Celgene Corporation
Jun 21, 2012
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Celgene Provides Regulatory Update

Application for new indication for REVLIMID® (lenalidomide) in newly-diagnosed and maintenance multiple myeloma has been withdrawn from CHMP; Plans to re-submit with more mature data

Pomalidomide NDA for patients with relapsed and refractory multiple myeloma accepted for standard review by U.S. FDA, PDUFA date set for Feb. 10, 2013; MAA for patients with relapsed and refractory multiple myeloma submitted to the EMA

2012 guidance and 2015 financial targets reaffirmed

Conference call to be held at 8:30 a.m. EDT, available by webcast

BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 21, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), is providing a regulatory update for REVLIMID (lenalidomide) and pomalidomide as treatments for multiple myeloma.

We have decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use (CHMP) for REVLIMID (lenalidomide), which was intended for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and REVLIMID (lenalidomide), or maintenance therapy following autologous stem cell transplantation.

In response to the CHMP’s request, we plan to re-submit with more mature data, which allows CHMP to conclude a clear benefit/risk ratio.

We are proceeding with submissions for REVLIMID (lenalidomide) in newly diagnosed multiple myeloma in Switzerland, Australia and other core markets. In the U.S., we are currently re-evaluating our REVLIMID (lenalidomide) newly diagnosed submission to FDA and anticipate submitting an application in 2013.

Our new drug application (NDA) for pomalidomide plus low-dose dexamethasone for patients with relapsed and refractory multiple myeloma was accepted for standard review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of Feb. 10, 2013.

We are seeking approval to market pomalidomide in combination with low-dose dexamethasone as a potential treatment for relapsed and refractory multiple myeloma patients who have received at least two prior therapies of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy. The NDA is based on data from a phase II study (MM-002) of pomalidomide. Results from this study were most recently presented at the 2012 American Society of Clinical Oncology annual meeting. Our international, randomized, placebo-controlled phase III study (MM-003), in relapsed and refractory multiple myeloma is anticipated to complete enrollment this July. Data are expected by the end of this year.

We have submitted a Marketing Authorisation Application (MAA) for pomalidomide in combination with dexamethasone to the EMA for the treatment of patients with relapsed and refractory multiple myeloma.

2012 Guidance and 2015 Financial Targets Reaffirmed

2012 Guidance

2015 Financial Targets

Conference Call and Webcast Information

Celgene will host a conference call to discuss the regulatory actions on Thursday, June 21, 2012, at 8:30 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon June 21, 2012, until midnight EDT June 28, 2012. To access the replay, in the U.S. dial 800-585-8367; international dial 404-537-3406; and participant passcode 69468804.

About REVLIMID®

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

Since 1998, Celgene continues to be a pioneer in creating environments in which patients can benefit from our disease-altering therapies safely. As a result, hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies through our performance-based risk management programs including, S.T.E.P.S.®, RevAssist® and RevMate®, which form the foundation of our commitment to patient safety.

U.S. Regulatory Information for Revlimid

REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy.

REVLIMID® (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Important Safety Information

WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. In women of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid fetal exposure to lenalidomide, REVLIMID is only available under a restricted distribution program called “RevAssist®.”

Information about the RevAssist program is available at www.REVLIMID.com or by calling the manufacturer’s toll-free number 1-888-423-5436.

HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors. (see DOSAGE and ADMINISTRATION)

DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with MM who were treated with REVLIMID and dexamethasone therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with REVLIMID may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient’s underlying risk factors.

CONTRAINDICATIONS:

Pregnancy Category X:

Allergic Reactions:

WARNINGS AND PRECAUTIONS:

Fetal Risk:

Reproductive Risk and Special Prescribing Requirements (RevAssist Program):

Hematologic Toxicity—Multiple Myeloma:

Deep Vein Thrombosis and Pulmonary Embolism:

Allergic Reactions:

Tumor Lysis Syndrome:

Tumor Flare Reaction:

Hepatotoxicity:

Second Primary Malignancies

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Nursing Mothers:

Geriatric Use:

Renal Impairment:

ADVERSE REACTIONS:

Multiple Myeloma

Myelodysplastic Syndromes

DOSAGE AND ADMINISTRATION:

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS

About Pomalidomide

Pomalidomide is an IMiDs® compound. Pomalidomide and other IMiDs continue to be evaluated in over 100 clinical trials. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.

About Multiple Myeloma

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains non-GAAP financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These non-GAAP measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. See the attached Reconciliations of GAAP to non-GAAP Net Income for explanations of the amounts excluded and included to arrive at non-GAAP net income and non-GAAP earnings per share amounts.

Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2012 Projected GAAP to Non-GAAP Net Income
(In thousands, except per share data)
           
      Range
      Low   High
           
Projected net income - GAAP   $ 1,566,000     $ 1,631,000  
           
  Before tax adjustments:        
 

Cost of goods sold (excluding amortization of acquired intangible assets):

       
  Share-based compensation expense     11,000       10,000  
           
  Research and development:        
  Share-based compensation expense     121,000       109,000  
  IPR&D impairment     22,000       22,000  
  Upfront payment     65,000       65,000  
           
  Selling, general and administrative:        
  Share-based compensation expense     118,000       107,000  
           
  Amortization of acquired intangible assets     199,000       199,000  
           
  Acquisition related (gains) charges and restructuring, net:        
  Change in fair value of contingent consideration     103,000       103,000  
  Acquisition and restructuring costs     2,000       1,000  
           
  Net income tax adjustments     (115,000)       (111,000)  
           
Projected net income - non-GAAP   $ 2,092,000     $ 2,136,000  
           
Projected net income per diluted common share - GAAP   $ 3.52     $ 3.67  
           
Projected net income per diluted common share - non-GAAP   $ 4.70     $ 4.80  
           
Projected weighted average diluted shares     445,000       445,000  

Source: Celgene International Sàrl

Celgene International Sàrl
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ir@celgene.com
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