|To: scaram(o)uche who wrote (3341)||12/17/2002 12:30:50 AM|
|Tech loses pulse, life sciences in '03? |
By Bambi Francisco, CBS.MarketWatch.com
Last Update: 12:17 AM ET Dec. 17, 2002
SAN FRANCISCO (CBS.MW) - In a year when blue-chip venture companies, like Kleiner Perkins, are compelled to downsize their funds, it's a wonder that anyone in the venture community can attract capital, let alone nearly a billion dollars.
MPM Capital, a venture outfit based in South San Francisco and Boston, managed to secure $900 million for its BioVentures III fund in the final weeks of this very dismal year -- a year in which VCs gave back more principal to investors than they raised.
It's the largest venture fund raised this year. It's also the largest biotech fund ever raised, and one of the largest health care funds, according to Thomson Venture Economics.
When a fund can raise that many zeros, it recalls the days of bravado when venture capitalists dueled each other over the size of their funds.
We all know what good that did for technology investing in the aftermath. Deep depression. The Nasdaq will be down for the third straight year this year. Venture returns are down 28 percent, with early-stage investments down 36 percent, in the last 12 months ending June.
Now, it's apparent where investors want to put fresh money to work: life sciences, essentially technology-driven health care products, such as biotech or medical devices. About 75 percent of MPM's fund is earmarked for biotech-related ventures.
Undoubtedly, MPM benefited from the tailwind coming from investors fleeing technology investing as they left even the most venerable venture outfits.
In this year, Accel Partners, an early investor in UUNet (now part of bankrupt WorldCom) as well as RealNetworks (RNWK: news, chart, profile), gave back $647 million to its limited partners this year. Redpoint Ventures, which invested in Tivo (TIVO: news, chart, profile), gave back $312 million, while Kleiner Perkins, whose golden egg in 2003 will likely be Google, gave back $156 million to its limited partners.
"2002 was a belated wave of givebacks after Crosspoint Ventures chose to give back its entire fund back in December 2000," said Jesse Reyes of Venture Economics.
From one bubble to another
But it's not as if biotech was the obvious alternative. The industry isn't exactly devoid of bubble characteristics. (Even though risk is part of venture investing, you'd think investors would seek some solace, and time away from adventurous bets.)
Not to mention, biotech has had its share of public relations snafus. Sam Waksal, the ousted CEO of Imclone, and Elan (ELN: news, chart, profile) haven't exactly been ideal models this year.
"These events cast a pall over the industry," said Dr. Luke Evnin of MPM, a former venture capitalist at Accel Partners, who characterizes this year as the worst for venture investing he's seen in the last dozen.
BioVentures II, a $600 million fund, took three to four months to raise its funding back in 2000, he recalled. The current fund took more than a year.
Yet this year Evnin and his cohorts at MPM managed to woo money away from the high-priced, ritzy Silicon Valley sprawl over to their digs in the working-class enclave of South San Francisco, the industrial city sandwiched between San Francisco and the airport. (The city is also the heart of biotech in this area, and home to Genentech (DNA: news, chart, profile), the grandfather of all biotech companies.)
Investors must have bought into something. Evnin believes it's partly the tech fallout and partly because the fund is able to diversify across early-stage to late-stage investments and even public companies. MPM also has a $300 million hedge fund that invests in public markets.
MPM's fundraising performance is "a standout in this environment," said Reyes. A couple of buyout companies managed to top the $2 billion mark in funds raised this year. See related story.
Some 646 venture funds raised $105 billion in 2000. By contrast a mere 118 funds were only able to raise $1.5 billion in the first nine months this year.
Still, it's hard to imagine that much money concentrated in one sector. "They are swinging for the fences," Reyes added.
To some extent, the challenge has only begun for MPM. The real trick will be putting that money to work. Only $17 billion has been invested in companies during the first nine months this year, compared to $105 billion in 2000.
Admittedly, it's easier to raise funds than to put it to work in the later-stage portfolio companies, said Evnin. To him it's the paradox in venture investing. Much of this has to do with the fact that tech stocks in the public market are weighing on the valuations of later-stage companies.
But Evnin also believes the venture health care sector has been "chronically under-funded." It's only now that he feels there is enough capital to grow and create value. Creating value takes patience, however. As in most VC funds, the MPM fund requires a 10-year commitment, and he's telling investors not to expect a return for at least the first four.
In fact, in 1997, MPM raised $230 million for its first fund. MPM just returned that initial investment to investors. The upside comes from companies that will mature over the next 1 to 5 years, said Evnin. While he doesn't expect any big IPOs in the first half of 2003, some of the companies he does have high hopes for include Idenix Pharmaceuticals, which makes drugs for the treatment of human viral diseases, and is in the process of developing commercialization for its Hepatitis B drug. Another company he's highlighting is Viacell, which is in the blood bank business and is also in the business of stem-cell amplification.
Just for the record, MPM's IPOs from its venture funds include Adolor (ADLR: news, chart, profile), Arena Pharmaceuticals, GPC Biotech (ARNA: news, chart, profile) and Sonic Innovations (SNCI: news, chart, profile).
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|To: scaram(o)uche who started this subject||12/17/2002 6:32:36 PM|
|FDA Advisory Committee Recommends Approval for MedImmune's FluMist(TM) to Prevent Influenza|
Tuesday December 17, 6:03 pm ET
GAITHERSBURG, Md., and RADNOR, Pa., Dec. 17 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended that the FDA approve FluMist(TM) (Influenza Virus Vaccine Live, Intranasal) to prevent influenza in healthy children, adolescents and adults ages 5 through 49.
If approved by the FDA, FluMist would be the first and only intranasal influenza vaccine in the United States.
The VRBPAC panel voted in favor of the product's safety in the 50-to-64- year age group, but indicated that they believed the data set on efficacy in the 50-to-64-year age group was inadequate at this time.
Advisory committees provide the FDA with independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies. Advisory committees consist of individuals who are recognized as experts in their field from many different sectors including medical professionals, scientists and researchers, industry leaders, and consumer representatives and patient representatives. While advisory committee recommendations are valuable, all final decisions related to a regulated product are made by the FDA. There can be no assurance that the FDA will follow the advisory committee's recommendation.
Dr. Edward M. Connor, MedImmune's senior vice president, clinical development, said, "We are very pleased with the outcome of today's VRBPAC meeting and believe that the results move us closer to our goal of bringing FluMist to market by the 2003-2004 flu season. We look forward to continuing to work with the FDA to answer any additional questions that remain in the agency's review of our application."
A total of 20,228 children, adolescents and adults received 28,979 doses of FluMist in 20 clinical trials structured to evaluate the safety and efficacy of the vaccine to prevent influenza in healthy people. In the trials, the most common adverse event attributable to FluMist was runny nose/nasal congestion.
"FluMist is cutting-edge technology in influenza vaccine delivery in the U.S. aimed at protecting the health of children and adults," says Bernard Poussot, president, Wyeth Pharmaceuticals. "FluMist, with its intranasal administration, may help reduce disease burden on the health care system by increasing influenza vaccination rates."
Influenza is the most common cause of medically attended acute respiratory illness in the U.S. often involving fever, chills, muscle weakness, cough, sore throat, nasal congestion, headache and general malaise. According to the Centers for Disease Control and Prevention and the American Lung Association, 20 to 50 million people are infected annually in the U.S., causing 70 million lost work days(1), 38 million lost school days(2), and 20,000 to 50,000 deaths per year (primarily in the elderly)(3). The annual burden of the disease to society has been estimated at $15 billion.
If and when FluMist is approved for marketing by the FDA, it would be marketed by MedImmune and Wyeth Pharmaceuticals, a division of Wyeth, as part of an ongoing global collaboration agreement.
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|To: scaram(o)uche who wrote (3343)||12/17/2002 6:34:49 PM|
|US FDA panel backs Corixa lymphoma drug Bexxar|
Tuesday December 17, 6:28 pm ET
BETHESDA, Md., Dec 17 (Reuters) - A U.S. advisory panel on Tuesday said the experimental cancer drug Bexxar, developed by Corixa Corp. (NasdaqNM:CRXA - News) and Britain's GlaxoSmithKline Plc (London:GSK.L - News), had benefits in treating non-Hodgkin's lymphoma.
The Food and Drug Administration advisory committee did not take a formal vote on Bexxar, which is aimed at helping non-Hodgkin's lymphoma patients whose disease has relapsed or become resistant to other treatment.
Nevertheless, members of the panel were impressed by Bexxar's data. "It's at least as good, if not better, than what's out there," said James Krook, a cancer specialist from Duluth, Minnesota.
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|To: scaram(o)uche who started this subject||12/17/2002 8:22:34 PM|
|BEXXAR(R) Receives Strong Support From FDA Advisory Panel|
Tuesday December 17, 8:13 pm ET
ODAC Panel Agrees That BEXXAR Studies Show Clinical Benefit in Chemotherapy-and Rituximab-Refractory Low-grade, Transformed Low-grade NHL
SEATTLE and PHILADELPHIA, Dec. 17 /PRNewswire-FirstCall/ -- Corixa Corporation (Nasdaq: CRXA - News) and GlaxoSmithKline (NYSE: GSK - News) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) agreed that studies of the investigational radioimmunotherapy BEXXAR® (tositumomab and iodine I 131 tositumomab) provided substantial evidence of clinical benefit in both rituximab-refractory patients and in chemotherapy-refractory, low-grade and follicular non-Hodgkin's lymphoma (NHL), with or without transformation. The panel voted 10-3 in support of the efficacy of BEXXAR therapy in rituximab-refractory patients and unanimously supported its clinical utility in chemotherapy-relapsed and refractory, low-grade NHL, with or without transformation. BEXXAR therapy is being co-developed in the United States by Corixa and GlaxoSmithKline.
The FDA is not bound by the Committee's action, but often takes its recommendations into consideration when determining marketing approval of a new product. The new Prescription Drug User Fee Act (PDUFA) goal date for the FDA to complete its review of all materials regarding BEXXAR therapy is May 2, 2003.
"We are very pleased to have the endorsement of ODAC on the clinical benefit demonstrated by BEXXAR therapy in our clinical trials," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa Corporation. "These positive panel votes validate many years of hard work by dedicated researchers and move us closer to being able to provide an important treatment option for physicians and their patients with low-grade non-Hodgkin's lymphoma."
"The compelling testimony provided by several patients who have battled NHL highlights the need for new treatment alternatives," said Kevin Lokay, vice president of Oncology at GlaxoSmithKline. "We look forward to continuing to work with Corixa and the FDA to complete the regulatory process and make BEXXAR therapy available to appropriate patients as soon as possible."
"Clinical trial results with BEXXAR therapy demonstrate that patients with relapsed or refractory low-grade NHL, even those who have been heavily pretreated, can achieve durable complete responses," explained Richard I. Fisher, M.D., director, James P. Wilmot Cancer Center, University of Rochester. "A therapy that can produce complete remissions that last more than a year, and in some cases as long as 8 years, after a single treatment would be a significant addition to our arsenal against the most aggressive forms of NHL."
The committee reached its conclusions following presentations from Corixa and the FDA regarding the safety and efficacy of BEXXAR therapy from a number of clinical trials, including studies that examined the effects of BEXXAR therapy on duration of clinical response in multiple relapsed, chemotherapy-refractory patients. Data were also presented from a randomized clinical trial comparing the efficacy of BEXXAR vs. the non-radiolabeled antibody present in the product. In addition, data were presented from a study of BEXXAR safety and efficacy in rituximab-failure patients. BEXXAR therapy resulted in a high level of durable responses across multiple clinical studies.
According to research presented to the Committee in the public meeting, 30 percent of the 250 patients evaluated in 5 clinical trials had a durable response to BEXXAR therapy with a time to progression of a year or more. These patients had a median time to disease progression of approximately 5 years, with some patients showing no signs of disease progression at up to 8 years.
The panel voted unanimously that the overall response rates and durations of responses observed across the 5 clinical trials conducted with BEXXAR therapy, in light of the toxicity profile observed, were likely to predict clinical benefit in patients with chemotherapy-refractory, low-grade and follicular NHL, with or without transformation. The majority of panel members (10 to 3) agreed that the results from a trial in Rituxan-refractory patients, plus data from other clinical trials, constituted substantial evidence of clinical benefit. The panel also made recommendations to the FDA about the designs of post-approval clinical trials already agreed to by Corixa.
About BEXXAR and Non-Hodgkin's Lymphoma
BEXXAR combines the targeting ability of a monoclonal antibody and the therapeutic potential of radiation, with patient-specific dosing. The radiolabeled monoclonal antibody attaches to the target molecule CD20 found on NHL cells, thereby mediating an immune response and delivering a dose of Iodine-131 radiation to tumor cells. BEXXAR therapy is the only investigational NHL therapy that is precisely dosed based on individual drug clearance rates, resulting from such factors as tumor size. Patient-specific dosing allows for the delivery of a predictable amount of radiation to each patient.
Non-Hodgkin's lymphoma is a form of cancer that affects the blood, bone marrow and lymphatic tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute (NCI), approximately 300,000 people are afflicted with NHL in the United States alone. Of that total, the NCI estimates that approximately 140,000 people have low-grade NHL or transformed low-grade NHL, an aggressive, difficult to treat, and particularly deadly form of the disease. Typically, the response rates and duration of response for NHL patients decline with each subsequent course of chemotherapy. The American Cancer Society estimates that 24,400 people will die of non-Hodgkin's lymphoma in the United States this year.
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|To: scaram(o)uche who wrote (3345)||12/20/2002 1:32:19 PM|
|BVF update. Lightened considerably on SNAP; not a surprise considering SNAP is being munched. And bought a 20%+ stake in this Canadian pink sheeter:|
>>VANCOUVER, Oct. 29 /PRNewswire-FirstCall/ - Micrologix Biotech Inc. (TSX: MBI - News) released its quarterly CEO Message, providing an update on its development programs and guidance on expected progress over the next 12 months. Specifically, this includes the following highlights (all dates are on a calendar year basis):
First Quarter 2003
- Initiation of Phase IIb clinical trial for MBI 594AN, for the
treatment of acne. This study will be conducted in approximately 10
centers in the US, enrolling 240 patients, with 2 active groups (2.5%
and 1.25%) and vehicle alone (placebo). The treatment period will be
12 weeks and the study will be powered for statistical significance at
the 80% level.
- Complete enrollment in Phase III trial of MBI 226, for the prevention
of CVC-related bloodstream infections. It is expected that
approximately 1400 patients will be enrolled in the study.
Third Quarter 2003
- Obtain results of the Phase III study of MBI 226.
Fourth Quarter 2003
- Complete the Phase IIb study of MBI 594AN.
- Complete validation of HCV Replication Assay and seek licensing
opportunities from pharmaceutical and biotechnology companies engaged
in HCV drug development.
- Identify a lead candidate in the lipopeptide program.
First Half 2004
- Initiate advanced non-clinical studies of lipopeptide product
candidate (clinical trials expected to begin in second half of 2004).
- Submit an NDA for MBI 226 with US FDA.
"We have made tremendous progress in transforming Micrologix into a sustainable, successful company for the long term," stated Jim DeMesa, M.D., President & CEO. "We are very proud that we have continuously done what we said we would do over the past year and expect to continue that practice going forward."
In addition to the highlights mentioned above, Dr. DeMesa provided guidance on some of the Company's objectives for the next 12-18 months. These include:
- Obtain a development and commercialization partner for MBI 594AN.
- Establish and advance development plan for MBI 1121, for the treatment
of HPV-induced genital warts.
- Establish early-stage corporate research and development
collaborations to further leverage the Company's resources and
- Continue to pursue opportunities to further develop and expand the
Company's product pipeline.
- Continue to manage and augment the Company's cash resources
aggressively to ensure appropriate capital for ongoing development
Additionally, the Company has initiated activity toward its goal of establishing a presence in the US capital markets. This has begun with the retention of a top-tier US investor relations firm, The Investor Relations Group, Inc. (IRG), based in New York.
IRG, founded by Dian Griesel, Ph.D., represents select publicly traded companies with a unique specialization for assisting those in the small-cap sector. IRG arranges one-on-one meetings for its portfolio companies with pre- qualified money managers handling investment portfolios that range from $10 million to $10 billion+, selected from its proprietary contact base of over 33,000 qualified fund managers who have an investing history in small-cap stocks.
In a recent press release, IRG announced the addition of Jeff Kraws as Co- President and Partner of IRG. Mr. Kraws has been frequently ranked as one of the Top 20 Pharmaceutical Analysts on Wall Street by Institutional Investor and other ranking services that evaluate analyst performance. He was recently awarded his third five-star rating in the last four years from Zacks Investment Research, the highest ranking available from Zacks. Additionally, Mr. Kraws was ranked by Zacks as one of the top five biotechnology analysts on the Street and among the top ten pharmaceutical analysts for stock selection performance. During very difficult market conditions, he has achieved a five- star rating for the second year in a row due to back-to-back excellence in stock performance of his pharmaceutical stock picks. Mr. Kraws was also recently ranked first among all pharmaceutical analysts in the industry for stock performance in 2001 as tabulated by analyst ranking from Starmine.com.
Mr. Kraws commented, "Micrologix appears to be a compelling market opportunity. We look forward to increasing the capital market's awareness of this Company as they advance their development programs and progress toward commercialization."
Micrologix Biotech Inc. is engaged in the research, development, and commercialization of drugs that advance therapy, improve health, and enrich lives. The Company's focus is toward anti-infective drug development with three product candidates in human clinical studies and earlier-stage candidates in various stages of research, development, and evaluation.
James DeMesa, MD
President & CEO
Investor & Media Relations Contacts:
Jonathan Burke Gino De Jesus/ Dian Griesel, Ph.D
Micrologix Biotech Inc. The Investor Relations Group
Telephone: 604-221-9666 Extension 241 Telephone: 212-825-3210
Toll Free: 1-800-665-1968 Email: firstname.lastname@example.org
Email: email@example.com <<
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|To: tuck who wrote (3346)||12/21/2002 12:10:55 AM|
|My predictions for the most important trends in 03:|
- good science is back en vogue again. There will be more early stage deals between big pharm and small biotechs
- the cost pressure in health care and the newest " landmark trial" results of biuretics versus ACE inhibitors or calcium channel blockers will have wide implications for the drug industry. Showing efficacy against placebo will not be good enough in the future, a new drug will have to prove itself against existing drugs and have to be cost efficient too. HMO and fublic institutions will run more of there own clinical trials in the future. Objective numbers will be clever marketing in the future.
- the FDA is back in business again and the regulatory climate is more favorable for biotechs and innovative drug companies.
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|To: tuck who wrote (3346)||12/21/2002 7:58:51 PM|
|Medline comes up negative for both DeMesa and Micrologix. For some reason, they sound familiar, more than just the usual "name sounds familiar".|
They've been around for awhile.....
Clement, the new V.P. R&D........
seems to have been productive at Abbott.
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|To: mopgcw who wrote (3347)||12/21/2002 8:15:35 PM|
|>> Wonder how he is licking his wounds on nrgn/insm? <<|
They've turned into pretty adept traders. Maybe they've made it up.
Anybody or any fund that survived last year? Bravo!
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