- I highly recommend listening to the Momenta Pharma $MNTA presentation at Goldman Sachs conference if you are interested in the biosimilars/biogenerics/follow-on biologics (FOBs) story and environment. Sometimes my notes are enough, but I urge you to invest the time to listen to this free flowing q&a session (the webcast link is on the Upcoming Events page)
- Additional information and resources on Momenta can be found on the MNTA research page.
- My complete notes are after the jump- fair warning they are pretty lengthy this time!
- Firmenich is a private flavor company and is Senomyx's $SNMX most important partner along with PepsiCo $PEP.
- Click here for SNMX research page (still under construction)
- Here are a few excepts/notes:
- "Firmenich posted record sales for its fiscal year ended June 30, 2010, regaining its position as growth leader in the fragrance and flavor industry amid global restocking after the worst recession in recent history. Sales increased 12.1% in local currencies, 8.7% in Swiss Francs, to reach CHF 2’873 million [~$3.4 billion]"
- "We continued to invest 10 percent of our annual turnover in innovation, as a key to future success. This included the development of new ingredients to inspire new pleasures in taste and smell. We also pursued new ways to support healthier diets through the reduction of sugar and salt in foods and beverages. We signed a new partnership agreement with US firm Senomyx, licencing sweet enhancers to develop Flavor solutions that will help our clients improve the nutritional profile of their products, without compromising on taste. The agreement complements Firmenich’s existing line of flavor enhancers."
- "Ingredients sales posted high single-digit growth, following the trend of the global recovery. In perfume ingredients, we recorded significant growth both in the sale of our innovative specialty ingredients and our naturals, as Fine Fragrance rebounded strongly during the second half of the year. Flavor ingredients also posted a strong progression, reflecting increased demand in foods and beverages. At the same time, the global Ingredients market saw fierce competition, particularly from emerging markets. We continued to invest in the development of unique, high value-added ingredients that support our clients in creating strongly differentiated brands. At the same time, we pursued investments in new methods of producing existing materials."
- "In FY10, we began commercialization of a new sucralose enhancer that we have developed for the flavor market. This enabled us to develop flavor solutions that reduce the use of sugar in a variety of our clients’ food and beverage products, without compromising on taste."
- "Finally, we completed the reorganization of our natural ingredients center in the south of France, which is fast becoming a symbol of our leadership in natural Fragrance and Flavor Ingredients. The site is a center of expertise focusing on research and development in the production of highly innovative and sustainable naturals, integrating sourcing, science and supply"
- Spectrum Pharma presented a webcast at the Jefferies conference on 6/7/11. Click here for more info on the SPPI research page.
- Here are my notes:
- Company's strength is in clinical development - both early and late stage. Do not hire contract research organizations (CROs), only use SPPI employees to run trials.
- Employees- about 75 in sales/marketing, all with at least 10 yrs oncology experience. 75 in regulatory/clinical affairs. Plus a few for HR/finance functions
- Core risk mitigating strategy- no drug discovery. Goal is to reduce the time to market. SPPI acquires drugs in various stages of development, each with existing human data
- 1q2011 did $40m product revenue, expect well over $100m in revenue for 2011 (note that the company later released an SEC form 8-k to make sure we know that this was just the CEO Raj running his mouth and in no way represents actual guidance - click here for link)
- belinostat and apaziquone NDA planned for 2012 (Belinostat had been forcast for 2011 upon licensing from TopoTarget)
- Broad pipeline behind two marketed and two advanced candidates, but not talk about today (Or ever...They never talk about other candidates and has been no progress of news since they killed the BPH drug licensed from AEZS, except for the collaboration for biosimilar Rituxan)
- Fusilev: in a year or two should be cruising with $180-200m per year (another non-guidance statement of course...depends heavily on competition between Fusilev and generic leuocovorin)
- New comment re submission for removal of Zevalin bioscan requirement: Submitted data on 8000 that pts got bioscan, 6 were abnormal. All 6 of these still got zevalin, and all showed durable efficacy (ie, a partial response PR or complete response CR), no new side effects
- Clinical trial in Rochester, MN compared Zevalin head to head vs rituxan- better outcome on all endpoints (didn't say if were statistically significant or how big the trial was - anyone have a link to the publication if there is one?): Overall Response Rate (ORR) 83% vs 55%; CR 38% vs 18%, Time to Progression (TTP) 12.1 vs 10.1 months
- Merck $MRK obtained good efficacy data with combination of carboplatin/paclitaxel plus histone deacetylase (HDAC) inhibitor- but their HDACi was too toxic so abandoned- belinostat is less toxic becaue is bone marrowing sparing-rationale for the ongoing combo studies
- pivotal trial in PTCL needs 100 pts (no comment on enrollment timeline).
- CUP results by end of 2011
- trial starting in NSCLC (not sure when...)
- apaziquone- bladder cancer is an ignored disease, despite being 5th highest cancer killer
- Phase 3 program with 1600 patients, partnered with Allergan $AGN, last pt observation will occur 12/2011, top line data early 2012, NDA would be in 2012
- Trial design- put ("instill") drug into bladder for 60 min after surgery
- 50/50 split of US rights, allergan has EU rights. SPPI still retains rights for india and some other countries (two separate Asian deals in place - see SPPI research page for details)
- webcast cut off mid sentence...but sounds like he was wrapping up...
- Isis Pharma $ISIS presented 6/9/11 at the Jefferies healthcare conference. Click here for the complete ISIS research page with detailed info on every Isis program.
- Here are my notes:
- Mipomersen: EU regulatory filing "next month", US FDA NDA "shortly thereafter"
- Will include info on >700 pts in mipomersen dossier, >100 over 1 yr
- Sanofi SNY/Genzyme GENZ are "far along in planning to launch this drug next yr"
- mipo liver side effect- no Hy's law cases or bilirubin changes (these would be more cause for concern). Elevated liver enzyme levels tended to decrease with continued tx- effect is also associated with the pharmacology of lipid lowering
- Longer-term extension studies- modest increases in liver fat deposits seen in small # of pts is associated with rapid LDL reduction, over time this stabilizes and in most cases go back down
- Company is exploring opportunities to present this new data at scientific conference in very near future
- Confirms plan to add 3-5 new drugs to pipeline by ye2011
- New pipeline charts- gray bars represent where they think the drugs will be in next 12 months (I will update the pipeline charts with the new images by therapeutic area on the ISIS research page)
- CRP p2 trials will start this yr (rheumatoid arthritis [RA] and multiple myeloma [MM] following stem cell transplant)
- ApoCIII p1 trial should provide evidence of target lowering and triglyercide lowering
- FXI hope to get activity data from p1 later in 2011
- Four type 2 diabetes drugs, each with unique mechanisms of action (MOA), can work individually or together
- FGFR4 p1 early 2012
- Eli Lilly $LLY survivin drug- expect p2 to finish up this yr w/ data this yr or early 2012
- eIF-4E and HSP27 p2 recruitng and going well
- STAT3 p2 late 2011 or early 2012
- TTR p2 2012
- SMN drug "about to start p1"
- GlaxoSmithKline $GSK first drug into p1 in less than 18 months, earned $48m so far. This deal has allowed expansion of Isis's rare disease efforts
- TTR drug has market of >50k pts worlwide
- Excalliard EXC-001- p3 planning is underway. But plan to do an additional p2 dose ranging studies. There is no approved drug for skin scarring. Estimate as $1.5b US market
The following presentation info was posted to the ISIS event calendar today- I will follow up with complete abstracts and/or data as soon as possible:
ISIS PHARMACEUTICALS AT 2011 FASEB SUMMER RESEARCH CONFERENCE
"PROTEASES IN HEMOSTASIS AND VASCULAR BIOLOGY"
JUNE 12-17, 2011
Session Type Poster Session
Date Monday & Tuesday, June 13-14, 2011
Time 4:00 p.m. to 6:00 p.m. M.T
Presentation REVERSAL OF VASCULAR PERMEABILITY BY TARGETED
INHIBITION OF PLASMA KALLIKREIN AND FACTOR XII
Session Type Oral Presentation
Date Tuesday, June 14, 2011
Time 9:10 p.m. – 9:25 p.m. M.T.
Abstract ANTISENSE TECHNOLOGY AS A THERAPEUTIC STRATEGY IN
HAEMOSTATIC AND INFLAMMATION DISORDERS
Session Type Poster Session
Date Wednesday & Thursday, June 15-16, 2011
Time 4:00 p.m. – 6:00 p.m. M.T.
Abstract ANTISENSE-MEDIATED INHIBITION OF COAGULATION
FACTOR XI IS A NOVEL THERAPEUTIC APPROACH TO
RESTRICT INFLAMMATION IN EXPERIMENTAL COLITIS
1) monoclonal antibodies (mAb)- block receptor at top of signaling cascade2) Tyrosine kinase inhibitors (TKI's) inhibit kinase activity - limitations: only binds one pocket of protein; can have mutations3) HSP90 is a new way: chaperone degrades the kinase protein itself. These oncoproteins need HSP90 for activation via binding
- Below find my notes from the Synta Pharma webcast at Jefferies on 6/9/11. The NSCLC field is abuzz after ASCO with more optimism than ever, and ganestespib's place as the leading HSP90 inhibitor in development opens many opportunities for Synta (click here for the complete SNTA research page).
- As I tweeted live yesterday, I added substantially to my SNTA holdings on 6/10/11, and it now represents one of my top three biotech holdings (along with MNTA and SNMX).
- Here are my notes:
- ganetespib has now been used in >400 pts (>150 in p1), is being evaluated in >15 trials
- ASCO 2011 was transformative for the lung cancer field, like has happend to breast cancer past 5-10 yrs. especially with regards to the ALK subpopulation
- There are just 2 drugs in the world in advanced development for this population: crizotinib (PFE)- which is very likely to be approved in next several months, and ganetespib (note INFI also is entering p2 in ALK and other subpopulations with their HSP90 inhibitor IPI-504...click here for details)
- slide 7- new pt scan data not even presented at ASCO
- ALK rearrangement represents about 5-12% of lung cancer (equals 12-28k treatable pts in US, just starting to test for this, population is larger than realized), KRAS mutant makes up 20-25% of lung cancer
- Generally in advanced NSCLC see response rates of a couple percent, tumor shrinkage in 30-40% of pts with active drugs- here with gantespib see 62-75% shrinkage as a single agent
- In ALK population with ganetespib, 7/8 pts had tumor shrinkage, may represent and role to play for the high unmet medical need in pts that are resistant/refractory to crizotinib - that drug is great beakthru but 40-50% of pts don't respond (similar to early days of HER2 and EGFR)...the two drugs have distinct and complementary mechanims of action so could be combined
- Following the data presentation Saturday 6/4, company has been in continuous meetings w/ pt, research, etc groups for last 72 hrs.
- First 50 yrs of cancer therapy was about chemotherapy, and the last 20 yrs has been about more specific therapies that interupt oncogenic pathways via:
- Depending on client protein, can use ganetespib as single agent to induce apoptosis (ie, ALK), or combo as sensitization agent (ie, cell cycle proteins)
- Have had 1st site intiiated for p2b/3 trial. Interim data expected by 1q2012.
- almost every lung cancer field participant has approached SNTA about doing combo w/ crizotinib. Both drugs are well tolerated, have different mechanisms. other TKIs also very attractive as combo therapies
- Should the soon to start p2b trial be positive, there is interest in moving to 1st line
- randomzed AML p2b trial being organized now w/ cooperative group
- quite a few more trials will start before end of 2011
- Elesclomol- only covered briefly today. Targets cancer metabolism- much more popular field in last 24 months
- SNTA has discovered additional new biomarkers that are even more relevant that previously described LDH
- Cash to 2h2012 (slide)... "towards end of next year" (verbal phrase)
- Very active partnership discussions. Today SNTA is in best position they have ever been in (seemed to be hinting that ganetespib deal could be bigger than previous GSK elesclomol deal which had $50m upfront). 4 pgms under active discussion. Confident one or more deals 2h2011
- Expect an official p2b trial initiation announcement shortly
- Expect additional p2 NSCLC data 2h2011
- Mid 2012 final data p2b stage 1 NSCLC data expected
- Gantespib- may well partner some asian rights, plan to maintain ownership as long as can (I expect an impressive Asian deal this year, but it is clear though that a US deal for ganetespib is not in SNTA's plans at this time...they want to wait for more data, as has been the trend with many cancer companies lately, such as MYRX).
- Here are my notes from the Infinity Pharma $INFI webcast 6/8/11 at the Jefferies conference. Note this slide deck had a number of new slides and I will get these loaded to the Infinity research page as soon as possible:
- "We are building a fully integrated sustainable biotech company"
- In 2012 will have 5 or more p2 trials underway. Use rigorous adaptive trial designs with companion biomarker strategies (new trial by then include additional for IPI-926, additional for IPI-504, purdue p2 pain trial)
- Have preclinical justification for a numner of additional IPI-926 indications
- 35k pancreatic cancer deaths per year in US. Median OS <6 months. <5% 5 yr survival rate. Gemcitabine is SOC, approved based on 6 wk improvement in survival
- Slide listing numerous pancreatic cancer trial failures- many have been 1x/2x/3x combined chemotherapy agents. Due to strong tumor stroma around these tumors, chemo doesn't penetrate thru the "dense shell". IPI-926 breaks down this shell
- In p1b trial saw PR at each of 3 doses. 5 PR's total (31% response rate)
- Side effects included reversible grade 1-2 elevated liver transaminases
- p2 portion of trial is "enrolling beautifully"
- No approved drug for chondrosarcoma- surgery is only option. IPI-926 p2 trial design was reviewed prior to initiation w/ FDA and EMEA. PFS is primary endpoint to allow placebo progressors to crossover
- IPI-504 (now more often calling it by retaspimycin HCl) HSP90 inhibitor
- docetaxel response rate (RR) is 8%, PFS 3 months in advanced NSCLC
- See poorest prognosis in squaous cell histology and in pts with a history of smoking, but these subgroups did best in 23pt p1b trial in combo w/ docetaxel (caution, extremely small numbers involved!)
- p1b no significant ocular toxicity seen (not sure what this means...this is NOT saying no ocular toxicity), no discontinuations for toxicity
- Adaptive design for newly initiated p2 trial- can enroll additional pts in groups w/ highest response
- 200k per yr diagnosed w/ stage 3-4 lung cancer
- Will be starting an additional trial in NSCLC in 2011 (no other details given)
- PI3K inhibitor IPI-145 (inhibits delta and gamma isoforms) ...working hard to file IND and expect p1 trial will begin 2h2011
- IPI-940 inhibitor of fatty acid amide hydrolase (FAAH)..MofA is basis thru which medical marijuana works
- This candidate is now handled by Purdue Pharma and its ex-US affiliate Mundipharma. p2 to start 2011
- INFI has $195m committed funding for 2011 and 2012- more possible, but allocated in 2 yr increments
- Also still have untapped $50m line of credit- accrues interest at prime rate, balloon payment in 2019
- Committed to robust discovery engine- will name another development candidate in 2011