|Sinovac Receives Clinical Trial Approval for Varicella; FDA Approves BELBUCA Buccal Film|
|By Josh Gee|
|Monday, 26 October 2015 19:05|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 26, 2015.
Sinovac Biotech Ltd. (NASDAQ: SVA), today announced that one of its subsidiaries, Sinovac Dalian, has received approval to begin human clinical trials on its varicella vaccine candidate. The clinical trial application for the varicella vaccine was officially accepted by the China Food and Drug Administration (CFDA) in January 2013.
In preparation to begin human clinical trials, Sinovac Dalian is currently finalizing the trial protocol, confirming the site, training staff and preparing for volunteer screening. The Company expects to complete the trial in 2017. Simultaneously, Sinovac Dalian is renovating of an existing building on its Dalian campus, which will serve as the commercial production plant for the varicella vaccine. The plant will have a designed annual capacity of 5 million doses.
The Company's varicella vaccine candidate is a live attenuated vaccine derived from a human cell line. Development of the vaccine began in 2010 and the clinical trial application was officially accepted by the CFDA in January 2013, after the preclinical study was completed. The Company expects to be able to commercialize its varicella vaccine by the end of 2019. Ultimately, Sinovac plans to develop a measles-mumps-rubella-varicella (MMRV) combination vaccine. The Company has licensed a mumps vaccine for sale in China, has clinical trial approval for its internally-developed rubella vaccine and plans to begin development of a measles vaccine.
Currently, the varicella vaccine is sold exclusively in the private-pay market in China by four domestic producers. In some regions, the varicella vaccine is included in the emergency immunization programs of several provinces for free vaccination due to outbreaks. According to the China CDC, the varicella vaccine is recommended to children over 12 months with different immunization schedules implemented in different provinces and it's specified in the product specification. Generally, a one-dose scheme is recommended for children from 12 months to 12 years old and two doses for those 13 years and older. Recently, one booster shot has been recommended for children 4 to 12 years old by some local CDCs. This is expected to become standard protocol throughout the country in the coming years, which would increase market demand. In the past five years, approximately 15-16 million doses were released to China market annually.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Obtaining the clinical trial approval marks a significant step in the R&D process for our varicella vaccine candidate. Once commercialized, this vaccine will be supplied to the existing market demand and support Sinovac Dalian for its asset utilization, cash flow and profitability in the near future, and position us to capture share with the potential market expansion in the coming years. Meanwhile, there is a meaningful opportunity for an MMRV vaccine in the private-pay market in the future. This represents another milestone as we further develop our vaccine product portfolio to fulfill China's unmet medical needs."
Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) TSXENL, and BioDelivery Sciences International, Inc. (NASDAQ: BDSI), announced the U.S. Food and Drug Administration has approved BELBUCA™ (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. BELBUCA™, which is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management, is expected to be commercially available in the U.S. during the first quarter of 2016 in seven dosage strengths, allowing for flexible dosing ranging from 75 micrograms to 900 micrograms every 12 hours. This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.
Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7619551-endo-pharmaceuticals-belbuca-fda-approval
"The availability of new, convenient and flexible treatment options is important for patients whose lives are burdened by chronic pain, a debilitating condition that affects more Americans than diabetes, heart disease and cancer combined," said Richard L. Rauck, M.D., Director of Carolinas Pain Institute, Winston Salem, NC. "BELBUCA™ provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility. For both opioid-naive and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, BELBUCA™ offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects."
BELBUCA™ is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BDSI's patented BioErodible MucoAdhesive (BEMA®) drug delivery technology. Through this unique delivery system, buprenorphine is efficiently and conveniently delivered across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Among chronic pain patients taking opioids, the vast majority are on daily doses of 160 mg of oral morphine sulfate equivalent (MSE) or less. With seven dosage strengths up to 160 mg MSE, BELBUCA™ offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.
"The FDA approval of BELBUCA™ represents an important and meaningful milestone for Endo Pharmaceuticals, demonstrating our strength in bringing a valuable new therapy from pipeline through approval. Our advancement of BELBUCA™ also underscores Endo's long-standing heritage of innovation and its commitment to supporting the pain community," said Rajiv De Silva, President and CEO of Endo. "We are proud to add BELBUCA™ to our diversified portfolio of branded and generic products and we look forward to preparing for the expected U.S. launch of the drug in early 2016."
The FDA approval of BELBUCA™ was based on two double-blind, randomized, placebo-controlled, enriched-enrollment Phase 3 studies in patients with moderate to severe chronic low back pain. In these pivotal trials, a total of 1,559 opioid-experienced (study BUP-307) and opioid-naive (study BUP-308) patients received study drug. The trials included an open-label period in which patients were titrated to a tolerated, effective dose of BELBUCA™ and then randomized to either continue on BELBUCA™ or receive a placebo buccal film.
In both studies, BELBUCA™ demonstrated a consistent, statistically significant improvement in patient-reported pain relief at every week from baseline to week 12, compared to placebo. The most common adverse reactions (>5%) reported by patients with BELBUCA™ in the clinical trials were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.
"We are excited about the FDA approval of BELBUCA™ as we believe it is a testament to the strength of BDSI's partnership with Endo, and our ability to combine our expertise and resources to advance the available options in the treatment of chronic pain," said Dr. Mark A. Sirgo, President and CEO of BDSI. "BELBUCA™ is uniquely formulated with our BEMA® drug delivery technology that allows for high bioavailability of buprenorphine in the bloodstream, and represents an important new option for patients and healthcare providers."
Allscripts (NASDAQ:MDRX), has significantly expanded its business relationship with Catholic Health Initiatives (CHI), one of the nation's largest nonprofit health systems. Beginning in Autumn, 2015, Allscripts Managed Services, through its TouchWorks® EHR and Allscripts Practice ManagementTM solutions, will provide CHI complete system support and operational management, as well as current and future upgrades, enhancements and optimization. CHI also added the Allscripts FollowMyHealth® patient engagement platform. The Allscripts Managed Services partnership is designed to direct resources toward initiatives that enhance patient outcomes and improve population health. As part of these initiatives, CHI will launch the FollowMyHealth patient engagement platform for 1,500 TouchWorks EHR providers, with full implementation and support services being provided by Allscripts. FollowMyHealth is a cloud-based patient engagement solution that makes it easy for patients and clinicians to stay connected. EHR-agnostic, FollowMyHealth integrates with all systems across the CHI healthcare organization. Patients have a single point of access regardless of an individual provider's software. "CHI is a national leader in delivering highly reliable, quality health care to its communities," said Senior Vice President of Allscripts Client Organization, John Sage. "Allscripts solutions and services will further enable CHI to focus on its core mission to treat patients without the distraction of also managing its IT systems and infrastructure."
BioBlast Pharma Ltd., (Nasdaq:ORPN), a clinical-stage biotechnology company developing meaningful therapies for patients with rare and ultra-rare genetic diseases, announced that it will report the interim Phase 2 clinical study results of Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) on Tuesday, October 27th. Company management will host a conference call & webcast at 8:30am Eastern Time. Conference Call and Webcast Information: Tuesday, October 27 at 8:30a.m. Eastern Time; US Toll-free: 1-888-378-4361; International: 1-719-457-2644; Conference ID: 124818; Webcast: http://public.viavid.com/index.php?id=116661; Replays available through November 10, 2015: US Toll-free: 1-877-870-5176; International: 1-858-384-5517; PIN Number: 124818; A replay of the webcast can be accessed by visiting the "Investors" page of the company's website at http://bioblast-pharma.com/.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) and its partner Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), announced earlier today that the U.S. Food and Drug Administration (FDA) approved BELBUCA™ (CIII) (buprenorphine HCl) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. FDA approval of BELBUCA has triggered a milestone payment to BDSI from Endo of $50 million pursuant to the 2012 worldwide license and development agreement between BDSI and Endo for the development and commercialization of BELBUCA. It is anticipated that BELBUCA may become commercially available in the U.S. during the first quarter of 2016, which may trigger additional milestone payments from Endo in the future if certain sales milestones are met. BDSI may also be entitled to receive tiered royalties on net sales of BELBUCA that start in the mid-teens. Based on current operations and forecasts, BDSI estimates that the $50 million dollar milestone payment from Endo, when combined with current cash on hand, provides BDSI with sufficient capital to operate its business to approximately the middle of 2017. "The FDA approval of BELBUCA is a major milestone for BDSI and a tribute to the exceptional working relationship between the teams at Endo and BDSI. I want to thank all of our employees at BDSI for achieving our third product approval," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "BELBUCA will provide a novel, alternative treatment option for millions of people suffering with chronic pain. Clinical trials demonstrated that twice daily administration of BELBUCA was well tolerated and controlled moderate to severe chronic pain. BELBUCA will also provide healthcare practitioners and their patients with a new buprenorphine treatment option. Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. Dr. Niraj Vasisht, Senior Vice President of Product Development and Chief Technical Officer at BDSI added, "Our patented BEMA delivery technology has enabled efficient and effective delivery of buprenorphine across the buccal mucosa and the seven approved dosages of BELBUCA will allow physicians to individualize titration and treatment based on the patient's analgesic needs."
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer agents, today announced that two abstracts have been selected for presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place November 5-9, 2015 in Boston, Massachusetts. Details for the presentations are as follows: CB-1158 Inhibits the Immuno-oncology Target Arginase, and Causes an Immune Mediated Anti-Tumor Response; Abstract #A195; Matthew Gross, Calithera Biosciences; Poster Session A, Tumor Immunology Targets; Friday, November 6, 2015 at 12:15-3:15 PM EST; Hynes Convention Center, Exhibit Hall C-D. Phase I study of CB-839, a First-in-class, Orally Administered Small Molecule Inhibitor of Glutaminase in Patients with Refractory Solid Tumors; Abstract #C49; Funda Meric-Bernstam, M.D., MD Anderson Cancer Center; Poster Session C, Clinical Trials; Sunday, November 8, 2015 at 12:30-3:30 PM EST; Hynes Convention Center, Exhibit Hall C-D. The meeting abstracts can be viewed online through the AACR website at www.AACR.org.
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory diseases, cancer, and sexual dysfunction, today announced the Company's Director of Business Development, Dr. Sari Fishman, will participate in BIO-Europe 2015 on November 2-4, 2015 in Munich, Germany. The 21st annual BIO-Europeis Europe's largest partnering conference serving the global biotechnology industry. Dr. Fishman is scheduled for over 30 meetings with decision makers at biotech and pharmaceutical companies interested in Can-Fite's pipeline of drug candidates including CF101 for autoimmune disease, CF102 for liver cancer, and CF602 for sexual dysfunction. "Having just received Orphan Drug Designation from the European Medicines Agency for CF102, this is a very good time for Can-Fite to be participating in partnering meetings in Europe. While we have licensing and distribution agreements for CF101 in South Korea and Canada, we are seeing increasing interest from pharma companies in other markets for each of our drug candidates," stated Can-Fite CEO Dr. Pnina Fishman.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that its Chief Medical Officer, Joseph Stauffer, D.O., M.B.A., will lead a track on "Technical Breakthroughs in Abuse Deterrence" at the 2nd Human Abuse Liability & Abuse-Deterrent Formulations conference on Tuesday, November 3, 2015, at the Hyatt Regency Bethesda in Bethesda, Maryland. In addition, Dr. Stauffer will deliver an oral presentation titled "Analyze the Scientific and Market Potential for Kappa Opioids" on Tuesday, November 3 from 11:00 to 11:45 a.m. ET, during which he will discuss developments in kappa opioid receptor agonists such as CR845, Cara's first-in-class peripherally-selective kappa opioid agonist, which has potential to be the only Schedule V or non-scheduled opioid for acute pain.
Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that the Board of Directors had appointed Michael Bruch Chief Financial Officer. Bruch (50), was appointed Interim Chief Financial Officer in May 2015. Prior to that he had served as Controller since joining the Company in 2003. As Controller he was responsible for the Company's Accounting and Internal Control functions. He also played a key role in integrating TotipotentRX after the 2014 merger between the two companies. Bruch has over 25 years of experience in various financial and managerial roles at a number of world-class companies, including General Electric and Dada Micro Scan (now Siemens Healthcare). He is a Certified Public Accountant and graduated with honors from California State University, Sacramento, with a Bachelor of Science degree in business administration. Robin C. Stracey, Cesca Therapeutics' CEO, commented, "I am delighted that Mike has accepted the position of Chief Financial Officer. He has done an outstanding job as Interim CFO, reinforcing our belief that he is the right person to lead the Company's Finance function as we continue our transformation into a fully integrated regenerative medicine company."
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), today announced an upcoming presentation of preclinical data from a study with the Company’s second generation cyclin dependent kinase (CDK) 2/9 inhibitor, CYC065, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, November 5-9, 2015, in Boston. The study evaluated the molecular rationale and dosing schedule of CYC065 for targeting tumors that are either dependent on sustained expression of CDK9 transcription targets, including Mcl-1 and MYC, or on activation of CDK2 by overexpression of cyclin E. Details of the presentation are as follows: Abstract Number: B182; Presentation Title: Molecular Basis for Clinical Development of the Novel CDK2/9 Inhibitor CYC065 in Oncology; Presentation Time: Saturday, November 7, 2015, 12:30 PM - 3:30 PM; Location: Exhibit Hall C-D; Poster Board Number: Poster Session B; Authors: Craig MacKay, Sheelagh Frame, Chiara Saladino, Elizabeth Pohler, Daniella Zheleva, David Blake. Cyclacel Ltd, Dundee, United Kingdom. The abstract can be accessed through the conference website, http://www.aacr.org/.
Endologix, Inc. (Nasdaq:ELGX) and TriVascular Technologies, Inc. (Nasdaq:TRIV) announced today that they have entered into a definitive merger agreement under which Endologix and TriVascular will combine in a stock and cash transaction. The transaction is valued at $9.10 per TriVascular share, or a total of approximately $211 million, based on Endologix's closing stock price of $13.81 per share on October 23, 2015. John McDermott, Chairman and Chief Executive Officer of Endologix, said, "This merger enhances the near and long-term growth potential of our business by bringing together two of the most innovative companies in the field of endovascular abdominal aortic aneurysm ("AAA") treatment. We believe the combined company will be uniquely positioned to provide physicians with three complementary products to treat a wide range of patient anatomies. These devices, the AFX®, Ovation® and Nellix® systems, each offer unique clinical advantages and together will offer physicians the ability to choose the best solution for each patient – all provided by one company. In addition to the existing products, the combined company will have a deep pipeline of new devices including AFX2 and the Ovation iX™ system that are both planned for market introduction by the first quarter of 2016. These new products are expected to be followed by additional new technologies including the launch of Nellix in the U.S., which is expected to receive PMA approval by the end of 2016." Mr. McDermott added, "In addition to the strong product portfolio, the merger brings together two experienced endovascular AAA sales and clinical teams in the U.S. and Europe. The combined organizations will provide broader coverage, increased clinical support and convenience for physicians and hospitals who want to access multiple technologies through a single company and representative." Christopher G. Chavez, President and Chief Executive Officer of TriVascular, said, "Endologix and TriVascular are two entrepreneurial companies that share a strong strategic focus on providing physicians with innovative and less invasive technologies to make endovascular aortic repair safer and available to more patients, including the significant number of patients with challenging aortoiliac anatomy. We believe physician and patient access to the Ovation platform will be significantly enhanced from a combined larger, stronger and more experienced field sales and service organization. We look forward to combining our significant and complementary expertise and capabilities for the benefit of our customers, patients, employees and stockholders."
Galena Biopharma (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that the Company will report its third quarter financial results on Monday, November 9, 2015 after the close of the financial markets. The company will host a webcast and conference call folllowing the announcement at 2:00 p.m. P.T./5:00 pm E.T. to discuss the financial results and provide a business update. The live webcast will include slides that can be accessed on the Company's website under the Investors section/Events and Presentations: http://investors.galenabiopharma.com/events.cfm. The conference call can be accessed by dialing (844) 825-4413 toll-free in the U.S., or (973) 638-3403 for participants outside the U.S. The Conference ID number is: 54883466. The archived webcast replay will be available on the Company's website for 90 days.
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that it will present clinical and preclinical data from its pipeline of targeted, investigational oncology medicines at the 27th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place in Boston on November 5-9, 2015. New results from the Phase 1 study of Loxo Oncology’s tropomyosin receptor kinase (TRK) inhibitor, LOXO-101, will be reported in a late-breaking oral presentation. This presentation was selected for inclusion in the press program, and as a result, only the abstract title will appear in the October 26, 2015 online data release. The study data will remain embargoed until November 8, 2015 at 10:30 a.m. Eastern Time. Loxo Oncology will also present two preclinical posters containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs. The posters will include in vitro and in vivo data on chemistry series showing potential best-in-class selectivity and target coverage profiles for these exciting emerging targets. Like TRK, RET and FGFR are known to participate in gene fusion events, and thus, activate cancers as single-gene alterations. In addition, RET and FGFR are also known to harbor activating gene mutations which are also likely to confer drug sensitivity. Loxo Oncology plans to use genetically driven patient enrollment strategies to demonstrate proof of efficacy early in clinical development for the RET and FGFR programs. Loxo Oncology recently announced enrollment of the first patient in its Phase 2 basket trial of LOXO-101. A basket trial is a new clinical trial design that enrolls patients based on a common, defining genetic feature of their cancer rather than based on an anatomic definition. General information about basket trial designs will be discussed in a plenary presentation on November 8, 2015 at 8:50 a.m. Eastern Time in the Veterans Memorial Auditorium by David Hyman, M.D. of Memorial Sloan Kettering Cancer Center, LOXO-101 global principal investigator.
MannKind Corporation (NASDAQ:MNKD) today announced the return of 9,000,000 shares of its common stock that were loaned to Bank of America, N.A. pursuant to a stock lending agreement dated August 18, 2010. The stock lending agreement was entered into to facilitate the establishment of hedge positions by investors in MannKind's offering Senior Convertible Notes due 2015, which closed on August 24, 2010. The stock lending agreement terminated a specified number of days following the date as of which the entire principal amount of Senior Convertible Notes due 2015 ceased to be outstanding and MannKind had settled all payments and deliveries in respect of such convertible notes, which occurred on August 17, 2015.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced topline results from the KEYNOTE-010 study of KEYTRUDA® (pembrolizumab) in advanced non-small-cell lung cancer (NSCLC) demonstrating that the trial met its primary objective. KEYNOTE-010 is a randomized, pivotal Phase 2/3 trial comparing two doses of KEYTRUDA (the FDA-approved 2mg/kg dose and a higher, investigational 10mg/kg dose, each given every 3 weeks), to docetaxel, a commonly used chemotherapy. Patients were enrolled who had failed prior systemic therapy for advanced NSCLC and whose tumors had PD-L1 (programmed death ligand-1) expression tumor proportion scores (TPS) of 1 percent or more. Outcomes were assessed in patients whose tumors were strongly PD-L1 positive (defined as TPS of 50 percent or more), and in all PD-L1 positive patients. A topline analysis revealed that treatment with KEYTRUDA was associated with longer overall survival (OS) compared with docetaxel treatment. This was true for both the approved and the investigational dose of KEYTRUDA, which showed similar efficacy. It was also true in both the first set of patients analyzed – those with a TPS of 50 percent or greater – and for all enrolled patients, all of whom had a TPS of 1 percent or greater. Treatment with KEYTRUDA, at both doses, also provided superior progression-free survival (PFS) versus that achieved following treatment with docetaxel in patients whose tumors had TPS values equal to or greater than 50 percent. For PFS, KEYTRUDA treatment was numerically but not statistically superior to docetaxel in the all PD-L1 positive group, again at both doses. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies in patients with advanced NSCLC. “The results from this trial provide part of a growing body of evidence supporting the potential of KEYTRUDA in the treatment of non-small-cell lung cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Advancing the standard of care in cancer requires a collaborative effort, and we are grateful to the patients, institutions and caregivers who participated in this study. We look forward to sharing our complete data with the scientific community and with regulatory agencies in the near future.”
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the recent publication of two peer-reviewed manuscripts that summarize the structural and biological assays used to evaluate equivalence between Glatopa™ and daily COPAXONE® 20 mg: “Demonstration of Equivalence of a Generic Glatiramer Acetate (Glatopa™),” in Journal of the Neurological Sciences, which can be found at: http://www.sciencedirect.com/science/article/pii/S0022510X15024740 "Equivalent Gene Expression Profiles between Glatopa™ and COPAXONE®,” in PLOS ONE, which can be found at: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0140299
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced positive top-line results from the Phase I study with YELIVA™ (ABC294640) in patients with advanced solid cancers. The study successfully met its primary and secondary endpoints, providing key information about the drug's safety, toxicities, pharmacokinetics (PK) and pharmacodynamics (PD), supporting the ongoing and planned Phase II studies with YELIVA™ (ABC294640). The top-line results from the Phase I study with YELIVA™ (ABC294640), demonstrating achievement of primary and secondary endpoints, were provided to RedHill by Apogee Biotechnology Corporation ("Apogee") and remain subject to the completion of an independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the clinical study report (CSR), expected by the end of the year or early 2016. Final results of the study will be presented in the appropriate scientific and medical forums following completion of the CSR. Charles D. Smith, Ph.D., Apogee's President and CEO, said: "Sphingosine kinase-2 (SK2) is a new potential target for anticancer therapy because it produces sphingosine 1-phosphate (S1P) which regulates cancer cell proliferation and inflammatory pathways. YELIVA™ (ABC294640), a first-in-class, orally-available inhibitor of SK2, is the only agent in its category in clinical trials. The drug has demonstrated anticancer activity in many preclinical models, and the results from this Phase I study in patients with advanced solid tumors indicate that it can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity."
Transcat, Inc. (NASDAQ:TRNS), today reported financial results for its second quarter ended September 26, 2015. Included in the reported results are those of five acquisitions over the last twelve months. Lee D. Rudow, President and CEO, commented, "Our Service segment performed to plan in the quarter with double-digit revenue growth and operating margin expansion, demonstrating strong operating leverage for the segment. However, we experienced a significant downturn in our Distribution segment due to the decline in the oil & gas industry combined with the strength of the U.S. dollar. We remain focused on initiatives to improve the performance of our Distribution segment and expect to continue to grow sales and gain market share in our higher-margin Service segment, both organically and through acquisitions." Second Quarter Fiscal 2016 Review (Results are compared with the second quarter of fiscal 2015); Second quarter consolidated revenue was $29.5 million, down $1.6 million, or 5.3%, over the prior-year period. Service segment revenue grew $1.6 million, or 12.7%, offset by a $3.2 million, or 17.4%, decline in Distribution segment sales. Second quarter consolidated gross profit declined 2.7% to $6.7 million. As a percentage of total revenue, gross profit was 22.9%, an improvement of 60 basis points over the prior fiscal year period. Second quarter consolidated operating income fell $0.1 million to $1.4 million. The year-over-year decline was driven by reduced volume in the Distribution segment, which was not fully offset by the operating leverage achieved on Service segment revenue growth. Net income was $0.9 million, a 2.2% increase over the prior-year period. Diluted earnings per share were $0.12, consistent with the prior-year period. Adjusted EBITDA was $2.4 million, consistent with the second quarter of 2015. Adjusted EBITDA as a percent of total revenue improved 40 basis points to 8.1%. See Note 1 on page 4 for a description of this non-GAAP financial measure and page 9 for the Adjusted EBITDA Reconciliation table.
TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation® Abdominal Stent Graft platform, today reported preliminary unaudited financial results for the third quarter ended September 30, 2015. Preliminary revenue for the third quarter of 2015 is expected to be approximately $9.5 million, reflecting growth of 20% over the third quarter of 2014 on a reported basis and 23% on a constant currency basis. Based on these preliminary estimates, US revenue is expected to be $6.5 million, reflecting growth of 20% year-over-year, and revenue from international customers is expected to be $3.0 million, reflecting growth of 19%, or 31% on a constant currency basis. "Our third quarter revenue demonstrates continued adoption of the Ovation platform, a clinically proven, less invasive solution for treatment of the broadest range of AAA anatomies," said President and Chief Executive Officer, Chris Chavez. "This afternoon we announced that we entered into a definitive merger agreement with Endologix, Inc. We are pleased to join Endologix, as we believe the combined capabilities and differentiated technologies of both companies following the closing of the merger, currently expected to be in early 2016, will allow us to more effectively advance our goal to improve and expand EVAR safely for more patients."
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced today that its Audit and Risk Committee and the full Board of Directors have reviewed the company's accounting for its Philidor arrangement and have confirmed the appropriateness of the company's related revenue recognition and accounting treatment. Based on its review conducted to date, Valeant also believes that the company is in compliance with applicable law. In light of the recent allegations made regarding Philidor, however, the Board of Directors has decided to establish an ad hoc committee of the board to review allegations related to the company's business relationship with Philidor and related matters. The committee will be chaired by Robert Ingram, the company's lead outside director. Other members will include Norma Provencio, chairman of the audit and risk committee; Colleen Goggins; and Mason Morfit, who has been appointed to the Board as an independent director. "As we have said previously, our accounting with respect to the Company's Philidor arrangements is fully compliant with the law," J. Michael Pearson, Chairman of the Board and Chief Executive Officer of Valeant said. "However, other issues have been raised publicly about Philidor's business practices, and it is appropriate that they be fully reviewed. This decision to create an ad hoc committee of the board, which I fully support, will help free management to focus on continuing to serve doctors and patients and run our business." "We operate our business based on the highest standard of ethics, and we are committed to transparency. These values are at the core of our business model, and if we find violations we will take appropriate action," Pearson said. "The board has complete confidence in Mike Pearson's performance as CEO and has fully supported the company's specialty pharmacy strategy. Mike operates with the highest degree of ethics, and we believe it is important that he and the management team be allowed to focus their efforts on continuing to serve patients and doctors and create long term value for our thousands of individual and institutional shareholders," Ingram said.
XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C. difficile) infection. Using its proprietary True Human technology, the Company has begun screening human blood samples from donors to identify and clone a therapeutic antibody candidate from individuals with natural immunity to C. difficile infection. C. difficile is the causative organism of antibiotic-associated pseudomembranous colitis, a potentially devastating inflammatory condition of the colon. The incidence of C. difficile infection has risen sharply over the last two decades and today is a leading cause of morbidity and mortality in hospital-acquired infections in the U.S. According to the U.S. Centers for Disease Control and Prevention (CDC), C. difficile is estimated to have caused almost half a million infections in the U.S. in 2011, with 29,000 deaths, often occurring within 30 days of initial diagnosis. Eight out of 10 deaths related to C. difficile infection in the U.S. occur in patients 65 years of age or older, where recurrent infections are common, and estimated treatment cost per infection ranges from $6,000-$9,000. John Simard, President and CEO of XBiotech, stated, "This program represents more than the addition of a new anti-infective product to our development pipeline. A successful True Human candidate could be the first oral monoclonal antibody against C. difficile, and a model for an oral antibody therapy approach. Recent outbreaks and increased virulence of C. difficile suggest the urgent need to identify novel approaches to treat the disease. We are eager to bring XBiotech's technology to develop a potential safe and effective therapy for this disease."
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has initiated a Phase 2 proof-of-concept study to evaluate the safety and ability to prevent hypoglycemia (dangerously low blood sugar) of a single dose of XOMA 358 in patients with congenital hyperinsulinism (HI). XOMA 358 is a fully human allosteric monoclonal antibody that reduces insulin receptor activity. HI is a genetic disorder in which the beta cells of the pancreas secrete excessive insulin that causes hypoglycemia, which can lead to brain damage or, in rare cases, death. HI is a rare disease, affecting approximately 1 in 50,000 newborns. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to XOMA 358 for the treatment of HI. "New treatments that safely and effectively attenuate insulin-induced hypoglycemia are needed for patients with congenital hyperinsulinism, as well as other diseases that cause hypoglycemia due to high insulin levels. There are no approved medications, and those currently used have inconsistent efficacy and issues with tolerability. Current disease management options are limited to continuous ingestion or infusion of glucose or surgical removal of part or all of the pancreas," said Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA. "We are developing XOMA 358 as a first-in-class therapeutic for patients with this potentially fatal disease, and we are pleased to be conducting this study at a world-class medical center recognized for its leadership in treating HI patients."