TAIPEI, Taiwan – It's been a long wait, but Taiwan's drug development industry might just be coming of age. While the island nation is still awaiting its first home-grown innovator drug, a number of companies are almost there. As evidence, market capitalization of companies in the sector has skyrocketed at an astounding rate over the past few years, jumping from $3 billion in 2009 to $15 billion in 2013, according to Taiwan's Bio Industry Organization. It's about time, since at least the mid
By Dave Silver | BioWorld International | Wednesday, June 12, 2013
LONDON – Autifony Therapeutics Ltd. has started Phase I development of AUT00063, its treatment for age-related hearing loss and tinnitus, and raised a further £5.5 million (US$8.5 million) to take that lead program through to clinical proof of concept. £5 million of the new money comes from Pfizer Venture Investments, the VC arm of Pfizer Inc., with the remainder coming from International Biotechnology Trust plc. The funding is an extension to the Series A round and brings the amount raised by
By Nuala Moran | BioWorld International | Wednesday, June 12, 2013
LONDON – A £9.3 million (US$14.43 million) publicly funded ubiquitin research program has overcome difficulties in drugging those key protein recycling targets, leading to the formation of UB Pharma Ltd., which has now set out to raise £4 million to £6 million to take the lead candidates through to the clinic. The new company is in the final stages of agreeing to exclusive licenses for all the intellectual property generated in the four-year program, which was funded by Scotland's technology
By Nuala Moran | BioWorld International | Wednesday, June 12, 2013
DUBLIN, Ireland – Royalty Pharma's bitter and protracted takeover battle for Elan Corp. plc will, one way or another, reach a climax next Monday when Elan shareholders vote on the company's recent M&A deals. Acceptance of those transactions, which requires a vote representing 50 percent of Elan's equity plus one share, would scupper Royalty's takeover bid. Rejection would signal the end of the road for Dublin, Ireland-based Elan, a company that has, over the years, taken its shareholders
By Cormac Sheridan | BioWorld International | Wednesday, June 12, 2013
LONDON – The identification of the exact molecule on the insides of blood vessels to which malaria parasites stick will allow an immediate start on work to develop vaccines and new therapies for severe forms of malaria, the scientists who made the discovery predicted. Research published in Nature showed that the malaria parasite, Plasmodium falciparum, binds to a human protein that plays a key role in regulating blood clotting and the response to inflammation. Thomas Lavstsen, assistant
By Sharon Kingman | BioWorld International | Wednesday, June 12, 2013
SHANGHAI, China – While the presidents from the U.S. and China have met in a summit to address human rights and cyber-attack issues, it's become clear that U.S. biopharmaceutical firms have not been immune to targeted hacking out of China. These efforts may have yielded valuable data from clinical trials or drug registration applications. Since the earliest identified cases in 2008, there has been a visible uptick in the number of hacking incidents involving biotech firms, according to Mandiant
By Shannon Ellis | BioWorld International | Wednesday, June 12, 2013
Andromeda Biotech Ltd., of Yavne, Israel, reported findings from an extension study of its Phase III trial of DiaPep277 in Type I diabetes. The open-label, 24-month extension study was designed to evaluate long-term safety, tolerability and efficacy for two years following the completion of the Phase III study, DIA-AID 1 in November 2011. Forty-three patients who completed two years in the DIA-AID 1 study and who had residual beta cell function (stimulated C-peptide over 0.2 nmol/L) were
Algeta ASA, of Oslo, Norway, and Avipep Pty Ltd., of Parkville, Australia, inked a collaboration to evaluate a targeted thorium conjugate based on combining Algeta's thorium-227 alpha-pharmaceutical payload with a next-generation antibody fragment, known as an Avibody, from Avipep that targets a number of solid tumor types. Avipep will provide access to an Avibody, and Algeta will provide access to chelation and conjugation technologies and its alpha particle-emitting payload. Both companies
Agios Pharmaceuticals Inc., of Cambridge, Mass., filed for an initial public offering (IPO) to raise up to $86 million to fund development of its pipeline in cancer and inborn errors of metabolism (IEMs), a subset of orphan genetic metabolic diseases. Agios's partner, Celgene Corp., of Summit, N.J., agreed to concurrently purchase an as-yet undetermined amount of common stock at the public offering price. Agios' two lead cancer programs target mutations in isocitrate dehydrogenase 1 and 2
By Catherine Shaffer | BioWorld Today | Wednesday, June 12, 2013
Privately held Dermira Inc. lifted its veil of silence, at least partially, to disclose $35 million in new funding. The infusion came in a Series B financing that included Japanese dermatology specialist Maruho Co. Ltd., of Osaka, and existing investors Bay City Capital, New Enterprise Associates and Canaan Partners as well as a "related transaction" that CEO Tom Wiggans coyly sidestepped. "It's a very good deal with a very good company and allows us to really drive our programs forward
By Marie Powers | BioWorld Today | Wednesday, June 12, 2013
It's not every day that a multimillion-dollar market suddenly opens up, inviting all comers to the ground floor of competition. But that's exactly what happened when the FDA put out its "open for business" sign for biosimilars. Even before the agency issued its first draft guidances last year on developing biologic copies and began meeting with interested sponsors, drugmakers were weighing their opportunities, developing strategies for entering the field and seeking out partners to strengthen
By Mari Serebrov | BioWorld Today | Wednesday, June 12, 2013
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a Phase II trial of Iclusig (ponatinib) in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The open-label study is designed to enroll about 45 patients and will provide initial data on the drug's efficacy and safety in patients with GIST following failure of prior tyrosine kinase inhibitor therapy. Patients whose tumors have an activating mutation in exon 11 of the cellular KIT, the primary
LONDON – The identification of the exact molecule on the insides of blood vessels to which malaria parasites stick will allow an immediate start on work to develop vaccines and new therapies for severe forms of malaria, the scientists who made the discovery predict. Research published in Nature showed that the malaria parasite, Plasmodium falciparum, binds to a human protein that plays a key role in regulating blood clotting and the response to inflammation. Thomas Lavstsen, assistant
By Sharon Kingman | BioWorld Today | Wednesday, June 12, 2013
For drug developers, it's hardly news that markets such as Brazil, Russia, India and China (BRIC) are not the once hoped-for promised land, and Frost & Sullivan has put together a report that outlines the reasons the situation may get worse. "I think the biggest challenge today for selling into BRIC for global companies is the need to understand customer segmentation and behavior – how to optimize this and ensure your product is customized to that need – trying to sell value beyond the product
By Randy Osborne | BioWorld Today | Wednesday, June 12, 2013
Achillion Pharmaceuticals Inc., of New Haven, Conn., named Milind Deshpande president and CEO. Agendia BV, of Amsterdam, the Netherlands, named Peter W. Schineller chief commercial officer. Bioinvent International AB, of Lund, Sweden, named Michael Oredsson president and CEO, to be effective within six months. Altherx Pharmaceuticals Inc., of Exton, Pa., added Michael R. Dougherty to its board. Cannabis Science Inc., of Colorado Springs, Colo., named Dorothy Bray CEO and director. Cellular
Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., entered into a development agreement with Welding GmbH & Co., of Hamburg, Germany, and SK Chemicals, of Seoul, South Korea, to develop and market an undisclosed drug candidate with potential U.S.-branded sales of approximately $500 million. Under terms of the agreement, Welding and SK will develop and manufacture the product, using SK's drug delivery system, for Breckenridge, which will have exclusive marketing and distribution rights in
Acknowledging that the train may have already left the station for Glaxosmithkline plc's (GSK) Avandia, some advisory committee members and other experts looked down the track last week to give the FDA an earful on how to get more meaningful data about diabetes drugs and avoid the process that derailed the one-time blockbuster Avandia. Ideally, data should come from randomized, controlled, double-blind, superiority trials – not from meta-analyses and observational studies, which can be loaded
By Mari Serebrov | BioWorld Today | Tuesday, June 11, 2013
Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported new findings presented during the APASL Liver Week in Singapore, highlighting the efficacy and safety of faldaprevir(+) plus pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) in Asia. The post-hoc sub-analysis of the Phase III STARTVerso 1 and 2 trials showed that both doses of faldaprevir were associated with high viral cure rates and a shorter treatment duration in that
Clovis Oncology Inc., of Boulder, Colo., said it commenced a public offering to raise $170 million. The number of shares and share price was not disclosed. Underwriters J.P. Morgan Securities LLC, Credit Suisse Securities and Leerink Swann will have a 30-day option to purchase up to an additional 15 percent of the number of shares sold to cover overallotments. Proceeds will be used for general corporate purposes, including funding of Clovis' development programs, general and administrative
TAIPEI, Taiwan – It's been a long wait, but Taiwan's drug development industry might just be coming of age. While the island nation is still awaiting its first home-grown innovator drug, a number of companies are almost there. As evidence, market capitalization of companies in the sector has skyrocketed at an astounding rate over the past few years, jumping from $3 billion in 2009 to $15 billion in 2013, according to Taiwan's Bio Industry Organization. It's about time, since at least the mid