Chemistry World Blog

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PHARMACEUTICAL

Allergan payout for ‘misbranding’ Botox

Allergan will plead guilty and pay $600 million (£390 million) to resolve the investigation into its marketing of Botox for therapeutic use.

The US pharma company has agreed that between 2000 and 2005 it promoted the drug for off-label uses, including the treatment of headache, spasticity and juvenile cerebral palsy.

The payout includes: $375 million to the US government for the ‘misbranding’ charge and $225 million as part of a civil settlement.

In the criminal charge against Allergan, federal prosecutors said that Allergan exploited on-label indications to increase on-label sales. In addition, they say that in several ways the company helped doctors make money from off-label use. ‘Allergan made it a top corporate priority to maximise sales of far more lucrative uses that were not approved by the Food and Drug Administration (FDA),’ said US attorney for the Northern District of Georgia Sally Yates.

In the civil cases, claimants said that Allergan made unsubstantiated and misleading statements about the safety Botox for off-label indications. In addition, they said the company told doctors to miscode Botox to ensure payment by government health care programs and induced them to inject more of the drug.

Although best known as a cosmetic product that reduces wrinkles, Botox has been approved for therapeutic use since 1989. In March, the FDA approved Botox for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.

The settlement is part of a wider US crackdown on health care fraud. The Department of Justice has recovered $3.1 billion since January 2009 in cases involving fraud against federal health care programs.

Takeda gamble on obesity pill

— obesity-5251830-JI

Takeda has agreed to pay $50 million (£32 million) upfront for marketing rights to Contrave (bupropion and naltrexone), a diet pill made by biotech Orexigen that has yet to receive regulatory approval.

In addition, the Japanese pharma company has agreed to pay up to $1 billion for regulatory and sales milestones and – following commercialisation – double-digit royalties on net sales.

The deal gives Takeda exclusive rights in the US, Canada and Mexico. Orexigen will retain the right to co-promote Contrave in the United States

‘It has been our belief that getting a partner involved early would be critical to a high-quality launch of Contrave,’ said Michael Narachi, president and chief executive of Orexigen.

The obesity market is one of the most attractive for the pharmaceutical sector. Two-thirds of US adults are overweight or obese and despite growing awareness of the problem it is getting worse rather than better.

Pfizer buys FoldRx

Pfizer and FoldRx have inked a deal that will see the pharma giant acquire the US company for an undisclosed amount.

FoldRx is working on small molecule drugs for the treatment of degenerative diseases caused by protein-misfolding and aggregation.

Its lead product candidate, tafamidis, is a first-in-class oral drug for the treatment of TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease.

FoldRx has filed a marketing authorisation application (MAA) for tafamidis with the European Medicines Agency. Furthermore, tafamidis has orphan drug status in the US and the EU and fast track status in the US for the treatment of ATTR-PN. Orphan drugs are drugs for rare medical conditions – so-called orphan diseases. The official designation is designed to encourage companies to pursue these drugs by opening the door to financial benefits in the corresponding markets, which are – by definition – small.

‘This transaction will add another important component to the growing portfolio of innovative in-line and investigational medicines for orphan and rare diseases within Pfizer’s specialty care business and will complement the current and planned future research and clinical development taking place in Pfizer’s specialty care neuroscience disease area,’ said Geno Germano, president and general manager in the Pfizer specialty care business unit.

According to FoldRx, the transaction is expected to close later this year.

Roche moves to mitigate ‘mounting pressures’

— Roche

Roche has launched an ‘operational excellence’ initiative that could lead to job cuts. The initiative will help the company ‘adapt cost structures and accelerate productivity improvements’.

The company says it is responding to ‘mounting pressures to curb healthcare costs – especially in the US and Europe – together with recent developments in late-stage projects in the Roche pipeline’.

‘We have launched this initiative from a position of strength’, said chief executive Severin Schwan. ‘By contrast with many of our competitors, we are only marginally affected by patent expiries. Furthermore, despite the recent setbacks, we have one of the strongest R&D product pipelines in the industry.’

Roche will announce details of the measures to be taken and the potential job cuts before the end of the year.

CHEMICAL

Private firm grabs chunk of Univar

A private equity firm has agreed to buy a 42.5 per cent stake in global chemical distributer Univar in a deal that values the company at $4.2 billion (£2.7 billion).

‘The company is a clear market leader in an industry with favourable secular trends, broad spread of risk, significant operational improvement runway and attractive geographic expansion opportunities,’ said David Wasserman, a partner at Clayton, Dublin & Rice (CDR) – the firm making the purchase.

John Zillmer will continue as the Univar president and chief executive. CDR operating partner William Stavropoulos, a former chairman and chief executive at Dow, will be the non-executive chairman.

Univar says it has benefitted in recent years from ‘the growing shift to third-party distribution in the chemical industry’. In 2009, the company racked up sales of $7.2 billion.

According to Univar, the transaction is expected to close in the fourth quarter of 2010.

Andrew Turley