South San Francisco) AV-101 An oral prodrug candidate Chronic neuropathic pain Completed its final Phase I study 1/24/13 Zogenix Inc. (San Diego) Relday A once-monthly subcutaneous formulation of risperidone Schizophrenia Phase I data showed that adverse events were generally mild to moderate and consistent with other risperidone products 1/4/13 DIABETES Biodel Inc. (Danbury, Conn.) BIOD-238 and BIOD-250 Ultra-rapid-acting insulin analogue-based formulations Type I diabetes Phase I data from a

Ltd. (Osaka, Japan) OCA Obeticholic acid Nonalcoholic steatohepatitis Began a Phase II trial 1/9/13 Tobira Therapeutics Inc. (South San Francisco) Cenicriviroc An oral, once-daily CCR5/CCR2 inhibitor HIV Phase IIb data showed it met the primary objective 1/8/13 INFLAMMATORY Receptos Inc. (San Diego) RPC1063 Selective sphingosine1 phosphate 1 receptor modulator Moderately to severely active ulcerative colitis Dosed the first patient in a Phase II study 1/7/13 XOMA Corp. (Berkeley, Calif

South San Francisco) and Genentech Inc. (South San Francisco) Zelboraf Vemurafenib...BRAF inhibitor Malignant melanoma First patient was dosed in a pivotal Phase III trial 1/18/13 Morphotek Inc. (Exton, Pa.) Farletuzumab Ovarian cancer drug Ovarian cancer Phase III trial of farletuzumab with carboplatin and taxane did not meet its primary endpoint of progression-free survival 1/14/13 Onyx Pharmaceuticals Inc. (South San Francisco) and Bayer AG (Leverkusen, Germany) Nexavar Sorafenib Locally

South San Francisco) and GlaxoSmithKline plc (London) UMEC-VI A combination of GSK573719 (umelidinium bromide) and vilanterol Chronic obstructive pulmonary disease Submitted an MAA in the European Union 1/10/13 MISCELLANEOUS Keryx Pharmaceuticals Inc. (New York) Ferric citrate Ferric citrate Hyperphos-phatemia in chronic kidney disease Filed an NDA in Japan 1/8/13 Santhera Pharmaceuticals Inc. (Liestal, Switzerland) Raxone Idebenone Blindness The CHMP turned down the drug by a narrow majority 1

South San Francisco) Avastin Bevacizumab Metastatic colorectal cancer FDA granted approval for patients receiving Avastin plus an irinotecan or oxaliplatin containing chemotherapy to continue to receive Avastin plus a different chemotherapy after their cancer worsens 1/25/13 Icon Bioscience Inc. (Sunnyvale, Calif.) Melphalan Intraocular injection formulated using the Verisome delivery technology Retinoblastoma Was granted orphan designation by the FDA 1/4/13 Telik Inc. (Palo Alto, Calif

Paris-based Sanofi SA is also in the clinic with a dual inhibitor, SAR245409 (XL765), which it in-licensed from Exelexis Inc., of South San Francisco

Paris-based Sanofi SA is also in the clinic with a dual inhibitor, SAR245409 (XL765), which it in-licensed from Exelexis Inc., of South San Francisco

Stifel Nicolaus Bird, Canaccord Genuity Cantor Fitzgerald $52.44 $290.7 Onyx Pharmaceuticals Inc. (South San Francisco; ONXX)13 1/15/13 1/16/13 4.4S $81.50 N/A BofA Merrill Lynch Barclays (co-lead) $358.6 N/A Synageva BioPharma Corp. (Lexington, Mass.; GEVA)14 1/3/13 1/3/13 2.5S $47.53 26.9 Morgan Stanley JP Morgan (co-lead) Cowen & Co...Canaccord Genuity Leerink Swann $118.825 $1.28B Theravance Inc. (South San Francisco; THRX)15 1/18/13 1/18/13 Notes N/A N/A BofA Merrill Lynch Leerink Swann

In February 2010, the South San Francisco-based firm implemented a restructuring plan to reduce clinical spend and support costs...The restructuring resulted from an unsuccessful merger with South San Francisco-based VaxGen Inc., a shell company, which had $33 million in cash at the time

KaloBios Pharmaceuticals Inc., of South San Francisco, completed its initial public offering of 8.75 million shares of common stock at $8 per share

Portola Pharmaceuticals Inc., of South San Francisco, inked a clinical collaboration with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, and Bayer AG, of Leverkusen, Germany, to evaluate the safety of PRT4445, an antidote for Factor Xa inhibitors, in healthy volunteers to have been administered oral anticoagulant Xarelto (rivaroxaban

Bullish investors had been expecting a favorable outcome, thanks largely to a press release issued by the South San Francisco-based orphan drug firm in mid-January, which said the FDA, which had pushed back the review date by three months in September, warned of another delay while it ironed out label and postmarketing requirements

Oxigene Inc., of South San Francisco, added David (Dai) Chaplin to its board

LLC exercise their overallotment option in full – is more than the $60 million South San Francisco-based KaloBios originally hoped to raise when the firm filed its S-1 back in October. (See BioWorld Today, Oct. 8, 2012.) The company set proposed terms in January calling for the sale of 3.9 million shares priced between $12 and $14, which would have brought in $50.7 million at the midpoint range

South San Francisco-based Genentech is "cautiously optimistic" that GA101 could replace Rituxan, "which is what we set out to do," Valente said

Concerns over the potential toxicity of BCX5191 also led to the termination of a proposed merger between BioCryst and Presidio Pharmaceuticals Inc., of South San Francisco, which had been intended, in part, to combine the two companies' work in HCV. (See BioWorld Today, Aug. 27, 2012, and Dec. 3, 2012...Portola Pharmaceuticals Inc., of South San Francisco, and Lee's Pharmaceutical Ltd., of Hong Kong, will jointly expand the Phase III APEX trial of betrixaban into China

Genentech Inc., of South San Francisco, part of the Roche Group, said the FDA approved Avastin (bevacizumab) for use in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line Avastin-containing regimen

Exelixis Inc., of South San Francisco, began selling Cometriq (cabozantinib) in the U.S...Genentech, of South San Francisco, a member of the Roche Group, said the FDA gave its go-ahead to a new use of already approved cancer drug Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC

VistaGen Therapeutics Inc., of South San Francisco, said it completed its final Phase I study of AV-101, an oral prodrug candidate in development for multiple conditions involving chronic neuropathic pain