Altana AG, of Bad Homburg, Germany, filed a suit at the Social Court in Berlin against the central association of German statutory health insurance companies with reference to their classification of Pantozol (pantoprazole) as part of a reference price group. Altana believes the therapeutic improvements of Pantozol, such as less interactions with other drugs, have not been taken into account in the establishment of reference price groups for the class of proton pump inhibitors. The suit is directed against that decision, as well as the missing transparency of the proceedings of the Federal Committee, Altana said, adding that reference prices for innovative drugs contravene the objectives of patent protection.
Amarillo Biosciences Inc., of Amarillo, Texas, and Hayashibara Biochemical Laboratories, of Okayama, Japan, entered a license and supply agreement for oral interferon-alpha. In the last 20 years, Amarillo has invested nearly $37 million to establish interferon as a therapeutic agent for a number of diseases. HBL has provided the company with more than $16.5 million in loans, grants and an equity investment. It holds 24 percent of Amarillo's shares. Amarillo has orphan drug designation for the product in oral warts in HIV+ patients, Behcet's disease and polycythemia rubra vera.
Chiron Corp., of Emeryville, Calif., and XOMA Ltd., of Berkeley, Calif., were scheduled to report several abstracts on CHIR-12.12, an antagonist antibody targeting CD40 in preclinical oncology development, at the American Society of Hematology meeting that began over the weekend in San Diego. Among the data to be reported were findings on the in vitro activity of the agent in chronic lymphocytic leukemia, as well as its antitumor activity against human multiple myeloma. Separately, Chiron agreed to grant Laboratory Corp. of America Holdings, of Burlington, N.C., a semi-exclusive license to use Chiron's hepatitis C virus intellectual property for nucleic acid testing for screening plasma donations in the U.S. LabCorp agreed not to challenge the validity or enforceability of certain Chiron hepatitis C patents. Financial terms were not disclosed.
Inamed Corp., of Santa Barbara, Calif., and Genzyme Corp., of Cambridge, Mass., received FDA approval to market Captique Injectable gel, a dermal filler product based on Genzyme's non-animal stabilized hyaluronic acid technology. Captique is indicated for the correction of moderate to severe facial wrinkles. Genzyme is Inamed's exclusive U.S. marketing and distribution partner for Captique.
Ista Pharmaceuticals Inc., of Irvine, Calif., said the FDA approved a single-use vial of Vitrase sterile solution for use as a spreading agent to facilitate the dispersion and absorption of other drugs. Vitrase is a formulation of highly purified, preservative-free ovine hyaluronidase. The company expects to launch the product early in the first quarter. In May, the FDA approved Vitrase in a 6,200 unit multi-purpose vial for the same indication. (See BioWorld Today, May 7, 2004.)
Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reached the target enrollment in the first of two pivotal Phase III trials of methylnaltrexone to treat opioid-induced constipation in patients with advanced medical illness, such as cancer, AIDS and sickle cell disease. The company expects to announce results from the 150-patient, multicenter study in early 2005. If the Phase III results are positive, the company plans to file a new drug application by the end of 2005.
ViroPharma Inc., of Exton, Pa., said Schering-Plough Corp., of Kenilworth, N.J., received a notice of early termination of the waiting period regarding its agreement to license pleconaril to treat the common cold in the U.S. and Canada. Schering-Plough has assumed responsibility for all future development and commercialization of the product. It has paid ViroPharma an initial license fee of $10 million, and will purchase ViroPharma's existing inventory of bulk-drug substance for up to an additional $6 million. ViroPharma also is eligible to receive up to an additional $65 million in milestone payments, as well as royalties. (See BioWorld Today, Aug. 24, 2004.)
YM BioSciences Inc., of Mississauga, Ontario, said its board adopted a shareholders' rights plan. The plan is designed to ensure that proposals to acquire YM would result in the board being able to determine that the value in the company is recognized by providing time to elicit competing bids.