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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Blood Pressure Drug Could Harm Stroke Patients, University of Oslo Study Finds

University of Oslo -- A drug that lowers blood pressure could harm patients if given after a stroke, says a new study. A Norwegian study of 2,000 stroke patients, who had high blood pressure, found that more of those treated with the drug candesartan suffered from kidney failure than those who were not given it.

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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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