Key Developments: Cornerstone Therapeutics Inc (CRTX.OQ)

CRTX.OQ on NASDAQ Stock Exchange Capital Market

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Latest Key Developments (Source: Significant Developments)

Cornerstone Therapeutics Inc Acquires Exclusive U.S. Marketing Rights To PERTZYE (Pancrelipase) For Treatment Of Exocrine Pancreatic Insufficiency In Patients With Cystic Fibrosis
Thursday, 9 May 2013 06:45am EDT 

Cornerstone Therapeutics Inc announced that it has entered into an agreement with Digestive Care, Inc. (DCI) to acquire exclusive U.S. rights to market PERTZYE (pancrelipase) for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF). PERTZYE is a unique pancreatic enzyme product and is protected by several U.S. patents(1). The PERTZYE formulation was previously marketed by DCI for more than a decade under the trade name PANCRECARB MS-16. It is estimated that about 90% of patients with CF receive pancreatic enzyme replacement therapy (PERT)(2) with the therapeutic category experiencing 24% annual growth from 2008-2012.  Full Article

Law Firm Kirby McInerney LLP Investigating Potential Claims on Behalf of Cornerstone Therapeutics Inc Shareholders
Monday, 25 Feb 2013 03:01pm EST 

Kirby McInerney LLP announced that it is investigating potential claims against the Board of Directors of Cornerstone Therapeutics Inc related to the proposed acquisition of the Company by Chiesi Farmaceutici S.p.A. (Chiesi). Under the terms of the agreement, Chiesi will acquire all of the outstanding common stock of Cornerstone that it does not already own for a cash purchase price of between $6.40 and $6.70 per share. The investigation concerns whether the Cornerstone Board of Directors is violating its fiduciary duties and whether the proposed per share consideration adequately values Cornerstone common shares.  Full Article

Briscoe Law Firm and Powers Taylor, LLP Investigate Going Private Proposal Of Cornerstone Therapeutics Inc
Friday, 22 Feb 2013 04:51pm EST 

Willie Briscoe and Powers Taylor, LLP announced that they are investigating potential legal claims against the Board of Directors of Cornerstone Therapeutics, Inc. (Cornerstone) related to a going private proposal by Chiesi Farmaceutici SpA (Chiesi) for shareholders. Under the terms of the going private proposal, Chiesi (which currently owns approximately 60% of the common stock) would acquire all outstanding shares of Cornerstone`s common stock for between $6.40 and $6.70 per share. The proposed acquisition price is well below at least one analyst`s estimated value of $14.00 per share and the 52-week high of $7.99.  Full Article

Bernstein Liebhard LLP Announces Investigation On Cornerstone Therapeutics Inc
Thursday, 21 Feb 2013 09:55am EST 

Bernstein Liebhard LLP announced that it is investigating whether the Board of Directors of Cornerstone Therapeutics Inc and Chiesi Farmaceutici SpA (Chiesi), the majority shareholder of Cornerstone Therapeutics, are breaching their fiduciary duties to the Company's shareholders in connection with an offer by Chiesi, to take the Company private.Under the terms of the offer, Cornerstone Therapeutics shareholders will receive between $6.40 and $6.70 in cash for each share of common stock they own. The investigation is focused on whether Chiesi Farmaceutici SpA's offer undervalues the Company's shares.  Full Article

Cornerstone Therapeutics Inc Announces Receipt Of Take-Private Proposal From Its Majority Stockholder
Wednesday, 20 Feb 2013 12:00am EST 

Cornerstone Therapeutics Inc announced that its Board of Directors has received a letter from Chiesi Farmaceutici SpA (Chiesi). In that letter Chiesi, which owns approximately 60% of the outstanding shares of the Company's common stock, made a proposal, subject to certain conditions, to acquire the shares of the Company's common stock that it does not already own for a cash purchase price of between $6.40 and $6.70 per share. The text of Chiesi's letter will be filed as an exhibit to a Report on Form 8-K to be filed on February 20, 2013 by the Company with the SEC. The Company cautions its stockholders and others considering trading in its common stock that no decisions have been made by the Board of Directors with respect to Chiesi's proposal. There can be no assurance that any agreement will result from the proposal submitted by Chiesi or that any transaction based on Chiesi's proposal will be consummated.  Full Article

Chiesi Farmaceutici SpA Announces Acquisition Of Cornerstone Therapeutics Inc-DJ
Tuesday, 19 Feb 2013 05:39pm EST 

Dow Jones reported that Chiesi Farmaceutici SpA offered to acquire Cornerstone Therapeutics Inc. in a deal valuing the Company at as much as $177.2 million as the shareholder looks to take the drug-discovery company private. In a filing with the U.S. Securities and Exchange Commission late February 19, 2013, Chiesi which holds a 65% stake in Cornerstone said it would buy the Company for $6.40 to $6.70 a share in an all-cash transaction. The bid is subject to due diligence, and Chiesi said it is prepared to move quickly to enter into a customary confidentiality agreement with Cornerstone and complete due diligence.  Full Article

Cornerstone Therapeutics Inc Announces Alastair McEwan As Chief Financial Officer
Wednesday, 7 Nov 2012 08:48am EST 

Cornerstone Therapeutics Inc announced the appointment of Alastair McEwan as Chief Financial Officer (CFO) effective November 6, 2012.  Full Article

Cornerstone Therapeutics Inc Terminates Chief Financial Officer-Form 8-K
Friday, 28 Sep 2012 09:14pm EDT 

Cornerstone Therapeutics Inc reported in its Form 8-K that on September 24, 2012, Cornerstone Therapeutics Inc. (Company) notified Vincent T. Morgus, the Company’s Executive Vice President, Chief Financial Officer (CFO) and Treasurer, that the Company had determined to exercise its rights under its employment agreement with Mr. Morgus to terminate Mr. Morgus’s employment. Accordingly, immediately following such notification, Mr. Morgus ceased serving as the Company’s Executive Vice President, Chief Financial Officer (CFO) and Treasurer. However, Mr. Morgus will remain an employee of the Company through October 19, 2012.  Full Article

Cornerstone Therapeutics Inc Drug For Low Salt Rejected By US Panel-Reuters
Thursday, 13 Sep 2012 12:33pm EDT 

Reuters reported that Cornerstone Therapeutics Inc failed to win a U.S. advisory panel's support on September 13, 2012 for a drug that treats low sodium levels in the blood. The panel of outside advisers to the Food and Drug Administration voted five to three to recommend rejection of lixivaptan for treating low sodium due to a condition that causes the body to have excess water. They also unanimously voted against using the drug to treat low sodium in heart failure patients. The FDA usually follows panel recommendations, but it is not required to. A final decision is expected by October 29. Most panel members said the drug's risks outweighed its modest benefit in raising sodium levels, and called for more trials to make sure it was safe. In a clinical trial in heart failure patients, lixivaptan was linked to more deaths compared to placebo -- though it was uncertain whether the drug actually caused the deaths.  Full Article

FDA Approves Cornerstone Therapeutics, Inc.'s ANDA For Generic Tussionex Pennkinetic Product
Monday, 2 Jul 2012 08:01am EDT 

Cornerstone Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product. The antitussive/antihistamine combination product is a generic equivalent for the product currently sold under the Tussionex Pennkinetic brand name. The product is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children six years of age and older. CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, Inc. and Neos Therapeutics, LP, a subsidiary of Neos Therapeutics, Inc. Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the active pharmaceutical ingredients (APIs), including a patent-protected version of hydrocodone polistirex. Neos developed the CRTX 067 drug product formulation using its formulation technology, Dynamic Time Release Suspension (DTRS), and Neos will be the exclusive manufacturer of the approved drug product.  Full Article

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