Boston Life Sciences Inc., of Boston, completed a private placement of $3.4 million in common stock with a small group of individual and institutional investors. The company’s CEO and president said the additional money would be used to support its clinical trial programs in 2002.
Allos Therapeutics Inc., of Westminster, Colo., and N-Gene Research Laboratories Inc., of Budapest, Hungary, said N-Gene granted Allos a license to its intellectual property surrounding BGP-15, a small molecule that is designed to reduce cellular stress induced by chemotherapy. Allos intends to develop the compound as the first orally available chemotherapy protectant capable of reducing or eliminating the need for supportive care therapy. Allos will acquire development and exclusive marketing rights for BGP-15 in the United States. Also, Allos will make an initial equity investment in N-Gene, subsequent equity investments and licensee payments based on certain development milestones and will pay a royalty based on sales in the U.S.
Amersham plc, of London, reached an agreement in principle to purchase the shareholding in Amersham Biosciences held by Pharmacia Corp., of Peapack, N.J. By buying the 45 percent stake in Amersham Biosciences, Amersham plc will completely own the business. Amersham will pay £704 (US$1 billion) in cash for the stake. To help pay for the transaction, Amersham said it is proposing an equity placement of 50 million new ordinary shares, plus 7.5 million shares to cover overallotments. The price for the shares will be established through a book-building exercise.
BioHeart Inc., of Fort Lauderdale, Fla., and Cambrex Corp., of East Rutherford, N.J., completed a supply agreement in which Cambrex will contract manufacture BioHeart’s autologous MyoCell therapy. BioHeart has approval to initiate U.S. clinical trials. Cambrex will support BioHeart’s worldwide trials from its BioWhittaker facilities in Maryland and Belgium. MyoCell is designed to regenerate damaged cell tissue through the transplantation of skeletal muscle cells.
BioSeek Inc., of Burlingame, Calif., appointed Peter Staple CEO. Staple served as executive vice president, chief administrative officer and general counsel at ALZA Corp., a wholly owned subsidiary of Johnson & Johnson, of New Brunswick, N.J. BioSeek focuses on applying technologies to the identification, validation and commercialization of therapeutic targets and human pharmaceuticals.
Cambridge Antibody Technology Group plc, of Melbourn, UK, extended the deadline for the acceptance of its offer to acquire all the outstanding shares of Drug Royalty Corp. Inc., of Toronto. The deadline has been extended until 9 p.m. on March 27. The company made the C$126 million (US$79.6 million) offer in January and the deadline initially was set for March 12. (See BioWorld Today, March 12, 2002.)
Commonwealth Biotechnologies Inc., of Richmond, Va., signed a contract research agreement with Insmed Inc., of Richmond, to conduct out-sourced research and development and GLP-rated studies in support of Insmed’s portfolio. The work can be expanded as new data and results are collected, and as Insmed moves forward with new drug candidates, but initially, Insmed will contract with Commonwealth to provide analytic and stability data on product development candidates selected by Insmed. Commonwealth will realize about $600,000 in gross revenues over a 24-month period. Upon execution of the agreement, Commonwealth received $139,000.
Copernicus Therapeutics Inc., of Cleveland, will receive up to $937,000 from the Cystic Fibrosis Foundation to advance the development of therapeutic treatments for cystic fibrosis. Copernicus’ nonviral approach to deliver the cystic fibrosis transmembrane regulator gene to the affected airway cells of CF patients may eventually provide a long-term treatment for this disease, the company said. The first subjects in a clinical trial are expected to receive Copernicus’ therapy in the next few weeks.
Debio Recherche Pharmaceutique, of Martigny, Switzerland, formed an agreement with Shearwater Corp., of Huntsville, Ala., to develop and commercialize a hydrogel technology to deliver macromolecular drugs and proteins as polyethylene-glycol conjugates. The deal provides for patents derived from research funded by Debio to be assigned to Debio in exchange for royalties to Shearwater on sales of products containing PEG hydrogels. Also, Shearwater received a license to make and use PEG hydrogels outside the drug delivery field in exchange for royalties to Debio.
Dov Pharmaceutical Inc., of Hackensack, N.J., set the price per share range for its initial public offering at $14 to $16 and its number of shares at 5 million. At that range, the offering would raise between $70 million and $80 million. Dov is focused on drug candidates for central nervous system, cardiovascular and urological disorders. The company filed for its IPO on Jan. 28. (See BioWorld Today, Jan. 30, 2002.)
Essential Therapeutics Inc., of Waltham, Mass., completed the acquisition of Maret Pharmaceuticals Inc., of Newport Beach, Calif., in a stock-for-stock exchange that closed Monday. Earlier this month, Essential said it would strengthen its clinical and preclinical pipeline through the acquisition of Maret in a deal valued at up to $6.8 million. (See BioWorld Today, March 4, 2002.)
GeneFormatics Inc., of San Diego, said it completed a cDNA library from germinal vesicle-staged human oocytes. The library offers the opportunity to identify and study required protein factors needed for human development, the company said. GeneFormatics analyzes entire genomes at the functional level to discover protein targets and potential leads.
Genmab A/S, of Copenhagen, Denmark, and Bionomics Ltd., of Adelaide, Australia, will collaborate to create and develop fully human antibodies to angiogenesis targets identified by Bionomics. The companies will share equally in the research and development costs and the commercial rights and returns from antibody products they co-develop. The research will focus initially on two angiogenesis targets identified and patented by Bionomics. Additional targets may be added.
Gilead Sciences Inc., of Foster City, Calif., initiated an early access program to provide adefovir dipivoxil 10 mg to people with chronic hepatitis B resistant to the currently available antiviral treatment lamivudine. The program will open initially in the U.S., then in Canada, Australia and countries in Europe as local approvals are obtained. Gilead anticipates submitting applications for approval of adefovir dipivoxil 10 mg in the U.S. and Europe in the first half of 2002. Early access programs are part of an effort by the FDA, European regulatory agencies and the pharmaceutical industry to make investigational drugs available during the later stages of clinical development for the treatment of serious or life-threatening diseases.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., requested a private letter ruling with the Internal Revenue Service relating to the spin-off of Ribapharm following its initial public offering. The request asks for an IRS ruling that ICN’s distribution of its entire remaining interest in Ribapharm to ICN’s stockholders following an IPO offering of a minority interest in Ribapharm will qualify as a tax-free spin-off under U.S. tax laws. The Ribapharm spinning out derives from a June 2000 decision to split ICN into three publicly traded companies. (See BioWorld Today, June 16, 2000.)
IGEN International Inc., of Gaithersburg, Md., completed a $36.8 million private placement, selling 1 million shares to Acqua Wellington Private Placement Fund Ltd. and Acqua Wellington Opportunity I Ltd. IGEN said it plans to use the proceeds to advance its product programs, to fund research and development, to provide working capital and for general corporate purposes. IGEN develops and markets biological detection systems based on its Origen technology.
Illumina Inc., of San Diego, received a $1.2 million Phase II research grant from the National Cancer Institute, of Bethesda, Md., to develop an immunoassay system based on Illumina’s BeadArray technology. The grant, funded through the institute’s innovative molecular analysis technologies program, is expected to help Illumina extend its bead-based array platform to the measurement and characterization of proteins and their post-translational modifications. Illumina is developing tools for large-scale analysis of genetic variation and function.
Infinity Pharmaceuticals Inc., of Boston, selected DecisionSite 7.0 by Somerville, Mass.-based Spotfire Inc. as its standard interactive analytic application environment. Infinity is using Spotfire DecisionSite in conjunction with other information technology to improve decision making in the development of new pharmaceuticals.
InSite Vision Inc., of Alameda, Calif., said scientific data on glaucoma genetics and its ISV-205 were presented at the fourth annual International Symposium on Ocular Pharmacology and Pharmaceutics conference held in Seville, Spain, Feb. 28 through March 3. ISV-205 is a development-stage drug candidate designed to treat a cause of glaucoma. In the presentation, the company said ISV-205 in a Phase II study prevented maximum elevation of the intraocular pressure compared with placebo in first-degree relatives of primary open-angle glaucoma patients. The company also said that in a Phase II study, ISV-205 significantly lowered intraocular pressure compared to the control vehicle, in ocular hypertensive patients who tested positive for a TIGR mutation.
Karo Bio USA Inc., of Durham, N.C., received a three-year award from the Department of the Army for drug discovery in prostate cancer. The project applies Karo’s technological approaches to better define the relationship of androgen receptor function to prostate cancer. Financial details were not disclosed.
MPB Cologne GmbH, of Cologne, Germany, contracted BioSecure Crops Inc., of Toronto, to enter a feasibility study on growing potato mini-tubers containing pharmaceutical proteins in contained-environment grow chambers. A series of chambers will be constructed by BioSecure using its GroWmax technology to establish production of mini-tubers supplied by MPB Cologne. Financial details were not disclosed.
NexMed Inc., of Robbinsville, N.J., said the Department of Health approved Befar in Hong Kong. Befar is the Chinese trademark of Alprox-TD, NexMed’s cream treatment for erectile dysfunction. The product launch of Befar in Hong Kong is scheduled to take place during the second quarter of 2002. In the U.S., NexMed is conducting a Phase III development program for Alprox-TD.
Paladin Labs Inc., of Montreal, entered an agreement to issue special warrants through a syndicate of agents co-led by CIBC World Markets and Yorkton Securities Inc., and including Desjardins Securities Inc., BMO Nesbitt Burns Inc., National Bank Financial Inc. and Sprott Securities Inc. Paladin will issue about 2.1 million special warrants at a price of C$9.50 (US$6) for proceeds of C$20 million. The agents have an overallotment option of 315,800 special warrants for proceeds of $3 million. Paladin focuses on acquiring or in-licensing pharmaceutical products for the Canadian market.
PerkinElmer Inc., of Boston, and NextGen Sciences Ltd., of Cambridgeshire, UK, formed an agreement resulting in the introduction of the ProteinArray Workstation, an automated system for processing protein microarrays. The system was developed by NextGen in collaboration with PerkinElmer Life Sciences using NextGen’s derived intellectual property and know-how. PerkinElmer Life Sciences will manufacture and have exclusive worldwide distribution rights to the system.
SangStat Medical Corp., of Fremont, Calif., said an independent Data Safety Monitoring Board decided to close the company’s comparative kidney transplant study early after an interim analysis revealed significantly fewer acute rejections in patients treated with Thymoglobulin (anti-thymocyte globulin, [rabbit]) vs. Simulect (Novartis AG’s basiliximab). The prospectively randomized Phase II study examined the use of Thymoglobulin or Simulect as induction therapy in high-risk kidney transplants. Induction therapy is administered at the time of transplant to prevent future acute rejection of the transplanted organ. In the interim analysis, the incidence of acute kidney rejection was 2.5 times greater among patients treated with Simulect than in patients who received Thymoglobulin, a statistically significant result.
Serono SA, of Geneva, reintroduced Crinone 8% (progesterone gel) to the U.S. market. The evaluation of product data from new batches of the product, which is designed for use in the treatment of infertile women, indicate that the viscosity changes that led to a voluntary recall of Crinone in April 2001 have been resolved, the company said. Columbia Laboratories Inc., of Livingston, N.J., manufactures the product.
Sun Microsystems Inc., of Santa Clara, Calif., and Paracel Inc., a business unit of Celera Genomics Group, of Rockville, Md., formed an agreement to market Paracel TranscriptAssembler and Paracel GenomeAssembler software on Sun platforms. The announcement was made at a conference in Boston. Separately, Sun said it is teaming with Acero Inc., of Cleveland, to provide a knowledge and data management platform for genomic-based drug discovery. Financial terms were not disclosed.
Tanox Inc., of Houston, said its board authorized spending up to $3 million to repurchase shares of its common stock. The purchases would be made on a discretionary basis in the open market or otherwise from time to time in amounts determined by management. Tanox focuses on the discovery and development of therapeutic monoclonal antibodies designed to address needs in asthma, allergy, inflammation and other disease areas.
V.I. Technologies Inc., of Watertown, Mass., reported results of studies that show complete loss of infectivity in red cells contaminated with Plasmodium falciparum treated with the Inactine system. P. falciparum is the parasite that causes the majority of malaria infections in the world. Since there is no approved lab test in the United States to screen donated blood for malaria, prevention depends on the exclusion of potentially infected donors who are identified during the donor interview.
Versicor Inc., of Fremont, Calif., started a Phase II trial with dalbavancin, for which it gained U.S. and Canadian rights from Biosearch Italia SpA, of Gerenzano, Italy. The study is for treatment of bloodstream infections that are catheter-related. Dalbavancin is being developed as the first once-weekly treatment for Staphylococcal and other serious Gram-positive hospital infections. The randomized, controlled comparative open-label Phase II study will evaluate the efficacy and safety of dalbavancin in 180 hospitalized patients with catheter-related bloodstream infections. Patients will be randomized to receive either one of two dalbavancin dosing regimens or vancomycin. They will be examined for overall clinical and microbiological responses at the conclusion of therapy and three weeks following therapy, as well as the time to resolution of bloodstream infections.