BioSpace BioPharm Exec
Wednesday, March 26, 2008
Time to Buy Biotech?

Okay, we know the market has been a brutal, whipsaw place for the past several months. And we know a lot of the forces behind that transcend the issues and concerns of a specific industry. But why is biotech getting handed such an outsized whooping right now?

Popular biotech indices like the AMEX Biotechnology Index (BTK) and the Nasdaq Biotechnology Index (NBI) don't really tell the story here. They are, respectively, highly selected toward large companies and market capitalization-weighted. So the $20 billion-and-up companies like Amgen, Biogen Idec, Genentech, Gilead Sciences, Genzyme, and Celgene pretty much drown out what's going on at the sub-$1 billion companies that make up the bulk of the industry.

So, yeah, the biotech indices are hurting, but anyone who follows the industry can tell you it feels much worse than even the numbers reflect. Many companies are at or below the nadir's set in 2002-2003, when the biotech sector bottomed out in a pique of pessimism--just look at Human Genome Sciences, deCODE Genetics, Exelixis, CV Therapeutics, Protein Design Labs, or Affymetrix…to pick just a few examples. Even Vertex Pharmaceuticals, an investment darling just a year ago, is starting to flirt with its 2003 lows despite any corporate development of real significance.

What's going on here? Well, I'm not here to defend these individual companies or the many others in the same boat. Some have been their own worst enemies, or have simply been unlucky in the clinic. But some have arguably taken a much worse thrashing than they deserve. Investors might want to note that anyone brave enough to wade into the beaten down biotech sector five years ago could have found rich rewards with any number of companies that offered triple-digit returns over the subsequent few years.

Yet they should also be aware of some of the factors leading to the currently low stock prices.

• Hedge funds own a lot of biotech stock--or at least, they used to. They also own a lot of debt instruments, many of which are backed by increasingly risky obligations. As the risk rating of these instruments rise, so does the overall risk ratio of a given fund. To balance this out, the funds could sell the debt instruments--but they're often illiquid and tough to dump these days. Or they could sell their biotech investments. Voila! Problem solved. You can see it in action with some of the more visible hedge funds. Witness Dan Loeb's Third Point, which recently dumped most of a 10% stake in CV Therapeutics, as just one example.

• The companies hardest hit tend to be those without products--which is not by itself too surprising, since speculative investments contingent on favorable clinical studies are hardly favored in already uncertain times. But even companies that do have current or near-term products are also being sent near five-year lows. One factor at play is that many of these are likely to need access to additional capital to reach their goals. That means either taking on debt--not an easy task in the current credit crunch--or issuing more equity--scarcely any better. The biotechs that are holding up OK are the ones with bulletproof balance sheets--that is, the large cap ones that weight the indices toward relative stability. If you think access to capital is going to remain a long-term problem, you'll probably want to steer clear of any company that isn't cash-flow positive or doesn't have enough cash to outlast the crisis.

• You can't sell a drug without first getting approval from FDA. From this understaffed, overburdened, risk-averse FDA. 'Nuff said.

That's why many folks are steering clear. But does it pay to be greedy while others are fearful, and invest in some of biotech's smaller and more unfortunate companies? A typical analyst would say no. They would say there are few catalysts on the horizon to turn sour sentiment around, too much uncertainty about the depth or length of our credit woes, and that it's more prudent to wait for a turn and miss a little upside before taking on a risky investment in a volatile sector.

There's certainly some wisdom to that. But let's not forget that many companies with valuations at multi-year lows are also sporting maturing pipelines of desperately needed products, and that Big Pharma--you know, those companies that do have bulletproof balance sheets--have proven themselves increasingly will to acquire biotech. More importantly, the value of future product sales, even heavily discounted for risk, definitely point to some bargains lurking out there. When this ship finally turns, you'll see some beaten down companies double in value before you know what's happening.

Maybe that's worth a nibble.

One of a crop of genomics companies founded in the mid-1990s, deCODE Genetics was created with the idea that it could sell information rather than drugs, relying on privileged access to the unique health care records and genetically homogenous population. That didn't quite work out, for legal, financial, and strategic reasons, and deCODE entered the drug discovery game. To date, that hasn't produced any revenues for deCODE, but this month the company showed the richness of its core competence. A study published in Nature picked through an incredibly complex phenotype--obesity--to show the roles that gene expression variations play. It's an impressive achievement, although in this difficult market, deCODE shares are trading near an all-time low -KT
deCODE genetics, Inc. (DCGN) Obesity Study Sheds Light on How Genetics Affects Risk and Onset of Common Diseases
More...

Wyeth (WYE), Progenics Pharmaceuticals, Inc. (PGNX) Bowel Drug Fails in Study
More...

Dendreon Corporation (DNDN) Says Provenge Trial Design Amended to Speed Results
More...

Diamyd, Inc. Gets Authorization to Begin Phase III Study in the US
More...

Cutting Dosage of Costly Drug Spurs a Debate
More...

GlaxoSmithKline (GSK)'s Bosatria Shows Promise In Late-Stage Study
More...


More Bench To Clinic News
CHI's 7th Annual World Pharmaceutical Congress Assays for Efficient and Safe Drug Development. Register by April 4th and save up to $200! International Pharmaceutical Regulatory And Compliance Congress
Sponsored by the Pharmaceutical Compliance Forum at the Paris Marriott Rive Gauche Hotel and Conference Center.
What's old is new again. In a move that surprised most observers, FDA Commissioner Andrew von Eschenbach asked Janet Woodcock to take a second tour of duty as head of FDA's Center for Drug Evaluation and Research (CDER). Woodcock, who served in the role from 1994-2005, presided over a period of greater productivity than the present in terms of number of drug approval, although she deserves neither all the credit nor all the blame for approval numbers. Nevertheless, despite the fact that this is technically a demotion for her, she was in charge of the committee to find a new CDER head--so she presumably wants the job. Most folks in the industry should be relatively happy to see her back. -KT
FDA Names Janet Woodcock as Permanent CDER Head
More...

John McCain Into the Fray Over the Cause of Autism
More...

Immtech Pharmaceuticals, Inc. Announces Update on Business Operations; Chief Executive Officer Takes Pay Cut
More...

Genitope Corporation (GTOP) Stops Cancer Vaccine Program, Looking at Finances
More...

PDL BioPharma, Inc. (PDLI) Stops Sale, will Cut 260 Jobs
More...

Critical Therapeutics, Inc. (CRTX) Announces Change in Management; New CEO Named
More...


More Career Track News
Periapproval Services. Covance is your natural selection for all of your post-approval needs. We offer a wide range of professional, analytical, and technical resources. Diabetes 2008: Developments and Opportunities in Drugs and Devices . This report provides an in-depth understanding of the diverse therapeutic and venture landscapes for the diabetes drug and device markets.
Is there value to be found among fallen biotech companies haunting penny stock never-neverland? Young specialty pharma company EUSA Pharma thinks so. It snapped up troubled Cytogen for mere pennies a share, gaining both a U.S. infrastructure, four marketed oncology products, and some more developmental programs. And it wasn't even looking to reverse merge its way public--EUSA, rather, delisted Cytogen to retain the charms of privacy. I've mentioned my doubts about modern takes on the specialty pharma model (ahem, Cadence Pharmaceuticals), so it's only fair to mention that EUSA actually seems to be doing a remarkable job at finding undervalued assets and quickly building a legitimately global organization. Oh--and in our January issue, I wondered if Lilly would follow the lead of Pfizer and Novo Nordisk and give up on inhalable insulin. Now we have our answer. There's only you, MannKind! -KT
EUSA Pharma to Acquire US Specialty Oncology Company Cytogen Corporation (CYTO) for $22.6M
More...

Alkermes (ALKS) Receives Notice from Eli Lilly and Company (LLY) Terminating Inhaled Insulin Program
More...

Eli Lilly and Company (LLY) and Transition Therapeutics Inc. (TTH.TO) Announce Licensing and Collaboration Agreement
More...

Pfizer Inc. (PFE) to Acquire Serenex to Extend Oncology Pipeline and Access Novel Technology Platform
More...

Silence Therapeutics plc and AstraZeneca PLC (AZN) Announce Collaboration to Develop Novel Approaches for siRNA Drug Delivery
More...


More Golden Handshakes News

• Biotech Bay (Emeryville, California)

Tethys Bioscience
Chief Medical Officer
Experience in defining current clinical practice with a focus on describing unmet clinical needs, then translating those unmet needs into potential high value biomarker product opportunities.
More...

• Bio NC (Chapel Hill, North Carolina)

Phillips Dipisa
Vice President, Clinical Development
This person will oversee and manage the clinical plans of new products as they are approved, reporting directly to the Senior Vice President Clinical Research.
More...

• BioCapital (Rockville, Maryland)

U.S. Pharmacopeia
Vice President, Monograph and Reference Materials Acquisition
This is a key management position in the Documentary Standards (DSD) and Reference Materials (RMD) Divisions, reporting jointly to the Chief Science Officer and Chief Reference Materials Officer.
More...

• BioMidwest (Indianapolis, Indiana)

Covance Inc.
Vice President Covance Biomarker Group
The Vice President Covance Biomarker Group will be responsible for developing Covance's global biomarker strategy from the early development through clinical and commercialization stages of the drug development cycle.
More...

Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!

The Pharm Country Career Fair is coming to King of Prussia, Pennsylvania on April 1, 2008 at the Radisson Valley Forge from 2:00 p.m. to 7:00 p.m. The BioSpace Career Fair in BioMidwest is coming to Oak Brook, Illinois on Tuesday, April 15, 2008 at the Chicago Marriott Oak Brook from 11:00 a.m. to 4:00 p.m.
If you haven't heard of Accelerator Corp., you should check it out. It was founded as a venture capital-backed incubator to nurture inchoate businesses coming out of Leroy Hood's Institute for Systems Biology. (Hood, of course, is the celebrated biologist and inventor of the automated DNA sequencer). But Accelerator has grown into a vehicle that funds very early stage work from a variety of life sciences entrepreneurs--work that likely wouldn't find conventional venture backing but that requires expensive lab facilities and proof of concept studies. Recodagen is the latest company to find a home at Accelerator, and is working on cancer therapeutics that target so-called "junk DNA." It comes not from Hood's lab but from Washington State University at Pullman. -KT
Recodagen Corporation is Seventh New Start-Up Launched by Accelerator Corporation
More...

Bostwick Laboratories Files for $100M IPO
More...

Shire Pharmaceuticals (SHPGY) Climbs on Talk of Pfizer Inc. (PFE) Bid Interest
More...

BrainCells Inc. Completes $30 Million Initial Closing of Series B Financing
More...

EKR Therapeutics, Inc. Raises Over $145 Million in Support of Growth
More...


More Money Talk News

International Medical Device Compliance Congress
will feature the exchange and presentation of company best practice policy and procedures at poster boards throughout the Device Congress Exhibit.
EuroPLX 36 Istanbul
Partnering event for Business Development & Licensing Executives seeking to partner in prescription drugs ranging from clinical candidates to value added generics, including bio-generics and biosimilars.
On February 27, Theravance reported a last-minute cancellation of an FDA advisory committee meeting on its antibiotic telavancin. Why? According to In Vivo's blog, it's the fallout from the company's decision to remove data from a study site prior to the meeting (itself a matter of some debate). In Vivo suggests this is a sort of zero tolerance stance resulting from Sen. Charles Grassley's (R-IA) investigation into allegedly fraudulent data submitted on Sanofi-Aventis' Ketek. Certainly Grassley's scrutiny into FDA oversight has been intense, but as to whether these dots really connect, I'm not sure. The day after announcing the cancellation, Theravance said its response to FDA's approvable letter from the previous October had been accepted, and that it has a new PDUFA date. Nevertheless, companies should take extra care to dot every' i' and cross every 't' in this environment. Also, note some new developments on two issues raised last month--a new biogenerics bill, and new draft legislation to address the fallout of the Supreme Court's decision in Riegel v. Medtronic. -KT
Theravance, Inc. (THRX) Says FDA to Review Response on Antibiotic
More...

Eli Lilly and Company (LLY) E-Mail Discussed Off-Label Drug Use
More...

Want Generic Biotech? You Might Wait 14 More Years
More...

Generic Pharmaceutical Association (GPhA) Statement on Reps. Eshoo-Barton Biologics Bill
More...

Draft Anti-Preemption Bill Would Legislatively Reverse Riegel Decision
More...


More Legal Briefs News
SafeBridge Potent Compound Safety "Boot Camp" is a comprehensive course in pharmaceutical potent compound safety for EH&S and related professionals in the pharmaceutical, chemical and biotechnology industries. BIOCOM's 5th Annual "Celebration of Life" Dinner attracts more than 1100 key professionals in the life science industry and acknowledges the accomplishments of the community.
Executives, investors, patients--we all love the PDUFA date, which puts a firm timeline on the FDA's review of new drug applications. But the resource-strapped agency came out and said it may just have to go ahead and miss those dates due to heavy workloads. Cardiome and CV Therapeutics are two companies that have already watched a PDUFA date come and go for apparently no reason other than FDA's inability to complete a timely review. Hmm...do they get their user fee back? -KT
FDA Gives Itself Okay To Miss Some Drug Approval Deadlines
More...

U.S. Advisers: Restrict Amgen (AMGN), Johnson & Johnson (JNJ) Anemia Drugs
More...

Amgen (AMGN) and Wyeth (WYE) Announce Enbrel Drug Gets Black Box Infection-Risk Warning
More...

Johnson and Johnson Pharmaceutical R&D (NJ) Says FDA Delays Antibiotic Review by 3 Months
More...

FDA Indicates That Genta Incorporated (GNTA)'s Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
More...


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.


East Coast Office:
    BioSpace, Inc.
    Ramshorn Executive Centre
    2399 Highway 34, Building A-5
    Manasquan, New Jersey 08736-1528 U.S.A.
    Phone: 732-528-3688
    Fax: 732-528-3668
West Coast Office:
    BioSpace, Inc.
    90 New Montgomery Street, Suite 414
    San Francisco, California 94105 U.S.A.
    Phone: 877-277-7585
    Fax: 415-576-9217
BioSpace.com - Life. Science. Community.



If someone forwarded this news to you and you'd like to receive your own complimentary monthly copy, simply join the BioSpace BioPharm Executive here.

Safely unsubscribe from Biospace.com e-mail at any time by managing your account here.
BioSpace in an onTargetjobs company