April 26 Issue of Centerwatch Weekly

Breaking News and Market Intelligence for April 26, 2010 the Clinical Trials Industry

A CenterWatch Publication

Almac partners with Queen’s University Belfast …2

Pfizer Warned by FDA for Inadequate Monitoring PRA expands into New Zealand …3

fizer received a warning letter a string of FDA-Pfizer letters regarding from the U.S. Food and Drug violations in the Geodon study. Company Profile ...5 P Administration (FDA) earlier this According to the FDA’s letter, Pfizer An interview with Diana Caldwell, month, citing the pharmaceutical giant failed to ensure proper monitoring at sever - president and co-founder for inadequate clinical trial monitoring al clinical trial sites between 2005 and Pearl IRB in the study of a pediatric drug— 2009, which resulted in overdosing of par - violations that led to the overdosing of ticipants for several days—one for as long Drug & Device Pipeline News ...7 at least 26 children. as 22 days. CenterWatch has identified 21 drugs and The drug, unnamed in the FDA’s letter, Pfizer received its first letter related devices that have entered a new trial phase is reported to be Geodon, which is used to the study in 2005, when an FDA investi - this week. to treat schizophrenia and bipolar disor - gation revealed “widespread overdosing of der. Pfizer is seeking FDA approval for study subjects at multiple study sites.” the drug to be used to treat children Despite efforts by Pfizer to improve the Trial Results ...8 between the ages of 10 and 17 years. monitoring process, additional overdoses CenterWatch reports on results for four Last week’s warning was the latest in page 4 drugs. Visit www.centerwatch.com for real-time updates on drugs in clinical trials.

Aptium Oncology Launches Myeloma Research Network Biotech Review ...9 as IOM Calls for Improvements in Cancer Research Biotech briefs from BioWorld Today .

ptium Oncology, a consulting and already in place and access to a large num - management company for cancer ber of GI cancer patients. We gathered Acenters, is putting together a net - those investigators and institutions togeth - work of investigators specifically focused on er, and we’re supplying them with a grant, myeloma and related cancers. the purpose of which is to enhance their The Aptium Oncology Myeloma programs,” said Marti McKinley, vice presi - Consortium (AMyC) is modeled after dent of clinical research programs for both Aptium’s GI Cancer Consortium, a group AGICC and AMyC. launched in 2008 to focus on gastrointesti - The researchers, who hail from 11 of the nal cancers. country’s largest cancer centers, will assist “What we did with the GI Consortium— in the development and execution of phase AGICC—was to pull together a group of Ib and phase II industry-sponsored trials. investigators who are opinion leaders in GI The institutions each receive $125,000 cancer treatment and who practice at insti - over two years to help them build their tutions that have robust GI programs page 4

Volume 14, Issue 17. Copyright © 2010 by CenterWatch. All rights reserved. CenterWatch Information Services CWWeekly April 26, 2010 2 of 9 Industry Br iefs The CenterWatch Monthly A monthly newsletter featuring in-depth stories on the clinical trials industry and grant opportunities. Annual subscriptions start at $399. JobWatch Coming soon: CenterWatch 2.0!! A web-based service listing clinical research jobs, career resources and a searchable resume database. Visit the JobWatch web site at CenterWatch founder Ken Getz has bought back the company. In collaboration with the http://www.centerwatch.com/jobwatch/. management team, Ken has ambitious plans to make CenterWatch's publications and Clinical Trials Listing Service™ services more relevant and valuable so that you're better informed, more effective and www.centerwatch.com This service provides an international listing of clinical successful. Stay tuned for updates on new and improved grant leads for investigative trials currently enrolling patients. sites; business development leads for contract service providers; postings of career Call David Heck, (513) 754-1705 opportunities; listings of clinical trials actively seeking patients; advertising and promo - CenterWatch Publications tional opportunities; and hard-hitting, original data and business analysis about the CenterWatch publishes a wide range of CME- global clinical trials industry. We appreciate your continued support and welcome your accredited training manuals, directories, brochures and drug intelligence information . For more information, suggestions on ways to make CenterWatch even better. visit our Store at http://store.centerwatch.com.

CenterWatch Main and Editorial Offices 100 N. Washington St, Suite 301, Boston, MA 02114 CROs in discovery: target validation and identify - Tel (617) 948-5100 Fax (617) 948-5101 [email protected] ing novel hits against those targets. They I Covance is closing a testing site in will concentrate their efforts in oncology. Kalamazoo, Mich., as part of the CRO’s The program is being co-funded by Almac ongoing efforts to cut back its preclini - Group, Queens University Belfast and Invest CW Weekly (ISSN 1528-5731) cal services. The site will be closed by Northern Ireland, a regional economic Steve Zisson Editorial Director November, and, according to published development agency that is part of the Sara Gambrill Senior Editor reports, 63 workers will lose their jobs. Department of Enterprise, Trade and Molly Rowe Senior Associate Editor Tracy Lawton Drug Intelligence Covance’s early-stage division has Investment. Target validation work will be Melissa Nazzaro Advertising struggled in recent months. Late last carried out at Queen’s, and Almac Group Steven Hasomeris Production Danielle Wooding Production summer, the CRO delayed plans to build will manage the project as well as own the a $145-million preclinical toxicology intellectual property. The agreement Send news submissions to Steve Zisson Tel (617) 948-5142 Fax (617) 948-5101 testing facility in Virginia, a site that between the two organizations allows [email protected] was purchased from Eli Lilly in 2007. In Almac to commercialize output from the

To subscribe to CWWeekly or other CenterWatch January, the company reported a 6% program, while Queen’s will receive pay - publications, contact Sales drop in year-end 2009 revenues for the ments when certain milestones are reached Tel (866) 219-3440 Fax (617) 948-5101 100 N. Washington St, Suite 301, Boston, MA 02114 early-development segment. based on the commercialization of drugs as they come through the pipeline. Through

To order reprints, contact Rick Lavallee I Tel (617) 948-5126 Almac Group , an integrated drug devel - this agreement, Almac Group has access to [email protected] opment services company based in the 350 scientists working at Queen’s Craigavon, Northern Ireland, has formed a University Belfast’s Centre for Cancer CenterWatch partnership with Queen’s University Belfast Research and Cell Biology. aimed at breaking through two bottlenecks Can your EDC system dispense medication? Ours can.

www.perceptive.com/eclinical

I United BioSource Corporation (UBC) Chiltern has worked with other IRT to a report in the New England Journal partnered with Singapore-based providers over the years and will continue of Medicine . The authors of the study Clearstate , a market intelligence firm to do so. conducted exploratory searches on clinical - focused on the healthcare and pharmaceu - trials.gov to find studies that required par - tical industry. Through this partnership, UBC I Preclinical CRO Charles River ticipants to be heterosexual. According to will offer market access, pricing and reim - Laboratories received a Certificate of the report, published in March, studies that bursement strategies for drug and device Good Laboratory Practice (GLP) compliance have sexual function as an endpoint are manufacturers in the Asia-Pacific region. from the Organization for Economic most likely to exclude people based on sex - UBC opened its first office in Asia-Pacific in Cooperation and Development (OECD) for ual orientation. Fifteen percent of the study February. This office—based in Tokyo—will Charles River’s Shanghai, China, facility. listings that used the terms "erectile dys - have a staff of 12 by the end of the year, According to the CRO, this is the first pre - function," "couples" and "hypoactive" had according to UBC CEO Ethan Leder. Leder clinical laboratory in China to receive GLP exclusionary language. The report went on told CenterWatch earlier this year that the certification from an OECD member coun - to say that studies that require participants Asia-Pacific region has grown increasingly try. The certification designates that the site to be in heterosexual relationships may also important to UBC as both regional and is in operating compliance with OECD prin - exclude non-married or single participants. worldwide clients have requested increased ciples of GLP for both toxicology and labo - services there. ratory services.

I UK-based CRO Chiltern International is I PRA International expanded its Asia- now a minority shareholder in San Francisco Pacific operations into New Zealand, hiring technology company endpoint Clinical, a staff there and establishing a legal entity. company that provides integrated response The New Zealand staff will work closely technology (IRT) for clinical trials. The own - with PRA’s office in Sydney, Australia. New ership stake comes as part of a strategic Zealand is a key research location for stud - partnership the companies have formed to ies in skin cancer, multiple sclerosis, and mutually expand each other’s services. “The asthma, the CRO said. The country is investment means Chiltern and our clients known for high recruitment rates, an effi - have access to expanded options in the cient regulatory environment and counter- mission critical IRT arena,” said Chiltern seasonality—which is advantageous to CEO Glenn Kerkhof. “For endpoint, working influenza and allergy studies. closely with a globally recognized full serv - ice CRO adds value as they expand their Patient Recruitment market and continue to strategically grow their operation.” Chiltern would not discuss I Gay men and lesbians are being excluded the specific terms of the agreement with from participation in some clinical trials endpoint but it is not exclusive. Kerkhof said based on their sexual orientation, according

Pfizer The drugmaker responded with a letter to monitoring and quality assurance the FDA, ensuring that efforts would be processes. Since that time, Pfizer has and monitoring violations were uncovered made to protect participants in the future, instituted several new measures designed in 2006 and 2007. These problems were but, in its latest warning, the FDA said to improve monitoring and execution of identified and reported to the FDA by Pfizer Pfizer needs to provide a more specific out - clinical trials, including our oversight of itself, but the FDA noted that the 2006 dis - line for ensuring proper monitoring. clinical investigators,” the statement said. covery was made by a Pfizer data manage - In a printed response on the company’s Pfizer has 15 days to respond to the ment unit, not a study monitor. web site, Pfizer was quick to point out that FDA’s letter, which was dated April 9. Pfizer Pfizer took steps to remedy the problem many of the violations had been discovered said that it had communicated with the by re-training staff and adding monitors, by the company itself. FDA and would spend the next two weeks but a July 2009 FDA inspection prompted “Many of the items cited by the FDA creating a plan to ensure that similar errors the latest warning letter when investigators were first uncovered and reported to the do not occur in the future. discovered that Pfizer was still not follow - FDA by Pfizer as far back as four years ing its own clinical trial safety guidelines. ago as part of our ongoing clinical trial

Aptium Oncology last week saying that the government- McKinley said problems like those cited funded Clinical Trials Cooperative Group in the report are what led to the formation programs. Aptium hopes this initial invest - Program, part of the National Cancer of Aptium’s consortia. ment will result in a long-term business Institute (NCI), is “approaching a state of “We see a big gap in the way that drugs strategy. crisis” as late-stage clinical trials are are developed, with pharma companies “It’s almost like another business line for being bogged down by waste and ineffi - kind of struggling to get trials up and run - the company,” McKinley said. “What we ciency. The Cooperative Group Program ning and recruited on time,” McKinley said. have set out to do—and what we are doing comprises more than 3,100 institutions AMyC will be directed by Brian Durie, with the GI consortium—is work with phar - and 14,000 investigators and enrolls M.D., the co-founder and chair of the ma companies to actually write the proto - about 25,000 patients a year. Despite International Myeloma Foundation. Fifteen cols with them and our investigators and to these resources, according to the report, investigators applied to be a part of the get the studies up and running. We take 40% of late-stage cancer trials end consortium, and 11 were selected based on care of contractual arrangements—we have before completion. the strength of the investigators, their asso - master agreements in place with each of the The report, conducted at the request of ciated institutions and their perceived abili - institutions. We’ll do the data collection, NCI director John Niederhuber, recommend - ty to quickly move studies through the clini - provide for the data analysis and work with ed that the Cooperative Group Program cal trial process. the companies to produce a clinical trial improve the design and conduct of cancer Aptium is planning for the first two report and then, of course, publish.” trials to be more efficient and provide myeloma trials to begin soon. The company’s The launch of the AMyc coincides with incentives to physicians and patients to GI Consortium has three trials ongoing for an Institute of Medicine report released increase participation. two different pharma companies.

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Year founded: 2010 Pearl IRB, Indianapolis, Indiana Employees: 20 An interview with Diana Caldwell, president and co-founder Tel: (317) 278-4100 Email: [email protected] Web site: www.pearlirb.com

How and why was Pearl IRB founded? To begin Pearl IRB, we first assessed the mar - ket and studied the needs of PIs, institutions, categories and the type of research—either Pearl IRB was founded earlier this year, and we sponsors and CROs for independent and central diagnostics or therapeutics. are the first and only commercial IRB in the state IRB services. We formed the company to align Another differentiator is that we are a of Indiana and one of the few in the Midwest. ourselves to meet those needs. We built our women-owned business. We offer the values and One of the reasons my co-founder Gretchen quality system, created critical processes and perspective that our combined 45 years in the Bowker, chief operating officer, and I formed assembled a powerhouse team with expertise industry brings to the table. Pearl IRB was to meet a need that we saw in the and experience in clinical research, IRBs, regula - clinical research industry for highly ethical, high tory and science that we think is needed to What challenges do you face? value and efficient IRB reviews. Unfortunately, for deliver top-quality service in this area. many principal investigators [PIs], sponsors and Overall, for all of us, the complexity and the chal - CROs [contract research organizations], the IRB What differentiates Pearl IRB from other lenges of multicenter large clinical trials place review process is perceived as a difficult, mysteri - IRBs? more burden and complexity on all of us. FDA ous and often very frustrating process that they has clearly demonstrated through their increased have to undergo before they can even get into High quality service and output. We engineered number of warning letters that they will give the clinic. this company to deliver high quality service with increased scrutiny to both commercial and insti - Our first priority is protecting human subjects, uncompromising ethics. Ethics and patients are tutional IRBs. Part of this is the fallout from the but we believe we can do that while also bal - front and center, but also customer service and a 2008 sting operation by the GAO [Government ancing the needs of institutions, sponsors and high quality review process are really important Accounting Office] that caught Coast IRB. This SMOs [site management organizations] and to us. Our tagline and the three things we talk created some bad press for commercial IRBs for CROs. The ultimate reason we founded Pearl IRB about are “Efficient. Ethical. Experienced.” a while. There have been more warning letters was to help patients. Our vision is to improve the We’re also going to provide training to PIs, sent out to not only commercial IRBs but also to clinical research process, which will lead to deliv - CRCs, clinical research associates, accreditation institutional IRBs. ering therapeutics and diagnostics to patients assistance and site monitoring and site remedia - We’ve also seen new draft guidance, which I sooner. Each of us has spent more than 15 years tion, so we can help with other ongoing site think was very welcome, which was released by on the sponsor side; therefore, we understand challenges they’re facing. FDA earlier this year in the IRB continuing review the sponsor research process and we have expe - Our board is very experienced. They possess process area, further articulating the IRB’s role in rienced firsthand the inefficiencies that kept a diversity of experience including members the process. It really addresses this trend of com - patients waiting. who have spent time with the FDA, members plexity of multisite studies. It asks the IRB to take I worked more than 15 years with Eli Lilly and with PI experience, sponsor industry folks, a more active role in looking across site data. A Company in business roles, primarily in sales people who have served on other IRBs and lot has changed since the days of one site, one and marketing and also in operations and also those who have SMO and CRO back - PI studies. finance. Gretchen’s background includes more grounds. Our board represents a 360-degree than 25 years in regulatory affairs and device perspective of clinical research. We’re also dif - How has the clinical research industry and drug development. For the last four years, ferentiated by the experience that spans changed? she was director of services at a regulatory across therapeutic categories in drugs, biolog - quality compliance consulting company called ics, devices and diagnostics. Sometimes, you’ll The industry, in general, faces increased scruti - Safis Solutions. She and I met while working see IRBs that have more of a drug focus and ny and an increased crunch in terms of fund - together there. Gretchen has been involved in some have more of a device/diagnostics focus. ing. One of the things that sponsors are the regulatory arena for 20 years. We have a good breadth of experience to increasingly doing is continuing to outsource cover all phases of research, the therapeutic page 6

all parts of the clinical research process. What are your plans for growth? Sponsors are looking for increased efficiency, expertise and cost savings. This trend is in Pearl This is not a part-time venture. This is a company IRB’s favor because outsourcing to an inde - that we’re committed to growing. We want to pendent IRB does help with efficiencies and expand nationally and internationally—first to provides more focused expertise. Our board is Canada in 2011. professionally dedicated to their board services We are in the process of obtaining state versus the internal institutional IRB folks who and national certification as a women-owned often have day jobs and other obligations that business right now. AAHRPP [Association for they need to meet. Time is money in clinical tri - the Accreditation of Human Research als, and our IRB saves time. Protection Programs] accreditation for IRBs is In addition, I think a centralized IRB allows not required, but we will be seeking that the sponsor and CRO to realize increased accreditation. We have built our quality sys - oversight and coordination, which ultimately tems around AAHRPP’s guidelines. We have offers better protection for subjects. A central - employees on board who have successfully ized IRB can help particularly with SAEs and built systems for other accredited IRBs and site coordination to better understand what’s have ensured that our systems were built to going on with the data. A central IRB provides industry best practices. efficiencies but it is also ultimately better for One of the challenges for all of us is that clinical trial subjects. there’s some inertia in the marketplace to We also see ongoing changes in the device change from the traditional model using a PI’s industry and an increased need for clinical tri - institution or hospital IRB. But the patients are als. We have extensive background in device waiting, and we all need to look at new and and diagnostic development as well as small more efficient models to improve the research and large molecules. Device manufacturers process. That may mean that an institution also desire more efficiency, and the expertise should outsource some or all of their reviews we bring can help them as well. The trend to a commercial IRB, that a sponsor will look and focus on personalized medicine is bring - to a centralized commercial IRB to provide ing about more drugs or biologics with com - increased efficiencies or a CRO partnering panion diagnostics. We understand the com - whenever they can. plexity that trend brings to protocols. Another challenge in the industry across all IRBs, but particularly institutional IRBs, is work overload. It is a common theme that there is more to review than capacity to do. This causes delays in studies and frustration for both parties. One of the answers to improved efficiency is a commercial IRB. Pearl IRB uses dedicated Editor’s Note: Organizations featured resources and business practices that allow the in our profiles have been selected by PI and the sponsor to clearly understand the CenterWatch editorial staff. If you would like laws and the oversight status and improves to be considered for a profile, please send communication among all parties. an email to [email protected].

Company Drug/Device Therapeutic Area Status Sponsor Info Acorda Therapeutics Glial Growth heart failure IND approved by the FDA; (914) 347-4300 Factor 2 (GGF2) phase I trials planned www.acorda.com Cornerstone CPI-613 cancer Phase I trials planned in the U.S. (609) 409-7050 Pharmaceuticals www.cornerstonepharma.com Genentech GDC-0623 solid tumors Phase I trials planned enrolling (650) 225-1000 62 subjects in the U.S. www.gene.com Stemedica allogeneic ischemic stroke IND approved by the FDA; (858) 658-0910 Cell Technologies stem cells phase I/II trials planned in the U.S. www.stemedica.com Transcept zolpidem tartrate insomnia Phase I trials planned enrolling (510) 215-3500 Pharmaceuticals 40 subjects in the Netherlands www.transcept.com Emisphere Tech/ oral PTH1-34 postmenopausal Phase I trials initiated enrolling (973) 532-8000 Novartis osteoporosis 120 subjects www.emisphere.com Algeta Alpharadin bone metastases from Phase I/II trials planned enrolling +47 23 00 79 90 prostate cancer 60 subjects in the U.S. www.algeta.com Ark Therapeutics Vascular Endothelial peripheral vascular Phase I/IIa trials initiated in Finland +358 (0) 17 240 875 Group Growth Factor-D disease www.arktherapeutics.com Allergan Botox (botulinum urinary tract symptoms/ Phase II trials planned enrolling (714) 246-4500 toxin type A) benign prostatic 274 subjects internationally www.allergan.com hyperplasia Ironwood IW-6118 pain following Phase II trials planned enrolling (617) 621-7722 Pharmaceuticals tooth extraction 90 subjects in Utah www.ironwoodpharma.com Mesoblast NeoFuse degenerative disc disease Phase II trials planned enrolling +61 3 9639 6036 12 subjects in Australia www.mesoblast.com Advaxis ADXS11-001 cervical cancer Phase II trials initiated in the U.S. (732) 545-1590 www.advaxis.com Morria MRX6 contact dermatitis Phase II trials initiated enrolling (917) 361-5210 Biopharmaceuticals 80 subjects in Israel www.morria.com NeoPharm LE-DT pancreatic cancer Phase II trials initiated enrolling (847) 887-0800 40 subjects in the U.S. www.neopharm.com Theravance TD-1211 opioid-induced Phase II trials initiated enrolling (650) 808-6000 constipation 50 subjects www.theravance.com Prana Biotechnology PBT2 Alzheimer's disease Phase IIb trials planned enrolling +61 3 9349 4906 525 subjects in Australia www.pranabio.com Nuon Therapeutics NU1618 chronic hyperuricemia Phase IIb trials planned (650) 645-1800 www.nuontherapeutics.com Lotus Laevo-Bambutero asthma Fast Track status granted by +86 10 6389 9868 Pharmaceuticals China's State Food & www.lotuspharma.com Drug Administration SuppreMol GmbH SM101 idiopathic Orphan drug status granted +49 (0)89 30 90 50 680 thrombocytopenic purpura by the FDA www.suppremol.com Alexion Soliris paroxysmal nocturnal Approved in Japan (203) 272-2596 Pharmaceuticals hemoglobinuria www.alxn.com Novartis Zortress prevention of organ FDA approved (888) 669-6682 (everolimus) rejection in kidney www.novartis.com transplant patients

Endocrinology strated reductions in viral loads (mean double-blind, placebo-controlled study changes in HCV RNA from baseline) that (VO61.08) enrolled 473 adults with grass I Phenomix released positive results from were comparable to that achieved with PEG- pollen-induced rhinoconjunctivitis. The a phase III trial of dutogliptin for the Intron administered once per week; 41%, subjects received either placebo or 300IR treatment of type 2 diabetes. This 24- 52% and 50% of the subjects had unde - sublingual tablet taken daily for approxi - week, international, randomized, double- tectable HCV RNA, respectively. Treatment mately six months starting four months blind, parallel-group, placebo-controlled was well tolerated, and there were no unex - before the grass pollen season and over study (PROT301) enrolled 542 subjects pected adverse events. Biolex plans to con - the grass pollen season. The primary end - with moderately elevated baseline hemo - tinue with the development of Locteron. point a reduction of the Average globin A1c (HbA1c) levels. The subjects Combined Score, a combination of the received dutogliptin 400mg or 200mg Oncology Rhinoconjunctivitis Total Symptom Score once daily or placebo. The primary end - and the Rescue Medication Score, com - point was statistically significant reduc - I Abraxis reported positive results from pared with placebo. This endpoint was tions of HbA1c compared with placebo at a phase I/II trial of Abraxane plus reached with statistical significance. Week 24. Reductions in HbA1c corrected gemcitabine for the treatment of pancre - Oralair was well tolerated. Development for placebo effects were 0.59% for the atic cancer. This open-label study of Oralair will move forward as planned. 400mg dose (p<0.0001) and 0.28% for enrolled a total of 67 subjects. In the the 200mg dose (p<0.0138). Statistical phase I portion, the subjects received significance was also observed at the weekly doses of Abraxane (100, 125, or 400mg dose for all secondary endpoints, 150mg/m2) in combination with gemc - including change from baseline in fasting itabine (1,000mg/m2) for three weeks and peak postprandial plasma glucose, (on Days 1, 8 and 15) with one week of change from baseline in glucose AUC (0 rest. The primary safety endpoint was the to 2 hours) after a standard test meal, identification of the maximum tolerated and percentage of subjects reaching dose and dose-limiting toxicities. The rec - treatment goal of HbA1c of less than ommended dose for the phase II portion 7.0%. Additional phase III trials are cur - was determined to be 125mg/m2 rently under way. Abraxane plus 1000 mg/m2 gemcitabine. In the 44 subjects treated at this dose, Infectious Disease the median overall survival time was 12.2 months, doubling the historical con - I Biolex issued positive interim results from a trol of gemcitabine administered alone. phase IIb trial of Locteron , a controlled- The combination also resulted in a con - release interferon alpha for the treatment of firmed overall response rate in 50% of hepatitis C. This trial enrolled 116 treatment- the subjects and a disease control rate of naive subjects with genotype-1, chronic hep - 68%. In the overall study (n=67), three atitis C. The subjects were randomized into patients achieved a complete response. A one of four dosing cohorts, the 320, 480 or phase III trial evaluating this combina - 640 µg dose of Locteron (administered once tion is currently under way. every two weeks) or a control arm consisting of standard of care, PEG-Intron (1.5 µg/kg, Respiratory administered every week); all subjects received weight-based ribavirin. The treat - I Stallergenes released positive results ment duration was 48 weeks. These interim from a phase III trial of their sublingual results are through 36 weeks of treatment. grass pollen immunotherapy tablet, The two highest doses of Locteron demon - Oralair . This U.S.-based randomized,

The stories included in Biotech Review have From BioWorld Today been provided to CenterWatch with the full permission of BioWorld Today and its publisher, AHC Media LLC. Copyright ©2010 I Celgene and privately held Agios plans to nix its agreement with Myriad. AHC Media LLC. Pharmaceuticals have entered a pre - Javelin said that it intends to terminate clinical collaboration in the area of cancer its agreement with Myriad shortly, unless BioWorld is located at 3525 Piedmont Road, metabolism, a deal that will bring in a that company ups its terms. If the agree - Building 6, Suite 400, Atlanta, GA 30305 hefty $130 million upfront for Agios, ment is terminated, Myriad would be U.S.A. Please call (800) 688-2421 or (404) including an equity investment. In return, entitled to repayment, in full, of the out - 262-5476 for more information. Or visit Celgene has an exclusive option to license standing balance under the $8.5 million www.bioworld.com. any clinical candidates resulting from the loan and security agreement with Javelin, Agios cancer metabolism research plat - with accrued interest, as well as stipulat - form at the end of phase I. Once the ed expenses of up to $1.5 million plus a exclusive collaboration period is up, termination fee of $2.9 million following Celgene may extend the deal through termination. Hospira and its wholly additional funding. Agios also could owned subsidiary, Discus Acquisition, receive up to $120 million in milestones have made a binding offer to buy out as well as royalties on sales, and also may Javelin at a per-share price of $2.20. In participate in the development and com - addition, Hospira will, subject to certain mercialization of certain products in the conditions, provide Javelin a working U.S. Agios will lead discovery and early capital facility under which Javelin may translational development for all cancer borrow up to $4.5 million to fund its metabolism programs, and Celgene will operating activities prior to closing a lead and fund global development and merger with Hospira; Javelin’s repayment commercialization of licensed programs. of the principal and accrued interest incurred under its arrangement with I Mersana Therapeutics signed a $334- Myriad; and $4.4 million for Javelin’s million deal with Teva Pharmaceuticals payment of the termination fee and cer - Industries for XMT-1107, a preclinical tain stipulated expenses that the compa - revival of the old antiangiogenic drug ny may be required to pay Myriad follow - fumagillin. Teva agreed to pay $334 mil - ing termination of its merger agreement. lion in upfront and milestone payments, as well as royalties, for rights to XMT- I Dynavax Technologies is raising $44 1107 worldwide except in Japan, where million through a public offering of stock Mersana plans to seek a regional partner. and warrants, providing cash to push Teva also is covering all development beleaguered hepatitis B vaccine Heplisav costs except those specific to Japan. Teva through its final phase III trials and has contracted with Mersana to run a toward a biologics license application fil - phase I solid tumor trial, which is slated ing next year. Dynavax is selling 30.3 mil - to begin this quarter. lion units priced at $1.4525 apiece. Each unit consists of one common share and I Just days before Javelin one five-year warrant to purchase one Pharmaceuticals and Myriad half of an additional share with an exer - Pharmaceuticals were to close on a cise price of $1.50. Wedbush PacGrow merger deal, a competing “superior” bid Life Sciences served as the sole under - came in from Hospira , and now Javelin writer for the financing.