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, 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 ...

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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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 ...

Theravance Inc. (THRX) is expected to release its second quarter earnings on July 23, 2009. We expect the company to post a net loss of $16.8 million or $0.27 per share on revenues of $16 million during the quarter. Theravance, being a developmental stage company, does not have any FDA approved products in the market. The revenue forecast is comprised of license and milestone payments.

Our revenue forecast for the second quarter includes a $10 million milestone payment due from Theravance’s partner; Astellas Pharma Inc. in connection with the NDA submission for Telavancin for the Hospital acquired Pneumonia (HAP) indication.

The second half of 2009 is very crucial for Theravance, as decisions regarding both of its NDA submissions on Telavancin will be taken during this period. The company has submitted an NDA for Telavancin for the treatment of complicated skin and skin structure infections (cSSSI) and HAP (both caused by gram-positive

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On Jul 15, 2009, Colorado-based biopharmaceutical company Array BioPharma Inc. (ARRY) filed an investigational new drug application (NDA) with the objective of initiating a phase I trial in cancer patients with its most advanced, wholly-owned MEK inhibitor, ARRY-162.

The open-label, multiple dose study is designed to evaluate the tolerability, safety and efficacy of the inhibitor following the oral administration of the drug to advanced cancer patients with solid tumors on a daily basis. The study is expected to commence in the third quarter of 2009.

Array is also evaluating the candidate for arthritis and chronic obstructive pulmonary disease (COPD). Currently, a worldwide phase II, double-blinded study (n=200) for ARRY-162 with active rheumatoid arthritis is in progress.

We think that Array's decision to evaluate its most advanced MEK inhibitor in the field of cancer will benefit cancer patients immensely. Further, management believes that ARRY-162 is not only well-suited for cancer treatment but

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Philips Healthcare to bolster chronic disease management in China

Philips (PHG) and project HOPE, which aims at providing education and solutions to health problems, announced a joint effort to support major hospitals and community healthcare centers in China to deal with chronic diseases. Philips' Healthcare division will provide technical knowhow as well as finance part of the program costs. The program will focus on heart diseases, stroke and respiratory ailments.

This project aims to develop infrastructure as well as capacity of medical care centers to provide long-term treatment to patients suffering from these diseases. Philips will provide training as well as advanced facilities to the centers under this collaboration. Patients will receive guidance on skills for self-administered care to ensure a healthier lifestyle.

According to report published by the Ministry of Health, chronic diseases such as coronary heart disease, stroke, and chronic obstructive pulmonary disease are major causes for death in

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