Merck, Hanwha to develop Enbrel biosimilar
WHITEHOUSE STATION, N.J. — Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.
Merck, which operates outside the United States and Canada as MSD to avoid confusion with Germany-based Merck KGaA, announced Monday a collaboration with Seoul, South Korea-based Hanwha Chemical to develop and commercialize HD203, a biosimilar version of Enbrel (etanercept), made by Amgen and Pfizer. The drug is used to treat such disorders as rheumatoid arthritis and psoriasis.
Under the agreement, Hanwha’s Bio Business Unit and a Merck subsidiary will work on the biosimilar, developed by Hanwha. Merck will be responsible for clinical development and manufacturing and will commercialize the drug in markets around the world, except Korea and Turkey, where Hanwha has marketing rights. Financial terms were not disclosed, but the companies said they will involve upfront commercial payments and potential milestones and royalties for Hanwha.
“This collaboration to develop and commercialize our lead biosimilar candidate with a leading global healthcare company such as Merck represents a significant event both strategically and financially for Hanwha, and underscores the success of our biopharmaceutical strategy,” Hanwha CEO K.J. Hong said. “We are excited and proud that Hanwha’s biobusiness is now well-positioned to make a major contribution toward providing access to a biosimilar form of one of the world’s leading biologic therapies.”
Merck revises labels for 16 drugs
SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.
Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.
“We commend Merck for their efforts,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “This was no small undertaking, and we are hopeful that Merck’s new standardized labels will aid in reducing pharmacy selection errors.”
The project included evaluating proposed label content and layout, selecting new packaging design and getting approval from the FDA.
Study finds possible link between ADT, diabetes
BOSTON — Men with prostate cancer are at a higher risk of developing diabetes or diabetes risk factors if they receive a therapy designed to block the production of testosterone, a new study has suggested.
According to research presented at The Endocrine Society’s 93rd Annual Meeting in Boston, androgen deprivation therapy, which blocks the male hormone that can boost the growth of prostate cancer, may increase the chance of diabetes and metabolic syndrome — a cluster of metabolic risk factors that increase the chance of developing diabetes, heart disease and stroke — among men.
In the study, lead author Maria Luisa Cecilia Rivera-Arkoncel, a fellow at the Philippine General Hospital in Manila, Philippines, and colleagues compared 38 men with prostate cancer who received ADT and 36 men with less advanced prostate cancer who did not receive hormonal therapy, all of whom received treatment between 2004 and 2010.
What the researchers found was that the prevalence of diabetes was 42% in the ADT group and 19% in the non-ADT group. What’s more, the group receiving ADT had a higher prevalence of the metabolic syndrome than the non-ADT group did — 37% vs. 28%, respectively.
"An increased risk of diabetes with ADT has not previously been demonstrated in the Filipino population, which already has a high prevalence of diabetes," Rivera-Arkoncel said, who noted that the study suggested but cannot prove that ADT is the cause of diabetes among men that receive this treatment.