|
||||||||||||||||||||||||||||||||||||||
|
|
WCTF.org Transplant NewsTransplant news, links, and other general medical news -- updated regularly.Wednesday, April 30, 2008Organ transplant - Wikipedia, the free encyclopedia
An organ transplant is the moving of a whole or partial organ from one body to another (or from a donor site on the patient's own body), for the purpose of replacing the recipient [read more]
Hahnemann University Hospital and St. Christopher's Hospital for Children Extend Current Agreement With Independence Blue Cross
Hahnemann University Hospital and St. Christopher's Hospital for Children Extend Current Agreement With Independence Blue Cross
PHILADELPHIA, April 30 /PRNewswire-USNewswire/ -- Hahnemann University Hospital, St. Christopher's Hospital for Children and Independence Blue Cross (IBC) announced today that they have reached agreement in principle on terms of new contracts. They have extended their current agreements while they define terms for new multi-year contracts. Hahnemann and St. Christopher's are both part of Tenet Healthcare Corporation's (NYSE:THC) national network of hospitals. The parties will continue to work together to finalize details of the new contracts with a targeted effective date of July 1, 2008. Members of IBC will continue to have access to health care services offered at the two hospitals, their outpatient centers and employed physician practices. The parties have been working to reach new agreements in advance of the current contract termination, which was to have occurred on April 30. "We are pleased to reach an agreement that avoids a potentially disruptive contract termination for our patients," said Michael P. Halter, chief executive officer of Hahnemann University Hospital. "This extension of our agreement means that we can continue providing care to our patients who are covered by Independence Blue Cross." Bernadette Mangan, chief executive officer of St. Christopher's Hospital for Children, said, "We welcome the opportunity to continue working with Independence Blue Cross to provide quality care for their members." "We value our longstanding relationship with Hahnemann and St. Christopher's Hospitals and are pleased that we have achieved an understanding as the basis for a new agreement," said I. Steven Udvarhelyi, chief medical officer and senior vice president. "More importantly, our members will continue to receive quality care from these institutions." About Independence Blue Cross Independence Blue Cross is a leading health insurer in Southeastern Pennsylvania. IBC and its affiliates provide coverage to nearly 3.4 million people. For 70 years, Independence Blue Cross has offered high-quality health care coverage tailored to meet the changing needs of members, employers, and health care professionals. Independence Blue Cross is an independent licensee of the Blue Cross Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. To learn more about Independence Blue Cross, visit www.ibx.com. About Hahnemann University Hospital Hahnemann University Hospital is a 540-bed academic medical center at Broad and Vine Streets in Philadelphia, Pa. The hospital is a tertiary care institution that specializes in cardiac services, heart failure and transplantation, OB/GYN, orthopedics, medical, surgical and radiation oncology, bone marrow transplantation, renal dialysis and kidney/pancreas/liver transplantation. Hahnemann has been named by U.S. News and World Report as one of the nation's top fifty hospitals for heart care and is also recognized by the American Heart Association as a leader in coronary artery disease and heart failure treatments. The hospital performed one of the city's first kidney transplants in 1963 and one of the first bone marrow transplants in 1976. Hahnemann became Philadelphia's first Level I Regional Resource Trauma Center for adults in 1986, and since then has been served by MidAtlantic MedEvac, an aeromedical transport program for critically ill patients. Hahnemann is proud to be the first hospital in Philadelphia to join with The Wellness Community of Philadelphia to offer onsite support and education services to cancer patients and their families. Hahnemann is fully accredited by the Joint Commission on the Accreditation of Healthcare Organizations, the nation's oldest and largest hospital accreditation agency. An affiliate of Drexel University College of Medicine, Hahnemann University Hospital is part of Tenet Pennsylvania, which also includes St. Christopher's Hospital for Children. To learn more about Hahnemann, visit www.hahnemannhospital.com. About St. Christopher's Hospital for Children St. Christopher's Hospital for Children is a 170-bed pediatric hospital located at 3601 A Street in Philadelphia, PA that has an academic affiliation with Drexel University College of Medicine and the Temple University School of Medicine. The hospital provides a wide range of pediatric medical and surgical specialties. With a medical staff of more than 270 pediatric specialists, St. Christopher's is a Level I Pediatric Trauma Center and provides programs such as kidney transplantation, cancer treatment, burn and wound care, minimally invasive surgery, and open heart surgery for the children of the greater Philadelphia area and from around the world. The hospital is fully accredited by the Joint Commission, the nation's oldest and largest hospital accreditation agency. St. Christopher's Hospital for Children is part of Tenet Healthcare Corporation's Hospitals in the Philadelphia market. To learn more about St. Christopher's Hospital for Children, visit www.stchristophershospital.com.
http://www.stchristophershospital.com/ Source: Hahnemann University Hospital CONTACT: Coleen Cannon of Hahnemann University Hospital, Office: Web Site: http://www.hahnemannhospital.com/
Cautious welcome for RP's organ transplant ban on foreigners (ABS-CBNNEWS.com)
Cautious welcome for RP's organ transplant ban on foreigners (ABS-CBNNEWS.com)
on organ transplants to foreigners but cautioned that loopholes may still allow kidney trafficking to persist. Congressional Organ and Tissue Donation Awareness Caucus Hosted Congressional Staff Meeting on April 29 to Spread the ... (PR Newswire via Yahoo! Finance)
On April 29, 2008, members of the American Society of Transplantation , American Society of Transplant Surgeons, the Association of Organ Procurement Organizations, National Kidney Foundation, and Donate Life America hosted a meeting with Congressional staffers in recognition of Donate Life Month. [full story]
Three Million Californians Say 'Yes!' to Organ and Tissue Donation
Three Million Californians Say 'Yes!' to Organ and Tissue Donation
Thousands Saved and Healed by Registered Organ and Tissue Donors SACRAMENTO, Calif., April 30 /PRNewswire-USNewswire/ -- Families of organ and tissue donors joined organ transplant recipients at the State Capitol on April 30 to formally thank lawmakers, the Department of Motor Vehicles (DMV) and the three million Californians who have pledged to save and heal lives by signing up on the state-authorized Donate Life California Organ & Tissue Donor Registry. Governor Arnold Schwarzenegger, along with Assemblywoman Sharon Runner (R - Lancaster) joined fellow legislators, DMV representatives, and allied health professionals to officially commemorate April's DMV/Donate Life California Month. "The benefits of organ and tissue donation are simply staggering," Governor Schwarzenegger said. "I am proud of the 3 million Californians who have signed up to be organ and tissue donors. Each person who becomes a donor can save the lives of eight people and dramatically improve the lives of 50 people. It truly is the gift of life." The number of individuals who wait for a life saving transplant continues to increase on a daily basis. California has the highest proportion of people on the national organ transplant waiting list, with about 20 percent of the nearly 100,000 candidates awaiting a life-saving transplant. "Californians have an extraordinary opportunity to help save lives and ensure their decision to do so is honored," Runner said. Runner authored Assembly Concurrent Resolution 125, a resolution recognizing April as DMV/Donate Life California Month to encourage Californians to sign up with the Donate Life California Registry. "Each of us has the power to save up to eight lives as an organ donor and heal up to 50 others as a tissue donor by restoring sight, mobility, and healing burns," Runner added. "I strongly encourage every Californian to sign up with the registry." Altogether, registered organ and tissue donors saved or healed more than 3,000 lives in 2007. Anyone can sign up on the Donate Life California Registry, and unlike blood donation, there are few automatic rule-outs. "We are pleased that in the last year, the Donate Life California Registry has shown its value as a tool to save and heal lives," Bryan Stewart, President of Donate Life California, said. "With one million designated donors signing up every eight months, the life-saving impact of the registry is on an upward trajectory." The success of the Donate Life California Registry owes much to its partnership with the Department of Motor Vehicles. "Today we celebrate three million Californians who have signed up to become organ and tissue donors," DMV Director George Valverde said. "Those 'pink dots' are more than mere symbols; they have taken on the power of advanced directives for organ and tissue donation for any California motorist who proudly chooses to display them." The vast majority of the registry's three million designated donors have signed up since the DMV began enrolling designated donors in July 2006. Due to the five year license renewal cycle, two-thirds of California drivers have not yet had the opportunity to check 'yes' when they renew their license, and state lawmakers urge individuals to do so. In all cases in which an eligible donor has not registered with Donate Life California, the donation decision falls on families, who consent to donation in about 60% of cases. When families are unsure of what their loved one wanted, after sometimes anguishing deliberation, they often decline to donate. Thus, documenting one's decision on the registry is a gift both to one's family and to potential recipients. "The registry's core promise - to save lives by ensuring individuals' wishes to donate are honored - is accomplishing its life-saving mission," Stewart said. Donate Life California is a nonprofit, state-authorized organ and tissue donor registry, administered by California's four nonprofit, federally designated organ procurement organizations, each responsible for facilitating the donation process in the state: California Transplant Donor Network, Golden State Donor Services, Lifesharing and OneLegacy. For more information, please visit http://www.dmv.ca.gov/about/donateLife/donateLife.htm, http://www.donatelifecalifornia.org/ or in Spanish at http://www.donevidacalifornia.org/. (Editor's note: Donate Life California statistics follows) Donate Life California Registry Enrollment, 2005-2007 Quarter Quarterly Cumulative Total
http://www.donateLIFEcalifornia.org Source: Donate Life California CONTACT: Kayla Garcia of the Office of Assemblywoman Sharon Runner, Web Site:
Pulmonary Fibrosis Patients Meet With Top Lung Doctors at Beth Israel Deaconess Medical Center
Pulmonary Fibrosis Patients Meet With Top Lung Doctors at Beth Israel Deaconess Medical Center
Idiopathic pulmonary fibrosis (IPF) patients learn from specialists, seek answers about incurable disease BOSTON, April 30 /PRNewswire-USNewswire/ -- The following announcement was released by The Coalition for Pulmonary Fibrosis: WHAT: "Living with IPF" Free Educational Seminar for Patients and Their Families Beth Israel Deaconess Medical Center (BIDMC) in partnership with The Coalition for Pulmonary Fibrosis (CPF), is hosting a free seminar for patients and families living with idiopathic pulmonary fibrosis (IPF), a fatal disease that affects 128,000 Americans and claims as many lives each year as breast cancer (40,000). Incidence and prevalence have grown more than 150 percent in just five years. The seminar will address: When: Where: Parking is available at the Pilgrim Road Garage on the West Campus for $10. Entrance is located off Crossover Street, which can be reached by either Pilgrim Road or Autumn Street. **DO NOT use the garage adjacent to Bruegger's Bagel off Longwood Avenue. WHO:
-- IPF patients who live in the Boston area
A recent study conducted by the Coalition for Pulmonary Fibrosis* found IPF awareness is alarmingly low -- less than one-third of Americans polled had heard of IPF, while 88 percent were aware of cystic fibrosis, and 85 percent knew of ALS, or Lou Gehrig's Disease. IPF is several times more common than cystic fibrosis and ALS, yet it receives a fraction of the research funding. * Respiratory Medicine: Volume 101, Issue 6, June 2007, Pages 1350-1354 Patient experiences with pulmonary fibrosis Collard, Tino, Noble, Shreve, Michaels, Carlson, Schwarz. (http://www.coalitionforpf.org/ofs/pdf/BRQRespiratoryMedicinePaper.pdf) The Coalition for Pulmonary Fibrosis (CPF) is a 501(c)(3) nonprofit organization, founded in 2001 to accelerate research efforts leading to a cure for pulmonary fibrosis, while educating, supporting, and advocating for the community of patients, families, and medical professionals fighting this disease. The CPF's nonprofit partners include many of the most respected medical centers and healthcare organizations in the U.S. For more information, visit www.coalitionforpf.org. Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and consistently ranks among the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.harvard.edu.
CONTACT: Teresa Barnes of The Coalition for Pulmonary Fibrosis, Web Site: http://www.coalitionforpf.org/
Blue Cross and Blue Shield Companies to Get Workers Out of The Office and on Their Feet in All 50 States
Blue Cross and Blue Shield Companies to Get Workers Out of The Office and on Their Feet in All 50 States
National Walk @ Lunch Day(SM) encourages healthier lifestyles WASHINGTON, April 29 /PRNewswire-USNewswire/ -- Blue Cross and Blue Shield companies nationwide are working with employers of all sizes to get their workers to take steps toward healthier lifestyles. Citing the tremendous cost that inactive lifestyles and preventable health conditions have on the nation's healthcare bill, Blue Cross and Blue Shield companies are holding lunchtime walks across America as part of the second annual National Walk @ Lunch Day. Blue Cross and Blue Shield companies are hosting the walks in all 50 states, the District of Columbia and Puerto Rico to engage employees, members and community leaders in healthy activities to promote the benefits of walking. Nationwide, thousands of walkers from companies, organizations, state and local governments are participating in this healthy initiative. Regular, brisk walking is one of the simplest and safest forms of physical exercise and a regular walking program can help control weight, condition the heart and lungs, strengthen bones and help you take the first step to a healthier future. Regular walking also has other positive impacts on health, including decreasing the risk of a heart attack, reducing the risk of developing type 2 diabetes, helping to control weight and improving muscle tone. "More than 60 percent of all adults in our country do not engage in the recommended amount of physical activity," said Scott P. Serota, president and CEO of the Blue Cross and Blue Shield Association (BCBSA). "This lack of regular physical exercise can lead to illness and chronic diseases down the road. National Walk @ Lunch Day is not only an opportunity for Americans to step outside and take a lunchtime walk, but it is an opportunity to join the Blue Cross and Blue Shield companies in leading a call to action for the nation to embark on a path to a healthier lifestyle." In Washington, D.C., CareFirst BlueCross BlueShield and Blue Cross and Blue Shield Federal Employee Program employees are joining the U.S. Department of Health and Human Services (HHS) in co-hosting a National Walk @ Lunch Day event at the Hubert H. Humphrey building for federal government employees. "Modern medical science gives every one of us the opportunity to be among the healthiest people who've ever lived," said Health and Human Services Deputy Secretary Tevi Troy. "But if you want to live a long and healthy life, you also have to eat well, avoid risky behaviors, and exercise regularly. We at HHS are encouraging people to make these smart choices, and it's great to see private companies doing this as well." Nationwide, hundreds of companies, organizations, state and local governments are hosting or participating in National Walk @ Lunch Day events across the country such as Emerson Hospital in Concord, Massachusetts, and Kayser-Roth Corporation in Greensboro, North Carolina. "Emerson Hospital is committed to the health and well-being of our employees," said Christine Schuster, president and CEO, Emerson Hospital. "We know our employees are busy, so walking at lunchtime is a great way to integrate exercise into our day while spending some time with co-workers outside of the office. I look forward to joining my team as we walk our way to better health." "Our goal at Kayser-Roth Corporation is to leave a legacy of healthier employees by creating an environment that encourages healthier lifestyles," said Rae Mackall, vice president of human resources at North Carolina- based Kayser-Roth Corporation. "We are encouraging our employees to walk on April 30th for National Walk @ Lunch Day as a way to motivate our team to walk everyday." Below are highlights of some of the National Walk @ Lunch Day activities taking place across the country: -- In Chicago, Blue Cross and Blue Shield of Illinois and BCBSA are -- Independence Blue Cross (IBC) will lead the charge on walking toward -- In addition to organizing walks at its offices across Arizona, Blue -- In Florida, Blue Cross and Blue Shield of Florida is holding more than -- In Baton Rouge, Blue Cross and Blue Shield of Louisiana is hosting an -- Anthem Blue Cross will mobilize their more than 4,000 associates from -- Blue Cross and Blue Shield of Vermont is hosting six community walks -- In Columbia, South Carolina, BlueCross BlueShield of South Carolina is -- Anthem Blue Cross and Blue Shield in Colorado will be joined by CBS4 For more information, please visit www.bcbs.com/walkatlunch.
CONTACT: Kelly Miller of Blue Cross and Blue Shield Association, Web Site: http://www.bcbs.com/walkatlunch
Temple University Hospital Auxiliary Honors Dr. Kenneth Mangan at 2008 'Acres of Diamonds' Gala
Temple University Hospital Auxiliary Honors Dr. Kenneth Mangan at 2008 'Acres of Diamonds' Gala
Every year since 1991, the Diamond Award is presented to an In attendance will be Dr. Ann Weaver Hart, President of Temple WHEN: Saturday, May 3, 2008 Note to Editors: Cocktails to begin at 6:30 p.m., with dinner to WHERE: Grand Ballroom Contact: Rebecca Harmon PRNewswire -- April 30
Web site:
Liver Transplant - Transplants - DukeHealth.org
For patients who need liver transplants, Duke offers comprehensive evaluation and care, including traditional transplants and a living-related transplant program. Transplant is an [full story]
Congressional Organ and Tissue Donation Awareness Caucus Hosted Congressional Staff Meeting on April 29 to Spread the ... (PR Newswire via Yahoo! Finance)
On April 29, 2008, members of the American Society of Transplantation , American Society of Transplant Surgeons, the Association of Organ Procurement Organizations, National Kidney Foundation, and Donate Life America hosted a meeting with Congressional staffers in recognition of Donate Life Month. [continued]
ViroPharma Incorporated Reports First Quarter 2008 Financial Results
ViroPharma Incorporated Reports First Quarter 2008 Financial Results
EXTON, Pa., April 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (NASDAQ:VPHM) reported today its financial results for the first quarter ended March 31, 2008. Key events since December 31, 2007 include: Development: -- Notified sites participating in Phase 3 study of Camvia(TM) (maribavir) Operational: -- Vincent J. Milano succeeded Michel de Rosen as president and chief Financial Results: -- Operating income was $20 million; Financial Highlights
Investment in our product pipeline and the Company continued to grow as research and development (R&D) and selling, general and administrative (SG&A) expenses were $27.8 million for the first quarter of 2008 compared to $12.5 million for the first quarter of 2007. These increases were due primarily to the costs, including the costs of increased personnel associated with our phase 3 program for maribavir, along with increased selling, general and administrative expense due to compensations costs, including share-based compensation, which resulted from increased headcount for our European operations and our Vancocin(R) sales force, as well as medical education activities and marketing efforts. Operating income in the first quarter ended March 31, 2008 was $19.5 million compared to $32.9 million in the first quarter of 2007. Operating income in the first quarter decreased primarily due to higher R&D and SG&A costs discussed above partially offset by the higher net sales. "The beginning of 2008 has been both a strong period of execution and growing momentum for the company," stated Vincent Milano, ViroPharma's president and chief executive officer. "Our efforts around maribavir, including the ongoing pivotal Phase 3 clinical studies, pre-launch activities, global filing strategy and launch plan development, are all proceeding towards our planned 2009 initial NDA and MAA filings. We've also had continued progress in our C. difficile franchise. The performance of Vancocin was strong, keeping us on track to generate between $210 and $235 million in net sales of the product this year; we successfully launched our new sales force with the goal of growing this trusted brand, which to this day remains the only FDA-approved and clinically proven treatment for these very sick patients with severe C. difficile infection (CDI); and, our work continued in optimizing the manufacturing for our non-toxigenic C. difficile opportunity which we hope to move into human trials later this year." Continued Milano, "We look forward to a number of significant events throughout 2008, starting in May with the completion of enrollment in our stem cell transplant study of maribavir. In the coming months, we anticipate the publication of the IDSA/SHEA CDI treatment guidelines which highlight the recommendation of Vancocin for treating patients with severe disease based upon compelling clinical trial data that demonstrated the superiority of Vancocin in this patient population." Net income in the first quarter ended March 31, 2008 was $17.5 million compared to $22.1 million for the same period in 2007. Net income per share for the quarter ended March 31, 2008 was $0.25 per share, basic and $0.22 per share, diluted, compared to a net income of $0.32 per share, basic, and $0.31 per share, diluted, for the same period in 2007. The primary drivers of the change in net income for the first quarter were the effects of decreased operating income discussed above, partially offset by increased interest income and a lower effective tax rate. Operating Highlights During the three months ended March 31, 2008, net sales of Vancocin increased 3.9 percent compared to the same period in 2007. The increase resulted from the impact of a price increase in February 2008, partially offset by a decrease in sales volume. The cost of sales for Vancocin for the three months ended March 31, 2008 decreased $0.3 million for the three months ended March 31, 2007 to $1.9 million from $2.2 million for the same period in 2007 due primarily to the decrease in sales volume. The total remaining costs and expenses associated with operating income were $29.5 million and $13.9 million, for the first quarter of 2008 and 2007, respectively. These increases are primarily due to research and development costs, increased compensation related to our European operations and Vancocin sales force, medical education activities and marketing costs. The Company's effective income tax rate was 28.5 percent and 39.4 percent for the quarters ended March 31, 2008 and 2007, respectively. Income tax expense includes federal, state and foreign income tax at statutory rates and the effects of various permanent differences. The decrease in the effective rate for the quarter ended March 31, 2008 as compared to the comparative periods in 2007 is primarily due to our current estimate of the impact of orphan drug credit for maribavir. We currently anticipate an effective tax rate in the range of approximately 27 percent to 31 percent for the year ended December 31, 2008, which includes an estimate related to orphan drug credit based upon estimates of qualified expenses and excludes the impact of discreet items and any potential changes in the valuation allowance. We continue to evaluate our qualified expenses and, to the extent that actual qualified expenses vary significantly from our estimates, our effective tax rate will be impacted. Regarding additional payments due to Lilly in connection with the Vancocin acquisition, net sales as of March 31, 2008 exceeded the milestone threshold of $45.0 million. As a result, the Company recorded additional purchase price of $2.1 million to intangible assets in March 2008. Working Capital Highlights As of March 31, 2008, ViroPharma's working capital was $619.5 million, which represents a $25.1 million increase from December 31, 2007. The three month increase is primarily the result of cash flows. Looking ahead in 2008 ViroPharma is commenting upon previously announced guidance for the year 2008 as a convenience to investors. The following guidance provided by ViroPharma are projections, based upon numerous assumptions, all of which are subject to certain risks and uncertainties. For a discussion of the risks and uncertainties associated with these forward looking statements, please see the Disclosure Notice below. For the year 2008, ViroPharma expects the following -- Net product sales are expected to be $210 to $235 million; -- Research and development (R&D) and selling, general and administrative -- The SFAS 123R impact to the above expenses will be in the range of $9 Non-GAAP Disclosures
Conference Call and Webcast ViroPharma is hosting a live teleconference and webcast with senior management to discuss the financial announcement, guidance, and other business results on April 30, 2008 at 9:00 a.m. Eastern Time. To participate in the conference call, please dial 877-366-0713 (domestic) and 302-607-2000 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call. Alternatively, the live webcast of the conference call can be accessed via ViroPharma's website at http://www.viropharma.com/. Windows Media or Real Player will be needed to access the webcast. An audio archive will be available at the same address until May 14, 2008. About ViroPharma Incorporated ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) approved for oral administration for treatment of antibiotic- associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in infectious diseases including cytomegalovirus (CMV) and non-toxigenic C. difficile (NTCD). For more information on ViroPharma, visit the Company's website at www.viropharma.com. Disclosure Notice Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide the Company's current expectations or forecasts of future events. Forward looking statements in this press release include the Company's financial guidance for 2008, and statements regarding ViroPharma's clinical development programs, including our ability to file an initial NDA for Camvia in 2009, commence clinical studies of NTCD in humans during 2008, the timing and content of final IDSA/SHEA CDI treatment guidelines or our ability to execute a future successful launch of Camvia. ViroPharma's 2008 revenue guidance is based upon the Company's plans to remain vigorous in its opposition to any bioequivalence approach considered for use in approving generic formulations of Vancocin that does not require rigorous scientific methods to demonstrate safety and efficacy consistent with good medicine and science. There can be no assurance that the FDA will agree with the positions stated in ViroPharma's Vancocin related submissions or that ViroPharma's efforts to oppose the OGD's March 2006 recommendation to determine bioequivalence to Vancocin through in vitro dissolution testing will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either ViroPharma's citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the OGD in March 2006, the threat of generic competition will be high. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. The company's actual results may vary depending on a variety of factors, including: -- the development of competitive generic versions of oral Vancocin, There can be no assurance that FDA or EMEA will not require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval of any of the company's product candidates, or that the company will be successful in gaining regulatory approval of any of its product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2008, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. VIROPHARMA INCORPORATED Consolidated Statements of Operations: Three months ended Costs and Expenses: Interest income 6,311 3,580 Basic net income per share $0.25 $0.32 Shares used in computing net income per share Consolidated Balance Sheets: March 31, December 31,
CONTACT: Vincent J. Milano, President, Chief Executive Officer, Web site:
Alexion Reports First Quarter 2008 Results
Alexion Reports First Quarter 2008 Results
Growing Awareness of PNH Drives Strong Demand for Soliris(R) in U.S. and Europe First Non-GAAP Profit; Sales Guidance Revised Upward Pipeline Progress in Neurology and Cancer First Quarter 2008 Financial Highlights: - Soliris(R) (eculizumab) net product sales were $45.5 million in Q1 2008, compared to net product sales of $33.9 million in Q4 2007. - Q1 GAAP net loss was $4.2 million, or $0.11 net loss per share, compared to a GAAP net loss of $12.3 million, or $0.33 net loss per share, in Q4 2007. - Q1 non-GAAP net income was $1.6 million, or $0.04 net income per share, compared to a non-GAAP net loss of $8.5 million, or $0.23 net loss per share, in Q4 2007. CHESHIRE, Conn., April 30 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the quarter ended March 31, 2008. First Quarter 2008 Financial Results: For the three months ended March 31, 2008, Alexion Pharmaceuticals, Inc. ("Alexion" or the "Company") reported total revenues of $45.6 million compared to total revenues of $6.3 million for the same period in 2007. First quarter 2008 revenues were primarily from net product sales of Soliris(R) (eculizumab): $45.5 million, compared to $1.0 million in the first quarter of 2007 and $33.9 million in the fourth quarter of 2007. Soliris, approved by the U.S. Food and Drug Administration (FDA) in March 2007 and the European Commission (EC) in June 2007, is the only drug specifically indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria ("PNH"), a rare, debilitating and life-threatening blood disease. The Company reports both GAAP results and non-GAAP results. Non-GAAP results are equal to GAAP results excluding the impact of share-based compensation. The following summary table is provided for investors' convenience. A further reconciliation and explanation of the GAAP to non-GAAP figures appears at the end of this announcement. (Millions of U.S. dollars, except per-share data)
Net Product Sales $45.5 $1.0 GAAP Net Loss (4.2) (32.7) GAAP Net Loss Per Share - Diluted $(0.11) $(0.92) Shares Used in Determining GAAP Loss Per Share 37,514 35,361 Shares Used in Determining Non-
Alexion's non-GAAP operating expenses for Q1 2008 were $39.5 million, compared to $36.1 million for Q1 2007. Non-GAAP research and development ("R&D") expenses for Q1 2008 were $14.0 million, compared to $18.8 million for the year-ago quarter. The lower R&D costs in Q1 2008 were the result of the non-recurrence of expenses associated with drug development, including Soliris registration and the Soliris extension study. Non-GAAP selling, general, and administrative ("SG&A") expenses for Q1 2008 were $25.5 million, compared to $17.2 million for Q1 2007. The increase in non-GAAP SG&A expenses primarily reflected costs associated with the expansion of the Company's commercial operations in the U.S. and Europe. First Quarter 2008 GAAP Financial Results
The Company recorded investment income of $0.8 million for Q1 2008, compared to $2.8 million in the same period last year. Interest expense in the first quarter was $0.6 million, compared to $0.7 million for the same period last year. Alexion incurred a GAAP net loss for the first quarter of 2008 of $4.2 million, or $0.11 per share, compared to a GAAP net loss of $32.7 million, or $0.92 per share, for Q1 2007. The GAAP net loss in Q1 2008 was reduced from a GAAP net loss of $12.3 million, or $0.33 per share in the prior quarter, Q4 2007. Balance Sheet: As of March 31, 2008, the Company had $107.0 million in cash, cash equivalents, restricted cash, and marketable securities, compared to $106.7 million at December 31, 2007. During the quarter, the Company drew down $18 million from its recently arranged credit facility for working capital purposes. "Demand for Soliris increased significantly in both the United States and Europe, as we educated more physicians, patients and payors about PNH and the compelling data from Soliris clinical trials," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "Our non-GAAP profit in the first quarter resulted from continued strong momentum in the Soliris launch, combined with the rigorous financial discipline we have applied as our organization has grown. The scientific, commercial and financial success of Alexion makes it possible for us to help more patients with PNH and research promising therapies for other serious and rare diseases." Research and Development: Soliris as a Treatment for Patients with PNH
Soliris as a Treatment for Patients with Rare and Severe Diseases
Other Studies of Soliris
Anti-CD200 Monoclonal Antibody for Cancer
Q1 2008 Soliris Commercial Update: In the first quarter, the Company continued to convert clinical trial patients to full commercial status in European countries and also added significant numbers of patients newly identified during the quarter in the U.S., as well as in Europe. "Our commercial teams remain focused on helping physicians improve the diagnosis and treatment of PNH and helping patients obtain access to Soliris. Overall, the result has been steady growth in new patient starts and high levels of access and compliance with Soliris therapy," said David Keiser, President and Chief Operating Officer of Alexion. "As in the past, we will expand our commercial team selectively when we see an opportunity to further educate physicians and support patients. All of these activities are in line with our objective that every patient who can benefit from Soliris will have access to it." Financial Guidance: As a result of the Company's strong sales performance in the first quarter, Alexion is revising its previously announced guidance for worldwide Soliris net product sales upward, from a range of $200 to $215 million to a range of $215 to $225 million for 2008. Further, the cost of sales, including actual and estimated royalties, is now expected to be improved to a range of 12 percent to 14 percent of net product sales, as compared to the previous estimate of 14 percent to 16 percent. Prior financial guidance in other expense areas remains unchanged: excluding share-based compensation of $26 to $28 million, R&D expenses in 2008 are anticipated to be in the range of $65 to $75 million and SG&A expenses in the range of $115 to $125 million. The Company expects to report a non-GAAP profit for the full year 2008. Conference Call/Web Cast Information
About Soliris
About Alexion
This press release includes certain non-GAAP financial measures that involve adjustments to GAAP figures. Alexion believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Alexion's past financial performance and its prospects for the future. The non-GAAP financial measures are included with the intent of providing both management and investors with a more complete understanding of underlying operational results and trends. In addition, these non-GAAP financial measures are among the primary indicators Alexion management uses for planning and forecasting purposes and measuring the company's performance. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures. A reconciliation of the non-GAAP to GAAP figures follows this press release. [ALXN-E] This news release contains forward-looking statements, including statements related to guidance regarding anticipated financial results for 2008, potential benefits and commercial potential for Soliris, timing and effect of sales of Soliris in the United States and various European markets, status of reimbursement, price approval and funding processes in Europe, progress in developing commercial infrastructure, interest regarding Soliris in the patient, physician and payor communities and expectations about commencement of clinical trials and studies. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Soliris, delays in arranging satisfactory manufacturing capability and establishing commercial infrastructure, delays in developing or adverse changes in commercial relationships, the possibility that results of clinical trials of Soliris are not predictive of safety and efficacy and Soliris is found to be less safe or effective when utilized in broader patient populations, the possibility that initial results of commercialization are not predictive of future rates of adoption of Soliris, the risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms or at all, the risk that third party payors (including governmental agencies) will not reimburse for the use of Soliris at acceptable rates or at all, the risk that estimates regarding the number of PNH patients are inaccurate, the risk that ongoing litigation may be resolved adversely, and a variety of other risks set forth from time to time in Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Annual Report on Form 10-K for the period ended December 31, 2007 and in our other filings with the Securities and Exchange Commission. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law. (Financial Tables Follow) ALEXION PHARMACEUTICALS, INC. Consolidated Statements of Operations Data: Cost of sales 5,464 85 Operating expenses: Operating loss (5,213) (34,825) Other income (expense): Income tax benefit 90 90 Net loss $(4,249) $(32,693) Net loss per share - basic and diluted $(0.11) $(0.92) Shares used in computing basic and
(a) Amount includes restricted cash of $417 and $958 ALEXION PHARMACEUTICALS, INC. Non-GAAP financial information is adjusted to exclude the impact of share-based compensation. The following table represents a reconciliation of GAAP to non-GAAP financial information for the three months ended March 31, 2008 and 2007, as well as the three months ended December 31, 2007: Non-GAAP Three Months Ended March 31, 2008 Basic and diluted net income (loss) Three Months Ended March 31, 2007 Basic and diluted net loss per share $(0.92) $0.14 $(0.78) Three Months Ended December 31, 2007 Basic and diluted net loss per share $(0.33) $0.10 $(0.23)
CONTACT: Irving Adler, Sr. Director, Corporate Communications, of
Qld to examine opt-out on organ donation (AAP via Yahoo!7 News)
Queensland may become the first Australian state to introduce an "opt out" system for organ donation. [more]
ArchivesMar 21, 2008 Mar 22, 2008 Mar 23, 2008 Mar 24, 2008 Mar 25, 2008 Mar 26, 2008 Mar 27, 2008 Mar 28, 2008 Mar 29, 2008 Mar 30, 2008 Mar 31, 2008 Apr 1, 2008 Apr 2, 2008 Apr 3, 2008 Apr 4, 2008 Apr 5, 2008 Apr 6, 2008 Apr 7, 2008 Apr 8, 2008 Apr 9, 2008 Apr 10, 2008 Apr 11, 2008 Apr 12, 2008 Apr 13, 2008 Apr 14, 2008 Apr 15, 2008 Apr 16, 2008 Apr 17, 2008 Apr 18, 2008 Apr 19, 2008 Apr 20, 2008 Apr 21, 2008 Apr 22, 2008 Apr 23, 2008 Apr 24, 2008 Apr 25, 2008 Apr 26, 2008 Apr 27, 2008 Apr 28, 2008 Apr 29, 2008 Apr 30, 2008 Subscribe to Posts [Atom] |
|
| |||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||