Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) Files An 8-K Other Events

Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) Files An 8-K Other Events
Item 8.01 Other Events.

Submission of Statement Setting out Grounds of Appeal in Opposition Proceeding in European Patent Office

On June 12, 2017, Alder BioPharmaceuticals, Inc. (“Alder”) submitted its statement setting out the grounds of appeal (the “Grounds of Appeal”) with respect to the decision of the Opposition Division (“OD”) of the European Patent Office “(“EPO”) in the opposition to Labrys Biologics Inc.’s (owned by Teva Pharmaceutical Industries Ltd.) (“Teva”) European Patent No. 1957106 B1 disclosed in “Item 3. Legal Proceedings” in Alder’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Alder previously filed its notice of appeal in the proceeding on March 31, 2017. Eli Lilly and Company and Teva have also appealed the OD’s decision. Alder continues to firmly believe that the use claims that were maintained and narrowed by the OD were nevertheless improperly granted by the EPO and upheld by the OD, and should be revoked in their entirety on appeal for the reasons set forth in the Grounds of Appeal.

 

 

 

 

 

 

This Form 8-K contains a forward-looking statement relating to Alder’s belief that the referenced patent should be revoked in its entirety, which is based upon Alder’s current plans, assumptions, beliefs, expectations, estimates and projections, and involves substantial risks and uncertainties. Actual results and the timing of events could differ materially due to these risks and uncertainties as well as other factors, which include, without limitation: the inherent uncertainty in legal proceedings involving intellectual property and the possibility that such proceedings may result in outcomes that are unfavorable to Alder; the timing, scope and costs of legal proceedings involving intellectual property; Alder’s ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the sufficiency of Alder’s capital and other resources; market competition; and other factors discussed under the caption “Risk Factors” in Alder’s Form 10-Q for the quarterly period ended March 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on April 27, 2017, and is available on the SEC’s website at www.sec.gov. Additional information will also be set forth in Alder’s other reports and filings it will make with the SEC from time to time. The forward-looking statement made in this Form 8-K speaks only as of the date of this Form 8-K. Alder 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 Alder’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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About Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR)

Alder Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company discovers, develops and focuses to commercialize therapeutic antibodies with the potential to transform current treatment paradigms. The Company’s pipeline includes ALD403, Clazakizumab and ALD1613. ALD403 is the Company’s monoclonal antibody targeted to calcitonin gene-related peptide (CGRP) for migraine prevention. Clazakizumab is a monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6 (IL-6), and is in development for both rheumatoid arthritis (RA) and psoriatic arthritis (PsA). ALD1613 is a monoclonal antibody that inhibits Adrenocorticotropic Hormone, and is being developed for the treatment of Cushing’s disease. Its candidate, Eptinezumab, is an investigational product candidate being developed as a migraine prevention treatment for patients with chronic and frequent episodic migraine. It is also is developing ALD1910, a genetically engineered monoclonal antibody.

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