Industry-leading consulting expertise. State of the art GMP/GLP facilities. Aptuit Laurus, India: world-class research center and large-scale drug substance manufacturer. Innovative technologies that streamline and expedite the process. Complete project management capabilities. Comprehensive regulatory compliance services. www.aptuit.com/science
Billy Tauzin is stepping down from his $2 million-a-year gig as head of PhRMA, the nation's largest pharmaceutical lobby. Politico asked if it had anything to do with dissatisfaction or concern on the part of board members over how he has handled or would handle the $80 billion deal PhRMA struck with the White House on financing reform. His answer? No, that's "bullcrap." It was just a personal decision.

Meanwhile, Big Pharma job cuts once again dominate the headlines. With GlaxoSmithKline preparing to axe a further 4,000 jobs, I was initially stunned to see this headline subsequently appear: "GlaxoSmithKline to Increase Headcount, Introduce More Products." How could they be shedding so many jobs and yet increasing headcount? And then it occurred to me--GlaxoSmithKline is actually decapitating former employees! Umm...well, no. It's actually something far more emblematic of the times. The company, like many other Big Pharmas, is expanding in developing countries, especially India and China, while scaling back dramatically in North America and Europe. (Late breaking update: GSK CEO Andrew Witty said in a recent press conference that the company is in fact planning to build a new green field biotech center in the U.K. that could employ up to 1,000 people, so perhaps there is another step forward to help counter the many steps backward we've seen in worldwide industry employment.)
-KT

PhRMA President Tauzin to Resign
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GlaxoSmithKline (GSK) (JOBS) Set to Slash 4,000 Jobs; Pharmaceutical Giant Pushes Into Emerging Markets as it Squeezes Costs in the West
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Enzon Pharmaceuticals, Inc. (ENZN) CEO Resigns, Replaced by Executive Committee
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Merck & Co., Inc. (MRK) Increases Profits, to Slash 15% of Workforce and Save Up to $3B
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AstraZeneca PLC (AZN) Announces Further Restructuring in R&D; 3,500 More Jobs Eliminated
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More Career Track News
Pharm-Olam International Pharm-Olam has clinical staff experienced in running diabetes studies in over 20 countries. Many areas have underreported cases and competition for patients, so let Pharm-Olam conduct a complimentary feasibility study specific to your protocol and study budgets to use in your resource planning. Contact us at www.pharm-olam.com, info@pharm-olam.com, USA +1 (713) 559-7900, UK +44 (0) 1344 891121 Clinical & Regulatory Sciences This professional certificate enables students to master practical aspects of clinical trial conduct and management, FDA regulations, International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines, procedural guidelines, and ethical considerations covering multiple aspects of clinical trials.
GlaxoSmithKline continues to be one of the hardest working dealmakers in the business, sealing an agreement with Apeiron for an early-stage acute respiratory distress syndrome drug as well as entering an indication-specific deal with Amgen, covering Enbrel for dermatology uses. (Amgen knows the ups and downs of this kind of deal, having managed a sometimes-tumultuous relationship with Johnson & Johnson on Epogen over the years.) GSK is also becoming the latest Big Pharma to get officially interested in rare diseases with the formation of a dedicated standalone unit.

Speaking of managing difficult relationships, Eli Lilly and Bristol-Myers Squibb have finally worked out their differences over necitumumab, the presumed fully humanized follow-on to Erbitux that has been held up by protracted bickering.(The news was buried in an earnings press release, but we've linked to a handy discussion).
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AstraZeneca PLC (AZN) Pays up to $1.2 Billion for Rigel Pharmaceuticals, Inc. (RIGL) Arthritis Drug
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GlaxoSmithKline (GSK) (JOBS) Signs $330 Million Deal with Apeiron Biologics
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With Their Rights Squabble Settled, Eli Lilly and Company (LLY) and Bristol-Myers Squibb Company (BMY) Look Ahead
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Genzyme Corporation (GENZ) in Icahn's Sights
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Amgen (AMGN) (JOBS), GlaxoSmithKline (GSK) (JOBS) Unit In Enbrel Promotion Pact
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More Golden Handshakes News

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Progenitor Cell Therapy
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Oversees the entire regulation process for all products/procedures requiring governmental approval by ensuring that all necessary applications are filed and handling all government interactions. Develops procedures to ensure regulatory compliance.
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Elevation Pharmaceuticals
VP Pharmaceutical Development
The Vice President of Pharmaceutical Development (VPPD) will report to the CEO and be responsible for leading and managing all product development and manufacturing activities of its drug products. Also, the VPPD will be principally responsible for managing the relationship with our device partner, including customization and qualification activities.
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Derive a science strategy that underpins Asterands business strategy that is to become a leader in human-based solutions for pharmaceutical companies engaged in drug discovery research. Gain agreement with the CEO and Board, and lead implementation of this strategy.
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• BioMidwest (Dublin, Ohio)

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Biotech Bay Career Fair Biotech Bay Career Fair
South San Francisco Conference Center, Tuesday, March 9, 2010. 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.
Pharm Country Career Fair Pharm Country Career Fair Bridgewater Marriott, Thursday, February 25, 2010. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Philadelphia/New Jersey region.
Ironwood Pharmaceuticals raised $188 million in its IPO, more than any other biotech company in the past 10 years. Now that's got to officially end the drought, right? Well...maybe not. It didn't look so good in the details, with the company boldly raising its offering price as its debut approached, then slashing it again shortly before the offering and going out for less than it had originally targeted. Also, one of its underwriters, Morgan Stanley, snatched up a large portion of the offered shares, indicating interest was low. Still, the company's new stock has risen since the offering and is holding onto higher levels. That's a small silver lining, but it may not be enough--queued companies like Anthera and Fluidigm are reportedly reconsidering their IPO plans.
-KT

Ironwood Pharmaceuticals IPO Raises Less Than Expected-Says Underwriter
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Anthera Pharmaceuticals, Inc. Sets IPO Terms, Will Price in the $13-$15 Per Share Range
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Fidelity-Backed Fluidigm Corporation May Delay IPO as Startup Deals Falter
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Eleven Biotherapeutics Completes $35 Million Series A Funding to Advance Pipeline of Innovative Protein-Based Therapeutics
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Alnara Pharmaceuticals, Inc. Secures $35 Million in Series B Round
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More Money Talk News

Clinical & Regulatory Sciences This professional certificate enables students to master practical aspects of clinical trial conduct and management, FDA regulations, International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines, procedural guidelines, and ethical considerations covering multiple aspects of clinical trials. CBI's West Coast Forum on Early Access Programs CBI's West Coast Forum on Early Access Programs. March 9 - 10, 2010. Early Access Programs (often referred to as Named Patient, Expanded Access and Compassionate Use Programs) provide pharmaceutical companies with an ethical and controlled mechanism to provide access to promising drugs that have the potential to meet genuine unmet medical needs.
Sam Waksal is back! Waksal, the waskally wabbit who wound up in jail in 2003 for insider trading related to ImClone...but who also took ImClone 90% of the way to the approval of the blockbuster, life-saving drug Erbitux...is in negotiations to acquire a privately held biotech company. (He is forbidden from being the officer of a publicly held company, but that wouldn't pertain here.) It's hardly a surprise Waksal would look to stay active in the biotech scene--this is, after all, what he does. Actually, he used to be the majority owner, along with junior partner Mariel Hemingway, of Sam's Restaurant on West 52nd St. in New York. But there's no indication so far that he's returning to this other line of work. (Okay, this isn't exactly a Legal Brief, but I had to fit it in somewhere!)
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AMAG Pharmaceuticals, Inc. (AMAG) Safety Update on Anemia Drug
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ImClone Systems Corporation (IMCL) Founder Waksal Forming New Biotech Venture
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Two U.S. Drug Safety Reviewers Urge GlaxoSmithKline (GSK)'s (JOBS) Avandia Come Off Market
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US FDA Warns Eli Lilly and Company (LLY), Sanofi-Aventis (France) (SASY.PA), Meda AB (MDABF.PK) on Misleading Promotions
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AstraZeneca PLC (AZN) Facing 26,000 Lawsuits Over Seroquel
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More Legal Briefs News
Asterand  - Partners in Human Tissue Research Asterand - Partners in Human Tissue Research
Asterand plc is the leading global supplier of high quality, well characterized human tissue and human tissue-based research services to drug discovery scientists. Our mission is to provide human tissues and services to accelerate the identification and validation of drug targets and enhance the selection of drug candidates with an increased likelihood of clinical success. http://www.asterand.com/Asterand/
BioSpace Research Store Big Pharma Mega-Mergers 1995 - 2014
Assess how much of Big Pharma's sales growth over 1995-2014 will be driven by M&A versus how much will be self-produced through organic growth. Assess how Datamonitor has classified each of the current Big Pharma players by their dominant M&A growth strategy Analyze the M&A and organic sales growth profiles for each Big Pharma company over the period 1995-2014.
Our friends in Rockville are working hard, and it's going to be a busy month ahead. Before the next issue of Biopharm Executive reaches your hands, FDA is scheduled to have received advisory panel recommendations and/or made approval decisions on between five and seven new biotech products. Yowza! Look for this space to be full next time around on news from InterMune, Salix Pharmaceuticals, Shire Pharmaceuticals, Amylin Pharmaceuticals, Somaxon Pharmaceuticals, and...depending on rescheduling, maybe even from Mannkind and Cell Therapeutics. (Given the tone of FDA's questions on Cell Therapeutics' pixantrone, however, the company has to be glad its scheduled advisory committee was delayed because of the winter storms, giving it time to regroup. Woohoo! Snow day!)

Actually, the agency was no slouch this month either, foul weather and all, having made some key approvals...and rejections.
-KT

US FDA Staff Questions Cell Therapeutics, Inc. (CTIC) Lymphoma Drug Pixantrone Data
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FDA Approves Roche (RHHBY)'s Rituxan Plus Chemotherapy for the Most Common Type of Adult Leukemia
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U.S. Denies Approval of XenoPort, Inc. (XNPT), GlaxoSmithKline (GSK) RLS Drug; Xenoport
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Cadence Pharmaceuticals, Inc. Says FDA Refuses to OK Pain Drug
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U.S. FDA Approves Labopharm (DDS.TO)'s Antidepressant Trazodone
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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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