|
First Union Securities Inc Cover MLNM By: First Union Securities Inc. 12/15/00 8:07:46 AM Morning Notes: Visit the CNET Brokerage Center for daily reports from the top Wall Street analysts. Millennium Pharmaceuticals (MLNM-NASDAQ) Stock Rating: 2 Target Price: $85 MLNM: CONFERENCE CALL HIGHLIGHTS INVESTMENT HIGHLIGHTS On December 14, 2000, the Oncologic Drugs Advisory Committee to the Food and Drug Administration voted 14 to 1 to recommend accelerated approval of Campath for the treatment of patients with chronic lymphocytic leukemia (CLL, a type of blood cancer) who have been treated with alkylating agents and have failed fludarabine therapy (fludarabine refractory CLL). In our opinion, the positive review by the Advisory Committee signals Millennium`s expanding downstream capabilities in clinical development and regulatory approval, both of which can be further leveraged to bring additional potential breakthrough drugs to market. The FDA will consider the Advisory Committee’s recommendation as it reviews the Biologics License Application (BLA) for Campath. In general, the FDA follows the recommendation of the Advisory Committee. Upon final approval by the FDA, Millennium Pharmaceuticals’ U.S. marketing partner and Schering AG`s U.S. subsidiary, Berlex, should be able to commence marketing and distribution of Campath in the United States. Millennium`s Marketing Authorization Application for Campath is also under regulatory review in Europe. Millennium plans to conduct additional comparative trials on Campath in a less heavily treated patient population in 2001, in order to satisfy the FDA`s current guidelines for granting accelerated approval. The management highlighted the following major milestones for Millennium: (1) Continue to develop breakthrough personalized medicines; (2) Enhance and increase the productivity of drug discovery and development process to deliver products to market faster and at a lower cost; (3) Continue to establish "over-the-top" alliances with major pharmaceutical companies, while retaining downstream rights to products; and (4) Merger and acquisition activity to acquire and integrate products, downstream capabilities and technology platforms to help it achieve its goal of becoming the biopharmaceutical company of the future. We arrived at our 12-month target price of $85 by applying a multiple of 60x to our 2002 revenue estimates of $296.8 million. DISCUSSION On December 14, 2000, the Oncologic Drugs Advisory Committee to the FDA voted 14 to 1 to recommend accelerated approval of Campath for the treatment of patients with chronic lymphocytic leukemia (CLL, a type of blood cancer) who have been treated with alkylating agents and have failed fludarabine therapy (fludarabine refractory CLL). In our opinion, the positive review by the Advisory Committee signals Millennium’s expanding downstream capabilities in clinical development and regulatory approval, both of which can be further leveraged to bring additional potential breakthrough drugs to market. The FDA will consider the Advisory Committee’s recommendation as it reviews the Biologics License Application (BLA) for Campath. In general, the FDA follows the recommendation of the Advisory Committee. Once approved, Campath will become Millennium’s first marketed product and thereby mark the company’s transition into a fully integrated pharmaceutical company. Furthermore, Campath will be the first antibody developed to treat patients with CLL and the first new drug indicated for the treatment of CLL in nearly 10 years. Upon final approval by the FDA, Millennium Pharmaceuticals’ U.S. marketing partner and Schering AG`s U.S. subsidiary, Berlex, should be able to commence marketing and distribution of Campath in the United States. Millennium`s Marketing Authorization Application for Campath is also under regulatory review in Europe. Millennium plans to conduct additional comparative trials on Campath in a less heavily treated patient population in 2001, in order to satisfy the FDA`s current guidelines for granting accelerated approval. Millennium has already submitted a preliminary study design for these comparative trials and currently awaits the FDA response. The proposed trial design would compare fludarabine followed by Campath versus fludarabine followed by observation. The management highlighted the following major milestones for Millennium: 1. Continue to develop breakthrough personalized medicines -Currently, the company has five other clinical-stage product candidates in its cancer and inflammation franchises. In the next year, we expect Millennium to advance its clinical pipeline across all three franchises - cancer, inflammation and metabolic disorders. 2. Enhance and increase the productivity of drug discovery and development process to deliver products to market faster and at a lower cost. Notable examples of this initiative include the technology component of Millennium’s alliance with Aventis wherein the two companies are working together to build predictive models for ADMET (absorption, distribution, metabolism, excretion and toxicity), Millennium’s microfluidics alliance with Caliper Technologies and its alliance with Abgenix to develop human monoclonal antibodies. 3. Continue to establish "over-the-top" alliances with major pharmaceutical companies, while retaining downstream rights to products. 4. Merger and acquisition activity. The goals for this are two-fold. We expect Millennium to continue to acquire and integrate technology platforms and downstream capabilities to help it achieve its goal of becoming the biopharmaceutical company of the future. Furthermore, we expect the company to potentially acquire currently marketed products as well as product candidates in late-stage clinical development. Additional information is available upon request. First Union Securities, Inc. makes a market in the shares of MLNM. This is for your information only and is not an offer to sell, or a solicitation of an offer to buy, the securities or instruments mentioned. Interested parties are advised to contact the entity they deal with, or the entity that has distributed this report to them. The information has been obtained or derived from sources believed by us to be reliable, but we do not represent that it is accurate or complete. Any opinions or estimates contained in this information constitute our judgement as of this date and are subject to change without notice. First Union Securities, Inc. (“FUSI”), or its affiliates may provide advice or may from time to time acquire, hold or sell a position in the securities mentioned herein. FUSI is a subsidiary of First Union Corporation and is a member of the NYSE, NASD and SIPC. Copyright © 2000 First Union Securities, Inc. FUSI is a separate and distinct entity from its affiliated banks and thrifts.SECURITIES: NOT FDIC-INSURED • NOT BANK-GUARANTEED • MAY LOSE VALUE |
|
| aus der Diskussion: | Campath durch ?!? MLNM realtime 5 $ im Plus |
| Autor (Datum des Eintrages): | gholzbauer (15.12.00 19:05:33) |
| Beitrag: | 19 von 22 (ID:2538766) |
| Alle Angaben ohne Gewähr © wallstreetONLINE | |