• Acorda Therapeutics Inc., of Ardsley, N.Y., said it completed the acquisition of Morrisville, N.C.-based Neuronex Inc., a privately held firm developing a nasal spray formulation of diazepam. Under the terms, Acorda, which gained an option to acquire Neuronex in February, paid $6.8 million to complete the transaction. (See BioWorld Today, Feb. 17, 2012.)

Eight months after the FDA issued a complete response letter (CRL) for a new drug application for Adasuve (loxapine) inhalation powder for agitation in schizophrenia and bipolar disorder, Alexza Pharmaceuticals Inc. won approval Friday. Adasuve combines Alexza's Staccato delivery system with the antipsychotic drug, loxapine. Adasuve is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. The FDA approval was based on a clinical data package involving more than 1 ,600 patients and subjects. In two Phase III trials, Adasuve was found to be effective in the acute treatment of agitation in adults with schizophrenia or bipolar I disorder. The 10-mg dose met the primary efficacy endpoint, with statistically significant reductions in agitation as compared to placebo at the two-hour post-dose time point. In December 2011, the Psychopharmacologic Drugs Advisory Committee split nearly down the middle, voting 9-8, with two abstentions, in favor of approval for single-dose Adasuve, administered via inhalation, with a risk evaluation and mitigation strategy (REMS) proposed by the FDA. Then in May 2012, the FDA dinged Alexza, of Mountain View, Calif., with a CRL related to manufacture of the delivery device. The company said it plans to launch Adasuve during the summer of 2013. As part of the company's clinical safety studies, an increased risk of bronchospasm in patients with pre-existing asthma or chronic obstructive pulmonary disease was identified. Alexza put in place a REMS program to ensure patient safety. Investor enthusiasm wasn't apparent on Friday. The company's stock (NASDAQ:ALXA) lost 43 cents, to close at $5.79.

• BioMarin Pharmaceutical Inc., of San Rafael, Calif., said the compensation committee of BioMarin's board approved the grant to 14 employees of stock options to purchase 19, 100 shares of common stock in the aggregate and about 5 million restricted stock units in the aggregate. The stock options and restricted stock units were granted pursuant to an inducement plan approved by the committee in May. The company granted to each of the 14 employees an option to purchase shares of BioMarin's common stock with an exercise price equal to $49.27, the closing price per share of BioMarin's common on Dec. 18.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., submitted a supplemental new drug application to the FDA for Entereg (alvimopan) for gastrointestinal recovery after bowel resection with primary anastamosis. It marks an expansion of the current label for patients needing surgery for colorectal disease. The application is based on Phase IV trials of patients undergoing radical cystectomy for bladder cancer.

• Elan Corp. plc, of Dublin, Ireland, said it completed the separation of a substantial portion of its drug discovery business into a new independent, publicly traded company, Prothena Corp. plc. Under the demerger, Elan shareholders as of Dec. 14 received one Prothena share for every 41 Elan shares. In addition, a wholly owned subsidiary of Elan subscribed $26 million and received Prothena shares representing 18 percent of the total outstanding ordinary shares of Prothena. The new firm began trading on Nasdaq under the symbol "PRTA."

• Genentech Inc., of South San Francisco, a member of the Roche Group, said the FDA extended the approval of Tamiflu (oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants 2 weeks of age and older. That makes Tamiflu the only prescription oral antiviral medicine approved to treat people of all ages, from infants 2 weeks old to elderly people. Tamiflu was first approved in the U.S. 13 years ago. The extension is based on two open-label safety and pharmacokinetic studies conducted in 136 infants younger than 1 year infected with influenza, which assessed how Tamiflu was absorbed and distributed in the body and how well it was tolerated in that group. Based on the studies, a 3 mg/kg dose of Tamiflu given twice daily for five days to infants is expected to have a similar safety and efficacy profile to that observed in older children and adults.

• Neptune Technologies and Bioressources Inc., of Laval, Quebec, filed for revocation of all Oslo, Norway-based Aker Biomarine ASA's Australian patents. Neptune is asking the Federal Court to declare that five patents relating to krill oil composition and methods of extraction are invalid, claiming those methods lack novelty and are not patentable inventions.

• OJSC RVC, of Moscow, started a program to acquire new investments and support new projects in medical science and biotechnology, energy efficiency, information technology and telecommunications. OJSC RVC is a government fund of funds and a development institute in Russia. The key event for the new program will be the Moscow International Forum for Innovative Development.

• Radius Health Inc., of Cambridge, Mass., and 3M Drug Delivery Systems, of St. Paul, Minn., jointly reported an exclusive partnership agreement for development and commercialization of BA058-transdermal (TD), a synthetic peptide analogue of human parathyroid hormone-related protein (hPTHrP). The agreement updates the general development agreement announced in May 2011 by the two companies for BA058-TD. BA058-TD, a short-wear time patch based on 3M's microstructured transdermal system technology, is being studied in a Phase II trial in healthy postmenopausal women with osteoporosis at 10 clinical centers. The product is also being studied as a daily subcutaneous injection in a Phase III study with 2,400 patients for fracture prevention in women with postmenopausal osteoporosis at high risk of fracture. (See BioWorld Today, May 25, 2011.)

• Sarepta Therapeutics Inc., of Cambridge, Mass., signed a clinical trial agreement with the National Institute of Allergy and Infectious Diseases to carry out a Phase I study of its influenza candidate, AVI-7100. Under the agreement, the NIAID will conduct the trial, assessing safety, tolerability, and pharmacokinetics in healthy volunteers at the NIH Clinical Center in Bethesda, Md.

• Stem Cell Therapeutics Corp., of Toronto, said it received shareholder approval for the board of directors to initiate a consolidation all of the company's issued and outstanding common shares. The consolidation ratio is yet to be determined but it will be in the range of one post-consolidation common share for each 10 to 30 outstanding pre-consolidation common shares.

• Synthetic Biologics Inc., of Rockville, Md., and Intrexon Corp., of Germantown, Md., said they have initiated development of a monoclonal antibody (mAb) therapy for the treatment of pertussis, more commonly known as whooping cough. The company will develop a mAb therapy, SYN-005, designed to neutralize the pertussis toxin. It is the second of three infectious disease indications the company intends to pursue as part of its August 2012 collaboration with Intrexon. In relation to the development of this potential therapy for pertussis, Synthetic Biologics has entered into an agreement with the University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. (See BioWorld Today, Aug. 9, 2012.)