Reporters Notebook

Supplier News

Johnson & Johnson is set to buy the remaining portion of Dutch biotech company Crucell that it doesn’t already own, J&J said.

At press time, the drug maker said the two companies were in “advanced negotiations” for J&J to buy the remainder of Crucell for around $2.3 billion. J&J currently owns slightly less than 18% of the company through an affiliate.

J&J said it would benefit from Crucell’s expertise in vaccines and gain a “strong platform” in the vaccine market. The drug maker said it plans to keep Crucell as the center for vaccines in the conglomerate and maintain its headquarters in Leiden, Netherlands.

Emergent BioSolutions has a new contract with the government to develop a vaccine for anthrax.

The Department of Health and Human Services announced that its Biomedical Advanced Research and Development Authority had given a $51 million contract to the company to develop an anthrax vaccine using the protective antigen, also known as rPA, to stimulate an immune response that neutralizes the bacteria’s toxins. The department said anthrax preparedness was one of BARDA’s top priorities and that the contract would build on its other anthrax developments.

Emergent will spend the first two years developing a final vaccine formulation and testing its stability. HHS also can extend the contract every year for up to three years, which would increase its value to $186.6 million.

The Food and Drug Administration has accepted a regulatory approval application for Sanofi Pasteur’s Fluzone Intradermal, an influenza virus vaccine administered in the skin, the vaccines arm of French drug maker Sanofi-Aventis announced. The company expected the FDA to take action on the vaccine in the first half of next year.

Adult vaccinations usually are injected into the muscle via a needle that is 1 in. to 1.5 in., but intradermal vaccinations allow the vaccine to be injected into the dermal layer of the skin with an extremely thin needle that’s 1.5 mm in length.

“Upon FDA licensure, this new formulation of Sanofi Pasteur’s Fluzone will be the first vaccine available in the United States using a novel micro-injection system for intradermal delivery of vaccine,” Sanofi Pasteur president and CEO Wayne Pisano said.

Oramed Pharmaceuticals has seen promising results from a clinical trial of an oral insulin for diabetes, the Israeli drug maker said.

The company said its exploratory clinical trial of the oral insulin capsule ORMD-0801 was successful. The company is developing the capsule as a treatment for patients with uncontrolled Type 1 diabetes. The company also is developing the oral insulin as a treatment for Type 2 diabetes.

“This study marks an impressive milestone for Oramed,” CEO Nadav Kidron said. “These results suggest a possible novel and unique indication for our oral insulin product in the treatment of Type 1 diabetes, in addition to our main indication for Type 2 diabetes.”

The Food and Drug Administration has approved a new treatment for gout, a painful condition that affects 3 million adults in the United States.

The FDA announced the approval of Savient Pharmaceuticals’ Krystexxa (pegloticase), a biotech drug for people who have not responded to or tolerated conventional therapies.

Gout results from the buildup of uric acid in the body, resulting in needle-like crystals in the joints and soft tissue that can cause swelling, redness, pain, stiffness and heat. It often affects obese people; those with high blood pressure, high cholesterol and diabetes; people with kidney disease; and women after menopause.

Savient said that it would put the company up for sale following the approval of Krystexxa because it “would be the best way to realize the full commercial potential of Krystexxa on a global basis” and would be the best choice for the company.

The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said.

The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.

If the patch is approved, Eisai will have marketing rights in the United States and promote the patch under a partnership with Pfizer.

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