Titan Pharmaceuticals (TTNP) - nächste Vervielfachungsmöglichkeit - 500 Beiträge pro Seite

[strongbuyamitelo]

Momentan laufen Bio-Tech-Werte ja schon auf fast groteske Weise nach Veröffentlichung einer positiven Studie nach oben.
Im November 2014 kündigte die Firma in einer PM an, dass Mitte 2015 Ergebnisse einer Phase III erwartet werden, also der letzten notwendigen Studie, bevor ein Medikament für den Markt zugelassen wird.
Im amerikanischem Forum wird schon heftig über die Veröffentlichung spekuliert.

Mit knapp 80 US-Cent und knapp über 100 Mio handelbaren Aktien ist hier bei positiven Ergebnissen eine Vervielfachung durchaus nicht unrealistisch.
Leider ein Pink-Wert, also nicht vor- oder nachbörslich handelbar.
Bei negativen Ergebnissen ist natürlich ein hoher Verlust drin.

Meiner Meinung nach unbedingt auf die Watchlist setzen.

[strongbuyamitelo]

http://www.titanpharm.com/press/2014/14-11-20-Titan-Announce…

[strongbuyamitelo]

Der letzte Quartalsbericht:

http://ih.advfn.com/p.php?pid=nmona&article=66851830


There were 110,327,707 shares of the Registrant’s Common Stock issued and outstanding on May 7, 2015.

[strongbuyamitelo]

[URANI]

Antwort auf Beitrag Nr.: 49.855.381 von strongbuyamitelo am 27.05.15 11:31:04

Mal beobachten

[strongbuyamitelo]

Braeburn Pharmaceuticals Reports Positive Results From Phase 3 Study Of Probuphine® For Opioid Addiction

FOR IMMEDIATE RELEASE

Braeburn Pharmaceuticals Reports Positive Results From Phase 3 Study Of Probuphine® For Opioid Addiction

New Drug Application Expected to Be Resubmitted in Second Half of 2015

Princeton, New Jersey — June 8, 2015 — Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine®, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. The study met the pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints, which were established in consultation with the U.S. Food and Drug Administration (FDA) prior to initiating the study. Braeburn has exclusive commercialization rights to Probuphine in the United States and Canada under a license from Titan Pharmaceuticals, Inc. (OTCQB: TTNP).

The subjects in this Phase 3 study were clinically-stable patients receiving maintenance treatment with a daily sublingual dose of buprenorphine/naloxone of 8mg or less for at least three months prior to entering the trial. The study enrolled 177 subjects who were randomized to receive either the Probuphine implants or sublingual tablets, for a treatment period of six months. Subjects in one group received four Probuphine implants plus daily placebo sublingual tablets. A second group received four placebo implants plus daily sublingual buprenorphine/naloxone tablets (<=8mg/day).

The primary objective of the study was to show non-inferiority between the two treatment groups and the primary efficacy analysis was a non-inferiority comparison of the proportion of treatment responders in each group. A responder was defined as having at least four out of six months free of illicit opiates based on urine testing and subject self-report. Analyses were carried out according to the pre-planned Statistical Analysis Plan. Response rates were 96.4% for the Probuphine arm and 87.6% for the sublingual buprenorphine/naloxone arm. The two-sided 95% confidence interval (0.009, 0.167) of the treatment difference (Probuphine - sublingual - buprenorphine/naloxone) was well within the pre-defined successful margin for non-inferiority. The safety and tolerability profiles for each treatment group were also comparable. The implantation procedures were well tolerated and comparable to observations from earlier studies with Probuphine.

“This study marks the first time that a well-controlled opioid treatment study has been conducted in stable patients,” said Richard N. Rosenthal, M.D., Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. “The data from this trial are encouraging and underscore the benefit of longer term medical treatments for patients with opioid addiction. I am confident that the implant, if approved by FDA, will be at least as effective as a sublingual formulation and have the added benefits of reducing problems related to compliance, misuse and abuse.”

“Today’s results bring us one critical step closer to our goal of making long-acting buprenorphine products available to patients,” said Behshad Sheldon, President and CEO of Braeburn. “We are grateful to the FDA for providing guidance on the study design and to our investigators for helping execute it. We hope these results pave the way for Probuphine, if approved by FDA, to become a uniquely effective option in addiction treatment, enabling patients to manage their treatment more conveniently and giving doctors confidence that medicine is delivered as intended, without worrying about it getting into the wrong hands or unintentionally harming children.”

This clinical study was designed in consultation with the FDA to address a key question in the Complete Response Letter (CRL) issued in April 2013 regarding the clinical benefit of Probuphine. Titan and Braeburn intend to resubmit the New Drug Application (NDA) for Probuphine to the FDA in the second half of this year. The NDA is still considered to be under priority review by the FDA based on Probuphine’s potential for decreased abuse, diversion, overdose, and pediatric exposure risk.

Highlights of the trial include:

• There were 177 subjects randomized in the study and 173 subjects were included in the Intent to Treat (ITT) population; 89 in the sublingual buprenorphine/naloxone arm and 84 in the Probuphine arm.
• There were 78 (87.6%) responders in the sublingual buprenorphine/naloxone arm and 81 (96.4%) responders in the Probuphine arm.
• The number of subjects with no evidence of illicit opioid use for all six months based on urine testing was higher in the Probuphine arm (88%) than the sublingual buprenorphine/naloxone arm (72%) (p=0.008).
• A sequential superiority analysis, which was conducted to further evaluate the observed numerical difference between the proportion of responders on the two treatment arms, indicates a statistically significant difference in favor of Probuphine over the sublingual buprenorphine/naloxone treatment arms, (p< 0.05).
• Symptoms of opioid withdrawal and cravings across the six month study were comparable in both treatment arms.
• The overall safety profile was comparable between treatment groups, and the implant insertion and removal procedures were generally well tolerated. A total of 23% of Probuphine treated subjects and 13.5% of subjects in the sublingual buprenorphine/naloxone group had an implant site adverse event, the majority of which were assessed by the clinical investigators as “mild” in severity.

“Abstinence from illicit opioid use is an important measure of successful treatment in this patient population, and the data from this study clearly support the use of Probuphine for maintenance treatment,” said Frank Vocci, Ph.D., President, Friends Research Institute, Inc. and Co-Lead Investigator of Braeburn’s Phase 3 Probuphine clinical study.

“The development of medications like Probuphine is critical to addressing the tremendous unmet need for new and effective addiction treatment options,” said Frank E. Young, M.D., Ph.D., Executive Vice President, Regulatory and Medical Affairs, Braeburn Pharmaceuticals. “Braeburn strongly believes in the potential of Probuphine to offer people living with opioid addiction a unique approach to achieving sustained, long-term recovery. We remain committed to working with the FDA toward the goal of adding Probuphine to the short list of proven medication-assisted treatment (MAT) options.”

If approved by the FDA, Probuphine would be the first marketed product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. Probuphine was developed using Titan's proprietary platform technology, ProNeura™, a non-biodegradable drug delivery implant designed to provide continuous, long- term steady state levels of medication in the blood. It is administered in a short subdermal insertion procedure in a physician’s office, and removed similarly at the end of the treatment period.

About the Phase 3 Probuphine Clinical Trial
The study population included 177 clinically stable patients who were receiving maintenance treatment with an FDA-approved sublingual formulation of buprenorphine/naloxone at a daily dose of 8 mg or less. Patients were randomized in a double-blind, double-dummy design to receive either (a) four Probuphine implants and placebo sublingual tablets or (b) to continue with daily sublingual buprenorphine/naloxone therapy and receive four placebo implants. Patient selection criteria restricted the trial to individuals who were previously stabilized on sublingual buprenorphine treatment at doses of 8mg or less, for a period of at least three months.

The efficacy and safety of Probuphine was previously studied in several clinical trials, including two successful, controlled Phase 3 studies in a total of 450 subjects over 24 weeks of treatment (results were published in the Journal of the American Medical Association and Addiction). The double-dummy design and patient selection criteria in this current trial distinguish it from the two earlier Phase 3 studies. In this trial, subjects were receiving buprenorphine treatment at daily doses of 8mg or less for a period of at least three months and considered to be stable patients by their physician, whereas in the first two trials enrolled subjects were de-novo patients who had not received any medication assisted therapy in the prior three months and were inducted at doses of 12-16mg and then treated with Probuphine. The current trial was designed consistent with FDA guidance and based on the results of the first two trials.

About Opioid Addiction
According to recent estimates, there are 2.2 million people with opioid dependence in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence were available in the U.S. only from a limited number of approved facilities. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatments. Sales of buprenorphine drug products for the treatment of opioid addiction in 2014 were approximately $1.75 billion in the United States.

About Probuphine®
Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple FDA-approved drug products for the treatment of opioid dependence, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.

Probuphine was developed using ProNeura™, Titan Pharmaceutical’s continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure, and removed in a similar manner at the end of the treatment period.

The efficacy and safety of Probuphine has previously been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow on study of 287 patients (published in the journal Addiction).

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a late-stage specialty pharmaceutical company focused on novel, long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions, which are often complicated by stigma and present significant public health challenges. Braeburn’s investigational product pipeline includes: Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. For more information on Braeburn, visit: www.braeburnpharmaceuticals.com.

Media contact:
Helen Shik
MSLGROUP Boston
781-684-0770
[e-mail]



https://braeburnpharmaceuticals.com/braeburn-pharmaceuticals…

[strongbuyamitelo]

Die erste Empfehlung aufgrund der heutigen Veröffentlichung der Studie.
1.50 -2 USD.

Monday, June 8, 2015
Another Positive Phase 3 For Titan Pharma With Probuphine
By Jason Napodano, CFA

On June 8, 2015, Titan Pharmaceuticals, Inc. (TTNP) reportedpositive topline results from a confirmatory Phase 3 study with Probuphine in subjects with opioid addiction. This is the third positive Phase 3 trial for the company since 2011. As a reminder, Titan completed two previous Phase 3 trials on the drug showing both superiority to placebo implants and non-inferiority to sublingual buprenorphine/naloxone for the treatment of opioid addiction (1stP3,2ndP3). The company filed for U.S. approval in October 2012, and along with commercialization partner, Braeburn Pharmaceuticals, was granted priority review by the agency in January 2013. In March 2013, the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) voted to recommend approval of the product; however, the FDA issued a complete response letter (CRL) in April 2013, seeking additional data on the use of the product in patients stable on lower doses of sublingual buprenorphine/naloxone than previously tested in the first two Phase 3 clinical trials. We believe the positive Phase 3 data released this morning by the company clears the way for a re-filing of the U.S. New Drug Application (NDA) in the next several months.

Titan Goes 3-for-3 In Phase 3

The positive topline data from the third Phase 3 trial released this morning only further strengthens the company’s claim that Probuphine is a safe and highly effective product for the treatment of opioid addiction. Probuphine is an ethylene-vinyl acetate (EVA) polymer that has been designed to elute buprenorphine over a controlled period of time. The product is extruded into rods roughly the size of a matchstick and implant in the arms of opioid addictions.



The confirmatory Phase 3 trial (PRO-814) was designed to show that patients currently taking ≤ 8 mg sublingual buprenorphine/naloxone and stable in their absence can be transitioned to Probuphine and maintain absence in a safe and effective manner. The study was a randomized, double blind, double dummy design that enrolled 177 patients into two parallel treatment arms. Patients were randomized to receive either four Probuphine implants, or to continue the daily sublingual buprenorphine therapy. The patients were treated for six months, and the primary analysis was a non-inferiority comparison of responders in the two arms.



In the trial, a responder was defined as having at least four out of six months free of illicit opioids based on urine testing and subject self-report. Analyses conducted according to the pre-planned Statistical Analysis Plan indicate response rates of 96.4% for the Probuphine arm and 87.6% for the sublingual buprenorphine/naloxone arm. The two-sided 95% confidence interval (0.009, 0.167) of the treatment difference (Probuphine - sublingual buprenorphine/naloxone) was well within the pre-defined successful margin for non-inferiority. In fact, sequential analysis showed that Probuphine was clinically superior to sublingual buprenorphine/naloxone (p < 0.05).



No additional data was provided in the press release, as Titan plans to present the full data from the PRO-814 at a medical conference in the near future. However, on the conference call Titan did note that one patient had an adverse event and needed to have the implant removed. We are not overly concerned with an adverse event rate of +0.6% (1 out of 173 patients that received implants). We note that there was no diversion (authorized implant removal) during the trial, consistent with what has been seen throughout the entire clinical program with Probuphine.

As noted above, based on the positive data we expect that Titan and Braeburn will be in position to re-file the NDA during the second half of the year. Titan and Braeburn have previously been working on completing the necessary CMC work required to re-file over the past year. We are expecting a six-month review, which should put the new action date in the first half of 2016. We are expecting approval at that time. Approval earns Titan a $15.0 million milestone from Braeburn.

…A Large Opportunity….

The current market for treatment of opioid addiction is dominated by Suboxone. The drug is most commonly used by oxycodone and heroin addicts looking to kick their habit. Between Suboxone tablets and Suboxone sublingual film, Reckitt took in over $1.3 billion in sales from the franchise in the U.S in 2012. There were an estimated 10.7 million prescriptions for opioid addiction in 2012, the majority Suboxone or another combination of buprenorphine / naloxone. Data from the FDA suggests there are over 1 million patients currently being treated for opioid addiction in the U.S., with an estimated 900,000 on Suboxone (below). We believe approximately 65% are stable on doses of 8 mg or less.



The majority of Suboxone prescriptions are written by general practitioners, family medicine doctors, doctors of osteopathy, psychiatrists, and internal medicine specialists. Once approved, Probuphine will be marketed under a Risk Evaluation and Mitigation Strategy (REMS) that mandates that the implantation procedure must take place at a DATA-2000 waived center, which keeps both the prescriber and person doing the implantation (may be the same person) under one roof. Given that Titan believes general practitioners and family medicine physicians can be easily trained to implant and remove Probuphine, this does not see limiting to the uptake of the drug. As such, we believe that Probuphine can capture 5-10% of the market away from the sublingual tablet for patients seeking help with their opioid addiction.

Titan’s plan is to create a steering committee that will oversee the training of physicians for the implantation / removal procedure. The plan is to have the 20 certified implanters from Titan’s clinical trials and 30 new physicians trained to act as master trainers upon the launch of the product. The goal is to have 2,000 implanters trained over the first 12 months after the launch. The training sessions will take place at 20-30 regional meetings with approximately 50-100 trainees per meeting.

We think the challenge for Titan and Braeburn will be getting physicians to show up to the training session (approximately 8 hours) and get certified to prescribe Probuphine under the REMS. Roughly 30% of Suboxone prescriptions are written by psychiatrist who both lack the surgical background and may not have the office setting or capabilities to implant the device. From a modeling standpoint, it might make sense to eliminate half of these doctors from any forecast. Dosing, or the lack of dosing flexibility, will eliminate another chunk of the market.

Above we note approximately 1 million subjects per year on buprenorphine. Our market assumption is that Braeburn can capture approximately 5-10% of the market five years after launch. This seems reasonable given the characteristics of the product and the potential for improved compliance and less diversion, but also takes into account some of the prescribers that we’ve peeled away, such as half the psychiatrists and around one-third of the market that is on doses of 12 mg or more of Suboxone. We remind investors that Titan and Braeburn were able to enroll 177 patients in the most recent Phase 3 trial in only four months. We think this is a testament to the size of the market and the opportunity for the drug.

We suspect that the price of Probuphine will run roughly the cost of 7-8 months of what it cost for Suboxone, or around $1,500 on launch, with price increases taking the product to $2,000 five years after launch. We assume the average patient will have 1.75 procedures per year (assumes one implant for six months with about 75% of the patients receiving re-implantation during removal of the first implants). Accordingly, we see peak sales of Probuphine at approximately $250 million (75,000 patients x $2,000 x 1.75). We have $0 revenues in our model for chronic pain indications at this time.

…Titan Still Looking Ex-U.S…

With the U.S. confirmatory Phase 3 study now complete and Braeburn preparing the re-filing of the NDA, Titan can turn is attention to areas outside the U.S. with Probuphine. In fact, management has already begun the process of engaging with key opinion leaders and regulatory consultants outside the U.S. in areas where Probuphine may be an attractive product. Furthermore, management expects to have some meetings scheduled before the end of the year with at least two or three different local health authorities in Europe. These talks are taking place on a country-by-country basis and it is too early to say at this point whether or not any of these countries will recognize the U.S. FDA approval as clearance for sale. However, management did state that countries that use buprenorphine stand out, such as Australia, France, Germany, U.K., Italy and some Scandinavian and Asian countries, and that there is early interest in these markets. We suspect that Titan may need to conduct new clinical studies prior to filing. Nevertheless, it is also possible that Titan secures development and commercialization agreements on a country or regional basis before U.S. approval. This is positive new for shareholders because any deal for development or commercialization of Probuphine outside of the Braeburn territory could come with upfront cash.

…Financial Position Solid…

Titan exited the first quarter of 2015 with approximately $13.4 million in cash.Net cash burn in the quarter totaled only $2 million. We believe that these funds are sufficient to support Titan’s planned operations into the fourth quarter of 2016. By that time, we expect U.S. approval of Probuphine, which will net Titan a $15.0 million milestone payment from Braeburn. We also believe that potential licenses outside the U.S. could occur in 2016, thus bringing in more non-dilutive cash to the company in 2016.

Potential for ProNeura Expansion to Other Indications in the Near Future
It’s also worth mentioning that Titan continues to look for additional product opportunities, and to expand the use of its ProNeura platform. For example, the company is moving forward with the ProNeura platform for the treatment of Parkinson’s disease. In support of the Parkinson’s indication, Titan received a notice of allowance from the U.S. Patent and Trademark Office for a patent application covering the sustained release of dopamine agonists utilizing the ProNeura technology. The patent, titled “Implantable Polymeric Device for Sustained Release of a Dopamine Agonist”, provides intellectual property protection of the program for Parkinson’s disease and is expected to have an expiration date of at least 2024. In addition to the U.S., Titan has similar issued patents in Europe, Japan, Australia, Canada, South Korea, Mexico, New Zealand, South Africa, and Hong Kong, while prosecution of patent applications continues in the U.S., Israel, India, and China.

Titan will continue to aggressively pursue its ProNeura Parkinson’s Disease program throughout 2015 and 2016. Titan plans to complete non-clinical studies to enable timely submission of the IND in the first half of 2016, and commence a Phase 1 proof-of-concept safety and efficacy clinical study in the second half of 2016, following potential approval of Probuphine. The product is similar to Probuphine, only instead of the EVA rods eluting buprenorphine, they are eluting ropinirole. Ropinirole was previously sold as Requip by GlaxoSmithKline for the treatment of Parkinson’s disease and Restless Leg Syndrome (RLS). GlaxoSmithKline posted peak sales of Requip XL, and extended release formulation of ropinirole, of $250 million in 2010. The goal of the ProNeura formulation is to slowly release, at continuous levels, ropinirole through the process of dissolution. Titan has conducted initial non-clinical studies with long-term delivery of dopamine agonists demonstrating the potential of this product in the treatment of Parkinson’s disease in non-clinical models of the disease and has commenced work on optimizing an implant formulation of ropinirole. This work, along with input from key scientific and regulatory advisors, is helping Titan plan the non-clinical studies and an appropriate proof-of-concept clinical study.

As per management, the plan is to possibly meet with the FDA for a pre-IND meeting by the end of 2015. We believe this product – especially if Probuphine gets approved – could bring significant value to shareholders through the signing of a development and commercialization partnership. As of yet, our financial model assumes no contribution from a ProNeura-PD candidate, so this represents upside to our fair value target.

Conclusion

We continue to be positive on the Titan Pharma story, and are looking forward to seeing the NDA go back under priority review by the end of 2015, with a potential new PDUFA date for the first half of 2016. We still see the shares worth $1.50 right now, with upside to the $2.00 level upon approval in 2016. Our model has very little contribution from ProNeura in Parkinson’s disease or in value for Probuphine outside the U.S. These present additional upside to our financial model.


http://bionapcfa.blogspot.de/2015/06/another-positive-phase-…


Bin heute zu 0,905 rein. Mal sehen...

[strongbuyamitelo]

Erinnert mich ein bisschen an aveo: Am Tag der Veröffentlichung einer positiven Studie erstmal nichts und am nächsten Tag ging es los.
Aktie ist aber weitgehend unbekannt. Vielleicht müssen erst ein paar Empfehlungen her.
Jedenfalls nimmt das Volumen nun langsam zu.
Aktuell: 0,925 USD.

Habe leider nur diesen kleinen RT-Chart:

[strongbuyamitelo]

So, heute auch als 8-k filing veröffentlicht.

http://ih.advfn.com/p.php?pid=nmona&article=67204237

[strongbuyamitelo]

Ein bisschen schleppend.