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Earlier this month, Medivation, Inc. (MDVN) and Pfizer, Inc. (PFE) initiated two phase III studies, CONTACT and CONSTELLATION, with Dimebon in patients with moderate-to-severe Alzheimer’s disease (AD). Dimebon is being developed in collaboration with Pfizer for the treatment of Alzheimer’s and Huntington diseases.
The CONTACT study will assess the potential benefits of adding Dimebon to ongoing [...]
Earlier this month, Medivation, Inc. (MDVN) and Pfizer, Inc. (PFE) initiated two phase III studies, CONTACT and CONSTELLATION, with Dimebon in patients with moderate-to-severe Alzheimer's disease (AD). Dimebon is being developed in collaboration with Pfizer for the treatment of Alzheimer’s and Huntington diseases.
The CONTACT study will assess the potential benefits of adding Dimebon to ongoing treatment with Pfizer’s Aricept on neuropsychiatric symptoms and activities of daily living. Meanwhile, the CONSTELLATION study will evaluate the effects of adding Dimebon to Forest Lab’s (FRX) Namenda, another standard of care, on cognition, memory and activities of daily living.
Preclinical studies indicate that Dimebon has the potential to protect brain cells from damage and enhance brain cell survival, by stabilizing and improving mitochondrial function. Dimebon’s mechanism is distinct from currently available Alzheimer’s medications.
Dimebon is currently in seven studies which are evaluating the safety and efficacy of the candidate across all stages of Alzheimer's disease, both as monotherapy as well as in combination with currently available Alzheimer's treatments, and in Huntington disease.
Dimebon’s unique mechanism of action and efficacy seen in clinical trials could make it a significant player in the worldwide Alzheimer’s market, which represents huge commercial potential. It is estimated that the market is currently worth about $5 billion.
Dimebon has successfully completed the first of two pivotal trials required to gain marketing approval in the U.S. for mild-to-moderate Alzheimer’s disease. A second confirmatory phase III study, CONNECTION, is currently ongoing. We expect to see top-line results from this study in the first half of 2010. Positive results should allow Medivation to go ahead with the filing of the new drug application (NDA) for the Alzheimer’s indication in 2011.
AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year.
The primary reasons for the increase in revenues were [...]
AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year.
The primary reasons for the increase in revenues were strong US sales of Toprol-XL benefiting from generic withdrawal, US sales of its H1N1 vaccine and robust growth in emerging markets.
AstraZeneca recorded strong sales across all geographies. Sales in North America, Emerging Markets and Established Markets increased (at CER) by 13%, 15% and 4%, respectively. The company expects double-digit revenue growth in Emerging Markets for the full year.
Among the product categories, apart from gastrointestinal and oncology, which recorded sales decline of 1% and 10% respectively, all other segments increased their revenues. AstraZeneca recorded more than 26% of its revenues during the quarter from cardiovascular drug sales.
This segment recorded the highest growth at 29%. Revenues for Respiratory and Inflammation, Neuroscience and Infection and others increased by 13%, 11% and 22%, respectively.
AstraZeneca’s gross margin improved to 84.9% from 81.3% in the year-ago period due to a reduction in cost of sales. Operating profit increased 29% to $3.6 billion due to improved gross margin and lower R&D expenditure, partially offset by higher SG&A expenses and less other income.
During the quarter, AstraZeneca received significant regulatory approval and entered into new licensing collaborations. These include:
· Approval from the US Food and Drug Administration (FDA) for Onglyza (saxagliptin) to be used for the treatment of type 2 diabetes mellitus in adults. In addition, the drug received marketing authorization from the European Commission.
· Approval from the US FDA for the H1N1 vaccine.
· Collaboration agreement with Forest Laboratories (FRX) for the development and commercialization of ceftaroline in all major markets other than the U.S., Canada and Japan. The drug is in a late stage of development for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). While Forest expects to file a New Drug Application (NDA) in the US by the end of 2009, AstraZeneca expects to file a Marketing Authorization Application (MAA) in Europe by the end of 2010.
· An exclusive worldwide license agreement with Nektar Therapeutics (NKTR) for two drug candidates; NKTR-118, a late stage investigational product for the treatment of opioid-induced constipation and NKTR-119, an early stage compound intended to deliver products for the treatment of pain without constipation as its side effect.
· AstraZeneca submitted a MAA for Brilinta and expects to submit the NDA by the year end.
While all these were positive developments, AstraZeneca has had its share of failures too. The company had to withdraw the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from both the US and the EU. The submission was withdrawn due to lack of positive data.
Cypress Bioscience, Inc. (CYPB) reported a net loss of 14 cents per share in the third quarter, 6 cents better than the Zacks Consensus Estimate of a net loss of 20 cents. Although revenues increased significantly from the year-ago period, net loss was higher due to higher operating expenses mainly due to costs associated with [...]
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