Three-Year Data from Phase 2 Trial of Genzyme Corporation Gaucher Disease Oral Compound Suggest Sustained or Further Improvement Across All Endpoints

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme Corporation (NASDAQ:GENZ - News) today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint. The results were presented for the first time this week at the Lysosomal Disease Network WORLD Symposium in Las Vegas, Nevada.

Genzyme previously reported that the eliglustat tartrate phase 2 trial had met its primary endpoint at one year, and that data demonstrated continued improvement through two years. The primary composite endpoint was a clinically meaningful response in at least two of three endpoints: improvements in spleen size, hemoglobin and platelet levels. The study has continued with 19 patients through three years. The extension phase of this trial is still ongoing.

Eliglustat tartrate continued to show robust clinical response through three years:

* Spleen volume decreased from baseline by a mean of 61 percent and liver volume decreased from baseline by 29 percent. * Hemoglobin level increased from baseline by a mean of 2.6 grams per deciliter. * Platelet count increased from baseline by a mean of 91 percent.

The study also analyzed the clinical response of patients in the phase 2 trial with respect to achieving therapeutic goals. Due to the heterogeneity of Gaucher disease, therapeutic goals were previously developed by experts involved in the treatment of Gaucher patients to assess their response to enzyme replacement therapy (ERT). Most patients dosed with eliglustat tartrate met established therapeutic goals for hemoglobin, platelets, spleen volume and liver volume, demonstrating progressive and clinically meaningful responses in multiple organ systems. At three years, 100 percent of patients met at least 3 of the 4 therapeutic goals developed for hematologic and organ volume parameters.

The three-year data also included analyses that suggest eliglustat tartrate positively impacts indicators of bone disease through three years of follow up. These indicators include bone mineral density in the lumbar spine, as measured by dual energy x-ray absorptiometry (DXA), and dark marrow signal in the femur, as visualized by magnetic resonance imaging (MRI). Dark marrow reflects the infiltration of lipid-laden Gaucher cells into bone marrow. Specifically:

* In the 18 patients at baseline with dark marrow in the femur visible by MRI, five improved by one year, seven by two years and 10 by three years, with the other eight patients remaining stable. * In the 15 patients with results available at all time points, bone mineral density in the lumbar spine showed clinically and statistically significant improvements after one year of treatment (T score = +0.4) which further improved after 2 years (T score = +0.6) and were sustained after three years of treatment.

Ravi S. Kamath, M.D., Ph.D., Staff Radiologist at Massachusetts General Hospital and Instructor in Radiology at Harvard Medical School, who is the central radiology reviewer for the phase 2 study, said, "These data suggest that eliglustat tartrate may have a meaningful clinical impact on bone disease in Gaucher disease type 1 patients."

The most common adverse events (AEs) reported in greater than 2 patients through three years included viral infections (six patients), urinary tract infections and upper respiratory infections (4 patients each), headache, increased blood pressure, diarrhea and abdominal pain (three patients each). Eight drug-related AEs, including one serious event, were reported in six patients. Most AEs overall and all drug-related AEs were considered mild. The largest number of AEs was reported during the first 3 months of treatment.

“For thirty years, Genzyme has pioneered treatments for patients with lysosomal storage disorders, including the very first enzyme replacement therapy for Gaucher disease,” said Genzyme’s President, Personalized Genetic Health, John P. Butler. “Our momentum continues through the phase 3 trials – the largest ever conducted for Gaucher - as we build upon our foundation and commitment to Gaucher and look to extend the therapeutic options available to patients and physicians.”

Eliglustat tartrate, a capsule taken orally, is being developed to provide a convenient treatment alternative for adult patients with Gaucher disease type 1, and to offer a broader range of treatment options for patients and physicians to achieve individual therapeutic goals. Genzyme is currently enrolling patients in three global, multi-center, phase 3 trials of eliglustat tartrate. This is the largest clinical program ever focused on Gaucher disease, with over 50 sites in more than 25 countries currently participating. Genzyme’s Gaucher disease portfolio also offers Cerezyme® (imiglucerase for injection), the standard of care for patients with Gaucher disease type 1, which is administered through intravenous infusions.

To learn more about the phase 3 trials of eliglustat tartrate, contact Genzyme Medical Information at medinfo@genzyme.com or 1-800-745-4447. More information can also be found at www.clinicaltrials.gov or www.explorerstudies.com.

About Gaucher disease

Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. People with Gaucher disease do not have enough of an enzyme, acid ß-glucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms. The most common form of Gaucher disease, type 1, does not typically affect the nervous system and brain.

About eliglustat tartrate

Eliglustat tartrate, a novel glucosylceramide analog given orally, is designed to partially inhibit the enzyme glucosylceramide synthase, which results in reduced production of glucosylceramide. Glucosylceramide is the substance that builds up in the cells and tissues of people with Gaucher disease. In preclinical studies, the molecule, developed with James A. Shayman, M.D. from the University of Michigan, has shown high potency and specificity. Based on its mechanism of action, which is independent of genotype, eliglustat tartrate may be a potential therapy for patients with Gaucher disease type 1. Initiation of the phase 2 and 3 studies of eliglustat tartrate in Gaucher disease followed completion of an extensive pre-clinical research effort and a phase 1 program. Over 300 subjects have now been treated in nine separate studies.

The data from the phase 2 trials with eliglustat tartrate were previously published in the journal Blood and the results can be found at the below references:

* Phase 2 data at the 1 year time point: Lukina et al. Blood, Aug 2010; Vol. 116: 893 - 899 * Phase 2 data at the 2 year time point: Lukina et al. Blood, Nov 2010; Vol 116: 4095 - 4098

Cerezyme important safety information

Approximately 15 percent of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6 percent of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension. Reactions related to Cerezyme administration have been reported in less than 15 percent of patients. Each of the following events occurred in less than 2 percent of the total patient population. Reported adverse events include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. For full prescribing information, please visit www.genzyme.com.

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 approximately 10,000 employees in locations spanning the globe.

With many established products and services helping patients in 100 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 immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need. 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.

Important Information

Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.

Genzyme® and Cerezyme® are registered trademarks of Genzyme Corporation. All rights reserved.

Contact:

Genzyme Corporation Media Contact: Lori Gorski, 617-768-9344 Lori.gorski@genzyme.com or Investor Contact: Patrick Flanigan, 617-768-6563

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Medivir AB Announces Positive Phase 2b 48-week (SVR24) Interim Results of TMC435 in Treatment-Naive Patients Chronically Infected With Genotype-1 Hepatitis C Virus

HUDDINGE, Sweden, February 22, 2011 /PRNewswire-FirstCall/ -- Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naive patients with hepatitis C virus (HCV) genotype-1.

- TMC435 was safe and well tolerated with no clinically relevant differences in adverse events between treatment groups and standard of care (SoC). - In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24 - Potent and consistent antiviral efficacy was demonstrated with SVR24 rates of up to 84%

"We are very pleased by both the efficacy and safety shown by TMC435 in this 48-Week interim analysis. With the additional features of once daily dosing, TMC435 also has a more convenient and competitive dosing regimen" stated Bertil Samuelsson, CSO of Medivir. "The recently published start of three global phase 3 clinical trials is an important milestone in the continued development of TMC435. We are now looking forward to the 48-week interim data from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients during Q2 2011."

The 48-week interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naive patients showed further consistent high antiviral activity, and the good safety and tolerability previously demonstrated was confirmed. The 24-week (EOT) interim results were presented at the AASLD conference in Boston, MA, in November 2010.

Study design

In the PILLAR study, 75mg or 150mg TMC435 was given for either 12 or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). Patients in the TMC435 arms stopped all treatment at week 24 if certain predefined response-guided criteria were met. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24. Patients who did not meet the above response-guided criteria continued with SoC until week 48 as did the placebo group.

Evaluation criteria

A protocol-defined interim analysis was performed when all patients completed their Week 48 visit or discontinued treatment earlier. Final SVR4 and SVR24 data were available for 98% (303/309; n/N) and 93% (288/309; n/N) of TMC435 treated patients, respectively. SVR24 is determined 24 weeks after the planned end of treatment (EoT) and was therefore not yet available for the patients in the placebo group and for some of those in the TMC435 group who received 48 weeks of treatment. SVR4, which is determined 4 weeks after the planned EoT, was available for 77% (59/77; n/M) of the patients in the placebo group.

Results - Efficacy

Potent and sustained antiviral efficacy was demonstrated in the SVR4 and SVR24 rates with no major differences between TMC435 doses or length of triple therapy. At week 4 after cessation of treatment 87.2%, 86.5%, 84.9% and 88.5% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels. At week 24 after cessation of treatment 83.6%, 76.1%, 83.1% and 84.4% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels, i.e. SVR24. At week 4 after cessation of treatment 71.2% in the placebo SoC group had achieved undetectable HCV RNA levels.

The results are derived from an intent-to-treat (ITT) analysis of the patient population who took at least one dose of the study medication and who reached the criteria for stopping all treatment at 24 weeks (83%).

Sustained Virological Response 4 and 24 Weeks after Planned End of Treatment (EoT);

TMC435 TMC435 TMC435 TMC435 Placebo 12PR24 24PR24 12PR24 24PR24 75mg q.d. 75mg q.d. 150mg q.d. 150mg q.d. % (n/N) N=78 N=75 N=77 N=79 N=77 SVR4 87.2 (68/78) 86.5 (64/74) 84.9 (62/73) 88.5 (69/78) 71.2 (42/59) SVR24 83.6 (61/73) 76.1 (51/67) 83.1 (59/71) 84.4 (65/77) N/A

* < 25 log10 IU/mL undetectable q.d.: once daily, PR: pegIFNalpha-2A and ribavirin,

SVR4 and SVR24: patients with undetectable HCV RNA 4 and 24 weeks after planned EoT, respectively. N/A: Patients in the control arm continue SoC until Week 48 and SVR24 data was not available

Results - Safety and Tolerability

TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. AEs leading to discontinuation of TMC435 or placebo treatment were reported in 7.8% of the placebo subjects and in 7.1% of the TMC435 treated subjects. In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia, and cardiac events. For each category of AEs of interest; the incidence was similar between TMC435 and placebo.

In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild on treatment reversible bilirubin elevations (total, direct and indirect) in the 150 mg TMC435 arm, which were normalized after TMC435 dosing was completed. There were no meaningful differences between treatment groups for any of the other laboratory parameters. Significant and rapid decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups.

Conference Call For Analysts and Investors:

There will be a conference call today, February 22 2011, for investors and sell-side analysts at 09:00 (EDT) / 14:00 (GMT) / 15:00 (CET) with the management team of Medivir to discuss this announcement. To dial-in to the conference call please use the following numbers:

Participant Telephone Numbers: +1-718-354-1385 USA +46(0)8-5352-6408 Sweden +44(0)20-7806-1951 UK Confirmation Code: 6641746

Alternatively, please contact Lindsey Neville at M:Communications on Tel: +44(0)207-920-2333, Email: Neville@mcomgroup.com.

Notes to Editors

About TMC435 in other clinical studies

TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.

The clinical phase 3 program started recently including

- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients - TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients - TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment

In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.

A phase 3 program for TMC435 has also recently been launched in Japan.

For additional information for these studies, please see http://www.clinicaltrials.gov

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese(TM)/Xerclear(R). Medivir's key pipeline asset, TMC435, a protease inhibitor, recently entered global phase 3 development for the treatment of hepatitis C and is partnered with Tibotec Pharmaceuticals.

Xerese(TM)/Xerclear(R) is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in North America. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.

For more information on Medivir, please see the company website: http://www.medivir.com

For additional information, please contact

Medivir (http://www.medivir.se)

Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292 M:Communications

Europe: Mary-Jane Elliott/ Amber Bielecka /Nick Francis Medivir@mcomgroup.com +44(0)20-7920-2330

USA: Roland Tomforde +1-212-232-2356

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Genentech: Lucentis Phase III Study Meets Primary Endpoint for Improving Vision in Patients With Diabetic Macular Edema (DME)

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.

The study, known as RISE, showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision (BCVA) of at least 15 letters on the eye chart at 24 months, compared to those in a control group, who received a placebo (sham) injection. BCVA is best corrected visual acuity, the best possible vision a person can achieve with corrective lenses, as measured by reading the eye chart. A preliminary analysis of the data did not reveal any unexpected safety signals and further analyses are ongoing. Topline results from the RISE study will be presented at the 34th Annual Macula Society Meeting, on March 10, 2011 in Boca Raton, Florida.

“DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”

Lucentis was recently approved for treatment of visual impairment due to DME in Europe, where it is marketed by Novartis. In the United States (U.S.), Lucentis was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006 and more recently for treatment of macular edema following retinal vein occlusion (RVO) in June 2010. RISE and RIDE are two identical, parallel confirmatory studies designed to support application to the U.S. Food & Drug Administration (FDA) for a potential new indication for Lucentis for DME.

About RISE (FVF4170g)

RISE is a multicenter, randomized, double-masked, sham injection-controlled, 36-month Phase III study designed to assess the safety and efficacy profile of Lucentis in 377 patients with DME. The primary endpoint compared the proportion of Lucentis and sham-treated patients who gained at least 15 letters in BCVA at month 24, relative to baseline. Patients were randomized to receive monthly injections of either 0.3 mg Lucentis (n=125), 0.5 mg Lucentis (n=125), or monthly sham injections (n=127). The study was not designed to compare the two doses of Lucentis, but each dose against the control group.

At three months, rescue laser treatment was made available to all patients, if needed based on pre-specified criteria. Laser treatment is the current standard of care for DME.

Secondary endpoints included other measures of visual acuity, need for laser treatments and changes in retinal anatomy. After month 24, patients in the control group are eligible to receive monthly injections of 0.5 mg Lucentis and all patients will continue to be followed for 36 months.

About DME

DME is swelling of the retina that occurs in people with diabetes, who suffer from a complication called diabetic retinopathy. Diabetic retinopathy is the most common diabetic eye disease and is characterized by damage to the blood vessels of the retina, the nerve layer at the back of the eye.1 It can manifest in a number of ways. In DME, the damaged blood vessels leak fluid into the central portion of the retina, called the macula, causing it to swell. The macula is the part of the eye responsible for sharp central vision.1

Approximately 26 million people in the U.S. have diabetes and 1.9 million new cases are diagnosed in people aged 20 and older each year.2 Between 40 and 45 percent of Americans diagnosed with diabetes have some stage of diabetic retinopathy.1 Up to 10 percent of all people with diabetes will develop DME during their lifetime and up to 75,000 new cases of DME are estimated to develop each year.3

The current standard of care for DME is laser surgery that helps seal the leaky blood vessels to slow the leakage of fluid and reduce the amount of fluid in the retina.1,4

According to the National Eye Institute (NEI), a patient may need multiple laser treatments to control the leaking fluid caused by DME.

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (AMD) in June 2006. Lucentis was also approved by the FDA for macular edema following retinal vein occlusion (RVO) on June 22, 2010.

Lucentis is designed to bind to and inhibit VEGF, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In wet AMD, these blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula, the portion of the eye responsible for fine, detailed central vision. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula.

In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) in those trials treated monthly with Lucentis maintained vision.

In two Phase III clinical trials studying macular edema following RVO, both studies showed that Lucentis administered monthly demonstrated an early (day seven) and sustained vision improvement of three lines or more on the study eye chart during the six-month study.

Lucentis Safety

Lucentis is a prescription medication given by injection into the eye, and it has side effects. Some Lucentis patients have had detached retinas and serious infections inside the eye. Lucentis should not be used in patients who have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.

Although not common, Lucentis patients have had eye- and non–eye-related blood clots (heart attacks, strokes and death). Some patients have increases in eye pressure within one hour of an injection.

Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure, such as developing a cataract. These can make a patient’s vision worse.

The most common side effects to the eye are increased redness in the whites of the eye, eye pain, small specks in vision and the feeling that something is in the eye. The most common non–eye-related side effects are nose and throat infections, headache and respiratory (lung) infections.

If a patient’s eye becomes red, sensitive to light, painful, or there is a change in vision, patients should call or visit their eye doctor right away.

Please visit http://www.lucentis.com for the Lucentis full prescribing information and additional important safety information.

Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye. Genentech retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

References:

1 National Eye Institute. Health Information. Available at: http://www.nei.nih.gov/health/diabetic/retinopathy.asp.

2 American Diabetes Association. Statistics. Available at: http://www.diabetes.org/diabetes-statistics.jsp.

3 Ali, F.A. A review of diabetic macular edema. Digital Journal of Ophthalmology, vol. 3, no. 6, 1997. Available at: http://www.djo.harvard.edu/site.php?url=/physicians/oa/387.

4 Kamjoo, S. et al, New Therapeutic Approaches to DME, Advanced Ocular Care, Dec 2010, Available at: http://bmctoday.net/advancedocularcare/2010/12/article.asp?f=new-therapeutic-approaches-to-dme

Contacts

Genentech, Inc. Terence Hurley, 650-467-6800 (Media) Karl Mahler, 011 41 61 687 8503 (Investors) Thomas Kudsk Larsen, 973-235-3655 (Investors)

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Exelixis, Inc. Cabozantinib (XL184) Phase 2 Data Demonstrate Encouraging Clinical Activity in Patients with Castration-Resistant Prostate Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ:EXEL - News) today reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial. The data support the findings that cabozantinib reduces or stabilizes metastatic bone lesions in nearly all patients evaluable by bone scan, reduces bone pain and narcotic analgesic medication and results in an increase in hemoglobin in patients with anemia. The data also suggest that cabozantinib shows an encouraging early signal of durable clinical benefit in both docetaxel-naïve and pretreated patients.

David C. Smith, M.D., Professor, Departments of Internal Medicine and Urology at the University of Michigan, presented the data on Thursday, February 17 in a poster session at the American Society of Clinical Oncology’s 2011 Genitourinary Cancers Symposium (Abstract #127) in Orlando, Florida.

As of the January 27, 2011 cut-off date, accrual in this cohort was complete at 168 patients, randomization was halted, and randomized patients were unblinded based on an observed high rate of clinical activity.

The efficacy-evaluable population for tumor response per mRECIST includes 100 patients with at least 12 weeks of follow-up. The bone scan evaluable population includes 62 patients with a baseline bone scan, evidence of bone metastasis, and at least 1 post-baseline assessment. All patients had measurable soft tissue disease, approximately half (47%) had evidence of visceral disease (e.g., liver or lung), and approximately half (47%) were docetaxel-pretreated.

High Rates of Complete or Partial Bone Scan Resolution

Of 62 patients evaluable by bone scan, 53 (85%) achieved either complete or partial resolution of metastatic lesions on bone scan by independent radiologist review. Eight other patients (13%) had stable disease (SD) on bone scan, resulting in an overall rate of disease control in bone of 98% (61/62). Only one patient (2%) had progressive disease as their best assessment. High rates of bone scan resolution were observed in both docetaxel-pretreated and docetaxel-naïve subgroups.

Increase in Hemoglobin in Patients with Anemia

CRPC patients with bone metastases frequently experience anemia, which in prior studies has been associated with a worse prognosis. In this study, the majority of patients with anemia (hemoglobin < 11g/dL) had sustained treatment-emergent increases in hemoglobin as compared with baseline. The median maximum rise in hemoglobin in anemic patients (Hb < 11 g/dL) was 2.2 g/dL (range, 0.6-3.5).

Preliminary Progression-Free Survival Results are Encouraging

The median follow-up for all 100 patients is 3.8 months (range, 0.7 to 15.2 months). In the Randomized Discontinuation Phase, a total of 31 patients with SD at Week 12 were randomized to either placebo or cabozantinib. The median progression free survival (PFS), assessed by investigators, is 40 days (95% Confidence Interval: 37, 82 days) for the placebo group (n=17), while median PFS data for the cabozantinib group (n=14) are not yet mature with a censoring rate of 79%.

For the overall population, excluding those randomized to placebo, the median PFS data for patients continuously treated with cabozantinib are not yet mature with censoring rates of 85% and 79% for the docetaxel-naïve and -pretreated populations, respectively. However, PFS appears to be independent of prior docetaxel therapy, which historically has conveyed a worse prognosis.

Improvement in Symptomatic Bone Pain

Data on bone pain and narcotic use, as assessed by the investigator, were collected retrospectively. A total of 43 patients had bone metastases and bone pain reported at baseline, and at least one post-baseline assessment of pain status. Of these patients, 26 (60%) had pain improvement at either Week 6 or 12. Narcotic analgesic medication was required at baseline for control of bone pain in 28 patients assessable for post-baseline review of narcotic consumption. Thirteen of 28 (46%) patients were able to decrease or discontinue narcotic medication for bone pain.

“These data are very exciting and reinforce the novel and differentiated profile of cabozantinib relative to other prostate cancer agents. Cabozantinib was effective at reducing or stabilizing metastatic bone lesions in nearly all patients evaluable by bone scan. Further, bone scan resolution observed in patients from this cohort is accompanied by important reductions of bone pain and narcotic analgesic medication as well as a sustained increase in hemoglobin in patients with anemia. Finally, cabozantinib shows an encouraging early signal of durable clinical benefit in both docetaxel naïve and pretreated patients,” said Michael Morrissey, PhD, president and CEO of Exelixis, Inc. “These interim data give us further confidence in our comprehensive development plan for cabozantinib in CRPC that includes three potential pivotal trials, the first focused on a composite endpoint that incorporates bone scan resolution and improvement in bone pain, and future trials evaluating overall survival and bone metastasis prevention in CRPC patients.”

Reduction and Stabilization of Soft Tissue Lesions Observed in the Majority of Patients

One hundred patients were evaluable for response by mRECIST. The overall Week-12 disease control rate (SD + partial response (PR)) was 74%. Tumor shrinkage was observed in 61 of 91 patients (67%) with measurable soft-tissue metastatic lesions and at least one post-baseline scan. To date, 6 of 100 patients (6%) evaluable by mRECIST achieved a confirmed PR. SD was reported in 82 patients (82%), and 2 other patients have had unconfirmed PRs awaiting confirmation. Prostate-specific antigen (PSA) changes were observed to be independent of reduction or stability of tumor target lesions, resolution of bone lesions on bone scan, and changes in bone pain.

Cabozantinib Affects Markers of Bone Formation and Resorption in CRPC Patients, Regardless of Prior Bisphosphonate Therapy

Alkaline phosphatase (ALP) and type I collagen C-telopeptides (CTx), which are markers of osteoblast (bone formation) and osteoclast (bone resorption) activity, respectively, are often elevated in patients with bone metastases. Reductions in levels of CTx and ALP have been correlated in the past with a reduced risk of skeletal-related events and mortality, respectively. Of 16 patients treated with cabozantinib who had ALP levels at least twice the upper limit of normal, known bone metastases, and at least 12 weeks of follow-up, 15 had decreases in ALP. Similarly, 42 of 48 patients with known metastases experienced a decrease in CTx, regardless of prior bisphosphonate status. ALP and CTx levels decreased from baseline by approximately 60% at Weeks 12 and 24, respectively.

“Cabozantinib has to date shown impressive activity in patients with metastatic CRPC. The interim data presented today clearly indicate that cabozantinib positively impacts both soft tissue and bone disease and appears to alleviate associated symptoms,” said David C. Smith, M.D., Professor, Departments of Internal Medicine and Urology at the University of Michigan. “Cabozantinib may offer a unique approach to the treatment of prostate cancer, particularly due to its effect on metastatic bone lesions, which are a key factor of morbidity and mortality in this disease and represent a major unmet medical need.”

Safety and Tolerability

Safety data are available for the lead in phase of the study for 100 patients with at least 12 weeks of follow-up. The most common = grade 3 adverse events (AEs), regardless of causality were fatigue (15%), hypertension (8%), PPE syndrome (5%), back pain (3%), decreased appetite, nausea, vomiting, rash, hemorrhage, abdominal pain (each 2%), diarrhea, dyspnea, and cough (each 1%). No cabozantinib-related grade 5 AEs were reported. At least one dose reduction was reported in 51% of patients.

To access the clinical data poster mentioned in this press release, please visit http://www.exelixis.com/sites/default/files/pdf/ASCOGU_2011_Cabozantinib-127.pdf

Cabozantinib Targets Key Pathways That Contribute to Prostate Cancer

Cabozantinib, an inhibitor of tumor growth, metastasis and angiogenesis, simultaneously targets MET and VEGFR2, key kinases involved in the development and progression of many cancers. Prominent expression of MET has been observed in primary and metastatic prostate carcinomas, with evidence for higher levels of expression in bone metastases. Overexpression of hepatocyte growth factor (HGF), the ligand for MET, has also been observed in prostate carcinoma, and increased plasma levels of HGF are associated with decreased overall survival in CRPC. Data from preclinical studies also suggest that both HGF and MET are regulated by the androgen signaling pathway in prostate cancer, where upregulation of MET signaling is associated with the transition to androgen-independent tumor growth. Additionally, both the MET and VEGFR signaling pathways also appear to play important roles in the function of osteoblasts and osteoclasts -- cells in the bone microenvironment that are often dysregulated during the establishment and progression of bone metastases.

The Significance of Bone Metastases in CRPC

The primary cause of morbidity and mortality in patients with CRPC is metastasis to the bone, which occurs in about 90% of cases. Bone metastases cause local disruption of normal bone remodeling, with lesions generally showing a propensity for an osteoblastic (bone-forming) phenotype on imaging. These lesions often lead to increased skeletal fractures, spinal cord compression, and severe bone pain. Osteoblastic lesions are typically visualized in CRPC patients by bone scan, which detects rapid incorporation of 99mTc-labeled methylene-diphosphonate radiotracer into newly forming bone. In addition, increased blood levels of ALP and CTx, markers for osteoblast and osteoclast activity, respectively, are often observed in CRPC patients with bone metastases, and are associated with shorter overall survival.

Conference Call and Webcast

An investor briefing webcast will be held in conjunction with the 2011 ASCO Genitourinary Cancers Symposium. The webcast will be held on Thursday, February 17, 2011, from 6:30-8:00 p.m. EST, and may be accessed by visiting the Event Calendar page under Investors at http://www.exelixis.com. An archived replay will be available on the Event Calendar page under Investors at http://www.exelixis.com and via phone until 11:59 p.m. EST on March 17, 2011. Access numbers for the replay are: 1-888-286-8010 (domestic) and 1-617-801-6888 (international). The replay passcode is 59328118.

About Cabozantinib

Cabozantinib, an inhibitor of tumor growth, metastasis and angiogenesis, simultaneously targets MET and VEGFR2, key kinases involved in the development and progression of many cancers. It has recently been shown in preclinical models that treatment with selective inhibitors of VEGF signaling can result in tumors that are more invasive and aggressive compared to control treatment. In preclinical studies, upregulation of MET has been shown to occur in concert with development of invasiveness after selective anti-VEGF therapy, and may constitute a mechanism of acquired or evasive resistance to agents that target VEGF signaling without inhibiting MET. Accordingly, treatment with cabozantinib in similar preclinical studies resulted in tumors that were less invasive and aggressive compared to control or selective anti-VEGF treatment. Therefore, cabozantinib has the potential for improving outcomes in a range of indications, including those where selective anti-VEGF therapy has shown minimal or no activity.

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer. The company is leveraging its biological expertise and integrated research and development capabilities to generate a pipeline of development compounds with significant therapeutic and commercial potential for the treatment of cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in phase 3, phase 2, and phase 1 clinical development. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Company, sanofi-aventis, GlaxoSmithKline, Genentech (a wholly owned member of the Roche Group), Boehringer Ingelheim, and Daiichi-Sankyo. For more information, please visit the company's web site at www.exelixis.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to the clinical and therapeutic potential of cabozantinib, including the ability for cabozantinib to offer a unique approach to the treatment of prostate cancer, the potential for cabozantinib to provide a durable clinical benefit in both docetaxel naïve and pretreated patients, Exelixis' belief that cabozantinib has a novel and differentiated profile relative to other prostate cancer agents, the comprehensive development plan for cabozantinib, the impact of cabozantinib on soft tissue, bone disease and associated symptoms in patients with CRPC, the ability for cabozantinib to target key pathways involved in the development and progression of many cancers and Exelixis' belief that cabozantinib has the potential for improving outcomes in a range of indications. Words such as "encouraging," “support,” "appears," "plan," “future,” "indicate,” “may,” “suggest,” "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Exelixis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the sufficiency of Exelixis' capital and other resources; the uncertain timing and level of expenses associated with the development of cabozantinib; the uncertainty of the FDA approval process; market competition and changes in economic and business conditions. These and other risk factors are discussed under "Risk Factors" and elsewhere in Exelixis' quarterly report on Form 10-Q for the quarter ended October 1, 2010 and Exelixis' other filings with the Securities and Exchange Commission. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Contact:

Exelixis, Inc. Charles Butler, 650-837-7277 Vice President Corporate Communications & Investor Relations cbutler@exelixis.com

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Medivation, Inc. and Astellas Pharma Inc. Announce Positive New, Long-Term Follow-Up Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients

SAN FRANCISCO, CA and TOKYO--(Marketwire - 02/15/11) - Medivation, Inc. (NASDAQ:MDVN - News) and Astellas Pharma Inc. today announced positive, new, long-term follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer. MDV3100 is a novel, triple-acting, oral androgen receptor antagonist. These new results showed that MDV3100 continues to show durable antitumor activity as evaluated by median times to prostate-specific antigen (PSA) progression and radiographic progression. These findings confirm the initial Phase 1-2 results published in The Lancet, in which MDV3100 consistently demonstrated anti-tumor activity in both chemotherapy-naïve and post-chemotherapy patients across endpoints, as evaluated by PSA levels, radiographic findings and circulating tumor cell (CTC) counts.

"We are very encouraged by these promising new, long-term efficacy findings, which continue to demonstrate the antitumor activity of MDV3100 and give us confidence that MDV3100 has the potential to benefit patients with advanced prostate cancer," said Lynn Seely, M.D., chief medical officer of Medivation.

Long-Term Follow-Up Results A total of 140 men with progressive disease were enrolled in the Phase 1-2 trial between July 2007 and December 2008. Of those, 18 remained on active treatment (16 chemotherapy-naive and 2 post-chemotherapy) at the time of this analysis.

PSA progression data were calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria)(1); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria)(2).

Median times to PSA progression presented in the poster are as follows:

-------------------------------------------------------------------------- Time to PSA Progression Chemotherapy-Naïve Post-Chemotherapy (n=65) (n=75) -------------------------------------------------------------------------- Per-protocol criteria Not reached 316 days (45 weeks)

-------------------------------------------------------------------------- PCWG2 criteria 281 days (40 weeks) 148 days (21 weeks)

-------------------------------------------------------------------------- PSAWG1 criteria 420 days (60 weeks) * 166 days (24 weeks) 812 days (116 weeks) ** --------------------------------------------------------------------------

*All chemotherapy-naïve patients **Subpopulation of chemotherapy-naïve patients who were also ketoconazole-naïve

The protocol-specified criteria define PSA progression as a 25% increase in PSA from starting baseline, provided that the increase is at least 5 ng/mL. This is the most liberal approach, and will produce the longest times to progression. The PCWG2 criteria define PSA progression as a 25% increase in PSA from nadir (i.e., from the lowest level of PSA attained by the patient on study), provided that the increase is at least 2 ng/mL. Under the PSAWG1 criteria, PSA progression requires: a 50% increase in PSA above nadir for patients who experienced a PSA decline of 50% on treatment; a 25% increase in PSA above nadir for patients who experienced a PSA decline < 50% on treatment; and a 25% increase in PSA above starting baseline for patients who did not experience any PSA decline on treatment; provided in each case that the PSA increase was at least 5 ng/mL. This is an intermediate approach to defining PSA progression, producing times to progression between those produced using the other two approaches.

The median times to radiographic progression presented in the poster are as follows:

--------------------------------------------- Chemotherapy-Naïve Post-Chemotherapy (n=65) (n=75) --------------------------------------------- 392 days (56 weeks) 175 days (25 weeks) ---------------------------------------------

Circulating tumor cell counts were available for 128 of 140 patients. Of those, 70 of 77 (91%) who had favorable pre-treatment counts ( < 5 cells/7.5 mL blood) remained favorable post-treatment, and 25 of 51 patients (49%) converted from unfavorable pre-treatment counts to favorable post-treatment counts.

"These positive long-term findings in both chemotherapy-naïve and post-chemotherapy advanced prostate cancer patients provide further support for our expanded development program into earlier-stage prostate cancer patients," said Steven Ryder, M.D., president, Astellas Pharma Global Development. "In addition to the ongoing Phase 3 PREVAIL trial, which is currently enrolling men with advanced prostate cancer who are chemotherapy-naïve, we and our partner Medivation plan to initiate two Phase 2 trials in earlier-stage prostate cancer in the first half of this year."

The new long-term follow-up findings will be presented in a poster session at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) in Orlando, Fla. on Thursday, February 17 (poster board #A71). The poster will include the most up-to-date data from the trial and will expand upon the results originally submitted in the abstract. The abstract (#177), titled "Antitumor activity of MDV3100 in pre- and post-docetaxel advanced prostate cancer: long-term follow-up of the Phase 1-2 study," is currently available on the ASCO website at www.ASCO.org.

Phase 1-2 Trial Design All patients in the open-label, dose-escalation, Phase 1-2 clinical trial had progressive disease upon enrollment and were heavily pretreated, with 77 percent having failed at least two lines of prior hormonal therapy and 54 percent having failed one or more chemotherapy regimens. A total of 140 men were enrolled in the trial, which evaluated MDV3100 doses between 30 and 600 mg/day. Patients could remain on treatment for as long as they continued to tolerate the drug and their disease did not progress. Efficacy endpoints included CTC counts, serum PSA levels, and soft tissue and bony metastases.

MDV3100 Phase 3 Clinical Development Program MDV3100 is currently being evaluated in two global Phase 3 studies in patients with advanced prostate cancer.

The randomized, double-blind, placebo-controlled Phase 3 AFFIRM trial completed enrollment in November 2010. This trial of 1,199 patients with advanced prostate cancer who were previously treated with chemotherapy is evaluating 160 mg/day of MDV3100 versus placebo. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, safety and tolerability.

A second Phase 3 clinical trial of MDV3100 in advanced prostate cancer, the PREVAIL trial, is currently enrolling patients. This randomized, double-blind, placebo-controlled, multi-national trial of approximately 1,700 patients with advanced prostate cancer is evaluating MDV3100 at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care. The co-primary endpoints of the trial are overall survival and progression-free survival; secondary endpoints include time to first skeletal-related event and time to initiation of cytotoxic chemotherapy. Information about patient eligibility and enrollment can be obtained by calling the PREVAIL study hotline toll-free at 1-888-243-4363.

About the Medivation/Astellas Collaboration In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize MDV3100. The companies are collaborating on a comprehensive development program that includes studies to develop MDV3100 for both early-stage and advanced prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. and Astellas will have responsibility for commercializing MDV3100 outside the U.S. Medivation received a $110 million up-front payment upon entering into the collaboration agreement, and is eligible to receive up to $335 million in development milestone payments, up to $320 million in commercial milestone payments, 50% of profits on sales in the U.S., and tiered, double-digit royalties on sales outside the U.S.

About MDV3100 MDV3100 is an investigational therapy in clinical development for advanced prostate cancer. In preclinical experiments published in Science in April 2009(3), the novel, triple-acting, oral androgen receptor antagonist provided more compIete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions - MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. In the preclinical experiments published in Science, MDV3100 was superior to bicalutamide in each of these three actions.

About Prostate Cancer Prostate cancer is the second most common non-skin cancer among men in the world and it is the sixth leading cause of cancer death among men worldwide. Patients whose prostate tumors have stopped responding to, or are growing despite the use of, active hormone treatment strategies are considered to have advanced prostate cancer. These patients have a poor prognosis and few treatment options.

About Medivation Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer, mild-to-moderate Alzheimer's disease and Huntington disease. For more information, please visit us at www.medivation.com.

About Astellas Pharma Inc. Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. Astellas has approximately 16,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.

This press release contains forward-looking statements, including statements regarding the continued clinical development of Medivation's product candidates, the therapeutic and commercial potential of Medivation's product candidates and the continued effectiveness of, and continuing collaborative activities under, Medivation's collaboration agreements with Pfizer and Astellas, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivation's product development activities, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, including Medivation's dependence on the efforts of and funding by Astellas for the development of MDV3100 and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2010, filed on November 5, 2010 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

(1) Scher, J Clin Oncol 26:1148-1159 (2008). (2) Bubley, J Clin Oncol 17:3461-3467 (1999). 3 Tran C, et al., Science. 2009;324:787-790.

Contacts: Medivation, Inc. Patrick Machado Chief Business Officer (415) 829-4101 WCG Nicole Foderaro (415) 946-1058 Astellas Jenny Keeney 847-317-5405

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Halozyme Therapeutics, Inc. Announces Roche Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera(R) (rituximab); Triggering $5 Million Milestone Payment

Halozyme Therapeutics, Inc. (HALO) Announces Roche (RHHBY) Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera(R) (rituximab); Triggering $5 Million Milestone Payment
2/16/2011

SAN DIEGO, Feb. 16, 2011/PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the first patient received subcutaneous (SC) MabThera (rituximab), an anticancer biologic, in a Phase 3 registration trial using Enhanze( technology (rHuPH20, recombinant human hyaluronidase). This represents the second Roche cancer medicine, in addition to Herceptin® SC (trastuzumab), to enter a Phase 3 registration study as part of the Halozyme-Roche collaboration. Initiation of the clinical trial has triggered a milestone payment of $5 million to Halozyme. MabThera is approved to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL) using different induction and maintenance treatments that are currently given intravenously (IV).

(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"The start of this Phase 3 subcutaneous MabThera trial in patients with follicular NHL signifies another major achievement for the Halozyme-Roche partnership, and represents the second Roche target to begin a pivotal trial. I congratulate the team on this important accomplishment," said Gregory Frost, Ph.D., Halozyme's president and CEO. "MabThera is the standard of care for several serious forms of blood cancer and we expect this subcutaneous alternative could provide a compelling administration option."

This innovative technology may allow patients with NHL to receive MabThera in less than 10 minutes via a simple SC injection at their physician's office. Administration of SC MabThera means that patients with NHL undergoing induction therapy or completing two years of maintenance treatment with MabThera would have the greater convenience of being able to receive a much shorter drug administration, a compelling and welcome benefit.

Offering SC MabThera treatment outside of the IV infusion center or hospital setting could also reduce costs and potentially help to maximize the efficient use of hospital resources. Additional information about this Phase 3 SC MabThera clinical trial can be found at clinicaltrials.gov and roche-trials.com.

Halozyme-Roche Collaboration

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme, rHuPH20, to three pre-defined biologic targets exclusive to Roche. In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialize rHuPH20 with an additional three potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on future product sales. Under the collaboration, Roche has access to Halozyme's expertise in developing and applying rHuPH20 to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

About Follicular Lymphoma and Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma is diagnosed in approximately 356,000 people worldwide each year according to the WHO. Follicular lymphoma, a cancer of the blood, is a common type of NHL and accounts for about 20% of the new cases of NHL each year. NHL unfortunately remains incurable and patients ultimately relapse and require additional treatments.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning, (i) Roche's progress under the collaboration, (ii) the potential achievement of various milestones, and (iii) the advantages of SC MabThera) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Senior Director, Investor Relations

SOURCE Halozyme Therapeutics, Inc.

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Phase III Data Published in The Lancet Show Baxter International, Inc.???s PREFLUCEL Protective Against Seasonal Influenza

DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. announced today results of a study published in this week’s issue of The Lancet that demonstrate effectiveness and tolerability of Baxter’s PREFLUCEL in protecting against seasonal influenza. The study data show nearly 80 percent protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile. PREFLUCEL is manufactured using Vero cell technology, offering an innovative method of vaccine production compared to conventional embryonated chicken egg production, which has been used for decades.

Investigators studied the safety, immunogenicity and protective efficacy of PREFLUCEL through a randomized, double-blind, placebo-controlled phase III trial conducted in more than 7,200 healthy volunteers in the United States during the 2008/2009 influenza season.

“Seasonal influenza claims thousands of lives every year, but can be very effectively prevented through wide-spread vaccination,” said Professor John Oxford, D.Sc., Barts and The London School of Medicine and Dentistry, Queen Mary, University of London. “This study provides important new information that Baxter’s Vero cell-derived seasonal vaccine is well-tolerated, immunogenic and efficacious and should be considered when planning public health preventive efforts around flu season.”

Study results indicated that participants responded positively to the vaccine, with 78.5 percent protective efficacy against culture-confirmed influenza infection (CCII) and robust immune responses (measured as seroprotection rates) against the three viral strains contained in the vaccine: A/H1N1- (88.0%), A/H3N2- (93.3%) and B-specific (97.1%). In addition to protection, study investigators found significantly reduced duration and severity of influenza symptoms in infected subjects in the vaccinated group, as compared with the placebo group in a subsequent analysis. The vaccine was well tolerated, with no treatment-related serious adverse events reported during the trial.

“PREFLUCEL has demonstrated robust immunogenicity and protective efficacy against common circulating flu strains, and may provide an important alternative to egg-based vaccines in planning seasonal influenza prevention efforts with a shorter production timeline,” said Hartmut Ehrlich, M.D., vice president of global research and development for Baxter’s BioScience business, and senior author of the publication. “The positive developments in vaccine cell-culture technologies may help contribute to improved strain selection and more robust vaccine supplies for the growing preventive health efforts around the world.”

The study was primarily designed to determine the efficacy of the vaccine in preventing CCII with viruses that were matched to one of the strains contained in the vaccine. Trial protocol also included assessing the correlation between antibody levels and CCII protection, as well as a comparison of the safety of the vaccine versus placebo.

Vero cell technology uses the natural virus, identical in protein composition to the virus circulating in nature, instead of genetically modified virus strains that are widely used for egg-based vaccine production. The resulting vaccine is of high purity because it is free of preservatives, antibiotics and egg proteins, and is suitable for adult and elderly populations, as well as people with egg or antibiotic allergies.

PREFLUCEL is available in Austria and Czech Republic for the 2010 to 2011 influenza season. Baxter expects to receive approval of PREFLUCEL in additional countries in Europe in 2011 through a repeat Mutual Recognition Procedure (rMRP).

Clinical trials on this vaccine are being completed as part of a U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, Office of Biomedical Advanced Research and Development Authority contract awarded in May 2006 to DynPort Vaccine Company LLC (DVC), a CSC company (NYSE:CSC - News).

About PREFLUCEL

PREFLUCEL is a seasonal vaccine composed of purified, inactivated split influenza virions. It is indicated for prophylaxis of influenza in adults and elderly and is the result of almost two decades of dedicated product development efforts to provide a safe and effective next-generation vaccine that can be dependably manufactured on an annual basis for each influenza season. PREFLUCEL is manufactured using Vero cell technology, Baxter’s proprietary technology platform.

PREFLUCEL clinical studies involved more than 15,000 participants, of which more than 9,000 adult and elderly participants received the vaccine. The most common undesirable effects observed were pain at the injection site, headache, fatigue, myalgia and malaise.

About Baxter

Baxter International Inc. (NYSE:BAX - News), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the company's Vero cell technology and expectations with respect to the approval of PREFLUCEL in additional European countries in 2011. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; market acceptance of vaccines developed with Vero cell technology; and other risks identified in the company's most recent filing on Form 10-K and other Securities and Exchange Commission filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6612824<=en

MULTIMEDIA AVAILABLE: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6612824 Contact:

Baxter International Inc. Media Contacts Kellie Hotz, (847) 400-4877 Marie Von Seyfried, +41 44 878 6263 or Investor Contacts Mary Kay Ladone, (847) 948-3371 Clare Trachtman, (847) 948-3085

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Data Monitoring Committee Unanimously Recommends Continuation of Celsion Corporation's Phase III ThermoDox(R) HEAT Study to Treat Primary Liver Cancer

COLUMBIA, MD--(Marketwire - 02/11/11) - Celsion Corporation (NASDAQ:CLSN - News), a leading oncology drug development company, today announced that after reviewing data from 482 randomized patients in its multinational, randomized, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radio frequency ablation for primary liver cancer (the HEAT study), the study's Data Monitoring Committee (DMC) has unanimously recommended that the trial continue enrollment. The HEAT study has enrolled over 86% of the 600 patients necessary to ensure that its primary end point, progression free survival, can be achieved with statistical significance.

"The DMC's recommendation to continue enrollment in the HEAT study marks an important milestone for Celsion and ThermoDox®, as it is its final scheduled evaluation ahead of enrollment completion," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We remain optimistic and encouraged by this progress and by the potential for ThermoDox® to establish an effective standard of care for the enduring unmet need of patients with primary liver cancer."

The Company further announced that the DMC has maintained its recommendation to continue withholding enrollment of additional patients in Japan pending certain guidance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The recommendation follows a review of safety data from 18 Japanese patients enrolled in the study, when compared to patient data from the rest of the Phase III trial. As a part of its commitment to Japan's PMDA, the DMC independently assesses patients randomized at Japanese sites. As previously noted, overall toxicities for patients in the HEAT study are consistent with doxorubicin's labeled safety profile. Doxorubicin, the active therapeutic in ThermoDox®, is a widely used chemotherapeutic with a well known safety profile and approved globally for use, including Japan, in many cancer indications.

Regarding enrollment in Japan, Mr. Tardugno added: "We will continue working with our Japanese development partner and the DMC toward a timely resolution and the resumption of patient enrollment in Japan. While this process is ongoing, current enrollment in the HEAT study is continuing at 66 sites in ten other countries. We intend to move forward toward enrollment and study completion."

The DMC for the HEAT study is comprised of an independent group of medical and scientific experts with the responsibility for reviewing and evaluating patient safety and efficacy data from the Company's Phase III HEAT study. The DMC reviews study data at regular intervals with their primary responsibilities to ensure the safety of all patients enrolled in the trial, the quality of the data collected, and the continued scientific validity of the trial design. The trial design and statistical plan for the HEAT study also incorporates a pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete and 190 progression-free survival events are realized in the study population) with the intent of evaluating safety and efficacy results to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success (a futility analysis) to continue, modify or terminate the trial.

About Primary Liver Cancer

Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 750,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.

About ThermoDox® and the Phase III HEAT Study

ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT Study, ThermoDox® is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 76 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with Radio Frequency Ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov.

About Celsion

Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Mayo Clinic, the University of Pisa, and the North Shore Long Island Jewish Health System.

For more information on Celsion, visit our website: http://www.celsion.com.

Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. Contact:

Investor Contact David Pitts Argot Partners 212-600-1902 Follow Yahoo! Finance on Twitter; become a fan on Facebook.

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