Alkermes, Inc. (ALKS) reported a second quarter fiscal 2010 net loss of 5 cents per share, compared with a profit of 2 cents in the year-ago period. The Zacks Consensus Estimate was a loss of 10 cents. Revenues in the quarter increased 1.9 % to $48.2 million from $47.3 million in the year-ago quarter. The increase was driven by manufacturing and royalty revenues from Risperdal Consta.   Total manufacturing revenues for the quarter came in at $32.8 million as against $33 million in the year-ago quarter.  Manufacturing revenues for the quarter included $31.9 million related to Risperdal Consta, marketed worldwide by Johnson & Johnson (JNJ) and manufactured by Alkermes, compared to $30.7 million for Consta and $2.3 million for Vivitrol for the year-ago quarter.   Royalty revenues for the quarter came in at $8.8 million, based on Risperdal Consta sales of $352.6 million, as against $8.4 ...

Cephalon Inc. (CEPH) reported strong third-quarter earnings of $1.62 per share that easily surpassed the Zacks Consensus Estimate of $1.42 per share and the year ago earnings of $1.18. Revenues increased 10.2% to $549 million, consisting of $535 million in product sales and $14.2 million in other revenues. Higher revenues and lower costs contributed to the robust results.   Revenues were driven by contributions from the central nervous system (CNS) and oncology franchises, which posted sales of $291.9 million (up 7%) and $83.1 million (up 58%), respectively. Oncology drug Treanda continued to perform well, with sales coming in at $54.5 million. Additional data presentations on Treanda should help drive sales, especially in the indolent non-Hodgkin’s lymphoma (NHL) market.   Cephalon reported $20.9 million in sales of its follow-on sleep franchise product, Nuvigil, which was launched on June 1, 2009. The company reported that Nuvigil gained a 19% share ...

Today, Dainippon Sumitomo and Sepracor (SEPR) have announced the successful completion of the initial share offering period, where almost 78.2% of Sepracor’s shares were tendered. The offer period has been extended to Oct 19, 2009, to enable other shareholders to tender their shares as well.  As a reminder, in September, the Japanese pharmaceutical company Dainippon Sumitomo Pharma Co had announced a deal to acquire Sepracor at $23 per share or $2.6 billion. However, soon after the announcement, shareholders of Sepracor filed a suit in a Delaware court against the company, citing the offered price as inadequate. They were seeking the court’s intervention to stop the deal and pay damages.  Additionally, certain aspects of the deal were against the interest of Sepracor’s shareholders. The deal included a $77.4 million termination fee and a “no solicitation" provision. Apart from restricting the possibility of any superior proposal, these provisions ...

Biovail Corporation (BVF) recently provided an update on its development plans for pimavanserin for Parkinson’s disease psychosis (PDP). The company is developing the candidate in collaboration with Acadia Pharmaceuticals, Inc. (ACAD) and stated that the partners remain committed towards the successful development of the candidate.  In early Sept. 2009, the companies had reported results from a pivotal phase III study (-012 study) in which pimavanserin failed to meet its primary endpoint of antipsychotic efficacy due to an unexpectedly high placebo response rate. Based on an analysis of the data from this study, the partners have decided to continue with the development of the candidate.  The companies intend to use findings from the -012 study and an ongoing phase III study (-014 study) for a new phase III trial. The new study will be conducted using a 40 mg dose of pimavanserin and Biovail will be ...

Yesterday, Novartis Pharma AG (NVS) signed an agreement with Vanda Pharmaceuticals Inc. for the acquisition of exclusive US and Canadian rights to Fanapt (iloperidone), an oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia.  Fanapt belongs to a new generation of schizophrenia drugs known as atypical antipsychotics. In addition to gaining exclusive commercialization rights to the oral formulation of Fanapt in the US and Canada, Novartis will also have exclusive rights to develop and commercialize a long-acting injectable (or depot) formulation of the medicine for these markets.  Vanda will receive an upfront payment of $200 million from Novartis. Besides this, the company will receive additional payments based on the achievement of defined development and commercial milestones. Vanda will also receive royalties on product sales. Vanda has retained rights to develop and commercialize Fanapt outside ...

Dr Stock Pick HOT News & Alerts!

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FREE Daily Stock Alerts From DrStockPick.com

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DrStockPick.com Watch List!

My Picks for Tuesday October 13, 2009, are:

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VASC, Vascular Solutions Inc.

VASC is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of five major categories: hemostat (blood clotting) products, extraction (clot removal) catheters, vein products, specialty catheters and access products.

VASC has received Food and Drug Administration clearance to sell the new Guardian II hemostasis valve, which is used in surgery

VASC is the exclusive U.S. distributor for the product, which is made by Ireland-based Zerusa Ltd.

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VNDA, Vanda Pharmaceuticals, Inc.

VNDA is a biopharmaceutical company

...

Cephalon, Inc. (CEPH) recently received priority review from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Nuvigil. The company had filed the sNDA in June 2009, seeking to expand Nuvigil’s label as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. Priority review status means that a response from the agency will be out in six months instead of the usual 10-12 month review period. As such, a response from the FDA should be out by December 29, 2009. Nuvigil is Cephalon’s follow-on sleep franchise product which received FDA approval in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). Cephalon launched Nuvigil in June 2009 and is promoting the product aggressively. The company has ...

Today morning, Japanese pharmaceutical company Dainippon Sumitomo Pharma Co., Ltd. confirmed that it signed a definitive agreement to buy U.S. pharmaceutical company Sepracor Inc. (SEPR). The deal has been valued at $23 per share or $2.6 billion.

The market was abuzz with rumors yesterday regarding the potential takeover. The rumors led to a 26.46% increase in Sepracor’s stock price. Trading was halted in the afternoon with Sepracor shares closing at $22.80.

This acquisition is the latest in a series of deals conducted by Japanese companies that are looking to tap the U.S. pharmaceutical market – the biggest in the world. Last year, we saw four such deals take place including Eisai’s acquisition of MGI Pharma, Takeda’s acquisition of Millennium Pharma and Shionogi’s acquisition of Sciele. Finally, Daiichi-Sankyo acquired a stake in India’s Ranbaxy Labs.

Following the completion of the acquisition, Sepracor will become a wholly owned subsidiary of Dainippon Sumitomo Pharma America

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For Immediate Release

Chicago, IL – August 28, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Alkermes, Inc. (ALKS), Johnson & Johnson (JNJ), AstraZeneca (AZN), Eli Lilly (LLY) and Pfizer (PFE).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Thursday’s Analyst Blog:

Setback for Alkermes’ Pipeline

On Wednesday, Alkermes, Inc. (ALKS) disclosed that it has received notification from Johnson & Johnson’s (JNJ) Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutical International stating that Janssen does not intend to continue with the development of the four-week long-acting injectable formulation of risperidone.

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On Wednesday, Alkermes, Inc. (ALKS) disclosed that it has received notification from Johnson & Johnson’s (JNJ) Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International stating that Janssen does not intend to continue with the development of the four-week long-acting injectable formulation of risperidone. A phase I study with the four-week formulation had been initiated in January 2009. Risperidone, which is marketed as Risperdal Consta, is Alkermes’ lead product. Risperdal Consta is the longer-lasting injectable version of Johnson & Johnson's schizophrenia drug Risperdal (risperidone). Risperdal Consta uses Alkermes' proprietary Medisorb technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. The product is approved in more than 85 countries worldwide and is available in 60 countries. Risperdal Consta is superior to the first-generation Risperdal in terms of efficacy, tolerability and frequency of dosage (one injection every two weeks). ...