Zalicus (NASADQ:ZLCS) will have data in the second half of this year that will provide important insights into the potential of its lead drug candidate, Z160, to be a breakthrough new class of non-opioid analgesic for the treatment of both chronic and acute neuropathic pain.

"There hasn't been a lot of innovation in the pain space in many years, and we are one of the few companies exploring multiple novel mechanisms to address pain," Justin Renz, EVP and CFO, says in an interview with BioTuesdays.com. "We have an opportunity for a breakthrough pain medication."

Mr. Renz explains that Z160 is an oral, state-dependent, N-type calcium channel blocker that is designed to target and modulate only those neurons transmitting pain signals-specifically neurons that are undergoing high frequency firing.

"Preclinical and clinical data to date with Z160 suggest that this state-dependent mechanism of action may avoid the severe psychiatric and neurological side

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.com, noting that the company is on track for a fourth quarter launch.

Abstral was approved by the FDA in January 2011 for inadequately controlled BTcP in patients who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. BTcP affects 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes. Abstral delivers the analgesic power and increased bioavailability of micronized fentanyl in a sublingual tablet, which dissolves under the tongue within seconds, relieves pain in minutes and lasts for the entire

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.com. "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.

After disappointing investors in March by terminating a Phase 2/3 clinical trial of an anti-psychotic drug candidate for the treatment of schizophrenia, BioLineRx (NASDAQ: BLRX) bounced back in April, posting positive Phase 2a results with an oral treatment for inflammatory bowel disease (IBD).

"BioLineRx is not a binary company, but has a broad and rich pipeline in different therapeutic areas, which helps us mitigate the risk of being overly dependent on any one or two drugs development programs," CFO and COO Philip Serlin says in an interview with BioTuesdays.com.

"Specifically, we have seven clinical-stage assets as well as several preclinical assets some of which are ready to enter the clinic," he adds.

Founded in 2003 by Teva Pharmaceuticals and a number of leaders in Israeli life sciences, BioLineRx's business model is based on acquiring molecules, mainly from academic institutions, and developing them to proof-of-concept in humans. The final stage includes

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.com. "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

Even though OncoGenex Pharmaceuticals (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.com. "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."

Mr. Cormack explains that custirsen is designed to block the production of clusterin, a cell-survival protein that is over-produced in several malignancies and in response to many cancer treatments.

Sucampo Pharmaceuticals (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 said in an interview with BioTuesdays.com. "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. Sucampo's two prostone-based compounds have an excellent safety profile, with Amitiza targeting the ClC-2-chloride channel and Rescula targeting the BK-potassium channel. Their therapeutic potential was first identified by Sucampo's founders, Drs. Ryuji Ueno and his wife, Sachiko Kuno. The company has over 580 issued patents

Even though Ohr Pharmaceutical (OHRP.OB) 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 BioTuesdays.com.

Ohr was founded in late 2008 on a strategy to acquire two late-stage clinical programs that address large unmet medical needs: wet AMD and cancer cachexia.

Squalamine was acquired from Genaera and OHR/AVR 118 from Advanced Viral Research, where Dr. Taraporewala

After posting positive trends in interim data, Prima BioMed (NASDAQ: PBMD) is focusing on two final data readouts in the second half this year from a Phase 2b clinical trial of its CVac cancer vaccine to treat epithelial ovarian cancer patients in remission after first-line or second-line therapy.

"This will support long-term development of CVac," CEO Matt Lehman says in an interview with BioTuesdays.com, referring to final efficacy and intracellular cytokine staining ((ICS)) data, which are designed to explain the product's mechanism of action by showing T-cell activity against the tumor.

Since ovarian cancer is generally diagnosed at a late stage, only 20% to 30% of patients with late-stage disease survive for five years. "A maintenance treatment like CVac would be the first of its type in this new market. We believe the product has potential to achieve market penetration within the first year after

As a leading supplier of materials used to remove wastes from the blood of kidney disease patients on dialysis, Rockwell Medical (RMTI) is gearing up to introduce two new therapies to the dialysis market in the next two years: an iron drug candidate and a generic vitamin D.

Rob Chioini
(Glenn Triest/Crain's Detroit Business)

"We think we can take a significant piece of these two markets based on benefits to patients and cost savings to the industry," CEO and founder Rob Chioini says in an interview with BioTuesdays.com. "Both of these products would move seamlessly into our existing customer base and through our current distribution channels servicing our operating business, so we expect to incur a minimal expense in the process."

Seventeen-year-old Rockwell currently manufactures and sells what's known as dialysate, a mixture of the company's bicarbonate and acid concentrates, such as sodium chloride, dextrose, magnesium, potassium, calcium and

With adoption of its SPY imaging technologies growing in operating rooms across North America, Novadaq Technologies (NVDTF.PK) has embarked on a long-term growth plan to image nerves and cancer cells with tissue-binding reagents that could represent a paradigm shift in the OR.

"The future of the installed base of SPY technologies will include providing surgeons with images of targeted tissues such as nerves and metastatic cancer cells," CEO Dr. Arun Menawat says in an interview with BioTuesdays.com.

"Before the start of a surgery, imagine a patient being painlessly injected with multiple imaging molecules, each of which will go to its own sweet spot, to light up nerves in one color, perfusion of blood vessels in another color and cancer cells in yet a third color," he adds.

"This would serve as a physiologically and anatomically enriched roadmap for a surgeon, who could then provide specific treatments for

Transition Therapeutics (NASDAQ: TTHI) and its Alzheimer's disease (AD) program could get a shot in the arm if two closely watched clinical trials by Eli Lilly (LLY) and a Pfizer (PFE)-J&J (JNJ) joint venture show indications that they help patients with mild AD symptoms. The results of these clinical trials are expected to be reported this fall.

Both pivotal trials are evaluating patients with mild-to-moderate symptoms of AD. However, there is a growing consensus in medical circles that once a patient develops late-mild and moderate symptoms, disease progression may be too fast to slow with drug therapy.

"At that point, there may be too much pathology underway to prevent disease progression," Transition CEO, Tony Cruz, says in an interview with BioTuesdays.com. "Amyloid accumulation occurs so early in the disease that by the time you have all these other pathologies that are also responsible for patient decline, he or she may

Drug developer IntelGenx (IGXT.OB) has its sights set on emulating the success of high flying, drug delivery company Biovail, before its merger into Valeant Pharmaceuticals (VRX), and founder and CEO Horst Zerbe thinks his company is almost there.

(Click to enlarge)

Horst Zerbe, Ph.D

"Like Biovail in its heyday, we have proprietary and unique drug delivery technologies, we provide regulatory services, and we have successfully compiled and submitted new drug applications and received approvals," he said in an interview with BioTuesdays.com, referring to the company's mission of making approved drugs better.

"Where we fall short is that Biovail had its own contract research organization to conduct clinical studies. We can't do that yet. The other area where we fall short is in the manufacturing area. Right now, we rely on manufacturing partners," he pointed out.

Dr. Zerbe explains that one of IntelGenx's drug delivery platforms - a rapidly dissolving film

After two unsuccessful bone marrow transplants, a seven-year girl from Romania, suffering from a type of bone marrow failure and facing certain death, appears to be on the road to recovery after receiving in May two intramuscular injections of 80 million PLacental eXpanded ("PLX") cells developed by Pluristem Therapeutics (PSTI) of Israel.

"This was a compassionate request from her doctor at Hadassah Hebrew University Medical Center in Jerusalem," chairman and CEO Zami Aberman says in an interview with BioTuesdays.com.

"She has experienced a reversal of her condition, with a significant increase in her red and white blood cells, and platelets," he adds. "For now, we have saved her life. She has been released from hospital and is back at home with her parents."

The life-saving treatment is an outgrowth of Pluristem's burgeoning pipeline of placenta-based cell therapies. Specifically, it stems from animal studies, suggesting that PLX cells can be potentially

AMRI (AMRI), a leading global contract drug research and manufacturing organization, is at an inflection point in returning to profitability.

"We think that some of the concepts coming out of marketing our SMARTSOURCING program make us uniquely positioned to provide a wide variety of services as one of the only players to go from target drug validation to manufacturing of active pharmaceutical ingredients on a global basis," Mark Frost, Senior VP of Administration and CFO, says in an interview with BioTuesdays.com.

"That differentiates us and allows us to provide strong options to our customers to manage their compounds," he adds.

The SMARTSOURCING program is a series of strategic sourcing options to enable customers to reach more successful outcomes, combining high quality scientific performance and enhanced decision-making, with the accountability of delivering results in a cost-competitive manner.

As part of its turnaround, AMRI is also streamlining its operations to improve margins,

With the launch of a global pivotal trial, NovaBay Pharmaceuticals (NBY) has achieved a major development milestone in its efforts to commercialize an eye drop for the treatment of adenoviral conjunctivitis with its anti-infective aganocide, NVC-422.

Dr. David Stroman

"What makes NVC-422 an attractive candidate is its broad spectrum of activity," Dr. David Stroman, Senior VP of Ophthalmology Development, says in an interview with BioTuesdays.

"We've already shown in the first conjunctivitis trial that NVC-422 is topically active," he says. "In the endgame, after we've done everything, a NVC-422 product will be extremely valuable, because a physician won't need to know whether a patient has either bacterial or viral conjunctivitis − he or she can treat for either."

Earlier this month, NovaBay began enrolling patients in a global Phase IIb clinical study, called BAYnovation, for treating adenoviral conjunctivitis, an extremely contagious form of pink eye. The study is designed to

Avita Medical (AVMXF.PK) has come up with a revolutionary answer to painful skin grafts that are commonly used to treat patients with burns, chronic wounds and scars: spray-on skin.

"Our ReCell Spray-On Skin product represents a true paradigm shift, because we can harness a patient's own skin to regenerate and expedite wound healing," Business Development Officer, Stella Sung, says in an interview with BioTuesdays.com. "And we've packaged it into an easy-to-use bedside kit for the clinician."

ReCell has obtained regulatory clearance in Europe, Australia and most recently, in China. The Australian-based company generated sales, mainly in Europe and Australia, of $4.54 million and gross profit of $3.5 million for the fiscal year ended June 30, 2011. Over 4,500 patients have been successfully treated with ReCell, with the kit selling for about €1,250 in Europe.

ReCell

"We are currently focused on achieving adoption with key opinion leaders in order to get

NovaBay Pharmaceuticals (NBY) says key study data demonstrating that development of resistance to its lead Aganocide compound, NVC-422, is highly unlikely for a variety of infectious organisms, including methicillin-resistant S. aureus (MRSA), compared with traditional antibiotics, were published in the May 2012 issue of Antimicrobial Agents and Chemotherapy, the journal for the American Society for Microbiology.

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NovaBay's two Distinct Anti-Infective Product Lines (Estimated Market Sizes)

NovaBay is developing NVC-422, a novel anti-infective with broad-spectrum bactericidal activity and novel mechanism of action to address the unmet medical needs in several large markets. Different topical formulations of NVC-422 are in mid-to-late-stage clinical development in ophthalmology, dermatology and urology.

"This is a seminal article for those in the industry of infectious diseases, as it confirms the potency of NVC-422 against potentially deadly bacteria, and shows the bacteria's low likelihood to develop resistance to NVC-422," Dr. Richard Odom, Sonoma Dermatology, Sonoma,

MediciNova (MNOV) expects to release results from two clinical trials in the current second quarter with its lead drug candidate, MN-221, opening the door to a possible pivotal trial.

"We'll have Phase 2b results by the end of May treating patients with acute exacerbations of asthma (AEA) in the emergency room and results by June from a Phase Ib multi-dose trial in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)," Chief Business Officer, Michael Coffee, says in an interview with BioTuesdays.com.

"Our hope is to move into a Phase III program in acute asthma at the end of 2012 or the beginning of 2013," he adds.

AEA is a severe asthma episode that fails to respond to initial bronchodilator or corticosteroid therapy.

Mr. Coffee explains that these attacks result in approximately two million emergency room visits in the U.S. annually, leading to about 500,000 hospitalizations annually and a nearly similar

Armed with a favorable decision in February that its ILUVIEN sustained-release implant is approvable in the European Union to treat diabetic macular edema (DME), pSivida (PSDV) expects sales of the device to begin by the end of the year.

"The formal review process has finished, and the next step is for our marketing partner, Alimera Sciences, to secure national licenses in Spain, Portugal, Germany, France, the U.K., Austria and Italy," pSivida CEO Paul Ashton says in an interview with BioTuesdays.com. "The commercial rollout will probably start in Germany and the U.K."

In a recent 8K filing with the SEC, pSivida said it believes it will take longer than originally anticipated to obtain marketing authorizations for ILUVIEN in the seven countries. National clearances are designed to be made within 30 days of closing the approval process. Alimera now believes these authorizations likely will be issued in the second and third quarters