• Adherex Technologies Inc., of Research Triangle Park, N.C., filed a registration statement with the SEC to prepare to list its common stock on a U.S.-based stock exchange, most likely the American Stock Exchange. In conjunction with the registration, the oncology company restated the footnote reconciling its Canadian Generally Accepted Accounting Principles (GAAP) audited consolidated financial statements to U.S. GAAP for the year ended June 30, which were previously filed with the Ontario Securities Commission. Adherex expects to begin trading on AMEX as "ADH" later this fall, and will continue to trade on the Toronto Stock Exchange as "AHX."

• Aeras Global TB Vaccine Foundation in Bethesda, Md., entered a $925,000 cooperative agreement from the Centers for Disease Control and Prevention in Atlanta to conduct epidemiologic studies in preparation for clinical trials of new tuberculosis vaccines in India. The funding is renewable for up to three years.

• Austrianova, of Vienna, Austria, received European regulatory backing to begin a pivotal trial of its NovaCaps product for pancreatic cancer. The company said the protocol feedback it received ensures that positive data generated by the trial would be suitable for approval. The two-armed, randomized, multicenter, open-label study is designed to evaluate the survival advantage for patients with inoperable pancreatic carcinoma pre-treated with encapsulated, cytochrome P450/2B1-expressing cells that locally convert ifosfamide into tumor-toxic metabolites, as compared to gemcitabine (Gemzar, Eli Lilly and Co.), the current standard therapy. Scheduled to begin in the second half of next year, it will include about 200 patients.

• GeoVax Inc., of Atlanta, gained an exclusive license to several AIDS vaccine technologies and patent applications that have emanated from joint research conducted by Emory University in Atlanta, the National Institutes of Health in Bethesda, Md., and the Centers for Disease Control and Prevention in Atlanta. A 42-month efficacy trial conducted in non-human primates demonstrated safety and protection against clinical AIDS in 22 of 23 vaccinates, and a Phase I trial with the GeoVax AIDS vaccine based on the licensed technology was completed by the HIV Vaccine Trials Network.

• Helix BioPharma Corp., of Aurora, Ontario, raised gross proceeds of C$213,000 (US$163,620) after placing 100,000 units. The deal follows the completion of a private placement earlier this month that generated gross proceeds of about C$4.4 million for the cancer therapy company. Each unit consists of one common share and one share purchase warrant, with each share purchase warrant entitling the holder to purchase a common share at C$3 until March 1, 2007.

• Invitrogen Corp., of Carlsbad, Calif., said it would replace Interstate Bakeries Corp. in the Standard & Poor's MidCap 400 Index after today's close of trading. Invitrogen develops, manufactures and markets research products.

• Joslin Diabetes Center in Boston said its researchers published findings in the September 2004 Journal of Clinical Investigation suggesting that insulin-producing beta cells formed within the pancreas in order to compensate for insulin resistance are not derived from duct cells. Rather, the beta-cell growth in insulin-resistant states occurs by epithelial-to-mesenchymal transition, a mechanism in which cells take on a more primitive form and begin replicating.

• Lexicon Genetics Inc., of The Woodlands, Texas, received an undisclosed payment after completing the second performance milestone in its drug discovery alliance with Genentech Inc., of South San Francisco. Under the nearly 2-year-old partnership, Lexicon is discovering the functions of potential therapeutic proteins and antibody targets identified through Genentech's internal drug discovery research. The payment is related to Lexicon's production of gene knockouts in mouse embryonic stem cell lines for all of the proteins selected for inclusion in the collaboration.

• Ligand Pharmaceuticals Inc., of San Diego, said it earned a $2 million milestone payment from Pfizer Inc., of New York, as a result of Pfizer's submission of a new drug application for lasofoxifene, a selective estrogen receptor modulator for the prevention of osteoporosis in postmenopausal women. The payment is payable in 181,818 shares of Ligand stock held by Pfizer. Ligand will retire the shares from treasury stock.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., said it would be included in the Russell 3000 Index when it is reconstituted effective Oct. 1. The company, which is working to sequence and engineer complex sugars to develop improved versions of existing drugs, completed its initial public offering June 25, and is one of 48 companies that recently have completed IPOs to be added to the reconstituted Russell U.S. indices.

• NeoPharm Inc., of Lake Forest, Ill., said researchers reported data at the company's Advances in Liposomes conference describing how liposomes are being designed to improve the therapeutic index for existing toxic drugs and new chemical entities. Other findings reported at the conference highlighted improvements made in the area of scale-up and manufacturing of liposomes.

• PowderMed Ltd., of Oxford, UK, began a Phase I trial of a therapeutic DNA cancer vaccine in collaboration with its partner, the Ludwig Institute for Cancer Research. The study, which will include up to 18 patients with non-small-cell lung cancer Stages IIIA, IIIB or IV, forms part of the Cancer Vaccine Collaboration. The product uses DNA encoding for the NY-ESO-1 tumor-specific antigen and the Particle Mediated Epidermal Delivery technology owned by PowderMed.

• Prestwick Pharmaceuticals Inc., of Washington, said the FDA designated tetrabenazine as a fast-track product and also gave it orphan drug status. It is being evaluated for the treatment of chorea associated with Huntington's disease, and remains in pivotal testing in the U.S. Tetrabenazine, a dopamine depletor that works by selectively blocking the VMAT2 transporter in the central nervous system, is approved in several European countries and Australia as Xenazine and in Canada as Nitoman.

• Provalis plc, of Deeside, UK, raised gross proceeds of £2.6 million (US$4.7 million) after placing about 33 million ordinary shares at 8 pence each. The company said it would use the funds to provide additional working capital and for its diabetes diagnostic product. Provalis also produces pharmaceutical products.

• Senetek plc, of Napa, Calif., reached an agreement to settle an SEC inquiry into whether the company, by advising a research analyst on two separate occasions to reduce draft analyst estimates of future revenues and earnings without simultaneously releasing the reduced estimates publicly, violated SEC policy. The inquiry was initiated when Senetek voluntarily notified the SEC that it had been advised by its counsel that it might have violated the policy. Senetek consented to an SEC finding that its communication to the analysts without simultaneously or promptly releasing the information publicly violated Regulation FD. The SEC ordered the company to cease and desist from future violations of SEC policy, but took no action against any individual at Senetek and imposed no monetary penalty.

• Sepracor Inc., of Marlborough, Mass., priced $500 million worth of zero percent convertible senior subordinated notes due 2024. The company plans to purchase about $99.9 million of its common stock concurrently with the offering, and intends to use remaining proceeds for general corporate purposes. Sepracor also granted the initial purchaser an option to buy up to an additional $100 million of notes. The notes, which will not bear interest and have a zero yield to maturity, will be general unsecured obligations of Sepracor and are subordinated in right of payment to all of its existing and future senior indebtedness. However, they are senior to Sepracor's 5 percent convertible subordinated notes due 2007, 0 percent Series A convertible senior subordinated notes due 2008 and 0 percent Series B convertible senior subordinated notes due 2010. The notes will be convertible at the option of the holder prior to maturity into cash plus, under certain circumstances, shares of Sepracor common stock at a conversion price of $67.20 per share, which represents a 30 percent premium to the Sept. 16 closing price of $51.69. The company may redeem all or part of the notes for cash on or after Oct. 20, 2009, at a redemption price equal to 100 percent of the principal amount of the notes redeemed. The private placement is expected to close on Sept. 22.

• Stratagene Corp., of La Jolla, Calif., responded to a federal lawsuit filed by Third Wave Technologies Inc., of Madison, Wis., saying that it believes claims in the patent-infringement allegation lack merit. Stratagene said it does not include overlapping DNA molecules in its kits, but in contrast its FullVelocity technology benefits from the sensitivity advantages of PCR amplification, something it added is not found in Third Wave's Invader methods.

The University of British Columbia in Vancouver said researchers at its Center for Molecular Medicine and Therapeutics, along with collaborators at the Academic Medical Center and Amsterdam Molecular Therapeutics in the Netherlands, published findings in this month's Human Gene Therapy showing that a super gene can deliver long-lasting treatment in mice with lipoprotein lipase deficiency. Therapy with the gene, which is carried by 20 percent of the general population, also might have implications in treating other genetic diseases.

• YM BioSciences Inc., of Mississauga, Ontario, said underwriters for its previously reported bought deal exercised their option to acquire more units, bringing the gross proceeds raised in the offering to about C$20 million (US$15.4 million). They elected to buy about 2 million more units, meaning the offering will consist of about 6.3 million units in the end. Each unit consists of a common share and one-half of a warrant. It is expected to close on or about Sept. 30. The lead underwriter is Dundee Securities Corp., and the syndicate also includes Canaccord Capital Corp., Sprott Securities Inc., Dlouhy Merchant Group Inc. and Haywood Securities Inc. (See BioWorld Today, Sept. 15, 2004.)

No Comments