4/6/23, 11:52 PM
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`EDGAR ONLINE - REGENERON PHARMACEUTICALS ... (REGN) - 8-K - 5/2/2006
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`Exhibit 99(a)
`
`FOR IMMEDIATE RELEASE
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`REGENERON REPORTS POSITIVE PHASE 1 DATA FOR THE VEGF
`TRAP IN AGE-RELATED MACULAR DEGENERATION
`Preliminary results show improvements in vision and retinal swelling
`VEGF Trap was well tolerated at all dose levels
`Company also announces initiation of phase 2 trial
`Tarrytown, New York (May 1, 2006) – Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN ) announced today positive preliminary results
`from its phase 1 trial of the Vascular Endothelial Growth Factor (VEGF) Trap in patients with the neovascular form of age-related macular
`degeneration (wet AMD). In addition to meeting its primary endpoints of safety and tolerability at all dose levels, the VEGF Trap
`demonstrated positive preliminary efficacy results. Based on these encouraging data, the Company announced today the start of a phase 2
`trial in wet AMD. The data from the phase 1 trial were presented today at the 2006 Association for Research in Vision and Ophthalmology
`(ARVO) Annual Meeting and are available on the Company’s web site, www.regeneron.com .
`“We are very encouraged both by the promising safety and tolerability data from this trial and by the observed improvements in both retinal
`swelling and visual acuity in patients following a single dose of this very high-affinity VEGF blocking agent,“ said George Yancopoulos,
`M.D., Ph.D., Regeneron’s Executive Vice President, Chief Scientific Officer, and President, Regeneron Research Laboratories. “With the
`start of the phase 2 trial, we hope to validate these early, preliminary findings in a more comprehensive study, determine an optimal dosing
`regimen, and progress rapidly to registration studies for the VEGF Trap in wet AMD. In addition, we have initiated a small pilot study in
`patients with diabetic macular edema (DME).”
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`About the Phase 1 Study
`A total of 21 patients with wet AMD received a single intravitreal injection of 0.05, 0.15, 0.5, 1, 2, or 4 milligrams (mg) of VEGF Trap.
`Patients were followed for 6 weeks at which time they were permitted, according to the study protocol, to receive other available treatments.
`The report presented at the ARVO meeting covers the initial 6-week evaluation phase of the trial, for which data is now available for all 21
`patients. Preliminary results were as follows:
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`Single doses of the VEGF Trap were generally well tolerated at all dose levels tested (0.05 to 4 mg), with no systemic or serious
`adverse events reported. Dose escalation to the highest planned dose was achieved without reaching a maximum tolerated dose
`(MTD).
`Of the 20 patients evaluable for efficacy, 95 percent had stabilization or improvement in visual acuity, defined as £ 15 letter loss on the
`Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart.
`The best corrected visual acuity (BCVA) for all patients in the study increased by a mean of 4.8 letters at 6 weeks. In the two highest
`dose groups (2 mg and 4 mg), the mean improvement in BCVA was 13.5 letters, with three of six patients gaining 15 or more letters.
`There was a large, rapid and sustained decrease in retinal thickness as measured by ocular coherence tomography (OCT). As measured
`by posterior pole OCT scans, the median excess retinal thickness was 194 microns at baseline and 60 microns at 6 weeks; as assessed
`by the Fast Macular Scan protocol, the median excess retinal thickness was 119 microns at baseline and 27 microns at 6 weeks.
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`Phase 2 Trial
`Based on the preliminary phase 1 results, the Company announced today the start of a 150 patient, 12 week, phase 2 trial of the VEGF Trap
`in wet AMD. The trial is designed to evaluate treatment with multiple doses of the VEGF Trap using different doses and different dosing
`regimens, as well as safety and efficacy.
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`Additional Data to be Presented at ARVO
`Listed below are the titles and presentation times for additional clinical and pre-clinical data that have been scheduled for presentation at
`ARVO:
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`Pharmacokinetics and Ocular Tissue Penetration of VEGF Trap after Intravitreal Injection in Rabbits (May 1, 8:30 am)
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`Pre-clinical Development of VEGF Trap for the Treatment of Neovascular Disease (May 1, 9:00 am)
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`Safety Evaluation of Intravitreal Administration of VEGF Trap in Cynomolgus Monkeys for 13 Weeks (May 1, 11:15 am)
`•
`Low Dose, Subconjunctival Administration of VEGF Trap Inhibits Suture-Induced Neovascularization and Inflammation (May 1,
`11:15 am)
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`Intravitreal Administration of VEGF Trap Suppresses Vascular Leak in the Retinas of Diabetic Rats (May 1, 11:15 am)
`Intravitreal Administration of VEGF Trap Inhibits Pathological Retinal Neovascularization in a Mouse Model of Oxygen-Induced
`Retinopathy (May 1, 11:15 am)
`Macular Edema: Lessons from Early Clinical Experiences (May 1, 1:15 pm)
`Histologic Evaluation of Laser-Induced Choroidal Neovascularization (CNV) in Primates Receiving Intravitreal Injections of VEGF
`Trap: Correlation with Florescein Angiography (May 1, 3:00 pm)
`A Double-Masked, Placebo-Controlled, Safety and Tolerabiltiy Study of Intravenous VEGF Trap in Patients with Diabetic Macular
`Edema (DME) (May 3, 8:30 am)
`Single Dll4 Allele Deletion Alters Retinal Vascular Development in Mice (May 3, 12:00 pm)
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`The VEGF Trap in Opthamalogy
`Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new
`blood vessels (angiogenesis) to support the growth of the body’s tissues and organs. It has also been associated with the abnormal growth
`and fragility of new blood vessels in the eye, which lead to the development of wet AMD. Other molecules that have been evaluated for
`treatment of wet AMD by blocking VEGF, including Macugen ® , which has been approved by the US Food and Drug Administration, have
`demonstrated that blocking VEGF can result in stabilization or improvement of vision in patients with wet AMD. Wet AMD is the leading
`cause of vision loss and blindness in Americans aged 65 and over, with approximately 1.5 million people affected with this condition in the
`United States.
`The VEGF Trap is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related placental
`growth factor (PlGF). The VEGF Trap is designed to block the interaction of these growth factors with cell-surface receptors and prevent the
`subsequent formation of the new blood vessels that play an important role in the development of wet AMD.
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`About Regeneron Pharmaceuticals
`Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment
`of serious medical conditions. Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and
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`inflammatory diseases and has preclinical programs in other diseases and disorders.
`This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs,
`finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical
`development of our drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict
`our ability to continue to develop or commercialize our drug candidates, competing drugs that are superior to our product candidates,
`unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any
`collaboration agreement, including our agreement with the sanofi-aventis Group, to be canceled or to terminate without any product
`success, risks associated with third party intellectual property, and other material risks. A more complete description of these and other
`material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission (SEC), including its Form
`10-K for the year ended December 31, 2005. Regeneron does not undertake any obligation to update publicly any forward-looking
`statement, whether as a result of new information, future events, or otherwise unless required by law.
`
`Contact
`Lauren Tortorete
`212.845.5609
`ltortorete@biosector2.com
`
`###
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