• Affymax Inc., of Palo Alto, Calif., received a $10 million milestone payment from Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, triggered by the acceptance and filing of a new drug application for peginesatide by the FDA. The companies are seeking approval of peginesatide as a once-monthly erythropoiesis stimulating agent for anemia associated with chronic kidney disease patients on dialysis. (See BioWorld Today, June 1, 2011.)

• Avila Therapeutics Inc., of Bedford, Mass., relocated to a 23,000-square-foot facility in Bedford.

• Genesis Biopharma Inc., of Los Angeles, inked a five-year cooperative research and development agreement (CRADA) with the National Cancer Institute to develop adoptive cell immunotherapies designed to destroy metastatic melanoma cells using a patient's tumor infiltrating lymphocytes. Specifically, the CRADA will support the in vitro development of improved methods for the generation and selection of tumor infiltrating lymphocytes with antitumor reactivity from melanoma patients, develop approaches for large-scale production of those lymphocytes and allow the conduct of clinical trials.

• Ironwood Pharmaceuticals Inc., of Cambridge, Mass., and Forest Laboratories Inc., of New York, submitted a new drug application to the FDA for linaclotide for the treatment of irritable bowel syndrome with constipation and chronic constipation. The guanylate cyclase type-C agonist was evaluated in a Phase III program comprising more than 2,800 patients in four double-blind, placebo-controlled trials and more than 3,200 patients in ongoing open-label, long-term safety studies. Ironwood and Forest plan to co-promote linaclotide in the U.S. Ironwood out-licensed the drug to Almirall SA, of Barcelona, Spain, for European development. Tokyo-based Astellas Pharma Inc. will develop and commercialize linaclotide in Indonesia, Japan, Korea, the Philippines, Taiwan and Thailand. (See BioWorld Today, Nov. 3, 2010.)

• Marina Biotech Inc., of Bothell, Wash., reported in vivo data showing that a single-stranded oligonucleotide construct, modified with the company's conformationally restricted nucleotide (CRN) technology, demonstrated high potency and good tolerability in inhibiting microRNA-122. The CRN modified antagonist was highly effective at a dose of 10 mg/kg, while demonstrating good tolerability with repeat dosing.

• Medivation Inc., of San Francisco, expects to report interim analysis data this year from its Phase III AFFIRM trial, which is evaluating MDV3100 on overall survival in 1,199 men with advanced prostate cancer who have previously been treated with docetaxel-based chemotherapy. Medivation is partnering with Astellas Pharma Inc., of Tokyo, to develop the androgen receptor antagonist across the spectrum of advanced prostate cancer disease states. (See BioWorld Today, March 19, 2009.)

• Paladin Labs Inc., of Montreal, made an offer to acquire all existing and outstanding shares of Afexa Life Sciences Inc., of Edmonton, Alberta, for 55 cents per share. Afexa derives most of its income from its cold and flu remedy, Cold-Fx, marketed in Canada to reduce the frequency, severity and duration of cold and flu symptoms. In July, Paladin purchased 15,421,300 shares of Afexa stock, to achieve beneficial ownership of 14.94 percent of shares in the company. The offer follows failure of previous acquisition discussions between Paladin and Afexa.

• Pharmacyclics Inc., of Sunnyvale, Calif., signed a five-year cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) for the development of PCI-32765, a Bruton's tyrosine kinase inhibitor for treatment of blood cancers. Under the agreement, the NCI will sponsor Phase I and II trials of the drug for various types of cancers, including non-Hodgkin lymphoma and multiple myeloma.

• Prolor Biotech Inc., of Nes-Ziona, Israel, will receive a grant from Israel's Office of the Chief Scientist for the development of its long-acting human growth hormone, hGH-CTP. It will use the $1.7 million grant to advance hGH-CTP into Phase III trials following positive results from a Phase II trial in adults with growth hormone deficiency.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said in its second quarter earnings update that it will continue to develop Xifaxan (rifaximin) 550-mg tablets for irritable bowel syndrome (IBS). The drug is approved for traveler's diarrhea and hepatic encephalopathy, but received a complete response letter for IBS earlier this year. Salix said an FDA advisory committee will be convened in November to help finalize the plans for a retreatment study. Salix anticipates starting the study late this year or early 2012, and expects it would take two years to complete the trial and reach an FDA decision. (See BioWorld Today, Feb. 25, 2011.)

• XenoPort Inc., of Santa Clara, Calif., and London-based GlaxoSmithKline plc submitted a supplemental new drug application seeking FDA approval of Horizant (gabapentin enacarbil) extended-release tablets for postherpetic neuralgia. Horizant is approved for restless legs syndrome. (See BioWorld Today, April 8, 2011.)