Corporate Activity — Mergers and Acquisitions

In this section we bring you a summary of corporate transactions in the pharmaceutical and diagnostic industries. For your convenience, the transactions are listed in alphabetical order within each category. If you are seeking information about a specific company, the quickest method of locating it is to search this issue’s company index (p60). Highlights reported in this issue include:

MGI Pharma has gone on a buying spree to build its cancer portfolio (p22). In addition to purchasing Zycos and Aesgen for $US50 million and $US32 million cash, respectively, MGI has also agreed to purchase exclusive worldwide rights to Dacogen™ (decitabine). The drug has been developed by SuperGen for the treatment of myelodysplastic syndromes. Phase III testing was completed in March and SuperGen plans to complete an NDA filing with the US FDA in Q4 of 2004. In October a Marketing Authorization Application (MAA) seeking approval of Dacogen was submitted to the European Agency for the Evaluation of Medicinal Products (EMEA) by SuperGen’s European subsidiary EuroGen Pharmaceuticals.

The completion of Sanofi-Synthelabo’s acquisition of Aventis has created Europe’s largest pharmaceutical company (p26). A key issue facing Sanofi-Aventis remains the Plavix® (clopidogrel) patent case (a pre-trial hearing is scheduled for 8 December). On a positive note, Acomplia™ (rimonabant) for the treatment of obesity is one of the near-term bright spots in the combined company’s pipeline. Recent interim data from the RIO-Europe study looks promising and has market analysts anticipating the full 2-year results. However, the analysts believe that data from RIO-Europe and RIO-North America will not be available until towards the end of Q1 2005, prior to filing in Q2.

In a similar vein, the world’s biggest biotech Amgen has acquired Tularik and gained access to technology for treating cancer and inflammation via gene regulation (p24). The gene-regulation technology focuses on selectively blocking the cascade of chemical reactions in the body that can cause diseases, including inflammation, which has been increasingly linked to major illnesses such as heart disease and arthritis. Prior to the $US1.3 billion purchase, Amgen had a 21% stake in the biotech company.

Impending Mergers and Acquisitions

Agilent Technologies of Palo Alto, CA, has signed an agreement to acquire the privately held company Silicon Genetics, a leading provider of software solutions for life-science discovery based in Redwood City, CA. With the addition of Silicon Genetics’ genomics data analysis and management tools to its portfolio, Agilent can become a market leader in life-science informatics. Silicon Genetics’ key products include: GeneSpring, a genomic expression visualization and analysis platform; Varia, a line of genetic analysis software; GeNet, a scalable repository for expression data. “We see informatics as a key to advancing integrated biological research, and our goal is to provide customers with functionality in new research areas to enhance their productivity, creativity and research success,” said Fran DiNuzzo, vice president and general manager of Agilent’s Integrated Biology Solutions business. Agilent’s Life Sciences and Chemical Analysis business is a world-leading provider of instruments, supplies, software and services to the life-science and chemical analysis markets. In 2003, these markets generated revenues of $US1.2 billion for Agilent. The company has a website at http://www.agilent.com/ and Silicon Genetics has a website at http://www.silicongenetics.com/.

Boehringer Ingelheim is to acquire the microtechnology specialist STEAG microParts of Dortmund, Germany. STEAG microParts’ core product is the innovative Respimat® Soft Mist™ Inhaler, which was co-developed with Boehringer Ingelheim. The company, under the name of Boehringer Ingelheim microParts, will be incorporated into the Boehringer Ingelheim Group as a legally independent company.

Canadian companies Cytovax Biotechnologies of Edmonton, AB, and Millenium Biologix of Kingston, ON, have entered into a definitive merger agreement; the transaction is expected to be completed by the end of November. Cytovax is a biotechnology company focused on developing peptide vaccines and monoclonal antibody therapeutics to either prevent the onset of the infection process in at-risk groups or treat those suffering from bacterial infections including those resistant to antibiotics. Millenium is a biomedical company focused on the development and commercialization of next-generation orthobiologic and skeletal tissue regeneration products which promote the repair and natural healing of human bone and other tissues. The companies have websites at http://www.cytovax.com/ and http://www.millenium-biologix.com/.

DNAPrint genomics of Sarasota, FL, has agreed to acquire a 51.77 % stake in German pharmaceutical company Biofrontera. DNAPrint has agreed to invest €20 million (approximately $US25 million) over 2 years in Biofrontera Series B preferred shares (68% of B shares) representing a 51.77% equity interest. This strategic investment will form the basis of future joint ventures between the two companies, expanding DNAPrint’s presence in Europe and giving Biofrontera a presence in North America. DNAPrint and Biofrontera have signed a joint venture framework agreement designed to integrate the companies’ technologies in a mutually beneficial way. The acquisition will transform DNAPrint from a population genomics company into a genomics-based pharmaceutical company devoted to the development of theranostic products. ‘Theranostics’ blend genomics-based tests with drugs as products to target segments of the patient population for enhanced efficacy and reduced side effects. Management expects the use of genome-based testing to facilitate the drug development process and accelerate selected drugs through the clinical trial process. DNAPrint has a website at http://www.dnaprint.com/.

Enhance Biotech of New York, NY, has signed a definitive merger agreement with Ardent Pharmaceuticals. Based in Research Triangle Park, NC, Ardent is a privately held biotechnology company with number of preclinical and clinical candidates in the areas of moderate to severe pain, urinary incontinence, premature ejaculation, depression and cardioprotection. Enhance Biotech has a late-stage development portfolio of products focusing on sexual dysfunction and dermatology. Under the terms of the agreement, Enhance shareholders will retain 55% of the stock in the merged entity, which will continue under the name of Enhance Biotech. Ardent shareholders will acquire 45% of the stock. The company’s operational headquarters will be located in North Carolina with corporate offices in New York and London. The merging companies have websites at http://www.ardentpharma.com/ and http://www.enhancelifesciences.com/.

Exelixis of South San Francisco, CA, has entered into a definitive agreement to acquire X-Ceptor Therapeutics, of San Diego, CA. Under the terms of the agreement, Exelixis will issue approximately 2.5 million shares of Exelixis common stock and pay approximately $US2.9 million in cash in exchange for all of the outstanding shares of capital stock of X-Ceptor on a fully diluted basis. X-Ceptor is developing small molecules that modulate nuclear hormone receptors (NHRs). NHRs represent a promising class of clinically and commercially validated gene targets that are implicated in a wide range of metabolic and cardiovascular disorders. The combination of Exelixis’ small-molecule discovery engine and oncology pipeline with X-Ceptor’s proprietary “reverse endocrinology’ platform and pipeline of NHR-targeted compounds advances Exelixis’ strategy to diversify into new therapeutic areas and is expected to accelerate the development and commercialization of a diverse, highly differentiated pipeline of products to treat diseases including metabolic syndrome, lipid disorders, hypertension and congestive heart failure. The acquisition is expected to close in Q4 of 2004 subject to customary closing conditions. The companies have websites at http://www.exelixis.com/ and http://www.x-ceptor.com/.

Hedley Technologies plans to acquire Axxess Pharma, a privately owned pharmaceutical and diagnostic company; both are Canadian companies. The acquisition is further progress in Hedley’s efforts to build a specialty pharmaceutical and diagnostic company. Axxess is currently focused in the areas of dermatology, therapeutic nutrition and pain management both in prescription and over-the-counter (OTC) medicines. It has distribution networks within Canada and internationally, principally selling to hospitals and pharmacies. Hedley will continue to market the Axxess product line under the Axxess Pharma brand. The company has a website at http://www.hedleytech.com/.

Johnson & Johnson Consumer France has entered into an agreement to acquire Biapharm, a producer and marketer of skincare products centered on the leading brand Biafine®. The acquisition expands J&J’s portfolio of pharmaceutical skin-care products. The Johnson & Johnson subsidiary is based in Issy-Les-Moulineaux, France; Biapharm is headquartered in Houdan, France.

Merck KGaA will acquire most of NM Pharma, the generics business of Pfizer in Scandinavia, for a purchase price of €53.8 million. After closing the transaction, Merck KGaA will integrate the product portfolio into its own existing Merck Generics infrastructure in Scandinavia. As a result of this deal, Merck Generics consolidates its leading position and will be the number one player in the Nordic generics market. Because of the strong NM brand recognition, the new company will operate under the name of Merck NM. Headquartered in Stockholm, Sweden, NM Pharma achieved sales of €39.1 million in 2003. The company has a website at http://www.merck.de/.

MGI Pharma of Bloomington, MN, and Aesgen of Princeton, NJ, have signed a definitive merger agreement under which MGI Pharma will acquire all outstanding equity of the privately held company for $US32 million in cash. MGI Pharma may also be obligated to make performance milestone payments of $US33 million upon regulatory approval and $US25 million if sales exceed $US50 million in the second year following product launch. In addition, MGI Pharma will pay a 5% royalty on product sales, including sales of Saforis™, a product candidate in development for treatment of oral mucositis. Data from a phase III trial of Saforis, conducted in 326 breast cancer patients receiving anthracycline-based chemotherapy regimens, was the subject of an oral presentation at ASCO 2004. Data indicated that patients receiving Saforis experienced a 22% risk reduction of clinically significant (WHO ≥ to grade 2) oral mucositis compared with placebo. A second pivotal, phase III trial to support a New Drug Application (NDA) filing with the US FDA will be initiated in early 2005. It is estimated that more than 15% of patients receiving chemotherapy experience significant oral mucositis, and more than 90% of patients receiving combination chemotherapy and radiation therapy for head and neck cancer experience significant oral mucositis. There are no FDA-approved drugs for the prevention or treatment of oral mucositis. MGI Pharma and Aesgen expect the transaction to close during 2004. The companies have websites at http://www.mgipharma.com/ and http://www.aesgen.net/.

MGI Pharma of Bloomington, MN, and privately held Zycos of Lexington, MA, have signed a definitive merger agreement under which MGI Pharma will acquire Zycos for $US50 million in cash. This transaction, which has been approved by the boards of directors of both companies, is subject to approval by the stockholders of Zycos. MGI Pharma and Zycos were expecting the transaction to close in September 2004. With this transaction, MGI Pharma takes a significant step toward building a leading oncology franchise. Zycos’ iterative drug formulation process allows for the rapid development of immune response therapeutics and has generated two compounds that are currently in clinical development. The most advanced clinical candidate is ZYC 101a, which has completed phase II studies in patients with cervical dysplasia, a potentially precancerous condition. The second Zycos compound in clinical development is ZYC300, an encapsulated plasmid encoding a novel tumor antigen that has completed a phase I/IIa study in 17 patients with late-stage metastatic hematological and solid tumors. The companies have websites at http://www.mgipharma.com/ and http://www.zycos.com/.

Nanogen of San Diego, CA, and Epoch Biosciences of Bothell, WA, have signed a definitive agreement to merge Epoch into Nanogen in an all-stock transaction. Epoch has a variety of products that are complementary to Nanogen’s and the merger will expand Nanogen’s reach in the rapidly growing clinical lab and research markets. The companies serve many of the same customers and both market in vitro diagnostic products that provide physicians information to predict, diagnose and treat disease. Epoch has developed advanced technologies that it incorporates in its MGB Eclipse™ Probe System, which consists of reagents and software for improving all types of molecular analyses, including gene expression, SNP (single nucleotide polymorphism) and mutation detection, and identification of infectious organisms. Nanogen has begun incorporating Epoch’s technology into its own assays. In July, Epoch launched 21 MGB Eclipse Detection Reagents, real-time analyte specific reagents (ASRs) for the molecular diagnosis of infectious and genetic diseases, and cancer. The real-time ASRs are complementary to the NanoChip® Molecular Biology Workstation, which accomplishes more complex analysis of multiple markers. Under terms of the merger, Nanogen has agreed to an offer price of $US2 per Epoch share, representing a 30% premium over the average closing price of Epoch’s shares for the 20 trading days ending on 1 September 2004. The merger is expected to close by the end of 2004. The companies havewebsites at http://www.nanogen.com/ and http://www.epochbio.com/.

Pfizer is to purchase the remaining 90% ownership of Meridica of Cambridge, UK, a drug-delivery technology company for $US125 million and a contingent payment. Meridica specializes in the development of solutions for inhaled, nasal and parenteral routes of administration. In addition to its unique micro-dosing system for dispensing drug powders, it has developed a novel multi-unit dose dry-powder inhaler for the delivery of drugs to the lung for the treatment of respiratory conditions. In October 2003, Pfizer purchased a 10% interest in the company and licensed the rights to Meridica’s dry-powder inhaler. The transaction is subject to normal conditions and is expected to close in Q4 of 2004.

Serologicals of Atlanta, GA, and Upstate Group, a privately held company headquartered in Charlottesville, VA, have entered into a definitive merger agreement, pursuant to which Serologicals will acquire Upstate for total consideration of $US205 million in Serologicals Common Stock and cash. Serologicals will issue up to 5 million shares of its Common Stock to the stockholders of Upstate, with the balance of the consideration to be funded in cash. As a result of this transaction, Serologicals will acquire a leading provider of cell signaling research reagents to academic and pharmaceutical investigators, and an outsource supplier to the drug-discovery activities of the pharmaceutical and biotech industries. The deal also allows Serologicals to become a significant presence in the preclinical drug screening and target validation market, the fastest growing segment of the life sciences tools industry, with a unique focus on kinase screening and protein interaction driven by proprietary intellectual property. Serologicals expects the acquisition to be completed during Q4 of 2004. The company has a website at http://www.serologicals.com/.

Solexa of Cambridge, UK, and Lynx Therapeutics of Hayward, CA, have signed a definitive agreement to merge. The companies anticipate that the transaction will be completed in late 2004. The combination is expected to build a leading company in the area of future DNA sequencing technologies. Next-generation DNA sequencing is expected to be based on molecular arrays and the two companies have each been advancing toward this target for more than five years. By combining technologies, intellectual property and highly experienced staffs, the companies expect to accelerate development with the goal of releasing their first commercial instrument system in 2005. This system is expected to substantially advance the pursuit of whole genome resequencing and of gene expression measurement by sequencing. These capabilities will be marketed in the near term to various research institutions, a group that already spends more than $US1 billion annually on DNA sequencing and gene expression. In the longer term the technologies also have the potential to transform the world of genetic diagnostics, by making whole genome sequencing a universal medical baseline. Earlier in 2004, the two companies jointly acquired intellectual property rights for DNA amplification on single molecule arrays. These amplified arrays are referred to as cluster technology. The combined company will be unique in its ability to market both cluster systems and single molecule systems. The companies have websites at http://www.solexa.com/ and http://www.lynxgen.com/.

St. Jude Medical and Endocardial Solutions, both headquartered in St. Paul, MN, have signed a definitive agreement whereby St. Jude will acquire Endocardial Solutions for $US11.75 per share in cash consideration which represents an aggregate purchase price of approximately $US273 million. Endocardial Solutions has a strategic focus of increasing clinical adoption of its EnSite® System for the diagnosis and treatment of atrial fibrillation (AF) and other arrhythmias and will become part of St. Jude’s AF Division. The agreement to acquire Endocardial Solutions follows St. Jude’s earlier acquisition of Epicor Medical and its definitive agreement to acquire Irvine Biomedical. Completion of the acquisition of Endocardial Solutions will further broaden St. Jude’s electrophysiology technology and programs consistent with the company’s ‘surround AF’ strategy, offering physicians sophisticated devices and catheter systems to diagnose, suppress and cure atrial fibrillation. The acquisition is expected to close toward the end of 2004. St. Jude has a website at http://www.sjm.com/.

Teva Pharmaceutical Industries of Israel has reached an agreement to acquire Pfizer’s Italian generic pharmaceutical marketing company Dorom. The all-cash transaction, which values Dorom at €69 million (around $US85 million at current exchange rates), is expected to close in December 2004, subject to conditions. Dorom is one of the two largest suppliers of generic pharmaceuticals to the Italian retail market. Dorom’s sales for the 12 months ending 30 June 2004 were approximately €30 million ($US37 million). Teva has a website at http://www.tevapharm.com/.

Other Impending Transactions

Neurome plans to purchase ‘substantially all’ the assets of Digital Gene Technologies, including the TOGA® technology, gene expression assays, existing datasets and know-how related to vaccine development programs. In conjunction with the asset purchase, Neurome will also acquire the entire patent estate. The acquisition will allow Neurome to successfully expand beyond its current core technologies in quantitative molecular neuropathology to include TOGA’s highly sensitive gene expression based surveys designed to characterize the role of important target molecules implicated in areas of important unmet medical need. TOGA — which stands for TOtal Gene expression Analysis — enables researchers to measure gene expression levels of both known and novel genes, and shortens the time required to identify and evaluate gene expression levels in various disease models. Both companies are based in La Jolla, CA; Neurome has a website at http://www.neurome.com/.

Peptech is in the very early stages of discussions with Genera Biosystems; both are Australian companies. Peptech’s preliminary interest in Genera is consistent with Peptech’s stated strategic objective of growth through strategic mergers and acquisitions that add shareholder value, as well as internally developed projects. While the Genera technology is in an area of general interest to Peptech, it has not yet been subjected to detailed scrutiny by Peptech’s management. Peptech is focused on the research and development of peptides and proteins in the areas of human pharmaceuticals and animal health. The company is positioning itself to become a globally recognized leader in biopharmaceutical development. The companies have websites at http://www.peptech.com/ and http://www.generabiosystems.com/.

Schering’s German subsidiary Jenapharm has agreed to sell its largely generic therapeutics business to Dermapharm, based in Bavaria, Germany, for an undisclosed price. The sale is part of Schering’s restructuring program, which includes a sharpening of its portfolio, job cuts, and the closure of production sites as Germany’s third largest pharma group aims to achieve an EBIT margin of 18% by 2006. The sale should be completed by Q4 of 2004. Jenapharm’s therapeutics business generated net sales of €38 million in 2003. Financial details of the transaction were not disclosed. Schering has a website at http://www.schering.de/.

Completed Mergers and Acquisitions

The world’s largest biotechnology company Amgen has acquired Tularik of South San Francisco, CA, in astock-for-stock transaction worth $US1.3 billion. The deal combines Amgen’s leadership in cellular and molecular biology and medicinal chemistry with Tularik’s innovation in gene regulation. It also accelerates Amgen’s planned expansion into the San Francisco Bay area, a major biotechnology hub. Amgen gains Tularik’s five novel clinical programs in the areas of cancer (hepatocellular, gastric and esophageal), inflammatory diseases, type 2 diabetes and obesity. In the cancer area, Tularik is currently conducting a pivotal study of T67 for the treatment of hepatocellular carcinoma and phase II trials with T607 for the treatment of gastric and esophageal cancer. Tularik will operate as a wholly owned Amgen subsidiary. Amgen has a website at http://www.amgen.com/.

Canadian company Angiotech Pharmaceuticals has completed its acquisition of NeuColl for an all-cash transaction of $US12.9 million. NeuColl is a privately held orthobiologics company based in Los Gatos, CA. NeuColl will form one of the cornerstones for Angiotech’s emerging orthopedic biomaterials franchise. Its initial product platform is a synthetic bone graft substitute comprised of collagen, a composite material of hydroxyapatite, and tricalcium phosphate. Angiotech has a website at http://www.angiotech.com/.

BioDelivery Sciences International (BDSI) of Newark, NJ, has acquired Arius Pharmaceuticals of Research Triangle Park, NC. Arius has now been reorganized with and into a newly formed, wholly owned subsidiary of BDSI. Arius is a specialty drug-delivery company whose portfolio of potential products will be focused on ‘acute’ treatment opportunities for surgical and oncology patients. BDSI is a biotechnology company that is developing patented and licensed delivery technologies for pharmaceuticals, vaccines, over-the-counter drugs, nutraceuticals and micronutrients. The company’s technologies include the patented Bioral™ nanocochleate technology and the patented BEMA™ (buccal) drug-delivery technology being developed by its Arius subsidiary. In 2004, Arius acquired an exclusive worldwide license to the BEMA delivery technology developed by Atrix Laboratories. Arius is developing BEMA fentanyl for treating cancer pain that is expected to enter phase III trials by mid-2005. BDSI has a website at http://www.biodeliverysciences.com/.

Bio-Rad Laboratories of Hercules, CA, has completed the purchase of MJ GeneWorks and its subsidiaries, including MJ Research, for approximately $US32 million in cash and the assumption of certain liabilities of those companies. MJ Research, based in Waltham, MA, is a life-science company that specializes in instruments and consumables used in modern biological research, including thermal cycling instrumentation and reagents used to amplify DNA. MJ Research pioneered the use of Peltier-effect technology and has introduced a number of other innovations in the thermal-cycling field. Bio-Rad has a website at http://www.bio-rad.com/.

Cephalon of West Chester, PA, has completed its acquisition of all of the outstanding shares of CIMA LABS. As a result of the acquisition, CIMA is now a wholly owned subsidiary of Cephalon. The company has a website at http://www.cephalon.com/.

Graffinity Pharmaceuticals of Heidelberg, Germany, and MyoContract of Liestal, Switzerland, have merged to form Santhera Pharmaceuticals. Santhera will focus on the discovery, development and commercialization of small-molecule drugs in the areas of neuromuscular and metabolic diseases. Santhera’s drug pipeline comprises an advanced clinical program in a neuromuscular disease, which will enter pivotal trials by early 2005, and three advanced preclinical programs in diabetes, cachexia/anorexia, and Duchenne muscular dystrophy. Financial details of the all-share transaction were not disclosed. The new company will be headquartered in Liestal with research and development operations in both Liestal and Heidelberg. In conjunction with the merger, Santhera has raised an additional €7 million (approximately $US8.4 million), which will provide the new company with total funding of more than €20 million to last until late 2006. The new company has a website at http://www.santhera.com/.

The German-American biotech company MediGene has acquired the anticancer drug candidates and other technology assets from insolvent Munich Biotech. The acquisition of these assets strengthens MediGene’s portfolio by adding a promising drug candidate and the EndoTAG™ platform technology to develop cutting-edge anticancer drugs. The drug candidate MBT-0206 has already gone through several clinical phase I trials in different cancer indications, on a total of more than 120 patients. Annual peak sales potential of the antiangiogenesis drug is estimated at more than €500 million. MediGene is a publicly quoted, German-American biotechnology company located in Martinsried, Germany and San Diego, CA, and is the first German biotech company with a marketed drug (Eligard® for the treatment of advanced prostate cancer). The company has a website at http://www.medigene.de/.

Canadian company Micrologix Biotech has completed the acquisition of MitoKor of San Diego, CA. The company created by the deal has a portfolio of clinical and preclinical development programs including five clinical-stage product candidates in hepatitis C, Alzheimer disease, catheter-related infections, acne, and human papillomavirus. Preclinical product opportunities include hepatitis B and C, arthritis, serious hospital acquired infections, Friedreich’s ataxia, retinitis pigmentosa, glaucoma, stroke/ischemia reperfusion injury, and obesity. Micrologix’ priorities for the next several months are to initiate the MBI-3253 phase IIa monotherapy trial for chronic hepatitis C infections, obtain a Special Protocol Assessment from the US FDA for the pivotal MBI-226 phase III catheter-related infection trial, advance MITO-4509 for Alzheimer disease into phase II, and partner MBI-594AN for the treatment of acne. Micrologix has a website at http://www.mbiotech.com/.

Neuro Discovery of Vancouver, BC, Canada, has closed the acquisition of Allon Therapeutics of San Diego, CA, for $US10.5 millon in equity, as well as converting $US8 million in special warrants held in escrow bringing the total deal to $US18.5 millon. The new company will trade as Allon Therapeutics. Allon is developing technology that has demonstrated potent neuroprotective capabilities in preclinical studies in a wide range of chronic and acute neurodegenerative diseases and conditions including Alzheimer disease, multiple sclerosis, stroke, and traumatic brain injury. Allon expects to file an investigational new drug (IND) application with the US FDA for its lead compound AL-108 in Q4 of this year and commence clinical trials early in 2005. The company has a website at http://www.allontherapeutics.com/.

OrthoLogic of Tempe, AZ, has completed the acquisition of Chrysalis BioTechnology of Galveston, TX. Under the terms of the definitive agreement, OrthoLogic paid $US2.5 million in cash and issued 3 462 124 shares of OrthoLogic common stock, valued at $US25 million, for substantially all of Chrysalis BioTechnology’s assets and intellectual property. An additional $US7 million in OrthoLogic common stock will be paid to Chrysalis shareholders upon the occurrence of certain future events, including the acceptance for filing by the US FDA of a New Drug Application (NDA) for a Chrysalin-based product. OrthoLogic is a drug-development company focused on commercializing several potential therapeutics comprising the Chrysalin® synthetic peptide, also known as TP508. OrthoLogic owns an exclusive license for all worldwide medical indications for the peptide, and is actively pursuing five orthopedic indications for Chrysalin. These include fracture repair and spine fusion, which are in human clinical trials, and cartilage defect repair, which is in late-stage preclinical trials. In non-orthopedic areas, a human clinical trial for chronic diabetic ulcers has been completed. The company has a website at http://www.orthologic.com/.

PediaMed has acquired Protein Therapeutics, a company focused on the discovery and development of new therapies for immunological diseases. The acquisition includes an investigational immunoglobulin drug that is entering phase II clinical trials for gastrointestinal dysfunction in autistic children. Headquartered in Florence, KY, PediaMed is a member of the Union Springs Portfolio of companies, which also includes Xanodyne Pharmaceuticals. PediaMed has a website at http://www.pediamedpharma.com/.

Sandoz (the generics business unit of Novartis) has completed the acquisition of Sabex Holdings, a leading Canadian generics pharmaceutical manufacturer in a $US565 million cash transaction that officially closed on 13 August 2004. Sabex was acquired from the US private equity firm RoundTable Healthcare Partners, which had held a majority stake in the company. The acquisition of Sabex establishes a new presence for Sandoz in Canada and provides an attractive global growth platform in the fast-growing injectable generics business. Sabex, which is based in Boucherville, Quebec, is a privately held generics manufacturer that offers a broad range of critical care and ophthalmic medicines as well as suppositories and other products covering more than 80 molecules.

Sanofi-Synthélabo has completed its acquistion of Aventis and has begun operating as Sanofi-Aventis. The new company is the world’s third largest pharmaceutical company, ranking number one in Europe. The completion of Sanofi-Synthélabo’s offer for Aventis occurred on 20 August 2004, with Sanofi-Synthélabo now controlling Aventis with 95.47% of the share capital. Sanofi-Synthélabo has a website at http://www.sanofi-synthelabo.com/.

Strakan and ProSkelia have completed their merger, with the newly merged company called ProStrakan. The new company has a broad portfolio of clinical and preclinical R&D projects, including a pure antagonist of the estrogen receptor, osteoclast adhesion receptor antagonists, an oral testosterone and oestradiol glucoside, a new generation SERM for osteoporosis, a topical antiandrogen for alopecia and acne, and a novel antiemetic patch. The company is headquartered in Scotland with the principal R&D operation being based at the former ProSkelia’s site at Romainville, near Paris. ProStrakan also announced the completion of the acquisition of the Spanish company Devon Farmaceutica.

Treasure Mountain Holdings of Salt Lake City, UT, has completed its merger with privately held Vyteris of Fair Lawn, NJ. Under the terms of the merger agreement, Vyteris became a wholly owned subsidiary of Treasure Mountain. Vyteris has developed and produced a prefilled, active transdermal drug-delivery system that delivers drugs through the skin comfortably, without needles. In May 2004, Vyteris received approval from the US FDA to launch its first product, the LidoSite™ Topical System. LidoSite is a topical delivery system indicated for use on normal intact skin to provide local anesthesia for needle stick procedures such as injections and intravenous therapies as well as superficial dermatological procedures. Vyteris has a website at http://www.vyteris.com/.

Other Completed Transactions

Accelrys has completed its merger with SciTegic, a leading provider of workflow software solutions for the research science market. The transaction is valued at about $US21.5 million. SciTegic is now a wholly owned subsidiary of Accelrys. Both companies are based on San Diego, CA. Accelrys has a website at http://www.accelrys.com/.

Aerovance has been spun out of Bayer to create an independent company focused on developing and commercializing biologic products for respiratory diseases. Aerovance has raised $US32 million through a Series B financing led by Apax Partners. In exchange for a minority equity stake in Aerovance, Bayer Pharmaceuticals has spun out the rights to two lead products to Aerovance: an IL4/13 receptor antagonist (AER-001) for severe asthma entering phase II studies and Bikunin (AER-002), a recombinant therapeutic protein for cystic fibrosis and chronic obstructive pulmonary disease (COPD) on track for the filing of an investigational new drug (IND) application. Bayer also spun out additional research-stage and preclinical programs in respiratory disease to Aerovance. The new company will be based in Berkeley, CA, and has a website at http://www.aerovance.com/.

Canadian company Altachem Pharma has sold the business assets and its interest in leasehold improvements associated with the manufacture of the medical diagnostic breath kit to Isodiagnostika for the sum of $Can500 000. Altachem received a $Can300 000 cash payment and the remaining $Can200 000 will be paid based on breath kit production until 30 November 2007, when the balance outstanding if any, will be paid. Based in Edmonton, Alberta, Altachem is developing a multi-tiered, integrated approach for the treatment of HIV/AIDS and cancer using novel therapeutic products and adjunct therapies. The lead products of Altachem are Bionex and its four proprietary drugs: ACP-HIP, HB Injectable (ACPSL-017), HB Topical and ACP 2127. ACP-HIP is currently in phase I clinical trials. Also based in Edmonton, Isodiagnostika develops and commercializes diagnostic test kits utilizing stable isotopes. Isodiagnostika developed the Helikit™, a ¹³C urea breath test for the detection of Helicobacter pylori and the Diatest™, a stable isotope breath test for the detection of insulin resistance. The companies have websites at http://www.altachempharma.com/ and http://www.isodiagnostika.com/.

Bayer and Schering-Plough have formed an alliance under which Schering-Plough will take over US marketing of Bayer’s primary-care medicines. The partnership was expected to become effective on 1 October. The deal could give Bayer a bigger presence in the world’s largest drug market, while offering Schering-Plough badly needed new products to sell and a potentially key marketing partner for some of its drugs in Europe and Japan. Under the alliance, Schering-Plough will take over US marketing of Cipro® [ciprofloxacin] and Avelox® [moxifloxacin], both broad-spectrum antibiotics for respiratory and skin infections, plus the antihypertensive Adalat® [nifedipine] and some small established primary-care drugs. The company will also handle US promotion of Bayer’s impotence treatment Levitra® [vardenafil]. Outside the US, Bayer will begin promoting some Schering-Plough cancer drugs in Europe; these could include Temodar® [temozolomide] for brain cancer and Caelyx® [liposomal doxorubicin] for brain and ovarian cancer and Kaposi’s sarcoma. The companies have websites at http://www.bayer.com/ and http://www.sch-plough.com/.

Boston Biomedica of West Bridgewater, MA, has completed the sale of substantially all of the assets and selected liabilities of its BBI Diagnostics and BBI Biotech divisions to SeraCare Life Sciences of Oceanside, CA. The purchase price was $US30 million in cash, plus the assumption of certain liabilities. At a special meeting, stockholders approved an amendment to the company’s restated articles of organization to change the company’s name to Pressure BioSciences (PBI). PBI is a publicly traded, early-stage company focused on the development of a novel technology called Pressure Cycling Technology (PCT). PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels (35 000 psi and greater) to control biomolecular interactions. PBI currently holds 13 US and foreign patents covering multiple applications of PCT in the life-sciences field, including in such areas as genomic and proteomic sample preparation, pathogen inactivation, control of enzymes, immunodiagnostics, and protein purification. The companies have websites at http://www.bbii.com/ and http://www.seracare.com/.

Computer Sciences Corporation (CSC) has acquired Porton International’s interest in DynPort Vaccine Company (DVC), a biopharmaceutical company focused on the development of biodefense biologics products. Formerly a joint venture between CSC and Porton, DVC has been the prime systems contractor for the US Department of Defense Joint Vaccine Acquisition Program since 1997. Products in development at DVC include vaccines for botulinum neurotoxin, tularemia, Venezuelan equine encephalitis, anthrax and plague, and a therapeutic blood product, vaccinia immune globulin, to treat complications of smallpox vaccination. CSC has a website at http://www.csc.com/.

Galapagos Genomics of Mechelen, Belgium, has created a new business unit for its viral-based discovery and validation service. This unit will operate under the name Galádeno from the Galapagos facility in Leiden, The Netherlands. The drug-discovery business will be conducted from the Mechelen facility and continueto trade under the name Galapagos. Galádeno will offer both individual adenoviral-based siRNA and full-length gene reagents for drug-target discovery and validation. Furthermore, the company will provide access to its human drugable genome collections FLeXSelect™ (cDNA) and SilenceSelect™ (siRNA), for customers wishing to perform functional screens. In addition, Galádeno will continue to offer its unique human primary cell-based functional screening platform to partners who wish to apply genome-wide siRNA and cDNA screening to novel target discovery and drug mechanism of action studies. The company andits new service unit have websites at http://www.galapagosgenomics.com/ and http://www.galadeno.com/.

Netherlands-based QIAGEN has completed the acquisition of the key assets of Molecular Staging (MSI) of New Haven, CT. Under the terms of the acquisition agreement, QIAGEN has acquired the major assets of MSI (which include over 160 applied or issued patents) for $US28.5 million in cash plus potential earn-outs of up to $US6.75 million. MSI, a privately held company, has developed a range of proprietary products and services based on its Multiple Displacement Amplification (MDA) technology. The key application of MDA is whole genome amplification (WGA). WGA is distinct from PCR since it allows nonspecific amplification of the complete genome to create more DNA for analyses, whereas PCR amplifies only specific, mostly very short stretches of DNA matching a predefined target sequence and is designed to detect specific sequences. The two technologies, WGA and PCR, are therefore often synergistic as samples can be pretreated with WGA to create sufficient sample amount for many subsequent analyses using PCR and other downstream applications. QIAGEN intends to launch a series of kits integrating MSI’s WGA technology to address specific customer needs in early 2005. QIAGEN also acquired MSI’s technology portfolio related to rolling circle amplification (RCA), which includes the exclusive rights to use this technology for protein applications. QIAGEN expects that products arising from this technology can target applications for both nucleic acids and proteins. The company has a website at http://www.qiagen.com/.

Quintiles Transnational of Research Triangle Park, NC, has completed the previously announced sale of assets relating to its specialty dermatology products company Bioglan Pharmaceuticals. Bradley Pharmaceuticals of Fairfield, NJ, through its wholly owned subsidiary BDY Acquisition, paid $US188.3 million in cash, including approximately $US5.4 million of direct costs for transferred inventory. Quintiles intends to use proceeds from the transaction to potentially pay down debt, to fund business growth initiatives and for other appropriate purposes. President and CEO of Bradley Pharmaceuticals, Daniel Glassman, said that “the addition of its [Bioglan’s] products and sales force will add significantly to Bradley’s existing dermatology presence”. The companies have websites at http://www.quintiles.com/ and http://www.bradpharm.com/.

Shire Pharmaceuticals of Basingstoke, England, and ID Biomedical of Vancouver, BC, Canada, have closed the sale of Shire’s vaccines business to ID Biomedical. The consideration was $US120 million, of which $US60 million is to be received in cash in two equal installments — one at closing and the other on the first anniversary of closing of the transaction. The remaining $US60 million was paid through the issuance of 4 931 864 subscription receipts to acquire common shares of ID Biomedical. If ID Biomedical completes one or more cash offerings within 22 months after closing, Shire may elect to exchange all or part of its subscription receipts for up to $US60 million cash. As part of the transaction, Shire provides ID Biomedical with a loan facility of up to $US100 million, which can be drawn down over the next 4 years. This facility can be used by ID Biomedical to fund development of injectable flu and pipeline products within the vaccines business acquired from Shire. The companies have websites at http://www.shire.com/ and http://www.idbiomedical.com/.

Name Changes

BioMedicines of Emeryville, CA, has changed its name to Intarcia Therapeutics. The privately held pharmaceutical company is developing therapies for the treatment of cancer, immunological, and infectious diseases. The company specializes in redirecting the development of drugs to new indications that meet significant unmet medical needs. Intarcia has agreements with ALZA, Boehringer Ingelheim, Chiron, Pfizer and Schering. The company has a website at http://www.intarcia.com/.

Chiral Quest of Princeton, NJ, has changed its name to VioQuest Pharmaceuticals and has created a new wholly owned subsidiary VioQuest Drug Development, which will concentrate on acquiring, developing and commercializing human therapeutics. The company also plans to assign substantially all of its operating and technology assets relating to its proprietary chemical catalysis platform to a second wholly owned subsidiary which will be re-named Chiral Quest. This second subsidiary will focus on providing chiral products, technology and services to the pharmaceutical and fine chemical industries. It will develop chemical catalysts and other products used in the synthesis of desired isomers of chiral molecules. VioQuest has a website at http://www.chiralquest.com/.

EPIX Medical of Cambridge, MA, has changed its corporate name to EPIX Pharmaceuticals to better reflect its focus on developing pharmaceutical products. EPIX develops pharmaceuticals for imaging that are designed to transform the diagnosis, treatment and monitoring of disease. The company uses its proprietary Target Visualization Technology™ to create imaging pharmaceuticals targeted at the molecular level, enabling physicians to use MRI to obtain detailed information about specific disease processes. The company’s lead product, MS-325, is the first imaging pharmaceutical specifically designed for Magnetic Resonance Angiography. A New Drug Application (NDA) for MS-325 was accepted for filing by the US FDA in February 2004. Germany-based Schering is the worldwide sales, marketing and development partner for MS-325, and has submitted MS-325 for marketing approval in the EU. The companies are also collaborating on the development of a second product, EP-2104R, for imaging blood clots using MRI. EPIX has a website at http://www.epixpharma.com/.

Large Scale Biology Corporation of Vacaville, CA, has renamed its wholly owned subsidiary Eclipse Diagnostics, which will now be called Predictive Diagnostics. The name change was undertaken to more accurately reflect the company’s ongoing focus in the new field of predictive diagnostic medicine. Predictive Diagnostics has developed its proprietary BAMF™ Technology for in silico biomarker discovery for use in early diagnosis of life-threatening diseases such as ovarian cancer. The subsidiary has a website at http://www.predictivediagnostics.com/.

Medeus Pharma of Oxford, UK, has changed its name to Zeneus Pharma. The company has also relocated its headquarters to The Oxford Science Park. The company has a website at http://www.zeneuspharma.co.uk/.

Micrologix Biotech has changed its name to Migenix. Migenix is headquartered in Vancouver, BC, Canada, with US operations in San Diego, CA, and is focused on advancing its pipeline of product candidates in the areas of infectious and degenerative diseases. The company has a website at http://migenix.com/.

Paradigm Genetics is now called Icoria. It is a biotechnology company applying its proprietary systems biology platform to the discovery and development of safer, more effective drugs and agrochemicals. Icoria is located in Research Triangle Park, NC, and has a website at http://www.icoria.com/.

Pharmadigm is now called Inflabloc Pharmaceuticals. It is a privately held, development-stage biotechnology company based in Salt Lake City, UT. Inflabloc’s therapeutic targets stem from the anti-inflammatory properties of dehydroepiandrosterone (DHEA) The company has a website at http://www.pharmadigm.com/.

SCOLR has changed its name to SCOLR Pharma. It is a specialty pharmaceutical company engaged in the development and licensing of its Controlled Delivery Technology® (CDT). The CDT platform consists of three patented oral drug-delivery technologies for prescription, over-the-counter and nutritional compounds. The company has a website at http://www.scolr.com/.

Drug Discovery Technologies

Diagnostic Technologies