With its long-anticipated acquisition of Horizon Therapeutics wrapped up final month, Thousand Oaks pharma big Amgen Inc. is incorporating Horizon’s drug improvement packages into a brand new enterprise line for uncommon illness therapies.
In the meantime, alongside its extra conventional enterprise strains, Amgen late final month received approval from america Meals and Drug Administration to market a drug it developed that’s much like Johnson & Johnson’s blockbuster drug Stelara.
Amgen’s new uncommon illness enterprise line was formally unveiled throughout the firm’s third quarter earnings teleconference name on Oct. 31.
Amgen Chief Govt Robert Bradway launched the enterprise line in his opening feedback as “a newly created uncommon illness enterprise that’s now the fourth leg of Amgen’s industrial stool, alongside our irritation, oncology and basic drugs companies.”
Bradway then launched Vikram Karnani because the chief of that enterprise. Karnani held a number of government posts at Dublin-based Horizon Therapeutics previous to its merger with Amgen, together with president of world industrial operations.
“We’re excited to carry collectively Horizon’s medicines, pipeline and uncommon illness experience with Amgen’s historical past of management in inflammatory illnesses, world infrastructure and world-class biologic capabilities,” Karnani stated earlier than briefing analysts on the decision on the standing of a number of medication Horizon had available on the market or in improvement.
Chief amongst these medication is Tepezza, the primary and solely drugs to this point accredited for the therapy of thyroid eye illness and one of many medication on the heart of the scrutiny that federal regulators utilized to the merger plan. Karnani stated that throughout the third quarter, Tepezza generated $453 million in gross sales, representing 2% quarter-over-quarter development.
“We’re assured that now as we’ve formally joined forces and have on-boarded the total industrial group, we’ll make important progress in advancing this necessary product over time to sufferers,” Karnani stated.
One other main drug Horizon had available on the market was Krystexxa, the one drugs to this point accredited to deal with uncontrolled gout; Karnani stated that drug had $253 million in third quarter gross sales, a rise of 32% over the identical quarter final 12 months.
Horizon’s different medication which have made it to market generated about $240 million in third quarter gross sales, he added.
“Wanting forward, we’re excited to work collectively by leveraging Amgen and Horizon’s mixed capabilities to make sure our medicines attain extra sufferers even quicker who’re affected by critical and uncommon illnesses globally,” he stated.
Earnings
As for Amgen general, third quarter revenues elevated 4% to $6.9 billion compared to the identical quarter final 12 months.
In his feedback to analysts within the convention name, Bradway stated quantity elevated 11% globally, which represents the corporate’s fourth consecutive quarter of double-digit quantity development.
Bradway famous that seven of the corporate’s medicines generated file gross sales throughout the quarter.
Among the many finest performers had been:
• Blincyto (used to deal with sufferers with a precursor type of acute lymphoblastic leukemia), which posted a 55% gross sales leap within the third quarter in comparison with the identical quarter final 12 months;
• Evenity (used to deal with osteroperosis in ladies after menopause), which noticed a 53% year-over-year development in gross sales; and
• Repatha (utilized in adults with heart problems to cut back the danger of coronary heart assault, stroke, and sure kinds of coronary heart surgical procedure), which recorded a 31% development in gross sales from the identical quarter final 12 months.
Amgen’s web revenue obtainable to shareholders throughout the third quarter was $1.7 billion, down from $2.1 billion for a similar quarter final 12 months. Amgen attributed a lot of this drop to a web impairment cost of about $650 million following a call to discontinue improvement of a drug to deal with prostate most cancers and transfer forward with improvement of an alternate drug.
The corporate additionally issued up to date steering for full-year earnings efficiency. In response to that steering, complete income is predicted to come back in between $28.0 and $28.4 billion, whereas capital expenditures had been anticipated to complete round $950 million. Whole share repurchases for the 12 months are to not exceed $500 million, the corporate stated.
Amgen shares fell on the day of the earnings launch (Oct. 31) to $255.70 from $263.19, however regained that misplaced floor in two days. The share value closed at $264.27 on Nov. 27.
New drug
On the identical day because the earnings launch and convention name, the Meals and Drug Administration accredited Amgen’s drug Wezlana for industrial use. Wezlana is a “biosimilar” drug for Stelara, the blockbuster drug from New Brunswick, New Jersey-based Johnson & Johnson. Stelara, which got here available on the market in 2009, has been Johnson & Johnson’s top-selling drug since 2019, with gross sales reaching $9.7 billion final 12 months.
In response to the Meals and Drug Administration’s web site, a biosimilar drug is very much like and has no clinically significant variations from an current agency-approved biologic, referred to as a reference product. In contrast with their reference product, biosimilars are made with the identical kinds of dwelling sources and usually have the identical energy, dosage, potential therapy advantages and unwanted effects.
Not like generic variations of a drug, biosimilars usually have extra advanced lively components and due to this fact will not be precise copies of the reference drug.
In an period of frequent shortages of essential pharmaceutical merchandise, biosimilars present a extra various provide chain and extra competitors, in addition to enabling different pharma corporations to share within the income for a extremely profitable basic remedy for a specific illness or situation.
“At the moment’s approval exemplifies the FDA’s longstanding dedication to assist a aggressive market for organic merchandise,” Sarah Yim, director of the company’s workplace of therapeutic biologics and biosimilars, stated within the company’s announcement. “This approval can empower sufferers by serving to to extend entry to protected, efficient and high-quality medicines at doubtlessly decrease value.”
Originally posted 2023-12-04 08:01:04.