My notes from the CC...
I've heard many CC's in my time, and this one has to be one of the best presentations I've ever heard...It was very professionally done, and extremely informational...The speakers spoke enthusiastically, and the slideshow was very well done and effective...If I had to grade it, I'd give it an A+...
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Executive Management:
Our executive team includes oncologists with first-hand experience treating patients and bringing drugs to market.
* James A. Bianco, M.D. Chief Executive Officer
* Louis A. Bianco EVP, Finance and Administration
* Dan Eramian EVP, Corporate Communications
* Craig W. Philips President
* Jack W. Singer, M.D. EVP, Chief Medical Officer
* Christina Waters President, CTI Sede Secondaria
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"Much accelerated pace by the FDA for the PUFDA approval date of April 23, 2010"
"Well capitalized to launch PIX in the 2nd quarter of 2010"
"Hair loss only 13% compared to 100% for other drugs"
"Well tolerated...Much less nausea and vomiting compared to other drugs"
"Very low cardiotoxicity compared to any other drug currently being used"
"Could become first line in Large Cell Lymphoma"
"Could be used in treating many other forms of cancer"
"More trials needed to see what else it's effective on, and other trials combining it with other drugs"
"The unmet need is for the second line Non-Hogekins NHL...PIX fills that need"
"Unique Role, Unlike Any Other Agent":
PIX can be used in patients that can not have transplants, or have had failed transplants. Low cardiac toxicity. Good for all lymphomas not just NHL. Also potential use in breast, osteosarcomas. Biggest unmet need is in multi-relapsed patients. 66% of the patients are high risk, 50% have node involvement and out of 90 patients (not treated with PIX) all but one died within 4mos. PIX patients have a high response rate with low toxicity and can be treated as out patients. PIX can be used immediately upon approval. PDUF date is April 23. Novartis has option to negotiate.
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The next few comments were borrowed from the Yahoo Message Board...
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A quick run down on our drugs:
First Pixantrone:
Look at the drugs 3 Pix alone is worth Billions. The data clearly shows it will be used as a first line treatment for NHL which in return will replace CHEMO. The drug is simply better, with way less side effects! PIX 40% CHEMO 27%! (Results are still improving as time goes by!)
Next Opaxio:
Published preclinical studies have demonstrated that, unlike standard paclitaxel and other chemotherapeutic agents that enhance radiation killing by a factor of 1.5 to 2.0, OPAXIO increases tumor specific radiation cell kill by a factor of 7.2 to 8.4-fold (Milas Luka et al, Poly(L-glutamic acid)-paclitaxel conjugate is a potent enhancer of tumor radiocurability, Int'l J. Radiat. Oncol. Biol.
Now Brostallicin:
High Anti-Cancer Activity: Brostallicin has a unique ability to retain activity in tumors that are resistant to other cancer drugs. Additionally, its anti-tumor activity remains high in the presence of a number of critical cancer causing genetic abnormalities that cause resistance to standard anti-cancer agents. This activity profile makes it of extreme interest in designing trials to test its activity in targeted patients with certain genetic abnormalities, such as mismatch-repair mutations in inherited breast, ovarian, and colorectal cancers that are generally resistant to treatment.
Brostallicin Clinical Research: We are currently studying brostallicin in a phase II trial as a single agent for patients with advanced or metastatic soft tissue sarcoma, and in a context of vulnerability trial in several patient populations! Phase 2 completed soon things are looking good!
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Although Pix is (broadly) grouped with anthracyclines it is NOT an anthracycline. It is an Anthracenedione.
There is a BIG difference and comparisons to the Zevalin market share are not comparing apples to apples in any way shape or form.
Analog (borrowed!): A Macaw is of the parrot family, a Parakeet is also of the parrot family. Which one would you rather tried taking a bite out of your finger? The one is more likely to cause serious and lasting damage than the other. You would not mistake one for the other. But they are both grouped as parrots. Pix is an analogue (daughter compound) of Mitoxantrone. Mitox and Anthracyclines both have irreversible cumulative serious cardio-toxicity.
An incident of CHF and occurrence 5% reduction in LVEF (how well the heart pumps). The first is reversible, the second is not clinically significant. Neutropenia is increased, but is manageable and treatable and routinely occurs during chemo. It is not persistent as anthracycline heart damage is. There has been no effective 3rd line treatment for NHL, so these were salvage patients (bless them). Their alternative was likely death from refractory disease. Instead, many are walking around with remissions.
PIXANTRONE achieved what it has been developed to do, be a safer alternative to anthracyclines (remember - it is not itself an anthracycline). It is a cancer drug for an unmet need that was successful in meeting its goals in fast tracked trials. Even Adam F has said he expects it will be approved.
It is also very likely that Pix will replace Mitoxantrone, which is the very cardiotoxic but only chemo agent approved for use in Secondary Aggressive Multiple Sclerosis. Trials are on-going in Europe for that, more than half way through phase 2 (PIXAMS).
The possiblilty also exist for PIX to be used for treatment of Myasthenia Gravis -- no info on that yet but you never know when pre-clinical trials might be going on....it's a stealth industry until they think they have something that's "a go!"
At any rate, it's not just that our pipeline runs deep, it's also that the drugs themselves show promise for many applications several of which are unmet medical needs.....
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as per final slide at CC...
NVS has an option to negotiate a license for Pixantrone - some elements of the agreement have been pre-determined & would have the following features...
reimburses CTI for certain past and future expenses
pays CTI $7,500,000.00 option fee upon license execution
pays $10,000,000.00 FDA approval milestone in third line aNHL
pays additional $94,000,000.00 in potential future registration and sales milestones
NVS controls future development and commercialization of product & future expenses
at CTI sole option may field 35 FTE in US at Novartis expense up to $9 million
pays CTI royalties for net sales in the US of 28 to 32% on net sales beyond $50M
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