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speaking about an underfollowed story.
compare the market caps of Allos alth, and Chemgenex CXS.ax
Chemgenex in Australia has the same kind of story with one tenth of the market cap. The have an open label pivotal trial with their drug Omacetaxine. Their drug has shown an 80 percent response rate in the t315i mutation of CML. It works in all of CML but the t315i mutation was the quickest way to get to market. It actually works against the stem cells as well as periperal leukemic cells, Gleevac doesn't. Below is a link to their corporate presentation. Their market cap is 70 million. This would be a great company for you to follow. They will need to raise cash before they commercialize unless they partner the drug or sell the company. They have an ADR listed but it isn't liquid enough. The raise could be done through the issuance of ADR's. It would provide US liquidity.
The alternative to a raise is to license Europe or sell the company but this is a drug a small company can commercialize themselves.
here is the link. look at the data. I will be approved.
http://www.chemgenex.com/pdf/CorporateoverviewJan2009.pdf
Booooooring, smarmy, wise-ass....so what, he wants more tax relief for those in the $100 mil. bonus crowd? Come on, can't these guys say anything useful....and I didn't vote for Obama...but I think the kind of crap you just posted isn't worth the ink spilled.
I take the long island railroad to get into manhatten
they are building a new office waiting room for passengers at the station. It has been under contruction for over a year. It is a small building that a private homebuilder in florida could build in 3 weeks. that is because a government entity is overseeing a contractor that is probably working on time and materials instead of a fixed price.
Imagine that on a trillion dollar scale building road and you will see that the stimulus will go to one guy holding the light bulb and six guys spinning him around, after they overcharge for the light bulb to begin with.
Tax question about blind trusts
I believe these big shots that join the government do not ever pay taxes on the gains.
that is the inducement to get the ceo of goldman sachs to join government for "chump change"
it was the same for RoberT Rubin
Innocence Lostby Erin Arvedlund Dec 17 2008
In the spring of 2001, a Barron's reporter was among the first to publicly question Bernie Madoff's record. She tells Portfolio.com how she did it.
http://www.portfolio.com/news-markets/top-5/2008/12/17/madoff-barrons
Bernie Madoff
Photograph by: Ruby Washington/The New York Times
In the spring of 2001, I was working at Barron’s covering the asset management business, and even though the dotcom bubble had burst and short-circuited the stock market, it was still a time of innocence.
It was before the 9/11 attacks on the World Trade Center, and sometimes I ate lunch sitting on the edge of its silver plaza fountain, in the sunshine between the two skyscrapers.
The Barron’s offices occupied half of one floor in the southern-most World Financial Center building in lower Manhattan, where Dow Jones published the magazine and the Wall Street Journal. One of Barron’s long-serving copy editors still smoked in her office (or at least, she and I got away with it until the cleaning lady sniffed us out). Staffers took turns supplying the weekly bottles of dry wine to those closing Friday evenings.
My first year at Barron’s I covered options—a beat not unlike covering horse racing. Buy a call option on a stock, and you are betting your "horse" will be a winner and cross the finish line at a certain price sometime in the future. I liked visiting the dimly lit American Stock Exchange on Church Street, behind Trinity Church, because the traders there still ducked in and out of little booths to scream orders into a crowd.
Electronic trading still felt new, even in 2001. Big broker-dealers like Susquehanna and Madoff were using computer programs, not people, to match buy-and-sell orders, but the dinosaurs on the trading floor scoffed, lit another cigarette, and puffed, "It'll never work."
During my second year at Barron’s, during which I began covering asset managers and hedge funds, that options background paid off. Hedge funds and options share certain lottery ticket-like appeal: Both offer plenty of upside, and staggering downside potential.
The hedge funds industry blossomed in earnest. In 1996, the top 50 hedge funds accounted for just $55 billion in assets; within seven years that number had grown to $150 billion. (The industry as a whole would top nearly $2 trillion by 2007).
Over cocktails at downtown bars such as the Blarney Stone, P.J. Clarke's, and the 14 Wall Street rooftop bar, I started asking options guys—typically quirky mathematical types with a nose for nonsense—about hedge funds.
It was one of these option traders who brought up Madoff. A strategist at a major investment bank and trading firm, he insisted we talk in person. On an April morning in his company's cafeteria, he told me he'd been asked to run some figures on behalf of a client who was thinking of investing with Madoff.
"The numbers don't make sense," he said. "I've been replicating this strategy six ways to Sunday and I can't make the returns come out right."
This was Madoff's hedge fund strategy, dubbed a "split-strike conversion." I took the train back home and resolved to find someone who could explain it to me.
I got a hold of offering documents for Fairfield Sentry, one of the feeder funds funneling money into Madoff. I then took the offering documents to several individuals whom I respected for their ability to formulate and implement complex option trades.
Not one of them could replicate it; nor could they come up with the source of Madoff's returns. Options were just not making that much money in 2001, especially with electronic trading pressing profit margins down to just pennies.
Other oddities: Our Barron's photographer couldn't locate a picture of Bernard Madoff any later than one taken in 1999. It was as if the guy didn't exist in the 21st century. But Madoff had rabid, religious fans. Individual investors who admitted they were "lucky" enough to get into Madoff's funds revered him. One man put his kids through college from the money earned in Madoff's funds.
A source at Merrill Lynch said he couldn't make sense of the returns and withdrew client funds that his predecessor had invested with Madoff.
Every reporter encounters a big story that feels risky—that carries the risk of offending someone important, someone big, someone savvy, someone smarter than you, or just someone who makes claims that can't be proved or disproved. But feelings aren't facts.
So I went with the facts: Nobody, but nobody, on Wall Street traded options the way Madoff did and made the money that he made. Years later, a hedge fund manager whom I had known since the late 1990s said simply: "Nobody traded options that successfully. That should have been a big red flag."
I worked for months compiling details about Madoff. I easily questioned more than 100 people as to whether they knew Madoff or knew anyone who had ever invested with him. Most either had heard of Madoff or knew of his firm. I could count on one hand the number of people who had actually met the man.
I was beginning to think I'd never be one of the lucky few, even after finishing my profile of him.
Suddenly, though, Madoff was made available to me just as the story was about to be printed. Over a scratchy international telephone line, Madoff told me he was traveling on a boat in Switzerland. "I can't really go into the details," he said of his strategy. He wasn't angry or upset. He sounded more than friendly. He just didn't tell me anything of note.
My article ran, with the headline "Don't Ask, Don't Tell," questioning why Madoff gave up hundreds of millions of dollars in fees (his firm didn't charge the typical two-and-20 hedge fund fees—2 percent of all money invested and 20 percent of any profit earned), as well as why he pressured investors to never reveal they had money with him, and why no one could understand how he made money.
Then there was nothing, silence. Over the ensuing years, fund-of-funds managers I spoke to repeated the rumors about Madoff. He remained a hot commodity in the hedge fund world, but no one had successfully been able to disprove his claims.
By the next bull market, Madoff ranked with Julian Robertson and George Soros—the godfathers of asset management, the founding fathers of Wall Street hedge funds. Madoff was running $17 billion in client funds and had houses in Manhattan; Montauk, New York; and Palm Beach, Florida. The facts were on his side.
Today, the innocence is gone. That Madoff mythology has evaporated, and in its wake even the most smug hedge fund investors are worried.
"There will be a lot more Madoffs discovered," says Edward Seidle, founder of Benchmark Financial Services, which specializes in investigations of pension fraud and money management abuses. "It will no longer be impolite to ask for the documents, sit down, and figure out whether the manager is for real."
Erin Arvedlund is a business reporter. She has worked as a columnist for Barron's, a foreign correspondent with the New York Times, and a staff writer for TheStreet.com. She can be reached at: erinarvedlund@yahoo.com.
Don't Ask, Don't Tell: Barron's 2001 Madoff Article
Two years ago, at a hedge-fund conference in New York, attendees were asked to name some of their favorite and most-respected hedge-fund managers. Neither George Soros nor Julian Robertson merited a single mention. But one manager received lavish praise: Bernard Madoff.
Folks on Wall Street know Bernie Madoff well. His brokerage firm, Madoff Securities, helped kick-start the Nasdaq Stock Market in the early 1970s and is now one of the top three market makers in Nasdaq stocks. Madoff Securities is also the third-largest firm matching buyers and sellers of New York Stock Exchange-listed securities. Charles Schwab, Fidelity Investments and a slew of discount brokerages all send trades through Madoff.
But what few on the Street know is that Bernie Madoff also manages $6 billion-to-$7 billion for wealthy individuals. That's enough to rank Madoff's operation among the world's three largest hedge funds, according to a May 2001 report in MAR Hedge, a trade publication.
What's more, these private accounts, have produced compound average annual returns of 15% for more than a decade. Remarkably, some of the larger, billion-dollar Madoff-run funds have never had a down year.
When Barron's asked Madoff Friday how he accomplishes this, he said, "It's a proprietary strategy. I can't go into it in great detail."
Nor were the firms that market Madoff's funds forthcoming when contacted earlier. "It's a private fund. And so our inclination has been not to discuss its returns," says Jeffrey Tucker, partner and co-founder of Fairfield Greenwich, a New York City-based hedge-fund marketer. "Why Barron's would have any interest in this fund I don't know." One of Fairfield Greenwich's most sought-after funds is Fairfield Sentry Limited. Managed by Bernie Madoff, Fairfield Sentry has assets of $3.3 billion.
A Madoff hedge-fund offering memorandums describes his strategy this way: "Typically, a position will consist of the ownership of 30-35 S&P 100 stocks, most correlated to that index, the sale of out-of-the-money calls on the index and the purchase of out-of-the-money puts on the index. The sale of the calls is designed to increase the rate of return, while allowing upward movement of the stock portfolio to the strike price of the calls. The puts, funded in large part by the sale of the calls, limit the portfolio's downside."
Among options traders, that's known as the "split-strike conversion" strategy. In layman's terms, it means Madoff invests primarily in the largest stocks in the S&P 100 index -- names like General Electric , Intel and Coca-Cola . At the same time, he buys and sells options against those stocks. For example, Madoff might purchase shares of GE and sell a call option on a comparable number of shares -- that is, an option to buy the shares at a fixed price at a future date. At the same time, he would buy a put option on the stock, which gives him the right to sell shares at a fixed price at a future date.
The strategy, in effect, creates a boundary on a stock, limiting its upside while at the same time protecting against a sharp decline in the share price. When done correctly, this so-called market-neutral strategy produces positive returns no matter which way the market goes.
Using this split-strike conversion strategy, Fairfield Sentry Limited has had only four down months since inception in 1989. In 1990, Fairfield Sentry was up 27%. In the ensuing decade, it returned no less than 11% in any year, and sometimes as high as 18%. Last year, Fairfield Sentry returned 11.55% and so far in 2001, the fund is up 3.52%.
Those returns have been so consistent that some on the Street have begun speculating that Madoff's market-making operation subsidizes and smooths his hedge-fund returns.
How might Madoff Securities do this? Access to such a huge capital base could allow Madoff to make much larger bets -- with very little risk -- than it could otherwise. It would work like this: Madoff Securities stands in the middle of a tremendous river of orders, which means that its traders have advance knowledge, if only by a few seconds, of what big customers are buying and selling. By hopping on the bandwagon, the market maker could effectively lock in profits. In such a case, throwing a little cash back to the hedge funds would be no big deal.
When Barron's ran that scenario by Madoff, he dismissed it as "ridiculous."
Still, some on Wall Street remain skeptical about how Madoff achieves such stunning double-digit returns using options alone. The recent MAR Hedge report, for example, cited more than a dozen hedge fund professionals, including current and former Madoff traders, who questioned why no one had been able to duplicate Madoff's returns using this strategy. Likewise, three option strategists at major investment banks told Barron's they couldn't understand how Madoff churns out such numbers. Adds a former Madoff investor: "Anybody who's a seasoned hedge- fund investor knows the split-strike conversion is not the whole story. To take it at face value is a bit naïve."
Madoff dismisses such skepticism. "Whoever tried to reverse-engineer, he didn't do a good job. If he did, these numbers would not be unusual." Curiously, he charges no fees for his money-management services. Nor does he take a cut of the 1.5% fees marketers like Fairfield Greenwich charge investors each year. Why not? "We're perfectly happy to just earn commissions on the trades," he says.
Perhaps so. But consider the sheer scope of the money Madoff would appear to be leaving on the table. A typical hedge fund charges 1% of assets annually, plus 20% of profits. On a $6 billion fund generating 15% annual returns, that adds up to $240 million a year.
The lessons of Long-Term Capital Management's collapse are that investors need, or should want, transparency in their money manager's investment strategy. But Madoff's investors rave about his performance -- even though they don't understand how he does it. "Even knowledgeable people can't really tell you what he's doing," one very satisfied investor told Barron's. "People who have all the trade confirmations and statements still can't define it very well. The only thing I know is that he's often in cash" when volatility levels get extreme. This investor declined to be quoted by name. Why? Because Madoff politely requests that his investors not reveal that he runs their money.
"What Madoff told us was, 'If you invest with me, you must never tell anyone that you're invested with me. It's no one's business what goes on here,'" says an investment manager who took over a pool of assets that included an investment in a Madoff fund. "When he couldn't explain how they were up or down in a particular month," he added, "I pulled the money out."
For investors who aren't put off by such secrecy, it should be noted that Fairfield and Kingate Management both market funds managed by Madoff, as does Tremont Advisers , a publicly traded hedge-fund advisory firm.
Full Story: http://online.barrons.com/article/SB989019667829349012.html
nwbo.
The cancer vaccine was developed at the Hutchinson Cancer Center. One the the smartest people I know swears by the technology, so instead of laughing you should cry that a drug like that is in the hands of a company without the funds to pursue it, so the drug is dying a slow death instead of helping people.
lol
Happy new year
>AMAG – does the stock soar or plunge at open tomorrow?<
The FDA indicated in its letter that the following additional information is required prior to granting approval of ferumoxytol:
data to clarify a specific chemistry, manufacturing and controls (CMC) question;
resolution of the deficiencies observed during the pre-approval inspection of the Company’s manufacturing facility; and
finalization of labeling discussions with the FDA. 33
discovery labs recieved this respones, how many years ago, and are still waiting for approval.
The now-discontinued compound, called MK-677, stimulates the release of insulin-like growth factor 1, or IGF-1, which has been shown in mice to reduce levels of beta amyloid protein that forms sticky plaques in the brain.
If Igf-1 would help in ALS then this approach would make more sense then giving IPLEX as insmed is doing. This drug gets to the brain.
Yes, there are some secondary endpoints that look good, but they won’t be enough to make Afresa a successful product, IMO.
reduction of severe hypoglycemia can be a big advantage in diabetes.
I don't own it but if it gets approved that can be an advantage that could differentiate it.
You didn't Highlight these items from the Mannkind pr
Other study highlights:
-- On average, patients in the AFRESA group gained less weight than did patients in the comparator group or subjects without diabetes.
-- Comparable decreases were observed in A1C levels between the AFRESA- treated group and the comparator group
-- Severe hypoglycemic events were significantly less common in the AFRESA group compared to the comparator group.
The reduction of weight gain and especially reduction of severe hypoglycemia is very important.
Here's a shocker, Mannkind tops that by quite a bit ($1.3B).
I beleive Corixa had burned through a almost a billion and a half before it was aquired for chump change
Biogen Idec (BIIB) is trading down over 4% after initial results from Novartis’ (NVS) one-year Phase III TRANSFORMS study with the oral compound FTY720 (fingolimod) showed superior efficacy to a current standard of care for patients with relapsing-remitting multiple sclerosis (MS). Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex). Morgan Stanley research commented that there are clearly issues relating to toxicity (two fatal herpes infections at 1.25mg dose, 3 cases of melanoma) however efficacy superiority over current standard of care (an interferon) combined with an adverse event profile that appears comparable (perhaps superior) to Tysabri means that FTY720 stands a good chance of gaining FDA approval.
Alth Investor/Analyst Briefing
December 2008
NASDAQ: ALTH
PTCL Commercial Opportunity Jim Caruso
4
Paul L. Berns, President and CEO
Pablo J. Cagnoni, M.D., Chief Medical Officer
Owen O’Connor, M.D., Ph.D., Principal Investigator of PROPEL
and the Director of the Lymphoid Development and Malignancy
Program and Chief of the Lymphoma Service at the Herbert
Irving Comprehensive Cancer Center at New York-Presbyterian
Hospital/Columbia University Medical Center, and Associate
Professor of Medicine at Columbia University College of
Physicians and Surgeons
Steven Horwitz, M.D., Assistant Attending Physician,
Lymphoma Service, Memorial Sloan-Kettering Cancer Center
Jim Caruso, Executive Vice President, Chief Commercial Officer
Introductions
5
Company Highlights
Oncology-focused biopharmaceutical company
Prioritized, high-potential R&D pipeline with 2 proprietary candidates in
development
– Pralatrexate – novel targeted antifolate with potential in hematologic
malignancies and solid tumors
o7 ongoing studies evaluating pralatrexate in multiple indications
oSPA-approved pivotal Phase 2 trial in PTCL; top line data
presentation ASH ’08; NDA submission expected 1H ’09
– RH1 – targeted chemotherapeutic prodrug
oPhase 1 study in advanced solid tumors & NHL ongoing
Business model focused on opportunities that can be addressed with a
targeted sales and marketing organization
Experienced management team with proven results
Worldwide exclusive rights to both pralatrexate and RH1
6
Financial Summary
in millions; unaudited
Cash at September 30, 2008 $96.4
Net cash use for nine months ended September 30, 2008 $30.7
Expected cash use in operations for 2008 $45-$49
Shares outstanding at September 30, 2008 81.1
7
Pablo Cagnoni
8
Pralatrexate: Unique Antifolate
A novel targeted antifolate designed to accumulate preferentially in
cancer cells
Based on preclinical studies, the Company believes that pralatrexate
selectively enters cells expressing RFC-1, a protein that is over
expressed on cancer cells compared to normal cells
Clinical evidence of activity in T-cell malignancies and NSCLC
SPA-approved pivotal Phase 2 trial ongoing in patients with relapsed
or refractory PTCL
– FDA Orphan Drug and Fast Track designation in patients with
T-cell lymphoma
Mechanistic rationale for development in other oncology indications
based on broad use of folate antagonists
9
Product Development Pipeline
Pralatrexate Preclinical Phase 1 Phase 2 Phase 3 NDA Market
Peripheral T-cell Lymphoma
Bladder Cancer
Non-Hodgkin’s Lymphoma
B-cell Non-Hodgkin’s Lymphoma
PDX + Gemcitabine
Cutaneous T-cell Lymphoma
RH1
Non-small Cell Lung Cancer
HEMATOLOGIC MALIGNANCIES
SOLID TUMORS
PROPEL: SPA approved,
registration trial
Solid Tumors/NHL
PDX vs. Erlotinib
Non-small Cell Lung Cancer
10
PROPEL: Key Clinical & Regulatory Milestones
Reached agreement under FDA’s SPA process Jul 2006
Initiated patient enrollment Aug 2006
Received FDA’s fast track designation Oct 2006
Positive outcome of 10-patient safety assessment Jan 2007
Positive outcome of 35-patient safety & response assessment Sep 2007
Positive outcome of 65-patient safety assessment Dec 2007
Completed patient enrollment Apr 2008
Reported 65-patient interim data May 2008
Reported top line results Dec 2008
Expect to Submit NDA in the First Half 2009
11
Owen A. O’Connor, MD, PhD
12
O.A. O’Connor, B. Pro, L. Pinter-Brown, L. Popplewell, N.
Bartlett, A. Shustov, M.J. Lechowicz, K. Savage, B. Coiffier, E.
Jacobsen, P.L. Zinzani, A. Goy, J. Zain, S. Wilroy, M. Patterson,
A. Boyd, M. Saunders, P. Cagnoni, S. Horwitz
PROPEL: A Multi-center Phase 2 Open-label Study
of Pralatrexate with Vitamin B12 and Folic Acid
Supplementation in Patients with Relapsed or Refractory
Peripheral T-cell Lymphoma (PTCL)
13
Pralatrexate in Patients with
Relapsed
Or Refractory
PEripheral T-cell
Lymphoma
PROPEL
14
Patients with peripheral T-cell lymphoma (PTCL) have a poor prognosis
with current treatment paradigms
New treatment options are needed for patients with PTCL, especially
for those with relapsed or refractory disease
Pralatrexate is a novel targeted antifolate designed to accumulate
preferentially in cancer cells
Pralatrexate has shown an encouraging response rate in patients with
T-cell lymphoma in earlier studies1
PROPEL was developed under the FDA Special Protocol Assessment
(SPA) program
Pralatrexate has US and EU orphan drug designation for T- cell non-
Hodgkin’s lymphoma (NHL) and FDA fast-track designation
PROPEL
Study Rationale
1O’Connor et al. AACR-NCI-EORTC International Conference Molecular Targets & Cancer Therapeutics 2007:283.
15
PROPEL
Pralatrexate Mechanism of Action
Plasma membrane
Lysosome
cysteine cysteine cysteine
cysteine
PDX PDX
(& Natural
Folates)
FPGS PDX
ATP + MgCl2
PDX(G)n
PDX FPGH
+ SH
Gn
?
ATP
ADP
RFC Mediates Tumor Selective
Accumulation of Pralatrexate
RFC
cMOAT/
MRP
ATPase
PDX(G)n
TMTX
16
Design Phase 2 single arm, open label, multi-center,
non-randomized, international
Target Population Adult patients with relapsed or refractory
PTCL
Number of Patients Minimum of 100 evaluable patients
Treatment
Pralatrexate 30 mg/m2 IV x 6 weeks followed
by 1 week rest (7 week cycle) in combination
with vitamin supplementation
Primary Endpoint Response rate by IWC (CR + CRu + PR)
Secondary
Endpoints
• Duration of response
• Progression-free survival
• Overall survival
PROPEL
Study
IWC: International Workshop Criteria
17
Pathological confirmation of PTCL
Progressive disease after at least 1 prior treatment
No restriction on maximum number of prior therapies
ECOG PS 0 – 2
Adequate hematological, hepatic, and renal function
Platelets ≥ 100,000 μL
ANC ≥ 1,000 μL
Bilirubin ≤ 1.5 mg/dL
ALT/AST ≤ 2.5 x ULN
Creatinine ≤ 1.5 mg/dL
PROPEL
Key Eligibility Criteria
Revised European American Lymphoma (REAL) World Health
Organization (WHO) disease classification
18
T/Natural killer (NK) cell leukemia/lymphoma
Adult T-cell leukemia/lymphoma (human T-cell leukemia virus [HTLV] 1+)
Angioimmunoblastic T-cell lymphoma
Blastic NK lymphoma (with skin, lymph node, or visceral involvement)
Anaplastic large cell lymphoma, primary systemic type
PTCL – unspecified
T/NK-cell lymphoma – nasal
Enteropathy-type intestinal lymphoma
Hepatosplenic T-cell lymphoma
Extranodal peripheral T/NK-cell lymphoma – unspecified
Subcutaneous panniculitis T-cell lymphoma
Transformed mycosis fungoides
PROPEL
Eligible T-cell Lymphoma Histological Types
19
Histologic confirmation of PTCL by independent central
pathology review:
– Cases that required further adjudication were referred to an
adjudicator (Dr. Eric Hsi, Cleveland Clinic)
A data monitoring committee performed safety assessments
after 10, 35, and 65 patients had completed 1 cycle of therapy
An independent central review team conducted the response
assessments, which included:
Radiology (CT/MRI and PET scan)
Skin photography
All relevant clinical data
PROPEL
Independent Central Review Assessments
20
Total Accrual
115 Patients enrolled (August 2006 – April 2008)
– 80 (69%) US
– 26 (23%) Europe
– 9 ( 8%) Canada
Safety and Efficacy Populations
Baseline and safety analyses
111 patients received ≥ 1 dose of pralatrexate
- 4 patients did not receive pralatrexate
Efficacy analyses
109 evaluable patients
- 2 additional patients deemed not evaluable based on ineligible
histology by central pathology review
PROPEL
Enrollment
21
Category Parameter
Pralatrexate Treated (N=111)
n Percent
Gender M/F 76 / 35 68% / 32%
Race White 80 72%
Black 14 13%
Asian 6 5%
Hispanic 9 8%
Middle Eastern 1 <1%
Unknown 1 <1%
Age (years) < 65 71 64%
≥ 65 40 36%
Mean (range) 57.7 21 – 85 yrs
ECOG PS 0 43 39%
1 49 44%
2 19 17%
PROPEL
Patient Characteristics
22
Histopathology
Per Independent
Central Review
(N=111)
n Percent
Per Investigator
(N=111)
n Percent
PTCL-unspecified 59 53% 51 46%
Anaplastic large cell lymphoma, primary systemic type 17 15% 17 15%
Angioimmunoblastic T-cell lymphoma 13 12% 18 16%
Transformed mycosis fungoides 12 11% 13 12%
Blastic NK lymphoma (with skin, lymph node, or visceral
involvement)
4 4% 4 4%
T/NK-cell lymphoma-nasal 2 2% 1 <1%
Extranodal peripheral T/NK-cell lymphoma unspecified 1 <1% 2 2%
Adult T-cell leukemia/lymphoma (HTLV 1+) 1 <1% 2 2%
T/NK-cell leukemia/lymphoma 0 0% 1 <1%
Mycosis fungoides (not transformed)* 1 <1% 0 0%
Inconsistent with T-cell lymphoma* 1 <1% 0 0%
Aggressive T-cell lymphoma 0 0% 1 <1%
Aggressive large cell T-cell lymphoma 0 0% 1 <1%
*Two treated patients excluded from efficacy analysis
PROPEL
Histology
23
PROPEL
Prior Therapy
Number of prior
systemic regimens
N = 111
Number of Regimens n Percent
1 23 21%
2 30 27%
3 23 21%
4 14 13%
≥ 5 21 19%
Median (range) 3.0 (1-12)
Number of prior
regimens (including
radiation and topical)
1 18 16%
2 27 24%
3 23 21%
4 16 14%
≥ 5 27 24%
Median (range) 3.0 (1-13)
53% of patients were refractory to the most recent line of prior therapy
25% of patients never had a response to any prior therapy
24
Type
Pralatrexate
(N=111)
n Percent
CHOP 78 70%
Platinum-containing combination chemotherapy 45 41%
Non platinum-containing combination chemotherapy 43 39%
Single agent chemotherapy* 36 32%
Autologous SCT 18 16%
Bexarotene 15 14%
Steroids alone 8 7%
HyperCVAD 8 7%
Denileukin diftitox 7 6%
Systemic investigational agents 7 6%
Other (e.g., interferon, cyclosporine, alemtuzumab) 13 12%
*other than denileukin diftitox or bexarotene
PROPEL
Prior Systemic Therapy for PTCL
25
PROPEL
Summary of Response by Central Review: IWC
Pralatrexate
(N=109)
n Percent 95% CI
Best
Response
CR+CRu+PR 29 27% 19-36
CR 10 9%
CRu 1 <1%
PR 18 17%
SD 23 21%
PD 40 37%
UE 3 3%
ND: off-treatment in C1 14 13%
69% of responders
did so after Cycle 1
C1: Cycle 1
26
PROPEL
Percent Change from Baseline in the Sum of Perpendicular Diameters
27
PROPEL
Duration of Response by Central Review: IWC
Duration of Response
n= 29
n (%) n still on treatment
> 3 months 17 (59%) 6
≤ 3 months 12 (41%) 1
Duration of response is measured from first day of documented
response* to PD or death. Patients receiving subsequent therapy
(including transplant) before PD is documented are censored
*Assessment of response occurs at the conclusion of every odd cycle
An accurate estimate of the median duration of response cannot
be reported at this time due to the current length of follow up
28
PROPEL
Duration of Treatment in Responders by Central Review: IWC
Days
Median duration of treatment = 179 days
CR
PR
CR CRu
CR
PR
PR PR
PR PR
PR CR
CR PR
CR PR PR PR CR
CR PR PR PR PR PR
CR
CR PR
PR
29
Pralatrexate
(N=109)
n Percent 95% CI
Best
Response
CR+CRu+PR 42 39% 29-48
CR 14 13%
CRu 4 4%
PR 24 22%
SD 21 19%
PD 40 37%
UE 1 < 1%
ND: off-treatment in C1 5 5%
PROPEL
Summary of Response by Investigator Assessment
30
PROPEL
Patient with Anaplastic Large Cell Lymphoma
CT October 3, 2006 CT March 2, 2007 CT April 13, 2007
October 16, 2006 January 2, 2007 January 29, 2007
Patient refractory to CHOP, DHAP and ICE
Received pralatrexate for 127 days prior to autologous SCT
31
PROPEL
Response Analyses by Key Subsets
Pralatrexate (N = 109)
n Percent
Response Rate IWC
Percent 95% CI
Region North America 85 78% 28% 19-39
Europe 24 22% 21% 7-42
Age < 65 70 64% 24% 15-36
≥ 65 39 36% 31% 17-48
Prior
systemic
therapy
1 regimen 23 21% 26% 10-48
2 regimens 29 27% 21% 8-40
> 2 regimens 57 52% 30% 18-43
Prior
transplant
Yes 18 17% 33% 13-59
No 91 83% 25% 17-35
Histology PTCL NOS 59 54% 31% 19-44
Angioimmunoblastic 13 12% 8% 0-36
Anaplastic LC 17 16% 29% 10-56
Transformed MF 12 11% 25% 5-57
Other 8 7% 25% 3-65
32
*includes 6 MedDRA preferred terms **includes 2 MedDRA preferred terms ***includes 3 MedDRA preferred terms
PROPEL
Adverse Events ≥ Gr 3 Occurring in ≥ 3% of Patients (n=111)
Any Grade Grade 3 Grade 4
Mucosal inflammation* 70% 17% 4%
Thrombocytopenia** 41% 14% 19%
Nausea 40% 4% 0%
Fatigue 36% 5% 2%
Anemia** 34% 16% 2%
Neutropenia** 24% 13% 7%
Dyspnea 19% 7% 0%
Hypokalemia** 15% 4% 1%
Abnormal LFTs* 13% 5% 0%
Abdominal pain 11% 4% 0%
Leukopenia** 11% 3% 4%
Febrile Neutropenia 5% 5% 0%
Sepsis 5% 3% 2%
Hypotension 5% 3% 1%
33
PROPEL is the largest prospective study ever conducted in
patients with relapsed or refractory PTCL
Patients in the study received a median of 3 prior systemic
regimens (range 1-12)
PROPEL established that pralatrexate has impressive clinical
activity in patients with relapsed or refractory PTCL
Central independent review of all relevant clinical data
revealed durable CRs and PRs
Responses were seen irrespective of the amount of prior
therapy
Mucosal inflammation and thrombocytopenia were the most
common Grade 3 - 4 AEs
Pralatrexate-based combinations may provide a novel platform
for future upfront T-cell treatment programs
PROPEL
Summary and Conclusions
34
Thank you to all patients, their families and the PROPEL
Study Team
Investigators and Institutions
Study Chair: Owen A. O’Connor – Columbia University
Steve Horwitz – Memorial Sloan Kettering
Barbara Pro – MD Anderson
Lauren Pinter-Brown – UCLA
Nancy Bartlett – Washington University
Leslie Popplewell – City of Hope
Kerry Savage – British Columbia Cancer Agency
Bertrand Coiffier – Centre Hospitalier Lyon Sud
Mary Jo Lechowicz – Emory University
Andrei Shustov – Fred Hutchinson Cancer Center
Eric Jacobsen – Dana Farber
Pier Luigi Zinzani – Ospedale Sant’Orsola
Christian Gisselbrecht – CHU Saint Louis
Andre Goy – Hackensack University Medical Center
Richard Furman – New York Presbyterian
Corinne Haioun – CHU Henri Mondor
Michael Crump – Princess Margaret Hospital
André Bosly – Cliniques Universitaires UCL
Brian Link – University of Iowa
Fay Young – University of Rochester
Hossein Borghaei – Fox Chase Cancer Center
Francine Foss – Yale University
Claire Dearden – Royal Marsden NHS Foundation
Olivier Casasnovas – CHU Dijon
Nicolas Mounier – CHU Nice
Acknowledgements
35
PROPEL/PTCL Q&A
36
Pablo Cagnoni
37
Pralatrexate: Expanded Lymphoma Development
Determine MTD
Evaluate safety and tolerability
Determine PK profile
Assess preliminary efficacy in
PTCL patients
Objectives
PDX followed the next day by
gemcitabine weekly x 2 or 3 with
1 week rest
1 mg vitamin B12 intramuscular
every 8 – 10 weeks and 1 mg folic
acid by mouth once a day
Treatment
Up to 54 patients in Phase 1
Up to 30 PTCL patients - Phase 2
Number of
Patients
Adult patients with relapsed or
refractory NHL or Hodgkin’s disease
Target
Population
Study Design Open-label, single-arm, multi-center
Determine optimal dose &
schedule
Evaluate safety and tolerability
Objectives
PDX weekly x 2 or 3 with 1
week rest
1 mg vitamin B12 intramuscular
every 8 – 10 weeks and 1 mg
folic acid by mouth once a day
Treatment
Number of Up to 56 patients
Patients
Adult patients with relapsed or
refractory CTCL
Prevalence 16,000 – 20,000
Target
Population
Study Open-label, single-arm, multi-center
Design
Phase 1/2a study: PDX + gemcitabine in NHL Phase 1 study: PDX in CTCL
38
Steve Horwitz, MD
39
S. Horwitz, M. Duvic, Y. Kim, J. Zain, M. Lechowicz,
P. Myskowski, H. Weissbrot, D. Wright, L. Chance,
T. Koutsoukos, P. Cagnoni, M. Saunders, O. A. O’Connor
Pralatrexate (PDX) is Active in
Cutaneous T-cell Lymphoma:
Preliminary Results of a
Multi-center Dose-finding Trial
40
Study Rationale
• Pralatrexate is a novel targeted antifolate designed to accumulate
preferentially in cancer cells
• Pralatrexate has demonstrated activity at a range of doses in
patients with relapsed/refractory T-cell lymphoma
• Maximum tolerated dose (MTD) in a trial of patients with
aggressive lymphomas:
• 30 mg/m2 weekly for 6 of 7 weeks
• CTCL has a more indolent course than peripheral T-cell lymphoma
(PTCL)
• Trial designed to identify active and well-tolerated dose and
schedule of pralatrexate in patients with CTCL
41
Study Design
• Eligible patients required to have progression of disease (PD) after
≥ 1 systemic therapy
• Eligible CTCL types included:
• Mycosis fungoides (MF)
• Sézary syndrome (SS)
• Primary cutaneous anaplastic large cell lymphoma (ALCL)
• Pralatrexate administered as an IV push; doses reduced in sequential
cohorts based on toxicity
• 3 out of 4 week schedule
• 2 out of 3 week schedule
• Study design was a de-escalation of the dose in sequential cohorts of
6-9 patients
42
Study Design
• Dose-limiting toxicity (DLT) is defined as:
• ≥ Grade 3 neutropenia
• ≥ Grade 2 thrombocytopenia or drug-related nonhematological
adverse event (AE)
• Febrile neutropenia
• Dose reduction or ≥ 1 dose of pralatrexate omitted in
Cycle 1 for treatment-related AE
• Cycle 2 delayed > 1 week for treatment-related AE
• Response evaluated using mSWAT
• Optimal dose and schedule defined:
• At least 1 response in up to 9 patients and incidence of DLTs <
33% to determine dose level/schedule
• No thrombocytopenia above Grade 1; no patients with Grade 4
hematological toxicity, Grade 3 or 4 infection or febrile
neutropenia
43
Patient Characteristics (N=24)
IVA-B 7
III 2
IIB 9
IB-IIA 6
Stage
CTCL-NOS 1
ALCL 1
SS 2
MF 20
Histology
Male:14 Female:10
57
(30-81)
Median Age (Range)
Radiation n = 13
Systemic 4 1-8
Therapy *
All Therapy 6 1-25
Median Range
Prior Therapy
*combination regimens counted
as a single therapy
44
Results: Safety
Constipation 5 0 0
Anemia 2 2 0
Vomiting 4 0 0
Fever 6 0 0
Nausea 11 0 0
Fatigue 11 0 0
Infection 11 2 0
(any)
Mucosal 11 4 0
inflammation
Adverse Event Grade 1/2 Grade 3 Grade 4
45
Results: Dose-limiting Toxicities
0 (pending
– treatment
ongoing)
10 mg/m2
3/4 weeks
6 3
-Grade 2 stomatitis
- Grade 3 stomatitis, Grade 2 mucosal inflammation
15 mg/m2 2
2/3 weeks
5 3
- Grade 1 skin ulcers, Grade 2 fatigue
- Grade 2 fatigue
- Grade 2 muscle spasms
- Grade 2 stomatitis
15 mg/m2 4
3/4 weeks
4 6
-Grade 2 stomatitis; Grade 3 elevated liver
function tests
- Grade 2 stomatitis
- Grade 3 mucosal inflammation
20 mg/m2 3
2/3 weeks
3 7
- Grade 2 stomatitis
- Grade 2 mucosal inflammation, hypoalbuminemia;
Grade 3 sepsis
20 mg/m2 2
3/4 weeks
2 3
-Grade 2 anorexia, myalgia/myositis, tumor
pain, dyspnea; Grade 3 acute renal failure and
hypoalbuminemia
- Grade 3 joint stiffness and muscle weakness
30 mg/m2 2
3/4 weeks
1 2
# pts DLT
with DLT
# pts in Dose schedule
cohort
Cohort
46
Results: Response by Dose Cohort
1
0
1
2
2
3
3
1
0
11
3
2
1
2
8
1
1
2
0 5 10 15 20 25
30 mg/m2, 3/4 wks (n=2)
20 mg/m2, 3/4 wks (n=3)
20 mg/m2, 2/3 wks (n=7)
15 mg/m2, 3/4 wks (n=6)
15 mg/m2, 2/3 wks (n=2)
10 mg/m2, 3/4 wks (n=2)
All (n=22)
CR PR SD PD
ORR = 55% (12/22)
CR = 5% (1/22)
PR = 50% (11/22)
47
Results: Response by CTCL Subtype/Stage
IIA 0/1 (0%)
PR MF/SS* IB 2/4 (50%)
CR ALCL IV 1/1 (100%)
IVB 1**/1 (100%)
IVA 2/5 (40%)
III 1/2 (50%)
IIB 5/8 (63%)
Number of
Responders/Number of Patients
with Subtype (%)
Response CTCL Subtype Stage
*SS response = 0/2 (0%)
**patient = MF + SS
48
Conclusions
• Pralatrexate is active in patients with CTCL with folic acid
and vitamin B12 supplementation
• Overall response rate = 55%
• Therapy has been well-tolerated
• No thrombocytopenia > Grade 1
• 4 patients had Grade 3 mucositis, no cases of Grade 4
observed
• Optimal dose to be determined after review of the final
cohort
49
A Phase 1/2a Open-label Study of
Pralatrexate and Gemcitabine in
Patients with Relapsed or
Refractory Lymphoproliferative
Malignancies
S. Horwitz, J. Vose, R. Advani, K. Sankhala,
S. Padmanabhan, P. Hamlin Jr., A. Chen, S. Wilroy,
J. Zain, D. Wright, H. Weissbrot, M. Hohenstein,
P. Cagnoni, M. Saunders, O. A. O’Connor
50
Study Rationale
– Pralatrexate + gemcitabine (Gem) are synergistic in a scheduledependent
manner in cell lines in vitro and in lymphoma
xenografts1
– Pralatrexate is active in peripheral T-cell lymphoma (PTCL) and
cutaneous T-cell lymphoma (CTCL)2,3
– Single-agent Gem has demonstrated promising preliminary
activity in the setting of relapsed Hodgkin’s lymphoma (HL) and
several subtypes of non-Hodgkin’s lymphoma (NHL)
– Phase 1/2 study of pralatrexate in combination with gemcitabine
designed for patients with relapsed/refractory lymphoma
1 Toner LE, et al. Clin Cancer Res 2006;12(3):924-932).
2 O’Connor, OA, et al. AACR-NCI-EORTC International Conference Molecular Targets and Cancer Therapies 2007:283.
3 Horwitz, S, et al. Ann Oncol 2008; 19(4)iv162.
51
Study Design
• Primary objectives of the study:
• Determine maximum tolerated dose (MTD)
• Determine recommended Phase 2 dose and schedule of
pralatrexate and gemcitabine
• Treatment Groups:
• A: Pralatrexate → Gem on sequential days
weekly for 3 of 4 weeks in 4-week cycle
• B: Pralatrexate → Gem on sequential days
every 2 weeks in 4-week cycle
• C: Pralatrexate → Gem on same day (1 hour later)
every 2 weeks in 4-week cycle
52
Study Design
• The following adverse events (AEs) were considered dose-limiting
toxicities (DLTs) when occurring during the first cycle of treatment
• Grade 4 neutropenia lasting for ≥ 7 days
• Grade 4 thrombocytopenia or any grade thrombocytopenia with
clinically significant bleeding (excluding epistaxis)
• ≥ Grade 3 febrile neutropenia
• ≥ Grade 3 non-hematological toxicity, excluding nausea/vomiting
in the absence of appropriate anti-emetic therapy
• Dose reduction needed in Cycle 1 for treatment-related AEs
• MTD defined as the highest dose level at which ≤ 33% of patients
experience a DLT
• Response assessed using the International Workshop Criteria
(IWC) every 2-3 cycles
53
Patient Characteristics (N=27)
Follicular lymphoma 3 11%
Disease Type
Composite DLBCL 1 4%
and T/NK-cell
Mediastinal B-cell 1 4%
HL 7 26%
DLBCL 7 26%
T/NK-cell 8 29%
Female 10 37%
Male 17 63%
Category Number Percent
Range: 2-13
(1-11 systemic)
3
(3 systemic)
Median prior regimens:
Median age: 65 years Range: 19-81 years
54
Safety
Related Adverse Events > Grade 2 in More Than 1 Patient
Cellulitis 2 0
Hypoxia 2 0
Pneumonia 3 0
Pancytopenia 2 0
Lymphopenia 0 2
Increased ALT 3 0
Leukopenia 1 2
Anemia 9 0
Neutropenia 9 2
Thrombocytopenia 4 7
Grade 3 Grade 4
55
Dose-limiting Toxicities
Same day,
every 2 weeks
Same day,
every 2 weeks
Sequential days,
every 2 weeks
Sequential days,
every 2 weeks
Sequential days,
every 2 weeks
Sequential days,
3/4 weeks
Sequential days,
3/4 weeks
Sequential days,
3/4 weeks
Schedule
C1 3 10/300 0
- Cellulitis (Gr 3)
- Pulmonary embolus (Gr 3)
- Thrombocytopenia (Gr 4)
B3 3 15/400 3
C2 7 10/400 1 - Hypoxia and pneumonia (Gr 3)
B2 4 10/400 1 - Cellulitis (Gr 3)
B1 3 10/300 0
- Neutropenia (Gr 3)
- Thrombocytopenia (Gr 4)
- Thrombocytopenia (Gr 4)
A-2 3 10/300 3
- Thrombocytopenia (Gr 3)
- Thrombocytopenia (Gr 4) and neutropenia
(Gr 3)
A-1 2 10/400 2
- Thrombocytopenia and neutropenia (Gr 4)
- Thrombocytopenia and neutropenia (Gr 3)
A1 2 15/400 2
# pts DLT
with
DLT
Dose
PDX/Gem
(mg/m2)
Cohort # pts
56
Preliminary Efficacy
A: CT Baseline
B: CT after cycle 4
A: PET Baseline
B: PET after cycle 4
A: Pretreatment: Right pelvic sidewall mass
B: Cycle 4 with PR by CT and resolution of PET avidity
• Patient with multiple
relapsed nodular
sclerosing Hodgkin’s
lymphoma
• Prior ASCT x 2,
previous Gem
• Treated in cohort
A1: pralatrexate 10/
Gem 400 (mg/m2)
• Sequential days,
3 out 4 weeks
57
Results: Evaluable Patients (N=22)
1 Mediastinal B-cell 1 SD
1+, 4+, 4+, 4+
Follicular
T/NK-cell
DLBCL
HL (nodular sclerosis)
Histology
2 2 PD
2 SD
4 PD
2 PR*
5 PD
4 PR
1 SD
1 PD
Response
6
1.5, 2
7
6
Response Duration
(months)
n
*1 pt had DLBCL + T/NK-cell
58
Conclusions
• Pralatrexate plus Gem on an every two-week schedule is active
and better tolerated than a weekly schedule in heavily pretreated
patients with refractory lymphomas
• Responses observed in 6 of 22 evaluable patients
• 4 patients with HL
• 2 patients with DLBCL
• Responses occurred on both the sequential dosing schedule
(5 patients) and the same-day dosing schedule (1 patient)
• The MTD for the every two-week, sequential-day schedule is
pralatrexate 10/Gem 400 (mg/m2)
• Enrollment ongoing to define the MTD for every two-week,
same day schedule
59
LYMPHOMA Q&A
60
Pablo
61
Product Development Pipeline
Pralatrexate Preclinical Phase 1 Phase 2 Phase 3 NDA Market
Peripheral T-cell Lymphoma
Bladder Cancer
Non-Hodgkin’s Lymphoma
B-cell Non-Hodgkin’s Lymphoma
PDX + Gemcitabine
Cutaneous T-cell Lymphoma
RH1
Non-small Cell Lung Cancer
HEMATOLOGIC MALIGNANCIES
SOLID TUMORS
PROPEL: SPA approved,
registration trial
Solid Tumors/NHL
PDX vs. Erlotinib
Non-small Cell Lung Cancer
62
Jim Caruso
63
Commercial Considerations
• Addressable U.S. PTCL Market
o Incidence - 5,500; prevalence - 9,500
• High Unmet Medical Need
o 5-year overall survival approximately 25%
o No labeled product or regimen
o NCCN PTCL Guidelines
• Transition from Clinic to Market
o PROPEL: largest prospectively designed PTCL study
- Size – patients – multi-center – independent review - ITT
o PROPEL response rates and duration
- Supports trial, use and adoption
o Pralatrexate product profile 97% favorable with surveyed NHL
physicians
- Oncologist TRx priorities: CR, duration, PR, AEs, dosing
o Attractive and scalable market
64
Commercial Considerations
• Commitment to patient support
• Revenue model
o Pricing
o Patient segments
o Reimbursement
• Potential for co-promotion or out-licensing to reach ex-US markets
• Worldwide exclusive rights for all indications
• Pralatrexate composition of matter patent protection through 2017
in U.S and Europe
• Potential 5-year extension under Hatch Waxman in U.S.
through 2022
65
Paul
66
Investor Presentation
December 2008
NASDAQ: ALTH
67
Backup Slides
68
PDX: Compelling Solid Tumor Opportunity
10-deaza-aminopterin demonstrated activity: 21% RR
MTX actively used 1st and 2nd line
No approved treatments/no SOC/unmet medical need
12,692 – 2nd
line
Bladder: Stage III/IV
Under Evaluation
Under Development
MTX well established in adjuvant setting
Cytotoxics utilized up to 4th – 5th lines of therapy
35,330 – 2nd
line r/m
Breast: Stage III/IV
Demonstrated antifolate clinical activity; no investigational
agent superior to MTX head-to-head
High unmet medical need; MST for Stage III/IV
approximately 6 mos.
16,926 –
recurrent/
metastatic
Head & Neck: Stage III/IV
PDX activity in relapsed NSCLC comparable to approved
agents: 11% RR w/o vitamins, TTP: 3 mos.
High unmet medical need: 5-yr survival rate for Stage
IIIB/IV approximately 15%
158,146 –
2nd & 3rd line
NSCLC: Stage IIIB/IV
2008 - U.S. Clinical and Commercial Rationale
Potential
Patients*
Tumor type
*Source: Decision Resources Patient Base, 2008
Potential for expanded development of PDX in solid tumors
69
PDX: Prior Clinical Results in Advanced NSCLC
• 11% response rate
• 13.5 months median survival
• 3 months median time to
progression
• Grade 3/4 stomatitis – 21% of
patients
Phase 2 study –
PDX in relapsed/refractory
stage IIIB/IV NSCLC
Dose without vitamin
supplementation: 135 - 150 mg/m2
Addition of vitamins to PDX treatment regimen enabled higher
dosing, which may lead to greater therapeutic benefit
Krug LM, Azzoli CG, Kris MG, et al. 10-propargyl-10-deazaaminopterin: an antifolate with activity in patients with previously treated non-small cell lung cancer. Clin Cancer Res 2003;9(6):2072-8.
• Data presented at AACR-NCIEORTC
2007Conference
• Previously treated Stage IIIB/IV
NSCLC patients
• Clinically significant radiologic
responses observed
• With vitamin supplementation:
MTD 270 mg/m2
Subsequent Phase 1 study-
PDX in relapsed/refractory
stage IIIB/IV NSCLC.
Recommended Phase 2 starting
dose: 190 mg/m2
70
PDX: Phase 2b Study - Advanced NSCLC
Response rate
Progression-free survival
Safety and tolerability
Secondary Endpoints
Primary Endpoint Overall survival
Pralatrexate arm:
- 190 mg/m2 which may be increased to 230 mg/m2or
reduced in 40 mg/m2 decrements
- IV push on days 1 and 15 of a 4-week/28 day cycle
Tarceva arm:
- 150 mg/day orally daily for a 4-week/28 day cycle
Concurrent vitamin supplementation:
- B12 (1mg intramuscular every 8-10 weeks)
- Folic acid (1 – 1.25 mg by mouth once a day)
Treatment
Number of Patients A minimum of 160 evaluable patients
Stage IIIB/IV non-small cell lung cancer (NSCLC) who are, or
have been, cigarette smokers who have failed treatment with
at least one prior platinum-based chemotherapy regimen
Target Population
Randomized, multi-center study comparing pralatrexate to
Tarceva
Study Design
71
PDX: Phase 2 Study - TCC of the Bladder
Duration of response
Clinical benefit rate
Progression-free survival (PFS)
Overall survival
Safety and tolerability of PDX
Secondary Endpoints
Primary Endpoint Response Rate
190 mg/m2, which may be reduced to 150 mg/m2
PDX on days 1 and 15 of a 4-week/28 day cycle
1 mg vitamin B12 intramuscular
every 8 – 10 weeks and 1 – 1.25 mg
folic acid by mouth once a day
Treatment
Number of Patients A minimum of 41 evaluable patients
Adult patients with advanced or metastatic relapsed
transitional cell carcinoma (TCC) of the urinary bladder
Target Population
Study Design Open-label, single-arm, multi-center
72
Disease Overview: NHL & PTCL
PTCL is an aggressive NHL subgroup with poor clinical prognosis
Non-Hodgkin’s Lymphoma (NHL) Peripheral T-Cell Lymphoma (PTCL)
2nd + line treatment
1st line treatment
Prognosis
Grade
Common
Subtypes
Cell Origin
Definition
No labeled product or regimen
No standard 2nd line treatment
- Aggressive (+/-Rituxan)
- ESHAP, ICE, DHAP (RR 30%-70%)
-Indolent
- Rituxan, Zevalin (RR 47%-80%)
No labeled product or regimen
- CHOP: 50-70% 1st line TRx response
rate, high relapse, short duration 4
CHOP + Rituxan
- DLBCL (Aggressive): 2.9 yrs EFS3
- Follicular (Indolent): 2.4 yrs median PFS 3
- Worse than aggressive B-cell NHL
- PTCL 5 yr OS = 25%2
- Better if NHL is of B-cell origin
- DLBCL (intermed. risk) 5 yr OS = 49%1
Indolent or aggressive Aggressive
PTCL NOS (not otherwise specified)
Angioimmunoblastic, Anaplastic large cell
Diffuse large B-cell, Follicular, Mantle, Burkitt
B-cell (85 - 90%) Mature T-cells (post-thymic)
T-cell (10 -15%)
Diverse group of cancers originating in Aggressive subgroup of NHL (10 -15%)
lymphatic system
1 Lossos et al., NEJM, 2004.; 2 Blood. 1997 Jun 1;89(11):3909-18; 3- Rituxan package insert; 4 Angelopoulou, M. et al., HAEMA, 2004
73
Duration of response
Progression-free survival
Overall survival
Secondary Endpoints
Primary Endpoint Response rate by IWC (CR + CRu + PR)
30 mg/m2 of pralatrexate weekly x 6 then 1 week rest
1 mg vitamin B12 intramuscular every 8 – 10
weeks; 1 mg folic acid by mouth once a day
Treatment
Number of Patients At least 100 evaluable patients
Target Population Adult patients with relapsed or refractory PTCL
Phase 2 single arm, open label, multi-center,
international
Trial Design
PROPEL: Pivotal Phase 2 Trial in PTCL
FDA Granted SPA; Fast Track and Orphan Drug Designations
Personally,
I think being a twenty percent owner of Moody's and being the wise investor that he is, that there is no way that Buffett didn't know what Moody's was doing. Maybe he should be getting called in before congress and asked what he knew about the ratings changes and totally eroneous ratings of the debt that caused this crisis.
MADRID (Reuters) - Investor Warren Buffett said on Wednesday that credit ratings group Moody's Corp (MCO.N: Quote, Profile, Research, Stock Buzz), in which his investment company Berkshire Hathaway Inc (BRKa.N: Quote, Profile, Research, Stock Buzz) owns some 20 percent, would be around a long time.
Moody's Investors Service, already under fire over the U.S. mortgage market crisis, took a fresh blow on Wednesday as it launched an investigation into a report that it had wrongly assigned triple-A ratings to complex European debt products and had then not downgraded them.
"I don't think one day will permanently change the franchise value of Moody's," Buffet, the world's richest person, said at a news conference in Madrid.
Years of shrewd investing is estimated to have earned Buffett a $62 billion fortune according to Forbes magazine and the nickname "the sage of Omaha".
(Reporting by Ben Harding; Writing by Martin Roberts; Editing by Greg Mahlich)
EVTC went public in 2007 by consummating a reverse merger with Renovis (#msg-22980262).]
evotec was public on the frankfurt exchange. They listed on Nasdaq by merging with Renovis but they paid a premium to its cash. The reverse mergers usually discount the cash.
he went to work for a fund. how were his returns. he left the fund so I guess he didn't do too well.
I don't think he should charge for his letter because I believe he makes a lot of money either posting a positive article that a hedge fund buddy of his is long, or posting a negative article about a company for hedge fund buddy that is short.
his reasoning is not very scientific. It seems more to be a snapshot that someone told him to write.
do you have an opinion on aryx
based on the definition that biotech companies need to have to get to profitablilty for their phase 3 assets to not need to be on the list of finding a home I guess all biotechs with less than a couple of hundred million in the banks should be on the list
why do you think they get an approvable letter, or are you basing that on the fact that most products get approvable letters nowadays
I was the one who added DYAX to the table. The answer to your question is here:
the debt on the cowen loan doesn't have to be paid off until 2016. They have enough cash to get them through approval and more.
dyax had over 74 million at 09/30/08 and the pdufa is in march. how can they not have the cash?
I think chtp has the cash to get the data
CV therapeutics new label should increase sales a lot.
http://www.cvt.com/pdf/Corporate%20Presentation%2011-12-08.pdf
they were were at a run rate with a label that basically said that the qt prolongation would kill you. The label now says the drug reduces arryhthmias which is the side effect of qt prolongation. the drug also lowers HBA1C which is a side effect of competitive drugs. It has gone from a third line drug to first line
I think it can become a 300 to 500 million dollar drug
– AASLD 2008 Wrap-Up Call with Vernon Bernardino featuring Raymond T. Chung, MD, Associate Professor of Medicine, Harvard Medical School and Director of Hepatology, Medican Director, Liver Transplant Program, Massachusetts General Hospital. A replay will be available for one week at (866) 551-4520, passcode: 233481. Related tickers: VRTX, SGP, ITMN, VRUS, Roche, ANDS
know GBM patients that are out more then 5 years
they aren't out more than five years because of avastin or erbitux.
YMI - I don't own YMI but the result of their H&N trial, their Pontine GLioma Trial, and this glio trial all are pretty good for a drug that doesn't bind to anything.
Having said that if I had a glio I would be using avastin, erbitux, and tem.
you are right, it wouldn't matter because none of them would help you.
MDVN – Just because PFE screwed up royally in the past (Macugen, Indiplon, Exubera, etc.) does not mean that they will screw up each and every time they ink a partnership deal. I’m inclined to think PFE sees something in Dimebon that others have missed.
you left out spending over a billion for esperion
when an SPA isn't an SPA. Uh sorry, we changed our minds.
POZEN Informed of FDA Internal Review of Gastric Ulcers as a Primary Endpoint in Clinical Trials
Friday October 17, 6:00 am ET
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that, as part of the FDA’s on-going discussions with the Company and their review of both the Special Protocol Assessment (SPA) for PA32540 and the Statistical Analysis Plan (SAP) for PN 400, the FDA is conducting an internal review on the acceptability of using endoscopic gastric ulcers as a primary endpoint in clinical studies. The Company has been advised by the FDA that an internal meeting could take place on this matter as soon as the FDA can gather all the interested parties together, but it did not expect that to happen until the first quarter of next year.
Dr. Marshall E. Reese, executive vice president, product development said, "It is unclear at this time what impact, if any, the FDA’s internal review will have on any previous agreements the Company has with the FDA on POZEN’s PN or PA development programs. We will continue to progress our development program for PN 400 since these clinical trials have been operating under an agreed development plan with the FDA. We anticipate top-line data to be available by year end.”
In April 2006, POZEN announced it completed an SPA and reached agreement with the FDA on the design of its pivotal trials for PN 200 (omeprazole 20 mg and naproxen 500 mg), which trial protocols specified the primary endpoint as the reduction in gastric ulcers versus enteric coated naproxen. After signing the collaboration agreement with AstraZeneca, the Company confirmed with the FDA that the development program agreed upon for PN 200 also applies to PN 400 (esomeprazole 20 mg and naproxen 500 mg).
In June 2008, POZEN submitted an SPA for the PA32540 pivotal studies, which are designed to demonstrate a reduction in gastric ulcers in subjects taking PA32540 versus subjects taking 325 mg of enteric coated aspirin. Based upon POZEN’s recent communications with the FDA, the Company believes that confirmation of using endoscopic gastric ulcers as the primary endpoint is the only remaining open issue in the design of the pivotal trials.
While it is not possible to predict the outcome of the FDA’s internal review, in the event that the agency determines that endoscopic gastric ulcers are not acceptable as the primary endpoint for our PN and PA trials, it is possible that POZEN will be required to meet other endpoints which may result in additional trials and associated increased costs and delay NDA approval.
POZEN will hold a webcast on Friday, October 17, 2008 at 8:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay at www.pozen.com.
About POZEN
You seem to be confusing the one-time drop in EPS from Lipitor’s patent expiration with the permanent boost to EPS that PFE could obtain from leveraging the balance sheet.
I am not confusing anything. I am sure you have cash in your account. You wouldn't buy pfe because their earnings are going to go down.
They shouldn't buy their own stock for the same reason.
A better use of their cash is to buy a company that would be accretive to their earnings.
PFE has $26B in cash, although some of this is in foreign subsidiaries. If they hypothetically used all of this cash to buy back shares at the current share price, it would decrease the number of shares outstanding by 25%. This would boost EPS to a larger degree than any other action including an acquisition or licensing of a blockbuster drug.
what is the point of increasing earnings per share in the short run when their earnings are going to fall off of a cliff in 2011.
the loss of lipitor will destroy their earnings power. what they should do is hold onto their cash unless their see an asset that will be accretive to their earnings by 2011. In 2011 unless they aquire good drugs they will be trading at cash.
I think PFE needs to aggressively buy back shares to exploit the under-leveraged balance sheet. Having a fat dividend is nice but they can and should do more, IMO.
As an investor, Pfizer's largets drug Lipitor is coming off patent in 2011 and their revenues are going to fall off of a cliff. They have nothing to make up for that and they have spent money on terrible purchases that probably will not bear fruit.
I wouldn't buy the stock so the only reason the company would do that is to support the stock price but that is a bad reason. A company should only buy back its stock if their money couldn't be better spent doing something else with it.
boston scientific at 7 dollars a share
new stent approval. Has anyone checked the data on it. stock has been cut in half in the last couple of weeks
The worst is yet to come
when you read this article it looks like this guy has a great track record in predicting what will happen next. Then read the article below this one and see what he said in 2006
http://www.marketwatch.com/news/story/worst-yet-come-investment-strategist/story.aspx?guid=%7B55B21789%2D3A26%2D495A%2DB0D3%2D5AF3F6ABDA18%7D&siteid=yhoof
'No market for old men,' TCW investment strategist warns in gloomy forecast
By Jonathan Burton, MarketWatch
Last update: 9:34 p.m. EDT Sept. 17, 2008Comments: 14SAN FRANCISCO (MarketWatch) -- An influential investment strategist has a dire forecast for U.S. stocks, credit markets and the continued independence of some of the nation's top financial institutions.
Jeffrey Gundlach, chief investment officer at Los Angeles-based mutual-fund company TCW Group Inc., told clients on a conference call late Wednesday that the crisis in credit and housing may not abate for several years and is actually getting worse.
In the deteriorating climate he sees unfolding, Gundlach said, ) could become an "AIG-sized debacle," Morgan StanleyWB, , ) won't be able to stand alone, default rates on even prime mortgages could soar, and European banks' woes are just beginning.
"This is no market for old men," said Gundlach, who also manages TCW's flagship Total Return Bond Fund (TGLMX:TGLMX
TGLMX, , ) . "This is no market for old-school thinking."
Gundlach based his assessment on a belief that housing prices still face several more years of decline, a protracted slump, he said, not seen since the Great Depression. Moreover, Gundlach said it's possible that home prices could be sluggish until 2022.
"If it's like the Depression experience -- and it sure is shaping up that way -- it could take several years. Maybe we won't see a bottom in home prices until 2014," he said.
Write-offs could top $1 trillion
As a forecaster, Gundlach didn't just climb aboard the gloom-and-doom wagon. He was early to spot the cracks that subprime loans were making in the financial system, and among the first to warn that an era of easy money would come to a bad end.
"The subprime market is a total unmitigated disaster and it's going to get worse," Gundlach told money managers and financial advisers at an investment conference in June 2007. See full story.
And Gundlach has put his shareholders' money where his mouth is, shunning derivatives and counterparty risk in his bond fund portfolio.
That defensive posture should offer protection in the continuing credit storm that Gundlach foresees. In this bleak scenario, an unprecedented -- and growing -- number of home foreclosures, along with mortgage loans that are under water as soon as they're originated and a glaring lack of buyers for even modestly risky assets keeps the financial system under enormous stress.
Expect loan default rates to rise, Gundlach said, not just in the subprime market, but among the top-drawer prime borrowers as well. The prime default rate could approach 10% from a current 2% before the carnage is over, he said.
"The current environment is maybe a little worse that what was experienced in the Depression in terms of the housing market," Gundlach said.
More troubles ahead
Accordingly, financial institutions may suffer write-offs that could surpass $1 trillion before conditions improve, he said. As of late August, credit losses and writedowns at the world's 100-largest banks and brokerages topped $506 billion, he noted.
Among the casualties, Gundlach said, is Citigroup. The company's balance sheet problems could be on a scale similar to that of insurer American International Group, which the U.S. bailed out this week.
"I would give a very meaningful probability to the biggest, next AIG-size debacle being Citigroup," the strategist said.
"I would definitely not be a buyer of Citigroup stock," Gundlach said.
"If I were going to buy financial market stocks," he added, "I would be a buyer of Wells Fargo (WFC:WFC
Other financial giants also won't escape the crisis unscathed, Gundlach said. "I don't see how Wachovia can make it as a stand alone," he said. He expressed the same sentiment about Morgan Stanley.
Indeed, late Wednesday the New York Times reported that Morgan Stanley was exploring a merger with Wachovia or another bank. See full story.
Europe's financial giants are in similar or even worse shape than their U.S. counterparts, Gundlach said, with "substantial exposures to assets which U.S. banks are now getting taken to the woodshed over. I would rate all European banks as not a buy."
The breakdown will take a further toll on U.S. stocks, Gundlach added. The S&P 500 will tumble below 800, he said, about 35% below its 1156 close on Wednesday.
Said Gundlach: "None of us have ever seen this, and it's no market for old men, but risk aversion is the order of the day."
Jonathan Burton is an assistant personal finance editor for MarketWatch, based in San Francisco.
http://www.businessweek.com/print/investor/content/mar2006/pi20060330_603758.htm
MARCH 30, 2006
The Best Fund Managers
By Aaron Pressman
Jeffrey Gundlach: TCW Galileo Total Return Bond Fund
This fund manager finds bargains in unusual places. That ability has put him on our list four times running
Mortgage-backed securities are the most complex and misunderstood of the fixed-income instruments, says Jeffrey Gundlach, one of the two co-managers of the $477 million TCW Galileo Total Return Bond Fund (TGLMX ). But where others shy away, Gundlach sees the market's rampant inefficiency leading to tremendous investing opportunities. His fund, a Standard & Poor's/BusinessWeek best fund manager selection for the fourth consecutive year, earned an average total return of 6.4% a year over the 2001-05 period, better than most peers and with less risk, according to S&P.
Gundlach, 46, along with co-manager Philip Barach, 53, starts with a proprietary mathematical model of the behavior of mortgages that often spots bargains where others don't. Last year, for example, investors were avoiding principal-only securities, known as POs. The securities receive only the principal payments, not interest, from an underlying pool of home loans.
Properly valuing POs requires figuring out just how fast homeowners are going to repay the loans. The securities had been trading at huge discounts as interest rates rose, on the premise that homeowners would hold onto their lower-rate mortgages rather than refinance or move. Gundlach thought otherwise, and loaded up on POs with loans made in 2002 and 2003. He was rewarded with a 14% average return on his investments when as the feared slowdown in prepayments didn't materialize.
WHAT HOUSING BUBBLE? Gundlach is still bullish on mortgage-backed securities, especially those same loans originated in the 2002-03 period. He thinks he will be able to make more than twice as much from them as from Treasury bonds.
What about the housing bubble? Gundlach doesn't see it. But even if he's wrong, he says he's doubly protected. The homes bought three and four years ago have already appreciated more than 30%, giving homeowners a pretty big cushion even if prices do fall. And all the mortgage obligations in the TCW fund carry triple-A bond ratings, because the loans are backed by Fannie Mae (FNM ) and Freddie Mac (FRE ).
One thing you don't find in the TCW fund lately is corporate bonds. Many total-return funds shift their investments around between the different fixed-income classes based on what looks cheapest. Gundlach concentrates on what he knows best. "The traditional method of switching around sounds good but we're more consistently successful," he says. His investors would certainly agree.
Wells Fargo Chairman eyes possible acquisitions
Wed Sep 17, 2008 10:09pm EDT
By Gina Keating
BEVERLY HILLS, California (Reuters) - The chairman of the No. 2 U.S. mortgage bank said on Wednesday that his company was "buying with both hands" and, given the distressed state of financial assets, he felt "like a kid in a candy store."
Wells Fargo (WFC.N: Quote, Profile, Research, Stock Buzz) Chairman Richard Kovacevich declined to comment to Reuters at a conference in Beverly Hills, California, on whether the company is interested in buying Washington Mutual Inc (WM.N: Quote, Profile, Research, Stock Buzz) or Wachovia Corp (WB.N: Quote, Profile, Research, Stock Buzz) but indicated he was interested in buying other banks in distress.
"Wells Fargo often buys fixer uppers," companies that have had some hard knocks and can be rehabilitated in two or three years, he said in a speech at the Association of Corporate Growth 2008 conference. "Given the financial conditions today I feel like a kid in a candy store. There is a lot out there today."
Seattle-based thrift Washington Mutual has hired Goldman Sachs & Co (GS.N: Quote, Profile, Research, Stock Buzz) and Morgan Stanley (MS.N: Quote, Profile, Research, Stock Buzz) to run an auction and potential suitors include Citigroup Inc (C.N: Quote, Profile, Research, Stock Buzz), HSBC Holdings Plc (HSBA.L: Quote, Profile, Research, Stock Buzz), JPMorgan Chase & Co (JPM.N: Quote, Profile, Research, Stock Buzz) and Wells Fargo & Co (WFC.N: Quote, Profile, Research, Stock Buzz), one source told Reuters.
"We are buying with both hands right now, as we have done for the past year," Kovacevich said, describing himself as a "confessed serial acquirer."
In an interview ahead of his speech, he told Reuters that Wells Fargo was not alone in looking for good deals.
"I think there's going to be a lot of mergers and acquisitions for either good reasons or because people don't have choices," he said.
Kovacevich also said he was hoping for an improvement to credit markets in the first half of next year.
"Hopefully between the first of the year and no later than the middle of the year ... (things will) for things to get more normal than they are now," he said.
During a question-and-answer portion of his speech, Kovacevich criticized fellow financial institutions for failing to manage their risks and liquidity.
"I've been through six cycles and this is the only cycle where the problems started with financial services companies," he said. "Usually what happens is our customers get into problems, then we get into problems, but we caused this."
He noted that that Wells Fargo lost 4 percent of market share per year between 2005 and 2007, and $160 billion in fees in 2006 alone because of its refusal to sell the type of risky mortgages that are now undermining the U.S. economy.
The failure of regulators to notice that "someone who has been in the business for 30 years wouldn't do it" shows that "our regulatory system is not working," he said.
He said more scrutiny should fall on incentives systems for financial institution executives who are rewarded even when risky bets don't pan out.
But he said U.S. Treasury Secretary Henry Paulson and Federal Reserve Chairman Ben Bernanke "have done the right things" in bailing out American Insurance Group.
"I know they didn't want to give AIG all the money they did given what they did with Lehman but it really had the potential to bring down not only the U.S. insurance markets ... but quite frankly a lot of the rest of the world," he said.
The key to a U.S. economic recovery, he said, is to "keep credit going (and) get housing to the bottom."
"It's not how far down to the bottom we get but how quickly we get there," he said. "I think we can get out of this but that's a lot of 'ifs' and it's kind of scary."
(Writing by Sinead Carew; Editing by Gary Hill)
This shows how effective aricept is
NEW YORK, Sept 15 (Reuters) - AstraZeneca Plc (AZN.L: Quote, Profile, Research, Stock Buzz) said on Monday that a study of the experimental Alzheimer's disease drug it is developing with Targacept Inc (TRGT.O: Quote, Profile, Research, Stock Buzz) failed to provide conclusive evidence of its effectiveness.
The companies said neither their AZD3480 nor the medicine to which it was being compared, donepezil, met the clinical trial's primary goal of statistically significant improvement according to a common Alzheimer's disease measurement known as ADAS-Cog.
The results of both drugs were impacted by an improvement seen in the group of patients who received a placebo, the British drugmaker and U.S. biotechnology company said.
AstraZeneca is expected to decide in December whether to continue its development of AZD3480.
Two of the three AZD3480 doses tested showed an improvement in secondary outcome measures of change in patients' behavior and ability to function, the companies said. Donepezil also showed an improvement on the secondary measures.
Neither donepezil nor AZD3480 showed improvement in any domain of the Cognitive Drug Research computerized test battery in the pooled dataset of all subjects.
The drug is also being studied as a treatment for cognitive dysfunction in schizophrenia patients.
Targacept Chief Executive Donald deBethizy said that despite the inconclusive results, he believes they warrant further study of the medicine. (Reporting by Bill Berkrot; Editing by Ted Kerr)
It was a credible offer.
I was talking to Carl and I offered him 70 dollars for Imclone.
he jumped to conclusions and thought I offered him 70 dollars a share.
I seem to remember that he offered to buy Biogen for 70 dollars a share when the stock was on its way over 80.
where is his offer now?
Oil Investors Pulled $39 Billion in Futures, Triggering Decline
By Daniel Whitten
Sept. 10 (Bloomberg) -- Commodity index investors, blamed for record oil prices, sold $39
billion worth of oil futures between their July record and Sept. 2, causing crude to
plunge, according to a report to be released today
The work by Michael Masters, president of the Masters Capital Management hedge fund,
blames investors who buy and hold an index of commodities for driving prices to records,
and for their subsequent drop. It comes a day before the U.S. Commodity Futures Trading
Commission is set to discuss its own study of energy trading with a congressional
committee.
Masters testified three times before Congress this year, arguing that limits on traders
would cut oil prices to $65 to $70 a barrel. He has been cited by lawmakers who
introduced at least 20 measures to curb speculation. Congressional pressure on the CFTC
to step up enforcement and restrict anonymous trades has pushed index traders out of
their positions, Masters said.
``I don't think it's just coincidence that the money came out after the pressure was put
on these folks,'' Masters, who wants legislation that would set limits on index commodity
holdings, said in an interview.
Crude oil futures surged to a record $147.27 on July 11, an increase of 53 percent for
the year, on the New York Mercantile Exchange, then fell 26 percent to $109.71 on Sept.
2. Oil dropped $3.08 to $103.26 yesterday on the Nymex.
``The speculators that drove prices up basically deflated the bubble,'' said Fadel Gheit,
director of oil and gas research at Oppenheimer Capital in New York. ``They said, `That's
it, the game is over. We are going to bet on another horse.'''
CFTC Report
The commission is expected to release a report tomorrow that will lay out its findings on
the impact of index investors and over-the-counter trading on commodities. Regulators may
require Wall Street banks to regularly disclose their energy futures positions connected
to the unregulated swaps market, according to people familiar with the discussions.
JPMorgan Chase and Co., Goldman Sachs Group Inc., Barclays Plc and Morgan Stanley control
70 percent of the commodities swaps positions, and swaps dealers are the largest holders
of Nymex crude oil futures contracts, Masters said.
Representatives for all four banks declined to comment. Banks enter into swaps with
airlines and hedge funds to profit from moves in crude prices and then offset some of
that risk in futures markets such as the Nymex.
``These large financial players have become the primary source of the recent dramatic and
damaging price volatility,'' Masters said in the report.
The commission has put out special requests for information from traders and imposed
limits on the number of U.S. oil futures contracts a trader can hold on Intercontinental
Exchange Inc.'s London-based ICE Futures Europe market.
Masters's Critics
Critics of Masters's earlier work said he lacks access to the data needed to draw his
conclusions. His hedge fund is based in the U.S. Virgin Islands.
Walter Lukken, the acting chairman of the commission, is among those who question the
validity of Masters's data.
``Just as weather forecasters have no effect on the weather, energy speculators have no
effect on the price of oil,'' said Scott Talbott, a lobbyist for the Financial Services
Roundtable, which represents investors. ``His fallacy is that he ignores the laws of
supply and demand, which determine the price of oil.''
Masters earlier this year reported that index speculators such as those that trade on
Standard & Poor's GSCI accounted for $260 billion of assets, up from $13 billion in 2003.
As of Sept. 2 that number was down to $223 billion, Masters said.
``For the supply and demand people, what I would like for them to explain is how from the
supply-and-demand rationale you could have oil at $95 in January, at $150 in June and
back to $100 in September,'' Masters said.
Hedge Fund Holdings
Masters's hedge fund held shares in the four major U.S. airlines, AMR Corp., Delta Air
Lines Inc., US Airways Group Inc. and UAL Corp, according to a June 30 regulatory filing.
Airlines hedge oil and have been hurt by commodity price fluctuations.
He said he extrapolates his numbers from agricultural data, which is publicly available,
to arrive at overall numbers that include oil futures investments.
In arguing for legislation, lawmakers, primarily Democrats will point to the Masters
report and a Massachusetts Institute of Technology report released in June alleging that
speculation caused the rise in energy prices.
``Why did so much money come into these markets and why is it leaving,'' asked Senator
Maria Cantwell, a Washington Democrat, in an interview. If Congress reduces scrutiny,
``do we see the run-ups happening again?''
CFTC data show that speculative net long positions in crude oil for non-commercial
traders dropped from 115,145 for the week ended March 11, to a net short position, or a
bet that prices would drop, for the week ended July 22, when prices started to plunge.
For the week ended Sept. 2, net long speculative positions were 14,331.
To contact the reporter on this story: Daniel Whitten in Washington at dwhitten2@bloomberg.net
Form 8-K for GENAERA CORP
--------------------------------------------------------------------------------
28-Aug-2008
Other Events
Item 8.01. Other Events
On August 27, 2008, MedImmune, LLC ("MedImmune") reported on www.clinicaltrials.gov that MedImmune has voluntarily suspended three ongoing phase 2 studies of MEDI-528 and that MedImmune's Investigational New Drug Application for MEDI-528 for the treatment of asthma was placed on clinical hold by the U.S. Food and Drug Administration.
Biomarin
someone must have puked at this dinner yesterday
from leerink swann
BioMarin Pharmaceuticals Inc. (BMRN) – $3.0B Mkt. Cap – New York Marketing – (August 12th – 14th)
Group Dinner 8/12 at 6:00pm, Maloney & Porcelli Restaurant (37 E.50th Street), New York, NY
Management Team: Stephen Aselage (Sr. Vice President) and Eugenia Shen (Investor Relations)
The Elanomaniacs always speak about the great dicovery platform that Elan has in developing Tysabri and the Alzheimers drugs
It call came from the aquisition of Athena back in 1996.
http://query.nytimes.com/gst/fullpage.html?res=9904EFDD1739F93AA25750C0A960958260
Irish Drug Concern to Buy Athena for $625 Million
By LAWRENCE M. FISHER
The Elan Corporation, an Irish company specializing in drug delivery technology, said today that it would acquire Athena Neurosciences Inc. for stock valued at about $625 million.
Athena, based in South San Francisco, has been the most prominent member of a group of biotechnology companies founded in the 1980's to pursue treatments for diseases of the brain and central nervous system.
While focusing its own research on Alzheimer's disease, Athena has followed a strategy of early commercialization by licensing from other companies generic and branded drugs for Parkinson's disease and other neurological ailments. It sells them through normal channels and its own home pharmacy telephone order service.
Last week, Athena received a conditional letter from the Food and Drug Administration stating that the drug Zanaflex, a potential new treatment for spasticity in spinal cord injury, was headed toward final approval. Although Zanaflex was licensed from another company, Sandoz Pharma Ltd. of Basel, Switzerland, Athena took it through clinical trials and the F.D.A. review on its own, and thus was a milestone for the company.
Elan's American depository receipts closed today at $60.50 a share, down $1.25, on the New York Stock Exchange. Athena shares closed at $17.25, up $2.125, in Nasdaq trading. Athena's shareholders get 0.2956 of an Elan American depository Share for each share they own.
Elan has had a 9 percent stake in Athena for about a year. Eli Lilly & Company owns 4 percent of Athena, and has joint rights with it to test mice that can develop Alzheimer's. John Groom, president and chief executive of Athena Nuerosciences, said the decision whether to continue collaboration with Lilly past the end of the year would be negotiated with Elan. Analysts said that Elan and Athena were a good fit, as Elan had begun moving in the direction of developing its own drugs, including one for multiple sclerosis that is in clinical trials and could benefit from Athena's well-established sales force.
"Elan has really been transforming itself into more of a fully integrated pharmaceutical company," said Sven Borho, an analyst with Mehta & Isaly. "With Athena, they acquire revenues, a sales force and an interesting pipeline of proprietary products."
With revenues of about $200 million, Elan is small, but not as small as Athena. Total sales of Elan's drugs, mostly new delivery versions of other companies' products, amount to nearly $1.5 billion. But since Elan makes sustained delivery and other new versions of drugs, typically for a royalty, the bulk of those revenues goes to partners like Marion Merrell-Dow and American Home Products.
In acquiring Athena, Elan gains currently marketed products for the treatment of epilepsy and Parkinson's disease; other products in development for multiple sclerosis, epilepsy, neuromuscular disorders and Parkinson's disease, and potential products in discovery for the treatment and prevention of Alzheimer's disease and multiple sclerosis. Athena also tests for the diagnosis of Alzheimer's disease.
"Athena adds complementary strengths, and it doesn't overlap with us," Donal J. Geaney, Elan's president and chief executive, said in a telephone interview. In Elan's chosen market niche, and particularly in multiple sclerosis, "we get critical mass," he said. "That's very important to us."
After the merger, Mr. Groom of Athena will become chief operating officer of Elan. Elan will have three operating divisions, reporting to Mr. Groom: Elan Technologies, for the development and application of drug delivery systems; Elan Pharma, which will conduct the company's United States nonneurological sales and marketing efforts, and Athena, which will continue to develop products for the diagnosis and treatment of central neurological diseases.
"What was really fortuitous, and somewhat ironic, about this transaction, is we both had arrived at the same goals," Mr. Groom said in a telephone interview. "Elan had chosen the central nervous system as an appropriate target for developing their own drugs, and we had always had that as our goal."
Nexavar was approved recently in Italy
Italy has 2-3 fold
larger than any other EU country. The basis for that was audit data in 2002 that has
roughly 13,000 deaths in Italy from HCC, 6000 in France and 4000 in Germany (France and
Germany being the next biggest). In talking to HCC docs they believe the market has
increased by about 50% since 2002, so roughly 19,000 deaths in 2008, on par with the US.
Better coordination between oncologist/interventional
radiologist/surgeon/gastroenterologist so I think they'll be able to access a bigger
portion of the market initially than they have in the US. Hope this helps