Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
IASLC is in Seoul, S. Korea this year.
Can't speak to Birchenough's track record, but Zhang is wrong more often than he is right.
DOVP
NBIX
POTP:
The company seems to be pursuing a registrational strategy of comparing Talabostat plus Taxotere to Taxotere alone ( as well as Talabostat plus Alimta vs. Alimta alone in third line). Since there is no prior head to head data to rely upon, we are using the next best thing: comparing two different trials in similiar patient populations, making adjustments for the differences and trying to get a sense of the possible outcomes in the pivotal trial.
ITT OR of 9% vs. a 5.5% - 5.7% for Taxotere alone (TAX 317 and TAX 320). Patient population was slightly worse/better in TAX 317 (more Stage IV, but no prior taxane treated patients and about 25% patients were 3rd line). Also, comparing phase II to phase III data. At least the phase II was multi-site.
<Who's going to ASCO?>
I will be at the investigators meeting Sunday night.
<Hehe—by the way, are you are pharmacist or medicinal chemist? If so, I have a question: Adderall says on the label that its bioavailability is lessened by fruit-juice acids… does it follow that its bioavailability is increased by bases such as those in a calcium-carbonate supplement? T.i.a.>
Neither....BS Engineering, MBA Finance. BTW, I do think your board is one of the best on the web (mainly due to the civil discourse and varied opinions).
You say potato, I say ....
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm#Therapeutic%20Equivalents
The statistical methodology for analyzing these bioequivalence studies is called the two one-sided test procedure. Two situations are tested with this statistical methodology. The first of the two one-sided tests determines whether a generic product (test), when substituted for a brand-name product (reference) is significantly less bioavailable. The second of the two one-sided tests determines whether a brand-name product when substituted for a generic product is significantly less bioavailable. Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the above tests was determined to be significant, and therefore, undesirable for all drug products. Numerically, this is expressed as a limit of test-product average/reference-product average of 80% for the first statistical test and a limit of reference-product average/test-product average of 80% for the second statistical test. By convention, all data is expressed as a ratio of the average response (AUC and Cmax) for test/reference, so the limit expressed in the second statistical test is 125% (reciprocal of 80%).
Actually it is +-20%, but close enough.
Here is where the problems arise. Let's say you are a diabetic and your blood sugar is controlled on X dose of generic A and generic A happens to be 15- 20% less bioavailable than the branded standard. The next month, you get the same dose of the same drug, but it is made by generic B, which happens to be 15-20% more bioavailable than the branded standard. You, the patient, crashes and the MD thinks that either you are not compliant or the generic drug sucks, when in reality the generic drug is perfectly fine.
<I find the degree of these survey results surprising.>
I don't. Do you know what the + or - percent of bioequivalence is required for a generic drug to qualify as an AB rated bioequivalent drug? That answer will partly explain why many MDs feel the way they do.
RE: DNDN
What is your(or anyone's opinion) opinion of the likelyhood of the FDA approving Provenge based on the first two phase III trials?
Is this filing significantly different from the ALTH filing a few years back? (aside from the fact that the ALTH filing was partly based on retrospective subgroup analysis)
Has any biologic been approved in the past that has missed its prospective primary endpoint?
Mr. Pot, please leave Mr. Kettle alone. Your post really displays a lot of anger and little substance. I do agree that "misguided politicizing should not be allowed." So, lets not have any.
YMI News
http://biz.yahoo.com/prnews/060413/to164.html?.v=24
YM BioSciences to acquire Eximias Pharmaceutical Corporation
Thursday April 13, 5:26 pm ET
- U.S. based Eximias to become a wholly-owned subsidiary of YM -
MISSISSAUGA, ON, April 13 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), the cancer product development company, today announced it has entered into a definitive agreement to acquire Eximias Pharmaceutical Corporation (Berwyn, Pennsylvania), a privately-held pharmaceutical company engaged in the acquisition, development and commercialization of products for the treatment of cancer and cancer-related disorders. Upon completion of the transaction, Eximias will become a wholly- owned subsidiary of YM operating as YM BioSciences USA Inc. and will serve as YM's base of operations in the United States. Eximias employs a seasoned management team and has cash resources in excess of $30M.
It's good to be the King!
Cougar: Great link.
Despite the sharks, you have educated at least one member of this board. Thanks.
UnderValued Bio's
I don't own it, but if you like LEXG take a look at PCOP and give me your opinion when you have a chance. On the other end of the spectrum, I think APPX is overvalued in the short term(Disclosure: I own the Jul 35 puts).
Lucentis: Last post on this topic.
It will not have an 80% market share at the end of 2006. If you think that, then you are misinformed. It will have a large market share. I don't think anyone disagrees about that.
Market research has repeatedly shown that there are late adopters in every medical specialty.
The data that you looked at that showed 80% of MDs have tried Avastin doesn't mean Avastin has an 80% market share. Two completely different things. I bet most of the MDs in the study tried Avastin after using another approved drug first or used Avastin as a last resort.
If you still disagree about any of the above then we can revisit it at the end of 2006.
<I think this point is moot because the approved dose of Lucentis will more than likely be 0.3mg.>
Both doses could be approved and even if just the 0.3 mg dose is approved the competition will say the 0.5 mg dose did not get approved because it caused MIs. That will keep slow adopters (10-20% of MDs) from using any dose of Lucentis for quite a while. The early adopters (30-40% of MDs)will use Lucentis as soon as it is available.
<<If Lucentis were really causing the MI/stroke AE’s seen in these trials, wouldn’t you expect to see an effect at both the 0.3mg and 0.5mg doses?>>
AE are normally dose related. Hence the MTD/ DLT trials which are performed prior to phase II trials. So these data are not unusual.
<<ANCHOR+MARINA
Lucentis 0.5mg 11/380 (2.9%)
Lucentis 0.3mg 6/378 (1.6%)
Control 5/381 (1.3%)>>
The incidence of MI/Stroke in the 0.5 mg Lucentis arm increased over 120% relative to control. This risk is not unlike the increased risk of endometrial cancer posed by tamoxifen vs. control. This obviously won't hinder approval, but the competition will be sure to point it out to conservative MDs.
Genentech Submits Biologics License Application for FDA Review of Lucentis(TM) in Wet Age-Related Macular Degeneration
Friday December 30, 9:00 am ET
BLA Includes Request for Priority Six-Month Review
http://biz.yahoo.com/prnews/051230/sfth019.html?.v=34
SOUTH SAN FRANCISCO, Calif., Dec. 30 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of Lucentis(TM) (ranibizumab) in the treatment of neovascular wet age-related macular degeneration (AMD). Lucentis is the first therapy for wet AMD to have shown improved vision in two pivotal Phase III trials and demonstrated a clinical benefit over verteporfin (Visudyne®) photodynamic therapy (PDT) in a head-to-head clinical trial. As part of the Lucentis BLA submission, Genentech has requested a Priority Review designation from the FDA, which, if granted, would give the FDA six months from the Agency's receipt of the submission to take action on the application.
The BLA submission is based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal Phase III trials, ANCHOR and MARINA, as well as one-year clinical data from the Phase I/II FOCUS trial. In addition to these registrational studies, Genentech is currently enrolling patients with wet AMD in a Phase IIIb safety study called SAILOR. Data from the Phase IIIb PIER study evaluating a less frequent dosing regimen for Lucentis are anticipated in the first half of 2006.
"This application represents a summary of data from more than six years of rigorous clinical study and the dedication of thousands of patients and physicians hoping to improve outcomes for those with this devastating disease," said Hal Barron, M.D., Genentech's senior vice president of Development and chief medical officer. "We look forward to working with the FDA in our efforts to bring this potential therapy to patients quickly as it may offer benefit to patients with all types of wet AMD."
ANCHOR
In November 2005, Genentech announced positive preliminary data from the pivotal Phase III ANCHOR study (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD), a randomized, two-year, multi-center, double-masked, active-treatment controlled study comparing two different doses of Lucentis to PDT in 423 patients with predominantly classic wet AMD. Approximately 94 percent of patients treated with 0.3 mg of Lucentis and 96 percent of those treated with 0.5 mg of Lucentis maintained (defined as a loss of less than 15 letters in visual acuity) or improved vision (defined as a gain of 15 letters or more) compared to approximately 64 percent of those treated with PDT alone [p<0.0001] during the first year of the two-year study. The Lucentis treatment groups further showed a statistically significant difference from the control arm in an important secondary endpoint: mean change in visual acuity (VA) from baseline to month 12. On average, VA among patients treated with Lucentis improved, while VA among patients treated with PDT declined. Based on these results, patients in the PDT-alone arm of the study will have access to Lucentis for the remainder of the study. One-year data from the ANCHOR study will be presented at the Macula 2006 meeting in New York in January.
MARINA
In July 2005, Genentech presented positive preliminary one-year results from the pivotal Phase III MARINA study (Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab In the treatment of Neovascular AMD), a randomized, two-year, multi-center, double-masked, sham-injection controlled study evaluating the safety and efficacy of two different doses of Lucentis in 716 patients with minimally classic or occult wet AMD. Nearly 95 percent of patients treated with Lucentis maintained or improved vision at 12 months. Additional one-year results include:
-- Twenty five percent (59/238) of patients treated with 0.3 mg of
Lucentis and 34 percent (81/240) treated with 0.5 mg of Lucentis
improved vision by a gain of 15 letters or more compared to
approximately 5 percent (11/238) of patients in the control group as
measured by the ETDRS eye chart.
-- Nearly 40 percent (188/478) of Lucentis-treated patients
(38.7 percent in the 0.3 mg group and 40 percent in the 0.5 mg group)
achieved a visual acuity score of 20/40 or better compared to
11 percent (26/238) in the control group.
-- Patients treated with Lucentis gained an average of approximately
seven letters in visual acuity (6.5 letters in the 0.3 mg group and
7.2 letters in the 0.5 mg group) compared to study entry, while those
in the control group lost an average of 10.5 letters.
-- The majority of patients treated with Lucentis (349/478)
(74.8 percent in the 0.3 mg group and 71.3 percent in the 0.5 mg
group) experienced a letter improvement of zero or more compared to
28.6 percent (68/238) in the sham group.
In October 2005, Genentech announced that patients still in the sham arm of the MARINA study would be crossed over to active treatment with Lucentis.
FOCUS
The FOCUS trial (RhuFab V2 Ocular Treatment Combining the Use of Visudyne® to Evaluate Safety) is a randomized, two-year, multi-center, single-masked study evaluating the safety, tolerability and efficacy of Lucentis in combination with PDT compared to PDT alone in 162 patients with predominantly classic subfoveal wet AMD. Preliminary one-year data were presented in July 2005 and showed that approximately 90 percent of patients maintained or improved vision when treated with the combination of Lucentis and PDT compared to approximately 68 percent of those treated with PDT alone (p = 0.0003).
Lucentis Safety Profile
In clinical trials to date, the most common side effects that occurred more frequently in the Lucentis arms (0.3 mg and 0.5 mg) than in the control arms were mild to moderate and included: conjunctival hemorrhage, eye pain, increased intraocular pressure and vitreous floaters.
Serious ocular adverse events that occurred more frequently in the Lucentis-treated arms were uncommon and included endophthalmitis and intraocular inflammation (less than 1 percent for each). Among non-ocular serious adverse events, cerebral vascular events and myocardial infarctions were observed in all three arms of both the Phase III MARINA and ANCHOR studies; in each study the combined rate of these events was similar in the control and the 0.3 mg Lucentis arms and slightly higher in the 0.5 mg Lucentis arm. Cerebral vascular events and myocardial infarctions were also seen in the Phase I/II study of Lucentis 0.5 mg in combination with Visudyne PDT (FOCUS), although the combined frequency of these events was approximately equal in both treatment arms.
Additional Phase III Studies
SAILOR
In November 2005, Genentech began enrollment in a Phase IIIb study, SAILOR, to make Lucentis available to eligible patients. SAILOR (Safety Assessment of Intravitreal Lucentis fOR AMD) is a Phase IIIb clinical study of Lucentis for patients with all types of new or recurrent active subfoveal wet AMD. It is a one-year study designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of Lucentis administered once a month for three months and thereafter as needed based on retreatment criteria. The study will be conducted at more than 100 sites in the United States and will enroll up to 5,000 patients. Those interested in additional information about the study can call toll-free 1-888-662-6728.
PIER
Genentech is also conducting PIER (A Phase IIIb, Multi-center, Randomized, Double-Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization with or without Classic CNV Secondary to Age-Related Macular Degeneration) with 184 patients in the United States. In this trial, Lucentis is administered once per month for the first three months followed thereafter by doses once every three months for a total of 24 months. Enrollment in this study is complete and preliminary results are expected in the first half of 2006.
About AMD
AMD is a major cause of painless central visual loss and is the leading cause of blindness for people over the age of 60. The National Eye Institute estimates that there are 1.6 million people with AMD in the United States alone and that this prevalence will grow to 2.95 million by 2020. AMD occurs in two forms: dry and wet.
The dry form is associated with atrophic cell death of the central retina or macula, which is required for fine vision used for activities such as reading, driving or recognizing faces. The wet form is caused by growth of abnormal blood vessels also known as choroidal neovascularization (CNV) or ocular angiogenesis under the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This results in a deterioration of sight over a period of months to years.
About Lucentis
Lucentis(TM) (ranibizumab) is a humanized therapeutic antibody fragment developed at Genentech and designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels). Lucentis is designed to block new blood vessel growth and leakiness, which lead to wet AMD disease progression and vision loss.
Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit. Genentech retains commercial rights for Lucentis in North America. Novartis has exclusive commercialization rights for the rest of the world.
About Angiogenesis
Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. In 1989 Napoleone Ferrara, M.D., and a team of scientists at Genentech conducted seminal work in the field, which resulted in the identification and cloning of a gene termed Vascular Endothelial Growth Factor (VEGF), now known as VEGF-A. The VEGF-A protein is believed to play a critical role in angiogenesis and serves as one of the key contributors to physiological or pathological conditions that can stimulate the formation of new blood vessels. The process of angiogenesis is normally regulated throughout development and adult life, and the uncontrolled growth of new blood vessels is an important contributor to a number of pathologic conditions, including wet AMD.
Re: Branded drug Quiz
I'm gonna guess Zocor. Maybe Nexxium or Plavix after that. I'm sure I'm missing something; maybe one of the anti-depressants.
INSM: Thanks. I might nibble a little this week.
INSM: Does anyone know for certain how many warrants and converts (convertible at 1.29 and 1.36) are still free to be excercised? Also, is anyoone picking this up at current prices?
Re: Aloxi
>>Will Zofran’s going off-patent have an material adverse impact on Aloxi?<<
It depends on the reimbursement for Aloxi vs generic Zofran. The ASP +6% model will give a bigger spread for Aloxi, but the outlay for the offices will be higher. When Zofran goes generic (4Q06 I believe) the ASP will be much higher than the cost, but that will be corrected when CMS sets the new ASP later in 2007. So, I would think that offices could make more money on generic Zofran for a short time (3 - 6 months after it goes generic), but then the spread would revert to being better with Aloxi.
Zofran is a billion dollar drug---US sales are $851M thru September, so it will easily do more than $1B in US sales this year.
<<<I also have other long positions in telk, imcl, ctic,>>>
CTIC?
I'm interested in what you like about it?
BTW, I also own IMCL, OSIP, and TELK.
>GPCB or SPPI?<
Do you have an opinion on Satraplatin and GPBC at current levels?
GPCB or SPPI?
For those who have followed the oral platinum agent development, which company stands to benefit/risk the most in the success/failure of this compound? any comments on valuation of both companies?
OSIP: Are you refering to the Morgan Stanley report? The 6% decline contained no adjustment to my knowledge. The best way to gain clarity on this subject is for someone to post the actual numbers.
Re: OSIP and Macugen sales.
False alarm as Sept is a 5 week IMS month and October is a 4 week month, so actual Macugen sales had extremely strong (double digit) growth when that is taken into account.
The Taxol label only looks at Q3W.
The Sikov trial in your link is listed as a Phase III ( It really is a randomized phase II). The Sikov trial I was referring to was just an induction weekly, but the initial reported OR published in Proc Am Soc Clin Onc 1998;17:112a Abstract 432 was 86%.
The Sonus trial you are referring to was 1st line MBC only and many of those were chemo nieve. The Taxol trials included many patients treated as 2rd line and greater MBC, where one would expect a lower OR. Also, the Perez trial included many MBC patients who had recieved prior Taxol based therapy and subsequently progressed or recurred. When you look at just 1st line MBC (some of who received a prior taxane in the adjuvant setting) the OR goes up to 33%. The link also is missing some trials, namely data by Breier et al, Alvarez et al, and Luck et al to name a few.
I do like your analysis. I am pretty certain Tocosol will get on the market under the 505b2. I just don't know how well it will fare. What is your opinion?
Sonus:
Comparing phase II (Tocosol) to phase III (Taxol) results can be very misleading. The phase II experience with weekly Taxol in MBC ranges from 33% (Perez et al) to 86% (Sikov et al) with numerous phase II trials in the 50%+ range.
CRTX: Are there any other barriers (i.e. method of use patents) that would create problems for CRTX's drug to be studied/used in CV applications? At first blush the story is appealing.
<<1) complete response
2) partial response
3) stable disease
4) progressive disease
1, 2 and 3 are consider responses. >>
Really? That would be news to every member of ASCO. For the sake of your portfolio, I hope you don't have a lot of oncology related investments.
NABI: Anyone following? Comments? Opinions?
TELK: Aside from the tax implications, I like your strategy.
PCOP: Any opinions? Comments?
OSIP:
LOL. How do these guys gain employment?
RE: Xinlay
Was this a surprise for anyone?
OSIP: The advantage that Taxotere and Alimta have over Tarceva in this setting is that Medicare will cover the use of Tax and Alimta. Medicare patients w/o drug coverage from a secondary cannot afford to pay for Tarceva. This will change in 2006.
The other advantage that Tax and Alimta have is that oncologists will make a small profit giving those drugs vs. no profit giving Tarceva.
FYI: Did not pick up any stock yesterday as OSIP did not reach $23.50. I have a few underwater options that I picked up earlier, but still will try to get some OSIP at $23 or lower later this month.
PGS, are you a buyer at $18 or are you on the sidelines for this one?