Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date I. Modified Agreements APRIL Affymax Inc. (Palo Alto, Calif.) Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) $180 Amended collaboration for Omontys, changing the deal from a profit-sharing arrangement to a milestone and royalty-based compensation structure to Affymax Takeda assumes full responsibility for Omontys and, if it reintroduces the drug to market, Affymax would be eligible to receive royalties and

Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Aeterna Zentaris Inc. (Quebec City) Ergomed Clinical Research Ltd. ND Co-development and profit-sharing agreement for AEZS-108 in endometrial cancer Ergomed will receive a single-digit percentage of any net income received by Aeterna Zentaris in that indication, up to a specified maximum amount 4/11/13 Aeterna Zentaris Inc. (Quebec City) Merck KGgA (Darmstadt, Germany) subsidiary ND Deal for manufacturing

Total Value in 2013: $6,192M* Number of Deals in 2013: 97 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Alchemia Ltd. (Brisbane, Australia) AstraZeneca AB (Sodertalje, Sweden; unit of AstraZeneca plc) $240 Deal for Alchemia's Diversity Scanning Array and Versatile Assembly on Stable Templates technologies to discover and develop small molecules for multiple targets in the oncology, respiratory, cardiovascular, metabolism, infection and neuroscience

Gilead Science Inc.'s oral targeted cancer drug, idelalisib (GS-1101), made a splash last week when the American Society of Clinical Oncology (ASCO) unveiled thousands of abstracts scheduled for presentation at next week's annual meeting in Chicago. In a press conference Wednesday afternoon, Jennifer R. Brown, director of the Chronic Lymphocytic Leukemia Center at the Dana-Farber Cancer Institute, provided Phase I findings suggesting idelalisib, as a single agent, has the potential to stave off

Company Company Deal Value Inspiration Biopharmaceuticals Inc. Baxter International Inc. $700M Chiasma Inc. Roche AG $595M Edison Pharmaceuticals Inc. Dainippon Sumitomo Pharma Co. Ltd. $545M Trevena Inc. Forest Laboratories Inc. $460M Abide Therapeutics Inc. Merck & Co. Inc. $430M Moderna Therapeutics Inc. AstraZeneca plc $420M Isis Pharmaceuticals Inc. Roche AG $393M Ambrx Inc. Astellas Pharma Inc. $300M Resolve Therapeutics LLC Takeda Pharmaceutical Co. Ltd. $255M Alchemia Ltd. AstraZeneca

Mirna Therapeutics Inc. announced last week that it has initiated a Phase I trial of MRX34, its microRNA (miRNA) mimic. Andreas Bader, director of research at Mirna, told BioWorld Insight the company believes it's the first miRNA mimic to enter the clinic. Strictly speaking, it's not the first drug in the clinic involving a miRNA. That distinction belongs to Santaris Pharma A/S, which has been in the clinic since 2008 with miravirsen (SPC3649), its inhibitor of miR-122, a liver specific miRNA

"Provided that these experiments are reproducible in the hands of others, the findings offer the potential to accelerate progress toward the development [of these cells] to treat a range of degenerative diseases." – Mary Herbert, professor of reproductive biology at Newcastle University, on the success in cloning human embryonic stem cells from skin cells via somatic cell nuclear transfer "After going over there and seeing how the landscape was changing, it seemed like there was a growing

Amending an oversight in the Jumpstart Our Business Startups (JOBS) Act, the House voted 416-6 to set a deadline for the SEC to implement Regulation A changes. The National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules. Under the proposal, as long as an initial human study of certain human gene transfers is approved by a registered institutional biosafety committee (IBC

Financings Acadia Pharmaceuticals Inc. priced a $100 million public offering of 8 million shares of common stock. Ambit Biosciences Corp. completed its IPO for gross proceeds of about $65 million. AxoGen Inc. filed a registration statement on Form S-1 for a proposed $15 million public offering. Discovery Laboratories Inc. closed a $14.25 million public offering of 9.5 million shares at $1.50. Dyax Corp. completed a $30 million registered direct offering to fund R&D activities. Erytech Pharma SA

Last week, researchers from Oregon Health & Science University reported that they had created embryonic stem cells via somatic cell nuclear transfer (SCNT), with a high enough efficiency to bring the creation of patient-specific embryonic stem cell lines into the realm of the possible. Successful medicine, though, takes more than scientific progress. And embryonic stem cells have always been the poster child for that fact. The scientific challenges are formidable in their own right. The hope of

Company (Location) Product Description Indication Status Date Activartis Biotech GmbH (Vienna, Austria) AVO113 Consists of dendritic cells loaded with antigens derived from each patient's tumor Glioblastoma The first interim analysis in a Phase III trial indicated there will be an overall survival benefit in treated patients 4/10/13 Aprea AB (Stockholm, Sweden) APR-246 Designed to reactivate mutant p53 Ovarian cancer Results showed that APR-246 acts synergistically with platinum compounds and

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvement

Company (Location) Product Description Indication Status Date Actavis Inc. (Parsippany, N.J.) Testosterone Gel 1.62%, a generic version of AbbVie Inc.'s AndroGel 1.62% Absence of endogenous testosterone Filed an abbreviated NDA with the FDA 4/2/13 Almirall SA (Barcelona, Spain) and Forest Laboratories Inc. (New York) Aclidinium bromide and formoterol fumarate A long-acting muscarinic beta2 agonist and a long-acting beta2 agonist Chronic obstructive pulmonary disorder Top-line Phase III data

Company (Location) Product Description Indication Status Date Pfizer Inc. (New York) Prevenar 13 Pneumococcal polysaccharide conjugate vaccine Infections Phase III data showed it met all primary and secondary objectives focused on immunogenicity, tolerability and safety in adults 18 to 49 4/30/13 Tetraphase Pharmaceuticals Inc. (Watertown, Mass.) Antibiotics Two next-generation antibiotic candidates Community-acquired multidrug-resistant infections Studies demonstrated efficacy 4/30/13 Trius

The Patient-Centered Outcomes Research Institute approved 51 new awards, totaling $88.6 million over three years, to fund comparative clinical effectiveness research (CER) projects that fall under the first four areas of its research agenda. Colorado, Florida and Indiana are the latest states to shoot down a bill that would require notification and recordkeeping if a pharmacy substitutes a biosimilar for the prescribed biologic. The legislation was modeled on principles the Biotechnology

As regulators, payers and drug developers become more comfortable with their use, interest in companion diagnostics to help direct targeted medicines to the right patient populations has surged in the past couple of years. Drug companies are certainly recognizing that companion diagnostics, when co-developed with potential therapeutics, can assist in regulatory approvals. The early applications have mainly been with cancer therapies and 2011 served as a pivotal year in the demonstration of the