Osiris Therapeutics (OSIR) reported a net loss of 21 cents per share in the third quarter of 2009, well above the Zacks Consensus Estimate of a net income of 6 cents. However, net loss in the year ago period was higher at 63 cents, mainly due to lower revenues.  Revenues in the reported quarter increased to $10.6 million compared to $0.995 million for the same period of the prior year. Osiris generates revenues from collaborative agreements, research licenses, and government contracts.  Revenues in the reported quarter included the recognition of $10 million in revenue under the company’s agreement with Genzyme Corporation (GENZ) for the development and commercialization of Prochymal and Chondrogen.  Osiris earned $0.4 million from its collaborative agreement with the Juvenile Diabetes Research Foundation (JDRF) for the development of Prochymal for type I diabetes, $0.1 million from its contract with the Department of ...

Theravance (THRX) announced its third quarter results after the closing bell yesterday. The company’s loss per share came in at 35 cents, a penny wider than the Zacks Consensus Estimate. It had earned 34 cents per share in the year-ago period. Revenues were $5.5 million during the quarter, compared with $6 million in prior-year quarter. Theravance receives revenues in the form of milestone payments from its collaborating partners including GlaxoSmithKline (GSK) and Astellas Pharma.   Operating expenses remained unchanged at $26.6 million. While R&D expenses declined 2.6% due to lower costs related to the regulatory process for telavancin (Vibativ), G&A expenses increased 8.7% due to higher employee related costs.

The reported quarter had been quite significant for Theravance with the company receiving US Food and Drug Administration (FDA) approval for its long awaited product Vibativ for the treatment of complicated skin and skin structure infections (cSSSI) caused by

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Recently, Novartis AG (NVS) announced that it has received a Complete Response Letter (CRL) for QAB149 (indacaterol) − a bronchodilator for the treatment of adults suffering from chronic obstructive pulmonary disease (COPD) − from the US Food and Drug Administration (FDA). The US agency has asked for additional information on the proposed dosing of the drug. Novartis had filed for the US approval of the drug in December last year.  Last month, the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of QAB149 in the European Union to treat COPD patients as a once-daily therapy with two doses (150 micrograms and 300 micrograms). The positive opinion from the CHMP is a boost to Novartis as it aims to be a strong player in the field of respiratory medicine. Currently, the market is dominated by big players such as GlaxoSmithKline (GSK), AstraZeneca (AZN) ...

Recently, Alkermes Inc. (ALKS) announced that its pipeline candidate, ALKS33, for addiction and nervous system disorders, gave positive results in two early stage clinical trials. Results from the two studies, ALK33-003 and ALK33-004, demonstrated that the candidate blocked the effects of an opioid with an action duration that supported once daily dosing.  The studies were initiated in May this year. ALK33-003, a randomized, double-blind, placebo-controlled, multi-dose study, evaluated the pharmacokinetics, safety and tolerability of multiple doses of ALKS33 in 30 healthy volunteers. ALK33-004, a randomized, single-blind, placebo-controlled, single-dose study, was designed to examine the ability of ALKS33 to block the effects of an opioid following a single oral dose of ALKS33 in 24 healthy, non-dependent, opioidexperienced subjects.  ALKS33, an oral opioid modulator, was generally well-tolerated in both the studies. The company intends to move the candidate into mid-stage studies by the end of this calendar year. ...

Recently, Humana Military Healthcare Services, a wholly owned subsidiary of Humana Inc. (HUM), announced the availability of an additional benefit for the beneficiaries of the TRICARE program (a medical program under the Department of Defense) in the South Region.  Humana Military Healthcare Services offers health insurance coverage under the TRICARE program to the dependents of active duty military personnel and retired military personnel coupled with their dependents. Humana Military has been a contractor of the Department of Defense for the administration of the TRICARE program since Jul 1, 1996.  The new benefit provides the families of soldiers enrolled in the TRICARE program access to a Chronic Obstructive Pulmonary Disease (COPD) Management Program. They will be able to call a dedicated registered nurse and receive education and coaching on how to deal with this lung disease which blocks airflow thereby resulting in breathing difficulties.  Humana started ...

Yesterday, Novartis (NVS) released encouraging data on its investigational respiratory drug QAB149 which is being developed for the treatment of patients suffering from chronic obstructive pulmonary disease (COPD). The drug, to be used once daily, improved lung function and significantly reduced breathlessness in a late stage trial compared to Pfizer’s (PFE) Spiriva (tiotropium), a treatment currently used. The data were presented this week at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna. QAB149 is currently under regulatory review in the European Union, the US and several other countries for the treatment of COPD. The trial carried out for both 12 weeks and 26 weeks showed better results with QAB149 compared to Spiriva. Apart from improving lung function and reducing breathlessness, patients on QAB149 recorded greater than 20% increase in days, when no 'relief' medication or therapies were required to treat severe breathlessness, compared ...

ALR Technologies, Inc.’s stock is currently trading at $0.21, up 425%, on massive volume of 3.3+ million traded shares. Earlier this month, QualityStocks highlighted the company in its daily newsletter when the stock was trading for only $0.04 and largely ignored by the investment community. To sign up for the newsletter, visit www.signup.qualitystocks.net.

Today, ALR Technologies announced that the US Patent and Trademark Office has approved its patent application regarding patient compliance and remote monitoring of patient’s use of nebulizer compressors. This approval protects the company’s Health-E-Connect health management communications system and, more importantly, grants ALRT the exclusive ability to remotely monitor the use of nebulizer compressors in the delivery of medications to patients with COPD, chronic asthma and cystic fibrosis.

With more than 750,000 investors signed up for the QualityStocks Daily Newsletter, it is no wonder that highly successful stock picks are made regularly. Using a proprietary data management system,

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We are disappointed with the failure of Osiris Therapeutics’ (OSIR) Prochymal, a drug derived from human stem cell for the treatment of graft-versus-host disease (GvHD), the most common complication of bone marrow transplants. Currently, there is no approved treatment available for this life-threatening disease.

Based on the preliminary results of two phase III trials conducted by the company, Prochymal was found to be ineffective compared to placebo. Following the setback, Osiris shares fell by 34% to $8.03, their greatest single day decline since August 2006.

In the first trial, where the drug was used along with steroids, 45% of patients responded to the combination compared to 46% who responded to steroid along with a placebo. In the second trial, when Prochymal was used on patients not benefiting from steroids, it did not show statistically significant improvement. However, the drug did have a positive impact on patients with GvHD-affected

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In a positive development yesterday, Forest Laboratories (FRX) and Nycomed announced that encouraging data from a phase III clinical trial of their lung drug was published in a prestigious medical journal. We are pleased to hear that the drug, Daxas (a phosphodiesterase, PDE 4 inhibitor), improved lung function and reduced exacerbations in chronic obstructive pulmonary disease (COPD).

The placebo-controlled trials were carried out in 4,500 patients spanning 10 countries. It evaluated the treatment in two studies, each of which covered a time span of 12 months and 6 months. Results showed that Daxas reduced COPD attacks by 17% per patient every year compared with a placebo and improved the volume of air that patients breathe out each second, a measure known as FEV1 by 48 millilitres.

Studies also showed additional benefits when Daxas was used with other treatments such as Pfizer’s (PFE) Spiriva and GlaxoSmithKline's (GSK)

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After the market close yesterday, South San Francisco based company Theravance Inc. (THRX) announced second-quarter results. The company reported lower net loss of $21.7 million or $0.35 per share as against $27.0 million or $0.44 per share in the year ago quarter.  Theravance currently does not have any FDA approved product and derives its revenue in the form of upfront and milestone payments from its collaborations. The company reported revenue of $5.5 million, flat from the year ago period. Revenue includes $2.7 million received from collaboration partner GlaxoSmithKline (GSK). During the quarter, Theravance received a milestone payment of $10 million in relation to the NDA filing for telavancin meant for the treatment of hospital acquired pneumonia (HAP). Under the company’s revenue recognition policy of the company, this payment will be amortized over the relevant performance period.  Though revenue in the reported quarter remained unchanged from ...