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BMRN: Anyone know why the big jump and volume today?
In addition to Dew’s warnings on Biotech investing (points 1 and 5 are my favorite) one other thing that really made me wonder was it appeared the DNDN wasn’t ready to go with Provenge even if they got approval. I am not sure how common it is but if you have a great drug with Block-buster potential, not to mention some potential competitors with similar technology a couple years down the road wouldn’t you be ready for launch within lets say a month or two of approval? They seemed like they were no were close and the manufacturing/CMC issues noted by the FDA add support to that.
I am curious if people on this board think Provenge will ever make it to market or is the survival advantage too questionable?
Other risk to ency is gild's ambrisentan will very likely push thelin to 3rd line treatment. If approved. Fun to watch with the pdufa's so close together.
I watch it for fun and investment purposes :). UTHR is one of my larger positions. I think ENCY is pretty cheap on a valuation basis now (even without US approval). The thing that scares is me is how much more Given will dilute the company. Knowing "the issue" has kept me following it more closely. I wonder if the company might consider a fund drive to reveal "the issue" rather then a financing, I'd considering putting in a few dollars to know.
On a serious note, I know everyone thinks Ambrisentan is going to be the dominate ETA. While I don't know enough to argue the point I think it'll take a while to knock off Tracleer and wouldn't be suprised to see Thelin get double digit market share (in markets where it is available).
There is also ENCY their SPA got them 2 approvables (so far)
PED:
Sorry hweb I don't have a paying membership to pm but thought to give you a heads up on the good PED Q
http://biz.yahoo.com/e/070508/ped10qsb.html
Haven't gone through it just looked at the top/bottom line and saw about .11 a share!! We should have a great day tomorrow. This isn't the first time Stanley Wirtheim (CFO) has gotten the Q out before the company PR.
Regards.
PED:
I wouldn't put too much weight on Allan Greene's comments about Q to Q fluctuation. He has been saying that for over a year. I think he wants people to be cautious because of the non-subscription revenue. In the past the company has gotten burned (bad quarter) because of things like Working values not having Consulting contracts, Video not having revenue and things of that sort so he has always tried to mute investor concerns with that remark.
Even with a so-so quarter I think the stock recovers. One of the 5% holders sold a while back and I am wondering if they want out for some reason. The stock is pretty thin so it would take it a few days to absorb todays volume.
I am looking forward to a good quarter, perhaps not as great as Q4 but your right the comp should be good and Skye has been generating great top-line results (above what they did before being acquired). Hopefully Working Values and the consulting had at least modest revenue and we should do OK.
Do you have a link to the posters for this years ASCO? I was at the sight the other day and didn't see 2007 but perhaps I wasn't at the right place. TIA
Satraplatin:
FYI I don't know if it has been noted here or not but on the Pharmion Morgan Stanley call they mentioned that in their modeling they had a price similar to Taxotere (16-17k) but would certainly look to see what GPC does and it could change depending on what/if any survival advantage was shown.
They also talked about 100 - 150 million sales (not sure how far out this was) I'd suspect this figure would be just in the approved indication.
Thanks for that info.
One thing InterMune had mentioned in the past (again beyond my HCV knowledge to agree with or refute) was that they were of the belief that the virus in the serum was not significant and in fact could not be inhibited with antiviral therapy and didn't even contain the NS3 protease. They mentioned the virus replicates primarily in the hepatize (sp?) [thus my concern with mentioning it being higher then expected in the serum when the emphasized so much liver concentrations and not serum levels]
Thanks did a quick edit. Don't know where I got 149 from
ITMN -
Appreciate your comments on this and HCV in general.
Even though Vertex may not be concerned about the Rash I am :).
The Q1 call is much more informative then the Deutsche Bank one.
Updates: Link to Q1 2007 Notes, Financials, Timeline
InterMune http://www.intermune.com/
Call Summaries
Q1 2007 http://www.investorshub.com/boards/read_msg.asp?message_id=19408521
Focus on Pulmonology and Hepatology. In Pulmonology focused on Idiopathic Pulmonary Fibrosis (IPF) and in Hepatology Protease Inhibitor recent collaboration with Roche and an undisclosed preclinical compound (in collaboration with Array).
IPF
• Scarring of lungs, unknown cause
• Median survival from diagnosis 2-5 years
• US Prevalence (for PF) 128,000, Incidence 48,000 each year http://tinyurl.com/u6kgo, journal abstract http://tinyurl.com/tqd6m IPF prevalence incidence 83K US and 30K incidence.
• No approved therapy steroid and immune suppressants used with little effect. Drugs used include: Imuran (Azathioprine), Cellcept (Mycophenolate mofetil), Rheumatrex (Methotrexate), Mucomyst/Parvolex (N-acetylcysteine [NAC]) and Prednisone along with off-label use of Actimmune. Other off-label use include: Remicade (Infliximab), Enbrel (Etanercept) and Gleevec (Imatinib).
Competitive Landscape for IPF
1. Genzyme (collaboration with what was CAT) in Phase 1
2. Bosentan (Tracleer) from Actelion, Phase 2 failed in their endpoint proceeding with Phase III (BUILD-3) believed to be mortality end point 390 patients, event-driven study with SPA, results expected late 2009.
3. Imatinib (Gleevec), I believe it failed Phase 2 not sure of status going forward.
4. Sildenafil (Phase 2) http://www.clinicaltrials.gov/ct/show/NCT00352482
5. Pipex (Tetrathiomolybdate) Phase I-II completed http://clinicaltrials.gov/ct/show/NCT00189176 Company filings say plans to initiate Phase 3
6. FivePrime Collaboration http://tinyurl.com/yz444l
7. Others?
Actimmune
• INSPIRE Trial DSMB stopped at interim analysis for lack of efficacy, http://tinyurl.com/37y9tn
• For more information on Actimmune please see prior ReadMe files
Pirfenidone
• Administration Orally active small molecule 3x day pill of either 267 mg capsules (CAPACITY 1) or 267 mg or 133 mg (CAPACITY 2)
• Acquired NA and EU rights from Marnac, http://www.marnac.com/ for Fibrotic Indications. (PR http://tinyurl.com/yy2qao and 10K’s) In March 2002, we licensed from Marnac, Inc., a privately held biopharmaceutical company, and its co-licensor, KDL GmbH, their worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases, including pulmonary, liver and renal fibrosis. Under the terms of the agreement, we received an exclusive license from Marnac and KDL in exchange for an up-front cash payment of $18.8 million and future milestone and royalty payments.
• Method Of Action (Company presentations) Preferentially binds to and disables the kinase p38-gamma. Significantly inhibits TGF-beta synthesis (fibrosis), Also inhibits TNF-alpha synthesis (inflammation)
• IP Protection (Conference call) Older compound patent from Marnac licensed covering anti-fibrotic uses 2011 expires. Basis of exclusivity more on Orphan drug. Granted in US (7 years) and Europe (10 years) after approval. Company states on Q4 2006 call that it is working on expanding IP and have certain activities and progress (very vague could be anything from follow-on compound to exploring new patents). Also stated at SIGnificant Investment conference 3/07
• Other Indications being studied in a number of trials (not all by InterMune). InterMune is seeking approval in Idiopathic Pulmonary Fibrosis. It is also conceivable that they later seek a broader approval for Fibrotic disease of the lung. Most notably an NIH study in Hermansky Pudlak Syndrome.
• Shionogi Phase 2 Results PR http://tinyurl.com/y5nwel Stopped after 6 months (efficacy). Treatment of 9 month. Observation/ Placebo/ Pirfenidone: Improved Minimal O2 Oximetry/6.1%/24.2% Declined Saturation/33.3/18.2% P=.016 Vital Capacity Improved/0%/9% Vital Capacity Declined/36.4%/13.4% P=.003
• InterMune Phase 2 Results PR http://tinyurl.com/y49zp7
• Journal Articles http://ajrccm.atsjournals.org/cgi/content/full/171/9/1040 (Shionogi Phase 2), http://ajrccm.atsjournals.org/cgi/content/full/159/4/1061
• Shionogi Phase 3 Top Line PR http://www.shionogi.co.jp/ir_en/news/detail/e_061222.pdf
CAPACITY Trials, http://www.capacitytrials.com/
http://www.clinicaltrials.gov/ct/show/NCT00287729
http://www.clinicaltrials.gov/ct/show/NCT00287716 - Three Arm Study
• Primary endpoint is change in forced vital capacity (FVC) after 60 weeks of treatment
• Two concurrent, multi-national trials CAPACITY 1 and CAPACITY 2
• Approximately 585 patients
• Randomized first patient April 27, 2006
• Expect enrollment to conclude Q4 of 2007, with top-line data expected in early 2009
• Exploring European partnering opportunities
• Enrollment proceeding “Very Well” (according to Q4 call) company still maintains enrollment expected to complete in Q4 2007.
• Differences between CAPACITY and Shionogi Phase 3 (Company presentations) Shionogi 250 patients, ours I-260, II-325, roughly same. Length Shionogi-52 ours 60 weeks. Dosing in Shionogi low dose 400mg TID high 600 TID, CAPACITY I-800mg TID, CAPACITY II 800mg and 400mg both TID, if account for avg. body weight of US/EU vs. Japan about 30mg/kg in each. Endpoint Shionogi change in Vital Capacity ours Change in Percent Predicted Forced Vital Capacity. Comparable measures of lung volume. Other difference is the patient population, Shionogi is Japanese ours is mainly NA and EU do not know of any metabolism difference in population or Pirfenidone between two groups.
InterMune 191 / PI Program
• Collaboration began with Array BioPharma http://tinyurl.com/y75d42
• Royalties due Described as “mid-single digits”. Array describes their royalties as 3% (generally speaking about royalty deals they have in past not just 191). As pointed out by rkrw (SI) and Dew other 3rd party royalties Chiron/others (~2%?)
• 191 General Characteristics
1. Active Sight NS3/4 PI
2. High affinity for and stability in the liver
3. Favorable pharmacokinetic profile potential Q12/BID dosing.
4. Good safety margins for: Body weights, organ weights, Clinical chemistry, clotting parameters and hematology, Renal, neurologic, gastrointestinal, immune and cardiovascular systems
5. Potency of ITMN compound is maintained against mutations that show resistance to other protease inhibitors
6. HCV protease selectivity is high
7. There were no significant effects on microscopic histopathology on any organ or tissue, including heart and liver
• 191 more specifics
1. Replicon Potency (genotype 1) EC-50 1.6nM, EC-90 14.1nM, EC-99 155.3, EC-999 1567.3 nM
2. 28 day preclinical tox suggests safe over wide dose range
3. Mutants D168A primary driver of 191 sensitivity. Hypersensitive mutation to Pegasys shift by about order may suggest suggests combo will result in protection against mutation.
4. Rat studies (looking at livers) various dose concentrations including 16 hours above EC 99.9 (3 log drop) 30 mg/kg equiv about 300mg in human to get similar human concentration.
• Some comparisons to VX-950/other PI’s
1. HCV replicon EC50 = ~2nM (VX-950=402nM, SCH-503034=200nM)
2. Mutations resistant to other PI primarily A156T 191 is highly active against mutation indicating complimentary profile with other PI’s in development
• 9/26/06 CTA submitted to the French Medicinal and Biological Products Evaluation Directorate http://tinyurl.com/yevhgh
• For technically oriented suggest listening to Think Equity “Think Tank” presentation by Dr. Blatt on 11/10/06 most technical info in company presentation to date.
• Phase 1A Trial Information http://tinyurl.com/32lvtz
1. One clinical trial site in Europe and will enroll approximately 74 healthy volunteers.
2. First patient dosed early January 2007.
3. Single-dose ascending dose in healthy volunteers.
4. Expects to complete the currently running Phase 1a study of ITMN-191 in healthy subjects in the first half of 2007.
5. Schering and Vertex held 1A until 1B that could be something we’ll do and have not disclosed plans yet.
• Phase 1B Trial Information (Press release/call) “InterMune plans to evaluate ITMN-191 in a Phase 1b randomized, double- blind, placebo controlled, multiple ascending dose study in patients infected with chronic hepatitis C virus. ITMN-191 will be administered to treatment naïve patients for 14 days and the study will include a cohort of non- responder patients. InterMune and its partner Roche expect to announce initial viral kinetic results from the Phase 1b trial in the second half of 2007.”
1. Not disclosing number of patients at this point
2. A specific cohort of non-responders in our mono-therapy studies so we can understand is there any difference in kinetics between non-responders and naïve patients. Ours will be the first in systematic fashion look at those directly.
3. We have very clear definition of what it means to be non-responder as operational defined in protocol. Will be a homogeneous group. (in response to question about type of non-responders)
• Other 191 Information
1. Looking at addition of ribavirin toxicology and PK (preclinical).
2. Plan to move quickly into Phase 2 of a design and duration of what would want to do in Phase 3 which you may imagine would include PEG-Interferon and Ribavirin.
Roche Collaboration http://tinyurl.com/y2e87x
• 60 million on closing, assuming successful develop in US and other countries will receive up to 470 million in milestones. 530 million total. Potentially 35 million (of 470 million) in next 12 months.
• Cost sharing – Roche responsible for 67% global development costs including all related mfg costs.
• Royalties outside US Roche commercializes all products from collaboration InterMune Royalties “mid-high teens %” depending on net sales level
• In US commercialize and share profits on 50/50 basis.
• Same economic terms would cover any 2nd generation PI’s developed and commercialized, roughly doubling value. Note this was clarified to mean excluding the up-front payment.
• Roche responsible for World-wide formulation development and manufacturing any compound.
• InterMune has 3rd party royalty obligations that total in mid single digits. Split 50/50 with Roche in US, InterMune responsible for them outside US
• Development self funding through development. Beyond significant post development milestones.
• Can opt out of either co-development or com-commercialization. If do so would receive higher x-US royalties and same royalties replace profit share in US.
• Expect to close pending Hart-Scott-Rodino around mid November
Other Pipeline/Interests
• Early stage preclinical program partnered with Array (undisclosed indication in Hepatology). Royalty described by Array as high single digits. Array Responsible for creating clinical trial and all synthetic process. InterMune take into clinical development through commercialization.
• Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod)
• Early stage work on PEGylated version of Actimmune (with Maxygen), does not appear to have much effort as this time. (http://tinyurl.com/yn4e4z)
• PEG-Alfacon (PEGylated version of Infergen) appears unlikely to be further developed.
• Research work in both Hepatology and Pulmonology
Financials
• Cash/securities 211.1 million (end of Q1 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• Shelf registration (http://tinyurl.com/29rsqc) for up to 175 million filed 12/28/2006
• 34 million shares outstanding
• 2007 Guidance
o Revenue (was 70– 90 million, removed with March INSPIRE study being stopped for futility)
o COGS (was 21-23%, removed with March INSPIRE study being stopped for futility)
o R&D 100-110 million. Including 5-10 million for est. FAS 123R.
o SG&A 30-35 million including 5-10 million for FAS 123R, , excludes INSPIRE discontinuation expenses and possible contract wind-down costs (for Actimmune).
• Government settlement for past Actimmune promotion (http://tinyurl.com/y3wa8a) . The company will pay $36.9 million plus 5% interest over five years. The first annual installment of $5 million paid in 2006. Note some acceleration terms exist should InterMune receive 150 million in partnering/licensing (capped at $10 million/year).
Time-Line/Medical Presentations
• Present 8 abstracts from Pulmonology research at ATS in May
• Present 3 abstracts of preclinical experience of 191 at EASL in April
• DDW poster on HCV binding kinetics of 191
• Q4 ’07 191 Phase 1B data
• Q4 ’08 Top line results from CAPACITY
InterMune Q1 2007 Earnings Release/Call Notes and Comments
Pirfenidone
. Capacity trial enrollment could be complete this month (May ’07). Results expected late 2008 [This is ahead of July time frame announced in March and end of ’07 that was prior guidance even before expanded enrollment. The treatment period is now 72 weeks]
. Study conduct excellent, low drop-out rate to date. Changed from 585 to 720 patients and 60 to 72 weeks increase power > 85% to detect 40% change in Vital Capacity > 95% power to see 50% change over placebo [from Deutsche Bank presentation].
. Shionogi Phase 3 Change in Vital Capacity decline relative reduction vs. placebo 44% (high dose) and 50% (low dose)
. Shionogi Phase 3 progression-free survival (death or > 10% decrease in Vital Capacity high dose) between the high-dose pirfenidone group and placebo (p=0.028)
. ATS (May 18-23) 8 posters related primarily to Pirfenidone alone or in combination with other therapies.
191
. “No serious adverse events were reported in the Phase 1a study.”
. Found range of doses that are well tolerated and quite confident will be efficacious and no SAE’s.
. Higher than anticipated exposure in certain dose cohorts, suggesting 191 may be administered in subsequent clinical studies at lower doses than estimated. “When dosed with food plasma exposure of 191 was significantly increased.” Plasma exposure observed at all doses given (some extremely low). When comparable dose taken without food plasma level was much lower. Did expect to see some exposure in plasma what was unexpected was level when dosed with food.
. 1B protocol to be amended and initiated in Q3 with (top-line) results expected in Q4 [Previously the company had hinted at starting the 1B even while the 1A was in progress and top-line data in 2H] . Treatment experienced group may or may not be part of 1B, may decided to pursue in a different study [previously had said a cohort of specific non-responders would be examined]
. As development goes may see ways to stretch to QD dosing but premature at this stage to explore.
. 2x day and 3x day dosing expected to be studied (as originally planned)
. EASL posters provided data from in vitro experiments alone and with Roche’s Pegasys and R1626. Significant synergy between compounds noted and HCV replicon eradicated in 14 days in the model.
. DDW presenting poster describing HCV binding kinetics that differentiate (immediate onset of Protease inhibition and very slow dissociation)
. Things that got InterMune attention on 950 - Felt time-line to approval for 950 longer then previously expected, substantial room to improve upon. After relatively short exposure of 950 a fair amount of adverse experience was noted.
Finance / Other
. Actimmune revenue 19.5 million [of note this number is basically flat from Q4 2006 revenue despite the March 5 announcement to end the INSPIRE trial for futility]. No change in reimbursement practices to date.
. 211 million cash and equivalent
. 2007 Full Year guidance: R&D 100-110, G&A 30-35, excludes INSPIRE discontinuation expenses and possible contract wind-down costs (for Actimmune)
. Negotiating with BI on final settlement regarding Actimmune supply agreement. Believe agreement allows for elimination of future obligations.
If you have access (even for the free version) to Nature there are some nice articles in this issue. They are overview type so if you want details may not be best place but for overview some peeked my curiosity to at least skim them:
Therapies for Alzheimer's disease
http://www.nature.com/nrd/journal/v6/n5/full/nrd2314.html
Includes a nice table of about 10 drugs in development (it looks a bit familiar though :) )
Cancer vaccines on the horizon
http://www.nature.com/nrd/journal/v6/n5/full/nrd2325.html
It also (aside from Dendreon of course) talks about viral vectors and where cancer vaccines may fit in the treatment of various cancers.
Lisdexamfetamine dimesylate
http://www.nature.com/nrd/journal/v6/n5/full/nrd2315.html
For those that follow the ADHD market (sorry I don't so no comment but see enough posts on this board that I thought I'd point it out)
Help with HCV science?
I am going through the latest InterMune call and trying to grasp some things to see if I can get a better sense for where 191 stands.
In a past call (Think Equity) InterMune said about 191 having an active transport and regular measures of bioavailability were not as meaningful since the serum level was not indicative of the concentration in the liver. Now on the latest quarterly call they said they expected to see some and where (pleasantly) surprised to see higher plasma concentrations when taken with food and seemed pleased that saw some concentrations even at the lowest dosing levels.
My questions for anyone wanting to help a HCV science neophyte. Should there be concern with higher then expected plasma level, especially if in fact 191 has an active transport and high affinity for the liver and given its binding to the NS3/4 protease? TIA for the help!!
Some more thoughts on the 1A information
After several listens and rereads I am not convinced that they did reach the maximum tolerated dose. Perhaps they did see something that is leading them to a slightly or perhaps even vastly different path of development though?
I am definitely going beyond my limited understanding of the science but was speculating on the following:
1-What if InterMune believes the rash (or perhaps other side effects the public is not weighing heavily) may be a class effect especially when combined with Ribavirin. Remember Vertex just gave us drop-out information but with if a lot of others developed the rash but stayed in the trial? Everyone is saying its no big deal HCV is much more deadly than some simple rash. But the FDA has the final say on how serious this is!
2-What if the PK of 1A led InterMune to believe they can get away with even less drug then their preclinical models suggest (and thus less exposure and potential side effect).
3- With Roche as a partner I am not bold enough to predict InterMune is going to try to get rid of Pegasys (or even Ribavirin) anytime soon.
4-What if InterMune instead wants to try just say 2 weeks of a PI with say 24 weeks of Pegasys/Ribavirin. Then in the 1B they are going to try even lower doses then planned (in addition to maintaining the previous development planned doses) and instead delay looking at the cohort of non-responders?
I think a lot of people cut InterMune short on their HCV knowledge thinking “oh Array created their drug”. I tend to think the exact opposite and successful or not they have some very knowledgeable people working there. They have been involved in the HCV area well before their PI program running trials with both Infergen and Actimmune. To me the idea of Infergen is quite novel and required some bright people to come up with (Dr. Larry Blatt was part of the team at Amgen that developed it).
Brazil Bypasses Patent on Sustiva
Brazil has no more of a ‘public heath emergency’ in HIV than the U.S. does.
I think there are a lot more extremes in distribution of wealth and the number living in poverty which are probably more likely to be HIV positive. I believe Brazil has strong opinions on HIV treatment in particular as I believe they are very active in HIV treatment in Africa. Considering what people thought (feared) with his workers union background, I wouldn't rule out this being one last stance for getting better terms. I believe a similar thing happened with Abbott's Kaletra before they reached a settlement.
SPPI:
And this on Ozarelix from the American Urology Association meeting too. There is an image too but don't know how to get them here on I-hub. I think this link should show it though:
http://tinyurl.com/2qoubv
[1552] THE EFFICACY AND SAFETY OF OZARELIX, A NOVEL GNRH ANTAGONIST, IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) DUE TO BENIGN PROSTATIC HYPERPLASIA (BPH).
Frans M J Debruyne, MD. ANDROS Mannenklinil, Arnhem, The Netherlands
Introduction and Objective: The efficacy and safety of ozarelix, a GnRH antagonist, given intramuscularly (IM) was assessed in men with moderate to severe LUTS due to BPH in a randomized, double-blind, placebo-controlled, multi-center, Phase II dose-ranging study. Methods: Eligible patients were treated with placebo (IM on Day -28 and -14) for 4 weeks (single-blind) to establish baseline International Prostate Symptom Score (IPSS) and uroflow values. Patients (N=144) meeting the inclusion criteria were randomly allocated to one of five treatment groups (placebo, ozarelix 5 + 5 [5mg IM on Day 1 + 5mg IM on Day 15]; 10 +10; 15 + 15 and 20 + 00) and were followed for 28 weeks. The primary efficacy endpoint was change in IPSS at 12 weeks compared to baseline. Secondary efficacy endpoints included changes in IPSS Quality of Life (QoL), patients with > 30% and > 40% improvement in IPSS, uroflow values (Qmax), PVR and prostate volume. Safety analysis included changes in erectile function (IIEF-5), treatment emergent AEs, lab values (incl. Testosterone [T], PSA) and vital signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, Qmax 9.7 mL/sec and prostate size (cm³) 41.6 at baseline. Results: At 12 weeks ozarelix significantly improved change from baseline scores for IPSS, IPSS >30% change and Qmax, compared with placebo (Table). Following administration, T levels declined transiently to non-castrate levels, but returned to baseline in all groups by 6 weeks. The mean sum of IIEF-5 scores remained unchanged over time for all treatment groups.
Serious AEs were reported in 4 patients on ozarelix (MI, pneumonitis, hypotension, renal colic) but were not considered treatment related. Conclusions: Ozarelix was well tolerated and demonstrated statistically significant and clinically meaningful efficacy in the treatment of LUTS secondary to BPH. No statistically significant impact on QoL or erectile function was observed. Based on the primary endpoint, ozarelix IM 15 +15 was the most effective regimen in this study.
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Satraplatin:
With Spectrum diluting today need some good news to help :). This is from the upcoming Urology Meeting
[1014] SATRAPLATIN SIGNIFICANTLY IMPROVES PROGRESSION FREE SURVIVAL (PFS) AND PAIN CONTROL IN PATIENTS WITH ADVANCED HORMONE-REFRACTORY PROSTATE CANCER (HRPC): PRELIMINARY RESULTS FROM THE PHASE III SPARC TRIAL
Oliver Sartor, Cora Sternberg, J Alfred Witjes, Gurkamal Chatta, David Vaughn, William Berry, Primo Lara, Jr, Faith E Nathan, Tom McKearn, Daniel P Petrylak. Dana-Farber Cancer Institute, Boston, MA; San Camillo Forlanini, Rome, Italy; Academisch Ziekenhuis Nijmegen, Nijmegen, The Netherlands; University of Pittsburgh, Pittsburgh, PA; University of Pennsylvania, Philadelphia, PA; US Oncology, Cary, NC; University California-Davis, Sacramento, CA; GPC-Biotech, Princeton, NJ; Columbia Presbyterian Medical Center, New York, NY
Introduction and Objective: Pain control constitutes a major clinical challenge in the treatment of metastatic HRPC and is a relevant therapeutic goal in this population. Satraplatin (S) is a novel oral platinum compound with demonstrated antitumor activity in a variety of tumors, including HRPC. The SPARC trial is a large, double-blind, placebo-controlled phase III study, evaluating S in combination with prednisone (P) for the treatment of HRPC patients who have failed one prior chemotherapy regimen. Methods: The SPARC trial enrolled patients with stage D2 metastatic HRPC who had failed 1 prior chemotherapy regimen. After stratification by performance status, Present Pain Intensity (PPI) and type of progression (PSA only vs radiographic), pts were randomized 2:1 to S (80 mg/m2 qd x 5 q5wk)/antiemetic + P (5 mg bid qd) or to placebo/antiemetic placebo + P (same schedule). Pain and analgesic use were recorded by patients in pain diaries during the entire observation period. Pain scores were evaluated using a PPI score, and pain response was defined by a reduction in weekly PPI score (≥ 2 points from BL over ≥ 5 consecutive weeks) in the setting of stable/decreasing weekly analgesic score (≤ 25% from BL). Disease progression was defined as a composite of radiologic progression, symptomatic progression, skeletal events, or death. Progression events were evaluated by a blinded independent expert review committee on an intent-to-treat basis. Results: 950 pts were accrued to the study over 28 months. Treatment with S resulted in a 40% reduction in the risk of disease progression over placebo (HR = 0.6; 95% CI: 0.5-0.7;P <.001). The effect of S on PFS increased over time. At median PFS, the improvement was 13% (11 vs 9.7 weeks), reaching 89% at the 75th PFS percentile (36 vs 19 weeks). S was equally effective regardless of whether or not patients received prior docetaxel treatment. Pain response rate was significantly higher in patients receiving S (24.2% vs 13.8%, P < .005), as was PSA response rate (25.4% vs 12.4%, P < .001), and median time to pain progression (66.1 vs 22.3 weeks, P <.001). The most common toxicities were myelosuppression (thrombocytopenia, neutropenia) and GI toxicities (nausea/vomiting, diarrhea), which were generally mild to moderate. Conclusions: Oral satraplatin is well tolerated and has clinically relevant activity in patients with metastatic HRPC.
Clinical / Regulatory / Litigation Calendar
[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: ITMN (191 and Pirfenidone trials).
ACHN – See GILD
ADLR – Approvable letter for Entereg issued 11/6/06 requesting safety data due in 2Q07.
AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results: 2H07.
ANDS – ANA975 for HCV placed on hold 6/26/06 due to preclinical safety issue; human trials expected to resume at end of 2007 following FDA analysis of animal tox study.
ANOR / AOM.TO – pivotal AMD3100 results any day.
ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.
BMY – Plavix litigation: trial began 1/22/07.
CEPH – Nuvigil approvable letter with minor issues received 3/30/07; response pending.
CLSC - Two phase 3 Trials 1600-2000 patients are complete, "top line data" on results due any day (April 2007 per recent PR). These were 10 week trials.
COLY – Phase-3 PF-3512676 in NSCLC (by PFE): 2008? (2 trials).
COR – CX-717 tox data submitted to FDA 4/18/07 requesting removal of dosing limitations; reply likely by mid-June.
CRME - IV RSD1235 NDA refiled, PDUFA Oct 19, 2007.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).
DDSS (formerly LBPFF) – Tramadol PDUFA June 19, 2007.
DNA – Avastin in breast cancer: FDA requested additional data confirmation on 9/11/06; resubmission by DNA pending.
DND.TO - CIP Isotretinoin PDUFA April 27, 2007. Tramadol PDUFA May 3, 3007.
DNDN – Provenge BLA PDUFA date: 5/15/07.
DORB – OrBec NDA in GVHD: ODAC May 9; PDUFA date July 21.
FRX - Milnacipran in fibromyalgia: see CYPB.
GILD – Viread for HBV: phase-3 results 3Q07, NDA (if successful) 4Q07.
GILD – GS9190 polymerase inhibitor for HCV: data from phase-1: 3Q07.
GPCB – Satraplatin SPARC trial: final overall survival: fall 2007. (The trial hit the primary PFS endpoint on 9/24/06; interim OS look announced on 6/8/06 failed to meet threshold for unblinding.) NDA submitted 2/16/07.
GTCB – ATryn EU launch for HD: July 2007.
GTCB – ATryn DIC program in EU: start of ph-2 (by Leo Pharma) any day.
GTCB – ATryn ph-3 for HD in U.S.: complete enrollment 1H07, report data 2H07, submit BLA end 2007.
GTCB – Merrimack MM-093 phase-2 data in RA/psoriasis to be presented at EULAR in June 2007. Results of phase-2 extenstion trial in RA: late 2007.
GTOP – Final MyVax results Dec 07.
IDIX – Sebivo in EU: endorsed by CHMP 2/23/07; approval expected April-May. (Approved in U.S. 10/06 and in China 3/07.)
IDIX – NM283+ribavirin drug-interaction study: top-line data by PR late June 2007; full data at medical conference in fall 2007 (probably AASLD).
IDIX – Tyzeka phase-3 in decompensated liver disease: enrollment complete in 1Q07 (75% complete as of 9/27/06).
IMCL –
1) CRYSTAL trial in first-line CRC hit its PFS endpoint (announced 1/10/07); full data release at ASCO in June, 2007.
2) Erbitux in NSCLC. OS in 1st-line FLEX study: 2H07.
3) Erbitux in pancreatic cancer, SWOG trial. Missed Primary Goal. Full Data release at Asco 2007.
4) Erbitux with Chemo in H/N. Extreme trial. Primary Goal (OS) met. Full Data at Asco 2007.
5) Critical Trials in 1st line mCRC upcoming OPUS (cet/Folfox) and CAIRO2 (capox/bev/cet) top line results 2H07
ITMN –
1) ITMN-191 Phase-1B Trial Initiation Q3 2007
PK data for ITMN-191: Q4 2007
2) Pirfenidone - CAPACITY Trial Enrollment Completion May 2007
CAPACITY Trial Top-line results Late 2008 (72 week treatment period)
JNJ: CoStar (CONR) data from U.S. pivotal trial: March 2007 at ACC
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients.
Expect full enrollment Nov/07 with Data by August /08.
This drug has zero side effects, zero competition, and No Partnership yet with Big Pharma as of 3/31/07.
the company has said that they will probably have the data by acc next year in March
Merrimack: see GTCB
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2007, trial results in 2008.
Novocell – see SRDX
NRMX, NRM.TO – North American Alzhemed trial complete Jan 07, results to follow. European Alzhemed trial complete 1H08 (?). Kiacta (Fibrillex) received an approvable letter on 8/11/06.
NVS – Tifacogin: enrollment complete 1H07 (#msg-15157973).
Paion Pa8.de Stroke results late May early June announced at a Stroke conference in Glasgow.
PHRM – See GPCB.
PPHM - Bavituximab 1B, adv. metastatic breast, lung or ovarian that failed prior chemo. 3/22/07 enrollment closed. top line data ~ May 07.
PPHM - Bavituximab 1B HCV 14 day monotherapy in non-responders/relapsers. 2/14/07 top-line info released. details at an upcoming conf.
RPRX
Proellex
*Uterine Fibroids Phase 2 (U.S.) Full Phase 2 data (mid-2007)
*One year extension data (4Q2007)
*Initiate pivotal trials (YE2007)
*Endometriosis Phase 1/2 (Europe) Full Phase 1/2 data (3Q2007)
*Initiate U.S. Phase 2 (mid-2007)
Androxal
*Male Secondary Hypogonadism Non-pivotal Phase 3 (U.S.) Full non-pivotal Phase 3 data (3Q2007)
*Initiate first pivotal Phase 3 (around YE2007)
SGP – Ph-2 data for SCH 503034 in HCV: 2H07
SNY – Acomplia advisory panel: 6/13/07; PDUFA date: 7/26/07.
SNY – Plavix litigation: trial began 1/22/07.
SPPI – See GPCB.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: late summer 2007 (enrollment complete 8/30/06).
TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.
VPHM – HCV-796 500mg phase-2 trial: 4-week data 3Q07, 12-week data 4Q07.
VRTX – PROVE-1/PROVE-2/PROVE-3 timetable: see #msg-12267294
YMI – AeroLEF ph-2b final results: ? (interim results announced on 9/27/06 failed to meet threshold).
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Morgan Stanley Questions -
FYI, On one of the presentations in the few seconds preceding you could hear two people talking softly. I could make out part of it which was something to the effect "ask a broad question". So my take is the moderators gave the speakers some heads-up but perhaps the questions from those in attendance were not prescreened.
ITMN:
Call happening now very interesting trying to read between the lines. Just guessing that the dose level reached a max dose (though company won't disclose when asked). To positive side get the clear impression InterMune has an Ace or two up their sleeve in what they saw/950 development. I think it is more then just the plasma level and "positive food effect". No clue given yet.
VRTX:
Appreciate the good notes on the call. One thing additional I thought interesting was when asked if 950 would be the leading HCV therapy 10 years from now (or something to that effect) the answer was no. And also talked about 2nd generation product that they'ld give more color on later this year. Hints at several areas to improve upon (many obvious ones come to mind).
GPC:
Yeah it could be as they state but I find it a bit unusual a company that is months away from an FDA decision that could likely lead to launching their first drug and they cut staff? Despite their comments to the contrary I wonder if they will seek to get a US partner to market satraplatin. A further speculation could mean that they are no where near agreement to co-promote terms with Spectrum so a sale avoids this controversy. I still believe they will settle with Spectrum.
http://biz.yahoo.com/prnews/070503/neth079.html?.v=4
GPC Biotech Consolidates Drug Discovery Activities
Thursday May 3, 10:49 am ET
- Waltham, Massachusetts Facility to be Closed
- All Drug Discovery to be Managed in Munich
- Ongoing Expansion of Clinical Development and Commercialization in Princeton, New Jersey
MARTINSRIED/MUNICH, Germany, May 3 /PRNewswire-FirstCall/ -- Princeton, N.J. and Waltham, Mass. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; Nasdaq: GPCB) today announced that it is consolidating its drug discovery efforts to one location. This consolidation involves closing the Company's facility in Waltham, Massachusetts and a staff reduction involving approximately 16% of the Company's total workforce. Affected employees will be eligible for severance packages that include severance pay, continuation of benefits and outplacement services. The drug discovery programs currently being managed in Waltham will be moved to Munich. The Company is continuing to build its clinical development and commercialization groups based in Princeton, New Jersey.
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Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: "With the acquisition of the assets and the hiring of many research scientists of Munich-based Axxima Pharmaceuticals in 2005, as well as the ending this year of the collaboration with ALTANA Pharma in Waltham, we have decided to consolidate our drug discovery activities into one location -- Munich -- and we will be making further investments in our drug discovery efforts there. While we believe this action makes sense for the Company strategically, it was not a decision we made lightly as it has necessitated the closing of our Waltham site. I would like to express my sincere appreciation to our Waltham- based employees for their important contributions to GPC Biotech."
Dr. Seizinger continued: "Importantly, we will continue to have a strong and growing presence in the U.S. at our Princeton, New Jersey site, where we have an ongoing effort to expand our clinical development team and build our commercialization organization, including hiring a field sales force for the U.S."
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany), and has a wholly owned U.S. subsidiary headquartered in Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at http://www.gpc-biotech.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward- looking statements contained in this press release. We direct you to GPC Biotech's Annual Report on Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech does not undertake any obligation to update these forward-looking statements, even if new information becomes available in the future.
Raising Capital -
Just curious if others have noticed what seems to be an increase in biotech companies raising cash this year? Don't have any hard numbers just a general observation from companies I follow (some I didn't think needed to do it anytime soon). Anyone who agrees would be curious on thoughts as to why?
VRTX:
I thought the Vertex Morgan Stanley Call was very good and worth a listen to those who follow the space. I am listening now and think I'll have to give it a second listen. Not sure on who the analysts are but some good hard questions (though dodged a lot of them) not just on Telaprevir but the whole market. Starting to get defensive about 191, can't say I blame them as its still early for 191.
I got the link from here but maybe from other places too:
http://www.fulldisclosure.com/conferencecall.asp?date=20070502&sortby=startdate&client=cb
I thought this was one of the better conference calls. While I didn't completely like the answer to why raising so much cash now it was good to see JJ address it. Suprisingly he was asked about his stock sales and answered too (Cash management, will sell less then 4%, finish by September).
Things sounded very positive as far as Naglazyme and Kuvan launch/potential. The BH4 programs sounds like it has some new life though I suspect not much value will go into it as investors will now take a "show me" approach. The Sickle cell trial will likely enroll first patient soon (perhaps this week).
SPPI:
I don't know why everyone is looking to attack Satraplatin, from Feuerstein's piece(as has since been discredited as pointed out by GPC and posted on this board) to the WSJ blog piece
http://blogs.wsj.com/health/2007/04/30/drugs-for-advanced-prostate-cancer-in-works/?mod=yahoo_hs
I am not a science person but to me even marginal benefit with an Oral Platinum has broad based potential in many chemo regimens. I think the survival data has a good possibility to be strong too (from comments and the interim trend conducted last year). The pain data to be presented at the Urology conference later this month seems spectacular but all people can do is find negatives about the drug??
The analysts seem intent on make GPC/Pharmion show them. So perhaps it takes a little while to get the potential reflected in the companies.
Biowatch and Dew thanks for your comments on Zevalin/radioimmunotherapy. From your comments/things I've read it seems efficacy's isn't the issue. It would be nice to see the therapy advance and maybe a buyer would have more incentive then Biogen (I was long BIIB a number of years ago before the Idec merger and don't have anything against Biogen).
I've wondered why Biogen gave up on Zevalin so quickly. I know its a long way from Rituxan but I thought it would help a lot more people. Would be especially interested in any thoughts on the efficacy/science by people on this board. If I am not mistaken isn't this one of the last murine MAB's?
http://news.yahoo.com/s/ap/20070501/ap_on_he_me/healthbeat_lymphoma_drugs_7
Lymphoma drug failure frustrates experts
By LAURAN NEERGAARD, AP Medical Writer Mon Apr 30, 9:40 PM ET
WASHINGTON - Only a fraction of patients with hard-to-treat lymphoma ever try two breakthrough "smart-bomb" drugs that bring radiation straight to cancerous cells — with just two shots a week apart, not the usual months of care. The marketing failure has a manufacturer trying to sell off one of the drugs, and increasingly frustrated specialists worry it will jeopardize attempts to expand this promising new field to fight other cancers, too.
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It's called radioimmunotherapy, harnessing homing device-like immune cells — antibodies — with a radioactive drug. The antibodies zero in on cancer and drop their payload, without as much damage to surrounding healthy tissue as chemotherapy can cause.
Only two such drugs are sold today, the lymphoma fighters Zevalin and Bexxar. But more than half a dozen early stage studies of others — against some particularly deadly malignancies, including pancreatic cancer, brain cancers, and advanced prostate cancer — are under way.
The issue: Despite research showing they work well, fewer than 10 percent of lymphoma patients who are candidates for Zevalin and Bexxar ever use them, says Dr. Mark Kaminski of the University of Michigan, a hematologist who co-invented Bexxar.
Why? Specialists cite a complex list of reasons, including that most oncologists aren't licensed to administer the radioactive infusion and must send their patients to a nuclear-medicine doctor. There's also confusion about the risks of radiation, which studies suggest are minimal, and when the drugs work best — early, not as a last-ditch therapy.
"There's lots of reasons to use them, and seems to be an inertia against them," says Dr. Mitchell Smith, lymphoma chief at Fox Chase Cancer Center in Philadelphia. "I do see it as unfortunate."
Indeed, sales are so weak that Zevalin maker Biogen Idec announced in December it was hunting a buyer to take over the drug. While the company insists Zevalin won't come off the market, the move is prompting fear on cancer blogs and from patients considering radioimmunotherapy that the option may disappear.
"Basically, they hit a home run" scientifically, says Kaminski. "The shock wave that goes through here is that if you can't get this to work in the marketplace, what's the sense of developing anything else along this line?"
Kaminski laments that about once a month, a patient seeks him after other doctors discouraged the therapy or advised it only after exhausting other options, including a rigorous bone marrow transplant.
Adds Dr. Bruce Cheson, hematology chief at Georgetown University Hospital: "When patients are presented this option, they say it's too good to be true: 'It's only a week, and I have a 70 percent chance of responding to it.'"
At issue are so-called low-grade forms of non-Hodgkin's lymphoma that strike thousands of Americans each year. They're incurable, but patients typically live a long time, beating back increasingly hard-to-treat recurrences every few years.
The leading treatment is Genentech and Biogen Idec's blockbuster seller Rituxan, a stand-alone antibody — no drug attached — that by itself kills cancer cells, and often is used together with chemotherapy to prolong a first remission. Rituxan is considered to have revolutionized lymphoma care.
But patients will relapse. When that happens, Zevalin and Bexxar are government-approved options. They use the same antibody target but with different radioactive drugs attached to give lymphoma a one-two punch. Studies suggest they fight the cancer's return at least as well as months of standard chemo.
More intriguing, about 20 percent of those patients have extremely long remissions, five to eight years. That's more likely when the drugs are used for a first relapse, not later when repeated chemo has ravaged the immune system, says Fox Chase's Smith.
Also, there's mounting evidence from small studies that even more patients have long-term remission if they use radioimmunotherapy first, instead of waiting to relapse. A closely watched government trial is trying to prove that, by comparing Bexxar plus standard chemotherapy to Rituxan plus chemo in about 500 newly diagnosed patients. Results are due in two years.
If that study pans out, "it'll have a huge impact on practice," predicted Dr. James Armitage of the University of Nebraska Medical Center, who tries to calm worried patients that the option won't disappear before that question is settled.
With radioimmunotherapy at a crossroads awaiting that science, proponents are talking up the drugs, to medical journals and patient advocacy groups. A petition pending before the Nuclear Regulatory Commission seeks to allow more oncologists to administer the shots. And Biogen Idec spokeswoman Naomi Aoki says her company is working to get more community oncologists licensed to use the drug, and plans to sell it to a company "also committed to making sure it's available."
___
Don't post much on Yahoo especially the BMRN board but I do check it. The comment about the Genzyme Aldurazyme numbers are misleading as actually I thought the numbers weren't so great (flat q over q which since there really shouldn't be any seasonal impact is more important then the Y over Y number). Hopefully Naglazyme is still going strong!
We should have had an update on the cardio vascular program by now so hopefully in the call we get one (along with what else they will do with BH4 including the Sickle Cell which like you note should have begun already). I am really hoping someone gets a good answer for why they raised so much cash, and hopefully it is a good reason (the conversion price was really bad for current shareholders IMHO).
I don't know the answer (off the top of my head) but I am pretty sure they were talking about it on Shire's last CC (or Investor Conference maybe Cowen?). I occasionally listen to their calls to find out how the Rare Disease side of their business is progressing. I guess you don't give credit for knowing where to find the answer?
Actimmune would fit the bill (controversial) but I believe it is no longer being tested in HCV (InterMune was testing it in combo with Infergen a couple years ago) unless I am behind on my news and Valient picked this up?
Biowatch, do you know if certain populations have a higher predisposition to PML?
If I recall correctly didn't Biogen sign a deal with a smaller company to investigate treatments for PML? Granted this is very early stage and may not amount to much.
I don't think quotes like this help either
"There is a big bucket of money sitting in every office. Every time you go in, you reach your hand in the bucket and grab a handful."
http://news.yahoo.com/s/nm/20070424/hl_nm/drugs_doctors_dc_1
Did anyone see the Feuerstein column this morning about JNJ developing their own protease? I had not heard this before. BI I had heard for some time (even before the Susquehanna conference but can't recall exactly where). If the JNJ rumor is true I wonder what implication that has for VRTX.
If Phase 1 trials go well and 191 turns out to be anywhere near as potent as preclinical data suggests might Roche first try a lot lower dose of 1626 before trying another Polymerase?
OK the deal is bad!! The pricing is not that much of a premium (considering how far out the notes go) and an adjustment allowance too!!
BioGenerics Survey:
It wasn't me but I thought (just to be different as whats expected usually doesn't come about) to Guess Shire. When they acquired TKT they had a Gene Activation platform it wasn't discussed much and I never really took the effort to get to know it but it seemed to offer promise.
http://www.shire.com/shire/Pipeline/technology/geneactivation.jsp?tn=5&m1=38
PS I don't really believe Shire will be the best play as it doesn't seem to fit their current acquisition oriented business model but one never knows :)
I'll admit to being caught off guard by this.
Obviously the market isn't pleased (nor was I) but after a little reflection this may turn out to be a positive.
First let me state I have absolutely no special insights and this is all pure speculation. The initial reaction is gee BH4 probably isn't looking good in anything (outside of PKU) and perhaps the company realizes that and needs to build a pipeline. I'll admit that thought isn't too pleasant but I think the stock is pretty cheap on current portfolio (and assuming Kuvan approval). I think Kuvan ends up being a much bigger drug then analysts expect. Now they certainly don't need the cash to launch it so what could the money be used for? Yeah they may want to sit on a lot of cash and JJ Bienaime (to me at least) seemed to raise much more then was necessary a while back. I thought giving him the benefit of the doubt (and I've been pretty happy with him as CEO to date) perhaps they have a rather sizeable deal in the works. I'll throw out one company ENCY they have struggle lately have a PAH program (one of the indications BH4 is being tested in) along with cardiovascular program and THEY NEED CASH!! They have some earlier stage drugs too so at the right price a deal may be good for BMRN's pipeline even as they develop BH4 in other indications. I think what the market may be overlooking in todays drop is that these notes will be 2017 so my guess is the conversion price is significantly higher then todays trading price!
Any one else care to speculate?
Thanks for posting the CIBC info.