Angiochem Inc., of Montreal, said a paper published in Molecular Cancer Therapeutics demonstrates that ANG4043, a peptide-monoclonal antibody (MAb) conjugate, entered the brain at therapeutic concentrations, resulting in significantly prolonged survival in mice. The antibody is directed against HER2, which is the protein targeted by Herceptin (trastuzumab, Roche AG). Because the MAb is conjugated to Angiopep-2, it is recognized by the LRP1 receptor and takes advantage of a receptor-mediated transcytosis mechanism to cross the blood-brain barrier.
Aprecia Pharmaceuticals Co., of Langhorne, Pa., said the FDA accepted for filing its new drug application for the first product using the firm's Zipdose technology for dispensing medicine with a sip of water or other liquid.
Biostem Technologies Inc., of Oakland Park, Fla., said the Financial Industry Regulatory Agency approved the company's name change from Caribbean International Holdings Inc. to Biostem Technologies Inc. and new trading symbol, BSEM, effective Tuesday. The firm said the change will reflect its efforts in regenerative medicine.
Calithera Biosciences Inc., of South San Francisco, said it signed an exclusive global license agreement with Mars Symbioscience, of Gaithersburg, Md., a division of Mars Inc., granting Calithera rights to research, develop and commercialize Symbioscience's portfolio of arginase inhibitors, discovered as part of Mars' cocoa flavanol research program, for use in human health care. The preclinical arginase inhibitor program will enhance Calithera's efforts to submit an investigational new drug application for an arginase inhibitor with the FDA near the end of 2015. No specific terms were disclosed, but Symbioscience will receive an up-front payment and will be eligible to receive future development and commercialization milestones as well as royalties on sales of approved products.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said it will start preclinical development of next-generation drug CF602, an A3 adenosine receptor allosteric modulator, for the indication of sexual dysfunction. Upon completion, the firm intends to file an investigational new drug application with the FDA.
Endo International plc, of Dublin, said it completed the acquisition rights for Natesto (testosterone nasal gel), a testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel Biopharma SRL, a wholly owned subsidiary of Trimel Pharmaceuticals Corp., of Toronto. The deal is valued at $25 million, including additional payments upon the achievement of certain regulatory and sales milestones.
Hemispherx Biopharma Inc., of Philadelphia, said it received a new research report from Howard University in Washington describing a study in which Ampligen (poly I:poly C12U) strongly inhibited the Ebola minigenome in the human embryonic kidney cell system. Those results, taken in conjunction with previous data on anti-Ebola actions of Ampligen reported by other U.S. and European collaborators, indicate that the antiviral molecular actions of Ampligen may be triggered at levels reached by the common human treatment regimens of Ampligen historically used in clinical studies in a variety of other human diseases.
Ignyta Inc., of San Diego, said the World Health Organization approved the international proprietary name entrectinib for the company's lead candidate, RXDX-101. An orally available, selective tyrosine kinase inhibitor, entrectinib is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK.
Insys Therapeutics Inc., of Phoenix, said the FDA granted orphan drug designation to its Liposome Entrapped Paclitaxel Easy to Use, or LEP-ETU, candidate for the treatment of gastric cancer. Insys acquired LEP-ETU through its 2010 merger with Neopharm Inc. (See BioWorld Today, Nov. 2, 2010.)
Iteos Therapeutics SA, of Gosselies, Belgium, agreed to license rights to preclinical compounds targeting Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2) to Pfizer Inc., of New York. Pfizer will be responsible for developing and commercializing the IDO1 and TDO2 candidates. The companies will collaborate to discover and validate new targets that enable tumors to evade immune responses, and the targets will be shared by the companies for additional independent or collaborative development. Iteos is set to receive an up-front payment of €24 million (US$29.7 million), plus an equity investment, licensing fees and collaborative funding, and the company is eligible to earn additional payments from Pfizer on the achievement of undisclosed development, regulatory and commercial milestones across the IDO1 and TDO2 programs, plus royalties on product sales. Iteos also has the opportunity to earn additional milestone and royalty payments for target programs advanced by Pfizer. (See BioWorld Today, May 31, 2012.)
Kempharm Inc., of Coralville, Iowa, said it had a pre-investigational new drug application meeting with the FDA concerning the firm's new molecular entity prodrug of hydromorphone, KP511. The drug, which is being developed for the treatment of moderate to severe pain, combines hydromorphone with one or more ligands and can be formulated in both immediate-release and extended-release dosage forms. It is designed to not release its hydromorphone component until it is metabolized in the gastrointestinal tract following oral administration.
Nektar Therapeutics Inc., of San Francisco, said partner Astrazeneca plc, of London, reported that Moventig (naloxegol) was granted marketing authorization in Europe for the treatment of opioid-induced constipation in adults who have had inadequate responses to laxatives. Moventig is a once-daily, oral, peripherally acting mu opioid receptor antagonist. The drug gained approval in September in the U.S., where it is sold as Movantik. (See BioWorld Today, Sept. 17, 2014.)
Redhill Biopharma Ltd., of Tel Aviv, Israel, said it submitted a marketing authorization application to the UK Medicines and Healthcare products Regulatory Agency and several other member states seeking approval of RHB-102 for cancer patients suffering from chemotherapy- and radiotherapy-induced nausea and vomiting. RHB-102, newly branded as Bekinda, is an oral, extended-release, once-daily pill formulation of the antiemetic drug ondansetron.
Selexis SA, of Geneva, and Symphogen A/S, of Copenhagen, entered a commercial license deal and agreed to continue their R&D license agreement. Symphogen licensed the rights to Selexis' Suretechnology Platform and SURE CHO-M Cell Line for the development of recombinant monoclonal antibody (MAb) mixtures for the treatment of various cancers and infectious diseases. Financial terms were not disclosed.
Supernus Pharmaceuticals Inc., of Rockville, Md., said it received a paragraph IV notice advising that Par Pharmaceutical Inc., of Woodcliff Lake, N.J., filed an abbreviated new drug application seeking approval for topiramate extended-release capsules, which Supernus markets as Trokendi XR. Supernus said it intends to "vigorously enforce" its intellectual property and said Trokendi XR is protected by five issued patents that expire no earlier than 2027.
Zydus Cadila Group, of New Delhi, India, said it launched a biosimilar of Humira (adalimumab, Abbvie Inc.) in India for rheumatoid arthritis and other autoimmune disorders. Zydus will market the product as Exemptia.
Zymeworks Inc., of Vancouver, British Columbia, said it extended its 2011 research collaboration with Merck & Co. Inc., of Whitehouse Station, N.J. Merck also gains expanded access to Zymeworks' Azymetric platform for the development of bispecific therapeutic candidates. (See BioWorld Today, Aug. 30, 2011.)