Astellas Pharma US Inc., of Northbrook, Ill., part of Astellas Pharma Inc., entered a distribution agreement with Tecnofarma International Ltd., of Buenos Ares, Argentina, to distribute enzalutamide (Xtandi in the U.S.) in Latin America, excluding Brazil, upon regulatory approvals in the various countries...Johnson & Johnson, of New Brunswick, N.J., said its Johnson & Johnson Innovation arm signed an agreement with the California Institute for Quantitative Biosciences (QB3) to allocate 5,000 square

Horizon Pharma Inc., of Deerfield, Ill., said in an SEC filing that it provided written notice to Mallinckrodt LLC, the pharmaceuticals business of Dublin, Ireland-based Covidien LLC, of the termination of the companies' co-promotion agreement dated June 14, 2012, effective 30 days after the date of such notice...to purchase all of the outstanding capital stock of ProFibrix, subject to the former's satisfactory review of the pending Phase III trial results with Fibrocaps, a dry powder topical

Hyperion Therapeutics Inc., of South San Francisco, said it completed the acquisition of Buphenyl (sodium phenylbutyrate) tablets and powder, from Ucyclyd Pharma Inc., a subsidiary of Valeant Pharmaceuticals International Inc., of Laval, Quebec, Buphenyl is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders (UCD...AstraZeneca is planning to develop ISIS-ARRx broadly to treat patients under a variety of settings during the course of prostate cancer

In other news, Perrigo received approval for the generic version of Sanctura XR (trospium chloride; Allergan Inc.) to treat overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency

plc, of Dublin, Ireland, said its board rejected New York-based Royalty Pharma's revised offer to acquire all of Elan's shares for $12.50 per share through its shell subsidiary Echo Pharma Acquisition Ltd., stating that the bid "grossly" undervalued the company...In other news, Elan priced its offering of $850 million aggregate principal amount of 6.25 percent senior notes due 2021 by its wholly owned subsidiaries, Elan Finance public limited co

AVEO Pharmaceuticals Inc., of Cambridge, Mass., said in an SEC filing that it was informed by partner Astellas Pharma Inc., of Tokyo, that Astellas no longer intends to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC...Medivation Inc., of San Francisco, said partner Astellas Pharma Inc., of Tokyo, submitted an application for marketing approval in Japan for enzalutamide in prostate

plc, of Dublin, Ireland, said its board on Thursday rejected New York-based Royalty Pharma's revised offer to acquire all of Elan's shares for $12.50 per share through its shell subsidiary Echo Pharma Acquisition Ltd., stating that the bid "grossly" undervalued the company...The Royalty offer was contingent on Elan's shareholders voting down all of its M&A transactions, including its recent $1 billion cash deal to buy a 21 percent stake in South San Francisco-based Theravance Inc.'s future royalty

In addition to RA and Crohn's, the pharma may develop GLPG0634 in psoriasis, irritable bowel syndrome and lupus, mirroring the path by which the label on its blockbuster Humira (adalimumab) was expanded beyond RA...Helsinn Healthcare SA, of Lugano, Switzerland, and Vifor Pharma, of Villars-sur-Glane, Switzerland, signed an exclusive license and distribution agreement for netupitant-palonosetron fixed-dose combination, an investigational Helsinn product for chemotherapy-induced nausea and vomiting

The pharma also will assume responsibility for funding and clinical development beyond Phase II and for completing regulatory and commercialization activities...In addition to RA and Crohn's, the pharma may develop GLPG0634 in psoriasis, irritable bowel syndrome and lupus, mirroring the path by which the label on its blockbuster Humira (adalimumab) was expanded beyond RA. (See BioWorld Today, March 1, 2012, and Jan. 3, 2013...Prior to the reacquisition, GSK experienced manufacturing issues and delays

Scientists at Bayer HealthCare's U.S. Innovation Center in San Francisco will work collaboratively with counterparts at QB3 and Mission Bay Capital in the structured public-private partnership, with QB3 bringing up to 60 companies a year from its network for Bayer to evaluate for potential partnerships...The company plans to use proceeds to repurchase common stock and for general corporate purposes, including the repayment of outstanding commercial paper borrowings and upcoming debt maturities

Even after the news broke Monday – and the Theravance share price (NASDAQ:THRX) gained more than 14 percent to hit $40 – the entire company was still only valued at $3.94 billion...Editor's note: To obtain a CD of the webinar, "Royalty Financing for Biotech and Medical Device Companies: How to Determine Eligibility and Take Advantage of this Unique Financing Opportunity" or for a deeper dive, BioWorld's Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking, call 800-477-6307

Even after the news broke Monday – and the Theravance share price (NASDAQ:THRX) gained more than 14 percent to hit $40 – the entire company was still only valued at $3.94 billion...Editor's note: To obtain a CD of the webinar, "Royalty Financing for Biotech and Medical Device Companies: How to Determine Eligibility and Take Advantage of this Unique Financing Opportunity" or for a deeper dive, BioWorld's Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking, call 800-477-6307

Acceleron Pharma Inc., of Cambridge, Mass., said preclinical research conducted by Acceleron scientists on the ACE-536 program were presented at the 12th International Symposium on Myelodysplastic Syndromes in Berlin...Zhejiang Beta Pharma will own 51 percent of it and Amgen will own the remaining 49 percent...The split is intended to increase the per-share trading price of the common stock to satisfy the $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market

In separate news, Hyperion said it exercised its option to acquire Buphenyl (sodium phenylbutyrate) tablets and powder, an FDA-approved therapy for the chronic management of the most prevalent UCDs, and Ammonul (sodium phenylacetate and sodium benzoate) injection, a hospital-based product used to treat UCD patients in hyperammonemic crisis, from Valeant Pharmaceuticals International Inc., of Montreal...The big pharma firm stated that it has opted to prioritize the fixed-ratio combination of Lantus

to formulate CytoDyn's PRO 140 bulk drug substance through a fill-and-finish process for clinical-ready vials to advance two National Institutes of Health (NIH)-funded Phase IIb studies...Pfenex Inc., of San Diego, awarded Glide Pharma, of Oxford, UK, a subcontract to develop a solid formulation containing the recombinant protective antigen (rPA) from Bacillus anthracis expressed in Pfenex Expression Technology, suitable for delivery with the Glide SDI (solid dose injector

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee

Achaogen Inc., of South San Francisco, was awarded a $60 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) supporting a global Phase III superiority study that will evaluate the efficacy and safety of plazomicin in treating patients with serious Gram-negative bacterial infections due to Carbapenem-resistant Enterobacteriaceae...Addex Therapeutics, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio...In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma

for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments...to conduct a review of merger and acquisition opportunities. (See BioWorld Today, Feb. 1, 2013...It expects to launch the product in Canada, and a number of Central American, South American and Asian countries in 2014 and 2015