Archive for November, 2013

Shire acquires ViroPharma for $4.20 billion

Posted on November 11th, 2013 by Valorem Life Sciences

Shire has hit the acquisition trail and is spending $4.20 billion to buy the US rare disease specialist ViroPharma.

The Ireland-headquartered group is paying $50 per share, which represents a 27% premium on ViroPharma’s closing share price on November 8. The deal gives Shire access to the hereditary angioedema drug Cinryze (C1 inhibitor [human]), which complements its own HAE drug Firazyr (icatibant).

Last year, Cinryze sales reached $321 million in the USA and for this year, North American revenues are forecast $395-$405 million. ViroPharma also sells Plenadren (hydrocortisone modified release) for adrenal insufficiency and Buccolam (midazolam), which treats prolonged seizures in infants, children and adolescents.

In terms of pipeline, two products are in Phase II – maribavir for the treatment of cytomegalovirus infection in transplant patients and VP20621 for the prevention of recurrent Clostridium difficile infection. ViroPharma also has an option to acquire Meritage Pharma, which is conducting Phase II trials with oral budesonide for eosinophilic oesophagitis.

Shire, which recently announced job cuts in the UK, says it will review these programmes to ensure its R&D resources are “appropriately deployed”. Chief executive Flemming Ornskov said the acquisition “will immediately benefit Shire and is entirely consistent with our clear strategic objective of strengthening our rare disease portfolio”.

He added that his company “is uniquely positioned to drive the continued success of Cinryze for the benefit of patients through our knowledge of the rare disease space, our international infrastructure and our biologics manufacturing expertise”. Mr Ornskov concluded by saying that Shire has conducted “a thorough and collaborative due diligence process over the last few months”, and the acquisition “is expected to create a $2 billion rare disease revenue base and delivers further strong growth prospects”.

Source: Pharma Times

FDA launches new plan to tackle drug shortages

Posted on November 4th, 2013 by Valorem Life Sciences

The US Food and Drug Administration has launched a two-pronged plan designed to combat the problem of medicine shortages.

The first scheme will see the agency look to improve its own response to “imminent or existing shortages, and for longer-term approaches for addressing the underlying causes of drug shortages”. The plan also highlights opportunities for drug manufacturers and others to prevent shortages “by promoting and sustaining quality manufacturing”.

Secondly, the FDA has issued a proposed rule requiring all manufacturers of “certain medically important prescription drugs” to notify the agency of a “permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply”. The rule also extends this requirement to makers of biologics.

The plan was made in response to an order from the Obama administration two years ago to resolve the shortage problem. Between 2005 and 2011, the number of new shortages quadrupled to 251. Although the figure fell to 117 last year, more than 300 ongoing shortages existed as 2013 got under way. The FDA Safety and Innovation Act also requires the agency to improve its response.

The agency notes that progress has already been made following President Obama’s 2011 executive order on reducing drug shortages. The number of new shortages in 2012 was 117, down from 251 in 2011, and since the Order, there has been a six-fold increase in notifications to the FDA.

Source: Pharma Times