Bionomics Ltd., of Adelaide, Australia, said it plans to present additional data from the DisrupTOR-1 trial of BNC105 in patients with metastatic renal cancer at the ASCO Genitourinary Cancers Symposium in Orlando. The new data, which extend a biomarker dataset presented at the European Society for Medical Oncology congress in Madrid in September 2014, showed that elevated baseline ferritin and lower baseline IL-8 were associated with improved progression-free survival, or PFS (P = 0.0291 and P = 0.0149, respectively). Nearly 9 in 10 (89 percent) of patients expressing elevated plasma levels of ferritin and lower plasma levels of IL8 at baseline showed PFS at six months. Bionomics said the results suggested that biomarker-based patient selection offered the potential to optimize clinical outcomes in treating renal cancer, offering a range of possibilities for using BNC105. At the 2014 BIO International Convention, Bionomics disclosed a preclinical deal with Merck & Co. Inc., of Whitehouse Station, N.J., targeting Alzheimer's disease and suggested it would seek a similar arrangement for the as-yet unpartnered BNC105. (See BioWorld Today, June 25, 2014.) In other news, Bionomics said its ordinary shares commenced trading on the OTCQX marketplace in the U.S.

Celltrion Healthcare Inc., of Incheon, South Korea, launched Remsima (infliximab) in 12 European markets: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK. Remsima, developed by Celltrion Inc., is the world's first biosimilar monoclonal antibody (for Remicade, from Johnson & Johnson, of New Brunswick, N.J.) to be approved by the EMA, the company said. It is indicated for the treatment of adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis and psoriatic arthritis. In other news, the FDA postponed the March 17 meeting of the Arthritis Advisory Committee that was scheduled to discuss Celltrion's application for a biosimilar to Remicade (infliximab, Johnson & Johnson). The postponement is due to information requests pending with the sponsor, the agency said. A new date for the meeting has yet to be announced.

Chugai Pharmaceutical Co. Ltd., of Tokyo, and Athersys Inc., of Cleveland, have entered a partnership and license agreement to exclusively develop and commercialize Multistem cell therapy for ischemic stroke in Japan. Multistem currently is being evaluated in a phase II study for ischemic stroke in the U.S. and Europe, and Athersys has begun preparations for clinical development in Japan, including engagement with the Japanese Health Authority. Chugai will be responsible for the development and commercialization of Multistem for ischemic stroke in Japan, and Athersys will have responsibility for product supply. Athersys will receive an up-front cash payment of $10 million from Chugai and would receive additional payments as the program is further advanced. Athersys is eligible to receive milestone payments from Chugai of up to $45 million upon the successful achievement of certain development and regulatory milestones, and sales milestones of up to approximately $150 million.

Curis Inc., of Lexington, Mass., said it priced a public offering of about 21.8 million shares of common stock priced at $2.75 per share, resulting in aggregate proceeds of $60 million. Funds will be used to support further preclinical testing and clinical studies of product candidates, including CUDC-907, and any product candidates the firm may exercise its option to in-license from Aurigene Discovery Technologies Ltd., of Bangalore, India, under the companies' immuno-oncology deal inked last month. Underwriters will have the option to purchase up to an additional 3.3 million shares of Curis to cover overallotments. Cowen and Co. LLC and RBC Capital Markets are acting as joint book-running managers, while Robert W. Baird & Co. and Roth Capital Partners LLC are acting as co-lead managers for the offering, set to close on or about March 2. Shares of Curis (NASDAQ:CRIS) closed at $3.16 last Wednesday, up 36 cents. (See BioWorld Today, Jan. 22, 2015.)

Cytokinetics Inc., of South San Francisco, said a paper published in the Journal of Pharmacology and Experimental Therapeutics showed preclinical data demonstrating that fast skeletal muscle troponin activator CK-2127107 was associated with increased exercise performance in a rat model of heart failure. Cytokinetics is developing CK-2127107 in collaboration with Tokyo-based Astellas Pharma Inc.

Karolinska Development AB, of Stockholm, confirmed receipt of SEK100 million (US$12 million) allotted to Thai Charoen Pokphand Group (CP Group) in the rights issue of convertibles as part of an unprecedented 2014 deal that would facilitate the transfer of innovation to Asia. Karolinska previously reported that payment had been delayed due to administrative constraints. According to CP Group, the trading volume of SEK was at the time too small among Hong Kong banks to satisfy the need for CP Group of getting access to SEK100 million. In order to continuously support Karolinska Development, extraordinary efforts by the CP Group were put in place in order to make the payment as soon as possible. (See BioWorld Today, Nov. 6, 2014.)

A team from the Japanese Keio University has used CRISPR engineering of intestinal organoids to gain new insights into colorectal cancer. Organoids are three-dimensional cultures comprising multiple cell types, combining experimental accessibility with more realistic conditions than traditional single cell cultures. In their experiments, the scientists used CRISPR to engineer organoids that had mutations in five major colorectal cancer drivers. They found that such cells were able to grow in the absence of signaling molecules from the intestinal niche, suggesting that multiple drivers can synergize to substitute their own signaling for that of the microenvironment. However, such cells did not metastasize when implanted into animals. The authors concluded that "although the molecular mechanism of the metastatic progression remains unknown, these results suggest that genetic lesions other than driver pathway mutations are required for colon carcinogenesis." Their work suggested genomic instability might be a contributor to metastatic behavior. The findings appeared in the Feb. 23, 2015, online edition of Nature Medicine.

Medivation Inc., of San Francisco, said U.S. net sales of Xtandi (enzalutamide) capsules, as earlier disclosed by partner Astellas Pharma Inc., of Tokyo, were $230.2 million for the quarter (up 82 percent vs. prior year) and $679.8 million for the full year 2014 (up 73 percent vs. prior year). Fourth quarter U.S. net sales increased approximately 27 percent compared to third quarter net sales of $181.4 million. An estimated 80 percent of the sequential quarter percentage increase represents underlying demand growth, following the September approval of the metastatic castration-resistant prostate cancer (mCRPC) chemotherapy-naive indication. Based on information provided by Astellas, Xtandi U.S. net sales for the quarter ended Dec. 31, included a $3.8 million favorable gross-to-net adjustment, as recorded by Astellas, and an increase in channel partner inventory of about one week, Medivation said. The firm beat consensus on fourth quarter earnings ($1.96 per diluted share vs. consensus' $1.24), partly due to milestone payments and an income tax benefit, noted RBC Capital Markets analyst Simos Simeonidis, who found the 2015 Xtandi projections conservative. "With the approvals of Xtandi in the pre-chemo mCRPC setting in the three major markets (U.S., European Union and Japan) occurring in 2014, Medivation issued 2015 guidance on U.S. Xtandi sales of $1.05B-$1.125B," he noted in a research report. "This suggests 55-65 percent year-over-year growth, and falls within consensus ($1.1 billion), and slightly below our projections of $1.16 billion." Shares of Medivation (NASDAQ:MDVN) closed Thursday at $119.74, up $5.90.

Mersana Therapeutics Inc., of Cambridge, Mass., said it raised $35 million in series B-1 financing round led by existing investor NEA. New investors Rock Springs Capital Management and Elliott Sigal, former head of R&D at New York-based Bristol-Myers Squibb Co. (BMS), participated in this round along with existing investors Pfizer Venture Investments and Fidelity Biosciences. The proceeds will fund the advancement of Mersana's pipeline of products based on its Fleximer antibody-drug conjugate platform with its first investigational new drug filing anticipated later this year. In addition the company also named Anna Protopapas as president and CEO. Most recently she was president of Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd.

Nanocarrier Co. Ltd., of Chiba, Japan, entered a joint research agreement with Chugai Pharmaceutical Co. Ltd., of Tokyo, for siRNA drugs. Nanocarrier has resolved to conduct a third-party allotment of shares to Chugai, valued at ¥500 million (US$4.19 million) to further strengthen the relationship between the two companies and enhance the partnership.

Orexigen Therapeutics Inc., of San Diego, said partner Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan, reported net U.S. sales of $6.5 million in the fourth quarter for obesity drug Contrave (naltrexone HCl/bupropion HCl extended release). Those sales earned Orexigen $1.3 million in royalties for the quarter. Contrave was launched Oct. 20, 2014, in the U.S. and is under review in the EU, where it is branded Mysimba. Orexigen posted a net profit of $600,000, or 0 cents per share, for the fourth quarter, below consensus estimates of 21 cents per share. For the full year, the firm reported a net loss of $37.5 million, or 32 cents per share. As of Dec. 31, it had about $104.2 million on its balance sheet. Shares of Orexigen (NASDAQ:OREX) gained 3 cents to close last Wednesday at $5.85.

Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its affiliate Otsuka Canada Pharmaceutical Inc., said Health Canada has approved Jinarc (tolvaptan) as the first pharmaceutical agent for the treatment of autosomal dominant polycystic kidney disease. Jinarc is indicated to slow the progression of kidney enlargement by targeting the underlying pathophysiology of the disease. Otsuka also said the Committee for Medicinal Products for Human Use of the EMA has recommended Jinarc for approval to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease in adults with chronic kidney disease stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

Revive Therapeutics Ltd., of Toronto, said it expanded its orphan drug pipeline to include the drug Bucillamine for the treatment of cystinuria and Wilson disease, by amending the material transfer agreement disclosed a year ago with a global pharma partner headquartered in Osaka, Japan. Revive will continue to have access to confidential information and clinical trial supply of Bucillamine, a disease-modifying antirheumatic drug, for the treatment of gout. In return, the unnamed pharma firm will have exclusive commercialization rights in Japan, Korea and Taiwan, and Revive will have exclusive commercialization rights in the rest of the world.

Taiho Pharma Europe Ltd., of London, a subsidiary of Japan-based Taiho Pharmaceutical Co. Ltd., submitted a marketing authorization application to the EMA for TAS-102 (trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer. In separate news, Taiho's oncology unit said the new drug application (NDA) for TAS-102 (trifluridine, tipiracil hydrochloride) was accepted for review by the FDA for standard review, with a PDUFA date of Dec 19. The oral drug is in development to treat refractory metastatic colorectal cancer. Taiho Oncology submitted the final portion of its rolling NDA on Dec. 19. (See BioWorld Today, July 1, 2014.)

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it opened a new office in Biopolis, Singapore, that will house its emerging markets business unit headquarters, Takeda Development Center Asia and Vaccine Business unit.

Tianyin Pharmaceutical Inc., of Chengdu, China, said it received notice on Feb. 24 from the NYSE telling it the company has fallen below some of the exchange's continued listing standards due to the delay in filing of its quarterly report for the period ended Dec. 31, 2014. To maintain its listing, the company must submit a plan of compliance by March 10, addressing how it intends to regain compliance. Tianyin said it's working with an auditor to gather up the data it needs for a 10-Q and expects to file one as soon as possible and before the deadline set by the exchange.

Twi Pharmaceuticals Inc., of Taipei, Taiwan, and Teva Pharmaceuticals Industries Ltd., of Jerusalem, reached an agreement that will transfer the U.S. sales and distribution rights of Twi's generic versions of Megace ES (megestrol acetate oral suspension, 625 mg/ 5 ml) and Lidoderm (lidocaine patch, 5 percent) from Teva to Twi. Twi will distribute both products through its wholly owned subsidiary, Twi Pharmaceuticals USA. Twi has assembled a sales and distribution team in the U.S. and plans to launch several products in the U.S. under its label this year.

A team led by scientists from the British University of Glasgow and the Australian Garvan Medical Research Institute has sequenced 100 pancreatic cancers to gain new insights into the genetic underpinnings of the disease. They were able to classify their samples into four subtypes, which could be used for treatment decisions. The authors were able to identify a subtype that had a high response rate to platinum-based therapies, and said that in general, their work had the potential to improve treatment decisions and outcomes for pancreatic cancer patients – improvements that are desperately necessary for a type of disease with a median survival of six months from diagnosis and a five-year survival rate in the single digits. The findings appeared in the Feb. 26, 2015, issue of Nature.

Citing preemption, a federal judge this week overturned a Maine law that permitted importation of prescription drugs from specified countries. The law, which went into effect in October 2013, allowed Maine residents to import drugs for personal use from licensed retail pharmacies in Australia, Canada, New Zealand or the UK – if the pharmacies met their country's statutory and regulatory requirements. (See BioWorld Today, Oct. 11, 2013.) The state's "singling out of certain countries from which pharmaceuticals may be imported compromises the tightly regulated structure" established by the Federal Food, Drug and Cosmetics Act, the judge ruled. The legal challenge to the law was brought by Maine-based trade associations, individual pharmacists and the Pharmaceutical Research and Manufacturers of America. The national trade association, which was dismissed early on in the case for lack of standing, hailed the decision as a significant victory that confirms the role the FDA plays in regulating the U.S. drug supply chain and protecting consumers from counterfeit and adulterated drugs.