Boston Scientific Corporation Message Board

Galena Biopharma (NASDAQ:GALE) plans to make its recently acquired Abstral sublingual tablets the market leader for the treatment of breakthrough cancer pain (BTcP) in the U.S., matching the product’s performance in Europe.

“Abstral is the latest and best-in-class drug for this indication,” president and CEO Mark Ahn says in an interview with BioTuesdays, noting that the company is on track for a fourth quarter launch...

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Oramed Pharmaceuticals (NASDAQ:ORMP) is awaiting a decision from the FDA, possibly later this week, to conduct a sub-study of the safety of its oral insulin candidate, ORMD-0801, before proceeding to a large, multi-center Phase 2 clinical trial later this year.

“Approving a clinical trial in the U.S. for oral insulin is a big deal,” CEO Nadav Kidron says in an interview with BioTuesdays. “We are ready to start the sub-study right away.”

On April 12, Oramed submitted a new IND application for the sub-study, which suggests that a decision could be made by the end of this week. The filing was in response to an initial IND for a Phase 2 trial that Oramed had filed at the end of December. For the sub-study, Oramed plans to enroll 30 Type 2 diabetic patients in a controlled in-patient setting for up to one week, with data likely available in four-to-five months.

The company has already administered nearly 1,500 doses of ORMD-0801 to 131 Type 1 and Type 2 diabetics as well as to healthy volunteers. “It has shown a good safety profile and achieved the pharmacokinetics that we were looking for,” Mr. Kidron says.

See BioTuesdays site for rest of article.........

May 2, 2013 by stephenkilmer · Leave a Comment

MLV & Co. has initiated coverage of Sucampo Pharmaceuticals (NASDAQ:SCMP) with a “buy” rating and $14 price target, saying “this is no longer the old Sucampo that in years past had one drug with nearly flat sales growth (and share price) sold in one market by a tepid partner.” The stock was changing hands at $8.82 Thursday morning.

“With the recent approval of Amitiza for opioid-induced constipation (OIC) and a broad relaunch of the drug by partner Takeda expected next month, we see Amitiza moving towards the cornerstone treatment position in the constipation market,” writes analyst Ed Arce.

“We see substantial long-term growth driven by a reinvigorated core business, two product launches in the past six months and a third expected in two weeks,” he said. “The overall business is now significantly de-risked, in our view, given that its key drug, Amitiza, has a unique three-indication label, and is available in the top two markets (U.S. and Japan), with a broad EU label expected in 2014.”

See BioTuesdays for rest of brief.

see BioTuesdays for article

....The U.S. level of compliance for colorectal cancer screening is a relatively low 45% to 50% as a national average, compared with screening compliance rates for other cancers, such as prostate, breast and cervical, which range from about 65% to 85%.

“The approval of blood tests to facilitate colorectal cancer screening is very much welcomed as we attempt to significantly increase compliance with screening colonoscopy at the appropriate age as there is still, unfortunately, a significant percentage of the U.S. population that has not undergone screening for colorectal cancer,” Dr. Robert Burakoff, clinical chief of gastroenterology and director of the Center for Digestive Diseases and of the Crohn’s and Colitis Center at Brigham and Women’s Hospital, Harvard Medical School, said in a statement regarding ColonSentry last year...

....The study results also highlight differences with GeneNews’ (TSX:GEN) ColonSentry blood test designed to assess an individual’s current risk for colorectal cancer. The ColonSentry test has been approved by the New York state department of health, the most stringent level of review for a clinical lab service in the US, and is commercially available through distributors and marketing partners in the US, Canada, Malaysia and China.

“As a risk-stratification test providing information about an individual’s current risk of having colorectal cancer, ColonSentry may facilitate a decision to undergo colonoscopy for those who would otherwise refuse the procedure,” GeneNews president and COO Gailina Liew said recently.

ColonSentry is the world’s first blood test to assess an individual’s current risk for colorectal cancer
“Importantly, it can also help prioritize patients at greater current risk for colorectal cancer in healthcare systems with limited colonoscopy capacity. Widespread adoption of the test could lead to earlier detection of colorectal cancer, improved patient outcomes and reduced healthcare costs.”

Exact’s Cologuard, which is not yet on the market, is attempting to be a potential replacement for colonoscopy and involves a patient handling their own stool. ColonSentry, on the other hand, is a risk-stratification test that requires only a small sample of blood and can be easily incorporated as a pre-screening measure into routine yearly physical exams.....

See BioTuesdays site for full brief

April 19, 2013 by Jennifer Poland · Leave a Comment

In a new research report, analyst Jason Mills of Canaccord Genuity discussed initial data presented at the SAGES conference Thursday evening by Dr. Michael Stamos of the University of California at Irvine from the PILLAR II study, which is evaluating the ability of Novadaq Technologies’ (NASDAQ:NVDQ; TSX:NDQ) PINPOINT endoscopic fluorescence imaging system to assess colon perfusion during laparoscopic left colectomies.

PILLAR II has so far delivered “outstanding results,” Mr. Mills writes. Out of 66 patients imaged to date, nearly 10% of patients had revisions to their procedure and there were an amazing 0% leaks. These results exceeded our “very good outcome” scenario, he said.

The zero leak rate compares to the historical 9% to 16% leak rate seen in lower colon anastomoses.
Mr. Mills reiterated his “buy” rating and $15 price target for Novadaq and recommended investors “add to positions. We believe Novadaq possesses one of the most attractive, emerging technologies in med-tech, that we think has the potential to be standard of care across a multitude of surgical procedures.” Shares of Novadaq closed at $10.22 on Thursday.

Stifel Nicolas analyst Rick Wise also reiterated his “buy” rating and $13 price target. “We believe the PILLAR results strongly demonstrate the clinical utility of PINPOINT and continue to believe that it will ultimately become the standard of care in this 50,000+ annual procedure market.”...see BioTuesdays site for rest of article.

....Pre-cancerous sensitivity, which was the key metric investors were looking at, was well below expectations,” Wedbush Securities analyst Zarak Khurshid told Reuters, adding that “lower pre-cancer sensitivity may limit the eventual addressable opportunity for the test.”

Exact Sciences CEO Kevin Conroy, speaking to investors on a conference call, acknowledged that the test’s detection rates in the study were not as high as expected, even though they met the trial’s main goals. The company had expected the test to detect 50% of pre-cancerous polyps.

The study results also highlight differences with GeneNews’ (TSX:GEN) ColonSentry blood test designed to assess an individual’s current risk for colorectal cancer. The ColonSentry test has been approved by the New York state department of health, the most stringent level of review for a clinical lab service in the US, and is commercially available through distributors and marketing partners in the US, Canada, Malaysia and China.

“As a risk-stratification test providing information about an individual’s current risk of having colorectal cancer, ColonSentry may facilitate a decision to undergo colonoscopy for those who would otherwise refuse the procedure,” GeneNews president and COO Gailina Liew said recently.

“Importantly, it can also help prioritize patients at greater current risk for colorectal cancer in healthcare systems with limited colonoscopy capacity. Widespread adoption of the test could lead to earlier detection of colorectal cancer, improved patient outcomes and reduced healthcare costs.”
Exact’s Cologuard, which is not yet on the market, is attempting to be a potential replacement for colonoscopy and involves a patient handling their own stool. ColonSentry, on the other hand, is a risk-stratification test that requires only a small sample of blood and can be easily incorporated as a pre-screening measure into routine yearly physical exams.... See BioTuesdays site for full brief.

April 16, 2013 by leonardzehr · Leave a Comment

OnPoint Medical Diagnostics (OTCQB:ONMD) is pioneering a “big-data” platform for delivering measurable, objective and automated quality assurance (QA) solutions for magnetic resonance imaging (MRI), with plans to expand its framework to include other modalities such as computed tomography (CT), ultrasound and mammography. The company was founded in 2010 to commercialize imaging QA technologies developed by Mayo Clinic, where testing began in 2006.

“We estimate there is a $6 billion global market opportunity for imaging QA and informatics,” president and CEO, William Cavanaugh, says in an interview with BioTuesdays. “Right now, with MRI, our competition is pencil and paper, three-ring binders and the fax machine, so we see this as a blue ocean opportunity.”

A big-data solution objectively measures each individual imaging scan and compares it against an internal standard or an industry benchmark......

See BioTuesdays site for the rest of this feature article.

April 11, 2013 by Jennifer Poland · Leave a Comment

Janney Capital Markets has initiated coverage of BioDelivery Sciences International (NASDAQ:BDSI) with a “buy” rating and a $10 fair value estimate. The stock closed at $4.47 yesterday.

“Well capitalized and on the cusp of turning from a drug development story into a drug launches story, we believe BDSI is at an inflection point,” writes analyst Jim Molloy.

BioDelivery is focused on the development and commercialization of pain and addiction management therapies by utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology. Both current product candidates use the opioid Buprenorphine administered via a small patch that adheres to the inside of the mouth with the drug being absorbed through the cheek.

Mr. Molly said that BEMA Buprenorphine/Naloxone (Bunavail) is being developed for the treatment of opioid dependence and he believes it could be a $100 million product in 2015.

“BDSI’s second compound is BEMA Buprenorphine for moderate to severe chronic pain partnered with one of the seminal names in pain medicine, Endo Health Solutions (NASDAQ: ENDP), and is in two phase 3 trials with data expected year end 2013′” he added.

April 9, 2013 by leonardzehr · Leave a Comment

BioDelivery Sciences (NASDAQ:BDSI) is on track to file a new drug application with the FDA this summer for its Bunavail treatment for opioid dependence, one of two Phase 3 candidates in its product pipeline.

“If all goes according to plan, in mid-2014, we should have an FDA decision on the approvability of Bunavail and be preparing a submission for an NDA on our chronic pain product, BEMA buprenorphine,” president and CEO Mark Sirgo, says in an interview with BioTuesdays. “NDA filings and positive clinical readouts are important value-driving events ahead of us.”

At the end of March, BioDelivery acquired a patented topical clonidine gel for the treatment of painful diabetic neuropathy from Arcion Therapeutics. Evidence has shown that clonidine stimulates an inhibitory receptor in the skin associated with pain fibers which, when activated, is believed to attenuate the pain associated with this condition.

“Though we remain focused on preparing our Bunavail NDA for filing in the coming months and completing our BEMA buprenorphine chronic pain Phase 3 trials, this product acquisition allows us to build our pipeline, while applying our expertise in pain product development, utilizing the FDA’s 505(b)(2) regulatory process, and diversifying outside of opioid therapy and our BEMA technology,” Dr. Sirgo says.

See site for rest of this week's feature on BDSI.....

April 2, 2013 by leonardzehr · Leave a Comment

Positive animal data reported by International Stem Cell (OTCBB:ISCO) last month brings the company one step closer to starting human testing of its stem cell technology to treat Parkinson’s disease.

“We have established that the symptoms of Parkinson’s disease can be treated with our stem cell-derived neuronal cells,” Simon Craw, executive vice president, says in an interview with BioTuesdays. “No one has successfully done this before.”

While there is human data to suggest that implanting neuronal cells into Parkinson’s disease patients can benefit their symptoms, Dr. Craw says there were two major problems associated with the earlier research. “These cells were sourced from human fetuses, which presents an ethical issue, and fetal neuronal cell transplantation for Parkinson’s caused a movement disorder known as dyskinesia in some patients.”

International Stem Cell’s (ISCO) core technology, parthenogenesis, creates pluripotent human stem cells from unfertilized oocytes (eggs), avoiding the ethical issues associated with the use or destruction of viable human embryos.....

See site for rest of this week's feature story on ISCO

March 26, 2013 by leonardzehr · Leave a Comment

Even though OncoGenex Pharmaceuticals (NASDAQ:OGXI) and its pivotal programs with lead oncology candidate, custirsen, are being closely followed, investors are beginning to notice the company’s second generation antisense drug, OGX-427.

“We have data in bladder and prostate cancer with OGX-427 that, we believe, indicates clinical activity,” co-founder, president and CEO, Scott Cormack, says in an interview with BioTuesdays. “This has engaged our interest, even more so than at the beginning of the program. As a result, we have diversified our clinical program to go into other indications in order to explore the potential of the drug.”

He points out, “Quite a few investors have come into the story, not only because of custirsen, but also with a keen interest in OGX-427.”........

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See BioTuesdays site for rest of article

Ladenburg highlights market potential for MediciNova’s MN-166
March 22, 2013 by leonardzehr · Leave a Comment

Ladenburg Thalmann outlined the market potential for MediciNova’s (NASDAQ:MNOV: OSE:4875) MN-166 (ibudilast) for the treatment of opioid and methamphetamine dependence after the company reported positive Phase 1b/2a data for the therapy earlier this week.

Analyst Matt Kaplan also reiterated his “buy” rating and $6 price target on Medicinova.

Currently, MN-166 is in a Phase 2a trial in patients with opioid dependence being run by investigators at Columbia University and a Phase 1b trial in methamphetamine dependent patients being run by investigators at UCLA.

“Importantly, we anticipate that data from the Phase 1b methamphetamine dependence study could be presented at the CPDD meeting in June 2013,” Mr. Kaplan writes. “Furthermore, the FDA recently granted fast track designation to MN-166 for the treatment of methamphetamine dependence, which may enable MN-166 to reach the market ahead of our expectations.”

He figures the market opportunity for MN-166 for the treatment of methamphetamine and opioid addiction is significant. Currently there is nothing approved for the treatment of methamphetamine addiction, and the incidence of treatment admissions for methamphetamine addiction is about 140,000 patients annually. In addition, there is an estimated prevalence of about 440,000 habitual users.

Mr. Kaplan is currently projecting a typical launch profile that reaches peak market penetration into the treatment seeking patient population of 27% in six years, which equates to approximately 41,000 patients utilizing MN-166 at peak in 2022.

Citing an essential monopoly at launch, “we believe there may be considerable upside potential to our initial market adoption assumptions. With the launch assumptions noted and an annual treatment WAC of $6,000, we believe that MN-166 could generate approximately $270-million in revenue.”

Regarding .... see BT for more

Sucampo Pharmaceuticals (NASDAQ:SCMP) expects to be generating revenue from three continents – North America, Europe and Asia – by the end of 2013 from its two approved prostones products, Amitiza for gastrointestinal diseases and Rescula for ophthalmics.

“This is in line with our goal to be a global company,” CFO Cary Claiborne says in an interview with BioTuesdays. “We are the only company developing and commercializing prostone compounds globally.”

Prostones are functional fatty acid metabolites that occur naturally in the body. Prostones work as selective ion channel activators, promoting fluid secretion, enhancing cell protection and acting locally to restore normal function in cells and tissues.

See Bio Tuesdays for rest of feature article posted this morning.

Even though Ohr Pharmaceutical (OTCBB:OHRP) will be releasing results, in the current quarter, of a Phase 2 clinical trial in patients with cancer cachexia, all eyes are on a Phase 2 study of its squalamine eye drop to treat wet age-related macular degeneration (AMD), with interim results due at the end of the year.

“We have had quite a bit of interest in partnering our OHR/AVR 118 drug candidate for cancer cachexia, and we will look to license out the program after Phase 2, because the company’s core focus is now ophthalmology and bringing second-generation products through the pipeline,” CEO Irach Taraporewala says in an interview with ........

See Bio Tuesdays site for more

DURECT (NASDAQ:DRRX) has a lot riding on a meeting in late March between its marketing partner, Pfizer, and the FDA to discuss resubmitting a new drug application for its lead pain drug, Remoxy, as a tamper-resistant formulation of oxycodone, a powerful opioid that is widely abused.

“Based on the feedback Pfizer receives from the FDA at that meeting, Pfizer will determine the next steps and/or required timing to respond to the Complete Response Letter for Remoxy,” Matt Hogan, CFO of DURECT, says in an interview with BioTuesdays. He gave this interview following his presentation at the BIO CEO conference in New York earlier this month.

“We will support Pfizer however we can as they complete whatever is required for the resubmission, and, once the NDA is resubmitted, it should undergo a six-month review by the FDA,” he adds.........

See BioTuesdays for more