Company* (Symbol) Product Description Indication Action/Date Avanir Pharmaceuticals Inc. (AMEX:AVN) Neurodex Oral combination of dextromethorphan and the enzyme inhibitor quinidine Pseudobulbar affect The company submitted the final modules of its rolling NDA filing (6/30) Barrier Therapeutics Inc. (BTRX) Sebazole Topical formulation of 2% ketoconazole, an antifungal agent Seborrheic dermatitis The FDA accepted for filing the NDA submission; the NDA was submitted in September (12/9
State of the Industry Report | Monday, May 8, 2006
Company* (Symbol) Product Description Indication Action/Date Adolor Corp. (ADLR) and GlaxoSmithKline plc (UK) Entereg Alvimopan capsules; mu opioid antagonist Post-operative ileus The FDA issued an approvable letter saying additional proof of efficacy was needed to support the NDA filed in June 2004 (7/22) Alkermes Inc. (ALKS) and Cephalon Inc. (CEPH) Vivitrol (formerly Vivitrex) Long-acting, injectable form of naltrexone Alcohol dependence The FDA issued an approvable letter
State of the Industry Report | Monday, May 8, 2006
Company* (Symbol) Product Description Indication Action/Date Amgen Inc. (AMGN) and Wyeth Enbrel (FDA-approved) Etanercept; anti-tumor necrosis factor-alpha antibody Psoriatic arthritis The FDA approved an expanded indication, to improve physical function in PA patients; it was approved for treating PA in 2002 (6/1) American Pharmaceutical Partners Inc. (APPX) Abraxane Paclitaxel protein-bound particles for injection; albumin-bound Metastatic breast cancer The FDA approved the drug
State of the Industry Report | Monday, May 8, 2006
Biotech Co.* (Country; Symbol) Agbiotech Partner (Country; Symbol) Type/Product Area Terms/Details (Date) AgraQuest Inc.* U.S. Department of Agriculture AgraQuest was awarded a Phase II Small Business Innovation Research grant for development of a biological fumigant The two-year, $296,000 grant wil be used for a product based on the fungus Muscodor albus that is expected to have multiple applications in post-harvest and soil-borne diseases (1/4) ArrayXpress Inc.* North Carolina
State of the Industry Report | Monday, May 8, 2006
Company* (Symbol) University/ Nonprofit Type Of Agreement Product Area Details (Date) FIRST QUARTER Adherex Technologies Inc. (AMEX:ADH) National Cancer Institute Level III collaboration For clinical development of the company's lead compound, ADH-1 (Exherin) Following additional preclinical work, they will negotiate a Cooperative Research and Development Agreement under which the NCI would sponsor trials (3/11) Affymetrix Inc. (AFFX) Harvard Medical School Agreement Harvard gets
State of the Industry Report | Monday, May 8, 2006
Company* (Country; Symbol) Company (Country) Type/Product Area Terms/Details (Date) FIRST QUARTER Geneva Bioinformatics SA* (Switzerland) Current Science Group (UK) They formed a joint venture company named Current BioData Ltd. The new company will focus on the further development and marketing of GeneBio's ProXenter discovery platform (3/3) NuGEN Technologies Inc.* MediBIC Inc.* (Japan) MediBIC will support the adoption of NuGEN's Ovation family of RNA amplification systems in Asia
State of the Industry Report | Monday, May 8, 2006
I. MODIFIED AGREEMENTS Company* (Country; Symbol) Company* (Country; Symbol) Change from original agreement Terms/Details (Date) FIRST QUARTER Cellegy Pharmaceuticals Inc. (CLGY) ProStrakan Group plc (UK; LSE:PSK) They renegotiated deal under which ProStrakan distributes Rectogesic in Europe ProStrakan will assume support responsibility, and purchase product directly from the manufacturer; Cellegy gets $2M and up to $0.75M in milestone payments (11/10) Curis Inc. (CRIS) Genentech Inc
State of the Industry Report | Monday, May 8, 2006
Company* (Country; Symbol) Company* (Country; Symbol) Product Terms/Details (Date) FIRST QUARTER Agencourt Bioscience Corp.* Amplicon Express Inc.* Alliance to co-market a suite of BAC library construction and sequencing services Each will provide technology to the effort focused on bacteria artificial chromosomes, which are vectors designed to clone DNA fragments (3/21) Ambion Diagnostics (unit of Ambion Inc.*) AcroMetrix Corp.* AcroMetrix will manufacture Armored RNA-based products
State of the Industry Report | Monday, May 8, 2006
Company* (Country; Symbol) Company* (Country; Symbol) Type/Product Area Terms/Details (Date) FIRST QUARTER Abgenix Inc. (ABGX) Genentech Inc. (NYSE:DNA) Genentech exercised its option to extend for three years a licensing agreement for antibody-generation technology Genentech purchased Abgenix stock and would pay milestone and royalty fees as products advance; the deal covering XenoMouse technology originally was signed in 1999 (3/14) Acadia Pharmaceuticals Inc. (ACAD) Sepracor Inc
State of the Industry Report | Monday, May 8, 2006
Biotech Co.* (Country; Symbol) Pharma Co. (Country) Product Terms/Details (Date) FIRST QUARTER Adolor Corp. (ADLR) GlaxoSmithKline plc (UK) Adolor will co-promote GSK's anti-thrombotic agent Arixtra in the U.S. Adolor is hiring a 30-person sales force and will receive undisclosed cost reimbursement for its promotional efforts (1/3) Alnylam Pharmaceuticals Inc. (ALNY) Dowpharma (unit of The Dow Chemical Co.) Deal for the manufacture and supply of Alnylam candidate RNAi
State of the Industry Report | Monday, May 8, 2006
I. MODIFIED AGREEMENTS Biotech Co.* (Country; Symbol) Pharma Co. (Country) Change from original agreement Terms/Details (Date) FIRST QUARTER Alliance Pharmaceutical Corp. (OTC BB:ALLP) LEO Pharma A/S (Denmark) LEO gained extra time to decide if it will license rights to Oxygent in Europe and Canada The evaluation period was extended until six days after Alliance submits to LEO results of a proof-of-concept study in surgery patients (3/2) Atugen AG* (Germany) Altana Pharma AG (Germany
State of the Industry Report | Monday, May 8, 2006
2005 Biotech-Big Pharma Collaborations#: New Agreements Biotech Co.* (Country; Symbol) Pharma Co. (Country) Type/Product Area Terms/Details (Date) FIRST QUARTER Addex Pharmaceuticals SA* (Switzerland) Ortho-McNeil Pharmaceutical Inc. (unit of Johnson & Johnson) Collaboration to discover, develop and sell compounds that modulate allosterically GPCRs for treating various CNS diseases Addex gets an up-front fee and research funding for two years; it also could earn milestone and royalty
State of the Industry Report | Monday, May 8, 2006
Company Acquired (Country; Symbol) Acquired By Or Merged With (Country; Symbol) Date Announced Date Completed Value (M)*** Terms/Details I. COMPLETED MERGERS AND ACQUISITIONS Pharmaceutical division of aaiPharma Inc. (PK:AAIIQ) Xanodyne Pharmaceuticals Inc.* 5/10/05 7/12/05 $209.3 Xanodyne paid $209.25M cash to acquire the pharmaceutical assets of aaiPharma in a deal approved by a bankruptcy court; Xanodyne also committed to purchase up to $30M in services from aaiPharma's services
State of the Industry Report | Monday, May 8, 2006
Company (Symbol) Funding Institution Amount (M) Type Details (Date) Aastrom Biosciences Inc. (ASTM) National Institutes of Health $0.79 Phase II SBIR grant To support development of the AastromReplicell System for large-scale manufacturing of cell-based products (10/18) Aastrom Biosciences Inc. (ASTM) National Institute of Diabetes and Digestive and Kidney Diseases $0.416 Phase II SBIR grant The grant will be used to support use of the company's tissue repair cells in bone
State of the Industry Report | Monday, May 8, 2006
Company (Symbol)# Partner (Country) Amt. (M) Triggering Event Details (Date) JANUARY Abgenix Inc. (ABGX) Amgen Inc. (AMGN) ND Milestone payment Triggered by Amgen's advancement into clinical trials of an undisclosed antibody created using Abgenix's XenoMouse technology (1/13) Abgenix Inc. (ABGX) Chiron Corp. (CHIR) ND Milestone payment Triggered by Chiron's filing of an IND for a fully human antibody, CHIR-12.12, targeting CD40 that was created using Abgenix's Xeno-Mouse
State of the Industry Report | Monday, May 8, 2006
Company Location Date Amt. (M) Details JANUARY Adenosine Therapeutics LLC Charlottesville, Va. 1/25/05 $3.5 Details on the financing were not disclosed Alexza Molecular Delivery Corp. Palo Alto, Calif. 1/6/05 $52 Alloy Ventures and Delphi Ventures co-led the Series D financing, which included Abingworth Bioventures, MDS Capital, Pacific Rim Ventures, T. Rowe Price, WestRiver Capital, Alejandro Zaffaroni, Frazier Healthcare, Versant Ventures, 5AM Ventures, Burrill & Co., CMEA
State of the Industry Report | Monday, May 8, 2006
Company (Symbol)# Type Of Financing Number Of Shares, Units Or Warrants (M) Amount Raised ($M) Investors; Placement Agents; Details (Date) JANUARY Aastrom Biosciences Inc. (ASTM) Private placement of stock 4.8S $12 The private placement concludes an October 2002 deal between Aastrom and Fusion Capital Fund II LLC, which also purchased $12M of stock in the first tranche (1/13) Alexion Pharmaceuticals Inc. (ALXN) Private placement of convertible notes N/A $150 The 1.375% convertible
State of the Industry Report | Monday, May 8, 2006
BioWorld ranked the underwriters of 2005's public offerings, both initial and follow-on, in two basic ways. First, the underwriters were ranked on the total amount of gross proceeds raised in both initial and follow-on public offerings combined. If an underwriting firm acted as the sole placement agent for an institutional offering then that firm was credited as "lead" underwriter. If more than one firm acted as placement agent then each was considered to be a co-manager, and credited as such
State of the Industry Report | Tuesday, April 25, 2006
BioWorld Financial Watch has tracked the price performance of biotechnology and biotech-related stocks on a weekly basis since July 1994. Since Aug. 8, 1994, BioWorld Financial Watch also has published data indicating the average percent change of all the stocks listed on U.S. exchanges both on a week-to-week basis and on a year-to-date basis. For the stocks included in BioWorld Financial Watch's 2005 stock indicator, see the list on page 421. The graph on page 435 plots the change in that
State of the Industry Report | Tuesday, April 25, 2006
Company* (Symbol) Product Description Indication Action/Date Avanir Pharmaceuticals Inc. (AMEX:AVN) Neurodex Oral combination of dextromethorphan and the enzyme inhibitor quinidine Pseudobulbar affect The company submitted the final modules of its rolling NDA filing (6/30) Barrier Therapeutics Inc. (BTRX) Sebazole Topical formulation of 2% ketoconazole, an antifungal agent Seborrheic dermatitis The FDA accepted for filing the NDA submission; the NDA was submitted in September (12/9