Biotech

Pfizer, Glaxo, J&J Grab ASCO Spotlight

twocents@thestreet.com (Adam Feuerstein) — Wed, 16 May 2012 22:01 GMT

BOSTON (TheStreet) -- New drugs from Pfizer and GlaxoSmithKline that precisely target genetic weaknesses in cancer were given spotlight treatment Wednesday night by the American Society of Clinical Oncology (ASCO) in a preview of its upcoming and closely followed annual meeting.

ASCO officials also highlighted a mid-stage study of Johnson & Johnson's Zytiga in early-stage (pre-surgical) prostate cancer patients. Later during the ASCO meeting, which starts in two weeks, J&J will present new Zytiga results from a phase III study in more advanced prostate cancer patients.

In all, ASCO released more than 4,500 research abstracts, or clinical summaries, of new cancer drug data Wednesday night in advance of its annual meeting. ...

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ASCO '12 Abstract Dump: Cancer Stocks in Focus

twocents@thestreet.com (Adam Feuerstein) — Wed, 16 May 2012 22:00 GMT

BOSTON (TheStreet) -- Investors got their first look at thousands of cancer drug research abstracts released Wednesday night by the American Society of Clinical Oncology (ASCO) in advance of its closely watched annual meeting.

Among the most significant cancer drug data unveiled for the first time Wednesday night came from phase III studies conducted by Aveo Pharmaceuticals and Exelixis, and randomized phase II studies of drugs discovered by Array BioPharma.

New disclosures of cancer drug data were also made available from Arqule, Ariad Pharmaceuticals, Pharmacyclics, Onyx Pharmaceuticals and Seattle Genetics, among many others. ...

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Hot Biotech Stocks Traded by Hedge Funds in First Quarter

twocents@thestreet.com (Adam Feuerstein) — Wed, 16 May 2012 11:10 GMT

BOSTON (TheStreet) -- Noteworthy hedge fund trading in biotech and drug stocks, culled from the 13F filings for the first quarter: Hedge funds and mutual funds that manage more than $100 million are required to disclose their equity holdings, options and convertible debt on a Form 13F filed SEC within 45 days of the end of a quarter. Funds aren't required to report short positions betting on declines. Since we're already midway through the second quarter, these positions in biotech and drug stocks may already have changed. Things that make you go "Hmmmm…." SAC Capital picks up a new, 1.2 million-share position in Ardea Biosciences during the first quarter. On April 23, AstraZeneca announces the acquisition of Ardea for $1.3 billion. RA Capital, savvy Boston investors who are particularly fluent in the hepatitis C drug market, established a new position in Biocryst Pharmaceuticals with a 3 million-share pickup. Biocryst's experimental BCX5191 won't be entered into human studies until later this year, but the drug belongs to the same "nuc" class as Gilead Sciences' GS-7977. Amylin Pharmaceuticals was a popular stock to buy in the first quarter with rumors swirling around a sale of the diabetes drug company to a Big Pharma suitor. Hedge funds Healthcor Asset Management, Calamos Advisors and Tang Capital and RedMile Group were just some of Wall Street's investor pros establishing new positions.

Not all investors are waiting around to see if Amylin is sold. Millennium Management and SAC Capital both disposed of sizeable stakes in the company during the quarter. The two funds likely took profits from the run-up in Amylin's stock price since the takeout rumors first surfaced on March 28. Human Genome Sciences, locked in a takeover fight with partner GlaxoSmithKline, showed similar pattern of opportunistic hedge fund buying and selling. Perhaps most notable is Adage Capital's liquidation of its entire 3.85 million-share position in Human Genome during the January quarter. Orbimed Advisors, with a healthcare portfolio valued at more than $3 billion, initiated new positions in Onyx Pharmaceuticals, ImmunoGen, Neurocrine BioSciences and Array Biopharma during the January quarter. Orbimed also bought new shares of Chemocentryx, which went public in February.

Biotech stock positions exited by Orbimed, as of March 31, include Pharmacyclics, Grifols, Intermune and United Therapeutics. Amarin expects an FDA approval decision on its prescription-grade fish-oil drug AMR101 on July 26. Ahead of that all-important catalyst, Millennium Management, SAC Capital and Sectoral Asset Management added significantly to their existing stakes in Amarin. New positions were established by Brookside Capital and Apex Capital. YM BioSciences received some Boston hedge-fund love in the first quarter. RA Capital and Adage Capital each bought 2.3 million and 2 million shares respectively. The same cannot be said for Balyasny Asset Management, which dumped 2.7 million shares of YM Bio during the quarter. The fund still retained a small 350,000-share stake as of March 31. Mutual fund giant bought 4.15 million shares of Arena Pharmaceuticals during the first quarter, a new position in the obesity drug company. Mutual funds still greatly outnumber hedge funds on Arena's holders list, as of the end of the first quarter. More hedge funds may have been short Arena heading into last week's FDA advisory panel. ...

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Mulling Arena Pharma's Future With Obesity Drug on Approval Path

twocents@thestreet.com (Adam Feuerstein) — Mon, 14 May 2012 19:09 GMT

SAN DIEGO (TheStreet) -- Thoughts, questions and reflections on Arena Pharmaceuticals following Thursday's FDA advisory panel, which voted 18-4 (with one abstention) to recommend the approval of lorcaserin for weight loss.

Congratulations, Arena. Well done. The company and its outside advisors did an excellent job presenting lorcaserin data to the panel. Not every argument the company made was necessarily persuasive, but it had data to back up its side. Most importantly, Arena was able to respond well to the questions and concerns raised by the experts on the panel about lorcaserin's safety -- rat tumors and cardiovascular risk, in particular.

Thinking back through the live blog of Thursday's panel, I can't recall any instance where Arena was dumbstruck or intimidated by the panelists' questions. Being well prepared is a big part of emerging from the FDA panel meat grinder with a positive outcome. ...

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A Health Care Fortnight for the Record Books

twocents@thestreet.com (Nathan Sadeghi-Nejad) — Mon, 14 May 2012 11:00 GMT

NEW YORK (TheStreet) -- I've been a professional investor for 15 years, and over that time I've listened to generalist investors gripe about the health care sector with mind-numbing cyclicality. Predictably, interest in health care investing often hits a nadir at the time of greatest opportunity. The complaints, which typically arise after major biotech blowups or government policy-fueled anxiety, range from absurdly broad-based assertions of disinterest (health care is "un-investable" is a common refrain) to specific anxiety about the sector's dependence on government as a payor.

Investors who dismiss the health care stocks often do so because they lack the expertise required to understand the sector. They're missing a lot. For those who think -- or have ever thought -- health care isn't a great sector for alpha generation, I present the first half of May in the year 2012, one of the busiest and most exciting two weeks for health care in recent memory. This week's column reviews -- in the first of two parts -- key events and the implications for relevant companies.

The Bapi Time Bomb Approaches ...

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Stocks to Watch: JPMorgan, Arena (Update 1)

twocents@thestreet.com (Alexandra Zendrian and Joseph Woelfel) — Fri, 11 May 2012 11:35 GMT

NEW YORK -- JPMorgan Chase recorded a $2 billion mark-to-market loss in its synthetic credit portfolio since the end of the first quarter, the bank said Thursday.

CEO Jamie Dimon called the trade "flawed, poorly reviewed, poorly executed" and said it reflected "sloppiness" and " bad judgment."

In a conference call Thursday, Dimon said the bank's Chief Investment Office suffered a trading loss of $2 billion in its synthetic credit portfolio, offset by a $1 billion securities gain, as a strategy to re-hedge its portfolio backfired. ...

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3 Stocks Sink to 52-Week Lows

twocents@thestreet.com (Alexandra Zendrian) — Thu, 10 May 2012 17:55 GMT

NEW YORK (TheStreet) -- Digital Generation, MannKind and Windstream sank to 52-week lows on Thursday.

Digital Generation

The digital technology services company reported Wednesday first-quarter net income of $988,000, or 4 cents a share, down from year-earlier net income of $12.7 million, or 45 cents. ...

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Arena Pharma: FDA Panel Live Blog

twocents@thestreet.com (Adam Feuerstein) — Thu, 10 May 2012 11:43 GMT

Arena Pharma FDA Panel Live Blog

WASHINGTON, D.C. (TheStreet) -- Arena Pharmaceuticals, the weight-loss drug lorcaserin and an FDA advisory panel: The Sequel.

For those that missed Part One, a quick recap: In September 2010, an FDA panel of experts voted 9-5 to recommend against the approval of Arena's lorcaserin. Panel members were unimpressed with the drug's mediocre efficacy and concerned about several potential safety problems, most notably a risk that a high prevalence of rat tumors could raised the cancer risk in humans. FDA followed the panel's negative recommendation and rejected lorcaserin. ...

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Pass on These IPOs

twocents@thestreet.com (Debra Borchardt ) — Thu, 10 May 2012 09:30 GMT

IPO Desktop President Francis Gaskins advises investors to take a pass on LINC Logistics, New Source Energy and Rib-X Pharmaceuticals.

Glaxo's Bid for Human Genome Turns Hostile: Hot Trends

twocents@thestreet.com (Brittany Umar) — Wed, 09 May 2012 12:48 GMT

NEW YORK (TheStreet) -- Popular searches on the Internet include GlaxoSmithKline as the company will go hostile with its $13-a-share cash tender offer for Human Genome Sciences, taking its bid straight to shareholders this week.

The decision comes after Human Genome's board rejected Glaxo's $2.6 billion bid last month, saying it did not reflect the inherent value of the company. Glaxo stands by its bid, which represents an 81% premium. Glaxo has not indicated when the tender would be launched this week. When it is, it will remain open for 20 business days.

The two companies sell Benlysta together and currently are working on two other experimental drugs, which Glaxo would receive full rights to if it purchases Human Genome. ...

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FDA's Review of Arena Pharma's Obesity Drug Sunnier Than Expected

twocents@thestreet.com (Adam Feuerstein) — Tue, 08 May 2012 16:10 GMT

Updated with correction to accurately describe the 6% mean weight-loss observed in the lorcaserin phase III trials.

SAN DIEGO (TheStreet) -- The FDA's review of Arena Pharmaceuticals' weight-loss drug lorcaserin is... and it's more positive than I expected.

The outcome of Thursday's FDA advisory panel is still unknown, of course, but Arena bulls (the "Areniacs") should feel more confident in a positive vote recommending lorcaserin's approval. ...

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Vertex Is the Next Gilead Sciences or Alexion

twocents@thestreet.com (Adam Feuerstein) — Mon, 07 May 2012 20:06 GMT

CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals is the next Gilead Sciences. You think I'm reaching? Okay, then Vertex is the next Alexion Pharmaceuticals.

Either way, the big move higher in Vertex's stock price Monday, spurred by the release of strong cystic fibrosis data, is totally justified and likely undervalues the company going forward.

Vertex shares rose $20.71, or 55%, to $58.12 Monday following the announcement that two drugs -- the experimental VX-809 and currently marketed Kalydeco -- significantly improved lung function in patients with the most common genetic mutation causing cystic fibrosis. ...

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As Hostile Takeover Bids Recede, Investors Bet on Earnings

twocents@thestreet.com (Antoine Gara) — Mon, 07 May 2012 17:24 GMT

NEW YORK (TheStreet) -- Just a few months ago, hostile bids for Georgia Gulf , Vulcan Materials and Illumina seemed to be a savior for faltering shares. Takeovers now seem less likely to work, but investor reaction to stalled premium share bids has been muted.

For many C-suites looking at the prospect of a European meltdown, the U.S. "fiscal cliff" caused by a divided Congress, and a still lukewarm economic recovery, it's been a difficult nine months, but few companies had it harder than those that became the target of activist funds and hostile corporate bidders as their shares tumbled.

Now analyst forecasts and the investor reaction signal that as those bids recede, the prospect of earnings recoveries in coming years may outweigh the share jolt of an immediate deal. ...

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Top 5 Small-Cap Stocks to Consider Buying

twocents@thestreet.com (StreetAuthority) — Mon, 07 May 2012 15:31 GMT

The following commentary comes from an independent investor or market observer as part of TheStreet's guest contributor program, which is separate from the company's news coverage.

By David Sterman

NEW YORK (StreetAuthority) -- It's crucial to avoid the trap of focusing on the same types of investments for your portfolio. ...

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Bristol-Myers Missing Hep C Data Raises Red Flags, May Boost Gilead, Idenix

twocents@thestreet.com (Nathan Sadeghi-Nejad) — Mon, 07 May 2012 11:00 GMT

NEW YORK (TheStreet) -- Since my return from the European Association for the Study of the Liver (EASL) conference two weeks ago, I have been unable to get over the strange behavior of executives at Bristol-Myers Squibb. As I discussed in my EASL wrap-up, investors should view with suspicion Bristol-Myers' complaints about Gilead Sciences' refusing to collaborate on a late-stage study of the hepatitis C drugs GS-7977 and daclatasvir partnership. Then there's Bristol-Myers' odd and prolonged silence about INX-189 -- the nucleoside polymerase inhibitor, or "nuc," acquired in the $2.5 billion Inhibitex deal.

I suspect something is wrong with Bristol-Myers' INX-189, which has since been renamed by the company as BMS-094. The red flags are popping up everywhere. If I'm right about Bristol-Myers being in trouble, Gilead's lead in the race to develop all-oral therapies for hepatitis C will expand and Idenix Pharmaceuticals' hepatitis C drugs become more attractive.

Let's examine the details: ...

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Biotech Stock Mailbag: Exelixis, Protalix, Arena

twocents@thestreet.com (Adam Feuerstein) — Fri, 04 May 2012 11:34 GMT

BOSTON (TheStreet) -- David Sobek, political scientist, amateur biotech investor and widely followed Twitter commentator (@dsobek) writes that Exelixis is an under-appreciated and under-valued biotech stock, particularly given some updates on the prostate cancer drug cabozantinib expected at the American Society of Clinical Oncology (ASCO) annual meeting in June.

"Exelixis represents both a long-term value play and has a good chance to surprise investors with their data presentations at ASCO," writes Sobek at Seeking Alpha.

I appreciate Sobek's perspective on Exelixis but told him (via Twitter) that he's fighting against Wall Street biotech investors and their generally dim view of cabozantinib's potential. That makes it tough for Exelixis bulls like Sobek to win. ...

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10 Best-Performing 'Dividend Aristocrats'

twocents@thestreet.com (Frank Byrt) — Thu, 03 May 2012 12:44 GMT

BOSTON (TheStreet) -- Investors, ravenous for reliable returns given the sketchy economic outlook, are gobbling up dividend stocks and dividend-focused mutual funds this year. That means high-yielding shares may continue to rise.

Indicative of investors' current interest in yield, both bond and dividend-focused equity mutual funds are being flooded with cash, while other fund categories are suffering outflows.

This year through April 25, dividend-focused stock funds had inflows of $17.3 billion, resulting in total net inflows of $1.1 billion for all types of mutual funds, which means other categories of stock funds had outflows of $18.4 billion, according to fund tracker EPFR Global. ...

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26 Drugs Facing FDA Approval in 2012

twocents@thestreet.com (Adam Feuerstein) — Wed, 02 May 2012 17:45 GMT

Calendar updated to include several drug approvals inadvertently omitted.

BOSTON (TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between May and December 2012. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs. ...

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Juicy Details From Tang Capital's Lawsuit Against Savient Pharma

twocents@thestreet.com (Adam Feuerstein) — Tue, 01 May 2012 19:06 GMT

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EAST BRUNSWICK, NJ (TheStreet) -- Savient Pharmaceuticals is insolvent and its directors are greedy pigs more interested in emptying the company's dwindling cash pile into their own pockets than repaying creditors, alleges a West Coast hedge fund and Savient's largest creditor in a lawsuit filed Tuesday. ...

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Arena: FDA Adds Obesity Docs to Panel

twocents@thestreet.com (Adam Feuerstein) — Tue, 01 May 2012 12:25 GMT

BOSTON (TheStreet) -- Thoughts and observations on obesity drug stocks as Arena Pharmaceuticals gets ready to bring lorcaserin in front an another FDA advisory panel on May 10.

My apologies for beginning with some shameless self promotion: I will be live-blogging the Arena FDA panel, providing eight hours-plus of continuous, play-by-play coverage and instant analysis as obesity experts review and ultimately pass judgment on lorcaserin's efficacy and safety.

Don't miss out on all the excitement and suspense. More than 22,000 readers logged into my live blog of the Vivus FDA panel in February, which resulted in a 20-2 vote in favor of Qnexa. I expect another big crowd on May 10, so mark your calendars. ...

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Celldex Screw-Up Nixes ASCO Data Slot

twocents@thestreet.com (Adam Feuerstein) — Tue, 01 May 2012 11:00 GMT

NEEDHAM, Mass. (TheStreet) -- A clerical error has cost Celldex Therapeutics the opportunity to present data on its breast cancer drug CDX-011 at the upcoming American Society of Clinical Oncology (ASCO) annual meeting.

This is hard to believe, but someone at Celldex clicked a wrong box on ASCO's online abstract submission form. As a result, ASCO rejected the CDX-011 abstract. Celldex appealed but ASCO refused to make an exception, the company says.

Doh! ...

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Barnes & Noble in Strategic Partnership With Microsoft: Hot Trends

twocents@thestreet.com (Brittany Umar) — Mon, 30 Apr 2012 12:37 GMT

NEW YORK (TheStreet) -- Popular searches on the Internet include Barnes & Noble as the book retailer is entering a strategic partnership with Microsoft.

Microsoft will make a $300 million investment in a new Barnes & Noble subsidiary. The new company will focus on developing a Nook e-reader application for Windows 8. Microsoft will obtain about 17.6% of the new company through its investment, while Barnes & Noble will own the remaining roughly 82.4%. The company has not yet been named.

The companies said they have settled their patent litigation. ...

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Biotech Stock Mailbag: AVI, Aveo, Spectrum

twocents@thestreet.com (Adam Feuerstein) — Fri, 27 Apr 2012 10:00 GMT

BOSTON (TheStreet) -- Renton L. opens this week's Biotech Stock Mailbag: "Was there anything noteworthy in the AVI BioPharma update announced this week? Are you still optimistic about this drug's chances; maybe the market is getting this drug all wrong?"

AVI's eteplirsen is the first drug ever to significantly increase the production of dystrophin in boys with Duchenne muscular dystrophy (DMD). That's pretty darn remarkable, so yes, I believe there is reason for optimism.

The problem is that eteplirsen's ability to generate dystrophin has not yet translated into a meaningful clinical benefit for DMD patients. AVI presented new data this week showing small improvements in walking ability in some patients. The data were highly variable, however: Two patients with increased dystrophin production actually performed significantly worse on a six-minute walk test. ...

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Amarin Shares Move Higher on Competing Fish Oil Data

twocents@thestreet.com (Adam Feuerstein) — Thu, 26 Apr 2012 14:41 GMT

PRINCETON, NJ (TheStreet) -- Omthera Pharmaceuticals released late-stage study results on its omega-3 (fish oil) drug Thursday, which while positive, don't appear to compare well to Amarin's competing product.

Amarin shares are up $1.43, or 14%, to $11.40 Thursday on reaction to the Omthera news.

Omthera said that a low and high dose of Epanova lowered triglyceride (TG) levels by 26% and 31% respectively in patients who entered the clinical trial with very high levels of the blood-based fat. ...

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Amgen Goes to Turkey, Loses Biotech Cred

twocents@thestreet.com (Adam Feuerstein) — Wed, 25 Apr 2012 13:23 GMT

BOSTON (TheStreet) -- Amgen is saying "elveda" to the biotech sector.

That's Turkish for "goodbye." With the $700 million purchase of Turkey's Mustafa Nevzat Pharmaceuticals, a maker of generic drugs, Amgen's claim as "the world's largest biotech company" no longer holds much meaning.

Amgen has graduated to become a "pharmaceutical company" joining the ranks of Merck, Bristol-Myers Squibb and Pfizer. ...

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Galena's Breast Cancer Vaccine Doomed to Fail

twocents@thestreet.com (Adam Feuerstein) — Tue, 24 Apr 2012 17:01 GMT

LAKE OSWEGO, Oregon (TheStreet) -- Galena Biopharma's breast cancer vaccine NeuVax will fail when results of a phase III clinical trial are eventually announced in three years or so.

I can boldy predict NeuVax's failure this far in advance because Galena is making the same mistakes and taking the same sloppy shortcuts that Keryx Pharmaceuticals did with its colon cancer drug perifosine. The warning signs with perifosine proved correct, as they will with NeuVax.

In early February, I called Galena (which was up 168% year to date at that time) a drug stock unworthy of the biotech bull market. This label still rings true, even more so given the stock's continued ascent. Galena's market value of nearly $80 million may seem puny but it's actually excessive when you consider that the company's only asset -- NeuVax -- is never going to reach the market. ...

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Vertex Hopes Two Cystic Fibrosis Drugs Better than One

twocents@thestreet.com (Adam Feuerstein) — Tue, 24 Apr 2012 12:25 GMT

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CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals is expected to report strong initial sales of its cystic fibrosis drug Kalydeco on Thursday as investors shift their attention away from the waning performance of the company's hepatitis C drug Incivek.

Soon after Vertex reports first-quarter earnings, investor attention moves to two, more important events that will have a far greater influence on the future direction of the company's stock price: 1) The first look at the potency of two new hepatitis C drugs; and 2) results from a mid-stage "combo" study of Kalydeco and the experimental drug VX-809 in cystic fibrosis patients with the most commonly occurring (and therefore most commercially lucrative) genetic mutation F508del. ...

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Amgen Founding CEO Rathmann Dies: Hot Trends

twocents@thestreet.com (Brittany Umar) — Tue, 24 Apr 2012 10:18 GMT

NEW YORK (TheStreet) -- Popular searches on the Internet Tuesday include Apple. IPhone rumors are buzzing around the Internet, as the company is reportedly planning its thinnest version of the smartphone yet.

Rumors say the newest iPhone could end up being just 7.9 millimeters thick thanks to a thinner battery and a switch of the iPhone's case from glass to metal. The panel could be thinner as well, according to reports that say Apple is planning to use new display technology that will use a panel's touch sensors inside the color filters instead of above them.

Many speculate that the sixth-generation iPhone will be out this fall. ...

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Grading Hep C Stocks Exiting EASL Confab

twocents@thestreet.com (Nathan Sadeghi-Nejad) — Mon, 23 Apr 2012 13:44 GMT

BARCELONA (TheStreet) -- Wow, it's been a busy few days at the European Association for the Study of the Liver (EASL) annual meeting in this beautiful Catalan capital. Investors obsessed with emerging hepatitis C therapies had plenty of new data to analyze.

Let me make one general observation about the future of hepatitis C treatment before I recap and grade each of the companies with a significant presence at the EASL meeting. Interferon -- the injectable immune system booster saddled with troublesome side effects -- is dead. The future of hepatitis C therapy belongs to interferon-free regimens. Physicians at the conference talked about interferon as if it were invented in medieval times. It's clear that any company seeking a role in hepatitis C going forward must develop or acquire an effective interferon-free regimen or face irrelevance.

Let's move to the winners and losers of EASL 2012. ...

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Biotech Stock Mailbag: Amarin

twocents@thestreet.com (Adam Feuerstein) — Mon, 23 Apr 2012 11:57 GMT

BOSTON (TheStreet) -- With my apologies, last week's Biotech Stock Mailbag is a few days late.

"Patent" asks, "Your latest thoughts on Amarin?"

The next challenge for Amarin and its ultra-purified fish oil AMR101 comes from Omthera Pharmaceuticals as it gets ready to announce late-stage study results from a potentially competitive omega-3 fatty acid product. ...

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