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First Union Securities Inc Cover MLNM
By: First Union Securities Inc.
12/15/00 8:07:46 AM
Morning Notes:
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
By: First Union Securities Inc.
12/15/00 8:07:46 AM
Morning Notes:
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
Friday December 15, 10:48 am Eastern Time
TheStreet.com - View from TSC
FDA Panel Backs Millennium-Ilex-Schering Cancer Drug
The drug marks the first marketed product for Millennium and Ilex.
By Dane Hamilton
Staff Reporter
y´
A Food and Drug Administration advisory panel Thursday gave Ilex Oncology (Nasdaq: ILXO - news) and Millennium (Nasdaq: MLNM - news) its early Christmas well wishes.
The FDA`s Oncologic Drugs Advisory Panel decided by a 14-1 vote that a new leukemia drug called Campath should be approved, pushing Millennium stock up as much as 10%. Now the companies need full approval by the FDA, which generally follows the lead of its advisory panels. The drug, a treatment for chronic lymphocytic leukemia, the most prevalent form of the blood cancer, was developed by a joint venture of the biotech companies.
The approval was mostly expected but represents a milestone for both companies, since it would be each company`s first drug on the market. Shares in both companies rose after the decision, with Millennium jumping 7% to $59.56 and Ilex rising 4.4% to $27.68.
The panel, the crucial gateway that must be transversed for almost all cancer drugs, wasn`t as kind to Maxim Pharmaceuticals (Nasdaq: MAXM - news) last night. The panel unanimously turned down Maxim`s Maxamine for advanced skin cancer, causing shares in that biotech to plunge a third straight day. Maxim dropped 28% to $9.37, after falling 44% and 22% Tuesday and Wednesday.
Campath, a monoclonal antibody, isn`t expected to be a huge seller, with some analysts expecting peak annual sales of around $150 million. The drug will be marketed in the U.S. by Berlex Labs , a subsidiary of Germany`s Schering (NYSE: SHR - news) , and will be used for patients who have failed other therapies. Revenue will be split evenly among the three companies.
"This is more of a milestone than a major revenue-building event," says Ellen Lubman, genomics analyst with Robertson Stephens , who has a strong buy rating on Millennium and no formal rating on Ilex. The bank advised Millennium in its fundraising this year. "We were pretty optimistic it would be approved," she says.
If approved, Campath will be "the most significant breakthrough in 10 years for CLL patients and an important addition to current treatments," the companies said in a statement.
Some 120,000 patients in the U.S. and Europe have CLL and are typically initially treated with chemotherapy and later a drug called fludarabine if initial treatment fails. If approved, Campath will be a third option for those who have failed initial treatments.
See TheStreet.com`s full site for more of its unique insider`s perspective on Wall Street.
TheStreet.com - View from TSC
FDA Panel Backs Millennium-Ilex-Schering Cancer Drug
The drug marks the first marketed product for Millennium and Ilex.
By Dane Hamilton
Staff Reporter
y´
A Food and Drug Administration advisory panel Thursday gave Ilex Oncology (Nasdaq: ILXO - news) and Millennium (Nasdaq: MLNM - news) its early Christmas well wishes.
The FDA`s Oncologic Drugs Advisory Panel decided by a 14-1 vote that a new leukemia drug called Campath should be approved, pushing Millennium stock up as much as 10%. Now the companies need full approval by the FDA, which generally follows the lead of its advisory panels. The drug, a treatment for chronic lymphocytic leukemia, the most prevalent form of the blood cancer, was developed by a joint venture of the biotech companies.
The approval was mostly expected but represents a milestone for both companies, since it would be each company`s first drug on the market. Shares in both companies rose after the decision, with Millennium jumping 7% to $59.56 and Ilex rising 4.4% to $27.68.
The panel, the crucial gateway that must be transversed for almost all cancer drugs, wasn`t as kind to Maxim Pharmaceuticals (Nasdaq: MAXM - news) last night. The panel unanimously turned down Maxim`s Maxamine for advanced skin cancer, causing shares in that biotech to plunge a third straight day. Maxim dropped 28% to $9.37, after falling 44% and 22% Tuesday and Wednesday.
Campath, a monoclonal antibody, isn`t expected to be a huge seller, with some analysts expecting peak annual sales of around $150 million. The drug will be marketed in the U.S. by Berlex Labs , a subsidiary of Germany`s Schering (NYSE: SHR - news) , and will be used for patients who have failed other therapies. Revenue will be split evenly among the three companies.
"This is more of a milestone than a major revenue-building event," says Ellen Lubman, genomics analyst with Robertson Stephens , who has a strong buy rating on Millennium and no formal rating on Ilex. The bank advised Millennium in its fundraising this year. "We were pretty optimistic it would be approved," she says.
If approved, Campath will be "the most significant breakthrough in 10 years for CLL patients and an important addition to current treatments," the companies said in a statement.
Some 120,000 patients in the U.S. and Europe have CLL and are typically initially treated with chemotherapy and later a drug called fludarabine if initial treatment fails. If approved, Campath will be a third option for those who have failed initial treatments.
See TheStreet.com`s full site for more of its unique insider`s perspective on Wall Street.
Yeah!
Kann mal jemand den Inhalt mit zwei Sätzen zusammenfassen.
Hab seit gestern Millennium und freu mich riesig!!
Eva
Hab seit gestern Millennium und freu mich riesig!!
Eva
Trading Spotlight
Das ist die einzige Nachricht die ich auf deutsch gefunden habe.
Ich halte mich bei Millennium eher an die amerikanischen News-
Lieferanten.
Die Nachricht ist von Donnerstag, aber das sollte nichts heißen, da die
wilden Kursbewegungen gestern, eindeutig vom Tripple-Witching-Day
geprägt wurden.
Ein Supertag um Nachzukaufen...!
US-Biotech – Millennium Pharma explodiert
Die Aktien des Pharmakonzerns Millennium Pharma [Nasdaq: MLNM Kurs/Chart ] steigen am Donnerstag bis 18:20 Uhr (MEZ) um 10,9 Prozent auf 61,62 Dollar – und damit auf ein neues Rekordhoch.
Anleger reagieren mit ihren Käufen auf die Nachricht, dass ein Komitee der US-Aufsichtsbehörde FDA (Food and Drug Administration) dem Unternehmen für das experimentelle Krebsmedikament Campath seine Unterstützung zugesagt hat. Millenium hat das Medikament gemeinsam mit ILEX Oncology [Nasdaq: ILXO Kurs/Chart ] entwickelt.
Das Medikament wäre für beide Firmen das erste Produkt im Markt. Zuvor muss allerdings noch die FDA Campath ihren Segen erteilen. Normalerweise folgt die Behörde aber den Empfehlungen ihrer Ausschüsse.
Das Komitee hatte sich mit 14 zu 1 Stimmen für Campath ausgesprochen.
© 14.12.20000 www.stock-world.de
------------------------------------------------------------------------
[Druckversion]
14.12.2000 18:50
mw
Ich halte mich bei Millennium eher an die amerikanischen News-
Lieferanten.
Die Nachricht ist von Donnerstag, aber das sollte nichts heißen, da die
wilden Kursbewegungen gestern, eindeutig vom Tripple-Witching-Day
geprägt wurden.
Ein Supertag um Nachzukaufen...!
US-Biotech – Millennium Pharma explodiert
Die Aktien des Pharmakonzerns Millennium Pharma [Nasdaq: MLNM Kurs/Chart ] steigen am Donnerstag bis 18:20 Uhr (MEZ) um 10,9 Prozent auf 61,62 Dollar – und damit auf ein neues Rekordhoch.
Anleger reagieren mit ihren Käufen auf die Nachricht, dass ein Komitee der US-Aufsichtsbehörde FDA (Food and Drug Administration) dem Unternehmen für das experimentelle Krebsmedikament Campath seine Unterstützung zugesagt hat. Millenium hat das Medikament gemeinsam mit ILEX Oncology [Nasdaq: ILXO Kurs/Chart ] entwickelt.
Das Medikament wäre für beide Firmen das erste Produkt im Markt. Zuvor muss allerdings noch die FDA Campath ihren Segen erteilen. Normalerweise folgt die Behörde aber den Empfehlungen ihrer Ausschüsse.
Das Komitee hatte sich mit 14 zu 1 Stimmen für Campath ausgesprochen.
© 14.12.20000 www.stock-world.de
------------------------------------------------------------------------
[Druckversion]
14.12.2000 18:50
mw
@dakinky
Die Nachricht ist fehlerhaft. Das Rekordhoch von MLNM war $89 intraday. Auf Schlusskursbasis ist es $86.
Die Nachricht ist fehlerhaft. Das Rekordhoch von MLNM war $89 intraday. Auf Schlusskursbasis ist es $86.
@ Förtschilein:
Du haßt natürlich recht, doch steht es mir nicht zu Nachrichten zu verändern.
Ich denke die Grundaussage des Textes war wichtiger als die Kursangaben.
Millennium könnte nun bald zu den ganz Großen im Biotech-Bereich
gehören, deshalb werden die alten Hochs auch bald geknackt...
dakinky
Du haßt natürlich recht, doch steht es mir nicht zu Nachrichten zu verändern.
Ich denke die Grundaussage des Textes war wichtiger als die Kursangaben.
Millennium könnte nun bald zu den ganz Großen im Biotech-Bereich
gehören, deshalb werden die alten Hochs auch bald geknackt...
dakinky
Monday January 8, 3:19 am Eastern Time
Roche, Millennium in arthritis diagnostics venture
(UPDATE: Adds comment from statement, market reaction)
BASEL, Switzerland, Jan 8 (Reuters) - Roche Holding AG`s Roche Diagnostics division has struck an alliance with Millennium Pharmaceuticals Inc (NasdaqNM:MLNM - news) to develop diagnostic products for rheumatoid arthritis, Roche said on Monday.
U.S.-based Millennium will receive a licensing fee, funding for research and milestone payments and royalties under the three-year deal.
Roche gets certain research and development rights for select diagnostic markers in this disease area. It will also market products resulting from the alliance, it said without giving financial details.
Roche certificates opened up 75 Swiss francs at 16,120 in a generally firmer Swiss market.
``The combination of Roche`s world-class strength in diagnostics with Millennium`s strong position in genomics and proteomics will bring revolutionary diagnostic products to market,`` said Heino von Prondzynski, the head of Roche`s diagnostics division.
Roche, Millennium in arthritis diagnostics venture
(UPDATE: Adds comment from statement, market reaction)
BASEL, Switzerland, Jan 8 (Reuters) - Roche Holding AG`s Roche Diagnostics division has struck an alliance with Millennium Pharmaceuticals Inc (NasdaqNM:MLNM - news) to develop diagnostic products for rheumatoid arthritis, Roche said on Monday.
U.S.-based Millennium will receive a licensing fee, funding for research and milestone payments and royalties under the three-year deal.
Roche gets certain research and development rights for select diagnostic markers in this disease area. It will also market products resulting from the alliance, it said without giving financial details.
Roche certificates opened up 75 Swiss francs at 16,120 in a generally firmer Swiss market.
``The combination of Roche`s world-class strength in diagnostics with Millennium`s strong position in genomics and proteomics will bring revolutionary diagnostic products to market,`` said Heino von Prondzynski, the head of Roche`s diagnostics division.
Jetzt aussteigen...
@Buckweiser
Offenbar konzentrieren die Shortseller ihre geballte Brutalität jetzt
auf die Biotechs. Die Marktkapitalisierung mancher Unternehmen ist einfach
abenteuerlich. Das geht jetzt zur Sache, auch bei Amgen und Biogen, den
"Platzhirschen".
vergesst den drendbruck !
keiner schaut zur zeit drauf die bios werden nicht weiter korrigieren das steht fest !
der index wird nicht unter 840 Punkte fallen, weil wir vorzeitig gute nachrichten vom markt bekommen werden ist egal von welcher firma, dann wird der bioboom wieder beginnen und die ganze welt investiert in bioaktien besonders in millenium pharma. !
gruß
abzocker
keiner schaut zur zeit drauf die bios werden nicht weiter korrigieren das steht fest !
der index wird nicht unter 840 Punkte fallen, weil wir vorzeitig gute nachrichten vom markt bekommen werden ist egal von welcher firma, dann wird der bioboom wieder beginnen und die ganze welt investiert in bioaktien besonders in millenium pharma. !
gruß
abzocker
MLNM .... absolute kaufkurse
50 % ..... plus auf die schnelle
150 %......plus auf sicht ein jahr
2000%..... für meine sicht 10 jahre
bie den kursen werde ich noch einige stücke einsammeln !!!!!!!!!!!!
gruss
50 % ..... plus auf die schnelle
150 %......plus auf sicht ein jahr
2000%..... für meine sicht 10 jahre
bie den kursen werde ich noch einige stücke einsammeln !!!!!!!!!!!!
gruss
Aussteigen hätte sich gelohnt (-18%), wenigstens einmal Recht gehabt, ich Klugsch....
MLNM auf 44,20 Euro! MediGene auf 47,00 Euro! Ja, merken die Investoren denn überhaupt noch was? Die Amerikaner kann ich ja noch verstehen, die machen eine (übertriebene) Marktkorrektur, wie das eben so ist an der Börse, aber der NEMAX??? Keiner mag ihn mehr. Ích seit heute auch nicht. Der Index hat sich in den letzten neun Monaten GEVIERTELT! Und die Bio`s sind fleißig am Aufholen. Na gut, LION Bioscience ist ein Mistwert, und davon gibt es viele, aber dieses undifferenzierte Runterprügeln frustriert. Also, ich hab`s jetzt dicke. Ich melde mich für die nächsten zwei Wochen aus sämtlichen Boards ab!
P.S.: Meine MLNM`s (Einstiegskurs: Geschenkte 62 Euro) kriegt keiner!
P.S.: Meine MLNM`s (Einstiegskurs: Geschenkte 62 Euro) kriegt keiner!
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