Week of August 1, 2011: McNeil-PPC Lowers Maximum Daily Dose for Acetaminophen Products Sold in the US; Sanofi Names David-Alexandre Gros as Chief Strategy Officer; and More.

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McNeil-PPC Lowers Maximum Daily Dose for Single-Ingredient Acetaminophen Products Sold in the US; Sanofi Names David-Alexandre Gros as Chief Strategy Officer; and More.

Company Notes

Baxter International has established Baxter Ventures to invest up to $200 million in equity in early-stage companies developing therapies that complement the company’s existing portfolio.

The California Institute of Technology (Caltech) and Zcube Srl, a research venture of the Italian pharmaceutical company Zambon, have signed an exclusive research and option agreement to develop and commercialize skin patches that contain embedded carbon nanotubes for delivering drugs. The patches will first be developed to administer drugs through the skin; other applications are envisioned for future use. Mory Gharib, Hans W. Liepmann Professor of Aeronautics and professor of bioinspired engineering, is the principal investigator at Caltech for the project.

FDA is notifying pharmaceutical companies that bioanalytical studies conducted by the contract research organization Cetero Research between April 2005 and June 2010, in support of marketing applications may need to be repeated or confirmed, according to an FDA notification. FDA is asking drug sponsors to identify those tests conducted by Cetero during the designated timeframe that were used to support new drug applications (NDAs) and abbreviated new drug applications. Drug sponsors will need to determine whether any testing done by Cetero needs to be redone. Also, FDA will send letters to drug sponsors with pending applications, requesting that they either repeat the bioequivalence testing done by Cetero or retest drug samples using a different test laboratory or contractor. FDA is taking this action as a result of two inspections of Cetero’s bioanalytical facility in Houston, Texas, conducted in 2010, as well as the company’s own investigation and third-party audit. The inspections and audit identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples, according to the FDA statement. FDA issued a

detailing the violations.

In a statement, Cetero said that it had initiated its own internal investigation of its Houston bioanalytical laboratory over two years ago and discovered the recording of inaccurate day/time data by a “small number of research chemists in its Houston facility” and contacted FDA to self-report its preliminary findings, seek agency feedback on its investigation plan, and contacted clients to make them aware of the situation. “The Untitled Letter does not accept the results of our rigorous scientific analysis and discredits the company’s 1200 dedicated and experienced employees. The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated,” said the company in its statement.

Eli Lilly India and the generic-drug company Lupin have entered into a collaboration to promote and distribute Lilly’s Huminsulin range of diabetes-treatment products, including Huminsulin R, Huminsulin NPH, Huminsulin 50/50, Huminsulin 30/70, and Humapen Ergo II. Lupin’s India formulations business will promote and distribute the range of products in India and Nepal, doubling the number of sales representatives behind the Huminsulin product line.

Eli Lilly, the biopharmaceutical company Amylin Pharmaceuticals, and Alkermes, a biotechnology company, have submitted their reply to a complete response letter issued in October 2010 by FDA regarding Bydureon (exenatide extended-release for injectable suspension), an investigational medication for Type II diabetes. The companies expect to receive an updated Prescription Drug User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class II resubmission, requiring up to six months for review. The NDA for Bydureon was submitted in May 2009. FDA issued complete response letters to the companies in March 2010 and October 2010.


In other news, Eli Lilly has announced that the US Court of Appeals for the Federal Circuit has overturned a prior ruling by the US District Court for the District of New Jersey and has upheld the validity of the company’s method-of-use patent on Strattera (atomoxetine). In the case of Eli Lilly and Company v. Actavis Elizabeth LLC, et al.,the court ruled in favor of Lilly, upholding the method-of-use patent which provides protection for Strattera through May 2017, according to a Lilly release.

Fujifilm and the pharmaceutical company Dr. Reddy’s Laboratories have signed a memorandum of understanding for an exclusive partnership for a joint venture in Japan to manufacture generic drugs. A definitive agreement is expected to be finalized this year. The new joint venture, which will be 51% owned by Fujifilm and 49% owned by Dr. Reddy’s, will develop, manufacture, and promote generic drugs. The joint venture intends to launch its first products in Japan in the next three to four years.

The consumer healthcare division of McNeil-PPC, a subsidiary of Johnson & Johnson, has announced plans for new dosing instructions that lower the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the US from 8 pills per day (4000 mg) to 6 pills per day (3000 mg). The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.

Novasep, a contract manufacturing organization, completed two successful FDA inspections for Novasep Synthesis in 2011. All five Novasep Synthesis sites passed FDA inspections in the last three years, the most recent ones at its Freeport, the Bahamas, facility in March 2011, and at its Chasse sur Rhône, France, facility in May 2011.

The contract development and manufacturing organization (CDMO) Pharmaceutics International (Pii) has expanded its formulation and manufacturing operations by adding hot-melt extrusion (HME) to its portfolio. The company has purchased 16-mm and 18-mm twin-screw extruders from Leistritz. Pii is planning to use this new expansion to help it carry out feasibility studies, to pilot scale cGMP productions for Phase I and II clinical trials using HME.

Pharmalucence, a CDMO, has selected Bosch Packaging Technology to provide an isolated pharmaceutical filling line for the new Pharmalucence production facility being constructed in Billerica, Massachusetts. Pharmalucence initiated construction of its new facility in early 2011.

The biopharmaceutical company Trius Therapeutics and Bayer Pharma have signed an exclusive agreement to develop and commercialize Trius’ Phase III antibiotic, torezolid phosphate in China, Japan, and all other countries in Asia, Africa, Latin America, and the Middle East, excluding North and South Korea. Under the agreement, Trius retains full development and commercialization rights outside the licensed territory, including the United States, Canada, and the European Union. In exchange for development and commercialization rights in its licensed territory, Bayer will pay Trius $25 million upfront and will support approximately 25% of the future development costs of torezolid required for global approval in acute bacterial skin and skin-structure infections and pneumonia. In addition, Trius is eligible to receive up to $69 million upon the achievement of certain development, regulatory, and commercial milestones and will receive double-digit royalties on net sales of torezolid in the licensed territory.

People Notes

Sanofi has named David-Alexandre Gros, MD, as chief strategy officer, effective Sept. 1, 2011. He will report to Christopher A. Viehbacher, CEO, and will join Sanofi’s group executive committee.