By Catherine Shaffer Staff Writer SAN FRANCISCO – Phase II deal values surpassed Phase III in 2012, leading a senior biopharma analyst for Deloitte Recap LLC, to say "2012 was certainly the year of the Phase II" in her talk summarizing Deloitte's analysis of 1,692 deals closed in 2012 at the firm's Allicense Conference in San Francisco on Monday. In Deloitte's analysis, 584 deals were licenses or joint ventures, with a total disclosed deal value of $27 million. Trends included decreasing merger

By Jennifer Boggs Managing Editor CHICAGO – Getting through an FDA advisory committee is an oft-dreaded rite of passage for developers of novel drug candidates, and stories of disastrous adcoms have a tendency to circulate around the biopharma industry like urban myths. For instance, there's the "tale of two adcoms," as Russo Partners' David Schull referred to the two adcom meetings prior to FDA approval of Arena Pharmaceuticals Inc.'s obesity drug Belviq (lorcaserin). Schull, who moderated a

By Marie Powers Staff Writer CHICAGO – Small biotechs, already smarting from the stingy venture capital (VC) market and cutbacks in government funding, are looking nervously over their shoulder at the increasingly cozy relationship between big pharmas and academic institutions. And well they should. In a Tuesday morning panel at the 2013 BIO International Convention, Roger Pomerantz, worldwide head of licensing and acquisitions at Merck & Co. Inc., of Whitehouse Station, N.J., and senior vice

By Randy Osborne Staff Writer CHICAGO – Officials from the China Food and Drug Administration (CFDA) stammered through a question-and-answer period in which the audience sought the agency's definition of an "innovative" drug, its stance on orphan therapies and its policy with regard to biosimilars, during the first day of the BIO 2013 International Convention here. The session seemed lost in translation, figuratively and sometimes literally. Chang Weihong and Haixwei Wang from the renamed

By Marie Powers Staff Writer Portola Pharmaceuticals Inc. became the 12th biotech in 2013 and the third in the second quarter seeking to move into the U.S. public markets, filing an S-1 with the SEC for an initial public offering (IPO). The company did not disclose the number of shares or price range. To date, six biotech IPOs – Stemline Therapeutics Inc., KaloBios Pharmaceuticals Inc., Tetraphase Pharmaceuticals Inc., Enanta Pharmaceuticals Inc., Chimerix Inc. and Omthera Pharmaceuticals Inc

By Anette Breindl Science Editor Somewhere around 10 percent of the U.S. population suffers from chronic insomnia, and around a third of those take drugs to help them sleep. Scientists from Merck & Co. Inc. have reported scientific data in support of their contention that a new type of insomnia drug can give sweet dreams without the side effects that dog the current crop of sleep-inducing agents. In the April 4, 2013, issue of Science Translational Medicine, they showed that both mice and

By Mari Serebrov Washington Editor Amazonian plants plucked from the ground. Baseball bats emerging from trees. Chocolate chip cookie ingredients separated from the dough. They were all part of the discussion Monday as the Supreme Court grappled with the science behind Myriad Genetics Inc.'s gene-based claims – and patent law itself. But such simple analogies don't work when it comes to determining whether isolated DNA can be patented, Gregory Castanias, an attorney representing the Salt Lake

By Nuala Moran Staff Writer LONDON – Cancer specialist Activartis Biotech GmbH will present positive survival data from the Phase II trial of its dendritic cell therapy in treating glioblastoma at the American Association of Cancer Research (AACR) Wednesday, as it steps up efforts to find a partner to back a Phase III study. The first interim analysis of the open-label, 100-patient trial indicated that when the final numbers are in there will be an overall survival benefit in patients treated

By Anette Breindl Science Editor WASHINGTON – Several presentations at the American Association for Cancer Research's (AACR) Annual Meeting this week underscored the size of the epigenetic space. Targeting epigenetic alterations has gone far beyond histone deacetylase (HDAC) and DNA methyltransferase (DNMT) inhibitors, which are the two classes of epigenetic enzymes that have approved drugs targeting them. HDAC inhibitors on the market are Istodax (romidepsin, Celgene Corp.) and Zolinza

By Mari Serebrov Washington Editor Much to-do has been made about the FDA's draft guidance on developing drugs for early stage Alzheimer's disease (AD), but some people are missing the point, especially if they think the agency is "loosening" its standards for Alzheimer's treatments, according to an FDA official. First off, the agency has no standard to loosen for drugs targeting the early stages of the disease, Russell Katz, director of the Office of Drug Evaluation I in the FDA's division of

By Nuala Moran Staff Writer LONDON – Clavis Pharma A/S is facing a merger or an orderly shutdown following the Phase III failure of elacytarabine, its lipid-enhanced version of cytarabine, in the 380-patient CLAVELA trial in advanced acute myeloid leukemia (AML). This is the second big failure of the lipid technology in five months, with Clavis reporting in November that CO-101 (CP-4126), a modified formulation of gemcitabine, had not shown any effect on overall survival in a 360-patient pivotal

By Mari Serebrov Washington Editor Adamant that pay-for-delay settlements between brand- and generic drugmakers are anticompetitive, the FTC is leaving no stone unturned in its efforts to get the settlements outlawed. Even as the commission was preparing for a Supreme Court hearing Monday on FTC v. Actavis Inc., it was working with lawmakers to get legislation enacted to bar the agreements or make them less attractive. One bill that enjoys bipartisan support, S. 214, would prohibit brand

By Anette Breindl Science Editor Emerging diseases are by their nature a disconcerting foe. As with any preventive measure, it's only possible to know for sure if a new infectious agent has gotten in under the radar when patients begin to present with unusual symptoms. Such was the case with HIV; by the time the Morbidity and Mortality Weekly Report described a cluster of five men with the opportunistic infection Pneumocystis carinii pneumonia in 1981, there were likely already thousands of

By Cormac Sheridan Staff Writer Underlining its ambitions in ophthalmology, Shire plc is acquiring SARcode Bioscience Inc. for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease. The acquisition, which is expected to close in the second quarter, comes hot on the heels of its recent purchase of Premacure AB, of Uppsala

By Mari Serebrov Washington Editor Adamant that pay-for-delay settlements between brand- and generic drugmakers are anticompetitive, the FTC is leaving no stone unturned in its efforts to get the settlements outlawed. Even as the commission was preparing for a Supreme Court hearing Monday on FTC v. Actavis Inc., it was working with lawmakers to get legislation enacted to bar the agreements or make them less attractive. One bill that enjoys bipartisan support, S. 214, would prohibit brand

By Mari Serebrov Washington Editor With sequestration swinging its two-edged blade through the funding for the National Institutes of Health (NIH) and other government research-focused programs, a lot has been said about its impact on the future pipeline of medical researchers. But federal funding isn't the only factor leading to a growing talent drain in the field. Part of the problem is education. And that's where industry can invest in its own future by exposing students as young as junior

By Sharon Kingman Staff Writer LONDON – Study of a family affected by an inherited neurological disease has helped to reveal the identity of an enzyme that could point the way to new therapies for cancer and cardiovascular disease. The existence of the enzyme, which plays a role in maintaining cell survival and DNA repair, has been predicted for at least 30 years and has even been shown to operate in cell cultures. But, until it was linked with the gene defect in the family studied, no one knew

By Nuala Moran Staff Writer LONDON – Mesoblast Ltd. has raised A$170 million (US$174.6 million) in a private placing, bringing total cash reserves for the stem cell specialist to A$332 million and providing funding for a Phase III trial in treating degenerating spinal discs. The shares will be issued at A$6.30, a 2.2 percent discount to the closing price of A$6.44 the day before the private placing was announced on March 6. The new shares represent less than 15 percent of the shares in issue so

By Mari Serebrov Washington Editor Although they hoped it wouldn't come to this, the FDA and National Institutes of Health (NIH) are preparing for the reality of the sequester sword. In the run-up to March 1, the FDA analyzed how the across-the-board cuts would affect its ongoing activities. "A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count," it concluded. That said, the