Sandoz got its hands on a collection of generic drug candidates as it agreed to acquire privately owned U.S. drug maker Oriel Therapeutics, the generics arm of Swiss drug maker Novartis said. Financial terms of the deal were not disclosed. Oriel focuses on drugs for such respiratory conditions as asthma and chronic obstructive pulmonary disease, and the deal gives Sandoz access to such development projects as Solis, a dry powder inhaler that uses Oriel’s FreePath drug-delivery technology.
“Oriel is a strong strategic fit with Sandoz, and the acquisition is expected to support our strategy of increasing the number of differentiated, higher-value products in our development pipeline,” Sandoz division head Jeff George said. “One of our strategic objectives is to offer fully substitutable generic versions of key branded medicines, including respiratory medicines.”
The Food and Drug Administration has approved a generic injectable drug for preventing bladder inflammation that can result from a certain chemotherapy treatment. Sagent Pharmacueticals announced that the FDA had approved mesna in the 1-mg/mL strength, used to reduce the incidence of hemorrhagic cystitis caused by ifosfamide chemotherapy, which is used to treat testicular, bone and other cancers. Mesna had sales of around $12 million in 2009, according to IMS Health.
Genentech, part of Swiss drug maker Roche, said it hopes to get Herceptin (trastuzumab) approved as a treatment for stomach cancer. Genentech applied for FDA approval of Herceptin plus chemotherapy as a treatment for adenocarcinoma of the stomach that includes the protein human epidermal factor receptor 2, which Herceptin is supposed to inhibit. Cancers that include HER2 tend to be more aggressive than those that don’t.
The FDA has approved Zortress (everolimus) tablets from Novartis for preventing rejection of transplanted kidneys in adults as part of a therapy that includes low doses of the immunosuppressant drug cyclosporine, corticosteroids and another Novartis organ transplant drug, Simulect (basiliximab), the Swiss drug maker said. Zortress is marketed in many foreign countries under the name Certican.
The FDA has approved Oravig (miconazole) from Strativa Pharmaceuticals for treating thrush, the drug maker said. Oravig is a tablet intended for patients 16 years and older with thrush, also known as oropharyngeal candidiasis. The company said Oravig was the first oral, local prescription formulation of miconazole approved for thrush in the United States. The drug is a buccal tablet, meaning it adheres to the gum to deliver the miconazole directly at the local site of infection.
“Oravig offers patients suffering from thrush a proven, effective treatment in a discreet and convenient once-daily formulation,” Strativa president John MacPhee said.
The FDA has approved a generic antidepressant made by Lupin Pharmaceuticals, the Indian generic drug maker said. The FDA approved Lupin’s imipramine pamoate capsules in the 75-mg, 100-mg, 125-mg and 150-mg strengths.
The capsules are a generic version of Tofranil-PM, made by Covidien, formerly Tyco Healthcare. Brand and generic imipramine pamoate capsules had sales of around $39 million in 2009, according to IMS Health.