05 December 2013

McKesson Launches Public Takeover Offer for Celesio

McKesson Corporation a leading North American healthcare services and information technology company, announced today that McKesson has launched the voluntary public takeover offer for the outstanding shares of Celesio (“Takeover Offer”) and tender offers for the outstanding convertible bonds of Celesio (“Tender Offers”) through its indirect wholly-owned subsidiary Dragonfly GmbH & Co. KGaA, in connection with the announcement on October 24, 2013 of McKesson’s agreement to acquire Celesio.
The publication of the offer document for the Takeover Offer has been approved by the Bundesanstalt für Finanzdienstleistungsaufsicht and is now available on www.GlobalHealthcareLeader.com in German and in an English translation. Celesio shareholders can now accept the Takeover Offer and tender their shares in Celesio at the offer price of €23 per share. The acceptance period will end on January 9, 2014 at 24:00 (CET) / 18:00 (EST).
In parallel to the Takeover Offer, McKesson launched the Tender Offers for Celesio’s outstanding convertible bonds at a price corresponding to the value of the underlying shares implied by a €23 per share offer price, which equals €53,117.78 per bond for Celesio’s convertible bond due 2014 (principal amount of €50,000) and €120,798.32 per bond for Celesio’s convertible bond due 2018 (principal amount of €100,000). The acceptance period for the Tender Offers will also end on January 9, 2014 at 24:00 (CET) / 18:00 (EST). The offer document for the Tender Offers is also available on www.allbestrx.com in German and in an English translation.
About McKesson Corporation
McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run better. McKesson partners with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit www.fda-approved-rx.biz.
THIS PRESS RELEASE IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION.
The Takeover Offer and the Tender Offers will be subject to the full terms and conditions to be set out in the respective offer document.
Disclaimer
This press release is for information purposes only and does not constitute an invitation to make an offer to sell Celesio shares. This announcement does not constitute an offer to purchase Celesio shares and is not for the purposes of McKesson making any representations or entering into any other binding legal commitments.
The offers to purchase Celesio shares (“Takeover Offer”) and convertible bonds (“Tender Offers” and together with the Takeover Offer, the “Offers”) are solely made by the respective offer document published by Dragonfly GmbH & Co. KGaA (“Dragonfly”), an indirect wholly-owned subsidiary of McKesson Corporation (“McKesson”), on December 5, 2013 and is exclusively subject to such offer document’s terms and conditions. The terms and conditions contained in such offer document may differ from the general information described in this press release.
Investors and holders of the shares or convertible bonds of Celesio are strongly advised to read the relevant documents regarding the Takeover Offer and the Tender Offers because they contain important information. Investors and holders of the shares or convertible bonds of Celesio can obtain these documents at the website http://www.drugsrxguide.biz.
The Tender Offers are not subject to the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz, (“WpÜG”)) and have not been reviewed by the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht (“BaFin”)).
Holders of the shares or convertible bonds of Celesio are strongly recommended to seek independent advice in order to reach an informed decision in respect of the content of the offer documents and with regard to the Takeover Offer or the Tender Offers.
The Offers are issued exclusively under the laws of the Federal Republic of Germany (“Germany”), the Takeover Offer especially under the WpÜG and the Regulation on the Content of the Offer Document, Consideration for Takeover Offers and Mandatory Offers and the Release from the Obligation to Publish and Issue an Offer, and certain applicable provisions of the securities laws of the United States of America (“United States”). Buy Vitamins online The Offers will not be executed according to the provisions of jurisdictions (including the jurisdictions of Australia and Japan) other than those of the Germany and certain applicable provisions of securities laws of the United States. Thus, no other announcements, registrations, admissions or approvals of the Offers outside Germany have been or will be filed, arranged for or granted. The holders of the shares of or convertible bonds of Celesio cannot rely on having recourse to provisions for the protection of investors in any jurisdiction other than such provisions of Germany. Online Pharmacy Blog Any contract that will be concluded on the basis of the Offers will be exclusively governed by the laws of Germany and will to be interpreted in accordance with such laws.
Neither McKesson nor any persons acting in concert with McKesson within the meaning of Section 2 para 5 of the WpÜG have authorized the publication, sending, distribution, or dissemination of this press release or any other document associated with the Offers by third parties outside Germany, the United States and Canada. Neither McKesson nor persons acting in concert with McKesson within the meaning of Section 2 para. 5 of the WpÜG are in any way responsible for the compliance of the publication, sending, distribution or dissemination of this press release or any other document associated with the Offers by a third party outside of Germany, the United States and Canada to any jurisdiction with legal provisions other than those of Germany, the United States and Canada.
The publication, sending, distribution or dissemination of this press release in certain jurisdictions other than Germany, the United States and Canada may be governed by laws of jurisdictions other than Germany, the United States and Canada in which the publication, sending, distribution or dissemination are subject to legal restrictions. Persons who are not resident in Germany, the United States or Canada or who are for other reasons subject to the laws of other jurisdictions should inform themselves of, and observe, the laws of such other jurisdictions.
This press release is not for release, publication or distribution, in whole or in part, in, into or from any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction.
If you are a resident of the United States, please read the following:
The Offers are being made for the securities of a non-U.S. company and will be subject to the disclosure and procedural laws, standards and practices of jurisdictions other than the U.S., although the Offers are made in reliance on, and compliance with, Section 14(e) of the Exchange Act and Regulation 14E thereunder, as exempted thereunder by Rule 14d-1(c).
In accordance with the Offers, McKesson, Dragonfly, certain affiliated companies and their respective nominees or brokers (acting as agents) may make certain purchases of, or arrangements to purchase, Celesio shares or convertible bonds outside the Offers during the period in which the Offers remain open for acceptance. If such purchases or arrangements to purchase are made, they will be made outside the United States and will comply with applicable law, including the Exchange Act.

02 September 2013

Onglyza® (saxagliptin) Achieves Primary Safety Endpoint, Demonstrating No Increased Risk for Cardiovascular Death, Heart Attack or Stroke in SAVOR Cardiovascular Outcomes Trial

AstraZeneca and Bristol-Myers Squibb Company today announced the full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. In this study, Onglyza® (saxagliptin) met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo. Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the same composite endpoint. Patients treated with Onglyza experienced improved glycemic control and reduced development and progression of microalbuminuria over two years as assessed in exploratory analyses.
“No other DPP-4 inhibitor and few other anti-hyperglycemic agents have been studied as extensively as Onglyza to address the question of cardiovascular safety”
The major secondary composite endpoint of cardiovascular death, non-fatal MI, non-fatal ischemic stroke or hospitalization for heart failure, unstable angina or coronary revascularization was balanced across the two arms.Buy Atarax (Hydroxyzine) pills online without prescription One component of the composite secondary endpoint, hospitalization for heart failure, occurred more in the Onglyza group compared to placebo. Rates of pancreatitis were low and balanced between Onglyza and placebo. Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza group than in the placebo group. More patients in the Onglyza group reported at least one hypoglycemic event compared to placebo. Results were presented today during a Hot Line session at the ESC Congress 2013 in Amsterdam, Netherlands, and published in The New England Journal of Medicine.
In the past, questions have been raised about the safety of many diabetes treatments, in particular regarding their impact on the risk of cardiovascular death, heart attack or stroke. Buy Atrovent (Ipratropium Bromide) tabs online without prescription Led by the academic research organizations TIMI Study Group and Hadassah University Medical Center and conducted at more than 700 sites worldwide, SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) was a randomized, double-blind, placebo-controlled trial of 16,492 patients designed to evaluate the cardiovascular safety and efficacy of Onglyza (saxagliptin) in adults with type 2 diabetes at risk for cardiovascular death, heart attack and stroke, compared to placebo.
“Given the correlation between diabetes and cardiovascular complications, there is a need for thorough assessments of the cardiovascular risks among therapies that improve glycemic control,” said Deepak L. Bhatt, MD, MPH, Senior Investigator of the TIMI Study Group, Brigham and Women’s Hospital, and a Principal Investigator for the trial. “The results from SAVOR add important evidence to the overall body of data to further define the clinical profile of saxagliptin for the treatment of type 2 diabetes.”
“No other DPP-4 inhibitor and few other anti-hyperglycemic agents have been studied as extensively as Onglyza to address the question of cardiovascular safety,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. Buy Tadalis Sx (Tadalafil) without prescription “Bristol-Myers Squibb and AstraZeneca are dedicated to meeting needs of physicians and patients in diabetes care and helping to ensure a better understanding of the value of our medications.”
“SAVOR is an important contribution to our knowledge of the safety of Onglyza in type 2 diabetes patients at an increased risk for cardiovascular events similar to those found in a real-world population,” said Briggs Morrison, MD, executive vice president, Global Medicines Development, AstraZeneca. “In addition, the data on pancreatitis and pancreatic cancer in a study of more than 16,000 patients provide important and timely scientific information from a robust, randomized trial for the diabetes community.”
Study Results
In the study, the primary composite endpoint of cardiovascular death, non-fatal MI or non-fatal ischemic stroke occurred in 613 patients (7.3%) in the Onglyza group vs. 609 patients (7.2%) in the placebo group (Hazard Ratio [HR]: 1.00; 95% Confidence Interval [CI]: 0.89, 1.12; non-inferiority p-value < 0.001; superiority p-value = 0.99). The major secondary endpoint, consisting of the primary composite endpoint and hospitalization for heart failure, unstable angina or coronary revascularization, occurred in 1,059 patients (12.8%) in the Onglyza (saxagliptin) group vs. 1,034 patients (12.4%) in the placebo group (HR: 1.02; 95% CI: 0.94, 1.11; p-value = 0.66). Hospitalization for heart failure, a component of this secondary composite endpoint, occurred at a greater rate in the Onglyza group (3.5%) than in the placebo group (2.8%) (HR: 1.27; 95% CI: 1.07, 1.51; p-value = 0.007). The pre-specified secondary endpoint of all-cause mortality occurred in 420 patients (4.9%) in the Onglyza group compared to 378 patients (4.2%) in the placebo group (HR: 1.11; 95% CI: 0.96, 1.27; p-value = 0.15).
Study physicians were allowed to actively manage patients’ glucose through concomitant use of other anti-diabetic drugs and dose titration. Fewer patients in the Onglyza group required the addition or increase of any new anti-diabetic medication compared to placebo (1,938 patients [23.7%] vs. 2,385 patients [29.3%], respectively; HR: 0.77; 95% CI: 0.73, 0.82; p-value < 0.001) or the initiation of insulin therapy for more than three months (454 patients [5.5%] vs. 634 patients [7.8%], respectively; HR: 0.70; 95% CI: 0.62, 0.79; p-value < 0.001). Patients in the Onglyza group had greater reductions in blood sugar levels both from baseline and compared to those in the placebo group, with mean reductions in glycosylated hemoglobin (HbA1c) levels of 0.5% at two years of treatment in the Onglyza group vs. 0.2% in the placebo group (p-value < 0.001). Buy Vitamins online More patients in the Onglyza group achieved or maintained goal HbA1c of less than seven percent compared to those in the placebo group at two years (40.0% vs. 30.3%; p-value < 0.001).
A total of 1,264 patients (15.3%) in the Onglyza group reported at least one hypoglycemic event compared to 1,104 (13.4%) in the placebo group (p-value < 0.001), which included patients with both major (177 patients [2.1%] vs. 140 patients [1.7%]; p-value = 0.047) and minor (1,172 patients [14.2%] vs. 1,028 patients [12.5%]; p-value = 0.002) events for the Onglyza and placebo groups, respectively. Hospitalization for hypoglycemia was infrequent and similar between groups (0.6% vs. 0.5%; p-value = 0.33).
Patients in the Onglyza group experienced reduced development and progression of microalbuminuria, and were more likely to have an improved albumin:creatinine ratio at two years (372 patients [11.1%] in the Onglyza group vs. 295 patients [9.2%] in the placebo group), and less likely to have a worsening ratio (414 patients [12.4%] in the Onglyza group vs. 457 patients [14.2%] in the placebo group), compared to placebo.
A number of pre-specified safety endpoints for diabetes treatments were evaluated (pancreatitis, cancer, liver abnormalities, renal abnormalities, thrombocytopenia, lymphocytopenia, infections, hypersensitivity or skin reactions, bone fractures and hypoglycemia).
All suspected cases of pancreatitis were independently reviewed and adjudicated by a committee of medical experts external to the sponsors and investigators. Pancreatitis occurred infrequently and the number of patients with acute or chronic pancreatitis was similar between the treatment groups (24 [0.3%] in the Onglyza (saxagliptin) group vs. 21 [0.3%], in the placebo group; p-value = 0.77). Definite/possible acute pancreatitis occurred in 22 patients (0.3%) in the Onglyza group vs. 16 patients (0.2%) in the placebo group (p-value = 0.42); definite acute pancreatitis in 17 patients (0.2%) vs. nine patients (0.1%) (p-value = 0.17); and chronic pancreatitis in two patients (< 0.1%) vs. six patients (0.1%) (p-value = 0.18), respectively. Boxing Forum - Online Pharmacy : Buy drugs without prescription There were five cases of pancreatic cancer in the Onglyza group and 12 cases in the placebo group (p-value = 0.095). Renal abnormalities were observed more frequently in the Onglyza group compared to the placebo group (5.8% vs. 5.1%, respectively; p-value = 0.04). The incidence of the other pre-specified safety endpoints was balanced between the two groups.
Study Design
The study included 16,492 adult patients with type 2 diabetes, 8,280 of whom were randomized to receive Onglyza and 8,212 of whom were randomized to receive placebo. Recruitment included patients with type 2 diabetes and baseline HbA1c levels of 6.5% to 12% on any diabetes treatment including diet, insulin and/or oral therapy (excluding GLP-1 agonists and DPP-4 inhibitors) who were at elevated risk for cardiovascular events according to two categories:
  • Patients ≥ 40 years of age with established cardiovascular disease, defined as ischemic heart disease, peripheral vascular disease or ischemic stroke.
  • Males ≥ 55 years of age and females ≥ 60 years of age with at least one of the following risk factors: dyslipidemia, hypertension or current smoking, but without established cardiovascular disease.
Further grouping was based on renal function, including patients with normal/mild (eGFR > 50 mL/min), moderate (30 - 50 mL/min) or severe (eGFR < 30 mL/min) renal impairment.
The primary safety objective was to establish that the upper bound of the 95% confidence interval for the estimated risk ratio comparing the incidence of the composite endpoint (cardiovascular death, non-fatal MI or non-fatal ischemic stroke) observed with Onglyza to that observed in the placebo group was less than 1.3. The primary efficacy objective was to determine, as a superiority assessment, whether treatment with Onglyza compared to placebo when added to current background therapy would result in a reduction in the composite endpoint of cardiovascular death, non-fatal MI or non-fatal ischemic stroke in patients with type 2 diabetes. Secondary efficacy objectives included a reduction in the primary composite endpoint together with hospitalization for heart failure, coronary revascularization or unstable angina pectoris, and reduction of all-cause mortality. Secondary safety objectives included the evaluation of safety and tolerability by assessment of overall adverse events and adverse events of special interest.
Patients were randomized between May 2010 and December 2011. The median follow-up was 2.1 years and maximum follow-up was 2.9 years.
About Onglyza® (saxagliptin)
As of September 2013, Onglyza is approved in 86 countries including those in the European Union, the United States, Canada, Mexico, India, Brazil and China.
Indication and Limitations of Use for Onglyza
Onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
Onglyza should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Onglyza has not been studied in patients with a history of pancreatitis.
Important Safety Information for Onglyza
Contraindications
  • History of a serious hypersensitivity reaction to Onglyza (e.g., anaphylaxis, angioedema, or exfoliative skin conditions)
Warnings and Precautions
  • Pancreatitis: There have been post-marketing reports of acute pancreatitis in patients taking Onglyza. After initiating Onglyza, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue Onglyza and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while using Onglyza.
  • Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin: When Onglyza was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of confirmed hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia when used in combination with Onglyza.
  • Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with Onglyza, including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with Onglyza, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue Onglyza, assess for other potential causes for the event, and institute alternative treatment for diabetes. Use caution in patients with a history of angioedema to another DPP-4 inhibitor as it is unknown whether they will be predisposed to angioedema with Onglyza.
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Onglyza or any other antidiabetic drug.
Most Common Adverse Reactions
  • Most common adverse reactions reported in ≥5% of patients treated with Onglyza and more commonly than in patients treated with control were upper respiratory tract infection (7.7%, 7.6%), headache (7.5%, 5.2%), nasopharyngitis (6.9%, 4.0%) and urinary tract infection (6.8%, 6.1%).
  • When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for Onglyza 2.5 mg, 5 mg, and placebo was 3.1%, 8.1% and 4.3%, respectively.
  • Confirmed hypoglycemia was reported more commonly in patients treated with Onglyza 2.5 mg and Onglyza 5 mg compared to placebo in the add-on to glyburide trial (2.4%, 0.8% and 0.7%, respectively), with Onglyza 5 mg compared to placebo in the add-on to insulin (with or without metformin) trial (5.3% and 3.3%, respectively),with Onglyza 2.5 mg compared to placebo in the renal impairment trial (4.7% and 3.5%, respectively), and with Onglyza 5 mg compared to placebo in the add-on to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively).
Drug Interactions
Because ketoconazole, a strong CYP3A4/5 inhibitor, increased saxagliptin exposure, the dose of Onglyza should be limited to 2.5 mg when coadministered with a strong CYP3A4/5 inhibitor (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
Use in Specific Populations
  • Patients with Renal Impairment: The dose of Onglyza is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min). Onglyza should be administered following hemodialysis. Onglyza has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of Onglyza and periodically thereafter.
  • Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. Onglyza, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Onglyza is administered to a nursing woman.
  • Pediatric Patients: Safety and effectiveness of Onglyza in pediatric patients have not been established.
Please click here for full U.S. Prescribing Information and Medication Guide for Onglyza® (saxagliptin).
About Diabetes
In 2012, diabetes was estimated to affect more than 370 million people worldwide. The prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterized by insulin resistance and dysfunction of beta cells in the pancreas, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.
The major cause of death and complications in patients with type 2 diabetes is cardiovascular disease. As many as 80% of patients with type 2 diabetes will develop and possibly die from a cardiovascular event.
About the AstraZeneca / Bristol-Myers Squibb Diabetes Alliance
Dedicated to addressing the global burden of diabetes by advancing individualized patient care, AstraZeneca and Bristol-Myers Squibb are working in collaboration to research, develop and commercialize a versatile portfolio of innovative treatment options for diabetes and related metabolic disorders that aim to provide treatment effects beyond glucose control.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
AstraZeneca Cautionary Statement Regarding Forward-Looking Statement
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This press release contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward looking statements reflect knowledge and information available at the date of preparation of this press release and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trade marks, or the risk of failure to obtain patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation. Nothing in this press release should be construed as a profit forecast.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

01 July 2013

Dr. Richard Jove Joins VGTI Florida as the New Institute Director

The Vaccine & Gene Therapy Institute of Florida (VGTI Florida®) is pleased to announce the appointment of Richard Jove, Ph.D., as the new director of the Institute. Dr. Jove will take up his new position beginning July 1, 2013.
    “Having the opportunity to contribute what I have learned, and to work closely with the talented researchers and staff at VGTI Florida, will help us bring new scientific discoveries to benefit patients in the clinic.”
“Dr. Jove brings to VGTI Florida the scientific leadership, research expertise, and a translational philosophy that will bring us to the next level in terms of basic and clinical research and the related improvement of health outcomes,” said Jay Nelson, Ph.D., CEO of VGTI Florida.
As an external member of the Scientific Advisory Board for VGTI Florida, Dr. Jove has already assisted the Institute in planning its research strategy for cancer and infectious disease. Buy Tofranil (Imipramine) pills online without prescription “I am very excited now to become a member of the internal leadership team at VGTI Florida as their mission of `Translating Research into Health®' has always been a guiding principle in my own research career,” said Dr. Jove. “Having the opportunity to contribute what I have learned, and to work closely with the talented researchers and staff at VGTI Florida, will help us bring new scientific discoveries to benefit patients in the clinic.”
Richard Jove has most recently served as the director of the Beckman Research Institute at City of Hope and deputy director of its Comprehensive Cancer Center in Los Angeles County, California. Buy Timoptic (Timolol) tabs online without prescription His work has been focused on developing more effective and safer therapies for the treatment of cancer. One of his primary roles has been encouragement of collaboration between scientists and clinical investigators for the development of scientific discoveries into novel cancer therapies for early phase clinical trials.
Prior to joining the City of Hope Dr. Jove held various leadership positions at the Moffitt Cancer Center in Tampa, Florida, following his establishing the Molecular Oncology Program at the University of Michigan Cancer Center in Ann Arbor.
“Dr. Jove is a welcome addition to the VGTI Florida team and we all look forward to his leadership and scientific background contributing to the growth of the institute. Buy Pilagan (Pilocarpine) without prescription With his global perspective and reach he is ideally suited to expand the depth and breadth on an international basis enhancing VGTI Florida’s worldwide translational research healthcare platform,” said Mel Rothberg, Chief Operating Officer of VGTI Florida.
“It’s not just about the science, more importantly it’s about the patients,” said Dr. Jove. Esperion Therapeutics Completes 33 Million Preferred Financing to Advance Its Novel Oral LDL-C Lowering Therapy to Later Stage Clinical Trials “VGTI Florida is an Institute that is not only doing the research, but developing the therapies, and I look forward to leading the institute and the recruitment of top researchers that will expand our focus on cancer.”
About VGTI Florida:
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VGTI Florida is an independent immunological research institute that is on an urgent mission to transform scientific discoveries into novel treatments and cures for existing and emerging infectious diseases, influenza and cancer. VGTI Florida is an independent non-profit 501(c)(3) organization located in the Tradition Center for Innovation in Port St. Lucie, Florida.

30 January 2013

AHF Challenges Gilead over AIDS Drug Price Gouging of U.S. Gov’t Programs on ‘Stribild’

As part of its ongoing campaign to pressure Gilead Sciences, Inc. and educate the public about the exorbitant price of HIV/AIDS medications, AIDS Healthcare Foundation (AHF) today challenged the company over its price discrimination for its four-in-one HIV drug, Stribild. In the United States, Gilead charges a yearly wholesale price (WAC) of $28,500 per patient for Stribild while charging only $16,600 in Canada – a difference of nearly $12,000 per patient. (At present, the US dollar is worth .99 of Canadian dollar).
“Gilead has made it loud and clear that without the kind of price controls that exist in Canada and Europe, its greed and blatant disregard for the health of its customers—people with HIV/AIDS—will continue undiminished.”
“There is no justification for Gilead to continue to charge $28,500 for Stribild in the U.S. while it is willing to cut the price in Canada and other countries,” said AHF President Michael Weinstein. Buy Loxitane (Loxapine) pills online without prescription “Gilead has made it loud and clear that without the kind of price controls that exist in Canada and Europe, its greed and blatant disregard for the health of its customers—people with HIV/AIDS—will continue undiminished.”
Stribild, Gilead’s four-in-one AIDS treatment combination, was approved by the Food and Drug Administration (FDA) in early September and immediately priced by Gilead at $28,500 per patient, per year, Wholesale Acquisition Cost (WAC). That price was over 35% more than Atripla, the company’s best selling combination HIV/AIDS treatment, and made Stribild the highest priced first line combination AIDS therapy today.
Already this year, on January 1st, Gilead raised the prices of four key AIDS medications in the U.S. by an average of 6%, including the price of Atripla, its best-selling three-in-one combination treatment, the price of which was increased by 6.9% to a Whole Acquisition Cost (WAC) of $1,878.23 per patient, per month. The other three HIV/AIDS medications that saw price hikes are Complera, which was raised by 5.8% to a WAC of $1,936.53; Emtriva, by 5.5% to a WAC of $478.45; and Viread, by 6% to a WAC of $771.39.
In late November, CATIE-News, an online site which states it is “Canada’s source for HIV and Hepatitis C information, reported the Canadian price for Stribild is $16,600 per patient per year. This is a 42% cost reduction compared to the $28,500 Stribild costs per patient per year in the US. This price reduction highlights Gilead's apparent willingness to gouge the pockets of US taxpayers and government-funded programs like the AIDS Drug Assistance Program (ADAP) while making price concessions to countries with sometimes stronger economies than the US.
About AIDS Healthcare Foundation
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to nearly 200,000 individuals in 28 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe.