SAN FRANCISO – One-third of all biotechnology deals in 2012 were for oncology assets, according to Deloitte Recap LLC, a higher percentage than any other therapeutic area. Cancer is a very appealing indication for biotech product development because of shorter development timelines, faster approvals and premium pricing. However, the bar is rising for clinical performance, and there are signs the honeymoon is over for the $100,000-per-year cancer therapy. A panel of experts at Deloitte's

Oxford BioTherapeutics (OBT) Ltd. entered a target validation deal with Boehringer Ingelheim GmbH that will offer near-term revenues, with the added prospect of long-term development milestones and product royalties. The shape of the deal is markedly different from the headline-grabbing pact involving five antibody and antibody-drug conjugate (ADC) programs it entered last year with Menarini Group, of Florence, Italy. (See BioWorld Today, Oct. 30, 2012.) That deal is focused on what for OBT

The possibility of an initial public offering (IPO) – noted in December, when Regado Biosciences Inc. collected $51 million in a Series E financing intended to help fund Phase III trials – moved closer to reality, as the firm filed a registration statement to trade on Wall Street. Regado, of Basking Ridge, N.J., did not specify in the paperwork the number of shares nor the proposed price range in the IPO, and a spokesperson said the firm's quiet period prevents further comment. The IPO could

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said prescribing information for Pradaxa (dabigatran etexilate), an oral anticoagulant for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation was updated. The label now carries a boxed warning, advising patients that discontinuing treatment puts them at increased risk of stroke, and the postmarketing experience section was updated to include thrombocytopenia. The label also now includes data from

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., reported updated median overall survival data from an ongoing Phase II trial of oral sapacitabine in older patients with intermediate-2 or high-risk myelodysplastic syndromes after treatment failure of front-line hypomethylating agents. Median overall survival to date for all 63 patients treated is about nine months, while median overall survival for each of the three randomization schedules is about 10 months for arm G, 10 months for

Shares of AVEO Oncology Inc. plummeted to historic lows Tuesday with the realization that the company may have to conduct a second Phase III trial before the FDA considers approving tivozanib to treat advanced renal cell carcinoma (RCC). In its heaviest trading since going public in March 2010, shares of the Cambridge, Mass.-based biotech (NASDAQ:AVEO) dropped to an all-time low, closing Tuesday at $5.11, down $2.33, or 31.3 percent. Prior to Tuesday's fall, which saw more than 10 million

The following data were reported from European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin: Pfizer Inc., of New York, presented results from a Phase III study investigating immunogenicity, tolerability and safety of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 18 to 49. The study met all primary and secondary objectives and provided the clinical foundation for the company's regulatory submission in the

Merck & Co. Inc., of Whitehouse Station, N.J., and Pfizer Inc., of New York, have entered a worldwide (except Japan) collaborative agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729), an investigational oral sodium glucose co-transporter (SGLT2) inhibitor being evaluated for the treatment of Type II diabetes. Ertugliflozin is Phase III-ready, with trials expected to begin later in 2013. Under terms of the agreement, Merck, through a subsidiary, and Pfizer

BioLineRx Ltd., of Jerusalem, said the first patient was enrolled in a Phase I/II trial of BL-8020, an orally available, interferon-free treatment for hepatitis C virus (HCV). The open-label trial will evaluate efficacy, safety and tolerability at two sites in France, enrolling up to 32 HCV-infected patients of any genotype who previously failed or relapsed following standard-of-care treatment. The primary endpoint is to evaluate the effect of the 16-week combination therapy, comprised of

Almac Discovery, a Craigavon, Northern Ireland-based member of Almac Group Ltd., licensed its anti-angiogenic peptide ALM201 to Shin Poong Pharmaceutical Co. Ltd., of Seoul, South Korea, for clinical development and marketing in South Korea. Shin Poong will make undisclosed up-front and milestone payments, along with royalties. The South Korean development program will run parallel with Almac's development program in Europe, where the cancer compound is entering Phase I/II trials in the UK

Auxilium Pharmaceuticals Inc. of Chesterbrook, Pa., reported net revenues of $66.2 million for the first quarter ending March 31, compared to net revenues of $73.6 million in the first quarter of 2012. The decrease was attributed to a fall in U.S. sales of Xiaflex (collagenase clostridium histolyticum, or CCH) and Testim. On a U.S. GAAP basis, Auxilium reported net loss of $8.2 million, or 17 cents per share, compared to a net loss of $1.7 million, or 4 cents per share, in the same period a

Spinning out assets into a new corporate entity is a business strategy that is starting to gain traction once again. Theravance Inc., of South San Francisco, is the latest company to join several pharmaceutical and biotechnology firms, including Abbott, Pfizer Inc. and Resverlogix Corp. to reveal that undertaking. Citing the fact that the move will unlock potential value for two different sets of company assets, CEO Rick Winningham noted in a conference call that it will also better align

LONDON – A 2.5 year investigation into the low level of uptake of biosimilars in Europe has concluded that – in the absence of automatic substitution – a hearts-and-minds education campaign covering physicians, payers and patients is the only lever that can be pulled at a pan-European level to drive the growth of the market. Among its findings, the Project Group on Market Access and Uptake of Biosimilars pinpointed a lack of understanding of biosimilars as a significant barrier to access. To

DUBLIN, Ireland – Opsona Therapeutics Ltd. raised €33 million (US$43.2 million) in a Series C funding round to take forward a first-in-class Toll-like receptor 2 (TLR-2) inhibitor, OPN-305, into a Phase II trial for preventing delayed graft function (DGF) in high-risk kidney transplant patients. The investment represents a shot in the arm for TLR biology, a field that has, so far, failed to deliver on its considerable promise. Despite intense interest in various TLR targets – there are 10 in

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 and acquisition activity

Drug discovery firm Forma Therapeutics Holdings LLC racked up another collaboration – its biggest so far – inking Celgene Corp. to a potential multicandidate deal targeting protein homeostasis, a new area of biology linked to oncology, neurodegenerative disorders and other diseases. Specific up-front payments were not disclosed, but Summit, N.J.-based Celgene agreed to fund up to $200 million for research and early development work based on "certain scientific criteria," said Steven Tregay

Derma Sciences Inc., of Princeton, N.J., said patient screening started in the second of two Phase III trials testing topical drug candidate DSC127 for the treatment of diabetic foot ulcers. The study will have three arms of 211 patients each and will test a 0.03 percent formulation of the drug against a topical vehicle and against a standard-of-care hydrogel. The first Phase III trial, which started in February, is testing two arms of 211 patients each, evaluating DSC127 vs. topical vehicle

Epizyme Inc., the latest biotech to take advantage of the emerging growth company provision in last year's JOBS Act, filed an S-1 Friday for a proposed $69 million initial public offering (IPO), though the number of shares and share price have not yet been disclosed. Proceeds from the IPO, along with the firm's cash of $85 million as of March 31, will be used in part to cover the costs of Phase I development of EPZ-5676 in mixed lineage leukemia (MLL), an aggressive subtype of the most common