Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed’s New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone) seeking approval for the treatment of moderate to severe pain in opioid tolerant patients.
The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date of 11/22/09 for a possible FDA decision. On 9/22/09, the FDA posted briefing documents on its website for the 23-September joint meeting of its Anesthetics and Life Support Advisory Committee and its Drug Safety and Risk Management Advisory Committee. At the meeting, the committees will review and discuss Exalgo NDA.
On 9/22/09, Star Scientific (NASDAQ: STSI) ($1.12, +14%, above-average volume) announced today that it will utilize a novel, patented method for the cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process was the subject of a patent application filed in December 2008 and has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured curing process.
STSI believes that this novel process, as reflected in its patent application, will enable the company to achieve the lowest toxin levels anywhere in the world and plans to submit the products to the FDA for approval to market as "modified risk" tobacco products, under Section 911 of the new Family Smoking Prevention and Tobacco Control Act, once formulation and testing of the new product is completed in early 2010 with an estimated date of 3/31/10 for this entry, representing the end of 1Q10.
On 9/22/09, Advanced Cell Technology (ACTC.PK) ($0.162, +13%, above-average volume) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.
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