News in brief from around the world… The past week has seen Roche begin its buyout of Foundation Medicine, a change of legal guard at the US Food and Drug Administration and the legalisation of medical cannabis in Luxembourg.
Companies
⇒ Roche announced on 2 July that it had commenced its buyout of all the outstanding stock of US company Foundation Medicine.
The deal, which was unanimously approved by both companies’ boards on 19 June, will see the Swiss company pay US$2.4 billion for all Foundation stock not already owned by Roche or its affiliates.
Foundation, which specialises in molecular research in cancer care, was described as an “important” addition to Roche’s personalised healthcare offering. “[W]e believe molecular insights and the broad availability of high quality comprehensive genomic profiling are key enablers for the development of, and access to, new cancer treatments,” Roche Pharmaceuticals CEO Daniel O’Day said in a statement.
A team from Davis Polk & Wardwell’s New York office advised Roche on the merger, while Foundation was represented by lawyers from Goodwin Procter.
Community
⇒ The US Food and Drug Administration’s chief counsel, Rebecca Wood, is standing down according to news reports citing a letter sent to agency employees by commissioner Scott Gottlieb on 29 June.
Gottlieb is reported to have written that Wood “has made the personal decision to step down as chief counsel at the end of July”.
Lowell Schiller, senior counsel to the commissioner, will reportedly serve as acting chief counsel as the agency searches for a more permanent replacement for Wood.
⇒ California boutique healthcare and life sciences law firm Nelson Hardiman has promoted litigation and compliance lawyer Salvatore Zimmitti to partner, effective 1 July.
Zimmitti, who worked at healthcare law firm Hooper Lundy & Bookman before joining Nelson Hardiman in 2014, represents clients in state and federal courts on a range of issues from white-collar fraud to medical marijuana defence.
“Sal has proven himself as a true leader within our firm,” managing partner Harry Nelson said in a statement. “In one high stakes, complex case after another, Sal has demonstrated that he has ‘the right stuff’ to deliver for our clients.”
Zimmitti praised the firm’s commitment to “strong and smart” client advocacy and the “unusual solidarity among the firm’s deep legal team”, adding that he felt “fortunate to have the opportunity to work on such a wide range of interesting matters” at the firm.
Regulation
⇒ The government of Luxembourg unanimously passed [link in French] a draft law on 28 June to decriminalise cannabis for medical use, becoming one of the first European countries to pass such legislation.
Following an opinion submitted by the Council of State, all general practitioners will be able to prescribe the drug, provided they receive specialised training. The original text of the law was more restrictive and would only have given prescription privileges to certain specialists, such as oncologists or neurologists.
The law provides for a review after two years to evaluate the number of patients who have benefited and possibly revise the list of diseases that can be treated with medical cannabis.
Courts and cases
⇒ A Delaware Bankruptcy Court has approved a request by US obesity treatment company Orexigen Therapeutics for its Chapter 11 sale to a new company set up by rival Pernix Therapeutics.
In an order on 28 June, Judge Kevin Gross approved the sale of all of Orexigen’s assets to stalking horse bidder Nalpropion Pharmaceuticals for US$75 million.
Orexigen filed for Chapter 11 bankruptcy protection with counsel from Hogan Lovells in March, citing debts of between US$100 million and US$500 million, compared to assets of between US$50 million and US$100 million.
The company launched its flagship obesity treatment, Contrave, in 2014 in partnership with Japanese pharma company Takeda, which took responsibility for commercialising the product in the US. However, in its first-day motion, Orexigen claimed that “due to a change in its overall business focus and objectives, in late 2015, Takeda began to adjust its priorities away from the commercialization and marketing of Contrave”.
The company then undertook to commercialise the drug itself, a process that it said “required significant capital investment to return the product to a growing prescription volume trajectory”. While the company achieved estimated net sales in 2017 of approximately US$98 million, this was short of its projections, and led to a “near-term liquidity crisis”.
The company first struck a deal with Nalpropion, saying at the time that it aimed to keep Contrave on the market.
