Financings

• Anadys Pharmaceuticals Inc. raised $17.5 million in a stock and warrant sale and cut 40% of its staff after adverse event data scuttled near-term hopes of a partnership for non-nucleoside polymerase inhibitor ANA598 in hepatitis C.

• Biovail Corp. priced a $300 million senior convertible note offering.

• MiRagen Therapeutics Inc. secured the second tranche of the $8 million Series A round it closed last year, as well as a $4 million Series A extension from new investors.

• OPKO Health Inc. got $31 million in a private placement.

• Pharmacyclics Inc. filed for a $24 million rights offering.

• Pharmaxis Ltd. raised $37.6 million in a private placement.

• Synairgen plc is raising $10.2 million in a private placement.

• Thallion Pharmaceuticals Inc. got $8.85 million in non-dilutive funding as part of a reorganization deal.

• Valeant Pharmaceuticals International priced a $365 million private placement of senior notes.

• Versartis Inc., a joint venture between Amunix Inc. and Index Ventures, closed an $11 million Series A financing.

• Xanodyne Pharmaceuticals Inc. raised $38 million in a venture round led by MPM Capital and named Michael Valentino as CEO.

 

Deals

• Celldex Therapeutics Inc. moved to buy CuraGen Corp. in a $94.5 million stock deal that will bring in 11 antibodies and some added cash.

• Concert Pharmaceuticals Inc. got $35 million up front in a potential $1 billion deal with GlaxoSmithKline plc for preclinical deuterium-modified drugs.

• Merck & Co. Inc. and AstraZeneca plc teamed up to combine AKT-inhibitor MK-2206 and MEK-inhibitor AZD6244 in a Phase I cancer trial (no terms).

 

. . . And More

• Conferences: ASCO 2009 released a flood of news, with prostate cancer, glioblastoma, vaccines, biomarkers and more making headlines and sending biotech stocks soaring. Check last week's issues of BioWorld Today for blow-by-blow coverage. Ditto for data on Crohn's disease, gastroesophageal reflux and other findings from DDW.

• Restructurings: TorreyPines Therapeutics Inc. bit the dust - its board approved a liquidation plan. Meanwhile Northfield Laboratories Inc. filed for Chapter 11 bankruptcy; Adolor Corp., A.P. Pharma Inc. and StemCells Inc. cut staff; and Halozyme Therapeutics Inc. deprioritized its bisphosphonate-PH20 Phase I program for osteoporosis.

• Advanced Life Sciences Inc. shares plunged 62% on a negative FDA panel vote for ketolide antibiotic Restanza (cethromycin) in community-acquired pneumonia.

• Affymax Inc. got another full-steam-ahead ruling from the data monitoring committee for its two Phase III trials of Hematide for anemia in chronic renal failure.

• ARCA Biopharma Inc. shares sank 45% on a complete response letter asking for another trial of beta-blocker Gencaro (bucindolol) in chronic heart failure.

• Avexa Ltd. switched Phase III patients receiving 1,200-mg of HIV drug apricitabine to an 800-mg dose, based on a data safety monitoring board recommendation.

• Catalyst Pharmaceutical Partners Inc. shares fell 57% on a Phase II failure with lead program CPP-109 (vigabatrin) for cocaine addiction.

• Clinical Data Inc.'s vilazodone met its primary and secondary endpoints in the second of two Phase III trials for major depressive disorder, providing further support for an NDA filing by the end of the year.

• CSL Biotherapies Inc.

inked a $180 million contract with HHS to provide bulk H1N1 influenza vaccine antigen, with initial delivery expected in September.

• Genmab AS's anti-CD20 antibody Arzerra (ofatumumab) got the thumbs up from ODAC for accelerated approval in chronic lymphocytic leukemia. But the FDA placed a partial clinical hold on Phase I/II and Phase II trials of anti-EGFR antibody zalutumumab, although Phase III trials were not affected.

• Kamada Ltd. submitted a biologics license application for its intravenous alpha-1 antitrypsin for alpha-1 antitrypsin deficiency.

• MedImmune Inc., a unit of AstraZeneca plc, won a $90 million contract to manufacture H1N1 influenza vaccine for HHS.

• Novavax Inc. saw its shares jump 74% after signing a deal with the NIH to evaluate its virus-like particle (VLP) vaccine against H1N1 influenza.

• Pfizer Inc. discontinued the SUN 1094 Phase III study of Sutent (sunitinib) plus paclitaxel vs. Avastin (bevacizumab, F. Hoffmann-La Roche Ltd.) plus paclitaxel for first-line breast cancer due to unlikelihood of improving survival.

• Sepracor Inc.'s new drug application for Stedesa (eslicarbazepine acetate) in adjunctive seizure treatment was accepted by the FDA with a Jan. 30 action date.

• Sucampo Pharmaceuticals Inc. smacked partner Takeda Pharmaceutical Co. Ltd. with the threat of a performance audit to find out why sales of Amitiza (lubiprostone) are lagging in constipation and irritable bowel syndrome.

• Theratechnologies Inc. filed a new drug application for growth hormone-releasing factor analogue tesamorelin (TH9507) in HIV-associated lipodystrophy.

• ViroPharma Inc. got a complete response letter asking for a new trial of Cinryze (C1-esterase inhibitor) in acute attacks of hereditary angioedema. The drug is approved for HAE prevention but is one of many racing for the acute HAE market. (See Friday's BioWorld Today for an overview of the space.)