WCTF.org Transplant News

Final Decision from European Commission Expected by Mid-2008

COLLEGEVILLE, Pa. and TARRYTOWN, N.Y., April 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), and Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), today announced that the companies have received a positive opinion for RELISTOR(TM) (methylnaltrexone bromide) subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The companies are seeking the approval of RELISTOR in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.

The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP's positive opinion for RELISTOR will now be forwarded to the European Commission for a final decision, which is anticipated by mid-year.

RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.

About the Subcutaneous RELISTOR Clinical Investigational Program

In March 2007, Progenics submitted a New Drug Application for subcutaneous RELISTOR for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care to the U.S. Food and Drug Administration. This application has a Prescription Drug User Fee Act (PDUFA) date of April 30, 2008. In May 2007, Wyeth submitted a Marketing Authorization Application (MAA) in Europe to the European Medicines Agency (EMEA) for subcutaneous RELISTOR. The EMEA review is ongoing. In August 2007, Wyeth submitted a marketing application to the Therapeutic Goods Administration division of the Australian government for subcutaneous RELISTOR. On March 28, 2008, RELISTOR received approval from Canada for the treatment of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care.

About the Companies

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non- prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

WYETH DISCLOSURE NOTICE: The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that RELISTOR will be commercially successful or that RELISTOR will be approved in the future in other formulations or indications and/or in other countries. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and postoperative ileus (intravenous formulation). In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate - a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.

PROGENICS DISCLOSURE NOTICE: The information contained in this document is current as of April 24, 2008. This press release contains forward-looking statements. Any statements contained herein that are not statements of historical fact may be forward-looking statements. When the Company uses the words "anticipates," "plans," "expects" and similar expressions, it is identifying forward-looking statements. Such forward-looking statements involve risks and uncertainties which may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. Such factors include, among others, the uncertainties associated with product development, the risk that clinical trials will not commence or proceed as planned, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that we may not be able to manufacture commercial quantities of our products, the uncertainty of future profitability and other factors set forth more fully in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its programs will result in a commercial product. Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. Thus, it should not be assumed that the Company's silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.

Editor's Note:
Additional information on Wyeth is available at http://www.wyeth.com/

Additional information on Progenics is available at http://www.progenics.com/

First Call Analyst:
FCMN Contact:

Source: Wyeth Pharmaceuticals

CONTACT: Wyeth: Media, Sal Foti, Wyeth Pharmaceuticals, +1-484-865-3490,
Douglas Petkus, Wyeth, +1-484-865-5140, Gwen Fisher, Wyeth Pharmaceuticals,
+1-484-865-5160, or Investors, Justin Victoria, Wyeth, +1-973-660-5340; or
Progenics Pharmaceuticals, Inc.: Investors, Richard W. Krawiec, Ph.D., Vice
President, Corporate Affairs, +1-914-789-2814, rkrawiec@progenics.com, Dory A.
Lombardo, Senior Manager, Corporate Affairs, +1-914-789-2818,
dlombardo@progenics.com, Media, Aline Schimmel, WeissComm Partners,
+1-312-284-4706, Julie Normart, WeissComm Partners, +1-415-946-1087

Web site:

http://www.wyeth.com/
http://www.progenics.com/

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Profile: Transplant News

- Full Results Presented at European Association for the Study of the Liver Annual Meeting -

SAN FRANCISCO, April 24 /PRNewswire/ -- Antipodean Pharmaceuticals, Inc. announced today, at the European Meeting for the Study of the Liver (EASL), the positive results of a Phase 2 trial of its lead compound MitoQ(R) (mitoquinone) in liver disease. The trial, conducted by Dr. Edward Gane, Associate Professor of Medicine, New Zealand Liver Transplant Unit at Auckland City Hospital, successfully met the primary clinical endpoint, the reduction of elevated liver enzymes.

In the 28-day trial, 30 patients with the Hepatitis C virus (HCV) were enrolled to study the effects of MitoQ on elevated liver enzymes. Researchers measured patients' baseline levels of aminotransferase (ALT), an enzyme released into the blood that indicates damage to the liver. The double-blind trial randomized patients to one of three treatment groups: MitoQ 40mg/day, MitoQ(R) 80mg/day or placebo. The primary endpoint was the reduction of levels of ALT. Patients who received MitoQ showed a significant decrease in ALT levels at the end of the study compared with baseline levels. The decrease from baseline was 26.4% (p<0.002) for patients in the 40mg dose group, and 28% (p<0.05) for patients in the 80mg dose group. These results suggest that MitoQ can reduce necroinflammation and may halt disease progression to fibrosis or cirrhosis.

The drug was well tolerated with no significant safety issues. Commonly reported adverse events (AEs) included nausea, headache and vomiting, which were usually mild and well tolerated. Only one patient withdrew from the study due to nausea. There were no significant laboratory or ECG abnormalities observed and no serious adverse events (SAEs) were reported.

"In patients with chronic liver disease, including the two patient populations with the largest unmet need -- patients with chronic hepatitis C, who have failed current standard of care, and patients with non-alcoholic fatty liver disease (NAFLD), there are currently no therapeutic options available to prevent progression to cirrhosis, liver failure and liver cancer," stated Dr. Gane. "In the future, these patients may benefit from maintenance therapy with interventions such as MitoQ, which block either hepatic necroinflammation or fibrogenesis."

"In the coming year, Antipodean plans to explore and develop its lead compound for the treatment of hepatological diseases, particularly non- alcoholic fatty liver disease (NAFLD)," said Ken Taylor, Ph.D., Chief Executive Officer of Antipodean Pharmaceuticals. "The Company is actively seeking to achieve this goal with the help of a pharmaceutical partner."

A 12-month study in patients in Parkinson's disease showed MitoQ to be well tolerated; however, there was no significant effect on disease progression. Dr. Barry Snow, Department of Neurology, Auckland Hospital, New Zealand and Principal Investigator of the trial of MitoQ in Parkinson's disease, believes that the lack of efficacy in Parkinson's Disease may have been due to the large number of impaired cells in that disease; these cells may have had limited or no ability to regenerate, and thus could not benefit from MitoQ's antioxidant properties. The Company believes MitoQ has therapeutic potential in diseases where cell regeneration occurs, such as hepatological and dermatological disorders.

About MitoQ(R)

MitoQ(R) is a mitochondria-targeted antioxidant that selectively blocks mitochondrial oxidative damage and prevents liver cell apoptosis. MitoQ is based on a novel technology, targeted lipophilic cations that transport and concentrate antioxidants into the mitochondria-organelles inside cells that provide energy for life processes-where they accumulate up to a thousand fold. Targeted antioxidants can reduce the hepatic oxidative damage that is induced by viral infection and that is also involved in the progression of NAFLD through to NASH, leading to fibrosis or cirrhosis.

About Non-alcoholic Fatty Liver Disease (NAFLD)

Symptoms of NAFLD include inflammation of the liver, often associated with alcoholic livers, but occurring in nonalcoholic patients, fat in the liver and liver damage. As with Hepatitis C, oxidative stress is involved in disease progression in NAFLD, which affects approximately 20% of the world's population.

There are no satisfactory treatment options currently available for NAFLD, and the incidence is growing rapidly as obesity rates rise. MitoQ(R) is a potent, targeted antioxidant that limits oxidative stress and cell degeneration by protecting the mitochondria from oxidative damage, and the Company believes it offers the potential to treat the oxidative stress observed in NAFLD patients.

About Antipodean

Antipodean is a clinical-stage pharmaceutical company developing targeted molecules that prevent oxidative damage to endothelial, epithelial and liver cells leading to apoptosis and fibrosis. The Company is developing a mitochondria-targeted antioxidant, MitoQ (mitoquinone mesylate), for the treatment of hepatic inflammatory disorders caused by oxidative stress such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). The Company's business plan is to develop drugs to the point of proof of principle and then partner further development. Antipodean has research collaborations with pre-clinical and clinical investigators in Cambridge, UK, Auckland, New Zealand, and several centers in the US to identify and develop lead compounds through to clinical proof-of-principle. Currently the Company's lead compounds target liver and skin diseases. Antipodean is located in San Francisco, California. Further information is available at http://www.antipodeanpharma.com/

First Call Analyst:
FCMN Contact:

Source: Antipodean Pharmaceuticals, Inc.

CONTACT: Charlotte Merckel of Antipodean Pharmaceuticals, Inc.,
+1-415-692-0610, cmerckel@antipodeanpharma.com

Web site: http://www.antipodeanpharma.com/

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Profile: Transplant News

ATLANTA, April 24 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE:CRY), a biomaterials, medical device and tissue processing company, announced today that it is conducting the 2008 Cardiac Allograft Symposium at its corporate headquarters training facility in suburban Atlanta, GA, April 25-26. The program will focus on current clinical outcomes, indications and surgical techniques of aortic valve replacement utilizing aortic allografts and the CryoValve(R) SG pulmonary human heart valves.

"As leaders in human tissue transplantation and cardiac reconstruction, it is both an honor and a privilege to host this advanced surgical training at our state-of-the-art facility and laboratory," said Steven G. Anderson, president and chief executive officer of CryoLife, Inc. "We look forward to bringing together this eminent group of cardiovascular surgeons and offering them the opportunity to learn the newest surgical techniques utilizing human aortic valves and our recently FDA-cleared CryoValve SG pulmonary valve."

The symposium's distinguished faculty includes: John W. Brown, M.D., professor of cardiothoracic surgery, Indiana University School of Medicine, Indianapolis, Ind; Paul E. Stelzer, M.D., senior faculty, cardiothoracic surgery, Mount Sinai School of Medicine, New York, N.Y.; Craig R. Saunders, M.D., chairman of cardiothoracic surgery, Saint Barnabas Health Care System, Newark, N.J.; Kent E. Ward, M.D., associate professor of pediatric cardiology, University of Oklahoma Health Sciences Center, Oklahoma City, Okla; Kenton J. Zehr, M.D., professor of surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.; and Edward Nowicki, M.D., assistant head, clinical investigations, Heart & Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

The program director is William F. Northrup, III, M.D., vice president, medical relations and education at CryoLife. Steven Goldstein, Ph.D., senior director, tissue technologies at CryoLife is also on the faculty. Some 20 surgeons from around the United States are expected to participate in the symposium.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the United States and Canada. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) Technology. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. Beginning May 1, 2008 CryoLife will distribute Hemostase MPH, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the United Kingdom and Germany for cardiac, vascular and general surgery, subject to certain exclusions. The Company also distributes the CryoLife-O'Brien(R) stentless porcine heart valve, which is CE marked for distribution within the European Community.

For additional information about the company, visit CryoLife's Web site: www.cryolife.com.

Media Contacts:

D. Ashley Lee Katie Brazel
Executive Vice President, Fleishman Hillard
Chief Financial Officer and Phone: 404-739-0150
Chief Operating Officer
Phone: 770-419-3355

First Call Analyst:
FCMN Contact: trott.felicia@cryolife.com

Source: CryoLife, Inc.

CONTACT: D. Ashley Lee, Executive Vice President, Chief Financial
Officer and Chief Operating Officer, CryoLife, Inc., +1-770-419-3355; or Katie
Brazel, Fleishman Hillard, +1-404-739-0150

Web site:

http://www.cryolife.com/

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Profile: Transplant News