Appendix 4E and Preliminary Ultimate Report - For the 12 months Ended 30 June 2024

“For the primary time, youngsters and adolescents with average to extreme plaque psoriasis and their caregivers have an oral choice to deal with this continual illness, with its extremely seen, uncomfortable signs,” mentioned Murdo Gordon , government vp of International Industrial Operations at Amgen. “Within the final decade, Otezla has been prescribed to over a million adults worldwide, and at present’s announcement represents the potential for Otezla to supply aid to many youthful sufferers.”

“Kids dwelling with average to extreme plaque psoriasis typically expertise uncomfortable and extremely seen signs, similar to itchy, dry lesions that will bleed or trigger ache. Nonetheless, remedy choices for this continual immune-mediated illness are restricted,” mentioned Leah M. Howard , JD, president and CEO of the Nationwide Psoriasis Basis. “Till now, FDA-approved systemic remedy choices for youth have been injections or infusions. The addition of an oral remedy choice with a well-established security profile is nice information for kids with this illness and their households.”

The FDA approval was based mostly on outcomes from SPROUT, a Section 3, multicenter, randomized, placebo-controlled, double-blind research which investigated the efficacy and security of Otezla in pediatric sufferers aged 6 to 17 years with average to extreme plaque psoriasis inadequately managed by or illiberal to topical remedy. The first endpoint – static Doctor’s International Evaluation (sPGA) response (outlined as an sPGA rating of clear [0] or virtually clear [1] with a minimum of a 2-point discount from baseline) – at week 16 was met with a 33.1% sPGA response for Otezla versus 10.8% for placebo (95% CI: 12.2%, 32.4%; P

The most typical unintended effects of Otezla embody diarrhea, nausea, higher respiratory tract an infection, rigidity headache and headache.

After the preliminary titration interval, the upkeep dosage of Otezla on this affected person group will likely be administered in both 20 or 30 mg doses, based mostly on weight, twice every day. The really helpful dose is 20 mg twice every day for pediatric sufferers weighing 20 kg to

Amgen is dedicated to supporting plaque psoriasis sufferers to make sure that applicable sufferers have reasonably priced entry to Otezla. For extra data, please go to Otezla.com .

About Psoriasis
Psoriasis is a continual illness the place pores and skin cells construct up shortly, usually inflicting purple or discolored, scaly, and itchy patches on the pores and skin. ¹ Roughly 125 million folks worldwide have psoriasis, together with round 14 million folks in Europe and greater than 8 million folks in the United States . ^2,3 About 80% of these sufferers have plaque psoriasis. ⁴ Amongst pediatric sufferers with plaque psoriasis, one in 5 have average to extreme illness. ⁵ Roughly one-third of those that get psoriasis are underneath 18 years outdated when the illness first surfaces. ⁶

About Otezla ^® (apremilast)
Otezla ^® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) particular for cyclic adenosine monophosphate (cAMP). PDE4 inhibition ends in elevated intracellular cAMP ranges, which is believed to not directly modulate the manufacturing of inflammatory mediators. The particular mechanism(s) by which Otezla exerts its therapeutic motion in sufferers isn’t properly outlined.

Since its preliminary FDA approval in 2014, Otezla has been prescribed to greater than 1 million sufferers worldwide. ⁷

INDICATIONS
Otezla ^® (apremilast) is indicated for the remedy of:

Grownup sufferers with plaque psoriasis who’re candidates for phototherapy or systemic remedy
Pediatric sufferers 6 years of age and older and weighing a minimum of 20 kg with average to extreme plaque psoriasis who’re candidates for phototherapy or systemic remedy
Grownup sufferers with lively psoriatic arthritis
Grownup sufferers with oral ulcers related to Behçet’s Illness

IMPORTANT SAFETY INFORMATION
Contraindications

Otezla is contraindicated in sufferers with a identified hypersensitivity to apremilast or to any of the excipients within the formulation

Warnings and Precautions

Hypersensitivity: Hypersensitivity reactions, together with angioedema and anaphylaxis, have been reported throughout postmarketing surveillance. If indicators or signs of significant hypersensitivity reactions happen, discontinue Otezla and institute applicable remedy
Diarrhea, Nausea, and Vomiting: Instances of extreme diarrhea, nausea, and vomiting had been related to the usage of Otezla. Most occasions occurred throughout the first few weeks of remedy. In some circumstances, sufferers had been hospitalized. Sufferers 65 years of age or older and sufferers taking medicines that may result in quantity depletion or hypotension could also be at a better danger of problems from extreme diarrhea, nausea, or vomiting. Monitor sufferers who’re extra inclined to problems of diarrhea or vomiting; advise sufferers to contact their healthcare supplier. Think about Otezla dose discount or suspension if sufferers develop extreme diarrhea, nausea, or vomiting
Despair: Rigorously weigh the dangers and advantages of remedy with Otezla for sufferers with a historical past of melancholy and/or suicidal ideas/conduct, or in sufferers who develop such signs whereas on Otezla. Sufferers, caregivers, and households ought to be suggested of the should be alert for the emergence or worsening of melancholy, suicidal ideas or different temper modifications, and they need to contact their healthcare supplier if such modifications happen

Plaque Psoriasis : Therapy with Otezla is related to a rise in melancholy. Throughout scientific trials in grownup sufferers with average to extreme plaque psoriasis, 1.3% (12/920) of sufferers reported melancholy in comparison with 0.4% (2/506) on placebo. Despair was reported as severe in 0.1% (1/1308) of sufferers uncovered to Otezla, in comparison with none in placebo-treated sufferers (0/506). Suicidal conduct was noticed in 0.1% (1/1308) of sufferers on Otezla, in comparison with 0.2% (1/506) on placebo. One affected person handled with Otezla tried suicide; one affected person on placebo dedicated suicide
Psoriatic Arthritis : Therapy with Otezla is related to a rise in melancholy. Throughout scientific trials, 1.0% (10/998) reported melancholy or depressed temper in comparison with 0.8% (4/495) handled with placebo. Suicidal ideation and conduct was noticed in 0.2% (3/1441) of sufferers on Otezla, in comparison with none in placebo-treated sufferers. Despair was reported as severe in 0.2% (3/1441) of sufferers uncovered to Otezla, in comparison with none in placebo-treated sufferers (0/495). Two sufferers who obtained placebo dedicated suicide in comparison with none on Otezla
Behçet’s Illness : Therapy with Otezla is related to a rise in melancholy. Through the scientific trial, 1% (1/104) reported melancholy or depressed temper in comparison with 1% (1/103) handled with placebo. No situations of suicidal ideation or conduct had been reported in sufferers handled with Otezla or handled with placebo

Weight Lower: Monitor physique weight commonly; consider unexplained or clinically vital weight reduction, and contemplate discontinuation of Otezla

Plaque Psoriasis : Physique weight lack of 5-10% occurred in 12% (96/784) of grownup sufferers with average to extreme plaque psoriasis handled with Otezla and in 5% (19/382) of sufferers handled with placebo. Physique weight lack of ≥10% occurred in 2% (16/784) of grownup sufferers handled with Otezla in comparison with 1% (3/382) of sufferers handled with placebo. Physique weight lack of 5%-10% occurred in 12% (19/163) of pediatric sufferers with average to extreme plaque psoriasis handled with Otezla in comparison with 2.5% (2/80) with placebo. Physique weight lack of ≥ 10% occurred in 1% (1/163) of pediatric sufferers handled with Otezla twice every day in comparison with 0% (0/80) of sufferers with placebo. Intently monitor progress (top and weight) in Otezla-treated pediatric sufferers. Pediatric sufferers who aren’t rising or gaining weight as anticipated could must have their remedy interrupted
Psoriatic Arthritis : Physique weight lack of 5-10% was reported in 10% (49/497) of sufferers taking Otezla and in 3.3% (16/495) of sufferers taking placebo
Behçet’s Illness : Physique weight lack of >5% was reported in 4.9% (5/103) of sufferers taking Otezla and in 3.9% (4/102) of sufferers taking placebo

Drug Interactions: Apremilast publicity was decreased when Otezla was co-administered with rifampin, a powerful CYP450 enzyme inducer; lack of Otezla efficacy could happen. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) isn’t really helpful

Hostile Reactions

Plaque Psoriasis : The most typical antagonistic reactions (≥ 5%) are diarrhea, nausea, higher respiratory tract an infection, and headache, together with rigidity headache. General, the security profile of Otezla in grownup sufferers with gentle to average plaque psoriasis and pediatric sufferers with average to extreme plaque psoriasis was in line with the security profile established in grownup sufferers with average to extreme plaque psoriasis
Psoriatic Arthritis : The most typical antagonistic reactions (≥ 5%) are diarrhea, nausea, and headache
Behçet’s Illness : The most typical antagonistic reactions (≥ 10%) are diarrhea, nausea, headache, and higher respiratory tract an infection

Use in Particular Populations

Otezla has not been studied in pregnant girls. Advise pregnant girls of the potential danger of fetal loss

Please click on right here for the total Prescribing Info for Otezla .

About Amgen
Amgen discovers, develops, manufactures and delivers modern medicines to assist thousands and thousands of sufferers of their combat towards a few of the world’s hardest illnesses. Greater than 40 years in the past, Amgen helped to ascertain the biotechnology business and stays on the cutting-edge of innovation, utilizing know-how and human genetic knowledge to push past what’s identified at present. Amgen is advancing a broad and deep pipeline that builds on its current portfolio of medicines to deal with most cancers, coronary heart illness, osteoporosis, inflammatory illnesses and uncommon illnesses.

In 2024, Amgen was named one of many “World’s Most Modern Firms” by Quick Firm and considered one of “America’s Greatest Massive Employers” by Forbes, amongst different exterior recognitions . Amgen is without doubt one of the 30 firms that comprise the Dow Jones Industrial Common ^® , and it’s also a part of the Nasdaq-100 Index ^® , which incorporates the most important and most modern non-financial firms listed on the Nasdaq Inventory Market based mostly on market capitalization.

For extra data, go to Amgen.com and comply with Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .

Amgen Ahead-Trying Statements
This information launch accommodates forward-looking statements which are based mostly on the present expectations and beliefs of Amgen. All statements, apart from statements of historic reality, are statements that may very well be deemed forward-looking statements, together with any statements on the end result, advantages and synergies of collaborations, or potential collaborations, with some other firm (together with BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the efficiency of Otezla ^® (apremilast) (together with anticipated Otezla gross sales progress and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (together with the potential efficiency and outlook of Horizon’s enterprise, efficiency and alternatives, any potential strategic advantages, synergies or alternatives anticipated because of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related bills going ahead), in addition to estimates of revenues, working margins, capital expenditures, money, different monetary metrics, anticipated authorized, arbitration, political, regulatory or scientific outcomes or practices, buyer and prescriber patterns or practices, reimbursement actions and outcomes, results of pandemics or different widespread well being issues on our enterprise, outcomes, progress, and different such estimates and outcomes. Ahead-looking statements contain vital dangers and uncertainties, together with these mentioned under and extra totally described within the Securities and Trade Fee studies filed by Amgen, together with our most up-to-date annual report on Kind 10-Ok and any subsequent periodic studies on Kind 10-Q and present studies on Kind 8-Ok. Except in any other case famous, Amgen is offering this data as of the date of this information launch and doesn’t undertake any obligation to replace any forward-looking statements contained on this doc because of new data, future occasions or in any other case.

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Even when scientific trials are profitable, regulatory authorities could query the sufficiency for approval of the trial endpoints we have now chosen. We develop product candidates internally and thru licensing collaborations, partnerships and joint ventures. Product candidates which are derived from relationships could also be topic to disputes between the events or could show to be not as efficient or as protected as we could have believed on the time of getting into into such relationship. Additionally, we or others might establish security, unintended effects or manufacturing issues with our merchandise, together with our units, after they’re in the marketplace.

Our outcomes could also be affected by our means to efficiently market each new and current merchandise domestically and internationally, scientific and regulatory developments involving present and future merchandise, gross sales progress of just lately launched merchandise, competitors from different merchandise together with biosimilars, difficulties or delays in manufacturing our merchandise and world financial situations. As well as, gross sales of our merchandise are affected by pricing strain, political and public scrutiny and reimbursement insurance policies imposed by third-party payers, together with governments, non-public insurance policy and managed care suppliers and could also be affected by regulatory, scientific and guideline developments and home and worldwide tendencies towards managed care and healthcare value containment. 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We depend on collaborations with third events for the event of a few of our product candidates and for the commercialization and gross sales of a few of our business merchandise. As well as, we compete with different firms with respect to a lot of our marketed merchandise in addition to for the invention and growth of recent merchandise. Additional, some uncooked supplies, medical units and part components for our merchandise are equipped by sole third-party suppliers. Sure of our distributors, prospects and payers have substantial buying leverage of their dealings with us. The invention of great issues with a product just like considered one of our merchandise that implicate a whole class of merchandise might have a cloth antagonistic impact on gross sales of the affected merchandise and on our enterprise and outcomes of operations. 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CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Kate Meyer , 872-867-0754 (media)
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References

Nationwide Psoriasis Basis. About Psoriasis. Obtainable at: https://www.psoriasis.org/about-psoriasis . Accessed June 4, 2024.
Nationwide Psoriasis Basis. Statistics. Obtainable at: https://www.psoriasis.org/content material/statistics . Accessed June 4, 2024.
Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the remedy of continual plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45.
Nationwide Psoriasis Basis. Plaque Psoriasis. Obtainable at: https://www.psoriasis.org/about-psoriasis/varieties/plaque . Accessed June 4, 2024.
Eichenfield LF, Paller AS, Tom WL, et al. Pediatric psoriasis. Pediatr Dermatol . 2018;35(2):170-181. Accessed June 4, 2024.
Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-Nationwide Psoriasis Basis pointers of take care of the administration and remedy of psoriasis in pediatric sufferers. Obtainable at: https://www.jaad.org/article/S0190-9622 (19)32655-6percent20/fulltext. Accessed June 4, 2024.
Amgen Information on File.