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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (3895)	5/29/2001 10:24:57 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

And here's Parexel's take on the same issue: U.S. clinical trial starts rise in 2000 5/18/2001 Clinical trial research starts for new drugs and biologics rose 7.1% in 2000, according to the newly released PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2001, an annual compendium of critical R&D and industry trend data for the pharmaceutical and biotechnology industries. As measured by commercial investigational new drug application (IND) submissions, which are applications that drug and biologic firms submit to notify the FDA that they intend to begin clinical trials for an investigational therapy, new clinical research starts rose for the second consecutive year, to 727. The 727 commercial INDs submitted in 2000 represent the second highest level in at least the past several years and perhaps ever—the 797 commercial INDs filed for drug and biological products in 1998 likely represent the all-time high, according to PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2001. Although commercial IND submissions provide a solid measure for clinical research starts in any year, there are certain limitations. For example, the FDA will place a certain percentage (8 to 10% in recent years) of the submissions on hold (i.e., delaying the initiation of the trials proposed in the IND) due to safety issues or other concerns. Clinical studies will be conducted under many of these INDs after the applicants address the concerns with the FDA, however. Biotech clinical trial research starts: ready to explode? The 7.1% increase in U.S. clinical research starts was fueled by a 27% surge in commercial INDs submitted in fiscal year 2000 for biological and biotech products, according to PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2001. Atlhough the 303 commercial INDs filed for biologic/biotech products in FY2000 might be an all-time high, it is only slightly more than the 299 filed in FY1998. Still, there are strong indications that biologic/biotech clinical starts are rising significantly. The 145 commercial biotech/biologic INDs submitted to the agency from October 2000 through January 2001 project out to 435 applications for FY2001, a 44% increase over FY2000 submissions and what would almost certainly be a record, according to the PAREXEL compendium. Meanwhile, commercial IND submissions for drugs declined slightly to 424 in 2000, a 4% decline from the 440 submitted in 1999. In each of the past two years, industry has been unable to match the 498 commercial IND submissions in 1998, what is the current record. Among the most active therapeutic areas for clinical trials, neuropharmacological INDs saw the largest jump, rising 22% in 2000, according to PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2001 . After dropping a stunning 33% in 1999, commercial IND submissions for oncology treatments declined by another 9.5% last year. In other therapeutic areas, clinical research starts for antiviral products dropped 49% and those for reproductive and urologic drugs declined 21% in 2000. Clinical research starts for dental and dermatological treatments rose 35% last year. New trials for metabolic and endocrine therapies rose by 13%, while those for cardio-renal drugs were up by 4%. Number of active drug clinical research programs continues to rise As measured by active commercial investigational new drug applications (IND), which are INDs under which pharmaceutical companies are thought to be actively researching new drugs, industry’s drug clinical trial activities rose just slightly in 2000. At year-end 2000, there were 3,661 active commercial INDs at the FDA, up 1.4% from the 3,611 at year-end 1999. The number of active commercial INDs for drug products (i.e., not including biotech/biological products) has been on a slow, but steady, rise over the past several years. Although active INDs have risen throughout the 1990s, the 3,661 commercial INDs active at year-end 2000 represent just a 12.9% increase over the 3,243 active as of year-end 1993. Despite declining IND submissions for cancer trials over the past two years, oncology applications continue to comprise the plurality of active commercial INDs. Oncology-related applications represented 12.6% of the active commercial INDs as of year-end 2000. The other more active therapeutic categories as of year-end 2000 included the following: neuropharmacology (12.3%); anti-inflammatory/analgesic/ophthalmic (10.6%); metabolism and endocrine (9.2%); reproductive and urologic (8.2%); and cardiovascular (7.2%). PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2001 is available for $325 from PAREXEL/Barnett by calling 800-856-2556 (x2587) or 610-565-2556, by fax at 610-565-9400, or online at www.barnettinternational.com. Source: PAREXEL