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Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in vtus (10)

Thursday
Jun282012

4 Reasons To Buy Ventrus Biosciences - Update @ Seeking Alpha

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs.

Today Markus Aarnio posted an update Ventrus @ Seeking Alpha:

"I wrote the article titled "4 Reasons To Buy Ventrus Biosciences" on May 21st. On June 25 Ventrus Biosciences (VTUS) reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints.

While the company intends to analyze the totality of its Phase 3 data further, it believes that current resources would be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures and the beginning of further development of VEN 308 (topical phenylephrine) in fecal incontinence. Consequently, Ventrus has no immediate plans to continue development of VEN 309, resulting in a reduction in expenses.

Conclusion - I believe the stock could trade at $8-$10 range in the best case scenario after VEN-307 approval sometime in 2014. I do not expect any major near term catalysts from the company before late 2013."

See the full story at Seeking Alpha.

Thursday
Jun142012

Brean Murray Initiates Coverage on Ventrus Biosciences (VTUS)

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures.

Analysts at Brean Murray, Carret & Co have initiated research on Ventrus Biosciences, assigning it a "buy" rating and a $30.00 price target. 

The analysts wrote,

"We are initiating coverage of Ventrus Biosciences Inc. with a Buy rating, as we believe that VEN 309 has blockbuster potential, given its proven efficacy, large target market and the lack of competitive prescription hemorrhoid drugs. Our Buy rating and 12?month target price of $30 are based on a DCF analysis using a 40% discount rate and a 6x multiple of the terminal value for the projected 2022 EBITDA of $936 million. Ventrus is focused on developing drugs for gastrointestinal indications. The company’s lead drug candidate, VEN 309, has completed several Phase 2 trials in patients with hemorrhoids, and within weeks, Phase 3 data will be released that we believe will support approval."
Monday
May142012

6 Low Debt Pharmaceutical Stocks Rated Buy Or Better @ Seeking Alpha (KERX, VTUS)

At Seeking Alpha, contributor ZetaKap wrote an article asking, "Interested in pharmaceutical companies? In search of companies that can manage their debt well? Do you prefer companies that can manage their long term debt? Are you after stocks that analysts are calling 'buy' or 'strong buy'? If so, you'll probably like this list."

About Keryx, ZetaKap wrote,

"Keryx Biopharmaceuticals Inc. has a Debt/Equity Ratio of 0.00 and Long Term Debt/Equity Ratio of 0.00 and Analysts' Rating of 1.80. The short interest was 13.77% as of 05/12/2012. Keryx Biopharmaceuticals, Inc., a biopharmaceutical company, together with its subsidiaries, focuses on the acquisition, development, and commercialization ofpharmaceutical products for the treatment cancer and renal disease. The company's products under development include KRX-0401 (perifosine), an oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, as well as affects other pathways associated with programmed cell death, cell growth, cell differentiation, and cell survival. Its KRX-0401 is in Phase III clinical development stage for the treatment of refractory advanced colorectal cancer and multiple myeloma, as well as in Phase I and Phase II clinical development stages for the treatment of other tumor types."

About Ventrus Biosciences, ZetaKap writes,

"Ventrus Biosciences Inc. has a Debt/Equity Ratio of 0.00 and Long Term Debt/Equity Ratio of 0.00 and Analysts' Rating of 1.40. The short interest was 3.14% as of 05/12/2012. Ventrus Biosciences, Inc., a development stage specialty pharmaceutical company, focuses on the development and commercialization of late-stage prescription drugs for gastrointestinal disorders, primarily hemorrhoidal disease, anal fissures, and fecal incontinence. It is developing three late-stage product candidates, including Iferanserin ointment (VEN 309) for the topical treatment of symptomatic internal hemorrhoids; Diltiazem cream (VEN 307), a topical treatment for the relief of pain associated with anal fissures; and Phenylephrine gel (VEN 308) for the treatment of fecal incontinence associated with ileal pouch anal anastomosis, an FDA orphan indication. The company was formerly known as South Island Biosciences, Inc."
Friday
May042012

Thursday's Bio-Pharma Drug Approval And Catalyst Event List @ Seeking Alpha (VTUS)

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures.

At Seeking Alpha, contributor Scott Matusow wrote an article about catalyst trades in the biopharma sector, which "can provide big profits if traded correctly. Some traders and investors who enjoy bringing more risk into play often times will hold through the catalyst event. While this does bring a lot more risk into play, the reward from engaging in this can be a massive one."

Matusow lists a handful of biopharma companies with near-term catalyst events associated with them, and includes their drug approval dates. About Ventrus Biosciences, one of the companies listed, he writes,

"Ventrus Biosciences (VTUS) 5/2/12 pps: $9.11/ Market cap: $113.02M - Ventrus focuses on the development and commercialization of late-stage prescription drugs for gastrointestinal disorders, primarily hemorrhoidal disease, anal fissures, and fecal incontinence.

Catalyst event: Phase 3 data due by May 15th, 2012 from Phase 3 European trial of VEN 307 (diltiazem cream) for Anal fissures."

Read the full article at SeekingAlpha.com.

Wednesday
Mar072012

Ventrus Biosciences releases VEN-309 Trial Webcast for patients with Hemorrhoids $VTUS

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures. The company's product candidate portfolio consists of three late-stage drugs - VEN307 for hypertension and angina, VEN308 for fecal incontinence, and VEN309 for symptomatic hemorrhoids - intended to treat these conditions, for which, to our knowledge, there are no currently FDA-approved prescription drugs in the US.

Ventrus announced that it is now enrolling patients in its VEN309 study, an important phase III clinical trial. The primary objective of the VEN309-Hem-SE3-001 study "is to evaluate the effect of a 5HT2a antagonist ointment (iferanserin) on cessation of bleeding, pain, and itching when administered intra-anally twice daily (BID) for 14 days in subjects with symptomatic internal hemorrhoids."

Key eligibility requirements* for participating in the study include:

  • Males or non-pregnant females, ages 18 to 75 years.
  • Symptomatic internal hemorrhoids, Grades I-III.
  • Bleeding (with itching and/or pain) from hemorrhoids for two consecutive days prior to randomization.
  • Complete colon evaluation within three years; no malignancy within five years.

*A full list of patient eligibility criteria is available upon request.

More information available at the VEN309 trial website. Additionally, Dr. Steven D Wexner, Chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida, was featured in a webcast providing additional information about hemorrhoids and the background of the study:

Tuesday
Jan172012

Tigenix: Allogenic Cell Therapy for Complex Anal Fistulas, $TIG

Last week at the BioTech showcase Tigenix (NYSE Euronext: TIG) presented as part of a panel of companies talking about auto-immune disease and many possible indications. One that caught our attention was Cx601.

Cx601 is an "EU-medicinal product" based on expanded mesenchymal stem cells obtained from adipose tissue (eASCs). This product is a member of the new generation of cell therapies.

  • According to Tigenix: Cx601 is the first medicinal product based on allogeneic (collected from donors) eASCs to be approved for clinical trials worldwide.
  • Cx601 is able to activate the physiological repair mechanisms of the body thanks to its capacity to interact with the body.
  • Prior clinical trials with eASCs suggest that Cx601 has a great therapeutic potential based on its anti-inflammatory, healing, and immunoregulatory properties.

Cx601 is a suspension for injection that contains donor-derived stem cells isolated and expanded from adipose tissue obtained by liposuction.

Cx601 is being evaluated in a Phase II clinical trial for the treatment of complex perianal fistula in patients with Crohn’s disease. Cellerix estimates that it will be able to start in 2011 the last phase of clinical development before starting the approval process.

A perianal fistula is an abnormal connection between the perianal space and outside skin surface. A fistula is considered to be complex when its treatment involves a high risk of causing loss of anal continence, the fistulous tract crosses more than 30% of external sphincter (high trans-sphincteric, suprasphinctetic, and extrasphincteric), several tracts are found, is recurrent, or patient has incontinence, local irritation, or Crohn’s disease.

Current treatment for complex fistula in patients with Crohn’s disease is poorly effective and costly. Patients with complex fistula but no inflammatory disease require surgery, with its attendant risk of fecal incontinence. We would note that Ventrus (NASDAQ: VTUS) is another company outside of Cell Therapy that is working in this area.


Cx601 acts by controlled reduction of inflammation in the fistula, promoting adequate homeostasis through the release of anti-inflammatory factors which in turn promote natural fistula closure.
Cx601 has been designated as an orphan drug by the European Medicines Evaluation Agency.

Clinical Development: An allogeneic therapy based on eASCs in clinical phase
The program is based on the local administration of allogeneic eASCs for the treatment of complex perianal fistula in patients with Crohn’s disease. Safety of this treatment has been documented by its use for treating patients in a compassionate use program. Designation as an orphan drug for Europe was achieved in a record time.


A Phase I/II, open label study of this product for the indication of complex perianal fistula derived from Crohn’s disease has been done (24 patients across 6 centers). The primary objectives of this study were to :

  • To show that administration of allogeneic cells from healthy donors is safe.
  • To assess the efficacy of Cx601 in terms of complete closure of complex perianal fistula 12 and 24 weeks after initial drug administration.

Tigenix is now hoping to move this program forward to a pivotal trial. Given the fact that Tigenix has developed ChondroCelect®, the company’s lead product for cartilage regeneration in the knee we believe this company is worth watching.

Sunday
Jan152012

Ventrus (VTUS): Hemorrhoid Drug-309- PIIb hits its Primary Endpoint

Last week Ventrus Biosciences (NASDAQ: VTUS) reported that the final results from its PIIb study of VEN 309 (Iferanserin ointment) for the treatment of internal hemorrhoid disease (HD) were published. This study was conducted in Europe (Germany) and was randomized, double-blind, t=14-day placebo-controlled trial evaluating the efficacy and tolerability of BID (twice-daily) VEN 309 for the cessation of bleeding and other symptoms associated with Hemorrhoids.

The study hit its primary endpoint demonstrating efficacy and safety. The primary efficacy endpoints was a severity scores for bleeding on days 7 & 14. Secondary efficacy endpoints were itching, pain and other related symptoms also on day 7 & 14. The study was well powered at n= 111 patients split between control (placebo) and active VEN 309 groups.

VEN 309 was associated with a statisically significant reduction in daily bleeding &  itching on both days seven and 14 (bleeding, p<0.0001 and p=0.0075, respectively; itching, p=0.0008 and p=0.027, respectively). In terms of pain relief the data showed a favorable trend but was not statisically significant. Given that this is a Phase II trial and not a Phase III trial we are not concerned, a larger Phase III (P3 n=600) should add enough pwer to see a significant result. 

VEN 309 is on track to be the first new treatment (FDA Approved) for hemorrhoids. VEN 309 is in a Phase 3 trial now with top-line results expected this spring to summer. 

Monday
Jan092012

ProActive Capital Resources Group Announces Client Participation at San Francisco Healthcare Conferences

JP Morgan's 30th Annual Healthcare Conference 

5th Annual OneMedForum San Francisco 2012

Biotech Showcase 2012 in San Francisco

New York, NY, January 9, 2012 – ProActive Capital Resources Group, a strategic corporate communications, investor relations and social media firm today announced that several of its clients will be presenting at three prestigious investor conferences in San Francisco next week. The following companies will be presenting their corporate presentations at JP Morgan's 30th Annual Healthcare Conference, the 5th Annual OneMedForum San Francisco 2012, and the Biotech Showcase 2012 in San Francisco.

“We are proud to have several of our clients presenting at these quality industry conferences as we continue to grow our healthcare practice at ProActive Capital,” stated Jeff Ramson, CEO of ProActive Capital Resources Group. “These healthcare conferences provide the visibility and help build awareness as our clients continue to execute on their growth initiatives.”

To schedule a one on one meeting with any of the companies please contact us at the number below.

Coronado Biosciences, Inc. (Nasdaq:CNDO), will present at the Biotech Showcase 2012 Conference on Wednesday, January 11, 2012 at 4:30 PM PT.

Ventrus BioSciences, Inc. (Nasdaq:VTUS) will be attending the conferences and is available for one on one meetings.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) will be presenting at JP Morgan's 30th Annual Healthcare Conference on Thursday, January 12, 2012 at 10:00 a.m. PT.

WaferGen Biosystems, Inc. (OTCBB:WGBS.OB) - The company is scheduled to present at OneMedForum on Tuesday, January 10, 2012 beginning at 10:00 a.m. PT.

Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP.OB), will be presenting at the Biotech Showcase 2012 on Monday, January 9, 2012 at 10:00 a.m. PT, as well as on Tuesday, January 10, 2012 at 10:15 a.m. PT at the OneMedForum Conference.

AtheroNova, (OTCQB: AHRO.OB) will be attending the conferences and is available for one on one meetings.

Fibrocell Science, Inc. (OTCBB:FCSC.OB), will be presenting at the 5th Annual OneMedForum on Wednesday, January 11, 2012 at 10:00 a.m. PT.

Cerecor Inc. (a privately held company) will present at the Biotech Showcase 2012 on Monday, January 9th at 10:00 AM PST. 

NeoStem, Inc. (NYSE Amex: NBS) will be presenting at Biotech Showcase 2012 on January 10, 2012 at 10:30 a.m. PT.

CytoSorbents Corporation (OTC.BB: CTSO.OB), will present at the OneMedForum 2012 on Wednesday, January 11, 2012 at 11:15a.m. PT.

For more information about each of the conferences, go to:

www.onemedplace.com/forum/

http://www.ebdgroup.com/bts/index.php

About ProActive Capital Resources Group, LLC

ProActive Capital Resources Group, LLC (“PACRG”) (www.proactivecrg.com) is dedicated to the discovery and creation of value in the small-cap marketplace. PACRG provides turnkey solutions that combine traditional investor relations services with the latest Internet, mobile and social media communications. The Company’s integrated digital media and global distribution platform www.ProActiveNewsroom.com connects innovative, emerging-growth companies to the investment community using a variety of user-friendly and interactive formats.

Investor Relations Contact:

Jeff Ramson

Proactive Capital Resources Group, LLC.

212-792-4294

jramson@proactivecrg.com