Licensing In Brief
This article was originally published in Pharmaceutical Approvals Monthly
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Sepracor/Acadia CNS partnership: Selective muscarinic receptors are the focus of Sepracor and Acadia's partnership for development of drug candidates targeting central nervous system disorders, announced Jan. 11. Sepracor will make an equity investment in Acadia and provide research funding, in addition to milestone payments and royalties. Acadia's selective m1 agonist clinical candidate for treatment of cognition in patients with schizophrenia will be a focus of the R&D collaboration, Sepracor says. The deal also includes an option to select a preclinical compound from Acadia's 5-HT2A antagonist program for use in combination with Sepracor's recently approved sleep agent Lunesta (eszopiclone).... GBt acquires Phase III Parkinson's drug: Additional Phase III trials of CHF512, a methyl ester of levodopa (melevodopa) and the decarboxylase inhibitor carbidopa, are slated to begin first-quarter 2006. Canadian firm GB Therapeutics announces the acquisition of the oral liquid Parkinson's disease therapy from Chiesi Jan. 27; the Italian firm is making an equity investment in GBt. The studies are designed to meet FDA and ICH guidelines targeting motor fluctuations, GBt says. CHF1512 (now GT1512) has greater solubility than other L-dopa formulations, and offers "a significantly faster onset of action, a significant decrease of the daily experience of…dyskinesias [and] a potential improvement in the functional ability, quality of life and non-motor symptoms associated with the disease," GBt CEO Anthony Giovinazzo says. GBt and Chiesi also have a licensing arrangement for Chiesi's Phase II neuropathic pain drug CHF3381.... BI discontinues bivatuzumab: Boehringer Ingelheim has discontinued development of bivatuzumab mertansine due to skin toxicity in Phase I trials in advanced carcinoma, partner ImmunoGen announces Feb. 9. The oncologic comprises BI's anti-CD44v6 antibody bivatuzumab and ImmunoGen's DM1 cytotoxic agent mertansine. BI licensed use of ImmunoGen's DM1 Tumor-Activated Prodrug technology in 2001; Boehringer is retaining the right to use the technology for a different antigen target, ImmunoGen reports. ImmunoGen also has collaborations with Centocor, Biogen Idec, Genentech, Abgenix, Millennium and Sanofi-Aventis, and has two wholly owned TAP compounds, huN901-DM1 and huC242-DM4.... Novartis/Schering AG angiogenesis co-promotion: Novartis and Schering AG are expanding their research collaboration on the oral angiogenesis inhibitor PTK787/ZK 222584 to cover co-promotion in North America, Europe and Japan, the firms announce Jan. 25. The deal is structured to be equal, with Novartis as the lead partner in North America and Schering AG in Europe - the lead partner "will bear the larger part of costs…and will thus retain a correspondingly larger percentage of the profits," Schering explains. PTK/ZK is in two Phase III studies in 2,000 metastatic colorectal cancer patients. Study results are expected to be released in the second quarter, and product submission is planned for the second half of 2005... Shire signs on with New River ADHD drug: Shire has signed an agreement for global commercialization of New River's Phase III attention-deficit/hyperactivity disorder treatment NRP104, the companies say Jan. 31. The firms will collaborate on development, manufacturing, marketing and sales. After an initial payment of $50 mil., Shire will pay $50 mil. upon NDA filing and up to $300 mil. in milestones "depending on the characteristics of FDA-approved product labeling," plus a $100 mil. sales bonus. NRP104 is expected to reach the market "by 2006." The licensing agreement encompasses other potential indications beyond ADHD. New River is also studying the amphetamine prodrug for cocaine dependence.... Basilea antibiotic to be partnered by J&J: Swiss firm Basilea and Johnson & Johnson subsidiary Cilag AG will jointly develop, manufacture and market Basilea's broad-spectrum cephalosporin antibiotic ceftobiprole, under a worldwide agreement announced Feb. 3. Upfront and milestone payments "may together total up to 370 mil. Swiss Francs," and Basilea will also receive "significant double-digit royalties on worldwide sales," the company reports. The first-in-class antibiotic, which was designed to target methicillin-resistant S. aureus, is in Phase III for complicated skin and skin structure infections ( 1 Pharmaceutical Approvals Monthly Nov. 1, 2004 , In Brief). Ceftobiprole has fast track status for CSSIs due to MRSA and for hospital-acquired pneumonia.... |