In Re Ribozyme Pharmaceuticals, Inc. SEC. Lit.

119 F. Supp. 2d 1156, 2000 U.S. Dist. LEXIS 18651, 2000 WL 1639740
CourtDistrict Court, D. Colorado
DecidedOctober 24, 2000
DocketCivil Action 99-B-2235, 99-B-2423, 00-B-02 and 00-B-017
StatusPublished
Cited by15 cases

This text of 119 F. Supp. 2d 1156 (In Re Ribozyme Pharmaceuticals, Inc. SEC. Lit.) is published on Counsel Stack Legal Research, covering District Court, D. Colorado primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Ribozyme Pharmaceuticals, Inc. SEC. Lit., 119 F. Supp. 2d 1156, 2000 U.S. Dist. LEXIS 18651, 2000 WL 1639740 (D. Colo. 2000).

Opinion

MEMORANDUM OPINION AND ORDER

BABCOCK, Chief Judge.

Defendants move pursuant to Rule 12(b)(6) to dismiss Plaintiffs Consolidated Class Action Complaint (Consolidated Complaint), and for judicial notice of several documents in support of their Rule 12(b)(6) motion. The motions are adequately briefed, and the parties presented oral argument on October 20, 2000. For the reasons set forth below, I grant in part and deny as moot in part Defendants request for judicial notice, and deny the motion to dismiss. Jurisdiction exists under 28 U.S.C. § 1331.

I.

The material facts, with disputes resolved in Plaintiffs favor, are as follows. This ease involves a class action on behalf of all persons who purchased or otherwise acquired the common stock of Defendant Ribozyme Pharmaceuticals, Inc. (“Ribo-zyme”) between the close of trading on November 15, 1999, and the close of trading on November 17, 1999. Defendant Ribozyme is a Delaware corporation with its principal executive offices in Colorado. Defendant Ralph E. Christoffersen resides in Colorado, and has been the Chief Executive Officer, President, and Director of Defendant Ribozyme since 1992.

Defendant Ribozyme is developing a new class of drugs containing ribozymes, a form of ribonucleic acid, to treat or prevent human disease. Defendant Ribozyme is developing one of those drugs, Angioz-yme, in collaboration with Chiron Corporation. Angiozyme is designed to inhibit the production of a protein essential to angiog-enesis, the process by which new blood vessels are formed. Because cancerous tumors rely on a supply of blood to develop and metastasize, it is hoped that An-giozyme will inhibit the growth of new blood vessels surrounding such tumors, and thereby restrict or halt the development, or spread of certain types of cancer in individuals suffering from the disease.

In its Form 10-K covering the period ending on December 31, 1998 and filed with the Securities and Exchange Commission on May 7, 1999, Defendant Ribozyme summarized the U.S. Government regulations governing the process by which new drugs receive approval by the Food and Drug Administration (FDA):

Before testing of any agents with potential therapeutic value in healthy human test subjects or patients may begin, stringent government requirements for preclinical data must be satisfied. The data, obtained from studies in several animal species, as well as from laboratory studies, are submitted in an IND application or its equivalent in countries outside the United States where clinical studies are to be conducted. The preclinical data must provide an adequate basis for evaluating both the safety and the scientific rationale for the initiation of clinical trials.
Clinical trials are typically conducted in three sequential phases, although these phases may overlap. In Phase I, which frequently begins with initial introduction of the compound into healthy human subjects prior to introduction into patients, the product is tested for safety, adverse effects, dosage, tolerance, absorption, metabolism, excretion and clinical pharmacology. Phase II typically involves studies in a small sample of the intended patient population to assess the efficacy of the compound for a specific indication to determine dose to tolerance and the optimal dose range as well as to gather additional information relating to safety and potential adverse effects. *1160 Phase III trials are undertaken to further evaluate clinical safety and efficacy in an expanded patient population at geographically dispersed study sites to determine the overall risk-benefit ratio of the compound and to provide an adequate basis for product labeling....
Data from preclinical and clinical trials are submitted to the FDA as an NDA for marketing approval and to other health authorities as a marketing authorization application. The process of completing clinical trials for a new drug is likely to take a number of years and requires the expenditure of substantial resources....

Defendants’ Request for Judicial Notice, Ex. A at 18. As to where in the process Angiozyme stood as of December 31, 1998, Defendant Ribozyme stated that it “ha[d] commenced Phase lb clinical trials testing safety and tolerability in approximately 16 cancer patients with a broad spectrum of solid tumors and metastasis.... [and] expected] to initiate Phase II clinical trials prior to the end of 1999.” Id., Ex. A at 7.

On August 11, 1999, Defendant Ribo-zyme issued a press release indicating that it had successfully completed the Phase la and lb trials, and that it was “preparing to enter multi-dose Phase I/II clinical trials in Q4 1999.” Id., Ex. C at 2. The press release also stated that “studies at several independent centers have demonstrated significant inhibition of both growth and metastases in preclinical trials.” Id., Ex. C at 1. Finally, the press release included accounts by Dr. Nassim Usman, Vice President of Research at Defendant Ribozyme and “Angiozyme program director” that Angiozyme “completely inhibited metastases in a clinically relevant colorectal cancer model,” and “halt[ed] tumor growth and metastases in a Lewis Lung murine model.” Id.

On November 15, 1999, Defendant Ribo-zyme issued a “Media Advisory” entitled “Colorado Pharmaceutical Co. Makes Cancer Drug History” announcing a press conference scheduled for November 17, 1999 (Press Release). The Press Release stated in part

[Defendant Ribozyme] presently has several drug compounds in development, of these Angiozyme — it’s cancer drug— has made significant progress. Angioz-yme is now in human clinical trials at the Cleveland Clinic Foundation and has taken an important step forward ... making both clinical history and industry news. [At the November 17, 1999 press conference, Defendant] Christof-fersen, Ph.D., and other senior RPI staff, will explain Angiozyme and its recent history-making leap, an achievement which may be of great significance to cancer patients everywhere.

Id., Ex. D. On November 16, 1999, the price of a share of stock in Defendant Ribozyme traded on NASDAQ opened at $13,625 after closing on November 15,1999 at $10.0625. Because the price then rose to $22 within one hour and twenty-five minutes, trading of Defendant Ribozyme’s stock was halted. During the halt, Maurice Wolin, vice president of medical affairs for Chiron Corporation (Chiron), stated both that “[w]e don’t know if we’re going to break ground here or not,” and he “doesn’t expect any major cancer-drug history to be made since it’s too early to say whether the drug works in humans.” Complaint at para. 38. Later on November 16, 1999, Shari Annes, vice president of corporate communications at Chiron, stated that the Press Release was “very over stated,” and “[t]here is always pressure [on small biotechnology companies] when anything good happens, no matter how small, to make it into big news.” Id.

Also during the halt in trading, Defendant Ribozyme issued a press release indicating that Angiozyme had entered Phase I/II testing as predicted by the May 7, 1999 Form 10-K and the August 11, 1999 press release.

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119 F. Supp. 2d 1156, 2000 U.S. Dist. LEXIS 18651, 2000 WL 1639740, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-ribozyme-pharmaceuticals-inc-sec-lit-cod-2000.