CC-10004 (apremilast) is Otezla. CTP-730 could be added to Otezla to make it a much more effective drug. If considerably more effective, it could make Otezla the number one arthritis drug on the market. Which arthritis is a huge market. Otezla isn't as effective as injectable arthritis drugs, but what if it could be? If CTP-730 could make it as effective, slightly less effective, or more effective, then you've got yourself a winner.
Most likely secret:
Celgene is developing novel orally available small molecules that inhibit the production of multiple proinflammatory mediators including interleukin-2 (IL-2), IL-12, interferon-gamma, TNF-alpha, leukotrienes, and nitric oxide synthase.
Celgene is developing novel orally available small molecules that inhibit the production of multiple proinflammatory mediators.
Our lead investigational drug, CC-10004 (apremilast) is an oral compound that is being studied in multiple Phase III clinical trials for the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. We successfully completed our early stage studies, demonstrating clinical activity and tolerability and meeting safety endpoints in a placebo controlled proof-of mechanism trial in moderate-to-severe psoriasis and psoriatic arthritis. With the initiation of six multi-center international clinical trials, we are advancing the clinical development of CC-10004.
CC-11050 is currently in Phase I clinical trials for chronic inflammatory diseases.
CC-10004 and CC-11050 are investigational products and are not approved for any indications.
CTP-221 consistently demonstrates greater potency in immunomodulatory and anti-proliferative in vitro efficacy assays compared to lenalidomide. Data highlights include:
A 2.7-fold increase in IL-2 induction in anti-CD3 stimulated peripheral blood mononuclear cells
A 3.7-fold greater inhibition of TNF-α production in LPS-stimulated whole blood
A 2.6-fold greater inhibition of proliferation of MM.1S human multiple myeloma cells
I know. But what's strange is they chose CTP-730 instead of CTP-221. Does that mean CTP-730 isbetter than CTP-221? The results for CTP-221 were already amazing. Just look it up. I've tried to post the results on here, but Yahoo hasn't let me.
Initially, Concert will get an unspecified upfront payment while the two work on one unnamed drug, but the partnership could expand significantly from there. Should Celgene buy in to Concert’s technology and “exercise its program options,” Concert could get up to $300 million in development, regulatory and sales milestones for each drug the Summit, NJ-based biotech utilizes Concert’s technology to help develop and advance, as well as royalties should Celgene ultimately ever sell those drugs. Concert provided little additional information about the drugs the two will develop, only indicating that the two companies will target the areas of cancer and inflammation, and Tung declined to specify further on Monday. RBC Capital analyst Michael Yee speculated in a research note Monday that one of the drugs is Concert’s CTP-221, a deuterium-modified version of Celgene’s blockbuster myeloma drug lenalidomide (Revlimid). Concert said in December that it expects to finish pre-clinical testing of CTP-221 and seek FDA clearance to begin clinical trials in 2013.
$28,450,000 is 5% royalty per year of $569,000,000 in sales of JZP-386.
$28,450,000 doesn't sound like much, but it is considering it's pure profit and considering the current market cap size of CNCE. And if the royalty percent is higher, that's more money.
Keep in mind, $100 would just be the co-pay price as far as tradition health insurance goes. No telling what the actual price of a bottle of AVP-786 would be. And 5% should represent the minimum royalty payment CNCE would receive. Gross/net profit shouldn't be an issue since it's a royalty and AVNR is handling all the research cost since they collaborated with CNCE. Assuming only half of 14 million "Americans" get a prescription for this, and let's say the actual cost of AVP-786 is $200 per bottle, even though it would probably would cost more, the royalty would still be $840,000,000 per year.
"There are millions of patients with MDD who do not respond adequately to existing therapies. With a mechanism of action addressing multiple neurotransmitter systems involved in depression, AVP-786, if approved, could offer a potential new treatment option for these patients. We look forward to initiating our clinical research program in the coming months."
The filing of this IND represents the first step in Avanir's plan to develop AVP-786 for a broad array of neurological and psychiatric conditions.
14 million Americans X $100 bottle of AVP786 = $1,400,000,000 revenue
5% royalty of $1,400,000,000 is $70,000,000
$70,000,000 X 12 (one bottle per month for each patient) is $840,000,000 revenue per year
Wouldn't that be all profit? Am I missing something?
Major depressive disorder affects approximately 14.8 million American adults, or about 6.7 percent of the U.S. population age 18 and older in a given year. While major depressive disorder can develop at any age, the median age at onset is 32.
Under the Avanir agreement, we received a non-refundable upfront payment of $2.0 million in February 2012 and a milestone payment of $2.0 million in April 2013. We are also eligible to receive, with respect to licensed products comprising a combination of deuterated dextromethorphan and quinidine, up to $4.0 million in development milestone payments, including $2.0 million related to initiation of dosing in a Phase 2 or Phase 3 clinical trial for AVP-786, up to $37.0 million in regulatory and commercial launch milestone payments and up to $125.0 million in sales-based milestone payments based on net product sales of licensed products. In addition, we are eligible for higher development milestones, up to an additional $43.0 million, for licensed products that do not require quinidine. Avanir is currently developing deuterated dextromethorphan only in combination with quinidine. Avanir also is required to pay us royalties at defined percentages ranging from the mid-single digits to low double digits below 20% on worldwide net product sales of licensed products. The royalty rate is reduced, on a country-by-country basis, during any period within the royalty term when there is no patent claim covering the licensed product in the particular country.
This stock price drop is unacceptable. And yet RAI & LO and barely down on an over 23 billion dollar lawsuit. This is some #$%$-backwards #$%$.
This is #$%$. Down again when the market soars & analyst says Yellen is wrong about biotechs :0( This is one backwards stock. Reacts negatively to anything & everything like it's a destined penny stock.
George Soro's fund invested over $700,000 in the $9.50's. Of course I've never seen any investment of his do good, but I've only seen about 2 of his. Like AGRO & ESNT.
I hope so. So far the market has ignored every single bit of positive news since the stock came out. I swear, you'd think diabetic kidney disease was a small market, or no one wants to spend money to live a little bit longer. I don't know what the deal is.
Roth Capital Keeps Concert Pharma (CNCE) at 'Buy'; SPA Filing is Sign of Confidence in CTP-499
10:30 AM ET, 07/08/2014 - Street Insider
Roth Capital reaffirms its Buy rating and $28 target price on Concert Pharmaceuticals (Nasdaq: CNCE) following news that the company held a successful end-of-phase II meeting with the FDA regarding its product CTP-499 intended for diabetic kidney disease.
Analyst Joseph Pantginis commented, The company s most advanced product, CTP-499, has generated positive Phase II data in diabetic kidney disease, including data supporting the drug s mechanism of action in reducing markers of fibrosis in the kidneys. Following this successful meeting, we believe the company is on the right track to proceed to the next stage. The SPA application, if approved, can help speed up the approval process and we view this application as a sign of confidence of CNCE in CTP-499 and its potential benefit to diabetic kidney disease patients. We believe that the visibility garnered through this successful FDA meeting could serve as a potential trigger for partnership interest in further developing CTP-499.
CNCE is also focusing on another product, CTP-354, developed for spasticity associated with multiple sclerosis and spinal cord injury; a Phase II program is expected to begin in 2H14.
Down over 5% today when the market is barely down. $10 per share should have been the floor on this thing. Unacceptable. FDA phase 3 approval & new partnership to be announced at any given time in the extreme near term, and this stock is falling like it's never going to happen. They had faith in ASPX. What's up with "THE LEADER" of deuterium chemistry medicine?