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PI3K's seem like they're a dime a dozen these days. Any reason to believe what they have is worth anything?
Quote " Velcade has similar and more than these risks, the difference - read Velcade label - is to identify patients at risk with clearly pre-defined dose reduction strategy"
This is something Onyx presumably has not done, which is another reason why the FDA likely punts the NDA.
Given syntax appears to be broadcasting that the ITT pop won't make stat sig, they will have to word the PR carefully.
Agree. I guess the expectations are for their NSCLC trial to have ok data, given some of the things SNTA has said about the KRAS subpop and HSP90's.
It should have some data soon.
http://clinicaltrials.gov/ct2/show/NCT01427946?term=%22Infinity+Pharmaceuticals%22&rank=19
I will say I do not like the risk/reward here with SNTA. Different story at $6 vs $4 going into the data. Seems like it will need to be pretty good, given the 50% run it has had for it go further up.
I dont get the strength in the name. Feel like it shouldve traded down further.
I do agree that in the long term, Carfilzomib will eventually be approved. I'm just not sure it will cut it the first time around.
Onyx can not unequivocally say there is not an effect, since there is no control arm.
FDA disagrees with your take and Onyx's on this. Never said it was therapeutic, but confounding.
re ONXX
I don't expect ONXX to get a positive vote or approval this time around. Likely wont be approved until 2014. Data doesnt support accelerated approval.
Quote - "Alan Auerbach developed Cougar Biotechnology and sold it to Johnson & Johnson (JNJ:NYSE) for just under $1 billion (B). He got a lot of institutional buy-in for his next company, which not coincidentally is called Puma Biotechnology (PBYI:OTCBB). Puma is developing a drug that was, for all intents and purposes, discarded by Pfizer Inc. (PFE:NYSE); however, the institutional community is familiar with Auerbach's success and believes he can pull it off again. That's the bottom line."
Anyone have an opinion on Puma and Neratinib?
I mentioned both of those drugs. (LDL drug and RA drug). I think the market for a once-monthly injection for LDL seems speculative. Not sure the RA drug can compete with JAKs.
Eylea needs to do $1b in sales, since they're not gonna get much out of the rest of their pipeline, which isnt all that impressive. Really underwhelmed by Zaltrap in oncology and the LDL drug looks good, but not sure of the market for it and Amgen's drug looked a little better too. Not sure if their RA drug is worth anything given the performance of JAKs.
The Fostiva overhang seems like a legitimate concern only if Roche buys them. In that event, Roche has pricing power and the sales force to detail both drugs. The idea that Ophthotech would partner with Regeneron over Roche seems absurd; think Jeffries is off their rocker here.
“We would expect Ophthotech to partner the program (or) potentially engage in a company sale prior to start of new human studies", Jeffries analyst Biren Amin says in a note. “We believe Regeneron has an active business development program, and may possibly engage Ophthotech.”
Read more: http://www.minyanville.com/sectors/biotech-pharma/articles/regeneron-eylea-ophthotech-fovista-samir-patel/6/13/2012/id/41716#ixzz1xjty9kwH
Ophthotech’s Novel Anti-PDGF Combination Agent FovistaTM Demonstrated Superior Efficacy over Lucentis® Monotherapy in Large Controlled Wet AMD Trial
Anti-PDGF (1.5 mg) Combination Therapy Resulted in Additional 62% Increase in Visual Outcome Compared to Lucentis Monotherapy
PRINCETON, N.J.--(BUSINESS WIRE)--Ophthotech Corporation today announced results from the first clinical trial to show statistically significant superior efficacy over Lucentis® (ranibizumab) monotherapy for the treatment of neovascular age-related macular degeneration (wet AMD).
“Based on these results, Ophthotech plans to expedite the preparation of a Phase 3 registration program with the goal of bringing Fovista anti-PDGF therapy to patients with wet AMD as soon as possible.”
In a prospective, randomized, controlled Phase 2b clinical trial of 449 patients with wet AMD, Ophthotech’s FovistaTM anti-PDGF therapy (1.5 mg), administered in combination with Lucentis anti-VEGF therapy, met the pre-specified primary efficacy endpoint of mean vision gain. Patients receiving the combination of Fovista (1.5 mg) and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019), representing a 62% additional benefit.
No significant safety issues were observed for either treatment group in the trial.
Enhanced visual outcomes of Fovista anti-PDGF (1.5 mg) combination therapy as compared to Lucentis monotherapy were demonstrated at every monthly timepoint. In addition, the relative magnitude of visual benefit continued to increase over time. The visual benefit of anti-PDGF (1.5 mg) combination therapy compared to Lucentis monotherapy was greater at the 6-month timepoint than at the 3-month timepoint. The increasing divergence of the efficacy curves suggests the benefit of chronic anti-PDGF combination therapy. A classic dose-response curve was observed.
"This is a truly remarkable finding for patients with wet AMD. To achieve a 62% relative visual benefit over anti-VEGF monotherapy is extraordinary,” commented retina specialist Carmen A. Puliafito, M.D., Dean of the Keck School of Medicine at the University of Southern California. “The very compelling and robust results of this well-executed study validate PDGF as an important target for wet AMD and set the stage for a new era of combination therapy via co-formulation or fixed-combination delivery. I look forward to the rapid development of this important drug for our patients."
The robust benefit of Fovista anti-PDGF (1.5 mg) combination therapy over Lucentis monotherapy was consistent across all subgroups including those analyzing baseline vision, lesion size and the proportion of patients gaining 1, 2, 3, 4 and 5 lines of vision (ETDRS standardized chart). An average absolute benefit of 7.4% over Lucentis monotherapy was present across all ETDRS lines of vision gain. In addition, a relative benefit of 25% over Lucentis monotherapy was attained in patients who gained 3 or more lines of vision, with 69% and 178% relative benefit in patients gaining 4 or more and 5 or more lines of vision, respectively.
Donald J. D'Amico, M.D., Professor and Chairman of Ophthalmology at the Weill Cornell Medical College, added, "This breakthrough study is a major step forward in our treatment of patients with wet AMD and represents a clear paradigm shift. This convincing study shows clinically significant improvements in visual outcomes in all patient subgroups over six months. In addition to delivering the promise of enhanced visual gain, I am delighted with the potential of pairing this anti-PDGF entity with any of the increasing number of anti-VEGF agents in the marketplace.”
“We are very encouraged by the strong and consistent enhanced efficacy demonstrated in this large trial,” stated Samir Patel, M.D., Co-Founder, President and Chief Executive Officer of Ophthotech. “Based on these results, Ophthotech plans to expedite the preparation of a Phase 3 registration program with the goal of bringing Fovista anti-PDGF therapy to patients with wet AMD as soon as possible.”
About the Phase 2b Trial of Fovista
The prospective, randomized, controlled Phase 2b trial evaluated the efficacy and safety of Fovista given in combination with Lucentis, compared with Lucentis monotherapy, for the treatment of patients with wet AMD. In this fully masked study, 449 patients were randomized to receive one of the following treatment regimens administered every four weeks for 24 weeks: Fovista 0.3 mg in combination with Lucentis 0.5 mg; Fovista 1.5 mg in combination with Lucentis 0.5 mg; or sham in combination with Lucentis 0.5 mg.
The primary efficacy endpoint in the study was the mean change in visual acuity from baseline at the week 24 visit. As pre-specified in the analysis plan, the Hochberg procedure was employed to account for multiple dose comparisons. Further results will be presented at future medical congresses.
About Fovista Anti-PDGF Therapy
Fovista, formerly known as E10030, is an aptamer directed against platelet-derived growth factor subunit B (PDGF-B), which regulates neovascular pericytes (cells associated with the walls of newly formed small blood vessels). Growth of new blood vessels (neovascularization) is a hallmark of wet AMD. Pharmacology studies indicate that Fovista binds to PDGF-B with high specificity and affinity and inhibits the functions of PDGF-B both in vitro and in vivo. In preclinical studies involving models of ocular neovascularization, concurrent inhibition of PDGF-B and vascular endothelial growth factor A (VEGF-A) signaling was superior to inhibition of the VEGF-A pathway alone, and demonstrated the potential to induce neovascular regression.
About Wet AMD
Age-related macular degeneration is a disease characterized by progressive degenerative abnormalities in the macula of the eye, a small area in the central portion of the retina.
Age-related macular degeneration is classified into one of two general subgroups: the “Dry” (non-neovascular) form of the disease; and the “Wet” (exudative or neovascular) form of the disease. The “Dry” form of AMD is characterized by a slow degeneration of the macula resulting in atrophy of the central retina, with gradual vision loss over a period of years. By contrast, “Wet” AMD typically causes sudden, often substantial, loss of central vision and is responsible for most cases of severe loss of visual acuity in this disease. Age-related macular degeneration is characteristically a disease of individuals aged 50 years or older, and is the leading cause of blindness in developed countries around the world.
About Ophthotech
Ophthotech Corporation is a privately held biopharmaceutical company based in Princeton, NJ focused on developing and commercializing therapies for dry and wet AMD. Ophthotech is developing a pipeline of compounds with strong scientific foundations for the treatment of AMD, with the goal of bringing them to market in an accelerated manner. Ophthotech’s venture investors include SV Life Sciences Advisers, Novo Ventures, HBM Partners and Clarus Ventures. For more information, please visit www.ophthotech.com.
There are some caveats before applying it directly to AMRN
- This wasnt the same dosage(1g vs 4g) or purity being used in AMRN's trials
- This wasn't a high TG population (median TG in origin is 142) or high CV risk trial
http://www.nejm.org/doi/full/10.1056/NEJMoa1203859
But I agree it does bring up some question marks.
Pretty sure the company is BS'ing investors. They had been actively pushing Seeking Alpha authors to write stories about them for the past 12 months, paying up to $5K for articles. This is a big red flag for me.
EXEL is just following MDVN and JNJ's lead on this.
See for example
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=63946013
Monthly cost at $5900! How will anyone afford the combo of Herceptin + Perjeta?
I still dont know. The data they submitted for accelerated approval doesnt seem to above the unofficial efficacy bar of ORR>20%. Think relapsed/refractory was only 15%. So despite what the panel might say, FDA might still reject.
I'm more interested in seeing them test BTK inhibitors in lupus, not RA. RA certainly an interesting opportunity, but very far off and crowded.
Their Phase 3 trial was quite small compared to Depomed's, so dont know how reliable their estimates are. Imagine the AE rates from the RLS trial are closer to the truth.
I was implying that it has taken them quite sometime to get things moving(file IND, etc) for the BG12 pro-drug. They've spent way too much time/energy/focus on Horizant.
Compare the labels on the AE profile. Definitely not the same. Also Horizant is BID vs Gralise once a day. I just dont see GSK wasting any time on it. Gralise only sold $1.7M in Q1 for PHN.
I hear ya on the BG12 pro drug call option, but XNPT is so slow....
http://us.gsk.com/products/assets/us_horizant.pdf
http://www.gralise.com/lib/PDFS/GRALISE_PI.pdf
Drug is inferior to Depomed's Gralise. AE profile of Horizant is not great. See XNPT going back to low/mid $4's
And you dont think doctors/Roche wont be trying to get T-DM1 Rx'd in first-line? Obviously it will depend on reimbursements, but if that doesn't end up being too big of an issue, I imagine it will be used earlier on. Oncologists at ASCO were very impressed with T-DM1 this year.
Multiple myeloma data probably not till next year ASH(maybe ASCO).
"PCYC-1111-CA: A Phase II study of ibrutinib in subjects with relapsed/refractory multiple myeloma (MM) has started to enroll with five patients in Q1 of calendar 2012. We are on track to complete enrollment of the first stage of the study (11 patients) by Q3, 2012. "
I am more excited about their preclinical BTK inhibitor for autoimmune disease. That could be a nice opportunity.
How will Perjeta (a/k/a pertuzumab) be effected by T-DM1? One could imagine Herceptin use will drop off considerably once T-DM1 is available. This also seems like it will be a very expensive course of therapy
I'm not kidding myself, I know some will use it in pre-chemo. However, I think the data doesnt support its use before Provenge.
I disagree that JNJ's data had much to do with the drop, but the perception MDVN is going to clean their clock is a bigger one.
If you look at the survival curves from the AA-302 study, you see absolutely no benefit until about 18 months, but median duration of therapy was only like 15 months in the Zytiga arm and 9 months in the control arm. A little weird to not see an OS advantage sooner considering most patients are off-therapy by that time.
I am not impressed at all with Zytiga OS for the pre-chemo population. The subgroup forest plot is somewhat a mess. They really should have waited longer.
I have posted some the slides from the conference.
I hadn't realized that he still held such a large chunk. Its value has plummeted and have considered adding about 10% weighting, since I think the pancreatic study ends up being successful.
I think one problem with the CVR is that if CELG takes a majority holding in it, it can force CVR holders to accept their average price. I guess it depends if CELG was buying the CVR at higher prices etc. Need to find the exact wording, but I know there was a backdoor for Celgene.
There is also a payout for revenues
Net Sales Payment: Payment to CVR holders based on Abraxane’s net sales for the year (this extends by default through December 31, 2025, renewable each year until 2030 unless the net sales have not been greater than $1 billion):
2.5% of net sales between $1 and 2 billion
5% of net sales between $2 and 3 billion
10% of revenue > $3 billion
The value of the CVR will depend on the following cash payments assuming certain regulatory milestones are met:
• $250 million cash payment upon certain US approval of Abraxane by the FDA for NSCLC (non-small cell lung cancer) with progression-free survival claim in US label; ($5.78/CVR)
• $300 million in cash upon the approval of Abraxane by the FDA for pancreatic cancer with overall survival claim in US label; ($6.93/CVR)
• $100 million cash payment upon FDA approval of Abraxane for pancreatic cancer by April 1, 2013;
• Potential cash royalty payments upon achievement of certain Abraxane and nab-pipeline products net revenue thresholds.
you can find more analysis here
http://www.pcsresearchservices.com/getattachment/c7b3d1bf-81d6-4e3f-a98b-f36d74a9b73c/ABRAXIS-CELGENE-CVRs.aspx
This study was pretty flawed in my opinion. Abraxane at 150mg is not the currently approved dosage; it was only used in a Phase 2 study. Also the use of Avastin in the study confounds the results
From "Eyebrows raised at ASCO over Abraxane vs paclitaxel study"
"150mg dose used in study never used in practice
However the findings, particularly in the Abraxane arm, caused raised eyebrows among oncologists at the meeting. The dose of the Celgene drug used was 150mg, well above the 100mg for which Abraxane is approved in over 40 or so countries, and when asked by PharmaTimes World News as to why the higher dose was selected, Dr Rugo noted that it had been used in a Phase II trial by the company.
However, Brian Gill, head of global corporate communications at Celgene, noted that there is only one trial to date "that is a true head-to-head study between Abraxane and paclitaxel". Those results showed statistical significance in time to disease-progression, PFS and overall survival. He added that "it was very curious to see why the decision was made to use the 150mg rather than the successful dose on the label" and expressed his surprise over the use of Avastin.
While Avastin is "a wonderful drug," lots of peer-reviewed publications note that the Roche drug, used in combination with other therapies, exacerbates toxicities, he told PharmaTimes World News. Between using the higher dose with Avastin, it appears that about 50% of patients actually discontinued the therapy in the latest study.
William Sikov of the Brown University School of Medicine, said he had no problems about the conduct of the study but questioned its design in terms of the 150mg dose, which would have led to missed and delayed doses in that arm. He was surprised by the broad statement that patients can do equally well on paclitaxel than Abraxane, a stance he felt was "contradictory" given that the latter is highly effective when used at the right dose.
When asked by PharmaTimes World News whether the 150mg dose was ever used in clinical practice, Dr Sikov gave a clear 'no', although occasionally 125mg is used. He noted that the 150mg used in the Phase II study had appeared to be the most active, although toxic as well, "but it is very different going from a 75-patient Phase II study to a 200-plus patient trial".
Other breast cancer specialists that spoke to this publication were also surprised that ASCO had chosen to highlight this study, with one suggesting that while making a case for the use of cheap generics is a valid one, in the case of Abraxane versus pacitaxel, the argument falls down."
http://www.pharmatimes.com/Article/12-06-05/Eyebrows_raised_at_ASCO_over_Abraxane_vs_paclitaxel_study.aspx
Exelixis Cabozantinib poster at 40mg. Small numbers(n=24) 67% bone scan response rate. Still looks quite active at 40mg
http://www.exelixis.com/sites/default/files/2012-06-04_Abstract_4566_cabozantinib_ASCO_2012_4566.pdf
Very impressive , data similar to first line TKIs and these are heavily pretreated patients.
I'm at their HCC presentation now
Safety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer
http://www.nejm.org/doi/full/10.1056/NEJMoa1200690
Safety and Activity of Anti–PD-L1 Antibody in Patients with Advanced Cancer
http://www.nejm.org/doi/full/10.1056/NEJMoa1200694#t=abstract
I finally got around to catching up with these guys. I must say that I see a lot more value in their shares than any other HCV company. Current marketcap is only $260M, which is half that of ACHN, yet has a partner in JNJ and collabs with the 2 leading nukes. (Honestly, I think ACHN is in really terrible shape).
Yeah, cant trust Gilead. I dont get why they are doing a collab with them anyways. They have 2 PI's in Phase 2 if I am not mistaken.
It is encouraging that they signed the recent research collaboration with BMY's nuke and NS5, since it means another large pharma sees a future in their drug.
Just hurts to even look at their 1-year chart... down 60+% YTD
Agree, the crossover seems like a poor-design esp if they dont have confirmation of an OS advantage as well and there is a competing drug that does. I really question what GSK was thinking with both of these trials.
The other problem they face is that Roche will be presenting updated OS data for the Zelboraf BRIM-3 trial 15-minutes after GSK's BREAK-3 presentation! A KOL I spoke with suspects the updated OS data will likely look pretty good.
8:00 AM - 8:15 AM
Abstract #LBA8500^
Phase III, randomized, open-label, multicenter trial (BREAK-3) comparing the BRAF kinase inhibitor dabrafenib (GSK2118436) with dacarbazine (DTIC) in patients with BRAFV600E-mutated melanoma.
8:15 AM - 8:30 AM
8:30 AM - 8:45 AM
Abstract #8502
Updated overall survival (OS) results for BRIM-3, a phase III randomized, open-label, multicenter trial comparing BRAF inhibitor vemurafenib (vem) with dacarbazine (DTIC) in previously untreated patients with BRAFV600E-mutated melanoma.