Current Business Highlights
ARCALYST® (rilonacept) – Inflammatory Diseases
The Company shipped
During the first quarter of 2009, the Company initiated a Phase 3 clinical development program with ARCALYST for the treatment of gout. The program includes four clinical trials, three of which are currently enrolling patients: Two Phase 3 clinical trials (called PRE-SURGE 1 and PRE-SURGE 2) will evaluate ARCALYST versus placebo for the prevention of gout flares in patients initiating urate-lowering drug therapy. A third Phase 3 trial in acute gout (SURGE) will evaluate treatment with ARCALYST alone versus ARCALYST in combination with a non-steroidal anti-inflammatory drug (NSAID) versus an NSAID alone. The Phase 3 program also includes a separate placebo-controlled safety study (RE-SURGE). The Company expects to report initial data from the Phase 3 program in 2010. Regeneron owns worldwide rights to ARCALYST.
Aflibercept (VEGF Trap) – Oncology
At the end of the first quarter of 2009, approximately one-half of the planned number of patients were enrolled in four Phase 3 trials that are evaluating combinations of aflibercept, an investigational anti-angiogenesis agent, with standard chemotherapy regimens for the treatment of cancer. One trial (called VELOUR) is evaluating aflibercept as a 2nd line treatment for metastatic colorectal cancer in combination with FOLFIRI (folinic acid (leucovorin), 5-fluorouracil, and irinotecan). A second trial (VANILLA) is evaluating aflibercept as a 1st line treatment for metastatic pancreatic cancer in combination with gemcitabine. A third trial (VITAL) is evaluating aflibercept as a 2nd line treatment for metastatic non-small cell lung cancer in combination with docetaxel. The fourth trial (
A Phase 2 single-agent study of aflibercept in advanced ovarian cancer (AOC) patients with symptomatic malignant ascites (SMA) is now fully enrolled, and initial data from this trial are expected by mid-2009. Aflibercept is being developed worldwide by Regeneron and its collaborator, sanofi-aventis.
VEGF Trap-Eye – Ophthalmologic Diseases
VEGF Trap-Eye is a specially purified and formulated form of VEGF Trap for use in intraocular applications that is being developed by Regeneron and its collaborator,
In a separate news release today,
The Phase 3 program (consisting of the VIEW 1 and VIEW 2 studies) that is evaluating VEGF Trap-Eye in patients with wet AMD continued to enroll patients during the first quarter of 2009. The companies expect to complete enrollment in both trials in 2009 and report initial data in late 2010.
Results of the extension stage of the Phase 2 study in wet AMD (the CLEAR-IT 2 study) will be presented on
In the original Phase 2 study, 157 patients were initially treated for 3 months with VEGF Trap-Eye: two groups received monthly doses of 0.5 or 2.0 mg (at weeks 0, 4, 8, and 12) and three groups received quarterly doses of 0.5, 2.0, or 4.0 mg (at baseline and week 12). Following the initial 3-month fixed-dosing phase, patients continued to receive VEGF Trap-Eye at the same dose on a PRN dosing schedule through one year, based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria.
The data to be presented at ARVO will report on 117 patients who elected to enter the extension stage of the study after receiving VEGF Trap-Eye for one year. These patients were dosed on a 2.0 mg PRN basis. On a combined basis, for these 117 patients, the mean gain in visual acuity was 7.3 letters (p<0.0001 versus baseline) at the 3-month primary endpoint of the original Phase 2 study, 8.4 letters (p<0.0001 versus baseline) at one year, and 7.1 letters (p<0.0001 versus baseline) at month 6 of the extension stage. Thus, after 18 months of dosing with VEGF Trap-Eye in the Phase 2 study, patients continued to maintain a highly significant improvement in visual acuity versus baseline, while receiving, on average, only 3.5 injections over the 15-month PRN dosing phase that extended from month 3 to month 18. Patients continue to be dosed in the extension stage of the Phase 2 study.
Among all the patients in the Phase 2 wet AMD study, VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of culture-negative endophthalmitis/uveitis in the study eye and two arterial thrombotic events; these were deemed not to be drug-related. Three deaths were reported—one patient with pancreatic cancer, one patient with squamous cell carcinoma of the lung, and one patient with pulmonary hypertension (a pre-existing condition), The most common adverse events were those typically associated with intravitreal injections and included conjunctival hemorrhage at the injection site and transient increased intraocular pressure following an injection.
In the Phase 2 DME study, additional clinical sites were opened during the first quarter of 2009. The study (called DA VINCI) is evaluating four different VEGF Trap-Eye regimens versus laser treatment. The study began in
Phase 1 clinical studies have begun with the first three human monoclonal antibodies generated by Regeneron using its VelocImmune® technology. REGN88 is an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis. REGN475, an antibody to Nerve Growth Factor (NGF) that binds NGF selectively without cross-reacting with other members of the neurotrophin family, is being developed for the treatment of pain. In addition, a Phase 1 trial is in the process of being initiated to evaluate REGN421, an antibody to Delta-like ligand-4 (Dll4), in patients with advanced malignancies. These antibodies are being developed within the Company’s human antibody collaboration with sanofi-aventis. Over the course of the next several years, the Company and sanofi-aventis plan to advance an average of two to three new fully human monoclonal antibodies into clinical development each year.
As part of its Academic VelocImmune Investigators’ Program (Academic VIP), during the first quarter of 2009 Regeneron entered into an agreement with The
Total revenues increased to
Contract research and development revenue relates primarily to the Company’s aflibercept and antibody collaborations with sanofi-aventis and the Company’s VEGF Trap-Eye collaboration with
|Three months ended|
|Contract research & development revenue|
|Total contract research & development revenue||$||61.1||$||46.4|
For the three months ended
|Three months ended|
|Regeneron expense reimbursement||$||5.4||$||11.7|
|Recognition of deferred revenue related to up-front payments||2.5||2.1|
|Regeneron expense reimbursement||38.4||19.3|
|Recognition of deferred revenue related to up-front payment||2.6||2.6|
|Total sanofi-aventis contract research & development revenue||$||49.6||$||35.7|
For the three months ended
|Three months ended|
|Cost-sharing of Regeneron VEGF Trap-Eye development expenses||$||7.5||$||5.7|
|Recognition of deferred revenue related to up-front and milestone payments||2.5||3.3|
|Total Bayer HealthCare contract research & development revenue||$||10.0||$||9.0|
In periods when the Company recognizes VEGF Trap-Eye development expenses that the Company incurs under the collaboration with
Technology Licensing Revenue
Regeneron has entered into non-exclusive license agreements with
Net Product Sales
Revenue and deferred revenue from product sales are recorded net of applicable provisions for prompt pay discounts, product returns, estimated rebates payable under governmental programs (including
Total operating expenses for the first quarter of 2009 were
Research and development (R&D) expenses increased to
Selling, general, and administrative (SG&A) expenses increased to
Other Income and Expense
Investment income decreased to
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain, and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron’s drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize its product and drug candidates, competing drugs that are superior to Regeneron’s product and drug candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and
|REGENERON PHARMACEUTICALS, INC.|
|CONDENSED BALANCE SHEETS (Unaudited)|
|March 31,||December 31,|
|Cash, restricted cash, and marketable securities||$||495,992||$||527,461|
|Property, plant, and equipment, net||109,840||87,853|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$||44,832||$||36,168|
|Total liabilities and stockholders' equity||$||681,421||$||670,038|
|REGENERON PHARMACEUTICALS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS (Unaudited)|
|(In thousands, except per share data)|
|For the three months|
|ended March 31,|
|Contract research and development||$||61,090||$||46,383|
|Net product sales||3,891|
|Research and development||82,146||61,270|
|Selling, general, and administrative||11,674||11,024|
|Cost of goods sold||392|
|Loss from operations||(19,231||)||(15,911||)|
|Other income (expense)|
|Net loss per share amounts, basic and diluted||$||(0.22||)||$||(0.15||)|
|Weighted average shares outstanding, basic and diluted||79,498||78,493|
Regeneron Pharmaceuticals, Inc.
Peter Dworkin, 914-345-7640
Laura Lindsay, 914-345-7800
Olga Fleming, 212-845-5636