Content about Branded

WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

NEW YORK — Innovation took center stage Thursday as Eli Lilly laid out its future growth strategies at a meeting with investors.

At its “Bridging to the Future” meeting, Lilly said it had 70 drugs in its research and development pipeline, including 33 in phases 2 and 3. The company said it expects at least 10 new drugs to enter phase 3 this year, including drugs in such areas as cancer, diabetes and neuroscience, as well as new therapeutic areas, such as autoimmune disorders.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

Valeant said it would buy rights for the eczema drug Elidel (pimecrolimus) and the cold sore drug Xerese (acyclovir and hydrocortisone) for the United States, Canada and Mexico. Valeant said, however, that Xerese has not yet received regulatory approval in Canada.

INDIANAPOLIS — A topical drug made by Eli Lilly restored testosterone to normal levels in men with abnormally low testosterone, according to results of a late-stage clinical trial.

Lilly announced results of a phase-3 trial of Axiron (testosterone) topical solution, a treatment for the condition, also known as hypogonadism. Study results also showed that the drug improved symptoms associated with it.

Hypogonadism results from damage or disease of the testicles, hypothalamus or pituitary glands that inhibits production of testosterone.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

Hi-Tech, which paid $3.6 million in cash for rights to the products and inventory, said some of Atley's drugs already have been approved by the Food and Drug Administration, while others were pending approval. The company didn't say which products it was acquiring the rights to, but noted that Hi-Tech subsidiary ECR Pharmaceuticals will produce and promote the products.

PARIS — An investigational Sanofi drug for diabetes works at least as well as a similar treatment already on the market, and results in less abnormally low blood sugar, according to late-stage clinical trial results presented at the American Diabetes Association’s 71st Scientific Sessions in San Diego this past weekend.

SAN DIEGO — New data from a late-stage clinical trial of a recently approved drug for Type 2 diabetes show improved blood-sugar control in adults who take it with metformin or alone.

Boehringer Ingelheim and Eli Lilly presented data from the study of Tradjenta (linagliptin) at the American Diabetes Association’s 71st Scientific Sessions in San Diego last weekend. The study showed reductions in blood sugar and weight, and a low incidence of abnormally low blood sugar, known as hypoglycemia.

The FDA approved Tradjenta as a treatment for Type 2 diabetes in May.

LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.

SAN DIEGO — An insulin product made by Eli Lilly appears likely to be more cost-effective than long-acting insulin analog, according to a study presented Friday at the American Diabetes Association’s 71st Scientific Sessions in San Diego.

The company conducted a study comparing the cost-effectiveness of LAIA, insulin lispro mix 75/25 and insulin lispro mix 50/50 in patients with Type 2 diabetes. Lilly sells insulin lispro under the brand name Humalog.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.