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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.

Erceg M.,PLIVA Inc | Vertzoni M.,National and Kapodistrian University of Athens | Ceric H.,PLIVA Inc | Dumic M.,University of Rijeka | And 2 more authors.
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2012

In this study, we evaluated the usefulness of biorelevant in vitro data and of canine data in forecasting early exposure after the administration of two phases of a BCS Class II compound, i.e., doxazosin base (DB) and its mesylate salt (DM). DB, DM, and doxazosin hydrochloride (DH) were prepared and characterized. In vitro data were collected in various media, including human aspirates. Solubilities of DB and DM in human gastric fluid were forecasted by data in fasted state simulating gastric fluid containing physiological components (FaSSGF-V2) but not by data in HCl pH 1.8. Unlike data in FaSSGF-V2, dissolution of DB and DM tablets in HCl pH 1.6 is rapid. Dissolution of DB tablet in FaSSGF-V2 is incomplete and conversion to DH seems to occur. Differences between DB and DM in dissolution in the small intestine are overestimated in the absence of physiological solubilizers. Using the in vitro data and previously described modeling procedures, the cumulative doxazosin profile in plasma was simulated and the 0-2 h profile was used for evaluating early exposure. Individual cumulative doxazosin profiles in plasma, after single DM tablet administrations to 24 adults, were constructed from corresponding actual plasma profiles. Compared with in vitro DM data in pure aqueous buffers, DM data in biorelevant media led to better prediction of early exposure. Based on intersubject variability in early exposure after DM administration and simulated profiles, the administered phase, DB or DM, does not have a significant impact on early exposure. Partial AUCs were used for evaluating early exposure after DB and DM administration in 4 dogs. Early exposure was significantly higher after administration of DM to dogs. Dogs are not appropriate for evaluating differences in early exposure after DB and DM administrations. © 2011 Elsevier B.V. All rights reserved.

Kwokal A.,PLIVA Inc | Cavuzic D.,PLIVA Inc | Roberts K.J.,University of Leeds
Crystal Growth and Design | Year: 2013

Crystallization of entacapone (E-2-cyano-N,N-diethyl-3-(3,4-dihydroxy-5- nitrophenyl) propenamide) in acetone solution at the 500 mL scale using a self-assembled layer of the host material on Au(111) as a seeding template was studied and monitored using attenuated total reflectance (ATR)-UV-vis spectroscopy and focused beam reflectance measurement (FBRM). The data reveal that the template promotes crystal growth at lower supersaturations and at an increased rate when compared to experiments carried out without the template. Crystals prepared using the template are also found to have superior properties compared to crystals produced without the template. Notably, use of the template produces crystals with a much narrower size distribution, greatly increased perfection and a more equant crystal morphology. These observations are consistent with the template providing a sympathetic surface for the promotion of crystallization through an analogous mechanism to that associated with conventional seeding, but with the added advantage of conferring a well-ordered, easily reproducible and more robust process. © 2013 American Chemical Society.

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).

Milovac N.,University of Zagreb | Juretic D.,University of Zagreb | Kusic H.,University of Zagreb | Dermadi J.,PLIVA Inc | Bozic A.L.,University of Zagreb
Industrial and Engineering Chemistry Research | Year: 2014

The UV/H2O2 process was applied for the degradation of aromatic carboxylic acids (ACAs). Benzoic acid, salicylic acid, gentisic acid, and gallic acid are chosen as typical water pollutants representing ACAs with the increased number of hydroxyl groups. The effect of the structural characteristics of ACAs and UV/H2O2 process parameters on their degradation kinetics was investigated by a statistical/empirical approach employing the design of experiments and response surface methodology. Different optimal conditions for maximal degradation rates were established, while degradation rates followed the decreasing order benzoic acid > salicylic acid > gentisic acid > gallic acid with the increasing number of hydroxyl groups. The inversed order was established in the case of mineralization kinetics. Structurally influenced degradation pathways of studied ACAs, with the shared sequence related to the preferable hydroxylation position at the benzene ring, are reflected in the observed changes in the biodegradability and toxicity toward Vibrio fischeri during UV/H2O2 treatment. © 2014 American Chemical Society.

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.

A new azithromycin-based series of antibacterial macrolones is reported, which features the use of a 4′-ester linked glycin for tethering the quinolone side chain to the macrolide scaffold. Among the analogs prepared, compounds 9e and 22f with a quinolon-6-yl moiety were found to have potent and well-balanced activity against clinically important respiratory tract pathogens, including erythromycin-susceptible and MLSB resistant strains of Streptococcus pneumoniae, Streptococcus pyogenes, and Haemophilus influenzae. In addition, potential lead compounds 9e and 22f demonstrated outstanding levels of activity against Moraxella catarrhalis and inducibly MLSB resistant Staphylococcus aureus. The best member of this series 22f rivals or exceeds, in potency, some of the most active ketolide antibacterial agents known today, such as telithromycin and cethromycin. © 2016 Elsevier Ltd. All rights reserved.

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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