CTIX Company info 08/25/2014 08:28:18 $CTIX Uh, oh! A gap

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Jake13
CTIX Company info 08/25/2014 08:28:18 $CTIX
Uh, oh! A gap means pain and lament to come. Go CTIX!
Roche to Acquire InterMune for $8.3 Billion
From the WSJ

If any of CTIX's drugs work, I think the Big Pharma will snap it up (assumign Leo will sell). I wouldn't mind holding for the next decade as the market cap grew to 30-40B



Swiss Pharmaceutical Giant Makes First Big Buy After a String of Much Smaller Purchases
By
Jonathan D. Rockoff and
Hester Plumridge
Aug. 24, 2014 12:00 p.m. ET
Associated Press
LONDON— Roche Holding AG ROG.VX +0.53% said Sunday it would pay $8.3 billion for a California biotech firm that has yet to turn a profit on a new drug to treat a deadly lung disease—the latest gamble by a pharmaceutical giant to buy its way into a lucrative corner of the industry.
The takeover would allow the Swiss company to expand its presence in the treatment of respiratory disorders, one of the world's biggest drug markets. Roche's offer of $74 a share represents a 38% premium over InterMune's ITMN +36.21% closing share price on Friday of $53.80, and a 63% premium before takeover speculation surrounding the biotech started circulating this month.
2014 has been one of the busiest years for pharmaceutical deal makers. Companies notched $87 billion in deals through June, more than all of last year and on pace to exceed the peak in recent years of $152 billion in 2009, according to EvaluatePharma.
Roche remained one of the M&A holdouts during the latest frenzy. Its last big deal was in 2009, when it paid $46.8 billion for the stake in biotech Genentech that it didn't already own. In 2012, Roche gave up a chance to buy gene-sequencing firm Illumina Inc. ILMN -0.05% rather than boost its $6.7 billion offer.
Bloomberg News
In InterMune, Roche found a suitable target. The biotech had attracted widespread industry interest, according to people familiar with the matter, because it has a drug, Esbriet, already approved in Europe and Canada.
Esbriet aims to treat a lung-scarring condition called idiopathic pulmonary fibrosis, which currently lacks an approved therapy in the U.S. Pharmaceutical executives look for such opportunities because companies can charge high prices for new drugs involving poorly treated diseases.
Idiopathic pulmonary fibrosis, which affects about 100,000 people in the U.S., has been an especially daunting medical target. Researchers aren't sure what causes it, though they believe genetics play a role. Scar tissue buildup in the lung becomes so thick that lungs have trouble supplying the brain and other organs with oxygen. The disease tends to attack middle-aged and older adults. Patients often die three to five years after diagnosis.
Although Esbriet hasn't been approved in the U.S., it is as close to a sure bet as Roche could ask for, given the drug's approval in Europe and Canada. Positive trial results posted earlier this year lend hope for approval by the U.S. Food and Drug Administration as early as November.
The drug also could potentially treat other diseases marked by tissue scarring in the liver and kidney. Some analysts estimate Esbriet could have more than $1 billion in yearly sales world-wide. InterMune has been charging about $40,000 a year per patient outside the U.S., according to Dan Welch, the company's chief executive.
The pricing reflects the value the medicine brings, Mr. Welch said. Approval in the U.S., he said, "would mean for the first time there is a treatment for these patients."
Esbriet, however, faces competition. German pharmaceutical group Boehringer Ingelheim has a rival drug candidate called nintedanib, which also is under U.S. regulatory review. A decision on nintedanib is expected in February.
Even before speculation about a takeover, InterMune's stock had roughly tripled in value in the first half of 2014 following better-than-expected results in the clinical testing of Esbriet. In May, the FDA gave the pill a "breakthrough therapy designation," allowing for a speedier review.
Drugs treating respiratory conditions like asthma generate about $33 billion in world-wide sales each year, according to EvaluatePharma.
Startups with experimental lung drugs have attracted heavy deal interest not only because of the market's size but also because research is pointing the way to new and better treatments. Last year, AstraZeneca PLC agreed to pay up to $1.15 billion for Pearl Therapeutics and its drug for a lung condition called chronic obstructive pulmonary disease, or COPD.
Competition to make headway in the respiratory market has already been heating up. GlaxoSmithKline, GSK.LN -0.35% which depends heavily on an aging asthma drug called Advair for sales, is launching two new therapies for COPD.
Roche, which focuses on cancer, autoimmune diseases and diagnostic tools, hasn't been much of a player in respiratory treatment. The Swiss company has only two such drugs on sale in the U.S.: Xolair for severe and allergic asthma and Pulmozyme for cystic fibrosis. It has also been developing a compound—called lebrikizumab—for severe asthma.
For InterMune, located in Brisbane, Calif., the deal marks a turnabout from several near-death experiences since its formation a dozen years ago. The company's first compound failed. In 2010, the FDA rejected Esbriet, whose chemical name is pirfenidone, asking for more data to prove effectiveness.
—Andrew Morse in Zurich contributed to this article.


CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/

Thanks for the info DJ.

You state that vancomycin is the "drug of choice" because of costs, not performance. I am glad we compared our B to a superior drug based on performance, not based on the cost of the drug. I am sure the health community will see this as a positive choice. Can you imagine the public response if Leo chose vancomycin as the comparison arm for the reason that "it is the drug of choice because it costs less than daptomycin"?
That comparison article was interesting, thanks for posting it.

After reading the Vancomycin vs Daptomycin discussion over the weekend, I've been trying to figure out if there were any specific reasons that Vanco was used for my spouse's MRSA skin infection that ending up becoming a bone infection. After surgery to remove his elbow joint, he received twice-daily 1000ml infusions of Vancomycin for 14 days followed by 4 weeks of oral Doxycycline, with good results.

The choice of Vancomycin was made by the leading Bone Infection specialist at a major University Hospital, with agreement from his Infectious Disease specialist.

Possible reasons for Vanco(?): He is diabetic and has had joint replacements in the past. Infusions were done at home instead of in the hospital. (Medicare would not pay for in-home infusions, but secondary insurance did.)

Just anecdotal comments, nothing more.

Good Morning, World Good Morning, CTIX!

Bid $2.03 ask $2.04 Orders already must be in to buy CTIX.
Jerry thanks for your insight and views. Ignore the silliness and keep posting.
PR watch .......

Comparison of the pharmacokinetic properties of vancomycin, linezolid, tigecyclin, and daptomycin
Kerry S Estes1 and Hartmut Derendorf2*





http://www.eurjmedres.com/content/15/12/533

Jok
More on Vancomycin


http://www.medicinenet.com/vancomycin-injection/article.htm

jok
vancomycin and its uses.


http://www.nlm.nih.gov/medlineplus/druginfo/m...04038.html
As always good luck and God bless
Most infectious disease doctors must treat infections based on the guidelines created by the pharmacy committee at their facility.

The facility is responsible for financial constrain and vancomycin is more economical then daptomycin and still is the drug of choice for ABSSSI and MRSA infections.

My hope is that the broad spectrum of Brilacidin is SUPERIOR to daptomycin and the lack of resistance both combined will push Brilacidin into the spotlight.

As always best wishes for Brilacidin to lead the pack.

Go CTIX !!!
I agree. Hmmm I wonder if this study is the "medical community" that Dr. J was talking about.

BTW, thanks for your advice Karin! Hope the quake did not affect you.

Quote:
That was an interesting study and shows why CTIX management chose to test Brilacidin against Daptomycin.

That was an interesting study and shows why CTIX management chose to test Brilacidin against Daptomycin.

From your post:
Quote:
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.





In Reply to 'Orion Nebula'
Pharmacotherapy

Daptomycin versus Vancomycin for Complicated Skin and Skin Structure Infections: Clinical and Economic Outcomes
Susan L. Davis, Pharm.D., Peggy S. McKinnon, Pharm.D., Levi M. Hall, Pharm.D., George Delgado, Jr., Pharm.D., Warren Rose, Pharm.D., Robert F. Wilson, M.D., Michael J. Rybak, Pharm.D., M.P.H.
Disclosures
Pharmacotherapy. 2007;27(12):1611-1618.


Study Objective. To assess the effect of daptomycin compared with vancomycin on the clinical and economic outcomes in patients with complicated skin and skin structure infections.

Design. Prospective, open-label study.

Setting. Level 1 trauma center in Detroit, Michigan.

Patients. Fifty-three adult patients with complicated skin and skin structure infections at risk for methicillin-resistant Staphylococcus aureus (MRSA) infection who were treated with daptomycin and a matched cohort of 212 patients treated with vancomycin.

Intervention. Patients in the prospective arm received intravenous daptomycin 4 mg/kg every 24 hours for at least 3 days but not more than 14 days. Historical controls received at least 3 days of vancomycin dosed to achieve trough concentrations of 5–20 µg/ml.

Measurements and Main Results. Outcomes evaluated included blinded assessments of clinical resolution, duration of therapy, and costs. The most common diagnoses were cellulitis (31%), abscess (22%), and both cellulitis with abscess (37%). Microbiology differed significantly between groups, with S. aureus found in 27 patients (51%) in the daptomycin group and 167 patients (79%) in the vancomycin group and MRSA in 22 (42%) and 159 (75%), respectively (p<0.001). The proportions of patients with clinical improvement or resolution of their infections on days 3 and 5 were 90% versus 70% and 98% versus 81% in the daptomycin versus vancomycin groups, respectively (p<0.01 for both comparisons), and 100% at the end of therapy in both groups. Among patients with complete resolution of their infections (41 patients [77%] with daptomycin vs 89 patients [42%] with vancomycin, p<0.05), median duration of intravenous therapy was 4 and 7 days, respectively, (p<0.001), and hospital costs were $5027 and $7552 (p<0.001).

Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.

Skin and skin structure infections are frequently encountered in medical practice. In 2004, these infections were the primary diagnosis in approximately 562,000 hospital discharges, with an average length of stay of 4.7 days, according to the most recent survey from the Centers for Disease Control and Prevention (CDC).[1] Bacterial skin diseases encompass a wide spectrum of clinical manifestations, ranging from local superficial infections to life-threatening aggressive infections. Prompt treatment with an appropriate antibiotic is an important factor in limiting the subsequent complications associated with skin infections.[2]

Skin and skin structure infections are most commonly caused by gram-positive organisms, including Staphylococcus aureus and Streptococcus species. The increasing prevalence of methicillin-resistant S. aureus (MRSA) in the hospital and community complicates the treatment of skin and skin structure infections. An important concern is that MRSA is associated with a significant increase in cost of care. In a case-control study of staphylococcal bloodstream infections, MRSA was associated with an additional 8 days of hospitalization and $17,400 when compared with methicillin-susceptible S. aureus.[3] Another group reported similar results in an observational cohort of patients with surgical site infections, in which MRSA was independently associated with an additional $13,900 in hospital costs/infection.[4] Further, in an analysis of clinical trial data in patients with complicated skin and soft-tissue infections, it was reported that treatment of MRSA with vancomycin resulted in total treatment costs of more than $6000.[5]

Daptomycin (Cubicin; Cubist Pharmaceuticals, Lexington, MA) is a novel lipopeptide antibiotic recently approved by the United States Food and Drug Administration for the treatment of complicated skin and skin structure infections caused by susceptible strains of gram-positive bacteria, such as Streptococcus species and S. aureus including MRSA. Daptomycin demonstrates bactericidal activity and is more rapidly bactericidal than vancomycin against staphylococci and enterococci.[6] In a randomized, investigator-blinded, clinical trial, clinical success rates at the end of therapy were similar between patients treated with daptomycin and those treated with standard therapy.[7] However, among patients who were successfully treated with daptomycin, a significantly greater (p<0.001) proportion of patients (63% vs 33%) required only 4–7 days of intravenous therapy compared with the control group (semisynthetic penicillins and/or vancomycin). This was supported by further analyses of the same trial, which revealed that patients with complicated skin and skin structure infections who were treated with daptomycin demonstrated a more rapid response than those treated with standard therapy.[7]





Quote:
VANCOMYCIN is currently the DRUG OF CHOICE


Please provide your source, if there is one.

Sounds like someone forgot about Leo's PR already.

"Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance."

http://cellceutix.com/cellceutix-prepares-for...ZqDPl.dpbs
I just finished reading 2 days worth of IHub catch up and realized that I could check in here every so often and not miss a beat. Not that it matters, as I haven't posted much, but I challenge all you future millionaires to DONATE $10,000 or more if you will to the Wounded Warriors Project when our stock hits $10 a share. I juat received news of a fellow Vietnam Vet's passing and in my melancholy moments, I thought we might fund a worthy cause in our soon to be windfall. Thanks if you do, and Semper Fi to any "jarheads" on the board.
Go CTIX and go Gamecocks!!!!
Jerry, Vanco is the primary, cheap treatment for MRSA. As I said, the Dapto vrs. Brila study is for general ABSSSI. Vanco is almost exclusively used for MRSA because 1) its cheap, 2) it does cause resistant strains if over prescribed for use against other bacterial infections, and 3) because it is currently effective against MRSA, until it's not. Dapto is the lead treatment for ABSSSI with over $1 billion a years in sales. Dapto was a good choice for the control arm. Brilacidin may soon replace Vanco for MRSA when Vanco eventually loses its efficacy.

Edit, thanks Orion Neb for that comparative study between Dapto and Vanco. I didn't know Dapto was superior against MRSA.
He's looking for cheaper shares again to cover his shorts.
It will change again after he consults his colleagues (google).
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