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

BioMarin Pharmaceutical Inc., of San Rafael, Calif., missed earnings estimates by 1 cent, posting a fourth-quarter GAAP net loss of $39.8 million, or 31 cents per share. The firm's revenue totaled $127.9 million, falling short of consensus estimates of $131.4 million. Sales of mucopolysaccharidoses enzyme replacement therapy Naglazyme (galsulfase) totaled $69.4 million, while sales of phenylketonuria drug Kuvan (sapropterin dihydrochloride) came in at $37.6 million for the three-month period

Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the European Committee for Medicinal Products for Human Use (CHMP) recommended approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of pseudobulbar affect, irrespective of neurologic cause. The CHMP also recommended approval of two dose strengths of Nuedexta: 20/10 mg and 30/10 mg capsules. Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a

CHICAGO – For Avaxia Biologics Inc., the decision to attend BIO 2013 was a no-brainer. The Lexington, Mass.-based company is in the middle of a Phase Ib study of lead compound AVX-470, an orally administered anti-TNF polyclonal antibody, in ulcerative colitis (UC). Results are expected in November, and if all goes well the company plans to report data in January 2014 at the J.P. Morgan Healthcare Conference in San Francisco. Based on preclinical safety and efficacy findings, founder and CEO

Listeria monocytogenes' main medical claim to fame is that it causes food poisoning. But by combining a weakened strain of the bacterium with a radioactive payload, scientists have used Listeria to kill metastases from pancreatic cancer. The bacteria were less effective at taking out the primary tumors. But, corresponding author Claudia Gravekamp told BioWorld Today, "we are quite successful" at dealing with the primary tumors – "primary tumors can be removed by surgery or radiation." The

Intolerant Hosts Can Damage Themselves One of the major reasons that influenza is dangerous is that it softens the body up for pneumonia, which can deliver a fatal blow to weakened individuals and is, in fact, responsible for the majority of the deaths that start with a flu infection. But why the flu should predispose to pneumonia to the extent that it does has remained unclear. Infected individuals cope in two different ways: by controlling infections via resistance, and via adapting to the

TAIPEI, Taiwan – When Taiwan and China signed the Economic Cooperation Framework Agreement (ECFA) in June 2010, the two politically opposed sides pledged to remove some of the barriers that have kept them separated since the end of the Chinese civil war of 1949; economically, if not politically. That agreement has implications that go beyond regional economics. Because of the ECFA, Taiwan may be slowly positioning itself to become an important gateway into the immense market of China for

WASHINGTON – While the intrinsic value of using companion diagnostics to target the right drugs to the right patients is recognized by all components of the health care system, including drugmakers, diagnostic developers, clinician and patient interest groups and payers, more cohesion is needed among all those parties – and at earlier stages in development – for personalized medicine to reach its potential value. A conference last week organized by the Personalized Medicine Coalition (PMC) and

Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis. The CHMP said it is of the opinion that the drug does not demonstrate a favorable risk-benefit profile and recommended against marketing authorization. Pfizer intends to appeal the opinion and seek a re-examination by CHMP. Xeljanz, a JAK inhibitor, gained

TAIPEI, Taiwan – With the number of confirmed H7N9 infections cases in China currently at 108 and 22 deaths, Taiwan confirmed its first case of H7N9 avian influenza infection – a 53-year-old Taiwanese returning to the island on April 9 after working in China's Jiangsu province. Meanwhile, viral material for use in both creating more accurate diagnostic kits and for vaccine production arrived in Taiwan, sent courtesy of Chinese health authorities. Taiwan's Department of Health has tasked