Forest Laboratories, Inc. to Acquire Clinical Data, Inc. in $1.2 Billion Buyout

NEW YORK & NEWTON, Mass.--(BUSINESS WIRE)-- Forest Laboratories, Inc. (Forest) (NYSE:FRX - News) and Clinical Data, Inc. (Clinical Data) (NASDAQ:CLDA - News) today announced that they have entered into a definitive merger agreement pursuant to which Forest will acquire Clinical Data, a specialty pharmaceutical company focused on the development of first-in-class and best-in-category therapeutics, for $30.00 per share in cash plus contingent consideration of up to $6.00 per share that may be paid upon achievement of certain commercial milestones related to Viibryd™. The upfront consideration of $30.00 per share represents a 6.6% premium to the volume-weighted average trading price of CLDA stock since the first trading day after the company announced the approval of Viibryd and that it was considering a potential change of control transaction and a 19.2% premium of the closing price on that day and totals $1.2 billion on a fully diluted basis, net of net cash acquired. Forest will finance the transaction with existing cash. The transaction was approved by the boards of both companies and is expected to be completed in the second quarter of 2011, subject to customary closing conditions.

The transaction will allow Forest to leverage its existing presence in the antidepressant category through the launch of Viibryd (vilazodone HCL tablets) which was developed by Clinical Data and approved by the FDA on January 21, 2011 for the treatment of adults with major depressive disorder (MDD). Viibryd is a selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. With Celexa® and Lexapro®, Forest has a proven track record of successfully commercializing novel anti-depressants. The market for the treatment of MDD is over 200 million prescriptions annually and increasing. Forest plans to launch Viibryd in the U.S. during the second half of 2011. Viibryd is expected to retain market exclusivity until March 2020 including full patent term extension of its composition of matter patent and anticipated pediatric exclusivity. Other patents may further extend this period.

Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories said, “We are pleased to enter into this agreement with Clinical Data. Depression is a debilitating disease that affects the daily lives of millions of patients. We believe that we are uniquely positioned to bring Viibryd to market in light of our long and successful experience of clinical development and expertise in the antidepressant market. This transaction is consistent with our strategy to acquire new products that will help offset the loss of revenues due to patent expiries. Viibryd will be the second new product that we expect to launch this year in addition to Teflaro™. In addition, we are hopeful to obtain FDA approval later this quarter for Daxas (roflumilast), for the treatment of COPD. We plan to submit New Drug Applications for aclidinium and linaclotide in the second half of this year and for two additional products in calendar 2012.”

The transaction is expected to be dilutive, net of synergies, to Forest’s earnings per share for the next three fiscal years, with earnings per share dilution in the range of ($0.55) to ($0.65) in fiscal 2012. The transaction may become accretive during fiscal 2014. The transaction is not expected to impact Forest’s fiscal year 2011 financial guidance. The launch of Viibryd will require significant incremental marketing and sales investment, including a planned sales force expansion. Additional sales resources will be necessary in order to adequately support Viibryd, as well as our currently marketed products Teflaro, Savella®, Bystolic®, Namenda and Lexapro and the anticipated launch of Daxas (roflumilast), pending FDA approval in calendar 2011.

In addition, the transaction brings to Forest Stedivaze™ (apadenoson), a potent agonist of the adenosine A2A receptor subtype with improved selectivity for this receptor over other subtypes (A1 and A2B). Stedivaze is a coronary vasodilator in Phase III development as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI).

Under the terms of the definitive merger agreement, it is anticipated that Forest will promptly commence a cash tender offer to purchase all of the outstanding shares of Clinical Data common stock for $30.00 per share in cash and the non-transferable contractual right that could deliver up to an additional $6.00 per share in cash if U.S. net sales of Viibryd over four consecutive fiscal quarters commencing from the date of the closing of the transaction reach or exceed $800 million within the first 5 years ($1.00 per share), $1.1 billion within the first 6 years ($2.00 per share) and $1.5 billion within the first 7 years ($3.00 per share). The terms of the contingent payments reflect the parties' agreement over the sharing of potential economic upside benefits from future U.S. net sales of Viibryd and do not necessarily reflect anticipated sales of the product. There can be no assurance such levels of net sales will occur or that any or all of the contingent payments will be made. In the tender offer Forest would also offer to purchase certain outstanding notes and warrants issued by Clinical Data that are convertible into or exercisable for shares of Clinical Data common stock. Under the terms of the definitive merger agreement, the transaction is conditioned upon, among other things, satisfaction of a minimum tender condition requiring that the securities tendered in the tender offer represent approximately 78.8% of the outstanding shares of Clinical Data common stock on a fully-diluted basis. In addition the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. In the event that the minimum tender condition is not met, and in certain other circumstances, the parties have agreed to complete the transaction through a one-step merger after receipt of stockholder approval. Randal J. Kirk, the Chairman of Clinical Data’s board of directors, and certain of his affiliates, as well as other directors and officers of Clinical Data, which beneficially own approximately 52.3 percent of Clinical Data’s outstanding shares on a fully diluted basis, have entered into agreements pursuant to which they will tender their outstanding securities into the tender offer and, if applicable, vote their outstanding shares of Clinical Data common stock in favor of the merger.

Morgan Stanley is acting as financial advisor to Forest and Covington & Burling LLP is acting as legal counsel. J.P. Morgan Securities LLC is acting as financial advisor to Clinical Data and Cooley LLP is acting as legal counsel.

About Viibryd

Viibryd is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd was established in two 8-week, multi-center, randomized, double -blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd antidepressant effect are unknown.

Important Safety Information

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Viibryd or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Viibryd is not approved for use in pediatric patients.

Contraindications

VIIBRYD must not be used concomitantly in patients taking MAOIs or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions with serotonergic drugs. Allow at least 14 days after stopping VIIBRYD before starting an MAOI.

Warnings and Precautions

* All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients. * The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions has been reported with antidepressants alone, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Symptoms of serotonin syndrome were noted in 0.1% of patients treated with VIIBRYD. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms while treated with VIIBRYD. * Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of mania or hypomania. * Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression. * Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate. * Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder. * The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. * Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly they may be at greater risk of developing hyponatremia while taking VIIBRYD. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Adverse Reactions

* The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence = 5% and at least twice the rate of placebo) were: diarrhea (28% vs. 9%), nausea (23% vs. 5%), insomnia (6% vs. 2%), and vomiting (5% vs. 1%).

About Clinical Data

The Company's lead product, Viibryd, was approved for marketing by the FDA on January 21, 2011 for the treatment of major depressive disorder in adults. The Company is also advancing its late-stage drug candidate, Stedivaze, a pharmacologic stress agent in Phase III development for use during myocardial perfusion imaging. Clinical Data has other early stage products in development. To learn more, please visit the Company's website at www.CLDA.com.

About Forest Laboratories

Forest Laboratories’ (NYSE:FRX - News) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties that could cause actual results to differ from those set forth in the forward looking statements, including that the transaction may not be timely completed, if at all; that, prior to the completion of the transactions, if at all, Clinical Data’s business may experience significant disruptions due to transaction-related uncertainty or other factors; the timing and the benefits of the business combination transaction involving Forest and Clinical Data, the ability to obtain regulatory approvals of the transaction on the proposed terms and schedule; the requirement that Clinical Data stockholders approve the transaction; the risk that the businesses will not be integrated successfully; uncertainties regarding the timing of launch of Viibryd and future sales of Viibryd; the risk that the cost savings and any other synergies from the transaction may not be fully realized or may take longer to realize than expected; the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings and Clinical Data’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

Notice to Investors

The tender offer for the outstanding common stock of Clinical Data and certain outstanding notes and warrants issued by Clinical Data referred to in this report has not yet commenced. This press release is neither an offer to purchase nor a solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Clinical Data common stock and certain outstanding notes and warrants issued by Clinical Data will be made pursuant to an offer to purchase and related materials that Forest intends to file with the Securities and Exchange Commission. At the time the offer is commenced, Forest will file a tender offer statement on Schedule TO with the Securities and Exchange Commission, and thereafter Clinical Data will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the offer. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement will contain important information that should be read carefully and considered before any decision is made with respect to the tender offer. Additionally, Clinical Data and Forest will file other relevant materials in connection with the proposed transaction of Clinical Data by Forest pursuant to the terms of the merger agreement. These materials will be sent free of charge to all stockholders of Clinical Data when available. In addition, all of these materials (and all other materials filed by Clinical Data with the Securities and Exchange Commission) will be available at no charge from the Securities and Exchange Commission through its website at www.sec.gov. Free copies of the offer to purchase, the related letter of transmittal and certain other offering documents will be made available by Forest and when available may be obtained by directing a request to Forest at www.frx.com. Investors and security holders may also obtain free copies of the documents filed with the Securities and Exchange Commission by Clinical Data by contacting Clinical Data Investor Relations at ir@clda.com.

INVESTORS AND SHAREHOLDERS OF CLINICAL DATA ARE ADVISED TO READ THE SCHEDULE TO, THE SCHEDULE 14D-9, AND THE PROXY STATEMENT, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER OR MERGER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

Additional Information about the Merger and Where to Find It

In connection with the potential one-step merger, Clinical Data will file a proxy statement with the Securities and Exchange Commission. Additionally, Clinical Data would file other relevant materials with the Securities and Exchange Commission in connection with the proposed acquisition of Clinical Data by Forest pursuant to the terms of an Agreement and Plan of Merger by and among Clinical Data, Forest Laboratories, Inc., a Delaware corporation and FL Holding CV and Magnolia Acquisition Corp., each of which are subsidiaries of Forest. The materials to be filed by Clinical Data with the Securities and Exchange Commission may be obtained free of charge at the Securities and Exchange Commission’s web site at www.sec.gov. Investors and stockholders also may obtain free copies of the proxy statement from Clinical Data by contacting Clinical Data Investor Relations at ir@clda.com. Investors and security holders of Clinical Data are urged to read the proxy statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger because they will contain important information about the merger and the parties to the merger.

Clinical Data and its respective directors, executive officers and other members of their management and employees, under the Securities and Exchange Commission rules, may be deemed to be participants in the solicitation of proxies of Clinical Data stockholders in connection with the proposed merger. Further, such persons may have direct or indirect interests in the proposed transaction due to, among other things, securities holdings, pre-existing or future indemnification arrangements, vesting of equity awards, or rights to severance payments or bonuses in connection with the proposed transaction. Information concerning the interests of these persons will be set forth in the Schedule 14D-9 and proxy statement relating to the proposed transaction when it becomes available. Information concerning the interests of Clinical Data’s participants in the solicitation, which may, in some cases, be different than those of Clinical Data’s stockholders generally, will be set forth in the proxy statement relating to the merger when it becomes available.

Conference Call Information

Forest will host a conference call at 10:00 AM EST today to discuss the transaction. The conference call will be webcast live on the Company’s website at www.frx.com and also on the website www.streetevents.com. Please log on to either website at least fifteen minutes prior to the conference call as it may be necessary to download software to access the call. A replay of the conference call will be available until March 22, 2011 at both websites and also by calling (800) 642-1687 (US or Canada) or +1 706 645-9291 (International), Conference ID: 46863592.

Contact:

Forest Laboratories, Inc. Frank J. Murdolo, 212-224-6714 Vice President - Investor Relations Frank.Murdolo@frx.com

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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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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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