On August 01, 2016 Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, reported financial results for the quarter ended June 30, 2016 and provided an update on recent corporate developments (Press release, Cempra, AUG 1, 2016, View Source [SID:1234514158]). The company will host a webcast and conference call today at 4:30 p.m. EDT.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter 2016 and Recent Corporate Highlights

On July 5, Cempra announced that the U.S. Food and Drug Administration (FDA) had accepted for filing Cempra’s two New Drug Applications (NDAs) for intravenous and oral capsule formulations of Solithera (solithromycin) in community-acquired bacterial pneumonia (CABP). Having been granted qualified infectious diseases product (QIDP) designation in 2013, solithromycin’s NDAs have qualified for an eight month priority review. The PDUFA dates are December 27, 2016 for oral and December 28, 2016 for intravenous. Subject to approval by the FDA, Cempra plans to launch Solithera in the U.S. in the first quarter of 2017.

In late June, Cempra completed the submission of its Marketing Authorization Application (MAA) for solithromycin to the European Medicines Agency (EMA) for the treatment of community-acquired bacterial pneumonia. The MAA is for both intravenous and oral capsule formulations.

In May, Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation, announced successful results for its Phase 2 community-acquired bacterial pneumonia clinical trial of solithromycin. In this study, 154 patients with CABP were randomized in a 2:1 ratio to receive five days of oral treatment with solithromycin or levofloxacin. All efficacy outcome measures favored solithromycin. Overall safety and tolerability was similar in both treatment groups, including hepatic events such as increases in alanine aminotransferase (ALT). Cempra has licensed solithromycin to Toyama Chemical for certain exclusive rights in Japan.
"Cempra continues to advance its programs successfully and I am excited by the progress we are making with both our clinical development programs and our commercial initiatives as we prepare for the launch of Solithera, subject to approval, early next year," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We remain confident in the data underpinning our NDA and MAA submissions and look forward to working with the regulators to bring the product to the patients who need treatment. In addition, we believe we have the people, strategy and financing in place to see us through our key milestones near-term including the initial commercialization of Solithera in the U.S."

Upcoming Clinical Development Milestones

Solithromycin

Solithromycin pediatric
Patient enrollment for Phase 1b trial continues.
Phase 2/3 pivotal trial with solithromycin for bacterial infections in pediatric patients has been initiated.
Phase 3 trial for solithromycin in urogenital gonorrhea is ongoing.
Phase 2 trial in chronic obstructive pulmonary disease (COPD) is ongoing.
Phase 2 trial in nonalcoholic steatohepatitis (NASH) is ongoing, interim results expected in fourth quarter 2016.
Review of EMA submission for solithromycin in the treatment of CABP is continuing.
Review of NDAs by the FDA is ongoing with 2016 PDUFA dates of December 27 for the oral formulation and December 28 for intravenous.
Taksta

Phase 3 trial in ABSSSI is ongoing and completion of patient enrollment is expected by the end of 2016.
An exploratory trial for Taksta in patients with refractory bone or joint infections is ongoing.
Financial Results for the Three Months Ended June 30, 2016

For the quarter ended June 30, 2016, Cempra reported a net loss of $24.8 million, or $0.51 per share, compared to a net loss of $25.0 million, or $0.57 per share for the second quarter in 2015. Research and development expense in the second quarter of 2016 was $16.0 million, a decrease of 32% compared to $23.7 million in the second quarter of 2015. The lower R&D expense was primarily due to the timing of payments for the order of active pharmaceutical ingredient (API) necessary to support the launch of solithromycin as the company begins its commercial readiness activities and a decrease in clinical expenses as the Phase 3 Oral and Phase 3 IV-to-Oral studies are complete. General and administrative expense was $12.0 million compared to $5.7 million in the second quarter of 2015, driven primarily by commercial readiness activities and increased headcount as the company continues to plan for commercialization of Solithera.

As of June 30, 2016, Cempra had cash and equivalents of $250.7 million and 50.7 million shares outstanding. During the second quarter Cempra implemented an at the market (ATM) financing program through which it sold 2.5 million shares resulting in net proceeds of $45.8 million which is included in cash and cash equivalents at the end of the second quarter. So far in the third quarter, the company has continued to utilize its ATM facility with the sale of approximately 1.6 million shares resulting in proceeds of approximately $29.2 million. In total, the company’s utilization of its ATM has resulted in the sale of approximately 4.1 million shares and net proceeds of approximately $75.0 million.

Updated Financial Guidance

The company’s current cash and equivalents, including the proceeds of the sale of common stock through the company’s ATM through the end of July, are expected to be sufficient to fund ongoing operations through 2017, assuming continued timely receipts under the BARDA contract and receipt of expected milestone payments from Toyama. This projection does not include any funds from additional financings or partnerships.

On August 1, 2016 FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, reported that it will have a major presence at the American Healthcare Radiology Administrators (AHRA) annual meeting held July 31-August 3, 2016, at The Gaylord Opryland Resort & Convention Center in Nashville, TN (Press release, Fujifilm, AUG 1, 2016, View Source [SID:1234514160]).

In addition to showcasing its comprehensive portfolio of digital radiography products and women’s imaging solutions, Fujifilm will sponsor the keynote presentation on Tuesday, August 2nd as well as lead an educational symposium on DR and the impact of the Consolidated Appropriations Act of 2016 on Wednesday, August 3rd.

"Our participation at AHRA 2016 will extend well beyond the walls of our booth, offering radiology professionals valuable information, insights and experience that they can take back to their facilities to improve department processes and patient outcomes." said Rob Fabrizio, director of strategic marketing, Digital Radiography and Women’s Health, FUJIFILM Medical Systems U.S.A., Inc.

Select highlights from Fujifilm’s comprehensive DR portfolio include:

FDR D-EVO GL – Begins shipping in the United States this month is the world’s first long length DR detector. It is designed to acquire long-length radiography for scoliosis and/or long leg exams with a simple, low dose, fast, single exposure. Featuring a huge 17×49" field of view, the FDR D-EVO GL saves time, enhances efficiency, image quality and dose for upright long-length radiography exams. It simplifies long length exams reducing chances for patient movement artifacts with faster setup and less chance for anatomy cut off due to a wider field of view compared to conventional multi-exposure DR. Compared to CR, the detector uses less dose and eliminates CR reader processing steps. The wait for a single exposure long length DR is over and the benefits far exceed conventional solutions available.

Virtual Grid – Also releasing this month is Fujifilm’s second generation grid simulation image processing. Virtual Grid intelligently interprets and corrects the effects of scatter radiation, adapting contrast to improve image quality for exams acquired without a grid. Virtual Grid brings valuable benefits to imaging, enhancing patient comfort; eliminating bulky grids, simplifying technologist productivity; making the detector lighter and faster to position, and lowering dose as much as 50% compared to exams performed with a grid. Virtual Grid can be used with both DR and CR, all anatomy, including long length images.

Focus on Education
Fujifilm’s ongoing commitment to education will be evident at AHRA 2016. On Tuesday, August 2nd at 9:45am, Fujifilm will sponsor the general session keynote speaker, Scott Steinberg, as he delivers his presentation, "Leading with Innovation: How to Future-Proof Yourself, Fearlessly Innovate, and Succeed in the New Normal." A celebrated speaker, author, futurist and strategic innovation consultant, Steinberg has earned a reputation for helping professionals and organizations cultivate competitive advantages.

On Wednesday, August 3rd from 7:15am-8:15am, Fujifilm will deliver an educational symposium titled "Navigating the New Consolidated Appropriations Act of 2016: Challenging Problems…DR Solutions." Led by Rob Fabrizio the session will cover the business and reimbursement impact of the new legislation on radiology departments. The session will also explore the benefits of a CR-to-DR transition including a variety of improvements to the domains of care as well as a facility’s bottom line. Attendees will have an opportunity to ask questions and will receive 1 ASRT approved credit.

For more information about Fujifilm, please visit: www.fujifilmhealthcare.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 1, 2016 Varian Medical Systems (NYSE: VAR) reported the creation of an interactive online group in which clinicians can share RapidPlan models for treating cancer patients using radiotherapy or radiosurgery (Press release, InfiMed, AUG 1, 2016, View Source [SID:1234514161]). Hosted on the OncoPeer Cloud Community, the RapidPlan Model Sharing group www.oncopeer.com is open to Varian customers, and allows clinicians to share RapidPlan models that can improve the efficiency and quality of treatment models and cancer care across multiple institutions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The first RapidPlan model shared on OncoPeer is a stereotactic body radiotherapy (SBRT) treatment of lung cancer that comes from the Beatson West of Scotland Cancer Centre in Glasgow, U.K. RapidPlan knowledge-based planning provides clinicians with models that have been shown to enhance the quality and speed of developing treatment plans for many types of external beam radiotherapy and allows clinicians to build and improve models.

"RapidPlan has positively increased the efficiency and quality of our treatment plan development," said Garry Currie, head of Radiotherapy Physics at the center in Glasgow. "By sharing our RapidPlan models on OncoPeer, we have the opportunity to share our knowledge and contribute to the collective understanding of high-quality treatment plan development around the world. Also, we create the opportunity to learn from others in the community so that we can continue to increase the quality of our plans here in Scotland."

Launched in 2015, OncoPeer enables users to initiate threaded discussions, form open or closed groups, share and comment about uploaded files, create events, monitor trending keywords within the community and sort information by keyword.

"We are very pleased with the growth of OncoPeer over the past year and the creation of new knowledge sharing groups like this one for RapidPlan, are testament to the desire of clinicians around the world to learn from each other in this fight against cancer," said Sukhveer Singh, vice president Oncology Continuum Solutions at Varian. "We will continue to expand this important knowledge sharing resource."

For more information on OncoPeer, visit: View Source

On August 1, 2016 Varian reported that Cancer patients in Ethiopia will gain access to modern radiotherapy treatments for the first time with the announcement that Varian Medical Systems (NYSE: VAR) has been selected to supply advanced medical linear accelerators to six hospitals in the country (Press release, InfiMed, AUG 1, 2016, View Source [SID:1234514162]). The Clinac iX treatment systems will be the first such devices offering treatments to cancer patients in a country of more than 90 million people.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The first phase of a cancer plan being rolled out by the Ethiopian government will see Varian supplying the treatment systems to Ethiopian university hospitals in the cities of Harar, Mek’ele, Jima, Hawasa, Gondar, and the capital Addis Ababa. The first of these projects is intended to start offering clinical treatments by the end of this year. The order for the six treatment machines was received by Varian in June.

"This is a well-considered plan by the Ethiopian government and Varian is delighted to be able to contribute by extending advanced care to an area of the world that is severely under-equipped," says Tom Duffy, Varian’s senior manager of Channel Management & Nile Delta Sales.

The Clinac iX systems will be capable of delivering fast and precise RapidArc treatments with image-guidance tools on each system. Each site will have an Eclipse system for treatment planning and 3 ARIA oncology information management workstations, and each hospital will have two radiotherapy bunkers to enable future expansion. Varian and Elsmed, one of its local representatives, are also working with the Ethiopian government to establish clinical education and training resources in the country.

"More than 70% of cancer patients require radiotherapy as part of their treatment and precise radiotherapy delivery requires image-guided treatments on modern machines, which is why a modern linear accelerator will be so important for our center," added Dr. Mathewos Assefa Woldegeorgis, of Black Lion University Hospital in Addis Ababa. "This machine will also help in the training of health professionals such as radiation oncologists, radiotherapists and medical physicists."

Udi Baruch, managing director of Israel-based Elsmed, said, "We will support this ambitious project through maintenance of the systems, intensive training programs for operators and also an ongoing knowledge sharing program between leading oncology institutes in Israel and the centers in Ethiopia in order to ensure the highest level of treatment in the most efficient and latest techniques."

On August 1, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the second quarter of 2016 (Filing, Q2, DURECT, 2016, AUG 1, 2016, View Source [SID:1234514170]). Total revenues were $3.2 million and net loss was $9.0 million for the three months ended June 30, 2016 as compared to total revenues of $4.4 million and net loss of $5.5 million for the three months ended June 30, 2015.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At June 30, 2016, we had cash and investments of $33.9 million, compared to cash and investments of $29.3 million at December 31, 2015. At June 30, 2016, we had $19.8 million in short and long term debt.

"The REMOXY ER PDUFA date of September 25, 2016 is now less than two months away and, if approved, this would be the first pharmaceutical product in our pipeline authorized for commercialization," stated James E. Brown, D.V.M., President and CEO of DURECT. "Our first two DUR-928 patient studies are progressing in Australia and we are moving forward with preparing two INDs which are required to enable future clinical trials in the U.S. For POSIMIR, we are in the process of amending the PERSIST Phase 3 trial in response to FDA advice while we continue enrollment in the trial."

Update of Selected Programs:

Epigenomic Regulator Program. DUR-928, our Epigenomic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.

Our first patient trial utilizing DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic (PK) Phase 1b trial of DUR-928 in NASH patients and matched control subjects. This study is being conducted in successive cohorts evaluating single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to a higher dose. The study is being conducted in Australia, and we anticipate that we will start obtaining results from this trial in the third quarter of 2016. This study is designed to enable and inform a subsequent multi-dose study in NASH and/or other patients with other liver function impairment. We are also preparing to request in the near future a pre-IND meeting with the FDA as precursor to submitting an IND later this year which is required to enable future clinical trials in liver diseases in the U.S.

Our second patient study with DUR-928, also being conducted in Australia, is currently screening patients with dosing expected shortly. This Phase 1b trial of DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function and matched control subjects. This study will be conducted in successive cohorts evaluating single-dose levels of DUR-928 administered by injection. After a PK/safety review at each dose, the study can proceed to a higher dose. We anticipate that this study will be completed in 2016, and that this study will enable and inform subsequent trials for patients with either acute kidney injury or other kidney function impairment. Our request for a pre-IND meeting has been granted by the FDA; we anticipate that feedback from that meeting will enable the filing of an IND later in the year which is required to enable future clinical trials in kidney diseases in the U.S.

REMOXY ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. The extended release oxycodone market is greater than $2 billion in the U.S. alone, and we are eligible for a potential royalty on REMOXY between 6.0% to 11.5% of net sales depending on sales volumes.

Pain Therapeutics (our licensee) resubmitted the NDA for REMOXY in March 2016. In April 2016, Pain Therapeutics announced that the FDA had determined that the NDA was sufficiently complete to permit a substantive review and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA). In May 2016, positive data from a REMOXY human abuse potential study was presented at the 35th Annual Scientific Meeting of the American Pain Society. Also in May 2016, the FDA informed Pain Therapeutics that there was a tentative date of August 5, 2016 for an Advisory Committee meeting to review the REMOXY NDA. In July 2016, Pain Therapeutics announced that the FDA had determined that the Advisory Committee meeting is unnecessary and would not be held on August 5. Pain Therapeutics also stated that the FDA advised them that the regulatory review remains active and is on-going, and the PDUFA date of September 25, 2016 remains unchanged.

POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.

In November 2015, we began enrolling patients for PERSIST, a new POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. We began recruiting patients for this trial comparing POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial. Starting in August 2016, we are implementing Part 2 of the PERSIST trial to evaluate POSIMIR against standard bupivacaine HCl rather than placebo as we have been doing in Part 1. Additionally, we are switching in Part 2 the primary efficacy endpoint (pain reduction on movement) from 0-72 hours after surgery to 0-48 hours after surgery. Assessing pain reduction on movement from 0-72 hours is now the key secondary efficacy endpoint and other efficacy endpoints, including 72-hour opioid use, remain the same. We expect to enroll approximately 264 patients in Part 2 of PERSIST, and we expect this part of the trial to take approximately one year to enroll. We believe that a positive outcome from this new trial design would result in a stronger NDA resubmission and potential commercial advantages. In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial.

ORADUR-ADHD Program. In 2013, we selected a formulation for the lead program in our ORADUR-ADHD (Attention Deficit Hyperactivity Disorder) program, ORADUR-Methylphenidate. This formulation was chosen based on its potential for rapid onset of action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a Phase 1 trial. In addition, this product candidate utilizes a small capsule size relative to the leading existing long acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing it in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.

Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.

Debt Refinancing. In July 2016, we refinanced our existing $20 million term loan with Oxford Finance into a new term loan that results in an extended maturity (to four years) and an extended interest only period (to 18 months).