Actelion announced that its PGI2 receptor agonist, ACT-293987, generated positive results in a Phase IIa study evaluating the drug candidate as a potential treatment for patients with pulmonary arterial hypertension (PAH).

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Based on the results, the company said it would advance the first-in-class compound into late-stage testing before the end of the year. The primary endpoint of the randomised, placebo-controlled study, which involved 43 patients, was change from baseline in pulmonary vascular resistance.

Vontobel analyst Andrew Weiss indicated that the drug “is a very interesting compound and could significantly expand the treatment options Actelion offers to PAH patients.” Weiss added that “a filing for (approval) is likely in 2013.” ACT-293987 is being developed in collaboration with Nippon Shinyaku.

Source: FirstWord

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The FDA issued a complete response letter requesting additional manufacturing information regarding the regulatory filing for Novartis’ meningitis vaccine Menveo for use in people aged 11 to 55 years old, the drugmaker reported Wednesday. Novartis spokesperson Eric Althoff indicated that a decision on the application is now expected to be delayed to late 2009 or early 2010.

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The company anticipates it will be able to fully respond to all questions in the FDA’s letter this year. Commenting on the news, Vontobel analyst Andrew Weiss anticipates the “financial impact is small.”

Earlier this year, Novartis said the filing of Menveo for use in infants would be delayed until 2011 after the FDA requested that it expand a late-stage clinical programme for the drug. Weiss noted that “after the infant application needing to perform an additional safety trial in 1500 infants, we view the delay of the adolescent and adult vaccine as a disappointment.”

Analysts have estimated that, if approved, Menveo could generate annual sales of $650 million.

Source: FirstWord

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Novartis reported Monday that Afinitor (everolimus) significantly reduced tumour size in patients with relapsed non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease in a Phase II study. Based on the results, which were presented at the European Hematology Association congress, the company indicated that it has initiated a Phase III study investigating the potential of Afinitor in preventing relapse in patients with diffuse large B-cell lymphoma (DLBCL).

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The Phase II trial involved 145 patients with relapsed/refractory aggressive or indolent NHL or Hodgkin’s disease whose disease progressed despite prior therapy. The single-arm study included patients with T-cell NHL, Hodgkin’s disease, follicular lymphoma, mantle cell lymphoma, DLBCL and small lymphocytic lymphoma, who received treatment with Novartis’ once-daily, oral drug. Results showed that 33 percent of patients achieved an overall response rate with a reduction in tumour size of 50 percent or more.

In the late-stage PILLAR-2 study currently underway, Afinitor is being investigated as an adjuvant treatment in poor-risk patients with DLBCL who achieved complete remission with first-line Rituxan (rituximab), which is marketed in the US by Genentech and Biogen Idec, combined with chemotherapy. Alessandro Riva, the global head of oncology development at Novartis, remarked that “we continue to see the potential of Afinitor in multiple types of cancer.”

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Earlier this year, Afinitor was approved by the FDA to treat advanced kidney cancer after prior therapy, and received a positive opinion in the EU for patients with the disease. Vontobel’s Andrew Weiss has forecast that the drug could reach peak sales of $500 million in the advanced kidney cancer indication alone.

Source: FirstWord

Popularity: 4% [?]

Roche announced Tuesday that the company is donating 5.65 million treatment courses of Tamiflu (oseltamivir) to the World Health Organization to replenish supplies that were depleted when previously donated stocks were sent to developing countries in response to the influenza A (H1N1) outbreak. The drugmaker also indicated that it could boost production of the antiviral treatment if required.

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Roche specified that two million Tamiflu packets would be held by the WHO to address regional outbreaks, while another three million courses would be held by Roche and deployed under the direction of the WHO as part of a rapid response stockpile. A further 650 000 courses of treatment will be kept in a newly established paediatric stockpile. William Burns, head of Roche’s pharmaceuticals division, said the H1N1 outbreak “emphasises the urgency of restoring WHO and Roche rapid response stockpiles, alongside national government stockpiles, to prepare for subsequent waves with this virus or for addressing newly emerging influenza strains.”

In related news, Roche also indicated that it could manufacture as many as 110 million courses of treatment over the next five months. After that time, the company said Tamiflu production could increase up to 36 million treatment courses per month by the end of the year, equating to a maximum annual capacity of 400 million courses per year. David Reddy, who heads Roche’s global pandemic preparedness task force, noted that “actual production output is dependent upon continued demand from governments for pandemic stockpiles of Tamiflu.”

Vontobel analyst Andrew Weiss remarked that “revenue from Tamiflu will only increase if demand from either governmental pandemic stockpile reloading or private-sector stockpiling starts to pick up.” He suggested that, currently, H1N1 “seems not to be as worrying as initially thought. However, the WHO continues to be worried, mainly on the back that the influenza virus could mutate into a more serious problem” and return as a threat this autumn.

Source: FirstWord

Popularity: 2% [?]

According to people close to the matter, Genentech’s board of directors is close to a deal to sell to Roche, for $95 per share, the outstanding 44-percent of stock in Genentech that Roche does not already own, The Wall Street Journal reported. The $95 share price, which is higher than Roche’s most recent offer of $93 per share, values the deal at $46.7 billion.

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The unnamed sources said an announcement could come as early as the close of trading on Monday March 9. They explained that discussions were held during the weekend, and that there have been delays due to negotiations over the timing and closing conditions. A potential deal could still fall apart, the people noted. A spokesman for Roche declined to comment on the news, while Genentech spokesman Geoffrey Teeter remarked that “we don’t comment on rumours.”

Meanwhile, Vontobel analyst Andrew Weiss noted that a bid of $95 to $100 a share fairly reflects the value of Genentech and he speculated that Roche might be required to raise its offer again to reach a deal. He remarked: “Roche’s improved bid and prolonged tender offer deadline, in our view clearly signal Roche’s intent to soon take Genentech private.”

Source: FirstWord

Popularity: 2% [?]

GlaxoSmithKline entered into an agreement to purchase commercial operations and product distribution rights from UCB in selected emerging markets for 515 million euros ($660.8 million) in cash, the companies reported. Under the deal, which is expected to be finalised in late March, the UK drugmaker will acquire several pharmaceutical brands in a number of disease areas, including epilepsy treatment Keppra (levetiracetam), allergy medications Xyzal (levocetirizine) and Zyrtec (cetirizine) in Asia Pacific, the Middle East, Latin America and Africa.

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UCB indicated that the more than 50 operations involved in the deal represent about 3 percent to 4 percent of the company’s revenue projection of at least 3.3 billion euros ($4.2 billion) for 2008. The agreement does not involve UCB’s more recent products or commercial operations in Brazil, Russia, India, China, South Korea and Mexico, which the Belgian drugmaker describes as “strategic emerging markets.”

UCB chief executive Roch Doliveux said the deal will allow the company to “continue to strengthen its core indication areas, [central nervous system] and immunology…while [GlaxoSmithKline] acquires assets which fit with its growth and diversification strategy.” The move also furthers the strategies outlined in UCB’s SHAPE programme.

Commenting on the news, Vontobel analyst Andrew Weiss remarked that since “Western European countries and the US are seeing growth falling on the one hand because of high penetration and on the other because they’re hit by a massive recession, [GlaxoSmithKline] is moving into under-penetrated emerging markets.”

Source: FirstWord

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European regulators granted marketing authorisation for Roche’s RoActemra (tocilizumab), in combination with methotrexate, to treat adults with moderate to severe rheumatoid arthritis who have failed to respond to existing therapies, the drugmaker announced on Wednesday.

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Vontobel analyst Andrew Weiss suggested that the EU approval could have a positive impact on Roche’s USUS approval in 2010,” said Weiss, who estimates peak sales could reach 1.2 billion Swiss francs ($1 billion). application for the drug. In December, the FDA requested additional information on the drug, known as Actemra in markets outside the EU. “The [European Medicines Agency's] green light is a clear sign that the FDA is overly cautious. Roche however will need to conduct the trial and then file the data. We expect US approval in 2010,” said Weiss, who estimates peak sales could reach 1.2 billion Swiss francs ($1 billion).

The drug is already approved in Japan, where it is marketed by Chugai.

Source: FirstWord

Popularity: 3% [?]

Roche on Monday dismissed a suggestion in a Financial Times report that the company would sacrifice its year-end dividend to help finance a rumoured higher bid for Genentech. Company spokesperson Daniel Piller said: “Our dividend policy remains unchanged.” However, Roche declined to comment on other details contained in the news report.

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Instead, the Swiss drugmaker reiterated plans stated in 2008 that it intends to raise its dividend payout ratio continuously over the next three years. The Financial Times report, which did not cite any sources, suggested that Roche is prepared to raise its current $89-per-share offer for the shares in Genentech it does not already own to $95 per share and would likely have to borrow $30 billion to $35 billion to conclude the purchase, in addition to doing away with its dividend. According to Merrill Lynch analyst Sachin Jain, frozen credit markets have hampered the drugmaker’s ability to secure sufficient financing for the transaction.

However, Vontobel’s Andrew Weiss remarked that “should Roche decide to sweeten its deal, this would be a positive sign for the Roche/Genentech deal in particular and the credit market in general,” adding that “with the new year just kicked off, credit departments within major banks are going to need to think about where to do business in 2009.” Weiss noted that Roche’s ability to generate strong free cash flow from products that benefit from relatively long patents may act in the company’s favour.

Analysts at Morgan Stanley estimate that the reported potential increased offer price for Genentech would raise Roche’s core earnings per share by an immediate 10 percent in 2010. “We anticipate Roche will ultimately be forced to offer in excess of $100 a share to secure Genentech board approval,” they predicted.

Source: FirstWord

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On Thursday, Johnson & Johnson reported that Zevtera (ceftobiprole) received approval in Switzerland as a treatment for complicated skin and soft tissue infections, including diabetic foot infections which have not spread to the bone. The antibiotic, which is co-developed with Basilea, is currently under review by regulators in the US and EU.

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Johnson & Johnson noted that the compound is the “first, broad-spectrum, anti-methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic with activity against a range of difficult-to-treat Gram-positive and Gram-negative hospital- and community-acquired pathogens including MRSA and Pseudomonas aeruginosa.” Commenting on the news, Vontobel analyst Markus Metzger said that “approval from Swissmedic is in-line with our and market expectations but certainly bodes well for the anticipated approval of ceftobiprole in Europe later this year and in the important US market by Q1 2009.” In March, the FDA issued an approvable letter for the drug.

Analysts forecast that the antibiotic, which is also being tested as a potential therapy for pneumonia, could generate peak sales ranging from 1 billion Swiss francs ($834 million) to 1.6 billion francs ($1.3 billion).

Source: FirstWord

Popularity: 2% [?]