Antisoma plc, of London, amended its licensing deal with Abbott Laboratories Inc., of Abbott Park, Ill., for Antisoma’s lead product, pemtumomab, under development for the treatment of ovarian and gastric cancer. Antisoma will receive enhanced royalties on all future sales, pending approval. Royalties had been fixed on an escalating basis. The new agreement also includes a milestone payment in addition to the previously announced payments linked to approvals and sales targets, and allows Antisoma, under certain conditions, to regain marketing rights to the product. In return, Antisoma will assume Abbott’s share of development costs spread over the next three years. (See BioWorld Today, Nov. 1, 1999.)
AtheroGenics Inc., of Atlanta, filed an investigational new drug application with the FDA for AGI-1096, an oral drug for the prevention of organ transplant rejection. The filing is the first step in initiating a Phase I trial to assess the safety and tolerability of AGI-1096 in healthy volunteers. The compound was developed with the company’s v-protectant technology.
CancerVax Corp., of Carlsbad, Calif., said it submitted an investigational new drug application to the FDA in December to initiate a pivotal Phase II/III trial of the Canvaxin therapeutic cancer vaccine as a treatment for metastatic colon cancer. The multicenter, international, randomized, open-label study will have a primary endpoint of overall survival. The trial will assess the safety and efficacy of Canvaxin vs. standard of care in patients with Stage IV colon cancer following surgical resection of the primary tumor and resection or ablation of any known metastases. CancerVax expects to enroll approximately 670 patients at 50 clinical sites in the U.S. and abroad.
Cell Therapeutics Inc., of Seattle, presented a new technology it said has the potential to make granulocyte-colony stimulating factor (G-CSF) less expensive to produce and easier to administer. The technology uses recombinant DNA technology to produce polyglutamates (PGs) linked to G-CSF. Company scientists said linking PG to a biologic therapeutic such as G-CSF might increase its plasma half-life, allowing less-frequent or lower dosing. CTI plans to scale up synthesis of selected PG-fusion proteins to evaluate pharmacokinetics and efficacy in preclinical models. The finding was presented at the 5th International Symposium on Polymer Therapeutics in Cardiff, Wales.
Discovery Therapeutics Inc., of Boston, changed its name to Aderis Pharmaceuticals and also said its lead product, Rotigotine CDS, a transdermal dopamine agonist for Parkinson’s disease, entered Phase III trials in the second half of 2001. It said the name change reflects its transition from an early stage development organization to an advanced clinical-stage biopharmaceutical company. Rotigotine CDS is partnered with Schwarz Pharma AG, of Monheim, Germany. Founded in 1994, Aderis has five products in clinical trials. The company is privately held and raised $45 million in its fourth round of financing last year. (See BioWorld Today, Oct. 10, 2001.)
Exelixis Inc., of South San Francisco, and Cytokinetics Inc., of San Francisco, entered into a collaboration to design and generate diverse, small-molecule compound libraries that each company will use to further advance its own drug discovery programs. This alliance marks the third chemistry-based partnership Exelixis established in 2001. Exelixis will use its combinatorial chemistry platform to synthesize compounds designed jointly by the two companies. The compounds will be jointly owned. Exelixis will receive undisclosed cash payments for compounds it delivers.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., filed an amended S-1 registration statement with the SEC to proceed with an initial public offering of a minority interest in Ribapharm Inc., ICN’s research and development subsidiary. According to an SEC filing, Ribapharm raised the number of shares to be sold from 18 million to 20 million. It expects the shares to be sold from $13 to $15 per share, which would raise between $234 million and $300 million. The IPO was originally filed in June 2000 after ICN decided to split into three separate publicly traded companies. (See BioWorld Today, June 16, 2000, and May 16, 2001.)
ILEX Oncology Inc., of San Antonio, said that research published in the Jan. 4 issue of Science provides evidence of a novel mechanism by which endogenous angiogenic inhibitors may cut off the supply of blood to solid cancerous tumors. Researchers, conducting studies of the endogenous angiogenic inhibitor Tumstatin, under development by ILEX, as well as peptide fragments thereof, identified a key receptor on the endothelial cell that may be functionally important to the action of Tumstatin against tumors. The study found that Tumstatin binds to this receptor only on dividing endothelial cells and does not allow them to form new capillaries required for the growth of tumors. In other news, ILEX completed the previously announced acquisition of the equity interests held by Millennium Pharmaceuticals Inc., of Cambridge, Mass., in the companies’ 50-50 Campath joint venture, Millennium & ILEX Partners LP. Sales of Campath were launched on May 30 in the U.S. and Aug. 6 in the European Union, where it is marketed under the trade name MabCampath. Campath was developed by Millennium & ILEX Partners in collaboration with Schering AG, of Berlin, which has worldwide sales and marketing rights (excluding Japan and East Asia). In the U.S., Campath is marketed by Berlex Laboratories Inc., of Richmond, Calif., Schering’s U.S. affiliate.
Innovative Drug Delivery Systems Inc., of New York, filed for an initial public offering, estimating its maximum take to be $69 million. It has proposed the Nasdaq ticker symbol IDDS. It said in its prospectus it plans to use proceeds for research and development activities, including clinical studies, milestone and other payments payable under its strategic agreements, working capital and other general corporate purposes. The company focuses on developing new drugs and improved formulations of existing drugs for the prescription pain management market. Underwriters are Thomas Weisel Partners LLC, of San Francisco, and Wells Fargo Securities Inc., also of San Francisco.
ISTA Pharmaceuticals Inc., of Irvine, Calif., said the initial section of the new drug application for Vitrase, a drug being developed for patients with severe vitreous hemorrhage, was submitted to the FDA. This initial submission was made after the FDA’s fast-track designation for Vitrase. ISTA plans to unmask its two Phase III trials of the drug and announce preliminary efficacy results on Jan. 30.
MedImmune Inc., of Gaithersburg, Md., said the waiting period regarding its $1.5 billion acquisition of Aviron Inc., of Mountain View, Calif., under the Hart-Scott-Rodino Antitrust Improvements Act has expired. MedImmune and Aviron last month entered a definitive merger agreement under which MedImmune will acquire Aviron through an exchange offer and merger transaction in which Aviron shareholders will receive 1.075 MedImmune shares for each Aviron share. The exchange offer is scheduled to expire at midnight Wednesday. (See BioWorld Today, Dec. 4, 2001.)
MPM Capital, of South San Francisco, closed to new investors the MPM BioEquities Fund. The fund now stands at $450 million in assets and invests mainly in publicly traded biotechnology stocks.
Tripos Inc., of St. Louis, entered a three-year, multimillion-dollar collaborative agreement with Pfizer Inc., of New York, to develop and deploy Lithium, a new software platform designed to enhance the speed and efficiency of drug discovery. Tripos and Pfizer will jointly design, develop and test a wide range of methodologies for analyzing and interpreting drug discovery data.
Neoprobe Corp., of Dublin, Ohio, completed the closing of its acquisition of Biosonix Ltd., of Hod Hasharon, Israel. Neoprobe issued about 9.7 million shares of common stock in exchange for all of the outstanding shares of Biosonix. An additional 2.1 million Neoprobe shares will be issued to Biosonix on the satisfaction of a milestone event involving Biosonix product development activity. Biosonix focuses on blood flow measurement. The deal was valued at about $4 million, based on Friday’s closing price.
Procyon Biopharma Inc., of Montreal, signed a licensing agreement with Biovail Corp., of Toronto, for the marketing rights in the United States to Fibrostat, a topical therapeutic for scar management. Procyon receives a $4 million equity investment, a potential $5 million licensing fee upon approval and commercialization of the product in the U.S., and double-digit royalties on sales. Also, Procyon may receive undisclosed payments based on development milestones. Procyon said the commercial launch of Fibrostat in North America is expected in 2004 or 2005.
Scios Inc., of Sunnyvale, Calif., began enrolling patients in a pilot study designed to evaluate the safety and tolerability of Natrecor (nesiritide) when administered in an outpatient setting to patients at high risk for hospitalization with chronic advanced congestive heart failure. FUSION (Management of Patients with CHF After Hospitalization with Follow-up Serial Infusions of Natrecor) is a multicenter, randomized, open-label trial that will be conducted at about 40 U.S. sites and enroll more than 200 patients. Patients will be randomized to receive either their usual long-term cardiac medications (with or without IV inotropes) or serial infusions of Natrecor in addition to their usual long-term cardiac medications (excluding IV inotropes) over a 12-week period.