Catalyst Announces Initiation of an Expanded Access Program to Provide Firdapse at No Cost to U.S. Patients with Lambert-Eaton Myasthenic Syndrome

Catalyst Pharmaceutical Partners, Inc. announced today it has begun the process required to establish an expanded access program (EAP) to make available in the United States its investigational potassium channel inhibitor, Firdapse™ (amifampridine phosphate or 3,4-DAP phosphate), to patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS) through their neuromuscular disease specialists. Lioresal (Baclofen) without prescription The product, currently in Phase 3 development, will be provided at no cost until sometime after approval. Program enrollment will begin in the next few months, pending FDA review and approvals.

“As part of our ongoing commitment to the LEMS community, we are making Firdapse available to those who would like access to this investigational drug, but are unable to participate in clinical studies or travel to sites where it is available”

“As part of our ongoing commitment to the LEMS community, we are making Firdapse available to those who would like access to this investigational drug, but are unable to participate in clinical studies or travel to sites where it is available,” said Patrick J. McEnany, CEO of Catalyst Pharmaceutical Partners, Inc.
Patients diagnosed with LEMS or physicians treating such patients can call toll free 1-844-FIRDAPSE (1-844-347-3277) to inquire about this program.
“In previously published clinical trials, amifampridine has been shown to reduce neuromuscular weakness and symptoms of autonomic dysfunction in LEMS patients while being well tolerated,” said Shin J. Oh, MD, Distinguished Professor Emeritus of Neurology, University of Alabama at Birmingham School of Medicine. About Lipitor (Atorvastatin) with free prescription “I am pleased that the company will be able to make its drug available to patients, who need it, while diligently pursuing FDA approval.”
Expanded access is a mechanism supported by regulatory agencies for getting investigational treatment to patients who have a life threatening or severely debilitating disease and who cannot be satisfactorily treated with an alternative therapy approved by the FDA. Expanded access programs are not required by regulatory agencies. These programs are initiated and supported by drug manufacturers in recognition of the promise an unapproved drug may hold for patients facing a life-threatening or severely debilitating disease.
About Lambert-Eaton Myasthenic Syndrome (LEMS)
LEMS is an autoimmune neuromuscular disease in which the release of acetylcholine is decreased at the neuromuscular junction, resulting in muscle weakness. About Amoxil (Amoxicillin) without prescription Patients with LEMS typically present with fatigue, muscle pain and stiffness that is generally more marked in the proximal muscles, most often muscles of the legs and trunk. Other symptoms may include reduced reflexes, drooping eyelids, facial weakness and swallowing problems. Patients often report a dry mouth, impotence, constipation and light-headedness on standing. On occasion, these problems can be life threatening when the weakness involves respiratory muscles. Approximately 50 percent of patients diagnosed with LEMS have an underlying malignancy, most commonly small cell lung cancer. LEMS is therefore regarded as a paraneoplastic syndrome (a condition that arises as a result of cancer elsewhere in the body).
About Firdapse
Firdapse, amifampridine phosphate or 3,4-diaminopyridine phosphate (3,4-DAP), is a potassium channel inhibitor. By blocking this ion channel, Firdapse increases the nerve repolarization time, which causes an increase in the influx of calcium, thereby causing more acetylcholine to be released, restoring muscle fiber contraction thus relieving muscle weakness caused by LEMS. About Acitretin with no prescription In addition to LEMS, other potential orphan neuromuscular indications for Firdapse include certain types of Myasthenia Gravis and Congenital Myasthenic Syndrome, among others.
Firdapse has been granted orphan drug and breakthrough therapy designations by the U.S. FDA, and orphan medicinal product designation in the European Union for the treatment of LEMS. It is approved and commercialized in the E.U. by BioMarin Pharmaceutical. Catalyst recently announced it has reached its patient enrollment target for its Phase 3, double-blind, placebo-controlled, clinical trial evaluating the safety and efficacy of Firdapse for the treatment of LEMS. Upon completion of the Phase 3 trial, assuming it is successful, Catalyst expects to begin submitting a rolling new drug application with the FDA in 2015.
About Catalyst's Commitment to LEMS Patients
Catalyst is committed to bringing all patients diagnosed with LEMS a quality, safe and effective, FDA approved product, regardless of financial circumstances. The Company is already working to establish a patient assistance program that will be designed to help patients without insurance, those in Medicare Part D, or Medicaid, and those facing financial challenges. Buy Vitamins online Catalyst will work hard to understand the needs of patients and is committed to helping them afford their medication.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company focused on the development and commercialization of prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette Syndrome. In 2012, Catalyst licensed Firdapse from BioMarin, and Catalyst assumed management of the Phase 3 pivotal trial, which was initiated by BioMarin. Firdapse is the first and only European approved drug for symptomatic treatment in adults with LEMS.
Catalyst is also developing a potentially safer and more potent vigabatrin analog (designated CPP-115) to treat infantile spasms, and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette syndrome. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission. For more information, please visit www.fda-approved-rx.biz.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. Boxing Forum - Online Pharmacy : Buy drugs without prescription A number of factors, including the anticipated timing of the receipt of top-line results from the double-blind, placebo-controlled portion of the Phase 3 trial of Firdapse, whether historic metrics of patients enrolled in the trial who complete the run-in phase of the trial and are randomized into the double-blind, placebo-controlled portion of the trial will continue to apply, such that at least 36 patients will be randomized into the double-blind, placebo-controlled portion of the trial from the patients already enrolled in the trial, whether the Phase 3 trial will be successful, whether the receipt of breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, whether an NDA for Firdapse will ever be accepted for filing by the FDA, the timing of any such NDA filing or acceptance, whether Catalyst will be the first company to receive an approval for 3,4-DAP, giving it 7-year marketing exclusivity for its product, whether any of Catalyst's product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2013 and its other filings with the U.S.Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

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 14^th 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.

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.