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News Article | July 19, 2017

"I am thrilled to have Raffi join our team. He is an accomplished financial executive who has held leadership roles in large multinational, specialty pharmaceutical and life sciences companies," said Vince Angotti, chief executive officer of AcelRx Pharmaceuticals. "His global financial and business leadership expertise along with significant transactional experience will be a valuable addition to AcelRx as we evolve into a commercial stage company." Prior to joining Amyris, Mr. Asadorian was the CFO for Unilabs, a private equity owned medical diagnostics company. At Unilabs, Mr. Asadorian led finance, corporate development, and investor relations, and was directly involved in defining and implementing the firm's overall strategy. Mr. Asadorian started his career at PricewaterhouseCoopers (PwC) where, as a partner in its Transaction Services group, he advised clients on mergers and acquisitions, joint ventures and related transactions and financings. While at PwC he advised Barr Pharmaceuticals on their acquisition of PLIVA and, after its acquisition, Mr. Asadorian joined Barr as SVP and CFO of its PLIVA subsidiary. In that role he oversaw a global finance team and was responsible for Barr's ex-US financial operations, until its acquisition by Teva Pharmaceuticals. "This is an exciting time to join AcelRx, especially with multiple upcoming milestones in the US and EU that have the potential to transform the company," commented Mr. Asadorian. "It is clear that the company has an experienced management team and a robust portfolio of late stage assets.  I look forward to contributing to this dynamic organization and its growth. " About AcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. A New Drug Application (NDA) for DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the United States Food and Drug Administration (FDA) and has been given a PDUFA date of October 12, 2017. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has passed validation and that the scientific review of the MAA is underway. The company's follow on product candidate, ZALVISO® (sufentanil sublingual tablet system), is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has completed enrollment in a Phase 3 clinical trial, IAP312, for which it anticipates top-line data results in mid-2017. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has begun. For additional information about AcelRx's clinical programs, please visit Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the European Medicines Agency (EMA) scientific review of the ARX-04 Marketing Authorisation Application (MAA); the DSUVIA and ARX-04 clinical trial results; AcelRx's pathway forward towards gaining approval of ZALVISO in the U.S., including successful completion of the IAP312 clinical study for ZALVISO; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for DSUVIA, ARX-04 and ZALVISO. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA, the EMA review of the ARX-04 MAA, and the possibility that the FDA or EMA may dispute or interpret differently clinical results obtained from the DSUVIA or ARX-04 Phase 2 and 3 studies; the ZALVISO development program, including successful completion of IAP312 and the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process, including adverse events; the success, cost and timing of all development activities and clinical trials, including the additional clinical trial for ZALVISO, IAP312; the accuracy of AcelRx's estimates regarding expenses, capital requirements and the need for financing; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on May 8, 2017. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Dinter D.,PLIVA Inc | Gajski G.,Institute for Medical Research and Occupational Health | Garaj-Vrhovac V.,Institute for Medical Research and Occupational Health
Journal of Applied Toxicology | Year: 2013

Atovaquone, a hydroxynaphthoquinone, is an anti-parasite drug, selectively targeting the mitochondrial respiratory chain of malaria parasite. It is used for both the treatment and prevention of malaria, usually in a fixed combination with proguanil. Although atovaquone has not often been associated with severe adverse reactions in the recommended dosages and has a relatively favorable side effect profile, the present study was undertaken to evaluate its cytogenotoxic potential towards human peripheral blood lymphocytes. Two different concentrations of atovaquone found in plasma when used in fixed-dose combination with proguanile hydrochloride were used with and without S9 metabolic activation: 2950ngml-1 used for prophylactic treatment and 11 800ngml-1 used in treatment of malaria. The results showed that lymphocyte viability was not affected after the treatment, suggesting that atovaquone was not cytotoxic in the given concentrations. With the alkaline comet assay we demonstrated that in human peripheral blood lymphocytes no significant changes in comet parameters occurred after the treatment. There were no differences in tested parameters with the addition of S9 metabolic activation, indicating that atovaquone either has no metabolite or it is not toxic in the given concentrations. Since no effects were observed after the treatment, it is to be concluded that atovaquone is safe from the aspect of genototoxicity in the recommended dosages. Copyright © 2011 John Wiley & Sons, Ltd. The present study evaluated the cytogenotoxic potential of antimalarial drug atovaquone towards human lymphocytes. Two different clinically relevant concentrations of atovaquone obtained from the plasma concentrations used for prophylactic treatment and the treatment of malaria were used with and without S9 metabolic activation. Atovaquone was not cytogenotoxic in the given concentrations, regardless of metabolic activation. Since no effects were observed after the treatment, it is to be concluded that atovaquone is safe from the aspect of genototoxicity. © 2011 John Wiley & Sons, Ltd.

Pepic I.,University of Zagreb | Lovric J.,University of Zagreb | Cetina-Cizmek B.,PLIVA Inc | Reichl S.,TU Braunschweig | Filipovic-Grcic J.,University of Zagreb
Drug Discovery Today | Year: 2014

The development and registration of reformulated ophthalmic products (OPs) requires eye-related bioavailability (BA) assessments. Common BA algorithms associated with other routes of application, such as the oral route, cannot be easily applied to eye-related BA testing. Here, we provide an analysis of the current literature and suggestions for further directions in the development of high-capacity, cost-effective, and highly predictive nonclinical models of eye-related drug BA. One, or a combination of these models, has the potential for routine use in research laboratories and/or the pharmaceutical industry to overcome various obstacles in reformulated OP development and registration. © 2013 Elsevier Ltd. All rights reserved.

Vanic Z.,University of Zagreb | Hurler J.,University of Tromsø | Ferderber K.,PLIVA Inc | Golja Gasparovic P.,PLIVA Inc | And 2 more authors.
Journal of Liposome Research | Year: 2014

Deformable propylene glycol-containing liposomes (DPGLs) incorporating metronidazole or clotrimazole were prepared and evaluated as an efficient drug delivery system to improve the treatment of vaginal microbial infections. The liposome formulations were optimized based on sufficient trapping efficiencies for both drugs and membrane elasticity as a prerequisite for successful permeability and therapy. An appropriate viscosity for vaginal administration was achieved by incorporating the liposomes into Carbopol hydrogel. DPGLs were able to penetrate through the hydrogel network more rapidly than conventional liposomes. In vitro studies of drug release from the liposomal hydrogel under conditions simulating human treatment confirmed sustained and diffusion-based drug release. Characterization of the rheological and textural properties of the DPGL-containing liposomal hydrogels demonstrated that the incorporation of DPGLs alone had no significant influence on mechanical properties of hydrogels compared to controls. These results support the great potential of DPGL-in-hydrogel as an efficient delivery system for the controlled and sustained release of antimicrobial drugs in the vagina. © 2014 Informa Healthcare USA, Inc.

As a member of the healthcare team, one of the important roles of a pharmacist is to provide the patients and healthcare professionals with accurate and clear information regarding safe and effective drug use. However, quick developments in the area of medicine, pharmacy and associated industries are bringing new products to the market every day. Consequently, education gained through the faculty of pharmacy cannot satisfy all the patients’ and consumers’ needs for medicines information. In addition to the continuous professional education, the pharmacists need access to quick and up-to-date sources of drug information. This paper presents the results of a cross-sectional study on drug information used by pharmacists in Croatia and their knowledge of the black triangle symbol for the products under additional monitoring. The study took place in 2014, 107 pharmacists employed in the Croatian community and hospital pharmacies participated. The study results conclude that there is a need for education on the topics of Summary of product Characteristics, on the meaning of the black triangle symbol, and availability of evidence-based medicine databases (such as Cochrane) and database on drug use during breastfeeding (LACTMED). © 2017, PLIVA d.d. All rights reserved.

Kwokal A.,PLIVA Inc | Roberts K.J.,University of Leeds
CrystEngComm | Year: 2014

The ability to direct the surface crystallisation of different polymorphs of entacapone by tuning the electrochemical potential of Au(100) templates is demonstrated. Under quiescent conditions, without polarization (at open circuit potential), entacapone crystallises in its stable form A on the template surface and concomitantly in its metastable form D in the bulk solution. When Au(100) is negatively polarized (-150 mV), form D is still formed in the bulk solution but the metastable form α is found to crystallise at the edges of the template. Both crystals of form A and α were observed to grow epitaxially over the Au template surface. The electrochemical templating effect is consistent with the polarisation changing the structure of the initially adsorbed layers of supersaturated solution at the template surface which directs the nuclei formation and the subsequent crystal growth processes. This study demonstrates, for the first time, the direction of polymorphic form using a low field polarized nucleation template. © 2014 the Partner Organisations.

Orsolic N.,University of Zagreb | Car N.,PLIVA Inc
Tumor Biology | Year: 2014

Nephrotoxicity, hepatotoxicity, myelosuppression, and genotoxicity are the major limitation for the clinical use of cisplatin as an anti-tumoural drug. Hyperthermia enhances the clastogenicity of cisplatin. In addition, hyperthermia is a promising approach for cancer therapy because it not only kills cancer cells directly, but also activates anti-cancer immunity as an indirect effect. The aim of this study was to determine whether preventive treatment with quercetin (QU) can reduce cisplatin-induced DNA damage in liver, kidney and blood cells and whether QU has the potential to serve as a beneficial supplement before cisplatin hyperthermal intraperitoneal chemotherapy (HIPEC) in order to gain immunomodulatory responses of mice to the tumor. Preventive treatment of mice with QU (50 mg kg-1) had a protective effect on cisplatin-induced DNA damage in normal cells, except kidney cells, in both normothermic and hyperthermic conditions without interfering with the antitumor efficacy of the combined regimen. Immunostimulation by QU is stressed as an important factor in the tumor-inhibiting effect of hyperthermia in addition to the well known selective heat killing of neoplastic cells. In conclusion, these results suggested that preventive treatment with QU could protect the blood, liver and kidney cells of mice against HIPEC-induced injury and increase survival of mice by improving the antitumor adaptive immunity with hyperthermia. © 2014 International Society of Oncology and BioMarkers (ISOBM).

Leksic E.,PLIVA Inc | Pavlovic G.,University of Zagreb | Mestrovic E.,PLIVA Inc
Crystal Growth and Design | Year: 2012

Four novel lamotrigine cocrystals, namely, 1:1 lamotrigine:phthalimide (1), 1:1:1 lamotrigine:pyromellitic diimide:DMF (2), 2:1:0.64 lamotrigine:caffeine: 3-pentanone (3), and 1:1 lamotrigine:isophthaldehyde (4), were discovered using a combined hot-stage thermomicroscopy and differential-scanning calorimetry screening technique. The utilized cocrystal screening method is rapid, requires the use of small amounts of material, and is highly suitable for compounds that are prone to solvate formation. The structurally characterized cocrystals were prepared in an attempt to develop lamotrigine cocrystals based on cocrystal formers involving carbonyl and amide functional groups. The prepared cocrystals are sustained by N-H(amide)•••N(pyridyl), N-H(amino) •••O(amide), and N-H(amino)•••O(carbonyl) hydrogen bonds. © 2012 American Chemical Society.

Pavlovic D.,PLIVA Inc | Pavlovic D.,Bar - Ilan University | Mutak S.,PLIVA Inc
ACS Medicinal Chemistry Letters | Year: 2011

A series of novel C-4″-substituted azithromycins was synthesized and evaluated for in vitro antibacterial activity against a panel of representative erythromycin-susceptible and macrolide-lincosamide-streptogramin (MLS) resistant pathogens. In summary, azithromycin and quinolone substructures merged in a mutually SAR-compatible design gave rise to a new class of antimicrobials with an improved spectrum and potency over azithromycin. Prototypical analogues 7f and 8f display an improved potency versus azithromycin against Gram-positive and fastidious Gram-negative pathogens. In particular, these new leads maintain activity against MLS-resistant strains of Streptococcus pneumoniae and Streptococcus pyogenes. In addition, they represent an improvement over telithromycin (1) and cethromycin (2) against the fastidious Gram-negative pathogen Haemophilus influenzae. © 2011 American Chemical Society.

Pavlovic D.,PLIVA Inc | Mutak S.,PLIVA Inc
Journal of Medicinal Chemistry | Year: 2010

A series of novel 6-O-substituted 8a-aza-8a-homoerythromycin A ketolides was synthesized and evaluated for in vitro antibacterial activity. Key strategic elements of the synthesis include the base-induced E-Z isomerization of 3-O-descladinosyl-6-O-allylerythromycin A 9(E)-oxime followed by ring-expanding reaction of the resulting 9(Z)-oxime via Beckmann rearrangement. The ketolides showed potent activity against a variety of erythromycin-susceptible and macrolide-lincosamide-streptogramin B (MLSB) resistant Gram-positive and fastidious Gram-negative pathogens. The best compounds in this series overcome all types of resistance in relevant clinical Gram-positive pathogens and display in vitro activity comparable to telithromycin and cethromycin. © 2010 American Chemical Society.

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