Amgen Inc sued Novartis AG's Sandoz in a federal court in the United States on Monday (May 1), accusing Sandoz's proposed versions of its multibillion-dollar
bone-strengthening drugs Prolia and Xgeva of infringing several patents.
Amgen asked the New Jersey court to block Sandoz's biosimilars of the drugs until its patents expire. One of the patents named in the complaint does not expire
until 2037.
Sandoz declined to comment on the lawsuit on Tuesday. Novartis, which is also named in the complaint, is preparing to spin Sandoz off into a standalone company
later this year.
Amgen's Prolia is used to treat osteoporosis. Xgeva, with the same active ingredient denosumab, treats bone cancer and prevents fractures in bone-cancer patients.
Novartis on Wednesday (February 1) predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last
year, as the Swiss drugmaker prepares to spin off its Sandoz generics business.
Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion.
Adjusted for overall negative currency effects, group sales in 2022 advanced 4 per cent to $50.5 billion as gains from heart failure drug Entresto and multiple
sclerosis (MS) drug Kesimpta were partly offset by competition from cheap generic copies of established MS drug Gilenya.
Novartis said it was on track to spin off its generics unit Sandoz in the second half of the year as part of its effort to sharpen its focus on its patented
prescription medicines.
Analysts have welcomed a programme unveiled in 2022 to trim costs and cut 8,000 jobs and plans to focus on fewer therapy areas and drug technologies. But the market
has been underwhelmed by prospects for medium-term growth from new drugs.
Swiss generic drugmaker Sandoz said on Thursday that it would pay $265 million (£209m) to settle a pricing antitrust case in the US.
Under the agreement, Sandoz is resolving all damages claims without admitting to any wrongdoing in the case brought in the US state of Pennsylvania.
"Under the terms of the agreement, Sandoz US will pay $265 million in exchange for a full release of all claims asserted against it in the direct purchaser
class action by the settlement class members," the company said in a statement, adding that the payment would be incorporated into 2023 results.
Sandoz became an independent company in October 2023, following the spinoff from Novartis.
"As a new public company, this settlement underscores the Sandoz commitment to integrity and sound governance, and is an encouraging step toward putting
allegations of legacy conduct behind us", it said in its statement.
The British Generic Manufacturers Association (BGMA) has elected Diane DiGangi Trench to be its new vice-chair.
DiGangi Trench takes up the position replacing Xiromed's Peter Ballard and in 12-months' time will assume the association's chair role from Accord's Peter Kelly.
With over 25 years of pharmaceutical industry experience, DiGangi Trench has held a number of senior commercial roles including stints with Takeda and Astra Zeneca.
She joined Sandoz in 2018 in the US, where she served as Vice-President, Market Access and Patient Services.
In 2021, she became the head of Sandoz' UK business and in her two years in role, she has led the organisation through a post-COVID recovery and growth phase to
prepare for the proposed spin out of the company from its parent, Novartis, expected later this year.
She said: "It's a great honor to take on the role of Vice Chair of the BGMA. The success of the generics and biosimilar industry is essential to the functioning of
the NHS. Generic medicines fill four out of five UK prescriptions and biosimilars enable the NHS to expand access to more patients. I am passionate about increasing
the sustainability of our industry so we can continue to play our vital part in the health of the nation."
Mark Samuels, BGMA chief executive, said: "We are extremely fortunate to be able to call upon the expertise of Diane who has already added significant value through
her role on the BGMA board and leadership of a key strategic committee.