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NEOL.PK Files NDA for Fentanyl Spray
publication date: Mar 7, 2011
author/source: Mark Messier
Before we even begin to discuss NEOL and its NDA filing, lets make something clear. Trading a stock like NEOL has serious risks attached to it. Do you see the ".PK" that is next to its ticker? This means that NEOL is traded on whats called "Pink Sheets" the lowest form of trading, even on the OTCBB. One of the many reasons that stocks tradon the 'pinks' is that their financial information is behind or has not been updated. Even though we consider an NDA filing a legitimate catalyst, we urge you caution and call this a highly speculative trade.
For more information on what the Pink Sheets are and what a this means, visit the link below:
More information on the Phase 3 studies of Fentanyl SL Spray can be found at ClinicalTrials.gov and Cancer.gov
ASCO Conference Presentation
Insys Therapeutics, Inc. Announces Submission of NDA for Fentanyl SL Spray
PHOENIX -- Insys Therapeutics, Inc. (formerly NeoPharm, Inc.) (Other OTC: NEOL.PK) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its cancer pain product candidate, Fentanyl SL Spray.
“This is a tremendous achievement for the Company, and evidences our continued dedication to the development of improved products in the supportive care and oncology space,” said Insys CEO Michael Babich. “We are excited for the prospects of Fentanyl SL Spray’s unique delivery system and look forward to building a sales force to launch this product candidate, if approved.”
NeoPharm, Inc. Announces Merger with Insys Therapeutics, Inc.
LAKE BLUFF, Ill., Oct 29, 2010 (BUSINESS WIRE) -- NeoPharm, Inc. (Other OTC: NEOL.PK), a biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced it has entered into a merger agreement with Insys Therapeutics, a Phoenix-based drug development company focused on pain and oncology.
Under the terms of the merger agreement, NeoPharm will issue approximately 19.5 million shares of common stock and 14.9 million shares of a newly-created convertible preferred stock to the stockholders of Insys, and a newly-formed subsidiary of NeoPharm will merge into Insys, with Insys surviving as a wholly-owned subsidiary of NeoPharm. Each share of the new convertible preferred stock of NeoPharm will be convertible into 35 shares of NeoPharm common stock and, until converted, will be entitled to the voting, dividend and liquidation rights of the same number of shares of common stock into which it is convertible. Upon completion of the merger and conversion of the new preferred stock, the shares issued to the former Insys stockholders will represent 95% of the outstanding shares of NeoPharm common stock. The transaction is expected to be consummated on or about November 8, 2010.
Insys is a privately held corporation that is majority owned by Dr. John N. Kapoor. Dr. Kapoor also serves as a director of NeoPharm and owns approximately 21% of the outstanding common stock of NeoPharm. Accordingly, NeoPharm's board established a special committee consisting solely of independent directors not affiliated with Dr. Kapoor and Insys to evaluate the proposed transaction and strategic alternatives. The special committee retained its own advisers and counsel, received a fairness opinion from an investment bank and unanimously recommended the merger to the NeoPharm board, which also unanimously approved the transaction. No vote or approval of NeoPharm stockholders is required to complete the merger. The approval of the NeoPharm stockholders is needed to increase the authorized shares of common stock of NeoPharm in order to provide sufficient shares for the conversion of the convertible preferred stock. NeoPharm intends to obtain that approval after the closing of the merger.
The NeoPharm board also has approved the distribution, immediately after the merger, of non-transferable contingent payment rights to its stockholders of record as of November 5, 2010. These rights will entitle the pre-merger stockholders to receive cash payments aggregating $20 million (equivalent to $0.70402 per share) if, prior to the five year anniversary of the merger, the U.S. Food and Drug Administration approves a new drug application for any one or more of NeoPharm's drugs currently under development (LEP-ETU, LE-DT and IL13-PE38) pursuant to an approval letter that grants NeoPharm the right to market and sell the drug immediately and provides for labeling that does not contain a "black box warning." The cash payments would be made within nine months of FDA approval. The distribution and payment of the contingent payment rights are subject to completion of the merger and applicable Delaware corporation law.
10/29/10 Merger Article
NEOL Pre-Merger Second Quarter 2010 Financial Results
For the second quarter ended June 30, 2010, NeoPharm reported a net loss of $0.8 million, or ($0.03) per basic and diluted share, as compared to a net loss of $1.9 million, or ($0.07) per share, for the same period last year. For the six months ended June 30, 2009, NeoPharm reported a net loss of $2.2 million, or ($0.08) per basic and diluted share, compared to a net loss of $4.2 million, or ($0.15) per share, for the same period last year. The decrease in the Company's net loss for the three and six months ended June 30, 2010 is primarily due to a $0.7 gain on the reversal of all prior unrealized losses related to its investments in auction rate securities ("ARS"), and continued decreases in general and administrative expenses. On June 30, 2010, the Company exercised its put option and redeemed all of its ARS investments at full par value, reversing all previously recorded unrealized losses and repaying its ARS loan in full with the proceeds of this redemption. The Company's general and administrative expenses decreased $0.4 million and $0.7 million for the three and six months ended June 30, 2010 in connection with continuing cost-savings initiatives in this area.
During the second quarter, the Company's cash outlays decreased to $1.3 million as compared to $1.9 million for the first quarter of 2010. This decrease in cash outlays is primarily attributable to the effectiveness of cost-saving measures, however the Company expects future cash outlays to increase consistent with the advancement and progression of its clinical trials and other preclinical development activities. The Company had $1.8 million in cash and cash equivalents as of June 30 2010, and projects that it has adequate resources to fund its operations into the fourth quarter of 2010. The Company is currently exploring various alternatives to continue its operations for the rest of 2010 and beyond, but no assurance can be given that such efforts will be successful.