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Wednesday, May 25, 2011
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Everything You Wanted to Know About ASCO (But Were Afraid to ASCO)

We're heading into the annual meeting of the American Society of Clinical Oncology (ASCO), which will be held June 3-7 in Chicago. The most exciting thing about the meeting will vary by your own personal interests, but there are some very helpful summaries out there that can give you a head start on digging through an avalanche of data. (Check out this broad overview from Kantar Health, this focus on melanoma from cancernetwork.com, this preview on RNAi therapeutics, and this one on leukemia drugs from MD Becker Partners.

ASCO's annual meeting covers a huge range of research, but it's still tempting to pick an annual theme (the official one, by the way, is "Patients, Pathways, Progress"). Certainly one focal point is metastatic melanoma--a deadly skin cancer that has had few useful treatment options until recently. More...

More By Karl Thiel

Did I mention ASCO? It's not the only show in town; at the American Urological Association meeting in Washington D.C., Amgen reported some new data on Xgeva (denosumab) in bone metastases from prostate cancer. Prostate cancer will be a focus of ASCO, too, and an important question over the next couple years will be which of these therapies prove most effective...or how they might be used together. Pfizer will be presenting data on 15 compounds at ASCO, including renal cell carcinoma drug Axitinib and Crizotinib, which showed impressive results in lung cancer.
-KT

Amgen (AMGN)'s XGEVA Phase 3 Trial Meets Primary Endpoint
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Pfizer Inc. (PFE) Presents New Phase 3 Data Showing Axitinib Significantly Extended Progression-Free Survival Compared With Sorafenib In Patients With Previously-Treated Advanced Renal Cell Carcinoma
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Pfizer Inc. (PFE) Lung Cancer Drug Shows Survival Benefit
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Pearl Therapeutics' Phase IIb Results Show a 50% Improvement in Lung Function with PT003 Compared to Spiriva(R) and Foradil(R) in Patients with COPD
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New Study Reveals Risks with Roche (RHHBY)'s Avastin for Wet AMD Versus Novartis AG's Lucentis
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More Bench To Clinic News
Another wrinkle in the saga of Forest Labs CEO Howard Solomon as one of the company's shareholders, the AFL-CIO, joins the U.S. government in calling for his ouster. My favorite thing about this latest development is that the AFL-CIO, according to Pharmalot, owns just 208 shares of Forest--worth about $7,330 as I write this. Shareholders so seldom put any pressure on companies that it is great to see one using its stature, rather than its actual stakeholding, to apply some leverage. Forest's board, on the other hand, is only going to listen to numbers; embarrassment obviously isn't a big motivator. And Novartis--well, we don't know what it is those senior executives did, but whatever it was, the company won't tolerate it.
-KT

AFL-CIO, a Forest Laboratories, Inc. (FRX) Shareholder, Wants Solomon Out as CEO
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Novartis AG Fires Senior Executives For Misconduct
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Inspire Pharmaceuticals, Inc. (ISPH) CEO, Workers Out as Merck & Co., Inc. (MRK) Closes Inspire Headquarters
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Sanofi (France) (SASY.PA)'s Zerhouni Ditches Old Model; Strives for "Open Innovation"
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AstraZeneca PLC (AZN) to Lay Off 135 in Westborough, Massachusetts
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More Career Track News
Takeda's decision to buy Nycomed shows that a trend we remarked on a couple years ago is still alive and well: Japanese pharma companies have healthy balance sheets, a strong yen, and a need to expand internationally. The recent earthquake underscores the need of these companies to diversify their supply chains. Indeed, this isn't the only major deal this month from a Japanese pharma, or even from Takeda itself, which also made an investment in stem cell company Fate Therapeutics. Valeant's hostile bid for Cephalon was overcome by a white knight offer from Teva, so we have one less fight to watch.
-KT

Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Nails Nycomed Buyout for $13.7 Billion, Skin Unit to Spin Off
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Allos Therapeutics, Inc. (ALTH) and Mundipharma AG Announce Strategic Collaboration for FOLOTYN; Allos to Receive $50 Million Upfront; Potentially up to $310.5 Million
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Alkermes (ALKS), Elan Drug Technologies in $960 Million Merger
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Teva Pharmaceutical Industries Limited (TEVA) to Buy Japanese Generic Drugmaker, Taiyo Pharmaceuticals Industry Co. Ltd. for $490 Million
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Teva Pharmaceutical Industries Limited (TEVA) to Buy Cephalon, Inc. (CEPH) for Over $6 Billion, Tops Valeant Pharmaceuticals International (VRX)
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More Golden Handshakes News

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Pharm Country Career Fair Pharm Country Career Fair
Hanover Marriott, Thursday, June 9, 2011, 11am to 4pm . Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the tri-state area.
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Grand Hyatt Washington, Monday, June 27, 2011, 2pm to 7pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the DC region.
Advanced Biohealing was all set to make a bold $200 million IPO when Shire swept in and bought the company instead. Advanced Biohealing sells Dermagraft, which it acquired from Smith & Nephew which in turn had acquired it from the erstwhile Advanced Tissue Sciences. And speaking of regenerative medicine, busy Takeda invested an undisclosed amount in Fate Therapeutics, which is developing a way to make adult stem cells act more like embryonic stem cells that can be differentiated into various types.

Meanwhile, Naurex raised money for an interesting antidepressant for treatment-resistant patients: a drug in the same class as recreational the drugs PCP and ketamine. But this is only a partial activator of the receptor and doesn't appear to have the same nasty side effects. Here's hoping it works for this undertreated class of patients.
-KT

Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Bets on Fate Therapeutics
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Naurex Inc. Raises $18 Million to Advance Novel Antidepressant
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Quintiles, Inc. (QTRN) Seeking $2.23 Billion in Loans for Refinancing
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Delenex Therapeutics Extends CHF 30.2 Million Series A Financing Round
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Celldex Therapeutics, Inc. (CLDX) Raises $31.5 Million
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More Money Talk News

There's nothing like bad blood between longtime partners. Bydureon, the extended release version of the diabetes drug Byetta, got shot down by FDA last year, but just last month received a positive opinion from European regulators. Now Amylin thinks Lilly is turning its back on the franchise by partnering with Boehringer Ingelheim on the competitive product linagliptin. Lilly will use the same sales force to promote the two drugs, which Amylin says is a breach of their marketing agreement--something Lilly denies. And Takeda's ongoing woes with Actos --which went off patent in January, although generics won't launch until next year -- highlights its need to build out the pipeline, a key motive for the Nycomed acquisition.
-KT
Amylin Pharmaceuticals, Inc. (AMLN) Files Suit Against Eli Lilly and Company (LLY)
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More Signs Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Diabetes Drug, Actos Linked to Bladder Cancer
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Feds Seeking $1B From Johnson & Johnson (JNJ) Over Risperdal Marketing
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Ranbaxy Laboratories (RANBAXY.BO), FDA in Settlement Talks Over $1 Billion Fine
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GlaxoSmithKline (GSK) May Settle 1,000 More Avandia Lawsuits, Attorney Says
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More Legal Briefs News
Let the hepatitis C battle begin! FDA approved both Vertex's Incivek (telaprevir) and Merck's Victrelis (boceprevir) within days of each other. Data appears to favor Incivek as the drug of choice, but it will remain to be seen if Vertex can make that message heard over Merck's strong existing marketing presence in hep C.

Also, in its first quarter earnings release, Vivus quietly mentions plans to resubmit for U.S. approval of the weight loss drug Qnexa in a limited market: men and women not of childbearing age. This gets around the chief problem with Qnexa, namely its association with birth defects--specifically cleft palate. The company is still hoping the FORTRESS study will clear the association, but it appears to be planning for failure. FDA will likely have some rigorous approval requirements, so it will be interesting to see how this shakes out.
-KT
FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s INCIVEK(TM) (telaprevir) for People with Hepatitis C
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FDA Clears Merck & Co., Inc. (MRK)'s Victrelis for Hepatitis C, First New Hep C Drug Approved in 20 Years
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VIVUS, Inc. (VVUS) to Submit Qnexa Application as Limited Indication
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Roche (RHHBY) Seeks Approvals for New Skin Cancer Drug
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Novartis Corporation (NVS) Gains FDA Approval for Afinitor(R) as First New Treatment in Nearly Three Decades for Patients with Advanced Pancreatic NET
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More Rockville Files News

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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