WCTF.org Transplant News

CHICAGO, April 21 /PRNewswire-USNewswire/ -- Ground was broken on the Ann & Robert H. Lurie Children's Hospital of Chicago today following remarks from Children's Memorial Hospital patients, philanthropist and transformational donor Ann Lurie, hospital leadership and public officials (First Lady Maggie Daley, Governor Rod Blagojevich, Senator Richard Durbin, Congressman Rahm Emanuel, Congressman Danny Davis and Congressman Jesse Jackson Jr.). The 288-bed hospital, located at 225 E. Chicago Avenue directly west of Northwestern Memorial's new Prentice Women's Hospital, is expected to open in 2012.

"This new facility represents our forward-thinking on behalf of future generations. New risks to children's health loom in the future, some that we can predict, others that may stagger us. That is why it is ever more important that we act today for what will come tomorrow," said Patrick Magoon, president and CEO.

The hospital will feature 12 beds dedicated to clinical research, an essential factor in speeding translation of research from the laboratory to the bedside and giving children access to the most advanced treatments. It will also include one of the nation's first pediatric comprehensive cardiac care units to keep children with heart problems in the same room with the same caregivers from admission to discharge.

Designed to be a "green hospital" to achieve LEED (Leadership in Energy and Environmental Design) certification, it will have all private rooms with space for at least one parent to sleep overnight and a "sky lobby" on the 11th and 12th floors to provide enhanced security for inpatient units and views of Chicago and Lake Michigan for patients and visitors.

"Today we are making history," said J. Christopher Reyes, Chairman of Children's Memorial Medical Center Board of Directors. "We are part of this journey for one reason: to improve the lives of our most precious resource, our children. Together we are making a great investment that will benefit our children and our communities for generations to come."

Children's Memorial must turn away a significant number of critically ill children each year because an appropriate bed is not available. The new facility will increase capacity by 30 percent. Its location on the campus of partner medical school, Northwestern University's Feinberg School of Medicine, will help Children's Memorial to continue to recruit and retain top physicians and scientists and better facilitate collaboration between pediatric and adult researchers. Its adjacency to Northwestern Memorial's Prentice Women's Hospital will offer convenience for families and direct clinical interaction to benefit newborns. Proximity to the Rehabilitation Institute of Chicago and Northwestern Memorial Hospital will improve transitional care for children with chronic illnesses into adult care.

"This is a momentous day in Illinois. We break ground on a genuinely modern and progressive facility committed to caring for the most vulnerable of our society -- our children. Families and children from around the world come to Children's Memorial to get the treatment they need," said Governor Blagojevich. "The hospital will help provide thousands of new jobs and re-emphasize that Illinois is a leader when it comes to quality heath care. The generosity of Ms. Lurie is truly inspirational and I applaud her for her compassionate gift."

Today's groundbreaking ceremony featured several patients of Children's Memorial from across Illinois, including children who have had cancer, a liver transplant, spina bifida, cystic fibrosis, cerebral palsy and a brain tumor. Twelve-year-old Daimhin McGrath, who had surgery to remove a deadly brain tumor at age 9 lives three blocks from the new hospital site, while Jacob Lowry, 10-year-old leukemia survivor, came 100 miles to participate in the celebration.

"I've been coming to the hospital my entire life, and my family and I consider it our second home," said Children's Memorial cystic fibrosis patient and hospital Kids Advisory Board member Katie Kelly.

First Call Analyst:
FCMN Contact:

Source: Children's Memorial Hospital

CONTACT: Julie Pesch, +1-773-880-3055 (office), +1-773-965-0868 (cell),
jpesch@childrensmemorial.org, of Children's Memorial Hospital

Web Site:

http://www.childrensmemorial.org/

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Profile: Transplant News

COMPANY WILL INITIATE COMMERCIAL LAUNCH PROGRAM TO ADD NEW CENTERS AND TO INCREASE AWARENESS AMONG CARDIOLOGISTS

PLEASANTON, Calif., April 21 /PRNewswire-FirstCall/ -- Thoratec Corporation (NASDAQ:THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has received FDA approval of its PMA (PreMarket Approval) application, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.

The approval follows a successful clinical trial involving more than 450 BTT patients, including those enrolled under Continued Access Protocols, and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.

"The HeartMate II is the first continuous flow device to receive FDA approval for this intended use in the U.S., representing a milestone in the treatment of advanced-stage heart failure patients and for the clinicians who treat them," said Gary F. Burbach, president and chief executive officer of Thoratec. "As our clinical trial indicated, the HeartMate II represents a new era in the treatment of advanced-stage heart failure with data demonstrating excellent survival rates, quality of life and functional capacity for a broad range of patients. This patient experience has created a high level of enthusiasm for the HeartMate II within the clinical community. We are hopeful that the device's trial experience, ease of implantation, small size and ability to provide longer duration support will result in broader adoption of mechanical circulatory support for the treatment of these patients," he added.

The approval was based on one-year follow-up data from the first 194 HeartMate II BTT patients enrolled in the trial. Highlights of the data included in the final PMA submission included:

-- The median duration of support was 132 days, and the cumulative
patient support in the trial was 109 years.
-- Survival to cardiac transplantation, recovery or ongoing on HeartMate
II support was 80 percent at six months and 77 percent at one year.
-- Eighty four percent of the patients survived to hospital discharge or
transplantation.
-- Significant improvements were observed across all measures of
functional status and quality of life as compared to baseline status.
-- The incidence of major adverse events with comparable
definitions -- including infections, strokes and bleeding requiring
surgery -- was significantly lower than what was clinically observed
in the previous BTT study of the HeartMate VE LVAS.

The approval allows the HeartMate II to be used to treat small patients (BSA < 1.5) based on body habitus if the treating clinician believes that the patient could benefit from the device. In addition, Thoratec will conduct a post-market study that includes a concurrent comparator. The study will follow 169 HeartMate II patients until outcome, or one year -- whichever comes first -- and gather data regarding survival, adverse events, patient gender, small patients and anticoagulation levels.

"With this BTT approval, we will now initiate our sales and marketing programs designed to place the HeartMate II in transplant centers that did not participate in the clinical trial. Our hope is to add about 40 new centers during the balance of the year, which would bring the total number of centers implanting the HeartMate II to approximately 80 centers.

"The foundation of this effort is a strong training program and support materials that provide best practices on patient selection, device implantation and patient discharge and follow-up to ensure optimal patient outcomes. In addition, we are implementing programs to educate referring cardiologists about the compelling data from our trial and to increase their understanding of and appreciation for the value of mechanical circulatory support available with the HeartMate II," Burbach continued.

"For a population having an unmet need and for which drug therapies have not proven to be an effective solution, we believe the HeartMate II represents a breakthrough therapy and new hope for these patients. It further demonstrates our leadership position in the mechanical circulatory support arena with the broadest portfolio of devices. We want to acknowledge the efforts of the clinicians and patients who participated in this landmark trial in making this day a reality," Burbach commented.

About HeartMate II

The HeartMate II is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. An axial flow device, the HeartMate II can pump up to 10 liters of blood per minute, the full output of a healthy heart, and is designed to provide long-term cardiac support. The device is implanted alongside a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle. It is easier to implant than prior devices, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life. The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly.

About Thoratec

Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS with more than 11,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies point-of-care blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com/ or http://www.itcmed.com/.

Many of the preceding paragraphs contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "believes," "views," "expects," "hopes," "could," "will," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the development of new markets including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, changes in the mix of existing markets for our products, the results of enrollment in and timing of clinical trials, including for the HeartMate II, regulatory approval processes, the effects of healthcare reimbursement and coverage policies, the effects of seasonality in Thoratec product sales, the effects of price competition from any Thoratec competitors and the effects of any merger and acquisition related activities. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

First Call Analyst:
FCMN Contact: keith.grossman@thoratec.com

Source: Thoratec Corporation

CONTACT: David Smith, Executive Vice President, Chief Financial Officer
of Thoratec Corporation, +1-925-847-8600; or Neal Rosen of Ruder-Finn,
+1-415-692-3058, for Thoratec Corporation

Web site:

http://www.thoratec.com/
http://www.itcmed.com/

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Profile: Transplant News

Will Host Conference Call Today at 5:00 p.m.

CAMBRIDGE, Mass., April 21 /PRNewswire-FirstCall/ -- Genzyme Corporation (NASDAQ:GENZ) announced today that the FDA has informed the company of its opinion that Myozyme(R) (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale. Production at this larger scale has already been approved in more than 40 countries.

Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale, including patients who participated in the Late-Onset Treatment Study (LOTS), Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe. Myozyme is the only treatment for Pompe disease -- a severe, progressively debilitating and life-threatening inherited disorder affecting a very small number of people throughout the world.

The FDA will require Genzyme to submit a separate biologics license application (BLA) to gain approval for Myozyme produced at the 2000L scale. The agency proposed that Genzyme initiate a rolling BLA review process by submitting results from the LOTS study. Genzyme expects the FDA to give the BLA priority review and to act on the application by the end of this year. The LOTS study, which met its co-primary efficacy endpoints, was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and adult patients with Pompe disease. Genzyme had already been preparing to submit results from this study to the FDA to fulfill a post-marketing commitment. Genzyme anticipates that this process will culminate in the availability of two commercial versions of Myozyme in the United States: one produced at the 160L scale and the other produced at the 2000L scale. The company expects to begin providing U.S. patients with commercial 2000L Myozyme during the first quarter of 2009.

To ensure that severely affected adults with Pompe disease in the United States have access to treatment, Genzyme, in collaboration with the FDA, created the Myozyme Temporary Access Program (MTAP) in May 2007. Through this program the company is currently providing Myozyme produced at the 2000L scale free of charge to approximately 140 patients. Infants and children with Pompe disease in the United States continue to receive commercially approved Myozyme produced at the 160L scale.

"We are extremely disappointed in the FDA's decision because it will further delay broad patient access to Myozyme, which is not possible under the MTAP program," said Henri A. Termeer, Genzyme's chairman and chief executive officer.

Financial Impact

Myozyme sales for 2008 are now expected to be approximately $275-$285 million compared to previous guidance of $320-$330 million, reflecting the delay in the approval of 2000L production. Genzyme anticipates that this delay will have an impact on 2008 non-GAAP earnings of approximately $0.10 per diluted share. This reflects both forgone commercial sales margin and the costs of continued administration of the MTAP program. Genzyme now expects 2008 non-GAAP earnings of approximately $3.90 per diluted share, compared with previous guidance of $4.00 per diluted share. GAAP earnings for 2008 are now expected to be approximately $2.65 per diluted share, compared with previous guidance of $2.75 per diluted share. GAAP figures include anticipated amortization and stock-compensation expenses and the effect of contingent convertible debt. Genzyme reaffirmed its commitment to 20 percent compound average growth in non-GAAP earnings per share through 2011.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

This press release contains forward-looking statements regarding Genzyme's financial outlook and business plans and strategies, including without limitation: its 2008 earnings guidance; its 2008 Myozyme revenue guidance; its plans regarding the timing and content of the BLA submission for Myozyme manufactured at the 2000L scale; it expectations regarding FDA approval of that BLA and the timing thereof; its anticipated non-GAAP compound growth rate through 2011; and its belief there is no difference in the clinical effectiveness or safety of Myozyme produced at the 160L and the 2000L scales. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: Genzyme's ability to obtain and maintain regulatory approvals for Myozyme produced at the 2000L scale and the timing thereof; Genzyme's ability to accurately anticipate regulatory actions on its Myozyme manufacturing applications; Genzyme's ability to manufacture its products, including Myozyme, in a timely and cost effective manner and in sufficient quantities to meet demand; Genzyme's ability to accurately forecast Myozyme revenues and the impact of reduced Myozyme revenues and other costs associated with the regulatory delay on earnings; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's 2007 Annual Report on Form 10K. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today's date and Genzyme undertakes no obligation to update or revise the statements.

Genzyme(R) and Myozyme(R) are registered trademarks Genzyme Corp. All rights reserved.

Conference Call Information

Genzyme will host a conference call today at 5:00 p.m. Eastern to discuss Myozyme manufacturing. To participate in the call, please dial 1-773-799-3828 and use passcode "Genzyme." The replay number for the call is 203-369-3292, and the replay will be available until midnight on May 5th. Today's call will also be Webcast on the investor events section of www.genzyme.com.

Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800- 905-4369 within the United States or 1-678-999-4572 outside the United States.

Media Contact:
Bo Piela
(617) 768-6579

Investor Contact:
Patrick Flanigan
(617) 768-6563

First Call Analyst:
FCMN Contact:

Source: Genzyme Corporation

CONTACT: Media, Bo Piela, +1-617-768-6579, or Investors, Patrick
Flanigan, +1-617-768-6563, both of Genzyme Corporation

Web site:

http://www.genzyme.com/

Company News On-Call:

http://www.prnewswire.com/comp/113803.html

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Profile: Transplant News