La Jolla Pharmaceutical Company Closes Offering of Common Stock

SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced the closing of its underwritten public offering of 5,395,000 shares of common stock at a public offering price of $10.50 per share, which includes the partial exercise of the underwriters’ option to purchase up to an additional 720,000 shares of common stock. Gross offering proceeds are approximately $56.6 million, including proceeds from the partial exercise of the underwriters’ option to purchase additional shares, before deducting customary underwriting discounts and commissions and offering expenses. La Jolla intends to use the net proceeds from the offering for general corporate purposes, including funding its ongoing and future clinical trials, and for general and administrative expenses. Jefferies LLC acted as sole book-runner for the offering. Chardan Capital Markets, LLC, H.C. Benzac (Benzoyl Peroxide) with no Rx Wainwright & Co., LLC, LifeSci Capital, LLC and Noble Financial Group, Inc. Betagan (Levobunolol) with no prescription acted as co-managers for the offering. The securities described above were offered pursuant to a shelf registration statement (File No. Buy Benzac (Benzoyl, Peroxide) with free Rx 333-197092), including a base prospectus, which was declared effective by the United States Securities and Exchange Commission (“SEC”) on July 11, 2014. About Cyklokapron with no Rx The specific terms of the offering are described in a prospectus supplement filed with the SEC in connection with the offering. Buy Progesterone Cream online This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. http://webmdreview.wordpress.com The offering was made only by means of the prospectus supplement and accompanying prospectus, copies of which may be obtained at the SEC’s website at .sec.gov, or by request at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: Prospectus_Department@Jefferies.com.

Samenvatting Iroko Pharmaceuticals sluit overeenkomst over ZORVOLEX in Latijns-Amerika

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Samenvatting GVK BIO lanceert nieuwe medisch-wetenschappelijke dienstverlener

. About Zanaflex (Tizanidine) without Rx MUMBAI, India--(BUSINESS WIRE)--GVK Biosciences heeft vandaag zijn nieuwe merk CLINOGENT onthuld. Co-dergocrine Mesylate De grootste Aziatische organisatie voor onderzoek en ontwikkeling brengt CLINOGENT op de markt voor medische ontwikkeling. CLINOGENT verleent end-to-enddiensten op medisch gebied, zoals onderzoek naar bio-equivalentie voor generische geneesmiddelen en pati"entonderzoeken in de laatste fases. Buy Nail Care online Hierbij brengt CLINOGENT wereldwijd uitzonderlijke expertise in oplossingen voor complexe data-analyse en problemen met de communicatie naar de consument. http://webmdreview.wordpress.com Buy Hard On Oral Jelly (Sildenafil Citrate) with no prescription De nieuwe onderneming zet zich in voor innovatieve oplossingen voor alle medische en wetenschappelijke uitdagingen die zijn klanten tegenkomen in de sector. Deze bekendmaking is officieel geldend in de originele brontaal. Kamagra Effervescent (Sildenafil Citrate) with free prescription Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

Howard Murad, M.D. Receives Lifetime Achievement “Visionary” Award at The Aesthetic Show

EL SEGUNDO, Calif.--(BUSINESS WIRE)--Howard Murad, M.D., founder of Murad, Inc., and the Inclusive Health® movement, received the Aesthetic Visionary Award for Lifetime Achievement at The Aesthetic Show’s annual Aesthetic Awards in Las Vegas this past weekend. Presenting the award to Dr. Murad, Andrew Ordon, M.D., host of the daytime talk show, “The Doctors,” also announced that for all future Aesthetic Award ceremonies, the lifetime achievement award will be referred to as “The Howard Murad, M.D. Aesthetic Visionary Award.” Recognized for his tireless research and contributions to science, healthy living and skincare, Dr. Dostinex (Cabergoline) without prescription Murad thanked the fellow medical professionals who had selected him for the honor and said, “The future of medicine is now. Droxia (Hydroxyurea) with free prescription By focusing on each patient as a whole person, instead of merely spot treating specific symptoms, we can truly help people unlock their potential to look younger, feel younger and live healthier, happier and more rewarding lives.” The Aesthetic Show, held this year at Wynn Las Vegas Resort, is the largest global medical education meeting focused on aesthetic medicine. Buy Diovan (Valsartan) with no prescription The Aesthetic Awards close the show each year to honor the best procedural outcomes and innovations by medical aesthetic physicians in the country, as selected by a panel of physician peers. Earlier in the weekend, Dr. Desolett with free Rx Murad delivered the event’s keynote address, in which he shared his Inclusive Health research and philosophies with other physicians attending the event. Buy Spices online Dr. http://webmdreview.wordpress.com Murad was also featured among the Aesthetic Visionaries sharing insights at the show’s opening session and welcome address. “It’s been a great honor to have Dr. Murad, a true medical thought leader and icon, on our stage sharing his insights and research pertaining to Inclusive Health and how the aesthetic medical community can take their existing procedures to the next level,” said Michael Moretti, President and Publisher of Medical Insight, Inc. and Chairman of The Aesthetic Show. “We couldn’t think of a more deserving recipient of our Aesthetic Visionary Award and are thrilled that the honor will bear his name moving forward.” For information about the work and career of Dr. Murad or to learn more about Inclusive Health, please visit MuradInclusiveHealth.com. ABOUT MURAD, INC. Murad was founded in 1989 by Dr. Howard Murad, a board certified dermatologist, trained pharmacist and Associate Professor at the UCLA, Geffen School of Medicine. Murad offers people a path to youthful good health through science-based, clinically-proven skincare and healthcare products that have been developed as part of Dr. Murad’s Inclusive Health® system of care. With a full range of skin-condition-specific, high-performance products for home and spa—backed by 19 unique patents for advancing the science of skin health and a 30 year legacy of research and clinical testing—millions of people look to Murad with confidence for products, services and tools to help them look, live and feel Better Every Day®. Murad is used and recommended by over 30,000 professionals all across the globe and is sold in over 35 countries. For more information go to Murad.com, Facebook.com/DrHowardMurad or @DrMurad on Twitter.

Aerie Pharmaceuticals Initiates Phase 3 Registration Trials of RhopressaTM, Novel Triple-Action Product to Lower Intraocular Pressure in Patients with Glaucoma

BEDMINSTER, N.J. & RESEARCH TRIANGLE PARK, N.C. & NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. Buy Hard On Oral Jelly (Sildenafil Citrate) with no prescription (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced that on July 11, dosing commenced of the first patients enrolled in the Company’s Phase 3 registration clinical trials of RhopressaTM, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Kamagra Effervescent (Sildenafil Citrate) with free prescription Aerie anticipates total enrollment of approximately 1,300 patients in three Phase 3 registration trials of RhopressaTM. About Zanaflex (Tizanidine) without Rx The trials will measure efficacy over three months and safety over 12 months. Co-dergocrine Mesylate The primary efficacy endpoint of the trials will be to demonstrate non-inferiority of IOP lowering for RhopressaTM compared to timolol. Buy Nail Care online Timolol is the most widely used comparator in registration trials for glaucoma. http://webmdreview.wordpress.com There will be two trials conducted in the United States, named “Rocket 1” and “Rocket 2,” and one safety-only study in Canada, named “Rocket 3.” Brian Levy, O.D., M.Sc., Aerie’s Chief Medical Officer, commented, “The initiation of the RhopressaTM Phase 3 clinical trials follows previous positive findings in Phase 2b trials, in which RhopressaTM demonstrated strong and consistent IOP lowering, irrespective of the patient’s baseline IOP. In contrast, currently marketed IOP-lowering agents, including prostaglandin analogues (PGAs), have been shown to be less effective at lower baseline IOPs, as reported in published studies. We believe this will be a key differentiation for RhopressaTM, along with targeting the trabecular meshwork, which is the diseased tissue in glaucoma. Furthermore, RhopressaTM has been shown to lower episcleral venous pressure, which may add to the IOP-lowering efficacy particularly at lower baseline IOPs.” Pending success of the studies and regulatory approval, Aerie expects RhopressaTM to compete against PGA products as an initial therapy for patients with IOPs of 26 mmHg or below at the time of diagnosis, which represents the significant majority of patients with glaucoma and ocular hypertension. Additionally, the Company believes RhopressaTM may be used as the add-on product of choice for patients on PGA therapy requiring further IOP lowering, due to its strong and consistent IOP-lowering effect, once-daily dosing and ability to target the trabecular meshwork. PGAs target the secondary uveoscleral outflow mechanism, which is not the diseased tissue in glaucoma. Aerie also believes Rhopressa™ may become the product of choice where PGAs may be contraindicated and for patients who are not responsive to PGAs or choose to avoid the cosmetic issues associated with PGAs. “The advancement of RhopressaTM into pivotal trials, following our recent reporting of positive RoclatanTM Phase 2b results last month, underscores Aerie’s commitment to delivering innovative medicines that hold promise for individuals with glaucoma,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “Given our current timelines, we expect to report top-line three-month efficacy results from the RhopressaTM Phase 3 clinical program in the middle of next year, and assuming successful data, we would be on track to file an NDA by mid-2016. With each advancement, we can further maximize the value of our lead programs in anticipation of regulatory approvals and ultimate commercialization.” Triple-Action RhopressaTM RhopressaTM is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Recent preclinical results have demonstrated that RhopressaTM also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). In the Company’s Phase 2b clinical trial, which was successfully completed in June 2013, RhopressaTM demonstrated a strong IOP-lowering effect, with mean IOP reductions of 5.7 and 6.2 mmHg on days 28 and 14, respectively. In addition, RhopressaTM demonstrated a consistent mean IOP-lowering effect irrespective of the baseline IOPs of the patients entered into the trial. This differentiates RhopressaTM from currently marketed IOP-lowering agents such as market-leading PGAs and beta blockers, which have their highest effect at higher baseline IOPs, while losing efficacy as the baseline diminishes, as shown in published studies. This is significant given that the significant majority of glaucoma patients have low to moderately elevated IOPs of 26 mmHg or below at the time of diagnosis. In the RoclatanTM Phase 2b trial recently completed in June 2014, RhopressaTM performed with similar results as it had in its Phase 2b trial completed in June 2013 and in addition demonstrated additive efficacy when used in combination with latanoprost, the most commonly prescribed PGA. Pending successful advancement of the Phase 3 registration studies, three-month efficacy results are expected to be released in mid-2015. If the trials are successful, the Company expects to submit a New Drug Application filing by mid-2016. About Aerie Pharmaceuticals, Inc. Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies. The Company is commencing two Phase 3 registration trials in the United States, named “Rocket 1” and “Rocket 2,” where the primary efficacy endpoint will be to demonstrate non-inferiority of IOP lowering for RhopressaTM compared to timolol, along with a third Phase 3 registration safety-only trial, named “Rocket 3,” in Canada. The Company also recently completed a Phase 2b clinical trial where RoclatanTM met the primary efficacy endpoint, demonstrating the statistical superiority of RoclatanTM to each of its components. Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; and our ability to protect our proprietary technology and enforce our intellectual property rights. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading "Risk Factors" in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

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Study New Cancer Care Payment Model Reduced Health Care Costs, Maintained Outcomes

MINNETONKA, Minn.--(BUSINESS WIRE)--A new cancer care payment model that rewards physicians for focusing on best treatment practices and health outcomes rather than the number of drugs they prescribe resulted in significant cost savings without affecting the quality of care. The three-year study, conducted by UnitedHealthcare and five medical oncology groups around the country, covered 810 patients with breast, colon and lung cancer, which are among the most common cancers in the United States, according to the National Cancer Institute. The pilot demonstrated that the new cancer care payment model resulted in a 34 percent reduction in medical costs. The details of the pilot were published today in the peer-reviewed publication Journal of Oncology Practice. The report, “Changing Physician Incentives for Affordable, Quality Cancer Care: Results of an Episode Payment Model,” demonstrates the potential effectiveness of new approaches to the current “fee-for-service” payment model for cancer therapy. Costs for cancer therapy, which were estimated by the National Cancer Institute at $124.6 billion in 2010, are projected to reach as high as $207 billion in 2020, suggesting there is an urgent need to rein in costs while finding the most effective treatments. Cancer therapy accounts for 11 percent of UnitedHealthcare’s commercial health plan spend and is expected to increase in the coming years. “The study, evaluating how physicians might be rewarded for improving clinical outcomes and reducing treatment costs rather than paying them based on the number of drugs administered to treat cancer, demonstrated a significant reduction in total costs for medical care without affecting the quality of care,” said Lee Newcomer, M.D., senior vice president of oncology at UnitedHealthcare and one of the article’s authors. About Lopressor (Metoprolol) with free Rx “These new payment models benefit patients, doctors, payers and the entire health system, and are particularly important as the nation faces ever-increasing health care costs.” The Journal of Oncology Practice article was co-authored by Dr. About Lotemax (Loteprednol) with free Rx Newcomer; Bruce Gould, M.D., medical director, Northwest Georgia Oncology Centers; Ray D. About Lasix (Furosemide) with free Rx Page, D.O., Ph.D., president of the Center for Blood and Cancer Disorders; and Sheila A. Buy Bystolic with free Rx Donelan, M.S., and Monica Perkins, Ph.D., associate directors of research & methods, oncology line of service, UnitedHealthcare. Smart, Sustainable Shift from “Fee-for-Service” ApproachUnder the pilot, participating medical oncologists were reimbursed upfront for an entire cancer treatment program, marking a shift away from the current “fee-for-service” approach, which may reward volume or high-cost procedures regardless of health outcomes. Buy General Brain Formulas online This new “bundled payment,” or “episode payment,” model was based on the expected cost of a standard treatment regimen for the specific condition, as predetermined by the doctor. http://webmdconsult.wordpress.com The oncologists were paid the same fee regardless of the drugs administered to the patient – in effect, separating the oncologist’s income from drug sales while preserving the ability to maintain a regular visit schedule with the patient. Patient visits were reimbursed as usual using the fee-for-service contract rates, and chemotherapy medications were reimbursed based on the average sales price. The oncology groups collaborated with UnitedHealthcare to develop more than 60 measures of quality and cost to compare the performance across groups and determine how to improve quality and reduce costs over the course of the study. There were no differences between the groups on the quality measures evaluated, which challenges the assumption that any reduction in resources, such as medical staff, would result in worse outcomes for patients. Researchers evaluated the treatment regimens based on the number of emergency-room visits, incidence of complications, side effects and, most importantly, health outcomes to determine which treatment regimens do the best job of helping to fight cancer. By measuring the comparative effectiveness of different treatment options, the program aimed to uncover best practices, and identify and reduce unnecessary drug administration that does not improve the patient’s health. The upfront fee to the oncologists covered the standard treatment period, which is typically six to 12 months. In cases of cancer recurrence, the bundled payments were renewed every four months during the course of the disease, which allowed the doctor to continue overseeing his or her patient’s care even if drug therapy was no longer effective. The payments also were continued for patients who were no longer receiving chemotherapy or who enrolled in hospice care. This approach was designed to reward oncologists at current levels for patient care while simultaneously severing the link between drug selection and income. Physicians were incented with the ability to earn an increased episode payment by improving their results. UnitedHealthcare did not play a role in determining which treatment plan the oncologists chose. The study, conducted between October 2009 and December 2012, covered 810 cancer patients with breast, colon and lung cancer, and examined the difference in cost before and after the payment change. The total cost of medical care for patients in the study was $64.76 million, a 34 percent reduction in medical costs for a savings of $33.36 million. The cost of chemotherapy medications, however, was $13.46 million higher for the episode group than for the control group, but the tested pilot model still produced the 34 percent overall costs savings. The study used a quality improvement incentive to reduce the total cost of care and improve outcomes. While the goal of the study was to remove the link between drug selection and medical oncology outcomes by providing incentives for decreased chemotherapy costs, drug costs still were higher. This finding demonstrates that the bundled payment approach was able to reduce overall medical spend through other channels. The study was not designed to determine specifically how the cost savings were achieved, though analysis suggested the primary difference was hospitalizations. “The episode payment project yielded significant savings for the treatment of cancer patients without any measurable effect on the health outcomes for patients,” said Dr. Gould, who participated in the pilot. “The health care community needs to embrace new approaches to payment if we want to ensure the sustainability of our health care system for future generations.” About UnitedHealthcareUnitedHealthcare is dedicated to helping people nationwide live healthier lives by simplifying the health care experience, meeting consumer health and wellness needs, and sustaining trusted relationships with care providers. The company offers the full spectrum of health benefit programs for individuals, employers and Medicare and Medicaid beneficiaries, and contracts directly with more than 800,000 physicians and care professionals, and 6,000 hospitals and other care facilities nationwide. Globally, UnitedHealthcare serves more than 45 million people in health benefits and is one of the businesses of UnitedHealth Group (NYSE: UNH), a diversified Fortune 50 health and well-being company. Click here to subscribe to Mobile Alerts for UnitedHealth Group.

Aesica Pharmaceuticals S.r.l. Meets New Serialization Requirements with a QAD ERP Upgrade

Aesica Pharmaceuticals S.r.l. Meets New Serialization Requirements with a QAD ERP Upgrade

SANTA BARBARA, Calif.--(BUSINESS WIRE)--QAD Inc. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of enterprise software and services, announced today that Aesica Pharmaceuticals S.r.l., the Italian division of Aesica Pharmaceuticals Limited, has upgraded to QAD Enterprise Applications Enterprise Edition (QAD EE). The upgrade helped Aesica meet the deadline for a new serialization regulation for the Chinese market. A recently published case study shares the complete details of the implementation and its benefits. Aesica is a leading pharmaceutical contract development and manufacturing organization (CDMO). Effexor (Venlafaxine) with free Rx The company, operating in a highly regulated industry, had to meet product serialization and tracking regulations to maintain customer safety, while fighting drug counterfeiting, streamlining the recall process and minimizing financial loss. Aesica Pharmaceuticals was faced with an unexpected challenge when the compliance deadline for a new Chinese serialization regulation was accelerated from twelve-months to three-months. About Effexor Xr (Venlafaxine) with no prescription To meet the accelerated deadline, Aesica chose to upgrade to QAD EE, which helped Aesica meet the new serialization regulations. “QAD has been a great partner to help Aesica meet the unexpectedly accelerated deadline from China,” said Maurizio Beninati, IT Manager Italy, Aesica Pharmaceuticals S.r.l. Buy Droxia (Hydroxyurea) with free prescription “We couldn’t have conquered this challenge without their help and expertise.” Working with QAD, Aesica Pharmaceuticals met the accelerated regulation deadline through leveraging the enhanced serialization capability of QAD EE. With the successful implementation, Aesica can now: Identify each individual packaging unit down to the smallest sellable unit. Aggregate individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets. Seamlessly track and trace each single pack of medication. Report serial numbers to the required government agencies once products have been produced and imported. About Aesica Aesica Pharmaceuticals S.r.l. Becoride with free Rx supplies contract development and contract manufacturing services for finished dose and active pharmaceutical ingredients to the world’s leading pharmaceutical companies and emerging biotechnology organizations. Buy Dry Vitamin E online With headquarters in the United Kingdom, it is one of the country’s fastest growing companies. http://webmdhelp.wordpress.com Aesica currently employs approximately 1,300 people at its headquarters in Newcastle upon Tyne and at manufacturing sites in Cramlington, Nottingham and Queenborough in the U.K., as well as Monheim and Zwickau in Germany and Pianezza, Italy. Aesica is a portfolio company of Silverfleet Capital, one of the leading European mid-market private equity firms, which invested in the business in October 2011. For additional information go to .aesica-pharma.co.uk. For media enquiries, please contact Alex Maw, Marketing Director on +44(0)191 2181963 or email alex.maw@aesica-pharma.com About QAD – The Effective Enterprise QAD Inc. (NASDAQ: QADA) (NASDAQ: QADB) is a leading provider of enterprise software and services designed for global manufacturing companies. For more than 30 years, QAD has provided global manufacturing companies with QAD Enterprise Applications, an enterprise resource planning (ERP) system that supports operational requirements, including financials, manufacturing, demand and supply chain planning, customer management, business intelligence and business process management. QAD Enterprise Applications is offered in flexible deployment models as on-premise software, in the cloud with QAD Cloud ERP or in a blended environment. With QAD, customers and partners in the automotive, consumer products, food and beverage, high technology, industrial products and life sciences industries can better align daily operations with their strategic goals to meet their vision of becoming more Effective Enterprises. For more information about QAD, call +1 805-566-6000 or visit .qad.com. “QAD” is a registered trademark of QAD Inc. All other products or company names herein may be trademarks of their respective owners. Note to Investors: This press release contains certain forward-looking statements made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expects”, “believes”, “anticipates”, “could”, “will likely result”, “estimates”, “intends”, “may”, “projects”, “should”, “would”, “might”, “plan” and variations of these words and similar expressions are intended to identify these forward looking statements. Forward-looking statements are based on the company’s current expectations and assumptions regarding its business, the economy and future conditions. A number of risks and uncertainties could cause actual results to differ materially from those in the forward-looking statements. These risks include, but are not limited to, evolving demand for the company s software products and products that operate with the company s products; the company s ability to sustain license and service demand; the company s ability to leverage changes in technology; the company s ability to sustain customer renewal rates at current levels; the publication of opinions by industry and financial analysts about the company, its products and technology; the reliability of estimates of transaction and integration costs and benefits; the entry of new competitors or new offerings by existing competitors and the associated announcement of new products and technological advances by them; delays in localizing the company s products for new or existing markets; the ability to recruit and retain key personnel; delays in sales as a result of lengthy sales cycles; changes in operating expenses, pricing, timing of new product releases, the method of product distribution or product mix; timely and effective integration of newly acquired businesses; general economic conditions; exchange rate fluctuations; and, the global political environment. In addition, revenue and earnings in the enterprise resource planning (ERP) software industry are subject to fluctuations. Software license revenue, in particular, is subject to variability with a significant proportion of revenue earned in the last month of each quarter. Given the high margins associated with license revenue, modest fluctuations can have a substantial impact on net income. Investors should not use any one quarter s results as a benchmark for future performance. For a more detailed description of the risk factors associated with the company and the industries in which it operates, please refer to the company s Annual Report on Form 10-K for its fiscal year ended January 31, 2014, and in particular, the section entitled “Risk Factors” therein, and in other periodic reports the company files with the Securities and Exchange Commission.

The Medicines Company erhält Erneuerung der Zulassung für Angiox® (Bivalirudin) von der Europäischen Arzneimittel-Agentur und der Europäischen Kommission

The Medicines Company erhält Erneuerung der Zulassung für Angiox® (Bivalirudin) von der Europäischen Arzneimittel-Agentur und der Europäischen Kommission

PARSIPPANY, New Jersey, USA--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) gab heute bekannt, dass die Europäischen Arzneimittel-Agentur (EMA), der Ausschuss für Humanarzneimittel (CHMP) und die Europäische Kommission die Zulassung für Angiox® (Bivalirudin) nach Prüfung der neuesten klinischen, Sicherheits- und Wirksamkeitsdaten sowie des Risikomanagementplans für Angiox erneuert haben. Die Empfehlung des CHMP, die Zulassung für Angiox zu erneuern, bestätigt das günstige Nutzen-Risiko-Profil des Arzneimittels. Angiox ist ein direkter Thrombininhibitor und ist in Europa als Gerinnungshemmer bei erwachsenen Patienten angezeigt, die sich einer perkutanen koronaren Intervention (PCI) unterziehen, darunter Patienten mit ST-Strecken-Hebungsinfarkt (STEMI), bei denen eine primäre PCI durchgeführt wird. Eine weitere Indikation von Angiox in Europa ist die Behandlung erwachsener Patienten mit instabiler Angina pectoris/ Nicht-ST-Hebungsinfarkt (IA/NSTEMI), bei denen eine dringende oder frühzeitige Intervention geplant ist. Die Zulassungserneuerung für Angiox ist in allen Mitgliedsstaaten der Europäischen Union und des Europäischen Wirtschaftsraumes gültig. In den Richtlinien der Europäischen Gesellschaft für Kardiologie (ESC), die bei der klinischen Entscheidungsfindung herangezogen werden, verfügt Angiox über eine günstige Klasse-1B-Empfehlung für die Anwendung bei STEMI- und NSTEMI-Patienten, bei denen eine primäre PCI durchgeführt wird. In über 20 Jahren klinischer Untersuchungen hat sich gezeigt, dass Bivalirudin unter Patienten, die sich einer PCI unterziehen, bei weniger Blutungen eine vergleichbare Wirksamkeit wie Heparin mit oder ohne Glykoprotein-IIb/IIIa-Rezeptorantagonisten (GPI) aufweist. Bivalirudin wurde in 13 multizentrischen klinischen Studien und einer randomisierten klinischen Studie in einem Einzelzentrum an mehr als 35.000 Patienten geprüft. Die Ergebnisse stützten die Anwendung von Bivalirudin bei PCI, unabhängig davon, ob der Zugang radial oder femoral erfolgt und welche Art P2Y12-Inhibitor verwendet wird. Bei STEMI-Patienten konnte für Bivalirudin eine Senkung der Mortalität bis zu drei Jahren nachgewiesen werden, die vom Blutungsstatus unabhängig war. Darüber hinaus wurden im Rahmen von großen Beobachtungsregistern, die die reale Anwendung in der Praxis erfassen, Daten von etwa 500.000 Patienten erhoben, die diese Ergebnisse bestätigen. „Die von EMA und CHMP gewährte erneute Zulassung unterstreicht den klinischen Wert und die Bedeutung von Angiox in der modernen interventionellen Kardiologie“, so Simona Skerjanec, Pharm.D., Senior Vice President und Acute Cardiovascular Care Global Innovation Group Leader bei The Medicines Company. „Angiox ist weiterhin eine wichtige Antithrombin-Option für interventionelle Kardiologen in aller Welt, die es als Teil ihres therapeutischen Arsenals im Herzkatheterlabor und im Rahmen der perkutane Koronarintervention zu schätzen wissen. Für Angiox wurde nachgewiesen, dass es im Vergleich zur Standardbehandlung ähnliche Ischämie-bezogene Ergebnisse bei weniger Blutungskomplikationen erzielt sowie eine Senkung der Mortalität in der Studie Horizons-AMI. Die Vorteile, die das Medikament bietet, stehen mit unserem Ziel, Leben zu retten, Leiden zu lindern und die Wirtschaftlichkeit im Gesundheitswesen weltweit zu verbessern im Einklang.” Über Angiox/Angiomax Angiox ist in Europa zurzeit als Gerinnungshemmer bei erwachsenen Patienten, bei denen eine PCI durchgeführt wird, angezeigt, darunter Patienten mit STEMI, die sich einer primären PCI unterziehen. Eine weitere Indikation von Angiox in Europa ist die Behandlung erwachsener Patienten mit instabiler Angina pectoris/ Nicht-ST-Hebungsinfarkt, bei denen eine dringende oder frühzeitige Intervention geplant ist. Die vollständigen Verschreibungsinformationen finden Sie unter .angiox.com. In den USA wird Bivalirudin unter dem Markennamen Angiomax vertrieben und ist bei Patienten angezeigt, die sich einer PCI unter vorläufiger Verwendung eines GPI unterziehen, sowie bei Patienten mit oder mit dem Risiko eines Heparin-induzierten Thrombozytopenie- und Thrombose-Syndroms (HIT/HITTS), bei denen eine PCI durchgeführt wird. Darüber hinaus ist Angiomax als Gerinnungshemmer bei Patienten mit instabiler Angina pectoris indiziert, die sich einer perkutanen transluminalen Koronarangioplastie (PTCA) unterziehen. Angiomax ist für die Anwendung mit Acetylsalicylsäure bestimmt. Angiomax ist nicht für die Anwendung bei Patienten mit akutem Koronarsyndrom (ACS) zugelassen, bei denen keine PCI oder PTCA durchgeführt wird. In klinischen Studien, die Angiomax mit Heparin verglichen, waren Blutungen (28%) die häufigste Nebenwirkung von Angiomax. Als weitere häufige Nebenwirkungen traten Kopfschmerzen, Thrombozytopenie und Fieber auf. Bei einem unerklärlichen Abfall des Blutdrucks oder des Hämatokrits sowie bei alle unklaren Symptomen sollte eine Blutung dringend in Betracht gezogen und Angiomax abgesetzt werden. Angiomax sollte bei Patienten mit Krankheitsbildern, die mit einem erhöhten Blutungsrisiko einhergehen, mit Vorsicht verwendet werden. Für die Gamma-Brachytherapie fand sich ein erhöhtes Risiko für die Bildung von Blutgerinnseln, auch mit tödlichem Ausgang, bei Anwendung von Angiomax. Angiomax ist bei Patienten mit schwerer aktiver Blutung oder Überempfindlichkeit gegenüber Angiomax oder seine Bestandteile kontraindiziert. Die vollständigen Verschreibungsinformationen zu Angiomax finden Sie unter .angiomax.com. Über The Medicines Company The Medicines Company hat sich zum Ziel gesetzt, Leben zu retten, Leiden zu lindern und zur Wirtschaftlichkeit im Gesundheitswesen beizutragen, in dem es sich auf 3000 Akut-/ Intensivmedizin-Krankenhäuser weltweit konzentriert. Das Unternehmen strebt danach, der führende Lösungsanbieter in drei Gebieten zu sein: akute Herz-Kreislauf-Erkrankungen, Chirurgie und perioperative Versorgung sowie schwere Infektionskrankheiten. Das Unternehmen ist in Nord- und Lateinamerika, Europa und Nahost sowie in der Asien-Pazifik-Region tätig und unterhält heute weltweit Zentren in Parsippany im US-Bundesstaat New Jersey und Zürich in der Schweiz. Die in dieser Pressemitteilung enthaltenen Aussagen über The Medicines Company, die sich nicht auf rein historische Daten beziehen und alle sonstigen nicht rein historischen Aussagen können als zukunftsorientierte Aussagen im Sinne der Safe Harbor-Bestimmungen gemäß des Private Securities Litigation Reform Act von 1995 erachtet werden. Ohne Einschränkung des Vorstehenden weisen die Wörter "glaubt", "sieht voraus" und "erwartet" und ähnliche Ausdrücke auf zukunftsorientierte Aussagen hin. Diese zukunftsorientierten Aussagen schließen bekannte und unbekannte Risiken und Unabwägbarkeiten ein, die dazu führen können, dass die tatsächlichen Ergebnisse, Aktivitäten, Leistungen oder Erfolge des Unternehmens wesentlich von den hier ausgedrückten oder enthaltenen zukunftsorientierten Aussagen abweichen. Wichtige Faktoren, die zu diesen Abweichungen beitragen können, sind insbesondere, ob Ärzte, Patienten und andere wichtige Entscheidungsträger die Ergebnisse klinischer Studien akzeptieren werden, sowie weitere Faktoren, die unter den Risikofaktoren in den regelmäßig vom Unternehmen bei der US-Börsenaufsicht SEC eingereichten Berichten und Zulassungserklärungen näher erläutert werden, insbesondere die Risikofaktoren, die im Quartalsbericht auf Formular 10-Q vom 12. Mai 2014 angegeben und durch Verweis Bestandteil dieser Erklärung ist. Das Unternehmen übernimmt ausdrücklich keinerlei Verpflichtung, diese zukunftsorientierten Aussagen zu aktualisieren. Hinweis: Diese Pressemitteilung wurde in den USA herausgegeben und soll US-amerikanischen Investoren und Journalisten als Quelle von Referenzinformationen dienen. Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die offizielle und autorisierte Version. Übersetzungen werden zur besseren Verständigung mitgeliefert. Nur die Sprachversion, die im Original veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit der originalen Sprachversion der Veröffentlichung ab.

Research and Markets Italy Alopecia Areata Market Highlights - 2014

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Strong growth at Merck’s Consumer Health Division builds on 80 years of delivery

DARMSTADT, Germany--(BUSINESS WIRE)--This summer, Merck’s Consumer Health division has marked 80 years since the launch of the world’s first commercial, powdered Vitamin C product Cebion®. Based on the substance discovery in 1932 through the later Nobel Prize winners Albert von Szent-Györgyi Nagyrapolt (Hungary) and Walter Norman Haworth (UK), Merck had initially started extracting ascorbic acid from diverse plants and flowers, before later on synthesizing the substance for mass production. The in-market launch in 1934 already saw a diversified portfolio with Cebion bulk, tablets and ampoules in different dosages. “2014 is a milestone year for Merck’s Consumer Health division, marking 80 years since the launch of the Cebion brand. This year has also already seen significant progress in fully integrating Neurobion and Floratil into the division and in achieving impressive growth in emerging and established markets. 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Integration of new arrivals on track In addition to marking 80 years of success with Cebion, Merck’s Consumer Health Division continues to diversify its portfolio. Acarbose with no Rx With Neurobion® and Floratil® two brands with annual turnover of over € 250 million were recently transitioned from Merck Serono and have now been incorporated into Merck’s Consumer Health division this year. Buy Alfalfa online This has enabled the division to triple the size of its Americas business and double the size of the business in Asia. http://webmdhelp.wordpress.com The incorporation of new brands into the division remains on track and has delivered ahead of expectations in the first quarter of 2014. Particularly successful has been the performance of Floratil in Brazil which has driven a market share turnaround with 45% year on year growth up to February 2014 based on a fresh DTC Marketing campaign which has resonated very well with local consumers. Strong financial performance in Q1 In the first quarter of 2014, the division reported a growth in organic sales ahead of the same period in 2013 (based on restated 2013 figures for the two new brands Neurobion and Floratil). Across the division, sales demonstrated organic growth of 5.7% to € 180 million countered by negative currency impacts of -6.5%. The first quarter of 2014 also showed a profit (EBITDA pre one-time items) increase of 5.0% to € 41 million versus € 39 million for the same period one year ago. Top organic sales performers compared with the first quarter of 2013 were Sangobion, Femibion and Cebion, while sales of both new brands Neurobion and Floratil also grew organically. About the Merck Consumer Health Division Brands of the Merck Consumer Health division, such as Neurobion®, Floratil®, Bion®, Nasivin®, Seven Seas®, Femibion®, Kytta®, Sangobion®, Sedalmerck®, and Cebion®, are innovative leaders in key markets, backed by science and trusted by consumers worldwide. The division Consumer Health is with its around 2,000 employees globally active in over 40 markets. Since 2014, the portfolio comprises of brands with annual total revenues of over $ 1 billion. Consumer Health is a division of the Merck Group with global headquarters in Darmstadt, Germany. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to .merckgroup.com/subscribe to register online, change your selection or discontinue this service. About Merck Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges. We generated total revenues of € 11.1 billion in 2013 with our four divisions: Merck Serono, Consumer Health, Performance Materials and Merck Millipore. Merck is the world s oldest pharmaceutical and chemical company. Since 1668 our name has stood for innovation, business success and responsible entrepreneurship. The founding family remains the majority owner of the company to this day. We are Merck, the original, and hold the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where we are known as EMD.

Riassunto Quintiles perfeziona l'acquisizione di Encore Health Resources

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