Amgen Inc., of Thousand Oaks, Calif., said it intends to raise about $2.5 billion through an offering of 30-year zero-coupon senior notes convertible into shares of Amgen common stock. Amgen may raise up to an additional $300 million upon exercise of an overallotment option granted in connection with the offering. Amgen expects to use the net proceeds from the offering to fund the purchase of approximately $650 million of its common stock that it is repurchasing simultaneously with the issuance of the notes and for general corporate purposes, including acquisitions, additional share repurchases, capital expenditures and working capital.
Applied Molecular Evolution Inc., of San Diego, agreed to optimize an additional antibody candidate for Eli Lilly and Co., of Indianapolis. In December, the companies announced their initial collaboration on an antibody and a non-antibody protein therapeutic for Lilly. The goal of the new collaboration is to apply Applied Molecular’s AMEsystem directed molecular evolution technology to create an optimized version of the antibody for clinical development. Applied Molecular will receive program funding and would receive additional payments if milestones are achieved, as well as royalties on sales. (See BioWorld Today, Dec. 20, 2001.)
Avant Immunotherapeutics Inc., of Needham, Mass., signed a clinical research agreement with the International Vaccine Institute aimed at conducting clinical trials of Avant’s Peru-15 cholera vaccine in Bangladesh. IVI plans to begin conducting clinical trials of Peru-15 in Bangladesh this year. Results from a Phase IIb study of Peru-15 demonstrated 100 percent protection against moderate and severe diarrhea and 93 percent protection against any diarrhea, suggesting that Peru-15 may be an excellent candidate as a potential single-dose, oral vaccine for travelers going to areas where cholera is endemic.
Brown Simpson Asset Management LLC, of New York, launched a life sciences fund focused on the small-cap market, called the Xmark Funds. Xmark invests in public biotechnology and medical device companies with market caps below $200 million. Brown Simpson is targeting a $125 million close for Xmark by December.
BTG plc, of West Conshohocken, Pa., acquired a new class of drug candidates, including lead candidate PMS 601, targeted to treat advanced and chronic HIV infection. Preclinical studies showed this series of piperazine derivatives can prevent HIV uptake by cells and inhibit viral replication. Initial studies indicate PMS 601 can also cross the blood-brain barrier. Early research indicated that this new class of therapeutics may improve the effects of existing HIV/AIDS drugs, such as AZT. BTG obtained rights to this compound series from the University of Paris VII and the French Atomic Energy Commission.
Cerus Corp., of Concord, Calif., and Baxter Healthcare Corp., of Deerfield, Ill., received FDA concurrence to proceed with their second pivotal Phase III trial of the Intercept Red Blood Cell System to evaluate its use for chronic transfusion support. The multicenter, double-blind, randomized trial is expected to enroll about 50 patients who require red blood cell transfusion support for the treatment of chronic anemia due to hereditary disorders such as sickle cell disease or thalassemia. The trial will run simultaneously with the companies’ Phase III trial for acute transfusion support.
CV Therapeutics Inc., of Palo Alto, Calif., and Isis Pharmaceuticals Inc., of Carlsbad, Calif., were presented with the seventh annual Helix Award at the Biotechnology Industry Organization’s CEO & Investor Conference held in New York. Isis received the award in the emerging company category and CV Therapeutics was honored in the large-cap category. The Helix Award is awarded for corporate excellence in the international biotechnology industry.
Genaera Corp., of Plymouth Meeting, Pa., reported a publication describing the relationship of its hCLCA1 mucoregulator target to mucus overproduction in asthma. The paper, published in this month’s issue of the Journal of Allergy and Clinical Immunology, says that hCLCA1 mRNA was increased in the lung epithelial and mucus-producing cells of asthmatic patients, and was strongly and selectively co-localized with mucus production.
Cytogen Corp., of Princeton, N.J., reported study results that show that Quadramet, approved in 1997 by the FDA for the treatment of pain in patients with metastatic bone lesions, can be used at higher doses to treat osteosarcoma, the most common type of cancer that develops in bone. In the Mayo Clinic study, 24 of 30 patients undergoing treatment with Quadramet experienced good to excellent results in delaying local progression of the cancer. All had failed two or more previous therapies and had multiple sites of bone cancer. In two patients, the cancer has been in complete remission for more than two years following treatment. Results were published in the Journal of Clinical Oncology.
DeCode Genetics Inc., of Reykjavik, Iceland, and MediChem Life Sciences Inc., of Woodbridge, Ill., said the Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, with respect to DeCode acquiring MediChem. The merger is expected to close in mid-March. The transaction is subject to a vote by MediChem stockholders at a meeting scheduled for March 14, as well as the satisfaction of other closing conditions. The merger was valued at $83.6 million at the time of announcement in January. (See BioWorld Today, Jan. 9, 2002.)
Genmab A/S, of Copenhagen, Denmark, said the FDA designated its HuMax-CD4 a fast-track product. HuMax-CD4 is in Phase III studies to treat patients with active rheumatoid arthritis who have failed to respond to treatment with methotrexate and TNF-alpha blocking agents. The fast-track designation gives Genmab the opportunity to submit a biologics license application in sequential sections, and have these sections reviewed as they are submitted, saving development time.
Genset SA, of Paris, agreed to sell its Oligonucleotides Division to the Proligo Division of Degussa AG, of Dusseldorf, Germany, for about EUR25 million (US$21.8 million). Proligo will purchase the division from Genset with Genset retaining a minority interest in certain Asian subsidiaries. The sale is expected to close late this quarter or in the second quarter. Genset focuses on drug targets and candidates in the central nervous system area and metabolic disorders.
GlycoDesign Inc., of Toronto, named Michael Thomas its new president and CEO, effective April 1. He also will be appointed to the board. Thomas succeeds Jeremy Carver, who is retiring as president and CEO. Most recently, he was president and CEO of DSM Pharmaceuticals Inc., a division of DSM NV, of the Netherlands. GlycoDesign develops glycotherapeutics for the treatment of cancer and cardiovascular, inflammatory and infectious diseases.
Hollis-Eden Pharmaceuticals Inc., of San Diego, reported positive results from a preclinical study of HE2500, an immune-regulating hormone, in an animal model of psoriasis. By week four, disease severity in mice receiving high-dose HE2500 was reduced to mild or absent compared to the severity observed in mice receiving placebo alone (moderate to severe). The results are being presented this week at the third International Congress in Geneva.
Hybridon Inc., of Cambridge, Mass., said investigators at the National Cancer Institute, of Bethesda, Md., and at Hybridon published results indicating that antisense shows activity in androgen-insensitive prostate cancer models, including both cell culture and mouse xenograft models. The results are published in February 2002 Clinical Cancer Research. The study examines the biological effects of GEM 231, Hybridon’s second-generation antisense anticancer product.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said it is commencing a cash tender offer and consent solicitation relating to all of its 8.75 percent Series B senior notes due 2008. The offer and consent solicitation is part of its previously announced restructuring plan, including the pending initial public offering of a minority interest in its wholly owned subsidiary, Ribapharm Inc. The offer is conditioned upon the completion of the Ribapharm offering. Using the fixed-spread formula, the purchase price for the notes will be set no later than two full business days prior to the expiration of the offer. There is about $194.6 million principal amount of notes outstanding.
ImClone Systems Inc., of New York, is still the subject of significant share purchases by Carl Icahn. Icahn received Federal Trade Commission clearance to purchase $500 million of ImClone stock, or about 40 percent of the company. The FTC granted Icahn early termination of the waiting period required under Hart-Scott-Rodino Antitrust Improvements Act. ImClone’s recently adopted shareholder rights act is designed to stop hostile takeovers by making it prohibitively expensive for an investor to continue to purchase shares after the investor has acquired 15 percent of the company.
Introgen Therapeutics Inc., of Austin, Texas, received notification that the U.S. Patent and Trademark Office approved the name Advexin as a registered trademark for Introgen’s gene-based cancer drug, formerly called INGN 210. The mark is registered in the U.S., the European Community and several other countries. Advexin is the subject of two randomized and controlled Phase III trials for the treatment of head and neck cancer as well as other studies for solid tumors.
Lexicon Genetics Inc., of the Woodlands, Texas, identified and validated in vivo a secreted protein from the human genome as a new target for the development of drugs to treat atherosclerosis. Lexicon discovered that by knocking out the LG914 protein, arteries remained clear when challenged in an atherosclerosis disease model in mice. Lexicon intends to develop LG914-inhibiting drugs as a potential new treatment for cardiovascular disease.
LifeCell Corp., of Branchburg, N.J., was awarded an $824,000, three-year grant by the Office of Naval Research to continue funding LifeCell’s cell preservation program. LifeCell currently markets three biologic products AlloDerm, Cymetra and Repliform which are based on its tissue matrix technology that directs cellular repopulation, enabling the products to become the patient’s own tissue. The company’s cell preservation program has been funded by, and conducted in collaboration with, the U.S. Department of Defense and includes initiatives to develop biologic products that would enable practical blood storage and mass availability.
Lorus Therapeutics Inc., of Toronto, said a report published in the journal Oncogene further establishes the R2 component of ribonucleotide reductase as an important target for the design of anticancer therapeutics. That target is the site of action of Lorus’ lead antisense drug, GTI-2040. The report, from the University of Manitoba in Canada and the Karolinska Institute in Sweden, details a mechanism through which a protein called c-Myc interacts with the R2 gene of ribonucleotide reductase, increasing the number of copies of the R2 gene.
Maxygen Inc., of Redwood City, Calif., said that the company and its collaborator, H. Lundbeck A/S, of Copenhagen, Denmark, intend to move an optimized interferon beta product into human trials. Lundbeck in-licensed the rights to develop and commercialize the multiple sclerosis and central nervous system indications of Maxygen’s compound in September 2000.
Medlyte Inc., of San Diego, presented data at the MedTech Insight West Coast Investment in Innovation conference in Irvine, Calif. The data demonstrated the ability of a sphingolipid inhibitor to significantly improve heart performance post-myocardial infarction in an ex vivo rat heart model. Medlyte is entering live animal model testing to demonstrate the efficacy of its candidate in achieving reduction in infarct size and heart damage when administered during an infarct or during reperfusion.
Nanosphere Inc., of Northbrook, Ill., said researchers at Northwestern University developed a nanoparticle-based DNA detection system with 10 times more sensitivity and 100,000 times more specificity than other genomic detection systems. The technology has specific detection probes that eliminate the need for PCR/fluorophore-based approaches, Nanosphere said. Results from the research were published in the Feb. 22, 2002, issue of Science.
Organogenesis Inc., of Canton, Mass., was removed from the Standard & Poor’s SmallCap 600 Index for lack of representation. Organogenesis’ stock (AMEX:ORG) fell 53 cents Thursday, or 27.89 percent, to close at $1.37. The company’s lead product, Apligraf, a cellular bi-layered skin substitute, is approved by the FDA for the treatment of venous leg ulcers and diabetic foot ulcers.
Pozen Inc., of Chapel Hill, N.C., said the FDA agreed to accept results from Pozen’s ongoing rat carcinogenicity study during the new drug application review for MT 100. Pozen also said FDA approval of the MT 100 NDA is still dependent on the successful completion and review of two carcinogenicity studies. Preliminary results of the first carcinogenicity study were submitted to the FDA earlier this year and the final report will be submitted in the next few weeks. The in-life portion of a two-year rat carcinogenicity study will be complete in August 2003. Pozen plans to submit its NDA for MT 100 in the first half of 2003. MT 100 is being developed as an oral, first-line treatment for migraine pain and associated symptoms.
Rigel Pharmaceuticals Inc., of South San Francisco, signed two agreements for intellectual property and technology complementary to the company’s current research and development programs. Rigel in-licensed from Penn State the Siclopps, or cyclic peptide, technology that will help enable the company to develop intracellular cyclic peptide libraries. Rigel also in-licensed the patent estate to the RBX, or ROC1, protein from the Oklahoma Medical Research Foundation. This protein is an ubiquitin ligase target with potential therapeutic importance in both oncology and inflammatory disease two areas in which Rigel is developing product candidates.
SignalGene Inc., of Montreal, and ArQule Inc., of Woburn, Mass., are applying their prototype computational compound design technology to ArQule’s p38 MAP kinase drug discovery program. SignalGene and ArQule developed the compound design technology through a January 2001 agreement. The companies will apply the technology to generate and prioritize chemical compound designs for the p38 MAP kinase target. ArQule will make and test selected compounds for biological activity against p38 MAP kinase and has development rights for any resulting lead compounds. SignalGene will receive research fees and additional payments based on the achievement of defined milestones for compounds that incorporate SignalGene’s chemical-structure designs.
Titan Pharmaceuticals Inc., of South San Francisco, received a $2 million milestone payment from Schering AG, of Berlin, Titan’s worldwide development partner for Spheramine, its cell therapy for the treatment of Parkinson’s disease. The milestone was triggered following completion of Titan’s Phase I/II study, and the decision to initiate larger, randomized clinical testing. Data from the recently completed 12-month study will be presented at medical conferences later this year.